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query-laysum
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7073
|
[
{
"role": "user",
"content": "Abstract: Background\nTraumatic wounds (wounds caused by injury) range from abrasions and minor skin incisions or tears, to wounds with extensive tissue damage or loss as well as damage to bone and internal organs. Two key types of traumatic wounds considered in this review are those that damage soft tissue only and those that involve a broken bone, that is, open fractures. In some cases these wounds are left open and negative pressure wound therapy (NPWT) is used as a treatment. This medical device involves the application of a wound dressing through which negative pressure is applied and tissue fluid drawn away from the area. The treatment aims to support wound management, to prepare wounds for further surgery, to reduce the risk of infection and potentially to reduce time to healing (with or without surgical intervention). There are no systematic reviews assessing the effectiveness of NPWT for traumatic wounds.\nObjectives\nTo assess the effects of NPWT for treating open traumatic wounds in people managed in any care setting.\nSearch methods\nIn June 2018 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nPublished and unpublished randomised controlled trials that used NPWT for open traumatic wounds involving either open fractures or soft tissue wounds. Wound healing, wound infection and adverse events were our primary outcomes.\nData collection and analysis\nTwo review authors independently selected eligible studies, extracted data, carried out a 'Risk of bias' assessment and rated the certainty of the evidence. Data were presented and analysed separately for open fracture wounds and other open traumatic wounds (not involving a broken bone).\nMain results\nSeven RCTs (1377 participants recruited) met the inclusion criteria of this review. Study sample sizes ranged from 40 to 586 participants. One study had three arms, which were all included in the review. Six studies compared NPWT at 125 mmHg with standard care: one of these studies did not report any relevant outcome data. One further study compared NPWT at 75 mmHg with standard care and NPWT 125mmHg with NPWT 75 mmHg.\nOpen fracture wounds (four studies all comparing NPWT 125 mmHg with standard care)\nOne study (460 participants) comparing NPWT 125 mmHg with standard care reported the proportions of wounds healed in each arm. At six weeks there was no clear difference between groups in the number of participants with a healed, open fracture wound: risk ratio (RR) 1.01 (95% confidence interval (CI) 0.81 to 1.27); moderate-certainty evidence, downgraded for imprecision.\nWe pooled data on wound infection from four studies (596 participants). Follow-up varied between studies but was approximately 30 days. On average, it is uncertain whether NPWT at 125 mmHg reduces the risk of wound infection compared with standard care (RR 0.48, 95% CI 0.20 to 1.13; I2 = 56%); very low-certainty evidence downgraded for risk of bias, inconsistency and imprecision.\nData from one study shows that there is probably no clear difference in health-related quality of life between participants treated with NPWT 125 mmHg and those treated with standard wound care (EQ-5D utility scores mean difference (MD) -0.01, 95% CI -0.08 to 0.06; 364 participants, moderate-certainty evidence; physical component summary score of the short-form 12 instrument MD -0.50, 95% CI -4.08 to 3.08; 329 participants; low-certainty evidence downgraded for imprecision).\nModerate-certainty evidence from one trial (460 participants) suggests that NPWT is unlikely to be a cost-effective treatment for open fractures in the UK. On average, NPWT was more costly and conferred few additional quality-adjusted life years (QALYs) when compared with standard care. The incremental cost-effectiveness ratio was GBP 267,910 and NPWT was shown to be unlikely to be cost effective at a range of cost-per-QALYs thresholds. We downgraded the certainty of the evidence for imprecision.\nOther open traumatic wounds (two studies, one comparing NPWT 125 mmHg with standard care and a three-arm study comparing NPWT 125 mmHg, NPWT 75 mmHg and standard care)\nPooled data from two studies (509 participants) suggests no clear difference in risk of wound infection between open traumatic wounds treated with NPWT at 125 mmHg or standard care (RR 0.61, 95% CI 0.31 to 1.18); low-certainty evidence downgraded for risk of bias and imprecision.\nOne trial with 463 participants compared NPWT at 75 mmHg with standard care and with NPWT at 125 mmHg. Data on wound infection were reported for each comparison. It is uncertain if there is a difference in risk of wound infection between NPWT 75 mmHg and standard care (RR 0.44, 95% CI 0.17 to 1.10; 463 participants) and uncertain if there is a difference in risk of wound infection between NPWT 75 mmHg and 125 mmHg (RR 1.04, 95% CI 0.31 to 3.51; 251 participants. We downgraded the certainty of the evidence for risk of bias and imprecision.\nAuthors' conclusions\nThere is moderate-certainty evidence for no clear difference between NPWT and standard care on the proportion of wounds healed at six weeks for open fracture wounds. There is moderate-certainty evidence that NPWT is not a cost-effective treatment for open fracture wounds. Moderate-certainty evidence means that the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. It is uncertain whether there is a difference in risk of wound infection, adverse events, time to closure or coverage surgery, pain or health-related quality of life between NPWT and standard care for any type of open traumatic wound.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Traumatic wounds are open cuts, scrapes or puncture wounds, where both the skin and underlying tissues are damaged. These wounds may have jagged edges and contain items such as gravel or glass. Injuries caused by road traffic accidents, stab and gunshot wounds, and animal bites are common types of traumatic wound.\nNPWT is a treatment that is used widely on different types of wounds. In NPWT, a machine that exerts carefully controlled vacuum suction (negative pressure) is attached to a wound dressing that covers the wound. Wound and tissue fluid is sucked away from the treated area into a canister. This is thought to increase blood flow and improve wound healing.\nWe wanted to find out if NPWT could help open traumatic wounds to heal more quickly and effectively. We wanted to know if people treated with NPWT experienced any side effects or other complications, such as wound infections and pain. We were also interested in the impact of NPWT on people's quality of life."
}
] |
query-laysum
|
7075
|
[
{
"role": "user",
"content": "Abstract: Background\nShift work is associated with insufficient sleep, which can compromise worker alertness with ultimate effects on occupational health and safety. Adapting shift work schedules may reduce adverse occupational outcomes.\nObjectives\nTo assess the effects of shift schedule adaptation on sleep quality, sleep duration, and sleepiness among shift workers.\nSearch methods\nWe searched CENTRAL, PubMed, Embase, and eight other databases on 13 December 2020, and again on 20 April 2022, applying no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) and non-RCTs, including controlled before-after (CBA) trials, interrupted time series, and cross-over trials. Eligible trials evaluated any of the following shift schedule components.\n• Permanency of shifts\n• Regularity of shift changes\n• Direction of shift rotation\n• Speed of rotation\n• Shift duration\n• Timing of start of shifts\n• Distribution of shift schedule\n• Time off between shifts\n• Split shifts\n• Protected sleep\n• Worker participation\nWe included studies that assessed sleep quality off-shift, sleep duration off-shift, or sleepiness during shifts.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts of the records recovered by the search, read through the full-text articles of potentially eligible studies, and extracted data. We assessed the risk of bias of included studies using the Cochrane risk of bias tool, with specific additional domains for non-randomised and cluster-randomised studies. For all stages, we resolved any disagreements by consulting a third review author. We presented the results by study design and combined clinically homogeneous studies in meta-analyses using random-effects models. We assessed the certainty of the evidence with GRADE.\nMain results\nWe included 11 studies with a total of 2125 participants. One study was conducted in a laboratory setting and was not considered for drawing conclusions on intervention effects. The included studies investigated different and often multiple changes to shift schedule, and were heterogeneous with respect to outcome measurement.\nForward versus backward rotation\nThree CBA trials (561 participants) investigated the effects of forward rotation versus backward rotation. Only one CBA trial provided sufficient data for the quantitative analysis; it provided very low-certainty evidence that forward rotation compared with backward rotation did not affect sleep quality measured with the Basic Nordic Sleep Questionnaire (BNSQ; mean difference (MD) −0.20 points, 95% confidence interval (CI) −2.28 to 1.89; 62 participants) or sleep duration off-shift (MD −0.21 hours, 95% CI −3.29 to 2.88; 62 participants). However, there was also very low-certainty evidence that forward rotation reduced sleepiness during shifts measured with the BNSQ (MD −1.24 points, 95% CI −2.24 to −0.24; 62 participants).\nFaster versus slower rotation\nTwo CBA trials and one non-randomised cross-over trial (341 participants) evaluated faster versus slower shift rotation. We were able to meta-analyse data from two studies. There was low-certainty evidence of no difference in sleep quality off-shift (standardised mean difference (SMD) −0.01, 95% CI −0.26 to 0.23) and very low-certainty evidence that faster shift rotation reduced sleep duration off-shift (SMD −0.26, 95% CI −0.51 to −0.01; 2 studies, 282 participants). The SMD for sleep duration translated to an MD of 0.38 hours' less sleep per day (95% CI −0.74 to −0.01). One study provided very low-certainty evidence that faster rotations decreased sleepiness during shifts measured with the BNSQ (MD −1.24 points, 95% CI −2.24 to −0.24; 62 participants).\nLimited shift duration (16 hours) versus unlimited shift duration\nTwo RCTs (760 participants) evaluated 80-hour workweeks with maximum daily shift duration of 16 hours versus workweeks without any daily shift duration limits. There was low-certainty evidence that the 16-hour limit increased sleep duration off-shift (SMD 0.50, 95% CI 0.21 to 0.78; which translated to an MD of 0.73 hours' more sleep per day, 95% CI 0.30 to 1.13; 2 RCTs, 760 participants) and moderate-certainty evidence that the 16-hour limit reduced sleepiness during shifts, measured with the Karolinska Sleepiness Scale (SMD −0.29, 95% CI −0.44 to −0.14; which translated to an MD of 0.37 fewer points, 95% CI −0.55 to −0.17; 2 RCTs, 716 participants).\nShorter versus longer shifts\nOne RCT, one CBA trial, and one non-randomised cross-over trial (692 participants) evaluated shorter shift duration (eight to 10 hours) versus longer shift duration (two to three hours longer). There was very low-certainty evidence of no difference in sleep quality (SMD −0.23, 95% CI −0.61 to 0.15; which translated to an MD of 0.13 points lower on a scale of 1 to 5; 2 studies, 111 participants) or sleep duration off-shift (SMD 0.18, 95% CI −0.17 to 0.54; which translated to an MD of 0.26 hours' less sleep per day; 2 studies, 121 participants). The RCT and the non-randomised cross-over study found that shorter shifts reduced sleepiness during shifts, while the CBA study found no effect on sleepiness.\nMore compressed versus more spread out shift schedules\nOne RCT and one CBA trial (346 participants) evaluated more compressed versus more spread out shift schedules. The CBA trial provided very low-certainty evidence of no difference between the groups in sleep quality off-shift (MD 0.31 points, 95% CI −0.53 to 1.15) and sleep duration off-shift (MD 0.52 hours, 95% CI −0.52 to 1.56).\nAuthors' conclusions\nForward and faster rotation may reduce sleepiness during shifts, and may make no difference to sleep quality, but the evidence is very uncertain. Very low-certainty evidence indicated that sleep duration off-shift decreases with faster rotation. Low-certainty evidence indicated that on-duty workweeks with shift duration limited to 16 hours increases sleep duration, with moderate-certainty evidence for minimal reductions in sleepiness. Changes in shift duration and compression of workweeks had no effect on sleep or sleepiness, but the evidence was of very low-certainty. No evidence is available for other shift schedule changes. There is a need for more high-quality studies (preferably RCTs) for all shift schedule interventions to draw conclusions on the effects of shift schedule adaptations on sleep and sleepiness in shift workers.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "• There is limited evidence that changes in shift schedules improve sleep quality, increase sleep duration, or reduce sleepiness.\n• More studies are needed to draw stronger conclusions about shift schedule changes on sleep and sleepiness."
}
] |
query-laysum
|
7076
|
[
{
"role": "user",
"content": "Abstract: Background\nAnthracycline combined with cytarabine has been the standard for induction therapy of newly diagnosed acute myeloid leukaemia (AML) for several decades. Due to theoretical advantages, idarubicin (IDA) might be the most effective and tolerable anthracycline. However, there is no evidence that would definitively prove the superiority of IDA over other anthracyclines.\nObjectives\nTo assess the efficacy and safety of IDA versus other anthracyclines in induction therapy of newly diagnosed AML.\nSearch methods\nWe identified relevant randomised controlled trials (RCTs) by searching the Cochrane Central Register of Controlled Trials (The Cochrane Library 2014, Issue 8), MEDLINE (from 1946 to 3 August 2014), EMBASE (from 1974 to 3 August 2014), Chinese BioMedical Literature Database (1978 to 3 August 2014), relevant conference proceedings and databases of ongoing trials.\nSelection criteria\nRCTs that compared IDA with other anthracyclines in induction therapy of newly diagnosed AML.\nData collection and analysis\nTwo review authors independently extracted data and assessed the quality of studies according to methodological standards of the Cochrane Collaboration. We estimated hazard ratios (HRs) for time-to-event data outcomes using the inverse variance method, and risk ratios (RRs) for dichotomous data outcomes using the Mantel-Haenszel method. We adopted a fixed-effect model and repeated the main meta-analysis by a random-effects model in a sensitivity analysis.\nMain results\nWe identified 2017 references. Ultimately, 27 RCTs (including 22 two-armed RCTs and five three-armed RCTs) involving 9549 patients were eligible. The consolidation treatments adopted in the studies were comparable and had no impact on the results. Overall, the risk of bias of the studies was unclear to high.\nEighteen RCTs (N = 6755) assessed IDA versus daunorubicin (DNR). The main meta-analyses showed that IDA compared with DNR prolonged overall survival (OS) (12 studies, 5976 patients; HR 0.90, 95% confidence interval (CI) 0.84 to 0.96, P = 0.0008; high quality of evidence) and disease-free survival (DFS) (eight studies, 3070 patients; HR 0.88, 95% CI 0.81 to 0.96, P = 0.004; moderate quality of evidence), increased complete remission (CR) rate (18 studies, 6692 patients; RR 1.04, 95% CI 1.01 to 1.07, P = 0.009; moderate quality of evidence), and reduced relapse rate (four studies, 1091 patients; RR 0.88, 95% CI 0.80 to 0.98, P = 0.02; moderate quality of evidence), although increased the risks of death on induction therapy (14 studies, 6349 patients; RR 1.18, 95% CI 1.01 to 1.36, P = 0.03; moderate quality of evidence) and grade 3/4 mucositis (five studies, 2000 patients; RR 1.22, 95% CI 1.04 to 1.44, P = 0.02; moderate quality of evidence). There was no evidence for difference in the risks of grade 3/4 cardiac toxicity (six studies, 2795 patients; RR 0.98, 95% CI 0.70 to 1.37, P = 0.91; moderate quality of evidence) and other grade 3/4 adverse events (AEs). None of the studies reported on quality of life (QoL).\nEight RCTs (N = 2419) evaluated IDA versus mitoxantrone (MIT). The main meta-analyses showed that there was no evidence for difference between arms in OS (six studies, 2171 patients; HR 0.98, 95% CI 0.89 to 1.08, P = 0.69; high quality of evidence), DFS (four studies, 249 patients; HR 0.88, 95% CI 0.70 to 1.10, P = 0.26; low quality of evidence), CR rate (eight studies, 2411 patients; RR 0.97, 95% CI 0.92 to 1.03, P = 0.32;moderate quality of evidence), the risks of death on induction therapy (five studies, 2055 patients; RR 1.10, 95% CI 0.88 to 1.38, P = 0.39; moderate quality of evidence) and relapse (three studies, 328 patients; RR 0.99, 95% CI 0.80 to 1.22, P = 0.89; moderate quality of evidence). There was no evidence for difference in the risks of grade 3/4 cardiac toxicity (one study, 160 patients; RR 0.67, 95% CI 0.11 to 3.88, P = 0.65; low quality of evidence) and other grade 3/4 AEs. None of the studies reported on QoL.\nTwo RCTs (N = 211) compared IDA with doxorubicin (DOX). Neither study assessed OS. One study showed that there was no evidence for difference in DFS (63 patients; HR 0.62, 95% CI 0.34 to 1.14, P = 0.12; low quality of evidence). The main meta-analysis for CR rate showed an improved CR rate with IDA (two studies, 187 patients; RR 1.28, 95% CI 1.03 to 1.59, P = 0.02; low quality of evidence). Neither study provided data for the risks of death on induction therapy and relapse. One trial showed that there was no evidence for difference in the risk of grade 3/4 cardiac toxicity (one study, 100 patients; RR 0.31, 95% CI 0.01 to 7.39, P = 0.47; very low quality of evidence). Neither study reported on QoL.\nTwo RCTs (N = 1037) evaluated IDA versus zorubicin (ZRB). Neither study assessed OS. One trial showed that there was no evidence for difference in DFS (one study, 155 patients; HR 1.25, 95% CI 0.83 to 1.88, P = 0.29; low quality of evidence). The main meta-analyses for CR and death on induction therapy both showed that there was no evidence for difference (CR rate: two studies, 964 patients; RR 1.04, 95% CI 0.96 to 1.13, P = 0.31; low quality of evidence. risk of death on induction therapy: two studies, 964 patients; RR 0.75, 95% CI 0.50 to 1.13, P = 0.17; moderate quality of evidence). Neither study reported the risks of relapse and grade 3/4 cardiotoxicity. One trial showed that IDA reduced the risk of grade 3/4 mucositis. Neither study reported on QoL.\nAuthors' conclusions\nCompared with DNR in induction therapy of newly diagnosed AML, IDA prolongs OS and DFS, increases CR rate and reduces relapse rate, although increases the risks of death on induction therapy and grade 3/4 mucositis. The currently available evidence does not show any difference between IDA and MIT used in induction therapy of newly diagnosed AML. There is insufficient evidence regarding IDA versus DOX and IDA versus ZRB to make final conclusions. Additionally, there is no evidence for difference on the effect of IDA compared with DNR, MIT, DOX or ZRB on QoL.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Acute myeloid leukaemia (AML) is a type of cancer that mainly affects bone marrow and peripheral blood. Although 40% to 45% of AML patients enjoy long-term disease-free survival, most patients will die of the disease. Induction therapy is the first phase of treatment of newly diagnosed AML which is essential for prolonging survival. An anthracycline (a class of chemotherapy drugs derived from the Streptomyces bacterium Streptomyces peucetius var. caesius) combined with cytarabine (a chemotherapy drug used mainly in treatment of haematological malignancies) has remained the standard of induction therapy for several decades. Nowadays there are several kinds of anthracyclines available, among which idarubicin (IDA) draws more attention because of its theoretical advantages in improving efficacy and reducing side effects. However, clinical trials comparing IDA with other anthracyclines have conflicting results."
}
] |
query-laysum
|
7077
|
[
{
"role": "user",
"content": "Abstract: Background\nMigraine is a common neurological problem associated with the highest burden amongst neurological conditions in terms of years lived with disability. Medications can be used as prophylaxis or rescue medicines, but are costly and not always effective. A range of psychological interventions have been developed to manage migraine.\nObjectives\nThe objective was to evaluate the efficacy and adverse events of psychological therapies for the prevention of migraine in adults.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL from their inception until July 2018, and trials registries in the UK, USA, Australia and New Zealand for randomised controlled trials of any psychological intervention for adults with migraine.\nSelection criteria\nWe included randomised controlled trials (RCTs) of a psychological therapy for people with chronic or episodic migraine, with or without aura. Interventions could be compared to another active treatment (psychological or medical), an attention-placebo (e.g. supportive counselling) or other placebo, routine care, or waiting-list control. We excluded studies where fewer than 15 participants completed each arm.\nData collection and analysis\nWe extracted study characteristics and outcome data at post-treatment and the longest available follow-up. We analysed intervention versus control comparisons for the primary outcome of migraine frequency. We measured migraine frequency using days with migraines or number of migraine attacks measured in the four weeks after treatment. In addition, we analysed the following secondary outcomes: responder rate (the proportion of participants with a 50% reduction in migraine frequency between the four weeks prior to and the four weeks after treatment); migraine intensity; migraine duration; migraine medication usage; mood; quality of life; migraine-related disability; and proportion of participants reporting adverse events during the treatment. We included these variables, where available, at follow-up, the timing of which varied between the studies. We used the GRADE approach to judge the quality of the evidence.\nMain results\nWe found 21 RCTs including 2482 participants with migraine, and we extracted meta-analytic data from 14 of these studies. The majority of studies recruited participants through advertisements, included participants with migraine according to the International Classification of Headache Disorders (ICHD) criteria and those with and without aura. Most intervention arms were a form of behavioural or cognitive-behavioural therapy. The majority of comparator arms were no treatment, routine care or waiting list. Interventions varied from one 20-minute session to 14 hours of intervention. No study had unequivocally low risk of bias; all had at least one domain at high risk of bias, and 20 had two to five domains at high risk. Reporting of randomisation procedures and allocation concealment were at high or unclear risk of bias. We downgraded the quality of evidence for outcomes to very low, due to very serious limitations in study quality and imprecision. Reporting in trials was poor; we found no preregistrations stipulating the outcomes, or demonstrating equivalent expectations between groups. Few studies reported our outcomes of interest, most only reported outcomes post treatment; follow-up data were sparse.\nPost-treatment effects\nWe found no evidence of an effect of psychological interventions for migraine frequency in number of migraines or days with migraine (standardised mean difference (SMD) −0.02, 95% confidence interval (CI) −0.17 to 0.13; 4 studies, 681 participants; very low-quality evidence).\nThe responder rate (proportion of participants with migraine frequency reduction of more than 50%) was greater for those who received a psychological intervention compared to control: 101/186 participants (54%) with psychological therapy; 37/152 participants (24%) with control (risk ratio (RR) 2.21, 95% CI 1.63 to 2.98; 4 studies, 338 participants; very low-quality evidence). We found no effect of psychological therapies on migraine intensity (SMD −0.13, 95% CI −0.28 to 0.02; 4 studies, 685 participants). There were no data for migraine duration (hours of migraine per day). There was no effect on migraine medication usage (SMD −0.06, 95% CI −0.35 to 0.24; 2 studies, 483 participants), mood (mean difference (MD) 0.08, 95% CI −0.33 to 0.49; 4 studies, 432 participants), quality of life (SMD −0.02, 95% CI −0.30 to 0.26; 4 studies, 565 participants), or migraine-related disability (SMD −0.67, 95% CI −1.34 to 0.00; 6 studies, 952 participants). The proportion of participants reporting adverse events did not differ between those receiving psychological treatment (9/107; 8%) and control (30/101; 30%) (RR 0.16, 95% CI 0.00 to 7.85; 2 studies, 208 participants). Only two studies reported adverse events and so we were unable to draw any conclusions.\nWe rated evidence from all studies as very low quality.\nFollow-up\nOnly four studies reported any follow-up data. Follow-ups ranged from four months following intervention to 11 months following intervention. There was no evidence of an effect on any outcomes at follow-up (very low-quality evidence).\nAuthors' conclusions\nThis review identified 21 studies of psychological interventions for the management of migraine. We did not find evidence that psychological interventions affected migraine frequency, a result based on four studies of primarily brief treatments. Those who received psychological interventions were twice as likely to be classified as responders in the short term, but this was based on very low-quality evidence and there was no evidence of an effect of psychological intervention compared to control at follow-up. There was no evidence of an effect of psychological interventions on medication usage, mood, migraine-related disability or quality of life. There was no evidence of an effect of psychological interventions on migraine frequency in the short-term or long-term. In terms of adverse events, we were unable to draw conclusions as there was insufficient evidence. High and unclear risk of bias in study design and reporting, small numbers of participants, performance and detection bias meant that we rated all evidence as very low quality. Therefore, we conclude that there is an absence of high-quality evidence to determine whether psychological interventions are effective in managing migraine in adults and we are uncertain whether there is any difference between psychological therapies and controls.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found no evidence that psychological treatments resulted in less migraine frequency in the four weeks following treatment. However, we could only include four studies in this analysis that were not high quality. Four studies reported the proportion of people whose migraines reduced in frequency by 50% or more, and in those studies, people who received psychological treatment were twice as likely to respond to treatment (i.e. 50% reduction in migraine frequency) as those in the control group.\nThere was no evidence that psychological treatments affected migraine intensity, medication use for migraine, mood or quality of life. Only two studies assessed adverse events, and so we were unable to draw conclusions.\nWe found very few follow-up data, and no evidence to support or refute any long-term effects of psychological treatment."
}
] |
query-laysum
|
7078
|
[
{
"role": "user",
"content": "Abstract: Background\nHyperbilirubinaemia occurs in approximately two-thirds of all newborns during the first days of life and is frequently treated with phototherapy. Although generally seen as safe, there is rising concern regarding phototherapy and its potentially damaging effects on DNA and increased side effects particularly for preterm infants. Other methods, such as enteral feeding supplementation with prebiotics, may have an effective use in the management of hyperbilirubinaemia in neonates.\nObjectives\nTo determine whether administration of prebiotics reduces the incidence of hyperbilirubinaemia among term and preterm infants compared with enteral supplementation of milk with distilled water/placebo or no supplementation.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 5), MEDLINE via PubMed (1966 to 14 June 2018), Embase (1980 to 14 June 2018), and CINAHL (1982 to 14 June 2018). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials.\nSelection criteria\nWe considered all RCTs that studied neonates comparing enteral feeding supplementation with prebiotics versus distilled water/placebo or no supplementation.\nData collection and analysis\nTwo reviewers screened papers and extracted data from selected papers. We used a fixed-effect method in combining the effects of studies that were sufficiently similar. We then used the GRADE approach to assess the quality of the evidence.\nMain results\nThree small studies evaluating 154 infants were included in this review. One study reported a significant reduction in the risk of hyperbilirubinaemia and rate of treatment with phototherapy associated with enteral supplementation with prebiotics (risk ratio (RR) 0.75, 95% confidence interval (95% CI) 0.58 to 0.97; one study, 50 infants; low-quality evidence). Meta-analyses of two studies showed no significant difference in maximum plasma unconjugated bilirubin levels in infants with prebiotic supplementation (mean difference (MD) 0.14 mg/dL, 95% CI -0.91 to 1.20, I² = 81%, P = 0.79; two studies, 78 infants; low-quality evidence). There was no evidence of a significant difference in duration of phototherapy between the prebiotic and control groups, which was only reported by one study (MD 0.10 days, 95% CI -2.00 to 2.20; one study, 50 infants; low-quality evidence). The meta-analyses of two studies demonstrated a significant reduction in the length of hospital stay (MD -10.57 days, 95% CI -17.81 to -3.33; 2 studies, 78 infants; I² = 0%, P = 0.004; low-quality evidence). Meta-analysis of the three studies showed a significant increase in stool frequency in the prebiotic groups (MD 1.18, 95% CI 0.90 to 1.46, I² = 90%; 3 studies, 154 infants; high-quality evidence). No significant difference in mortality during hospital stay after enteral supplementation with prebiotics was reported (typical RR 0.94, 95% CI 0.14 to 6.19; I² = 6%, P = 0.95; 2 studies; 78 infants; low-quality evidence). There were no reports of the need for exchange transfusion and incidence of acute bilirubin encephalopathy, chronic bilirubin encephalopathy, and major neurodevelopmental disability in the included studies. None of the included studies reported any side effects.\nAuthors' conclusions\nCurrent studies are unable to provide reliable evidence about the effectiveness of prebiotics on hyperbilirubinaemia. Additional large, well-designed RCTs should be undertaken in neonates that compare effects of enteral supplementation with prebiotics on neonatal hyperbilirubinaemia with supplementation of milk with any other placebo (particularly distilled water) or no supplementation.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is inadequate evidence to assess the effectiveness of prebiotics on neonatal jaundice. According to the available data, the incidence of neonatal hyperbilirubinaemia (low-quality evidence) and treatment with phototherapy (low-quality evidence) were decreased by feeding supplementation with prebiotics, but only one small study reported on these outcomes.\nThe meta-analyses of these small studies demonstrated a significant reduction in the length of hospital stay (low-quality evidence) and a significant increase in stool frequency (high-quality evidence) in infants with prebiotic supplementation versus placebo. Furthermore, meta-analyses showed no significant difference in maximum plasma bilirubin levels (low-quality evidence), duration of phototherapy (low-quality evidence) and neonatal mortality (low-quality evidence) between groups. The review found only three randomised clinical trials that compared prebiotic supplementation with a placebo. More research is needed."
}
] |
query-laysum
|
7079
|
[
{
"role": "user",
"content": "Abstract: Background\nThere is a common perception that smoking generally helps people to manage stress, and may be a form of 'self-medication' in people with mental health conditions. However, there are biologically plausible reasons why smoking may worsen mental health through neuroadaptations arising from chronic smoking, leading to frequent nicotine withdrawal symptoms (e.g. anxiety, depression, irritability), in which case smoking cessation may help to improve rather than worsen mental health.\nObjectives\nTo examine the association between tobacco smoking cessation and change in mental health.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group's Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO, and the trial registries clinicaltrials.gov and the International Clinical Trials Registry Platform, from 14 April 2012 to 07 January 2020. These were updated searches of a previously-conducted non-Cochrane review where searches were conducted from database inception to 13 April 2012.\nSelection criteria\nWe included controlled before-after studies, including randomised controlled trials (RCTs) analysed by smoking status at follow-up, and longitudinal cohort studies. In order to be eligible for inclusion studies had to recruit adults who smoked tobacco, and assess whether they quit or continued smoking during the study. They also had to measure a mental health outcome at baseline and at least six weeks later.\nData collection and analysis\nWe followed standard Cochrane methods for screening and data extraction. Our primary outcomes were change in depression symptoms, anxiety symptoms or mixed anxiety and depression symptoms between baseline and follow-up. Secondary outcomes included change in symptoms of stress, psychological quality of life, positive affect, and social impact or social quality of life, as well as new incidence of depression, anxiety, or mixed anxiety and depression disorders.\nWe assessed the risk of bias for the primary outcomes using a modified ROBINS-I tool. For change in mental health outcomes, we calculated the pooled standardised mean difference (SMD) and 95% confidence interval (95% CI) for the difference in change in mental health from baseline to follow-up between those who had quit smoking and those who had continued to smoke. For the incidence of psychological disorders, we calculated odds ratios (ORs) and 95% CIs. For all meta-analyses we used a generic inverse variance random-effects model and quantified statistical heterogeneity using I2. We conducted subgroup analyses to investigate any differences in associations between sub-populations, i.e. unselected people with mental illness, people with physical chronic diseases.\nWe assessed the certainty of evidence for our primary outcomes (depression, anxiety, and mixed depression and anxiety) and our secondary social impact outcome using the eight GRADE considerations relevant to non-randomised studies (risk of bias, inconsistency, imprecision, indirectness, publication bias, magnitude of the effect, the influence of all plausible residual confounding, the presence of a dose-response gradient).\nMain results\nWe included 102 studies representing over 169,500 participants. Sixty-two of these were identified in the updated search for this review and 40 were included in the original version of the review. Sixty-three studies provided data on change in mental health, 10 were included in meta-analyses of incidence of mental health disorders, and 31 were synthesised narratively.\nFor all primary outcomes, smoking cessation was associated with an improvement in mental health symptoms compared with continuing to smoke: anxiety symptoms (SMD −0.28, 95% CI −0.43 to −0.13; 15 studies, 3141 participants; I2 = 69%; low-certainty evidence); depression symptoms: (SMD −0.30, 95% CI −0.39 to −0.21; 34 studies, 7156 participants; I2 = 69%' very low-certainty evidence); mixed anxiety and depression symptoms (SMD −0.31, 95% CI −0.40 to −0.22; 8 studies, 2829 participants; I2 = 0%; moderate certainty evidence). These findings were robust to preplanned sensitivity analyses, and subgroup analysis generally did not produce evidence of differences in the effect size among subpopulations or based on methodological characteristics. All studies were deemed to be at serious risk of bias due to possible time-varying confounding, and three studies measuring depression symptoms were judged to be at critical risk of bias overall. There was also some evidence of funnel plot asymmetry. For these reasons, we rated our certainty in the estimates for anxiety as low, for depression as very low, and for mixed anxiety and depression as moderate.\nFor the secondary outcomes, smoking cessation was associated with an improvement in symptoms of stress (SMD −0.19, 95% CI −0.34 to −0.04; 4 studies, 1792 participants; I2 = 50%), positive affect (SMD 0.22, 95% CI 0.11 to 0.33; 13 studies, 4880 participants; I2 = 75%), and psychological quality of life (SMD 0.11, 95% CI 0.06 to 0.16; 19 studies, 18,034 participants; I2 = 42%). There was also evidence that smoking cessation was not associated with a reduction in social quality of life, with the confidence interval incorporating the possibility of a small improvement (SMD 0.03, 95% CI 0.00 to 0.06; 9 studies, 14,673 participants; I2 = 0%). The incidence of new mixed anxiety and depression was lower in people who stopped smoking compared with those who continued (OR 0.76, 95% CI 0.66 to 0.86; 3 studies, 8685 participants; I2 = 57%), as was the incidence of anxiety disorder (OR 0.61, 95% CI 0.34 to 1.12; 2 studies, 2293 participants; I2 = 46%). We deemed it inappropriate to present a pooled estimate for the incidence of new cases of clinical depression, as there was high statistical heterogeneity (I2 = 87%).\nAuthors' conclusions\nTaken together, these data provide evidence that mental health does not worsen as a result of quitting smoking, and very low- to moderate-certainty evidence that smoking cessation is associated with small to moderate improvements in mental health. These improvements are seen in both unselected samples and in subpopulations, including people diagnosed with mental health conditions. Additional studies that use more advanced methods to overcome time-varying confounding would strengthen the evidence in this area.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 102 studies in more than 169,500 people: some studies did not clearly report how many people took part. The studies used a range of different assessment scales to measure people's mental health symptoms.\nMost studies included people from the general population (53 studies); 23 studies included people with mental health conditions; other studies included people with physical or mental health conditions, or long-lasting physical conditions, who had recently had surgery, or who were pregnant.\nWe combined and compared the results from 63 studies that measured changes in mental health symptoms, and from 10 studies that measured how many people developed a mental health disorder during the study."
}
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query-laysum
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7080
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[
{
"role": "user",
"content": "Abstract: Background\nPharmacotherapies such as loop diuretics are the cornerstone treatment for acute heart failure (AHF), but resistance and poor response can occur. Ultrafiltration (UF) is an alternative therapy to reduce congestion, however its benefits, efficacy and safety are unclear.\nObjectives\nTo assess the effects of UF compared to diuretic therapy on clinical outcomes such as mortality and rehospitalisation rates.\nSearch methods\nWe undertook a systematic search in June 2021 of the following databases: CENTRAL, MEDLINE, Embase, Web of Science CPCI-S and ClinicalTrials.gov. We also searched the WHO ICTRP platform in October 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared UF to diuretics in adults with AHF.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We contacted study authors for any further information, and language interpreters to translate texts. We assessed risk of bias in included studies using Risk of Bias 2 (RoB2) tool and assessed the certainty of the evidence using GRADE.\nMain results\nWe included 14 trials involving 1190 people. We included people who had clinical signs of acute hypervolaemia. We excluded critically unwell people such as those with ischaemia or haemodynamic instability. Mean age ranged from 57.5 to 75 years, and the setting was a mix of single and multi-centre. Two trials researched UF as a complimentary therapy to diuretics, while the remaining trials withheld diuretic use during UF. There was high risk of bias in some studies, particularly with deviations from the intended protocols from high cross-overs as well as missing outcome data for long-term follow-up.\nWe are uncertain about the effect of UF on all-cause mortality at 30 days or less (risk ratio (RR) 0.61, 95% confidence interval (CI) 0.13 to 2.85; 3 studies, 286 participants; very low-certainty evidence). UF may have little to no effect on all-cause mortality at the longest available follow-up (RR 1.00, 95% CI 0.73 to 1.36; 9 studies, 987 participants; low-certainty evidence).\nUF may reduce all-cause rehospitalisation at 30 days or less (RR 0.76, 95% CI 0.53 to 1.09; 3 studies, 337 participants; low-certainty evidence). UF may slightly reduce all-cause rehospitalisation at longest available follow-up (RR 0.91, 95% CI 0.79 to 1.05; 6 studies, 612 participants; low-certainty evidence).\nUF may reduce heart failure-related rehospitalisation at 30 days or less (RR 0.62, 95% CI 0.37 to 1.04; 2 studies, 395 participants; low-certainty evidence). UF probably reduces heart failure-related rehospitalisation at longest available follow-up, with a number needed to treat for an additional beneficial effect (NNTB) of 10 (RR 0.69, 95% CI 0.53 to 0.90; 4 studies, 636 participants; moderate-certainty evidence).\nNo studies measured need for mechanical ventilation.\nUF may have little or no effect on serum creatinine change at 30 days since discharge (mean difference (MD) 14%, 95% CI −12% to 40%; 1 study, 221 participants; low-certainty evidence). UF may increase the risk of new initiation of renal replacement therapy at longest available follow-up (RR 1.42, 95% CI 0.42 to 4.75; 4 studies, 332 participants; low-certainty evidence).\nThere is an uncertain effect of UF on the risk of complications from central line insertion in hospital (RR 4.16, 95% CI 1.30 to 13.30; 6 studies, 779 participants; very low-certainty evidence).\nAuthors' conclusions\nThis review summarises the latest evidence on UF in AHF. Moderate-certainty evidence shows UF probably reduces heart failure-related rehospitalisation in the long term, with an NNTB of 10. UF may reduce all-cause rehospitalisation at 30 days or less and at longest available follow-up. The effect of UF on all-cause mortality at 30 days or less is unclear, and it may have little effect on all-cause mortality in the long-term.\nWhile UF may have little or no effect on serum creatinine change at 30 days, it may increase the risk of new initiation of renal replacement therapy in the long term. The effect on complications from central line insertion is unclear.\nThere is insufficient evidence to determine the true impact of UF on AHF. Future research should evaluate UF as an adjunct therapy, focusing on outcomes such as heart failure-related rehospitalisation, cardiac mortality and renal outcomes at medium- to long-term follow-up.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are uncertain whether UF has an impact on death rates at a short-term follow-up, as there are not enough data. At the longest time of follow-up, UF may have little effect on death rates.\nUF may reduce readmission to hospital rates within the short and long term. In particular, readmission rates from heart failure are probably reduced by 31% when followed up over a longer time frame (up to one year). The benefit of reducing heart failure-related rehospitalisation is seen in 1 of 10 people treated with UF.\nUF may increase the risk of needing long-term dialysis. It is not clear whether UF affects kidney function at 30 days since hospital discharge, or if the risk of central line complications are greater with UF. No studies researched the effect of UF on needing mechanical breathing support, or its effect on cost and health economics.\nMore robust studies looking at UF in conjunction with current therapy are needed. These should focus on outcomes that are important to patients, such as heart failure-related hospital readmission rates, cardiac death rates and kidney damage at medium to long term."
}
] |
query-laysum
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7081
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[
{
"role": "user",
"content": "Abstract: Background\nCorruption is the abuse or complicity in abuse, of public or private position, power or authority to benefit oneself, a group, an organisation or others close to oneself; where the benefits may be financial, material or non-material. It is wide-spread in the health sector and represents a major problem.\nObjectives\nOur primary objective was to systematically summarise empirical evidence of the effects of strategies to reduce corruption in the health sector. Our secondary objective was to describe the range of strategies that have been tried and to guide future evaluations of promising strategies for which there is insufficient evidence.\nSearch methods\nWe searched 14 electronic databases up to January 2014, including: CENTRAL; MEDLINE; EMBASE; sociological, economic, political and other health databases; Human Resources Abstracts up to November 2010; Euroethics up to August 2015; and PubMed alerts from January 2014 to June 2016. We searched another 23 websites and online databases for grey literature up to August 2015, including the World Bank, the International Monetary Fund, the U4 Anti-Corruption Resource Centre, Transparency International, healthcare anti-fraud association websites and trial registries. We conducted citation searches in Science Citation Index and Google Scholar, and searched PubMed for related articles up to August 2015. We contacted corruption researchers in December 2015, and screened reference lists of articles up to May 2016.\nSelection criteria\nFor the primary analysis, we included randomised trials, non-randomised trials, interrupted time series studies and controlled before-after studies that evaluated the effects of an intervention to reduce corruption in the health sector. For the secondary analysis, we included case studies that clearly described an intervention to reduce corruption in the health sector, addressed either our primary or secondary objective, and stated the methods that the study authors used to collect and analyse data.\nData collection and analysis\nOne review author extracted data from the included studies and a second review author checked the extracted data against the reports of the included studies. We undertook a structured synthesis of the findings. We constructed a results table and 'Summaries of findings' tables. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence.\nMain results\nNo studies met the inclusion criteria of the primary analysis. We included nine studies that met the inclusion criteria for the secondary analysis.\nOne study found that a package of interventions coordinated by the US Department of Health and Human Services and Department of Justice recovered a large amount of money and resulted in hundreds of new cases and convictions each year (high certainty of the evidence). Another study from the USA found that establishment of an independent agency to investigate and enforce efforts against overbilling might lead to a small reduction in overbilling, but the certainty of this evidence was very low. A third study from India suggested that the impacts of coordinated efforts to reduce corruption through increased detection and enforcement are dependent on continued political support and that they can be limited by a dysfunctional judicial system (very low certainty of the evidence).\nOne study in South Korea and two in the USA evaluated increased efforts to investigate and punish corruption in clinics and hospitals without establishing an independent agency to coordinate these efforts. It is unclear whether these were effective because the evidence is of very low certainty.\nOne study from Kyrgyzstan suggested that increased transparency and accountability for co-payments together with reduction of incentives for demanding informal payments may reduce informal payments (low certainty of the evidence).\nOne study from Germany suggested that guidelines that prohibit hospital doctors from accepting any form of benefits from the pharmaceutical industry may improve doctors’ attitudes about the influence of pharmaceutical companies on their choice of medicines (low certainty of the evidence).\nA study in the USA, evaluated the effects of introducing a law that required pharmaceutical companies to report the gifts they gave to healthcare workers. Another study in the USA evaluated the effects of a variety of internal control mechanisms used by community health centres to stop corruption. The effects of these strategies is unclear because the evidence was of very low certainty.\nAuthors' conclusions\nThere is a paucity of evidence regarding how best to reduce corruption. Promising interventions include improvements in the detection and punishment of corruption, especially efforts that are coordinated by an independent agency. Other promising interventions include guidelines that prohibit doctors from accepting benefits from the pharmaceutical industry, internal control practices in community health centres, and increased transparency and accountability for co-payments combined with reduced incentives for informal payments. The extent to which increased transparency alone reduces corruption is uncertain. There is a need to monitor and evaluate the impacts of all interventions to reduce corruption, including their potential adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review suggests that some strategies to fight corruption in the health sector can have an effect on corruption. These strategies include the use of independent agencies to investigate and punish corruption, telling healthcare workers that they are not allowed to accept payments from pharmaceutical companies, ensuring that information about healthcare prices is clear and accessible to the public together with increasing healthcare worker salaries. However, the certainty of this evidence varies. We need more high-quality studies that assess the effects of these and other strategies."
}
] |
query-laysum
|
7082
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[
{
"role": "user",
"content": "Abstract: Background\nCognitive behavioural therapy (CBT) is a psychosocial treatment that aims to help individuals re-evaluate their appraisals of their experiences that can affect their level of distress and problematic behaviour. CBT is now recommended by the National Institute for Health and Care Excellence (NICE) as an add-on treatment for people with a diagnosis of schizophrenia. Other psychosocial therapies that are often less expensive are also available as an add-on treatment for people with schizophrenia. This review is also part of a family of Cochrane Reviews on CBT for people with schizophrenia.\nObjectives\nTo assess the effects of CBT compared with other psychosocial therapies as add-on treatments for people with schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Study Based Register of Trials (latest 6 March, 2017). This register is compiled by systematic searches of major resources (including AMED, BIOSIS CINAHL, Embase, MEDLINE, PsycINFO, PubMed, and registries of clinical trials) and their monthly updates, handsearches, grey literature, and conference proceedings, with no language, date, document type, or publication status limitations for inclusion of records into the register.\nSelection criteria\nWe selected randomised controlled trials (RCTs) involving people with schizophrenia who were randomly allocated to receive, in addition to their standard care, either CBT or any other psychosocial therapy. Outcomes of interest included relapse, global state, mental state, adverse events, social functioning, quality of life and satisfaction with treatment. We included trials meeting our inclusion criteria and reporting useable data.\nData collection and analysis\nWe reliably screened references and selected trials. Review authors, working independently, assessed trials for methodological quality and extracted data from included studies. We analysed dichotomous data on an intention-to-treat basis and continuous data with 60% completion rate. Where possible, for binary data we calculated risk ratio (RR), for continuous data we calculated mean difference (MD), all with 95% confidence intervals (CIs). We used a fixed-effect model for analyses unless there was unexplained high heterogeneity. We assessed risk of bias for the included studies and used the GRADE approach to produce a 'Summary of findings' table for our main outcomes of interest.\nMain results\nThe review now includes 36 trials with 3542 participants, comparing CBT with a range of other psychosocial therapies that we classified as either active (A) (n = 14) or non active (NA) (n = 14). Trials were often small and at high or unclear risk of bias. When CBT was compared with other psychosocial therapies, no difference in long-term relapse was observed (RR 1.05, 95% CI 0.85 to 1.29; participants = 375; studies = 5, low-quality evidence). Clinically important change in global state data were not available but data for rehospitalisation were reported. Results showed no clear difference in long term rehospitalisation (RR 0.96, 95% CI 0.82 to 1.14; participants = 943; studies = 8, low-quality evidence) nor in long term mental state (RR 0.82, 95% CI 0.67 to 1.01; participants = 249; studies = 4, low-quality evidence). No long-term differences were observed for death (RR 1.57, 95% CI 0.62 to 3.98; participants = 627; studies = 6, low-quality evidence). Only average endpoint scale scores were available for social functioning and quality of life. Social functioning scores were similar between groups (long term Social Functioning Scale (SFS): MD 8.80, 95% CI -4.07 to 21.67; participants = 65; studies = 1, very low-quality evidence), and quality of life scores were also similar (medium term Modular System for Quality of Life (MSQOL): MD -4.50, 95% CI -15.66 to 6.66; participants = 64; studies = 1, very low-quality evidence). There was a modest but clear difference favouring CBT for satisfaction with treatment - measured as leaving the study early (RR 0.86, 95% CI 0.75 to 0.99; participants = 2392; studies = 26, low quality evidence).\nAuthors' conclusions\nEvidence based on data from randomised controlled trials indicates there is no clear and convincing advantage for cognitive behavioural therapy over other - and sometimes much less sophisticated and expensive - psychosocial therapies for people with schizophrenia. It should be noted that although much research has been carried out in this area, the quality of evidence available is mainly low or of very low quality. Good quality research is needed before firm conclusions can be made.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Thirty-six randomised controlled trials, randomising in total 3542 people with schizophrenia could be included. The quality of evidence from these trials is very low to low. For important outcomes such as relapse, rehospitalisation, mental state, death, social functioning, quality of life no real differences were found between CBT compared with other psychosocial treatments. The number of participants leaving the study early was used as an indirect measure for satisfaction with treatment. Slightly more people allocated to other psychosocial treatments groups left early compared to CBT groups. Results were not robust enough to make firm conclusions."
}
] |
query-laysum
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7083
|
[
{
"role": "user",
"content": "Abstract: Background\nTrauma is the leading cause of death in people under the age of 45 years. Over the past 20 years, intraoperative autologous transfusions (obtained by cell salvage, also known as intraoperative blood salvage (IBS)) have been used as an alternative to blood products from other individuals during surgery because of the risk of transfusion-related infections such as hepatitis and human immunodeficiency virus (HIV). In this review, we sought to assess the effects and cost of cell salvage in individuals undergoing abdominal or thoracic surgery.\nObjectives\nTo compare the effect and cost of cell salvage with those of standard care in individuals undergoing abdominal or thoracic trauma surgery.\nSearch methods\nWe ran the search on 25 November 2014. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), Ovid MEDLINE, Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily and Ovid OLDMEDLINE, EMBASE Classic + EMBASE (OvidSP), PubMed, and ISI Web of Science (SCI-Expanded & CPSI-SSH). We also screened reference lists and contacted principal investigators.\nSelection criteria\nRandomised controlled trials comparing cell salvage with no cell salvage (standard care) in individuals undergoing abdominal or thoracic trauma surgery.\nData collection and analysis\nTwo authors independently extracted data from the trial reports. We used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nOnly one small study (n = 44) fulfilled the inclusion criteria. Results suggested that cell salvage did not affect mortality overall (death rates were 67% (14/21 participants) in the cell salvage group and 65% (15/23) in the control group) (odds ratio (OR) 1.07, 95% confidence interval (CI) 0.31 to 3.72). For individuals with abdominal injury, mortality was also similar in both groups (OR 0.48, 95% CI 0.11 to 2.10).\nLess donor blood was needed for transfusion within the first 24 hours postinjury in the cell salvage group compared with the control group (mean difference (MD) -4.70 units, 95% CI -8.09 to -1.31). Adverse events, notably postoperative sepsis, did not differ between groups (OR 0.54, 95% CI 0.11 to 2.55). Cost did not notably differ between groups (MD -177.81, 95% CI -452.85 to 97.23, measured in GBP in 2002).\nAuthors' conclusions\nEvidence for the use of cell salvage in individuals undergoing abdominal or thoracic trauma surgery remains equivocal. Large, multicentre, methodologically rigorous trials are needed to assess the relative efficacy, safety and cost-effectiveness of cell salvage in different surgical procedures in the emergency context.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Trauma is the leading cause of death in people under the age of 45 years. Over the past 20 years, transfusions using an individual's own blood, salvaged during surgery through a process called 'cell salvage' (also known as intraoperative blood salvage), have been used as an alternative to blood products donated from other individuals (standard care) during surgical procedures. Many people prefer this because of the risk of transfusion-related infections such as hepatitis and human immunodeficiency virus (HIV) from donor blood. In this review, we aimed to determine how effective cell salvage is, compared with usual care, in individuals undergoing abdominal or thoracic (chest) trauma surgery. We considered outcomes including the survival of the individual, their need for extra blood and the costs of this procedure compared with standard care."
}
] |
query-laysum
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7084
|
[
{
"role": "user",
"content": "Abstract: Background\nThe increased birth rate of twins during recent decades and the improved prognosis of preterm infants have resulted in the need to explore measures that could optimize their growth and neurodevelopmental outcomes. It has been postulated that co-bedding simulates twins' intrauterine experiences in which co-regulatory behaviors between them are observed. These behaviors are proposed to benefit twins by reducing their stress, which may promote growth and development. However, in practice, uncertainty surrounds the benefit-risk profile of co-bedding.\nObjectives\nWe aimed to assess the effectiveness of co-bedding compared with separate (individual) care for stable preterm twins in the neonatal nursery in promoting growth and neurodevelopment and reducing short- and long-term morbidities, and to determine whether co-bedding is associated with significant adverse effects.\nAs secondary objectives, we sought to evaluate effects of co-bedding via the following subgroup analyses: twin pairs with different weight ranges (very low birth weight [VLBW] < 1500 grams vs non-VLBW), twins with versus without significant growth discordance at birth, preterm versus borderline preterm twins, twins co-bedded in incubator versus cot at study entry, and twins randomized by twin pair versus neonatal unit.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group (CNRG). We used keywords and medical subject headings (MeSH) to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2), MEDLINE (via PubMed), EMBASE (hosted by EBSCOHOST), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and references cited in our short-listed articles, up to February 29, 2016.\nSelection criteria\nWe included randomized controlled trials with randomization by twin pair and/or by neonatal unit. We excluded cross-over studies.\nData collection and analysis\nWe extracted data using standard methods of the CNRG. Two review authors independently assessed the relevance and risk of bias of retrieved records. We contacted the authors of included studies to request important information missing from their published papers. We expressed our results using risk ratios (RRs) and mean differences (MDs) when appropriate, along with 95% confidence intervals (95% CIs). We adjusted the unit of analysis from individual infants to twin pairs by averaging measurements for each twin pair (continuous outcomes) or by counting outcomes as positive if developed by either twin (dichotomous outcomes).\nMain results\nSix studies met the inclusion criteria; however, only five studies provided data for analysis. Four of the six included studies were small and had significant limitations in design. As each study reported outcomes differently, data for most outcomes were effectively contributed by a single study. Study authors reported no differences between co-bedded twins and twins receiving separate care in terms of rate of weight gain (MD 0.20 grams/kg/d, 95% CI -1.60 to 2.00; one study; 18 pairs of twins; evidence of low quality); apnea, bradycardia, and desaturation (A/B/D) episodes (RR 0.85, 95% CI 0.18 to 4.05; one study; 62 pairs of twins; evidence of low quality); episodes in co-regulated states (MD 0.96, 95% CI -3.44 to 5.36; one study; three pairs of twins; evidence of very low quality); suspected or proven infection (RR 0.84, 95% CI 0.30 to 2.31; three studies; 65 pairs of twins; evidence of very low quality); length of hospital stay (MD -4.90 days, 95% CI -35.23 to 25.43; one study; three pairs of twins; evidence of very low quality); and parental satisfaction measured on a scale of 0 to 55 (MD -0.38, 95% CI -4.49 to 3.73; one study; nine pairs of twins; evidence of moderate quality). Although co-bedded twins appeared to have lower pain scores 30 seconds after heel lance on a scale of 0 to 21 (MD -0.96, 95% CI -1.68 to -0.23; two studies; 117 pairs of twins; I2 = 75%; evidence of low quality), they had higher pain scores 90 seconds after the procedure (MD 1.00, 95% CI 0.14 to 1.86; one study; 62 pairs of twins). Substantial heterogeneity in the outcome of infant pain response after heel prick at 30 seconds post procedure and conflicting results at 30 and 90 seconds post procedure precluded clear conclusions.\nAuthors' conclusions\nEvidence on the benefits and harms of co-bedding for stable preterm twins was insufficient to permit recommendations for practice. Future studies must be adequately powered to detect clinically important differences in growth and neurodevelopment. Researchers should assess harms such as infection, along with medication errors and caregiver satisfaction.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, researchers reported no differences between the co-bedded group and the group receiving care separately in terms of weight gain, episodes of major disturbances in their breathing, heart rate or oxygenation level (apnea, bradycardia, or desaturation episodes), length of hospital stay, and occurrence of infection. Conflicting results were noted in the two included studies that assessed infants' pain response after heel prick."
}
] |
query-laysum
|
7085
|
[
{
"role": "user",
"content": "Abstract: Background\nShared care has been used in the management of many chronic conditions with the assumption that it delivers better care than primary or specialty care alone; however, little is known about the effectiveness of shared care.\nObjectives\nTo determine the effectiveness of shared care health service interventions designed to improve the management of chronic disease across the primary/specialty care interface. This is an update of a previously published review.\nSecondary questions include the following:\n1. Which shared care interventions or portions of shared care interventions are most effective?\n2. What do the most effective systems have in common?\nSearch methods\nWe searched MEDLINE, Embase and the Cochrane Library to 12 October 2015.\nSelection criteria\nOne review author performed the initial abstract screen; then two review authors independently screened and selected studies for inclusion. We considered randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after studies (CBAs) and interrupted time series analyses (ITS) evaluating the effectiveness of shared care interventions for people with chronic conditions in primary care and community settings. The intervention was compared with usual care in that setting.\nData collection and analysis\nTwo review authors independently extracted data from the included studies, evaluated study quality and judged the certainty of the evidence using the GRADE approach. We conducted a meta-analysis of results when possible and carried out a narrative synthesis of the remainder of the results. We presented the results in a 'Summary of findings' table, using a tabular format to show effect sizes for all outcome types.\nMain results\nWe identified 42 studies of shared care interventions for chronic disease management (N = 18,859), 39 of which were RCTs, two CBAs and one an NRCT. Of these 42 studies, 41 examined complex multi-faceted interventions and lasted from six to 24 months. Overall, our confidence in results regarding the effectiveness of interventions ranged from moderate to high certainty. Results showed probably few or no differences in clinical outcomes overall with a tendency towards improved blood pressure management in the small number of studies on shared care for hypertension, chronic kidney disease and stroke (mean difference (MD) 3.47, 95% confidence interval (CI) 1.68 to 5.25)(based on moderate-certainty evidence). Mental health outcomes improved, particularly in response to depression treatment (risk ratio (RR) 1.40, 95% confidence interval (CI) 1.22 to 1.62; six studies, N = 1708) and recovery from depression (RR 2.59, 95% CI 1.57 to 4.26; 10 studies, N = 4482) in studies examining the 'stepped care' design of shared care interventions (based on high-certainty evidence). Investigators noted modest effects on mean depression scores (standardised mean difference (SMD) -0.29, 95% CI -0.37 to -0.20; six studies, N = 3250). Differences in patient-reported outcome measures (PROMs), processes of care and participation and default rates in shared care services were probably limited (based on moderate-certainty evidence). Studies probably showed little or no difference in hospital admissions, service utilisation and patient health behaviours (with evidence of moderate certainty).\nAuthors' conclusions\nThis review suggests that shared care improves depression outcomes and probably has mixed or limited effects on other outcomes. Methodological shortcomings, particularly inadequate length of follow-up, may account in part for these limited effects. Review findings support the growing evidence base for shared care in the management of depression, particularly stepped care models of shared care. Shared care interventions for other conditions should be developed within research settings, with account taken of the complexity of such interventions and awareness of the need to carry out longer studies to test effectiveness and sustainability over time.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Review authors found 42 relevant studies; 39 were randomised controlled trials. Studies were based in 12 different countries that use a range of healthcare systems. Investigators examined shared care for a range of chronic conditions, with diabetes and depression the most commonly included. Most studies examined shared care interventions that consisted of multiple elements and lasted an average of 12 months.\nStudy results suggest that shared care Interventions lead to improved outcomes for patients with depression. However, effects of shared care on a range of other outcomes are less certain. Shared care probably has limited or no effect on clinical outcomes, apart from modest effects on improving blood pressure management and mixed effects on patient-reported outcome measures (such as quality of life and ability to carry out daily tasks), medication prescribing and use, participation in shared care services and management of risk factors. Shared care probably would have little or no effect on hospital admissions, use of services and patient health behaviours."
}
] |
query-laysum
|
7086
|
[
{
"role": "user",
"content": "Abstract: Background\nTotal mesorectal excision is the standard of care for stage I rectal cancer. Despite major advances and increasing enthusiasm for modern endoscopic local excision (LE), uncertainty remains regarding its oncologic equivalence and safety relative to radical resection (RR).\nObjectives\nTo assess the oncologic, operative, and functional outcomes of modern endoscopic LE compared to RR surgery in adults with stage I rectal cancer.\nSearch methods\nWe searched CENTRAL, Ovid MEDLINE, Ovid Embase, Web of Science - Science Citation Index Expanded (1900 to present), four trial registers (ClinicalTrials.gov, ISRCTN registry, the WHO International Clinical Trials Registry Platform, and the National Cancer Institute Clinical Trials database), two thesis and proceedings databases, and relevant scientific societies' publications in February 2022. We performed handsearching and reference checking and contacted study authors of ongoing trials to identify additional studies.\nSelection criteria\nWe searched for randomized controlled trials (RCTs) in people with stage I rectal cancer comparing any modern LE techniques to any RR techniques with or without the use of neo/adjuvant chemoradiotherapy (CRT).\nData collection and analysis\nWe used standard Cochrane methodological procedures. We calculated hazard ratios (HR) and standard errors for time-to-event data and risk ratios for dichotomous outcomes, using generic inverse variance and random-effects methods. We regrouped surgical complications from the included studies into major and minor according to the standard Clavien-Dindo classification. We assessed the certainty of evidence using the GRADE framework.\nMain results\nFour RCTs were included in data synthesis with a combined total of 266 participants with stage I rectal cancer (T1-2N0M0), if not stated otherwise. Surgery was performed in university hospital settings. The mean age of participants was above 60, and median follow-up ranged from 17.5 months to 9.6 years. Regarding the use of co-interventions, one study used neoadjuvant CRT in all participants (T2 cancers); one study used short-course radiotherapy in the LE group (T1-T2 cancers); one study used adjuvant CRT selectively in high-risk patients undergoing RR (T1-T2 cancers); and the fourth study did not use any CRT (T1 cancers).\nWe assessed the overall risk of bias as high for oncologic and morbidity outcomes across studies. All studies had at least one key domain with a high risk of bias. None of the studies reported separate outcomes for T1 versus T2 or for high-risk features.\nLow-certainty evidence suggests that RR may result in an improvement in disease-free survival compared to LE (3 trials, 212 participants; HR 1.96, 95% confidence interval (CI) 0.91 to 4.24). This would translate into a three-year disease-recurrence risk of 27% (95% CI 14 to 50%) versus 15% after LE and RR, respectively.\nRegarding sphincter function, only one study provided objective results and reported short-term deterioration in stool frequency, flatulence, incontinence, abdominal pain, and embarrassment about bowel function in the RR group. At three years, the LE group had superiority in overall stool frequency, embarrassment about bowel function, and diarrhea.\nLocal excision may have little to no effect on cancer-related survival compared to RR (3 trials, 207 participants; HR 1.42, 95% CI 0.60 to 3.33; very low-certainty evidence). We did not pool studies for local recurrence, but the included studies individually reported comparable local recurrence rates for LE and RR (low-certainty evidence).\nIt is unclear if the risk of major postoperative complications may be lower with LE compared with RR (risk ratio 0.53, 95% CI 0.22 to 1.28; low-certainty evidence; corresponding to 5.8% (95% CI 2.4% to 14.1%) risk for LE versus 11% for RR). Moderate-certainty evidence shows that the risk of minor postoperative complications is probably lower after LE (risk ratio 0.48, 95% CI 0.27 to 0.85); corresponding to an absolute risk of 14% (95% CI 8% to 26%) for LE compared to 30.1% for RR. One study reported an 11% rate of temporary stoma after LE versus 82% in the RR group. Another study reported a 46% rate of temporary or permanent stomas after RR and none after LE.\nThe evidence is uncertain about the effect of LE compared with RR on quality of life. Only one study reported standard quality of life function, in favor of LE, with a 90% or greater probability of superiority in overall quality of life, role, social, and emotional functions, body image, and health anxiety. Other studies reported a significantly shorter postoperative period to oral intake, bowel movement, and off-bed activities in the LE group.\nAuthors' conclusions\nBased on low-certainty evidence, LE may decrease disease-free survival in early rectal cancer. Very low-certainty evidence suggests that LE may have little to no effect on cancer-related survival compared to RR for the treatment of stage I rectal cancer. Based on low-certainty evidence, it is unclear if LE may have a lower major complication rate, but probably causes a large reduction in minor complication rate. Limited data based on one study suggest better sphincter function, quality of life, or genitourinary function after LE. Limitations exist with respect to the applicability of these findings. We identified only four eligible studies with a low number of total participants, subjecting the results to imprecision. Risk of bias had a serious impact on the quality of evidence. More RCTs are needed to answer our review question with greater certainty and to compare local and distant metastasis rates. Data on important patient outcomes such as sphincter function and quality of life are very limited. Results of currently ongoing trials will likely impact the results of this review. Future trials should accurately report and compare outcomes according to the stage and high-risk features of rectal tumors, and evaluate quality of life, sphincter, and genitourinary outcomes. The role of neoadjuvant or adjuvant therapy as an emerging co-intervention for improving oncologic outcomes after LE needs to be further defined.\n\nGiven the provided abstract, please respond to the following query: \"What is early rectal cancer?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Rectal cancer presents at an early stage in one-third of patients and does not invade beyond the muscle layer of bowel wall; this is classified as stage I, or early rectal cancer. People with early rectal cancer may experience bleeding or pain, or only get diagnosed on screening colonoscopy. We undertook this review to compare standard surgery for rectal cancer to a new, smaller surgery that has been increasingly adopted in recent decades."
}
] |
query-laysum
|
7087
|
[
{
"role": "user",
"content": "Abstract: Background\nCorticosteroids are medications with anti-inflammatory and immunosuppressant properties. Systemic corticosteroids administered through the oral, intravenous, or intramuscular routes have been used to treat various types of low back pain, including radicular back pain (not due to spinal stenosis), non-radicular back pain, and spinal stenosis. However, there is uncertainty about the benefits and harms of systemic corticosteroids for low back pain.\nObjectives\nTo evaluate the benefits and harms of systemic corticosteroids versus placebo or no corticosteroid for radicular low back pain, non-radicular low back pain, and symptomatic spinal stenosis in adults.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was September 2021.\nSelection criteria\nWe included randomized and quasi-randomized trials in adults of systematic corticosteroids versus placebo or no corticosteroid.\nData collection and analysis\nWe used standard Cochrane methods. The major outcomes were pain, function, need for surgery, serious adverse effect, and presence of hyperglycemia. The minor outcomes were quality of life, successful outcomes, non-serious adverse events, and withdrawal due to adverse events. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nThirteen trials (1047 participants) met the inclusion criteria. Nine trials included participants with radicular low back pain, two trial with low back pain, and two trials with spinal stenosis. All trials blinded participants to receipt of systemic corticosteroids. Seven trials were at low risk of bias, five at unclear risk, and one at high risk of selection bias. Two trials were at high risk of attrition bias. Doses and duration of systemic corticosteroid therapy varied.\nRadicular low back pain\nFor radicular low back pain, moderate-certainty evidence indicated that systemic corticosteroids probably slightly decrease pain versus placebo at short-term follow-up (mean difference (MD) 0.56 points better, 95% confidence interval (CI) 1.08 to 0.04 on a 0 to 10 scale) and may slightly increase the likelihood of experiencing improvement in pain at short-term follow-up (risk ratio (RR) 1.21, 95% CI 0.88 to 1.66; absolute effect 5% better (95% CI 5% worse to 15% better).\nSystemic corticosteroids may not improve function at short-term follow-up (standardized mean difference (SMD) 0.14 better; range 0.49 better to 0.21 worse) and probably increase the likelihood of improvement in function at short-term follow-up (RR 1.52, 95% CI 1.22 to 1.91; absolute effect 19% better, 95% CI 8% better to 30% better). Systemic corticosteroids were associated with greater improvement in function versus placebo at long-term follow-up (MD −7.40, 95% CI −12.55 to −2.25 on the 0 to 100 Oswestry Disability Index) and greater likelihood of functional improvement (RR 1.29, 95% CI 1.06 to 1.56), based on a single trial. There was no difference in likelihood of surgery (RR 1.00, 95% CI 0.68 to 1.47).\nEvidence indicated that systemic corticosteroids (administered as a single dose or as a short course of therapy) are not associated with increased risk of any adverse event, serious adverse events, withdrawal due to adverse events, or hyperglycemia, but estimates were imprecise as some trials did not report harms, and harms reporting was suboptimal in trials that did provide data. Limitations included variability across trials in interventions (e.g. corticosteroid used, dose and duration of treatment), clinical settings, and participants (e.g. duration of symptoms, methods for diagnosis); limited utility of subgroup analyses due to small numbers of trials; methodologic limitations or suboptimal reporting of methods by some trials; and too few trials to formally assess for publication bias using graphical or statistical tests for small sample effects.\nNon-radicular low back pain\nEvidence on systemic corticosteroids versus placebo for non-radicular pain was limited and suggested that systemic corticosteroids may be associated with slightly worse short-term pain but slightly better function.\nSpinal stenosis\nFor spinal stenosis, limited evidence indicated that systemic corticosteroids are probably no more effective than placebo for short-term pain or function.\nAuthors' conclusions\nSystemic corticosteroids appear to be slightly effective at improving short-term pain and function in people with radicular low back pain not due to spinal stenosis, and might slightly improve long-term function. The effects of systemic corticosteroids in people with non-radicular low back pain are unclear and systemic corticosteroids are probably ineffective for spinal stenosis. A single dose or short course of systemic corticosteroids for low back pain does not appear to cause serious harms, but evidence is limited.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "For radicular low back pain:\n– systemic corticosteroids may have small benefits on pain and function soon after treatment (short-term follow-up), and might improve function for a while after treatment (long-term follow-up);\n– benefits appear small, but systemic corticosteroids may be useful as they have few side effects when used for a short period of time, are widely available, and have low costs; systemic corticosteroids probably do not help avoid surgery;\n– it is unclear whether effectiveness of systemic corticosteroids varies according to the duration of symptoms as optimal dose and duration of treatment for radicular low back pain is unknown; avoiding higher doses may reduce risk of harms.\nFor non-radicular back pain and spinal stenosis:\n– benefits of systemic corticosteroids are unclear."
}
] |
query-laysum
|
7088
|
[
{
"role": "user",
"content": "Abstract: Background\nHodgkin lymphoma (HL) is a B-cell lymphoma accounting for 10% to 15% of all lymphoma in industrialised countries. It has a bimodal age distribution with one peak around the age of 30 years and another after the age of 60 years. Although HL accounts for fewer than 1% of all neoplasms worldwide, it is considered to be one of the most common malignancies in young adults and, with cure rates of 90%, one of the most curable cancers worldwide. Current treatment options for HL comprise more- or less-intensified regimens of chemotherapy plus radiotherapy, depending on disease stage. [18F]-fluorodeoxy-D-glucose (FDG)-positron emission tomography (PET, also called PET scanning) is an imaging tool that can be used to illustrate a tumour's metabolic activity, stage and progression. Therefore, it could be used as a standard interim procedure during HL treatment, to help distinguish between individuals who are good or poor early responders to therapy. Subsequent therapy could then be de-escalated in PET-negative individuals (good responders) or escalated in those who are PET-positive (poor responders). It is currently unknown whether such response-adapted therapeutic strategies are of benefit to individuals in terms of overall and progression-free survival, and the incidence of long-term adverse events (AEs).\nObjectives\nTo assess the effects of interim [18F]-FDG-PET imaging treatment modification in individuals with HL.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; latest issue) and MEDLINE (from 1990 to September 2014) as well as conference proceedings (American Society of Hematology; American Society of Clinical Oncology; European Hematology Association; and International Symposium on Hodgkin Lymphoma) for studies. Two review authors independently screened search results.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing FDG-PET-adapted therapy with non-adapted treatment in individuals with previously untreated HL of all stages and ages.\nData collection and analysis\nTwo review authors independently extracted data and assessed the quality of trials. As none of the included studies provided HRs for OS, we described risk ratios (RRs) for this outcome and did not pool the data. As an effect measure we used hazard ratios (HRs) for progression-free survival (PFS). We described RRs for the dichotomous data on AEs. We also calculated 95% confidence intervals (CIs).\nMain results\nOur search strategies led to 308 potentially relevant references. From these, we included three studies involving 1999 participants. We judged the overall potential risk of bias as moderate. The studies were reported as RCTs; blinding was not reported, but given the study design it is likely that there was no blinding. One study was published in abstract form only; hence, detailed assessment of the risk of bias was not possible.\nTwo trials compared standard treatment (chemotherapy plus radiotherapy) with PET-adapted therapy (chemotherapy only) in individuals with early-stage HL and negative PET scans. The study design of the third trial was more complex. Participants with early-stage HL were divided into those with a favourable or unfavourable prognosis. They were then randomised to receive PET-adapted or standard treatment. Following a PET scan, participants were further divided into PET-positive and PET-negative groups. To date, data have been published for the PET-negative arms only, making it possible to perform a meta-analysis including all three trials.\nOf the 1999 participants included in the three trials only 1480 were analysed. The 519 excluded participants were either PET-positive, or were excluded because they did not match the inclusion criteria.\nOne study reported no deaths. The other two studies reported two deaths in participants receiving PET-adapted therapy and two in participants receiving standard therapy (very-low-quality evidence). Progression-free survival was shorter in participants with PET-adapted therapy (without radiotherapy) than in those receiving standard treatment with radiotherapy (HR 2.38; 95% CI 1.62 to 3.50; P value < 0.0001). This difference was also apparent in comparisons of participants receiving no additional radiotherapy (PET-adapted therapy) versus radiotherapy (standard therapy) (HR 1.86; 95% CI 1.07 to 3.23; P value = 0.03) and in those receiving chemotherapy but no radiotherapy (PET-adapted therapy) versus standard radiotherapy (HR 3.00; 95% CI 1.75 to 5.14; P value < 0.0001) (moderate-quality evidence). Short-term AEs only were assessed in one trial, which showed no evidence of a difference between the treatment arms (RR 0.91; 95% CI 0.54 to 1.53; P value = 0.72) (very-low-quality evidence). No data on long-term AEs were reported in any of the trials.\nAuthors' conclusions\nTo date, no robust data on OS, response rate, TRM, QoL, or short- and long-term AEs are available. However, this systematic review found moderate-quality evidence that PFS was shorter in individuals with early-stage HL and a negative PET scan receiving chemotherapy only (PET-adapted therapy) than in those receiving additional radiotherapy (standard therapy). More RCTs with longer follow ups may lead to more precise results for AEs, TRM and QoL, and could evaluate whether this PFS advantage will translate into an overall survival benefit.\nIt is still uncertain whether PET-positive individuals benefit from PET-based treatment adaptation and the effect of such an approach in those with advanced HL.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To date, no robust data on OS are available. This systematic review shows that individuals with early-stage HL have a shorter PFS after PET-adapted therapy compared with those who receive standard therapy. More RCTs with longer follow ups may lead to more information on adverse events, treatment-related mortality and QoL, and could evaluate whether the PFS advantage seen with standard therapy will translate into a benefit in terms of OS."
}
] |
query-laysum
|
7089
|
[
{
"role": "user",
"content": "Abstract: Background\nMonoclonal antibodies (mAbs) are laboratory-produced molecules derived from the B cells of an infected host. They are being investigated as a potential therapy for coronavirus disease 2019 (COVID-19).\nObjectives\nTo assess the effectiveness and safety of SARS-CoV-2-neutralising mAbs for treating patients with COVID-19, compared to an active comparator, placebo, or no intervention. To maintain the currency of the evidence, we will use a living systematic review approach.\nA secondary objective is to track newly developed SARS-CoV-2-targeting mAbs from first tests in humans onwards.\nSearch methods\nWe searched MEDLINE, Embase, the Cochrane COVID-19 Study Register, and three other databases on 17 June 2021. We also checked references, searched citations, and contacted study authors to identify additional studies. Between submission and publication, we conducted a shortened randomised controlled trial (RCT)-only search on 30 July 2021.\nSelection criteria\nWe included studies that evaluated SARS-CoV-2-neutralising mAbs, alone or combined, compared to an active comparator, placebo, or no intervention, to treat people with COVID-19. We excluded studies on prophylactic use of SARS-CoV-2-neutralising mAbs.\nData collection and analysis\nTwo authors independently assessed search results, extracted data, and assessed risk of bias using the Cochrane risk of bias tool (RoB2). Prioritised outcomes were all-cause mortality by days 30 and 60, clinical progression, quality of life, admission to hospital, adverse events (AEs), and serious adverse events (SAEs). We rated the certainty of evidence using GRADE.\nMain results\nWe identified six RCTs that provided results from 17,495 participants with planned completion dates between July 2021 and December 2031. Target sample sizes varied from 1020 to 10,000 participants. Average age was 42 to 53 years across four studies of non-hospitalised participants, and 61 years in two studies of hospitalised participants.\nNon-hospitalised individuals with COVID-19\nFour studies evaluated single agents bamlanivimab (N = 465), sotrovimab (N = 868), regdanvimab (N = 307), and combinations of bamlanivimab/etesevimab (N = 1035), and casirivimab/imdevimab (N = 799). We did not identify data for mortality at 60 days or quality of life. Our certainty of the evidence is low for all outcomes due to too few events (very serious imprecision).\nBamlanivimab compared to placebo\nNo deaths occurred in the study by day 29. There were nine people admitted to hospital by day 29 out of 156 in the placebo group compared with one out of 101 in the group treated with 0.7 g bamlanivimab (risk ratio (RR) 0.17, 95% confidence interval (CI) 0.02 to 1.33), 2 from 107 in the group treated with 2.8 g (RR 0.32, 95% CI 0.07 to 1.47) and 2 from 101 in the group treated with 7.0 g (RR 0.34, 95% CI 0.08 to 1.56). Treatment with 0.7 g, 2.8 g and 7.0 g bamlanivimab may have similar rates of AEs as placebo (RR 0.99, 95% CI 0.66 to 1.50; RR 0.90, 95% CI 0.59 to 1.38; RR 0.81, 95% CI 0.52 to 1.27). The effect on SAEs is uncertain. Clinical progression/improvement of symptoms or development of severe symptoms were not reported.\nBamlanivimab/etesevimab compared to placebo\nThere were 10 deaths in the placebo group and none in bamlanivimab/etesevimab group by day 30 (RR 0.05, 95% CI 0.00 to 0.81). Bamlanivimab/etesevimab may decrease hospital admission by day 29 (RR 0.30, 95% CI 0.16 to 0.59), may result in a slight increase in any grade AEs (RR 1.15, 95% CI 0.83 to 1.59) and may increase SAEs (RR 1.40, 95% CI 0.45 to 4.37). Clinical progression/improvement of symptoms or development of severe symptoms were not reported.\nCasirivimab/imdevimab compared to placebo\nCasirivimab/imdevimab may reduce hospital admissions or death (2.4 g: RR 0.43, 95% CI 0.08 to 2.19; 8.0 g: RR 0.21, 95% CI 0.02 to 1.79). We are uncertain of the effect on grades 3-4 AEs (2.4 g: RR 0.76, 95% CI 0.17 to 3.37; 8.0 g: RR 0.50, 95% CI 0.09 to 2.73) and SAEs (2.4 g: RR 0.68, 95% CI 0.19 to 2.37; 8.0 g: RR 0.34, 95% CI 0.07 to 1.65). Mortality by day 30 and clinical progression/improvement of symptoms or development of severe symptoms were not reported.\nSotrovimab compared to placebo\nWe are uncertain whether sotrovimab has an effect on mortality (RR 0.33, 95% CI 0.01 to 8.18) and invasive mechanical ventilation (IMV) requirement or death (RR 0.14, 95% CI 0.01 to 2.76). Treatment with sotrovimab may reduce the number of participants with oxygen requirement (RR 0.11, 95 % CI 0.02 to 0.45), hospital admission or death by day 30 (RR 0.14, 95% CI 0.04 to 0.48), grades 3-4 AEs (RR 0.26, 95% CI 0.12 to 0.60), SAEs (RR 0.27, 95% CI 0.12 to 0.63) and may have little or no effect on any grade AEs (RR 0.87, 95% CI 0.66 to 1.16).\nRegdanvimab compared to placebo\nTreatment with either dose (40 or 80 mg/kg) compared with placebo may decrease hospital admissions or death (RR 0.45, 95% CI 0.14 to 1.42; RR 0.56, 95% CI 0.19 to 1.60, 206 participants), but may increase grades 3-4 AEs (RR 2.62, 95% CI 0.52 to 13.12; RR 2.00, 95% CI 0.37 to 10.70). 80 mg/kg may reduce any grade AEs (RR 0.79, 95% CI 0.52 to 1.22) but 40 mg/kg may have little to no effect (RR 0.96, 95% CI 0.64 to 1.43). There were too few events to allow meaningful judgment for the outcomes mortality by 30 days, IMV requirement, and SAEs.\nHospitalised individuals with COVID-19\nTwo studies evaluating bamlanivimab as a single agent (N = 314) and casirivimab/imdevimab as a combination therapy (N = 9785) were included.\nBamlanivimab compared to placebo\nWe are uncertain whether bamlanivimab has an effect on mortality by day 30 (RR 1.39, 95% CI 0.40 to 4.83) and SAEs by day 28 (RR 0.93, 95% CI 0.27 to 3.14). Bamlanivimab may have little to no effect on time to hospital discharge (HR 0.97, 95% CI 0.78 to 1.20) and mortality by day 90 (HR 1.09, 95% CI 0.49 to 2.43). The effect of bamlanivimab on the development of severe symptoms at day 5 (RR 1.17, 95% CI 0.75 to 1.85) is uncertain. Bamlanivimab may increase grades 3-4 AEs at day 28 (RR 1.27, 95% CI 0.81 to 1.98). We assessed the evidence as low certainty for all outcomes due to serious imprecision, and very low certainty for severe symptoms because of additional concerns about indirectness.\nCasirivimab/imdevimab with usual care compared to usual care alone\nTreatment with casirivimab/imdevimab compared to usual care probably has little or no effect on mortality by day 30 (RR 0.94, 95% CI 0.87 to 1.02), IMV requirement or death (RR 0.96, 95% CI 0.90 to 1.04), nor alive at hospital discharge by day 30 (RR 1.01, 95% CI 0.98 to 1.04). We assessed the evidence as moderate certainty due to study limitations (lack of blinding). AEs and SAEs were not reported.\nAuthors' conclusions\nThe evidence for each comparison is based on single studies. None of these measured quality of life. Our certainty in the evidence for all non-hospitalised individuals is low, and for hospitalised individuals is very low to moderate. We consider the current evidence insufficient to draw meaningful conclusions regarding treatment with SARS-CoV-2-neutralising mAbs.\nFurther studies and long-term data from the existing studies are needed to confirm or refute these initial findings, and to understand how the emergence of SARS-CoV-2 variants may impact the effectiveness of SARS-CoV-2-neutralising mAbs. Publication of the 36 ongoing studies may resolve uncertainties about the effectiveness and safety of SARS-CoV-2-neutralising mAbs for the treatment of COVID-19 and possible subgroup differences.\n\nGiven the provided abstract, please respond to the following query: \"What are ‘monoclonal’ antibodies?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Antibodies are made by the body as a defence against disease. However, they can also be produced in a laboratory from cells taken from people who have recovered from a disease.\nAntibodies that are designed to target only one specific protein – in this case, a protein on the virus that causes COVID-19 – are ‘monoclonal’. They attach to the COVID-19 virus and stop it from entering and replicating in human cells, which helps to fight the infection. Monoclonal antibodies have been used successfully to treat other viruses. They are thought to cause fewer unwanted effects than convalescent plasma, which contains a variety of different antibodies."
}
] |
query-laysum
|
7090
|
[
{
"role": "user",
"content": "Abstract: Background\nRheumatoid arthritis (RA) affects a large proportion of the population. Low Level Laser Therapy (LLLT) was introduced as an alternative non-invasive treatment for RA about ten years ago. LLLT is a light source that generates extremely pure light, of a single wavelength. The effect is not thermal, but rather related to photochemical reactions in the cells. The effectiveness of LLLT for rheumatoid arthritis is still controversial. This review is an update of the original review published in October 1998.\nObjectives\nTo assess the effectiveness of LLLT in the treatment of RA.\nSearch methods\nWe initially searched MEDLINE, EMBASE (from 1998), the registries of the Cochrane Musculoskeletal Group and the field of Rehabilitation and Related Therapies as well as the Cochrane Central Register of Controlled Trials (CENTRAL) up to June 2001. This search has now been updated to include articles published up to June 2005.\nSelection criteria\nFollowing an a priori protocol, only randomized controlled trials of LLLT for the treatment of patients with a clinical diagnosis of RA were eligible. Abstracts were excluded unless further data could be obtained from the authors.\nData collection and analysis\nTwo reviewers independently selected trials for inclusion, then extracted data and assessed quality using predetermined forms. Heterogeneity was tested using chi-squared. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results were analyzed as weighted mean differences (WMD) with 95% confidence intervals (CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Dichotomous outcomes were analyzed with relative risks.\nMain results\nA total of 222 patients were included in the five placebo-controlled trials, with 130 randomized to laser therapy. Relative to a separate control group, LLLT reduced pain by 1.10 points (95% CI: 1.82, 0.39) on visual analogue scale relative to placebo, reduced morning stiffness duration by 27.5 minutes (95%CI: 2.9 to 52 minutes) and increased tip to palm flexibility by 1.3 cm (95% CI: 0.8 to 1.7). Other outcomes such as functional assessment, range of motion and local swelling did not differ between groups. There were no significant differences between subgroups based on LLLT dosage, wavelength, site of application or treatment length. For RA, relative to a control group using the opposite hand, there was no difference observed between the control and treatment hand for morning stiffness duration, and also no significant improvement in pain relief RR 13.00 (95% CI: 0.79 to 214.06). However, only one study was included as using the contralateral limb as control. .\nAuthors' conclusions\nLLLT could be considered for short-term treatment for relief of pain and morning stiffness for RA patients, particularly since it has few side-effects. Clinicians and researchers should consistently report the characteristics of the LLLT device and the application techniques used. New trials on LLLT should make use of standardized, validated outcomes. Despite some positive findings, this meta-analysis lacked data on how LLLT effectiveness is affected by four important factors: wavelength, treatment duration of LLLT, dosage and site of application over nerves instead of joints. There is clearly a need to investigate the effects of these factors on LLLT effectiveness for RA in randomized controlled clinical trials.\n\nGiven the provided abstract, please respond to the following query: \"Does low level laser therapy work for treating rheumatoid arthritis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Six studies of medium quality were reviewed and provide the best evidence we have today. Collectively, these studies tested over 220 people with rheumatoid arthritis. The studies compared how well people did while receiving either laser therapy or a 'placebo' (fake) laser therapy. Laser therapy was given mostly on the hands and generally for two to three times a week for four weeks. There were also many different wavelengths and dosages given."
}
] |
query-laysum
|
7091
|
[
{
"role": "user",
"content": "Abstract: Background\nIt is well known that poverty is associated with ill health and that ill health can result in direct and indirect costs that can perpetuate poverty. Social protection, which includes policies and programmes intended to prevent and reduce poverty in times of ill health, could be one way to break this vicious cycle. Social protection, particularly cash transfers, also has the potential to promote healthier behaviours, including healthcare seeking. Although social protection, particularly conditional and unconditional cash transfers, has been widely studied, it is not well known how recipients experience social protection interventions, and what unintended effects such interventions can cause.\nObjectives\nThe aim of this review was to explore how conditional and unconditional cash transfer social protection interventions with a health outcome are experienced and perceived by their recipients.\nSearch methods\nWe searched Epistemonikos, MEDLINE, CINAHL, Social Services Abstracts, Global Index Medicus, Scopus, AnthroSource and EconLit from the start of the database to 5 June 2020. We combined this with reference checking, citation searching, grey literature and contact with authors to identify additional studies. We reran all strategies in July 2022, and the new studies are awaiting classification.\nSelection criteria\nWe included primary studies, using qualitative methods or mixed-methods studies with qualitative research reporting on recipients’ experiences of cash transfer interventions where health outcomes were evaluated. Recipients could be adult patients of healthcare services, the general adult population as recipients of cash targeted at themselves or directed at children. Studies could be evaluated on any mental or physical health condition or cash transfer mechanism. Studies could come from any country and be in any language. Two authors independently selected studies.\nData collection and analysis\nWe used a multistep purposive sampling framework for selecting studies, starting with geographical representation, followed by health condition, and richness of data. Key data were extracted by the authors into Excel. Methodological limitations were assessed independently using the Critical Appraisal Skills Programme (CASP) criteria by two authors. Data were synthesised using meta-ethnography, and confidence in findings was assessed using the Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) approach.\nMain results\nWe included 127 studies in the review and sampled 41 of these studies for our analysis. Thirty-two further studies were found after the updated search on 5 July 2022 and are awaiting classification. The sampled studies were from 24 different countries: 17 studies were from the African region, seven were from the region of the Americas, seven were from the European region, six were from the South-East Asian region, three from the Western Pacific region and one study was multiregional, covering both the African and the Eastern Mediterranean regions. These studies primarily explored the views and experiences of cash transfer recipients with different health conditions, such as infectious diseases, disabilities and long-term illnesses, sexual and reproductive health, and maternal and child health. Our GRADE-CERQual assessment indicated we had mainly moderate- and high-confidence findings. We found that recipients perceived the cash transfers as necessary and helpful for immediate needs and, in some cases, helpful for longer-term benefits. However, across conditional and unconditional programmes, recipients often felt that the amount given was too little in relation to their total needs. They also felt that the cash alone was not enough to change their behaviour and, to change behaviour, additional types of support would be required. The cash transfer was reported to have important effects on empowerment, autonomy and agency, but also in some settings, recipients experienced pressure from family or programme staff on cash usage. The cash transfer was reported to improve social cohesion and reduce intrahousehold tension. However, in settings where some received the cash and others did not, the lack of an equal approach caused tension, suspicion and conflict. Recipients also reported stigma in terms of cash transfer programme assessment processes and eligibility, as well as inappropriate eligibility processes. Across settings, recipients experienced barriers in accessing the cash transfer programme, and some refused or were hesitant to receive the cash. Some recipients found cash transfer programmes more acceptable when they agreed with the programme's goals and processes.\nAuthors' conclusions\nOur findings highlight the impact of the sociocultural context on the functioning and interaction between the individual, family and cash transfer programmes. Even where the goals of a cash transfer programme are explicitly health-related, the outcomes may be far broader than health alone and may include, for example, reduced stigma, empowerment and increased agency of the individual. When measuring programme outcomes, therefore, these broader impacts could be considered for understanding the health and well-being benefits of cash transfers.\n\nGiven the provided abstract, please respond to the following query: \"What are the main findings?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 127 studies in the review and sampled 41 of these studies for our analysis. Thirty-two further studies were found after the updated search on 5 July 2022 and are awaiting classification. The sampled studies were from 24 different countries, across all World Health Organization regions. These studies primarily explored the views and experiences of cash transfer recipients with different health conditions, such as infectious diseases, disabilities and long-term illnesses, sexual and reproductive health, and maternal and child health. We had mainly moderate-to-high confidence in our findings. We found that people receiving the cash transfers saw them as necessary. They described the cash as helpful in the short term, and sometimes in the long term. However, people often felt that the amount given was too little to meet their needs. They also felt that the cash alone was not enough to change their behaviour and that they also needed other types of support, such as social or psychological support or training and opportunities for employment. People described how the cash empowered them and made them more independent, especially women and people with disabilities. In some settings, people experienced pressure from family or programme staff on how to use cash. People described how the cash had improved their relationships with their families and the community. However, in communities where some received the cash and others did not, this could also cause tension, suspicion and conflict. Some people also described being stigmatised for receiving cash transfers. While people often experienced barriers to accessing cash, some refused or were hesitant to receive the cash. Some recipients found cash transfer programmes more acceptable when they agreed with programme goals and processes."
}
] |
query-laysum
|
7092
|
[
{
"role": "user",
"content": "Abstract: Background\nThis overview reports on interventions for pain relief and for subfertility in pre-menopausal women with clinically diagnosed endometriosis.\nObjectives\nThe objective of this overview was to summarise the evidence from Cochrane systematic reviews on treatment options for women with pain or subfertility associated with endometriosis.\nMethods\nPublished Cochrane systematic reviews reporting pain or fertility outcomes in women with clinically diagnosed endometriosis were eligible for inclusion in the overview. We also identified Cochrane reviews in preparation (protocols and titles) for future inclusion. The reviews, protocols and titles were identified by searching the Cochrane Database of Systematic Reviews and Archie (the Cochrane information management system) in March 2014.\nPain-related outcomes of the overview were pain relief, clinical improvement or resolution and pain recurrence. Fertility-related outcomes were live birth, clinical pregnancy, ongoing pregnancy, miscarriage and adverse events.\nSelection of systematic reviews, data extraction and quality assessment were undertaken in duplicate. Review quality was assessed using the AMSTAR tool. The quality of the evidence for each outcome was assessed using GRADE methods. Review findings were summarised in the text and the data for each outcome were reported in 'Additional tables'.\nMain results\nSeventeen systematic reviews published in The Cochrane Library were included. All the reviews were high quality. The quality of the evidence for specific comparisons ranged from very low to moderate. Limitations in the evidence included risk of bias in the primary studies, inconsistency between the studies, and imprecision in effect estimates.\nPain relief (14 reviews)\nGonadotrophin-releasing hormone (GnRH) analogues\nOne systematic review reported low quality evidence of an overall benefit for GnRH analogues compared with placebo or no treatment.\nOvulation suppression\nFive systematic reviews reported on medical treatment using ovulation suppression. There was moderate quality evidence that the levonorgestrel-releasing intrauterine system (LNG-IUD) was more effective than expectant management, and very low quality evidence that danazol was more effective than placebo. There was no consistent evidence of a difference in effectiveness between oral contraceptives and goserelin, estrogen plus progestogen and placebo, or progestogens and placebo, though in all cases the relevant evidence was of low or very low quality.\nNon-steroidal anti-inflammatory drugs (NSAIDS)\nA review of NSAIDs reported inconclusive evidence of a benefit in symptom relief compared with placebo.\nSurgical interventions\nThere were two reviews of surgical interventions. One reported moderate quality evidence of a benefit in pain relief following laparoscopic surgery compared to diagnostic laparoscopy only. The other reported very low quality evidence that recurrence rates of endometriomata were lower after excisional surgery than after ablative surgery.\nPost-surgical medical interventions\nTwo reviews reported on post-surgical medical interventions. Neither found evidence of an effect on pain outcomes, though in both cases the evidence was of low or very low quality.\nAlternative medicine\nThere were two systematic reviews of alternative medicine. One reported evidence of a benefit from auricular acupuncture compared to Chinese herbal medicine, and the other reported no evidence of a difference between Chinese herbal medicine and danazol. In both cases the evidence was of low or very low quality.\nAnti-TNF-α drugs\nOne review found no evidence of a difference in effectiveness between anti-TNF-α drugs and placebo. However, the evidence was of low quality.\nReviews reporting fertility outcomes (8 reviews)\nMedical interventions\nFour reviews reported on medical interventions for improving fertility in women with endometriosis. One compared three months of GnRH agonists with a control in women undergoing assisted reproduction and found very low quality evidence of an increase in clinical pregnancies in the treatment group. There was no evidence of a difference in effectiveness between the interventions in the other three reviews, which compared GnRH agonists versus antagonists, ovulation suppression versus placebo or no treatment, and pre-surgical medical therapy versus surgery alone. In all cases the evidence was of low or very low quality.\nSurgical interventions\nThree reviews reported on surgical interventions. There was moderate quality evidence that both live births or ongoing pregnancy rates and clinical pregnancy rates were higher after laparoscopic surgery than after diagnostic laparoscopy alone. There was low quality evidence of no difference in effectiveness between surgery and expectant management for endometrioma. One review found low quality evidence that excisional surgery resulted in higher clinical pregnancy rates than drainage or ablation of endometriomata.\nPost-surgical interventions\nTwo reviews reported on post-surgical medical interventions. They found no evidence of an effect on clinical pregnancy rates. The evidence was of low or very low quality.\nAlternative medicine\nA review of Chinese herbal medicine in comparison with gestrinone found no evidence of a difference between the groups in clinical pregnancy rates. However, the evidence was of low quality.\nAdverse events\nReviews of GnRH analogues and of danazol reported that the interventions were associated with higher rates of adverse effects than placebo; and depot progestagens were associated with higher rates of adverse events than other treatments. Chinese herbal medicine was associated with fewer side effects than gestrinone or danazol.\nThree reviews reported miscarriage as an outcome. No difference was found between surgical and diagnostic laparoscopy, between GnRH agonists and antagonists, or between aspiration of endometrioma and expectant management. However, in all cases the quality of the evidence was of low quality.\nAuthors' conclusions\nFor women with pain and endometriosis, suppression of menstrual cycles with gonadotrophin-releasing hormone (GnRH) analogues, the levonorgestrel-releasing intrauterine system (LNG-IUD) and danazol were beneficial interventions. Laparoscopic treatment of endometriosis and excision of endometriomata were also associated with improvements in pain. The evidence on NSAIDs was inconclusive. There was no evidence of benefit with post-surgical medical treatment.\nIn women with endometriosis undergoing assisted reproduction, three months of treatment with GnRH agonist improved pregnancy rates. Excisional surgery improved spontaneous pregnancy rates in the nine to 12 months after surgery compared to ablative surgery. Laparoscopic surgery improved live birth and pregnancy rates compared to diagnostic laparoscopy alone. There was no evidence that medical treatment improved clinical pregnancy rates.\nEvidence on harms was scanty, but GnRH analogues, danazol and depot progestagens were associated with higher rates than other interventions.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 17 Cochrane systematic reviews. Fourteen reported measures of pain relief and eight reported fertility outcomes. All the reviews were high quality. The quality of the evidence for specific comparisons and outcomes ranged from very low to moderate, due to limitations in the primary studies, inconsistency between the studies and imprecision in the findings."
}
] |
query-laysum
|
7093
|
[
{
"role": "user",
"content": "Abstract: Background\nExercise training is commonly recommended for individuals with fibromyalgia. This review examined the effects of supervised group aquatic training programs (led by an instructor). We defined aquatic training as exercising in a pool while standing at waist, chest, or shoulder depth. This review is part of the update of the 'Exercise for treating fibromyalgia syndrome' review first published in 2002, and previously updated in 2007.\nObjectives\nThe objective of this systematic review was to evaluate the benefits and harms of aquatic exercise training in adults with fibromyalgia.\nSearch methods\nWe searched The Cochrane Library 2013, Issue 2 (Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, Health Technology Assessment Database, NHS Economic Evaluation Database), MEDLINE, EMBASE, CINAHL, PEDro, Dissertation Abstracts, WHO international Clinical Trials Registry Platform, and AMED, as well as other sources (i.e., reference lists from key journals, identified articles, meta-analyses, and reviews of all types of treatment for fibromyalgia) from inception to October 2013. Using Cochrane methods, we screened citations, abstracts, and full-text articles. Subsequently, we identified aquatic exercise training studies.\nSelection criteria\nSelection criteria were: a) full-text publication of a randomized controlled trial (RCT) in adults diagnosed with fibromyalgia based on published criteria, and b) between-group data for an aquatic intervention and a control or other intervention. We excluded studies if exercise in water was less than 50% of the full intervention.\nData collection and analysis\nWe independently assessed risk of bias and extracted data (24 outcomes), of which we designated seven as major outcomes: multidimensional function, self reported physical function, pain, stiffness, muscle strength, submaximal cardiorespiratory function, withdrawal rates and adverse effects. We resolved discordance through discussion. We evaluated interventions using mean differences (MD) or standardized mean differences (SMD) and 95% confidence intervals (95% CI). Where two or more studies provided data for an outcome, we carried out meta-analysis. In addition, we set and used a 15% threshold for calculation of clinically relevant differences.\nMain results\nWe included 16 aquatic exercise training studies (N = 881; 866 women and 15 men). Nine studies compared aquatic exercise to control, five studies compared aquatic to land-based exercise, and two compared aquatic exercise to a different aquatic exercise program.\nWe rated the risk of bias related to random sequence generation (selection bias), incomplete outcome data (attrition bias), selective reporting (reporting bias), blinding of outcome assessors (detection bias), and other bias as low. We rated blinding of participants and personnel (selection and performance bias) and allocation concealment (selection bias) as low risk and unclear. The assessment of the evidence showed limitations related to imprecision, high statistical heterogeneity, and wide confidence intervals.\nAquatic versus control\nWe found statistically significant improvements (P value < 0.05) in all of the major outcomes. Based on a 100-point scale, multidimensional function improved by six units (MD -5.97, 95% CI -9.06 to -2.88; number needed to treat (NNT) 5, 95% CI 3 to 9), self reported physical function by four units (MD -4.35, 95% CI -7.77 to -0.94; NNT 6, 95% CI 3 to 22), pain by seven units (MD -6.59, 95% CI -10.71 to -2.48; NNT 5, 95% CI 3 to 8), and stiffness by 18 units (MD -18.34, 95% CI -35.75 to -0.93; NNT 3, 95% CI 2 to 24) more in the aquatic than the control groups. The SMD for muscle strength as measured by knee extension and hand grip was 0.63 standard deviations higher compared to the control group (SMD 0.63, 95% CI 0.20 to 1.05; NNT 4, 95% CI 3 to 12) and cardiovascular submaximal function improved by 37 meters on six-minute walk test (95% CI 4.14 to 69.92). Only two major outcomes, stiffness and muscle strength, met the 15% threshold for clinical relevance (improved by 27% and 37% respectively). Withdrawals were similar in the aquatic and control groups and adverse effects were poorly reported, with no serious adverse effects reported.\nAquatic versus land-based\nThere were no statistically significant differences between interventions for multidimensional function, self reported physical function, pain or stiffness: 0.91 units (95% CI -4.01 to 5.83), -5.85 units (95% CI -12.33 to 0.63), -0.75 units (95% CI -10.72 to 9.23), and two units (95% CI -8.88 to 1.28) respectively (all based on a 100-point scale), or in submaximal cardiorespiratory function (three seconds on a 100-meter walk test, 95% CI -1.77 to 7.77). We found a statistically significant difference between interventions for strength, favoring land–based training (2.40 kilo pascals grip strength, 95% CI 4.52 to 0.28). None of the outcomes in the aquatic versus land comparison reached clinically relevant differences of 15%. Withdrawals were similar in the aquatic and land groups and adverse effects were poorly reported, with no serious adverse effects in either group.\nAquatic versus aquatic (Ai Chi versus stretching in the water, exercise in pool water versus exercise in sea water)\nAmong the major outcomes the only statistically significant difference between interventions was for stiffness, favoring Ai Chi (1.00 on a 100-point scale, 95% CI 0.31 to 1.69).\nAuthors' conclusions\nLow to moderate quality evidence relative to control suggests that aquatic training is beneficial for improving wellness, symptoms, and fitness in adults with fibromyalgia. Very low to low quality evidence suggests that there are benefits of aquatic and land-based exercise, except in muscle strength (very low quality evidence favoring land). No serious adverse effects were reported.\n\nGiven the provided abstract, please respond to the following query: \"Pain on a scale of 0 to 100 units\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Those who did aquatic exercise rated their pain seven units better at the end of the study than those who did not exercise."
}
] |
query-laysum
|
7094
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the original Cochrane review first published in Issue 1, 2003, and previously updated in 2009, 2012 and 2014. Chronic pain, defined as pain that recurs or persists for more than three months, is common in childhood. Chronic pain can affect nearly every aspect of daily life and is associated with disability, anxiety, and depressive symptoms.\nObjectives\nThe aim of this review was to update the published evidence on the efficacy of psychological treatments for chronic and recurrent pain in children and adolescents.\nThe primary objective of this updated review was to determine any effect of psychological therapy on the clinical outcomes of pain intensity and disability for chronic and recurrent pain in children and adolescents compared with active treatment, waiting-list, or treatment-as-usual care.\nThe secondary objective was to examine the impact of psychological therapies on children's depressive symptoms and anxiety symptoms, and determine adverse events.\nSearch methods\nSearches were undertaken of CENTRAL, MEDLINE, MEDLINE in Process, Embase, and PsycINFO databases. We searched for further RCTs in the references of all identified studies, meta-analyses, and reviews, and trial registry databases. The most recent search was conducted in May 2018.\nSelection criteria\nRCTs with at least 10 participants in each arm post-treatment comparing psychological therapies with active treatment, treatment-as-usual, or waiting-list control for children or adolescents with recurrent or chronic pain were eligible for inclusion. We excluded trials conducted remotely via the Internet.\nData collection and analysis\nWe analysed included studies and we assessed quality of outcomes. We combined all treatments into one class named 'psychological treatments'. We separated the trials by the number of participants that were included in each arm; trials with > 20 participants per arm versus trials with < 20 participants per arm. We split pain conditions into headache and mixed chronic pain conditions. We assessed the impact of both conditions on four outcomes: pain, disability, depression, and anxiety. We extracted data at two time points; post-treatment (immediately or the earliest data available following end of treatment) and at follow-up (between three and 12 months post-treatment).\nMain results\nWe identified 10 new studies (an additional 869 participants) in the updated search. The review thus included a total of 47 studies, with 2884 children and adolescents completing treatment (mean age 12.65 years, SD 2.21 years). Twenty-three studies addressed treatments for headache (including migraine); 10 for abdominal pain; two studies treated participants with either a primary diagnosis of abdominal pain or irritable bowel syndrome, two studies treated adolescents with fibromyalgia, two studies included adolescents with temporomandibular disorders, three were for the treatment of pain associated with sickle cell disease, and two studies treated adolescents with inflammatory bowel disease. Finally, three studies included adolescents with mixed pain conditions. Overall, we judged the included studies to be at unclear or high risk of bias.\nChildren with headache pain\nWe found that psychological therapies reduced pain frequency post-treatment for children and adolescents with headaches (risk ratio (RR) 2.35, 95% confidence interval (CI) 1.67 to 3.30, P < 0.01, number needed to treat for an additional beneficial outcome (NNTB) = 2.86), but these effects were not maintained at follow-up. We did not find a beneficial effect of psychological therapies on reducing disability in young people post-treatment (SMD -0.26, 95% CI -0.56 to 0.03), but we did find a beneficial effect in a small number of studies at follow-up (SMD -0.34, 95% CI -0.54 to -0.15). We found no beneficial effect of psychological interventions on depression or anxiety symptoms.\nChildren with mixed pain conditions\nWe found that psychological therapies reduced pain intensity post-treatment for children and adolescents with mixed pain conditions (SMD -0.43, 95% CI -0.67 to -0.19, P < 0.01), but these effects were not maintained at follow-up. We did find beneficial effects of psychological therapies on reducing disability for young people with mixed pain conditions post-treatment (SMD -0.34, 95% CI -0.54 to -0.15) and at follow-up (SMD -0.27, 95% CI -0.49 to -0.06). We found no beneficial effect of psychological interventions on depression symptoms. In contrast, we found a beneficial effect on anxiety at post-treatment in children with mixed pain conditions (SMD -0.16, 95% CI -0.29 to -0.03), but this was not maintained at follow-up.\nAcross all pain conditions, we found that adverse events were reported in seven trials, of which two studies reported adverse events that were study-related.\nQuality of evidence\nWe found the quality of evidence for all outcomes to be low or very low, mostly downgraded for unexplained heterogeneity, limitations in study design, imprecise and sparse data, or suspicion of publication bias. This means our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect, or we have very little confidence in the effect estimate; or the true effect is likely to be substantially different from the estimate of effect.\nAuthors' conclusions\nPsychological treatments delivered predominantly face-to-face might be effective for reducing pain outcomes for children and adolescents with headache or other chronic pain conditions post-treatment. However, there were no effects at follow-up. Psychological therapies were also beneficial for reducing disability in children with mixed chronic pain conditions at post-treatment and follow-up, and for children with headache at follow-up. We found no beneficial effect of therapies for improving depression or anxiety. The conclusions of this update replicate and add to those of a previous version of the review which found that psychological therapies were effective in reducing pain frequency/intensity for children with headache and mixed chronic pain conditions post-treatment.\n\nGiven the provided abstract, please respond to the following query: \"Bottom line\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Psychological therapies reduce pain frequency immediately following treatment for children and adolescents with chronic headache and reduce pain intensity for children and adolescents with mixed chronic pain conditions. Psychological therapies also reduce disability for children and adolescents with mixed chronic pain conditions immediately following treatment and up to 12 months later, and for children with headache conditions up to 12 months later."
}
] |
query-laysum
|
7095
|
[
{
"role": "user",
"content": "Abstract: Background\nReal-time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking.\nObjectives\nTo assess the effectiveness of real-time video counselling delivered individually or to a group in increasing smoking cessation, quit attempts, intervention adherence, satisfaction and therapeutic alliance, and to provide an economic evaluation regarding real-time video counselling.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialised Register, CENTRAL, MEDLINE, PubMed, PsycINFO and Embase to identify eligible studies on 13 August 2019. We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to identify ongoing trials registered by 13 August 2019. We checked the reference lists of included articles and contacted smoking cessation researchers for any additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), randomised trials, cluster RCTs or cluster randomised trials of real-time video counselling for current tobacco smokers from any setting that measured smoking cessation at least six months following baseline. The real-time video counselling intervention could be compared with a no intervention control group or another smoking cessation intervention, or both.\nData collection and analysis\nTwo authors independently extracted data from included trials, assessed the risk of bias and rated the certainty of the evidence using the GRADE approach. We performed a random-effects meta-analysis for the primary outcome of smoking cessation, using the most stringent measure of smoking cessation measured at the longest follow-up. Analysis was based on the intention-to-treat principle. We considered participants with missing data at follow-up for the primary outcome of smoking cessation to be smokers.\nMain results\nWe included two randomised trials with 615 participants. Both studies delivered real-time video counselling for smoking cessation individually, compared with telephone counselling. We judged one study at unclear risk of bias and one study at high risk of bias. There was no statistically significant treatment effect for smoking cessation (using the strictest definition and longest follow-up) across the two included studies when real-time video counselling was compared to telephone counselling (risk ratio (RR) 2.15, 95% confidence interval (CI) 0.38 to 12.04; 2 studies, 608 participants; I2 = 66%). We judged the overall certainty of the evidence for smoking cessation as very low due to methodological limitations, imprecision in the effect estimate reflected by the wide 95% CIs and inconsistency of cessation rates. There were no significant differences between real-time video counselling and telephone counselling reported for number of quit attempts among people who continued to smoke (mean difference (MD) 0.50, 95% CI –0.60 to 1.60; 1 study, 499 participants), mean number of counselling sessions completed (MD –0.20, 95% CI –0.45 to 0.05; 1 study, 566 participants), completion of all sessions (RR 1.13, 95% CI 0.71 to 1.79; 1 study, 43 participants) or therapeutic alliance (MD 1.13, 95% CI –0.24 to 2.50; 1 study, 398 participants). Participants in the video counselling arm were more likely than their telephone counselling counterparts to recommend the programme to a friend or family member (RR 1.06, 95% CI 1.01 to 1.11; 1 study, 398 participants); however, there were no between-group differences on satisfaction score (MD 0.70, 95% CI –1.16 to 2.56; 1 study, 29 participants).\nAuthors' conclusions\nThere is very little evidence about the effectiveness of real-time video counselling for smoking cessation. The existing research does not suggest a difference between video counselling and telephone counselling for assisting people to quit smoking. However, given the very low GRADE rating due to methodological limitations in the design, imprecision of the effect estimate and inconsistency of cessation rates, the smoking cessation results should be interpreted cautiously. High-quality randomised trials comparing real-time video counselling to telephone counselling are needed to increase the confidence of the effect estimate. Furthermore, there is currently no evidence comparing real-time video counselling to a control group. Such research is needed to determine whether video counselling increases smoking cessation.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies on 13 August 2019, and found two that met our inclusion criteria. Our main focus was to learn if video counselling delivered individually or to a group could help people quit smoking and to learn how it compared with other types of support to help people quit. We also studied the effect of real-time video counselling on the number of times people tried to quit, the number of sessions they completed, their satisfaction with the counselling, their relationship or bond with the counsellor and the costs of using video communication to help people quit smoking. Both studies took place in the USA, and included people from rural areas or women with HIV. Both studies gave one-to-one video sessions to individuals. There were eight video sessions in one study and four video sessions in the other study. Both studies compared video counselling to telephone counselling and looked at whether people quit smoking, the number of sessions they completed and their satisfaction with the programme. One study examined the number of times people tried to quit and one study looked at the relationship or bond with the counsellor."
}
] |
query-laysum
|
7096
|
[
{
"role": "user",
"content": "Abstract: Background\nTelangiectasias (spider veins) and reticular veins on the lower limbs are very common, increase with age, and have been found in 41% of women. The cause is unknown and the patients may be asymptomatic or can report pain, burning or itching. Treatments include sclerotherapy, laser, intense pulsed light, microphlebectomy and thermoablation, but none is established as preferable.\nObjectives\nTo assess the effects of sclerotherapy, laser therapy, intensive pulsed light, thermocoagulation, and microphlebectomy treatments for telangiectasias and reticular veins.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 16 March 2021. We undertook additional searches in LILACS and IBECS databases, reference checking, and contacted specialists in the field, manufacturers and study authors to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs that compared treatment methods such as sclerotherapy, laser therapy, intensive pulsed light, thermocoagulation, and microphlebectomy for telangiectasias and reticular veins in the lower limb. We included studies that compared individual treatment methods against placebo, or that compared different sclerosing agents, foam or laser treatment, or that used a combination of treatment methods.\nData collection and analysis\nThree review authors independently performed study selection, extracted data, assessed risks of bias and assessed the certainty of evidence using GRADE. The outcomes of interest were resolution or improvement (or both) of telangiectasias, adverse events (including hyperpigmentation, matting), pain, recurrence, time to resolution, and quality of life.\nMain results\nWe included 3632 participants from 35 RCTs. Studies compared a variety of sclerosing agents, laser treatment and compression. No studies investigated intensive pulsed light, thermocoagulation or microphlebectomy. None of the included studies assessed recurrence or time to resolution. Overall the risk of bias of the included studies was moderate. We downgraded the certainty of evidence to moderate or low because of clinical heterogeneity and imprecision due to the wide confidence intervals (CIs) and few participants for each comparison.\nAny sclerosing agent versus placebo\nThere was moderate-certainty evidence that sclerosing agents showed more resolution or improvement of telangiectasias compared to placebo (standard mean difference (SMD) 3.08, 95% CI 2.68 to 3.48; 4 studies, 613 participants/procedures), and more frequent adverse events: hyperpigmentation (risk ratio (RR) 11.88, 95% CI 4.54 to 31.09; 3 studies, 528 participants/procedures); matting (RR 4.06, 95% CI 1.28 to 12.84; 3 studies, 528 participants/procedures). There may be more pain experienced in the sclerosing-agents group compared to placebo (SMD 0.70, 95% CI 0.06 to 1.34; 1 study, 40 participants; low-certainty evidence).\nPolidocanol versus any sclerosing agent\nThere was no clear difference in resolution or improvement (or both) of telangiectasias (SMD 0.01, 95% CI −0.13 to 0.14; 7 studies, 852 participants/procedures), hyperpigmentation (RR 0.94, 95% CI 0.62 to 1.43; 6 studies, 819 participants/procedures), or matting (RR 0.82, 95% CI 0.52 to 1.27; 7 studies, 859 participants/procedures), but there were fewer cases of pain (SMD −0.26, 95% CI −0.44 to −0.08; 5 studies, 480 participants/procedures) in the polidocanol group. All moderate-certainty evidence.\nSodium tetradecyl sulphate (STS) versus any sclerosing agent\nThere was no clear difference in resolution or improvement (or both) of telangiectasias (SMD −0.07, 95% CI −0.25 to 0.11; 4 studies, 473 participants/procedures). There was more hyperpigmentation (RR 1.71, 95% CI 1.10 to 2.64; 4 studies, 478 participants/procedures), matting (RR 2.10, 95% CI 1.14 to 3.85; 2 studies, 323 participants/procedures) and probably more pain (RR 1.49, 95% CI 0.99 to 2.25; 4 studies, 409 participants/procedures). All moderate-certainty evidence.\nFoam versus any sclerosing agent\nThere was no clear difference in resolution or improvement (or both) of telangiectasias (SMD 0.04, 95% CI −0.26 to 0.34; 2 studies, 187 participants/procedures); hyperpigmentation (RR 2.12, 95% CI 0.44 to 10.23; 2 studies, 187 participants/procedures) or pain (SMD −0.10, 95% CI −0.44 to 0.24; 1 study, 147 participants/procedures). There may be more matting using foam (RR 6.12, 95% CI 1.04 to 35.98; 2 studies, 187 participants/procedures). All low-certainty evidence.\nLaser versus any sclerosing agent\nThere was no clear difference in resolution or improvement (or both) of telangiectasias (SMD −0.09, 95% CI −0.25 to 0.07; 5 studies, 593 participants/procedures), or matting (RR 1.00, 95% CI 0.46 to 2.19; 2 studies, 162 participants/procedures), and maybe less hyperpigmentation (RR 0.57, 95% CI 0.40 to 0.80; 4 studies, 262 participants/procedures) in the laser group. All moderate-certainty evidence. High heterogeneity of the studies reporting on pain prevented pooling, and results were inconsistent (low-certainty evidence).\nLaser plus sclerotherapy (polidocanol) versus sclerotherapy (polidocanol)\nLow-certainty evidence suggests there may be more resolution or improvement (or both) of telangiectasias in the combined group (SMD 5.68, 95% CI 5.14 to 6.23; 2 studies, 710 participants), and no clear difference in hyperpigmentation (RR 0.83, 95% CI 0.35 to 1.99; 2 studies, 656 participants) or matting (RR 0.83, 95% CI 0.21 to 3.28; 2 studies, 656 participants). There may be more pain in the combined group (RR 2.44, 95% CI 1.69 to 3.55; 1 study, 596 participants; low-certainty evidence).\nAuthors' conclusions\nSmall numbers of studies and participants in each comparison limited our confidence in the evidence. Sclerosing agents were more effective than placebo for resolution or improvement of telangiectasias but also caused more adverse events (moderate-certainty evidence), and may result in more pain (low-certainty evidence). There was no evidence of a benefit in resolution or improvement for any sclerosant compared to another or to laser. There may be more resolution or improvement of telangiectasias in the combined laser and polidocanol group compared to polidocanol alone (low-certainty evidence). There may be differences between treatments in adverse events and pain. Compared to other sclerosing agents polidocanol probably causes less pain; STS resulted in more hyperpigmentation, matting and probably pain; foam may cause more matting (low-certainty evidence); laser treatment may result in less hyperpigmentation (moderate-certainty evidence). Further well-designed studies are required to provide evidence for other available treatments and important outcomes (such as recurrence, time to resolution and delayed adverse events); and to improve our confidence in the identified comparisons.\n\nGiven the provided abstract, please respond to the following query: \"What are telangiectasias and reticular veins?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Telangiectasias (spider veins) are small dilated blood vessels near the skin surface measuring less than 1.0 mm in diameter. Reticular veins have a diameter of less than 3.0 mm and are deeper in the skin. The cause is unknown, and they can be solely cosmetic, or can result in pain, burning or itching. Telangiectasias and reticular veins on the legs are very common, increase with age, and have been found in 41% of women over the age of 50 years. Risk factors include family history, pregnancy, local trauma, obesity and hormonal factors"
}
] |
query-laysum
|
7097
|
[
{
"role": "user",
"content": "Abstract: Background\nPeople with urothelial carcinoma of the bladder are at risk for recurrence and progression following transurethral resection of a bladder tumour (TURBT). Mitomycin C (MMC) and Bacillus Calmette-Guérin (BCG) are commonly used, competing forms of intravesical therapy for intermediate- or high-risk non-muscle invasive (Ta and T1) urothelial bladder cancer but their relative merits are somewhat uncertain.\nObjectives\nTo assess the effects of BCG intravesical therapy compared to MMC intravesical therapy for treating intermediate- and high-risk Ta and T1 bladder cancer in adults.\nSearch methods\nWe performed a systematic literature search in multiple databases (CENTRAL, MEDLINE, Embase, Web of Science, Scopus, LILACS), as well as in two clinical trial registries. We searched reference lists of relevant publications and abstract proceedings. We applied no language restrictions. The latest search was conducted in September 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared intravesical BCG with intravesical MMC therapy for non-muscle invasive urothelial bladder cancer.\nData collection and analysis\nTwo review authors independently screened the literature, extracted data, assessed risk of bias and rated the quality of evidence according to GRADE per outcome. In the meta-analyses, we used the random-effects model.\nMain results\nWe identified 12 RCTs comparing BCG versus MMC in participants with intermediate- and high-risk non-muscle invasive bladder tumours (published from 1995 to 2013). In total, 2932 participants were randomised.\nTime to death from any cause: BCG may make little or no difference on time to death from any cause compared to MMC (hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.79 to 1.20; participants = 1132, studies = 5; 567 participants in the BCG arm and 565 in the MMC arm; low-certainty evidence). This corresponds to 6 fewer deaths (40 fewer to 36 more) per 1000 participants treated with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations and imprecision.\nSerious adverse effects: 12/577 participants treated with BCG experienced serious non-fatal adverse effects compared to 4/447 participants in the MMC group. The pooled risk ratio (RR) is 2.31 (95% CI 0.82 to 6.52; participants = 1024, studies = 5; low-certainty evidence). Therefore, BCG may increase the risk for serious adverse effects compared to MMC. This corresponds to nine more serious adverse effects (one fewer to 37 more) with BCG. We downgraded the certainty of the evidence two levels due to study limitations and imprecision.\nTime to recurrence: BCG may reduce the time to recurrence compared to MMC (HR 0.88, 95% CI 0.71 to 1.09; participants = 2616, studies = 11, 1273 participants in the BCG arm and 1343 in the MMC arm; low-certainty evidence). This corresponds to 41 fewer recurrences (104 fewer to 29 more) with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations, imprecision and inconsistency.\nTime to progression: BCG may make little or no difference on time to progression compared to MMC (HR 0.96, 95% CI 0.73 to 1.26; participants = 1622, studies = 6; 804 participants in the BCG arm and 818 in the MMC arm; low-certainty evidence). This corresponds to four fewer progressions (29 fewer to 27 more) with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations and imprecision.\nQuality of life: we found very limited data for this outcomes and were unable to estimate an effect size.\nAuthors' conclusions\nBased on our findings, BCG may reduce the risk of recurrence over time although the Confidence Intervals include the possibility of no difference. It may have no effect on either the risk of progression or risk of death from any cause over time. BCG may cause more serious adverse events although the Confidence Intervals once again include the possibility of no difference. We were unable to determine the impact on quality of life. The certainty of the evidence was consistently low, due to concerns that include possible selection bias, performance bias, given the lack of blinding in these studies, and imprecision.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The content of this review is current to September 2019. We included only studies where chance determined what treatment people in the study would get."
}
] |
query-laysum
|
7098
|
[
{
"role": "user",
"content": "Abstract: Background\nAlthough supervised exercise therapy (SET) provides significant symptomatic benefit for patients with intermittent claudication (IC), it remains an underutilized tool. Widespread implementation of SET is restricted by lack of facilities and funding. Structured home-based exercise therapy (HBET) with an observation component (e.g., exercise logbooks, pedometers) and just walking advice (WA) are alternatives to SET. This is the second update of a review first published in 2006.\nObjectives\nThe primary objective was to provide an accurate overview of studies evaluating effects of SET programs, HBET programs, and WA on maximal treadmill walking distance or time (MWD/T) for patients with IC. Secondary objectives were to evaluate effects of SET, HBET, and WA on pain-free treadmill walking distance or time (PFWD/T), quality of life, and self-reported functional impairment.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (December 16, 2016) and the Cochrane Central Register of Controlled Trials (2016, Issue 11). We searched the reference lists of relevant studies identified through searches for other potential trials. We applied no restriction on language of publication.\nSelection criteria\nWe included parallel-group randomized controlled trials comparing SET programs with HBET programs and WA in participants with IC. We excluded studies in which control groups did not receive exercise or walking advice (maintained normal physical activity). We also excluded studies comparing exercise with percutaneous transluminal angioplasty, bypass surgery, or drug therapy.\nData collection and analysis\nThree review authors (DH, HF, and LG) independently selected trials, extracted data, and assessed trials for risk of bias. Two other review authors (MvdH and JT) confirmed the suitability and methodological quality of trials. For all continuous outcomes, we extracted the number of participants, mean outcome, and standard deviation for each treatment group through the follow-up period, if available. We extracted Medical Outcomes Study Short Form 36 outcomes to assess quality of life, and Walking Impairment Questionnaire outcomes to assess self-reported functional impairment. As investigators used different scales to present results of walking distance and time, we standardized reported data to effect sizes to enable calculation of an overall standardized mean difference (SMD). We obtained summary estimates for all outcome measures using a random-effects model. We assessed the quality of evidence using the GRADE approach.\nMain results\nFor this update, we included seven additional studies, making a total of 21 included studies, which involved a total of 1400 participants: 635 received SET, 320 received HBET, and 445 received WA. In general, SET and HBET programs consisted of three exercise sessions per week. Follow-up ranged from six weeks to two years. Most trials used a treadmill walking test to investigate effects of exercise therapy on walking capacity. However, two trials assessed only quality of life, functional impairment, and/or walking behavior (i.e., daily steps measured by pedometer). The overall methodological quality of included trials was moderate to good. However, some trials were small with respect to numbers of participants, ranging from 20 to 304.\nSET groups showed clear improvement in MWD/T compared with HBET and WA groups, with overall SMDs at three months of 0.37 (95% confidence interval [CI] 0.12 to 0.62; P = 0.004; moderate-quality evidence) and 0.80 (95% CI 0.53 to 1.07; P < 0.00001; high-quality evidence), respectively. This translates to differences in increased MWD of approximately 120 and 210 meters in favor of SET groups. Data show improvements for up to six and 12 months, respectively. The HBET group did not show improvement in MWD/T compared with the WA group (SMD 0.30, 95% CI -0.45 to 1.05; P = 0.43; moderate-quality evidence).\nCompared with HBET, SET was more beneficial for PFWD/T but had no effect on quality of life parameters nor on self-reported functional impairment. Compared with WA, SET was more beneficial for PFWD/T and self-reported functional impairment, as well as for some quality of life parameters (e.g., physical functioning, pain, and physical component summary after 12 months), and HBET had no effect.\nData show no obvious effects on mortality rates. Thirteen of the 1400 participants died, but no deaths were related to exercise therapy. Overall, adherence to SET was approximately 80%, which was similar to that reported with HBET. Only limited adherence data were available for WA groups.\nAuthors' conclusions\nEvidence of moderate and high quality shows that SET provides an important benefit for treadmill-measured walking distance (MWD and PFWD) compared with HBET and WA, respectively. Although its clinical relevance has not been definitively demonstrated, this benefit translates to increased MWD of 120 and 210 meters after three months in SET groups. These increased walking distances are likely to have a positive impact on the lives of patients with IC. Data provide no clear evidence of a difference between HBET and WA. Trials show no clear differences in quality of life parameters nor in self-reported functional impairment between SET and HBET. However, evidence is of low and very low quality, respectively. Investigators detected some improvements in quality of life favoring SET over WA, but analyses were limited by small numbers of studies and participants. Future studies should focus on disease-specific quality of life and other functional outcomes, such as walking behavior and physical activity, as well as on long-term follow-up.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics and key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 21 trials in which a total of 1400 participants with intermittent claudication (65% male, mean age 66 years) had been assigned to supervised exercise therapy, home-based exercise therapy, or walking advice (search last run December 2016). The overall methodological quality of included trials was moderate to good. However, some trials had enrolled only small numbers of participants. Trials lasted from six weeks to two years.\nThis review shows that patients participating in a supervised exercise program improve their walking ability to a greater extent than those completing a home-based exercise program or just following walking advice. After three months, the maximal walking distance for participants following the supervised exercise program was 120 or 210 meters farther than the maximal walking distance for those who followed a home-based exercise program or received walking advice, respectively. To put these increases in context, a US football field is roughly 90 meters (or 100 yards) long. Before participating in the exercise program, the maximal walking distance of participants was 290 meters with a pain-free walking distance of 140 meters, so this improvement is likely to have a positive impact on their lives. Results of the home-based exercise program were similar to those reported for walking advice.\nCompared with home-based exercise therapy, supervised exercise therapy was more beneficial for pain-free walking distance but had no effect on quality of life measures nor on self-reported functional impairment. Compared with walking advice, supervised exercise therapy was more beneficial for pain-free walking distance and self-reported functional impairment, as well as for some quality of life measures (e.g., physical functioning, pain, and physical component summary after 12 months), and home-based exercise therapy had no effect.\nData show no obvious effects on mortality rates. Thirteen of the 1400 participants died, but no deaths were related to exercise therapy. Overall, adherence to supervised exercise therapy was approximately 80%, which was similar to that reported with home-based exercise therapy. Only limited adherence data were available for walking advice groups."
}
] |
query-laysum
|
7099
|
[
{
"role": "user",
"content": "Abstract: Background\nThe perimenopausal and postmenopausal periods are associated with many symptoms, including sexual complaints. This review is an update of a review first published in 2013.\nObjectives\nWe aimed to assess the effect of hormone therapy on sexual function in perimenopausal and postmenopausal women.\nSearch methods\nOn 19 December 2022 we searched the Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, ISI Web of Science, two trials registries, and OpenGrey, together with reference checking and contact with experts in the field for any additional studies.\nSelection criteria\nWe included randomized controlled trials that compared hormone therapy to either placebo or no intervention (control) using any validated assessment tool to evaluate sexual function. We considered hormone therapy: estrogen alone; estrogen in combination with progestogens; synthetic steroids, for example, tibolone; selective estrogen receptor modulators (SERMs), for example, raloxifene, bazedoxifene; and SERMs in combination with estrogen.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. We analyzed data using mean differences (MDs) and standardized mean differences (SMDs). The primary outcome was the sexual function score. Secondary outcomes were the domains of sexual response: desire; arousal; lubrication; orgasm; satisfaction; and pain. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 36 studies (23,299 women; 12,225 intervention group; 11,074 control group), of which 35 evaluated postmenopausal women; only one study evaluated perimenopausal women. The 'symptomatic or early postmenopausal women' subgroup included 10 studies, which included women experiencing menopausal symptoms (symptoms such as hot flushes, night sweats, sleep disturbance, vaginal atrophy, and dyspareunia) or early postmenopausal women (within five years after menopause). The 'unselected postmenopausal women’ subgroup included 26 studies, which included women regardless of menopausal symptoms and women whose last menstrual period was more than five years earlier. No study included only women with sexual dysfunction and only seven studies evaluated sexual function as a primary outcome. We deemed 20 studies at high risk of bias, two studies at low risk, and the other 14 studies at unclear risk of bias. Nineteen studies received commercial funding.\nEstrogen alone versus control probably slightly improves the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.50, 95% confidence interval (CI) (0.04 to 0.96; I² = 88%; 3 studies, 699 women; moderate-quality evidence), and probably makes little or no difference to the sexual function composite score in unselected postmenopausal women (SMD 0.64, 95% CI −0.12 to 1.41; I² = 94%; 6 studies, 608 women; moderate-quality evidence). The pooled result suggests that estrogen alone versus placebo or no intervention probably slightly improves sexual function composite score (SMD 0.60, 95% CI 0.16 to 1.04; I² = 92%; 9 studies, 1307 women, moderate-quality evidence).\nWe are uncertain of the effect of estrogen combined with progestogens versus placebo or no intervention on the sexual function composite score in unselected postmenopausal women (MD 0.08 95% CI −1.52 to 1.68; 1 study, 104 women; very low-quality evidence).\nWe are uncertain of the effect of synthetic steroids versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 1.32, 95% CI 1.18 to 1.47; 1 study, 883 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 0.46, 95% CI 0.07 to 0.85; 1 study, 105 women; very low-quality evidence).\nWe are uncertain of the effect of SERMs versus control on the sexual function composite score in symptomatic or early postmenopausal women (MD −1.00, 95% CI −2.00 to -0.00; 1 study, 215 women; very low-quality evidence) and of their effect in unselected postmenopausal women (MD 2.24, 95% 1.37 to 3.11 2 studies, 1525 women, I² = 1%, low-quality evidence).\nWe are uncertain of the effect of SERMs combined with estrogen versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.22, 95% CI 0.00 to 0.43; 1 study, 542 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 2.79, 95% CI 2.41 to 3.18; 1 study, 272 women; very low-quality evidence).\nThe observed heterogeneity in many analyses may be caused by variations in the interventions and doses used, and by different tools used for assessment.\nAuthors' conclusions\nHormone therapy treatment with estrogen alone probably slightly improves the sexual function composite score in women with menopausal symptoms or in early postmenopause (within five years of amenorrhoea), and in unselected postmenopausal women, especially in the lubrication, pain, and satisfaction domains. We are uncertain whether estrogen combined with progestogens improves the sexual function composite score in unselected postmenopausal women. Evidence regarding other hormone therapies (synthetic steroids and SERMs) is of very low quality and we are uncertain of their effect on sexual function. The current evidence does not suggest the beneficial effects of synthetic steroids (for example tibolone) or SERMs alone or combined with estrogen on sexual function. More studies that evaluate the effect of estrogen combined with progestogens, synthetic steroids, SERMs, and SERMs combined with estrogen would improve the quality of the evidence for the effect of these treatments on sexual function in perimenopausal and postmenopausal women.\n\nGiven the provided abstract, please respond to the following query: \"What is menopause and its effects on women?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Menopause is when women's periods stop, usually at around the age of 45 to 55 years. During menopause the ovaries gradually stop producing estrogen, the hormone that regulates periods. The reduction in estrogen can cause unwanted symptoms before periods stop (perimenopausal), during menopause and after menopause (postmenopausal). Symptoms include mood changes, hot flushes, and night sweats. Sexual complaints such as painful intercourse, lack of interest in sex, and problems related to arousal or orgasm are common after menopause and can affect women's self-esteem, self-confidence, and sexual health."
}
] |
query-laysum
|
7100
|
[
{
"role": "user",
"content": "Abstract: Background\nPeritoneal dialysis (PD) relies on the optimal functionality of the flexible plastic PD catheter present within the peritoneal cavity to enable effective treatment. As a result of limited evidence, it is uncertain if the PD catheter's insertion method influences the rate of catheter dysfunction and, thus, the quality of dialysis therapy. Numerous variations of four basic techniques have been adopted in an attempt to improve and maintain PD catheter function. This review evaluates the association between PD catheter insertion technique and associated differences in PD catheter function and post-PD catheter insertion complications\nObjectives\nOur aims were to 1) evaluate if a specific technique used for PD catheter insertion has lower rates of PD catheter dysfunction (early and late) and technique failure; and 2) examine if any of the available techniques results in a reduction in post-procedure complication rates including postoperative haemorrhage, exit-site infection and peritonitis.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 24 November 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nWe included randomised controlled trials (RCTs) examining adults and children undergoing PD catheter insertion. The studies examined any two PD catheter insertion techniques, including laparoscopic, open-surgical, percutaneous and peritoneoscopic insertion. Primary outcomes of interest were PD catheter function and technique survival.\nData collection and analysis\nTwo authors independently performed data extraction and assessed the risk of bias for all included studies. Main outcomes in the Summary of Findings tables include primary outcomes - early PD catheter function, long-term PD catheter function, technique failure and postoperative complications. A random effects model was used to perform meta-analyses; risk ratios (RRs) were calculated for dichotomous outcomes, and mean differences (MD) were calculated for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. The certainty of the evidence was evaluated using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.\nMain results\nSeventeen studies were included in this review. Nine studies were suitable for inclusion in quantitative meta-analysis (670 randomised participants). Five studies compared laparoscopic with open PD catheter insertion, and four studies compared a 'medical' insertion technique with open surgical PD catheter insertion: percutaneous (2) and peritoneoscopic (2).\nRandom sequence generation was judged to be at low risk of bias in eight studies. Allocation concealment was reported poorly, with only five studies judged to be at low risk of selection bias. Performance bias was judged to be high risk in 10 studies. Attrition bias and reporting bias were judged to be low in 14 and 12 studies, respectively.\nSix studies compared laparoscopic PD catheter insertion with open surgical insertion. Five studies could be meta-analysed (394 participants). For our primary outcomes, data were either not reported in a format that could be meta-analysed (early PD catheter function, long-term catheter function) or not reported at all (technique failure). One death was reported in the laparoscopic group and none in the open surgical group. In low certainty evidence, laparoscopic PD catheter insertion may make little or no difference to the risk of peritonitis (4 studies, 288 participants: RR 0.97, 95% CI 0.63 to 1.48; I² = 7%), PD catheter removal (4 studies, 257 participants: RR 1.15, 95% CI 0.80 to 1.64; I² = 0%), and dialysate leakage (4 studies, 330 participants: RR 1.40, 95% CI 0.49 to 4.02; I² = 0%), but may reduce the risk of haemorrhage (2 studies, 167 participants: RR 1.68, 95% CI 0.28 to 10.31; I² = 33%) and catheter tip migration (4 studies, 333 participants: RR 0.43, 95% CI 0.20 to 0.92; I² = 12%).\nFour studies compared a medical insertion technique with open surgical insertion (276 participants). Technique failure was not reported, and no deaths were reported (2 studies, 64 participants). In low certainty evidence, medical insertion may make little or no difference to early PD catheter function (3 studies, 212 participants: RR 0.73, 95% CI 0.29 to 1.83; I² = 0%), while one study reported long-term PD function may improve with peritoneoscopic insertion (116 participants: RR 0.59, 95% CI 0.38 to 0.92). Peritoneoscopic catheter insertion may reduce the episodes of early peritonitis (2 studies, 177 participants: RR 0.21, 95% CI 0.06 to 0.71; I² = 0%) and dialysate leakage (2 studies, 177 participants: RR 0.13, 95% CI 0.02 to 0.71; I² = 0%). Medical insertion had uncertain effects on catheter tip migration (2 studies, 90 participants: RR 0.74, 95% CI 0.15 to 3.73; I² = 0%).\nMost of the studies examined were small and of poor quality, increasing the risk of imprecision. There was also a significant risk of bias therefore cautious interpretation of results is advised.\nAuthors' conclusions\nThe available studies show that the evidence needed to guide clinicians in developing their PD catheter insertion service is lacking. No PD catheter insertion technique had lower rates of PD catheter dysfunction. High-quality, evidence-based data are urgently required, utilising multi-centre RCTs or large cohort studies, in order to provide definitive guidance relating to PD catheter insertion modality.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the Cochrane Kidney and Transplant Specialised Register up to November 2022. Only 17 of the identified studies could be used in this review. A total of 658 participants were included in the analyses from 9 of the included studies. The other eight studies were only suitable for a descriptive review."
}
] |
query-laysum
|
7101
|
[
{
"role": "user",
"content": "Abstract: Background\nLow-molecular-weight heparins (LMWHs) and heparinoids are anticoagulants that may have more powerful antithrombotic effects than standard unfractionated heparin (UFH) but a lower risk of bleeding complications. This is an update of the original Cochrane Review of these agents, first published in 2001 and last updated in 2008.\nObjectives\nTo determine whether antithrombotic therapy with LMWHs or heparinoids is associated with a reduction in the proportion of people who are dead or dependent for activities in daily living compared with UFH.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched February 2017), the Cochrane Central Register of Controlled Trials (CENTRAL: the Cochrane Library Issue 1, 2017), MEDLINE (1966 to February 2017), and Embase (1980 to February 2017). We also searched trials registers to February 2017: ClinicalTrials.gov, EU Clinical Trials Register, Stroke Trials Registry, ISRCTN Registry and the World Health Organization (WHO) International Clinical Trials Registry Platform.\nSelection criteria\nUnconfounded randomised trials comparing LMWH or heparinoids with standard UFH in people with acute ischaemic stroke, in which participants were recruited within 14 days of stroke onset.\nData collection and analysis\nTwo review authors independently chose studies for inclusion, assessed risk of bias and trial quality, extracted and analysed the data. Differences were resolved by discussion.\nMain results\nWe included nine trials involving 3137 participants. We did not identify any new trials for inclusion in this updated review. None of the studies reported data on the primary outcome in sufficient detail to enable analysis for the review. Overall, there was a moderate risk of bias in the included studies. Compared with UFH, there was no evidence of an effect of LMWH or heparinoids on death from all causes during the treatment period (96/1616 allocated LMWH/heparinoid versus 78/1486 allocated UFH; odds ratio (OR) 1.06, 95% CI 0.78 to 1.47; 8 trials, 3102 participants, low quality evidence). LMWH or heparinoid were associated with a significant reduction in deep vein thrombosis (DVT) compared with UFH (OR 0.55, 95% CI 0.44 to 0.70, 7 trials, 2585 participants, low quality evidence). However, the number of the major clinical events such as pulmonary embolism (PE) and intracranial haemorrhage was too small to provide a reliable estimate of the effects.\nAuthors' conclusions\nTreatment with a LMWH or heparinoid after acute ischaemic stroke appears to decrease the occurrence of DVT compared with standard UFH, but there are too few data to provide reliable information on their effects on other important outcomes, including functional outcome, death and intracranial haemorrhage.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The search was updated to February 2017."
}
] |
query-laysum
|
7102
|
[
{
"role": "user",
"content": "Abstract: Background\nCOVID-19 infection poses a serious risk to patients and – due to its contagious nature – to those healthcare workers (HCWs) treating them. If the mouth and nose of HCWs are irrigated with antimicrobial solutions, this may help reduce the risk of active infection being passed from infected patients to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves, or alterations in the natural microbial flora of the mouth or nose. Understanding these possible side effects is particularly important when the HCWs are otherwise fit and well.\nObjectives\nTo assess the benefits and harms of antimicrobial mouthwashes and nasal sprays used by healthcare workers (HCWs) to protect themselves when treating patients with suspected or confirmed COVID-19 infection.\nSearch methods\nInformation Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.\nSelection criteria\nThis is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed randomised controlled trials (RCTs). We therefore planned to include the following types of studies: RCTs; quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.\nWe sought studies comparing any antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered to HCWs, with or without the same intervention being given to the patients with COVID-19.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) viral content of aerosol, when present (if intervention administered to patients); 4) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 5) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe found no completed studies to include in this review. We identified three ongoing studies (including two RCTs), which aim to enrol nearly 700 participants. The interventions included in these trials are povidone iodine, nitric oxide and GLS-1200 oral spray (the constituent of this spray is unclear and may not be antimicrobial in nature).\nAuthors' conclusions\nWe identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by two RCTs and a non-randomised study. We are concerned that only one of the ongoing studies specifically states that it will evaluate adverse events and it is not clear if this will include changes in the sense of smell or to the oral and nasal microbiota, and any consequences thereof.\nVery few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular, where those receiving the intervention are otherwise fit and well, it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.\n\nGiven the provided abstract, please respond to the following query: \"Why is this question important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. Most people infected with COVID-19 develop a mild to moderate respiratory illness, and some may have no symptoms (asymptomatic infection). Others experience severe symptoms and need specialist treatment and intensive care.\nCOVID-19 spreads from person to person primarily through droplets that are produced when an infected person coughs, sneezes or talks. A person can also become infected by touching a surface or object that has viral droplets on it, and then touching their own mouth or nose.\nHealthcare workers who treat people with COVID-19 are at risk of becoming infected themselves. Self-administered use of an antimicrobial mouthwash (to rinse the mouth) or nasal spray (sprayed into the nose) might help healthcare workers to protect themselves against infection. Antimicrobial mouthwashes and nasal sprays are liquids that kill or stop the growth of micro-organisms such as viruses or bacteria.\nAs with any medical treatment, antimicrobial mouthwashes and nasal sprays have potential risks as well as benefits. It is possible that using mouthwashes or nasal sprays could cause a variety of unwanted (adverse) effects, including irritation, allergic reactions or loss of smell. They may also remove micro-organisms from the mouth or nose that are useful for protecting the body against infection.\nTo assess the benefits and risks of self-administered antimicrobial mouthwashes and nasal sprays for healthcare workers treating patients with COVID-19, we set out to review the research evidence."
}
] |
query-laysum
|
7103
|
[
{
"role": "user",
"content": "Abstract: Background\nPerineal trauma, due to spontaneous tears, surgical incision (episiotomy), or in association with operative vaginal birth, is common after vaginal birth, and is often associated with postpartum perineal pain. Birth over an intact perineum may also lead to perineal pain. There are adverse health consequences associated with perineal pain for the women and their babies in the short- and long-term, and the pain may interfere with newborn care and the establishment of breastfeeding. Aspirin has been used in the management of postpartum perineal pain, and its effectiveness and safety should be assessed. This is an update of the review, last published in 2017.\nObjectives\nTo determine the effects of a single dose of aspirin (acetylsalicylic acid), including at different doses, in the relief of acute postpartum perineal pain.\nSearch methods\nFor this update, we searched the Cochrane Pregnancy and Childbirth's Trials Register (4 October 2019), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (4 October 2019) and screened reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs), assessing single dose aspirin compared with placebo, no treatment, a different dose of aspirin, or single dose paracetamol or acetaminophen, for women with perineal pain in the early postpartum period. We planned to include cluster-RCTs, but none were identified. We excluded quasi-RCTs and cross-over studies.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included RCTs. Data were checked for accuracy. The certainty of the evidence for the main comparison (aspirin versus placebo) was assessed using the GRADE approach.\nMain results\nWe included 17 RCTs, 16 of which randomised 1132 women to aspirin or placebo; one RCT did not report numbers of women. Two RCTs (of 16) did not contribute data to meta-analyses. All women had perineal pain post-episiotomy, and were not breastfeeding. Studies were published between 1967 and 1997, and the risk of bias was often unclear, due to poor reporting.\nWe included four comparisons: aspirin versus placebo (15 RCTs); 300 mg versus 600 mg aspirin (1 RCT); 600 mg versus 1200 mg aspirin (2 RCTs); and 300 mg versus 1200 mg aspirin (1 RCT).\nAspirin versus placebo\nAspirin may result in more women reporting adequate pain relief four to eight hours after administration compared with placebo (risk ratio (RR) 2.03, 95% confidence interval (CI) 1.69 to 2.42; 13 RCTs, 1001 women; low-certainty evidence). It is uncertain whether aspirin compared with placebo has an effect on the need for additional pain relief (RR 0.25, 95% CI 0.17 to 0.37; 10 RCTs, 744 women; very low-certainty evidence), or maternal adverse effects (RR 1.08, 95% CI 0.57 to 2.06; 14 RCTs, 1067 women; very low-certainty evidence), four to eight hours after administration. Analyses based on dose did not reveal any clear subgroup differences.\n300 mg versus 600 mg aspirin\nIt is uncertain whether over four hours after administration, 300 mg compared with 600 mg aspirin has an effect on adequate pain relief (RR 0.82, 95% CI 0.36 to 1.86; 1 RCT, 81 women) or the need for additional pain relief (RR 0.68, 95% CI 0.12 to 3.88; 1 RCT, 81 women). There were no maternal adverse effects in either aspirin group.\n600 mg versus 1200 mg aspirin\nIt is uncertain whether over four to eight hours after administration, 600 mg compared with 1200 mg aspirin has an effect on adequate pain relief (RR 0.85, 95% CI 0.52 to 1.39; 2 RCTs, 121 women), the need for additional pain relief (RR 1.32, 95% CI 0.30 to 5.68; 2 RCTs, 121 women), or maternal adverse effects (RR 3.00, 95% CI 0.13 to 69.52; 2 RCTs, 121 women).\n300 mg versus 1200 mg aspirin\nIt is uncertain whether over four hours after administration, 300 mg compared with 1200 mg aspirin has an effect on adequate pain relief (RR 0.62, 95% CI 0.29 to 1.32; 1 RCT, 80 women) or need for additional pain relief (RR 2.00, 95% CI 0.19 to 21.18; 1 RCT, 80 women). There were no maternal adverse effects in either aspirin group.\nNone of the included RCTs reported on neonatal adverse effects.\nNo RCTs reported on secondary review outcomes of: prolonged hospitalisation due to perineal pain; re-hospitalisation due to perineal pain; fully breastfeeding at discharge; mixed feeding at discharge; fully breastfeeding at six weeks; mixed feeding at six weeks; perineal pain at six weeks; maternal views; or maternal postpartum depression.\nAuthors' conclusions\nSingle dose aspirin may increase adequate pain relief in women with perineal pain post-episiotomy compared with placebo. It is uncertain whether aspirin has an effect on the need for additional analgesia, or on maternal adverse effects, compared with placebo. We downgraded the certainty of the evidence because of study limitations (risk of bias), imprecision, and publication bias.\nAspirin may be considered for use in non-breastfeeding women with post-episiotomy perineal pain. Included RCTs excluded breastfeeding women, so there was no evidence to assess the effects of aspirin on neonatal adverse effects or breastfeeding.\nFuture RCTs should be designed to ensure low risk of bias, and address gaps in the evidence, such as the secondary outcomes established for this review. Current research has focused on women with post-episiotomy pain; future RCTs could be extended to include women with perineal pain associated with spontaneous tears or operative birth.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for evidence in October 2019, and included 17 randomised controlled studies, involving 1132 women, published between 1967 and 1997. All women had perineal pain following an episiotomy (usually within 48 hours after birth), and were not breastfeeding. The women received either aspirin (doses ranging from 300 mg to 1200 mg) or fake pills (placebo), by mouth. The methodological quality of the studies was often unclear. Two studies did not contribute any data for analyses.\nAspirin compared with placebo may increase adequate pain relief for mothers four to eight hours after administration (low-certainty evidence). It is uncertain whether aspirin compared with placebo has an effect on the need for additional pain relief, or on adverse effects for mothers, in the four to eight hours after administration (both very low-certainty evidence).\nThe effects of administering 300 mg versus 600 mg aspirin (1 study), 600 mg versus 1200 mg aspirin (2 studies), or 300 mg versus 1200 mg aspirin (1 study) are uncertain for adequate pain relief, the need for additional pain relief, or adverse effects for the mother.\nNo studies reported on adverse effects of aspirin for the baby, or other outcomes we planned to assess: prolonged hospital stay, or readmission to hospital due to perineal pain; perineal pain six weeks after childbirth, women's views, or postpartum depression."
}
] |
query-laysum
|
7104
|
[
{
"role": "user",
"content": "Abstract: Background\nAccurate diagnosis of tuberculosis in people living with HIV is difficult. HIV-positive individuals have higher rates of extrapulmonary tuberculosis and the diagnosis of tuberculosis is often limited to imaging results. Ultrasound is such an imaging test that is widely used as a diagnostic tool (including point-of-care) in people suspected of having abdominal tuberculosis or disseminated tuberculosis with abdominal involvement.\nObjectives\nTo determine the diagnostic accuracy of abdominal ultrasound for detecting abdominal tuberculosis or disseminated tuberculosis with abdominal involvement in HIV-positive individuals.\nTo investigate potential sources of heterogeneity in test accuracy, including clinical setting, ultrasound training level, and type of reference standard.\nSearch methods\nWe searched for publications in any language up to 4 April 2019 in the following databases: MEDLINE, Embase, BIOSIS, Science Citation Index Expanded (SCI-EXPANDED), Social Sciences Citation Index (SSCI), Conference Proceedings Citation Index- Science (CPCI-S), and also ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform to identify ongoing trials.\nSelection criteria\nWe included cross-sectional, cohort, and diagnostic case-control studies (prospective and retrospective) that compared the result of the index test (abdominal ultrasound) with one of the reference standards. We only included studies that allowed for extraction of numbers of true positives (TPs), true negatives (TNs), false positives (FPs), and false negatives (FNs). Participants were HIV-positive individuals aged 15 years and older. A higher-quality reference standard was the bacteriological confirmation of Mycobacterium tuberculosis from any clinical specimen, and a lower-quality reference standard was a clinical diagnosis of tuberculosis without microbiological confirmation. We excluded genitourinary tuberculosis.\nData collection and analysis\nFor each study, two review authors independently extracted data using a standardized form. We assessed the quality of studies using a tailored Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. We used the bivariate model to estimate pooled sensitivity and specificity. When studies were few we simplified the bivariate model to separate univariate random-effects logistic regression models for sensitivity and specificity. We explored the influence of the type of reference standard on the accuracy estimates by conducting separate analyses for each type of reference standard. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 11 studies. The risks of bias and concern about applicability were often high or unclear in all domains. We included six studies in the main analyses of any abnormal finding on abdominal ultrasound; five studies reported only individual lesions.\nThe six studies of any abnormal finding were cross-sectional or cohort studies. Five of these (83%) were conducted in low- or middle-income countries, and one in a high-income country. The proportion of participants on antiretroviral therapy was none (1 study), fewer then 50% (4 studies), more than 50% (1 study), and not reported (5 studies). The first main analysis, studies using a higher-quality reference standard (bacteriological confirmation), had a pooled sensitivity of 63% (95% confidence interval (CI) 43% to 79%; 5 studies, 368 participants; very low-certainty evidence) and a pooled specificity of 68% (95% CI 42% to 87%; 5 studies, 511 participants; very low-certainty evidence). If the results were to be applied to a hypothetical cohort of 1000 people with HIV where 200 (20%) have tuberculosis then:\n- About 382 individuals would have an ultrasound result indicating tuberculosis; of these, 256 (67%) would be incorrectly classified as having tuberculosis (false positives).\n- Of the 618 individuals with a result indicating that tuberculosis is not present, 74 (12%) would be incorrectly classified as not having tuberculosis (false negatives).\nIn the second main analysis involving studies using a lower-quality reference standard (clinical diagnosis), the pooled sensitivity was 68% (95% CI 45% to 85%; 4 studies, 195 participants; very low-certainty evidence) and the pooled specificity was 73% (95% CI 41% to 91%; 4 studies, 202 participants; very low-certainty evidence).\nAuthors' conclusions\nIn HIV-positive individuals thought to have abdominal tuberculosis or disseminated tuberculosis with abdominal involvement, abdominal ultrasound appears to have 63% sensitivity and 68% specificity when tuberculosis was bacteriologically confirmed. These estimates are based on data that is limited, varied, and low-certainty.\nThe low sensitivity of abdominal ultrasound means clinicians should not use a negative test result to rule out the disease, but rather consider the result in combination with other diagnostic strategies (including clinical signs, chest x-ray, lateral flow urine lipoarabinomannan assay (LF-LAM), and Xpert MTB/RIF). Research incorporating the test into tuberculosis diagnostic algorithms will help in delineating more precisely its value in diagnosing abdominal tuberculosis or disseminated tuberculosis with abdominal involvement.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Abdominal ultrasound can be done after other tests (e.g. the chest x-ray did not indicate tuberculosis ) or it can be done before other tests in people suspected of having tuberculosis. This review focuses on situations where other tests are not available."
}
] |
query-laysum
|
7105
|
[
{
"role": "user",
"content": "Abstract: Background\nAnti-neutrophilic cytoplasmic antibodies (ANCA)-associated vasculitis (AAV) are a group of rare auto-inflammatory diseases that affects mainly small vessels. AAV includes: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA). Anti-cytokine targeted therapy uses biological agents capable of specifically targeting and neutralising cytokine mediators of the inflammatory response.\nObjectives\nTo assess the benefits and harms of anti-cytokine targeted therapy for adults with AAV.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (2019, Issue 7), MEDLINE and Embase up to 16 August 2019. We also examined reference lists of articles, clinical trial registries, websites of regulatory agencies and contacted manufacturers.\nSelection criteria\nRandomised controlled trials (RCTs) or controlled clinical trials of targeted anti-cytokine therapy in adults (18 years or older) with AAV compared with placebo, standard therapy or another modality and anti-cytokine therapy of different type or dose.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included four RCTs with a total of 440 participants (mean age 48 to 56 years). We analysed the studies in three groups: 1) mepolizumab (300 mg; three separate injections every four weeks for 52 weeks) versus placebo in participants with relapsing or refractory EGPA; 2) belimumab (10 mg/kg on days 0, 14, 28 and every 28 days thereafter until 12 months after the last participant was randomised) or etanercept (25 mg twice a week) with standard therapy (median 25 months) versus placebo with standard therapy (median 19 months) in participants with GPA/MPA; and 3) infliximab (3 mg/kg on days 1 and 14, before the response assessment on day 42) versus rituximab (0.375g/m2 on days 1, 8, 15 and 22) in participants with refractory GPA for up to 12 months. None of the studies were assessed as low risk of bias in all domains: one study did not report randomisation or blinding methods clearly. Three studies were at high risk and one study was at unclear risk of bias for selective outcome reporting.\nOne trial with 136 participants with relapsing or refractory EGPA compared mepolizumab with placebo during 52 weeks of follow-up and observed one death in the mepolizumab group (1/68, 1.5%) and none in the placebo group (0/68, 0%) (Peto odds ratio (OR) 7.39, 95% confidence interval (CI) 0.15 to 372.38; low-certainty evidence). Low-certainty evidence suggests that more participants in the mepolizumab group had ≥ 24 weeks of accrued remission over 52 weeks compared to placebo (27.9% versus 2.9%; risk ratio (RR) 9.5, 95% CI 2.30 to 39.21), and durable remission within the first 24 weeks sustained until week 52 (19.1% mepolizumab versus 1.5% placebo; RR 13.0, 95% CI 1.75 to 96.63; number needed to treat for an additional beneficial outcome (NNTB) 6, 95% Cl 4 to 13). Mepolizumab probably decreases risk of relapse (55.8% versus 82.4%; RR 0.68, 95% CI 0.53 to 0.86; NNTB 4, 95% CI 3 to 9; moderate-certainty evidence). There was low-certainty evidence regarding similar frequency of adverse events (AEs): total AEs (96.9% versus 94.1%; RR 1.03, 95% CI 0.96 to 1.11), serious AEs (17.7% versus 26.5%; RR 0.67, 95% CI 0.35 to 1.28) and withdrawals due to AEs (2.9% versus 1.5%; RR 2.00, 95% CI 0.19 to 21.54). Disease flares were not measured.\nBased on two trials with different follow-up periods (mean of 27 months for etanercept study; up to four years for belimumab study) including people with GPA (n = 263) and a small group of participants with MPA (n = 22) analysed together, we found low-certainty evidence suggesting that adding an active drug (etanercept or belimumab) to standard therapy does not increase or reduce mortality (3.4% versus 1.4%; Peto OR 2.45, 95% CI 0.55 to 10.97). Etanercept may have little or no effect on remission (92.3% versus 89.5%; RR 0.97, 95% CI 0.89 to 1.07), durable remission (70% versus 75.3%; RR 0.93, 95% CI 0.77 to 1.11; low-certainty evidence) and disease flares (56% versus 57.1%; RR 0.98, 95% CI 0.76 to 1.27; moderate-certainty evidence). Low-certainty evidence suggests that belimumab does not increase or reduce major relapse (1.9% versus 0%; RR 2.94, 95% CI 0.12 to 70.67) or any AE (92.5% versus 82.7%; RR 1.12, 95% CI 0.97 to 1.29). Low-certainty evidence suggests a similar frequency of serious or severe AEs (47.6% versus 47.6%; RR 1.00, 95% CI 0.80 to 1.27), but more frequent withdrawals due to AEs in the active drug group (11.2%) compared to the placebo group (4.2%), RR 2.66, 95% CI 1.07 to 6.59).\nOne trial involving 17 participants with refractory GPA compared infliximab versus rituximab added to steroids and cytotoxic agents for 12 months. One participant died in each group (Peto OR 0.88, 95% CI, 0.05 to 15.51; 11% versus 12.5%). We have very low-certainty evidence for remission (22% versus 50%, RR 0.44, 95% Cl 0.11 to 1.81) and durable remission (11% versus 50%, RR 0.22, 95% CI 0.03 to 1.60), any severe AE (22.3% versus 12.5%; RR 1.78, 95% CI 0.2 to 16.1) and withdrawals due to AEs (0% versus 0%; RR 2.70, 95% CI 0.13 to 58.24). Disease flare/relapse and the frequency of any AE were not reported.\nAuthors' conclusions\nWe found four studies but concerns about risk of bias and small sample sizes preclude firm conclusions.\nWe found moderate-certainty evidence that in patients with relapsing or refractory EGPA, mepolizumab compared to placebo probably decreases disease relapse and low-certainty evidence that mepolizumab may increase the probability of accruing at least 24 weeks of disease remission. There were similar frequencies of total and serious AEs in both groups, but the study was too small to reliably assess these outcomes. Mepolizumab may result in little to no difference in mortality. However, there were very few events.\nIn participants with GPA (and a small subgroup of participants with MPA), etanercept or belimumab may increase the probability of withdrawal due to AEs and may have little to no impact on serious AEs. Etanercept may have little or no impact on durable remission and probably does not reduce disease flare.\n\nGiven the provided abstract, please respond to the following query: \"Why this question is important\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The body’s defence (immune) system fights injury or infection by sending white blood cells to surround and protect the affected area. This causes redness and swelling, called inflammation.\nVasculitis is an inflammation of the blood vessels. In vasculitis, instead of reacting to harm, the immune system attacks healthy blood vessels. The reason for this reaction is often unknown.\nOne rare type of vasculitis is antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). AAV covers three different conditions that are grouped together because they all affect small blood vessels:\n- MPA: microscopic polyangiitis;\n- GPA: granulomatosis with polyangiitis; and\n- EPGA: eosinophilic granulomatosis with polyangiitis.\nThe areas of the body most commonly affected are kidneys, lungs, joints, ears, nose and nerves. It is important to treat AAV early, to prevent serious damage to these organs.\nCurrently, the recommended treatment for AAV is to use medicines that control the immune system and medicines against inflammation (steroids). However, this treatment causes serious unwanted effects. Medicines that target cytokines (small molecules that influence the immune system’s reactions) are an alternative option. To evaluate the benefits and risks of anti-cytokine medicines, we reviewed the evidence from research studies."
}
] |
query-laysum
|
7106
|
[
{
"role": "user",
"content": "Abstract: Background\nCrohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract, in which the pathogenesis is believed to be partly influenced by the gut microbiome. Probiotics can be used to manipulate the microbiome and have therefore been considered as a potential therapy for CD. There is some evidence that probiotics benefit other gastrointestinal conditions, such as irritable bowel syndrome and ulcerative colitis, but their efficacy in CD is unclear. This is the first update of a Cochrane Review previously published in 2008.\nObjectives\nTo assess the efficacy and safety of probiotics for the induction of remission in CD.\nSearch methods\nThe following electronic databases were searched: MEDLINE (from inception to 6 July 2020), Embase (from inception to 6 July 2020), the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane IBD Review Group Specialised Trials Register, World Health Organization (WHO) International Clinical Trials Registry, and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) that compared probiotics with placebo or any other non-probiotic intervention for the induction of remission in CD were eligible for inclusion.\nData collection and analysis\nTwo review authors independently extracted data and assessed the methodological quality of included studies. The primary outcome was clinical remission. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for dichotomous outcomes.\nMain results\nThere were two studies that met criteria for inclusion. One study from Germany had 11 adult participants with mild-to-moderate CD, who were treated with a one-week course of corticosteroids and antibiotics (ciprofloxacin 500 mg twice daily and metronidazole 250 mg three times a day), followed by randomised assignment to Lactobacillus rhamnosus strain GG (two billion colony-forming units per day) or corn starch placebo. The other study from the United Kingdom (UK) had 35 adult participants with active CD (CDAI score of 150 to 450) randomised to receive a synbiotic treatment (comprised of freeze-dried Bifidobacterium longum and a commercial product) or placebo. The overall risk of bias was low in one study, whereas the other study had unclear risk of bias in relation to random sequence generation, allocation concealment, and blinding. There was no evidence of a difference between the use of probiotics and placebo for the induction of remission in CD (RR 1.06; 95% CI 0.65 to 1.71; 2 studies, 46 participants) after six months. There was no difference in adverse events between probiotics and placebo (RR 2.55; 95% CI 0.11 to 58.60; 2 studies, 46 participants). The evidence for both outcomes was of very low certainty due to risk of bias and imprecision.\nAuthors' conclusions\nThe available evidence is very uncertain about the efficacy or safety of probiotics, when compared with placebo, for induction of remission in Crohn's disease. There is a lack of well-designed RCTs in this area and further research is needed.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is up-to-date as of 6 July 2020."
}
] |
query-laysum
|
7107
|
[
{
"role": "user",
"content": "Abstract: Background\nPostpartum mini-laparotomy tubal ligation (PPTL) is a contraceptive method that works by interrupting the patency of the fallopian tubes. Several methods are used for intraoperative pain relief, such as systemic administration of opioids or intraperitoneal instillation of lidocaine.\nObjectives\nTo evaluate the effectiveness of and adverse effects associated with interventions for pain relief in women undergoing PPTL.\nSearch methods\nWe searched for eligible studies published on or before 31 July 2017 in the CENTRAL Register of Studies Online, MEDLINE, Embase, PsycINFO, and CINAHL. We examined review articles and searched registers of ongoing clinical trials, citation lists of included studies, key textbooks, grey literature, and previous systematic reviews for potentially relevant studies.\nSelection criteria\nWe included randomised controlled trials (RCT) that compared perioperative pain relief measures during PPTL.\nData collection and analysis\nTwo review authors independently assessed the titles, abstracts, and full-text articles of potentially relevant studies for inclusion. We extracted the data from the included studies, assessed risk of bias, and calculated and compared results. Discrepancies were resolved by discussion, or by consulting a third review author. We computed the inverse variance risk ratio (RR) with 95% confidence interval (CI) for binary outcomes, and the mean difference (MD) with 95% CI for continuous variables.\nMain results\nWe found only three RCTs, in which a total of 230 postpartum women participated. Most of our analyses were based on relatively small numbers of patients and studies. Overall, the certainty of evidence regarding the effectiveness of interventions was low, due to risk of bias and imprecision. We found very low-certainty evidence regarding the safety of interventions because of risk of bias and imprecision. Two studies had unclear risk of selection bias. One study had unclear risk of reporting bias and a high risk of other bias associated with the study protocol.\nWomen who received an intraperitoneal instillation of lidocaine experienced lower intensity intraperitoneal pain than those given a placebo (pooled MD -3.34, 95% CI -4.19 to -2.49, three studies, 190 participants, low-certainty evidence), or an intramuscular injection of morphine (MD -4.8, 95% CI -6.43 to -3.17, one study, 40 participants, low-certainty evidence). We found no clear difference in intraperitoneal pain between women who had an intramuscular injection of morphine added to an intraperitoneal instillation of lidocaine and those who had an intraperitoneal instillation of lidocaine alone (MD -0.40, 95% CI -1.52 to 0.72, one study, 40 participants, low-certainty evidence). An intramuscular injection of morphine alone was not effective for intraperitoneal pain relief compared to placebo (MD 0.50, 95% CI -1.33 to 2.33, one study, 40 women, low-certainty evidence). None of the studies reported any serious adverse events but the evidence was very low-certainty. Intraperitoneal instillation of lidocaine may reduce the number of women requiring additional pain control when compared to placebo (RR 0.27, 95% CI 0.17 to 0.44, three studies, 190 women, low-certainty evidence).\nAuthors' conclusions\nAn intraperitoneal instillation of lidocaine during postpartum mini-laparotomy tubal ligation before fallopian tubes were tied may offer better intraperitoneal pain control, although the evidence regarding adverse effects is uncertain. We found no clear difference in intraperitoneal pain between women who received a combination of an injection of morphine, and intraperitoneal instillation of lidocaine and those who received an intraperitoneal instillation of lidocaine alone. These results must be interpreted with caution, since the evidence overall was low to very low-certainty.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The certainty of evidence regarding the effectiveness of these interventions was low due to risk of bias and imprecision of results. The certainty of evidence regarding the safety of the interventions was very low because of risk of bias and imprecision."
}
] |
query-laysum
|
7108
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane Review first published in The Cochrane Library 2008, Issue 3.\nUpper abdominal surgical procedures are associated with a high risk of postoperative pulmonary complications. The risk and severity of postoperative pulmonary complications can be reduced by the judicious use of therapeutic manoeuvres that increase lung volume. Our objective was to assess the effect of incentive spirometry compared to no therapy or physiotherapy, including coughing and deep breathing, on all-cause postoperative pulmonary complications and mortality in adult patients admitted to hospital for upper abdominal surgery.\nObjectives\nOur primary objective was to assess the effect of incentive spirometry (IS), compared to no such therapy or other therapy, on postoperative pulmonary complications and mortality in adults undergoing upper abdominal surgery.\nOur secondary objectives were to evaluate the effects of IS, compared to no therapy or other therapy, on other postoperative complications, adverse events, and spirometric parameters.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 8), MEDLINE, EMBASE, and LILACS (from inception to August 2013). There were no language restrictions. The date of the most recent search was 12 August 2013. The original search was performed in June 2006.\nSelection criteria\nWe included randomized controlled trials (RCTs) of IS in adult patients admitted for any type of upper abdominal surgery, including patients undergoing laparoscopic procedures.\nData collection and analysis\nTwo authors independently assessed trial quality and extracted data.\nMain results\nWe included 12 studies with a total of 1834 participants in this updated review. The methodological quality of the included studies was difficult to assess as it was poorly reported, so the predominant classification of bias was 'unclear'; the studies did not report on compliance with the prescribed therapy. We were able to include data from only 1160 patients in the meta-analysis. Four trials (152 patients) compared the effects of IS with no respiratory treatment. We found no statistically significant difference between the participants receiving IS and those who had no respiratory treatment for clinical complications (relative risk (RR) 0.59, 95% confidence interval (CI) 0.30 to 1.18). Two trials (194 patients) IS compared incentive spirometry with deep breathing exercises (DBE). We found no statistically significant differences between the participants receiving IS and those receiving DBE in the meta-analysis for respiratory failure (RR 0.67, 95% CI 0.04 to 10.50). Two trials (946 patients) compared IS with other chest physiotherapy. We found no statistically significant differences between the participants receiving IS compared to those receiving physiotherapy in the risk of developing a pulmonary condition or the type of complication. There was no evidence that IS is effective in the prevention of pulmonary complications.\nAuthors' conclusions\nThere is low quality evidence regarding the lack of effectiveness of incentive spirometry for prevention of postoperative pulmonary complications in patients after upper abdominal surgery. This review underlines the urgent need to conduct well-designed trials in this field. There is a case for large RCTs with high methodological rigour in order to define any benefit from the use of incentive spirometry regarding mortality.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included adults (aged 18 years and above) admitted for any type of upper abdominal surgery. The evidence is current to August 2013. We found 12 studies with a total of 1834 participants. The maximum period of time that a patient was followed by the doctor was seven days postoperatively. The quality of the included studies was uncertain because of poor reporting in the published articles."
}
] |
query-laysum
|
7109
|
[
{
"role": "user",
"content": "Abstract: Background\nAround 16% of adults have symptoms of overactive bladder (OAB; urgency with frequency and/or urge incontinence), with prevalence increasing with age. Anticholinergic drugs are commonly used to treat this condition.\nThis is an update of a Cochrane Review first published in 2002 and last updated in 2006.\nObjectives\nTo assess the effects of anticholinergic drugs compared with placebo or no treatment for treating overactive bladder syndrome in adults.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 14 January 2020), and the reference lists of relevant articles. We updated this search on 3 May 2022, but these results have not yet been fully incorporated.\nSelection criteria\nWe included randomised or quasi-randomised trials in adults with overactive bladder syndrome that compared an anticholinergic drug alone with placebo treatment.\nData collection and analysis\nTwo review authors independently assessed eligibility and extracted data from the included studies, including an assessment of the risk of bias. We assessed the certainty of the body of evidence using the GRADE approach. We processed data as described in the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nWe included 104 studies, 71 of which were new or updated for this version of the review. Although 12 studies did not report the number of participants, there were 47,106 people in the remainder of the included studies. The majority of the studies had insufficient information to allow judgement of risk of bias and we judged them to be unclear for all domains. Nine anticholinergic drugs were included in these studies: darifenacin; fesoterodine; imidafenacin; oxybutynin; propantheline; propiverine; solifenacin; tolterodine and trospium. No studies were found that compared anticholinergic drugs to no treatment.\nAt the end of the treatment period, anticholinergics may slightly increase condition-specific quality of life (mean difference (MD) 4.41 lower, 95% confidence interval (CI) 5.28 lower to 3.54 lower (scale range -100 to 0); 12 studies, 6804 participants; low-certainty evidence). Anticholinergics are probably better than placebo in terms of patient perception of cure or improvement (risk ratio (RR) 1.38, 95% CI 1.15 to 1.66; 9 studies, 8457 participants; moderate-certainty evidence), and the mean number of urgency episodes per 24-hour period (MD 0.85 lower, 95% CI 1.03 lower to 0.67 lower; 23 studies, 16,875 participants; moderate-certainty evidence).\nCompared to placebo, anticholinergics may result in an increase in dry mouth adverse events (RR 3.50, 95% CI 3.26 to 3.75; 66 studies, 38,368 participants; low-certainty evidence), and may result in an increased risk of urinary retention (RR 3.52, 95% CI 2.04 to 6.08; 17 studies, 7862 participants; low-certainty evidence). Taking anticholinergics may be more likely to lead to participants withdrawing from the studies due to adverse events (RR 1.37, 95% CI 1.21 to 1.56; 61 studies, 36,943 participants; low-certainty evidence). However, taking anticholinergics probably reduces the mean number of micturitions per 24-hour period compared to placebo (MD 0.85 lower, 95% CI 0.98 lower to 0.73 lower; 30 studies, 19,395 participants; moderate-certainty evidence).\nAuthors' conclusions\nThe use of anticholinergic drugs by people with overactive bladder syndrome results in important but modest improvements in symptoms compared with placebo treatment. In addition, recent studies suggest that this is generally associated with only modest improvement in quality of life. Adverse effects were higher with all anticholinergics compared with placebo. Withdrawals due to adverse effects were also higher for all anticholinergics except tolterodine. It is not known whether any benefits of anticholinergics are sustained during long-term treatment or after treatment stops.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that people who take an anticholinergic drug for overactive bladder may feel a positive change in their quality of life. Also, our results show that more patients will probably perceive an improvement or cure of their symptoms of overactive bladder when compared to those who take the placebo treatment.\nTaking an anticholinergic drug probably results in a small reduction in the number of urgency episodes and the number of times people with overactive bladder go to the toilet in one day.\nTwenty-two people in every 100 given an anticholinergic drug felt they had a dry mouth as a side effect of the drug, compared to 6 in 100 taking placebo. Taking anticholinergics may therefore increase the risk of having a dry mouth. Anticholinergics may also result in an increased risk of urinary retention: fewer than 2 in every 100 people felt they were unable to completely empty their bladder after taking an anticholinergic drug in comparison to fewer than 0.5 in every 100 people after taking placebo."
}
] |
query-laysum
|
7110
|
[
{
"role": "user",
"content": "Abstract: Background\nTraumatic eye complaints account for 3% of all hospital emergency department visits. The most common traumatic injury to the eye is blunt trauma, which accounts for 30% of these visits. Blunt trauma frequently leads to traumatic iridocyclitis, thus causing anterior uveitis. Iridocyclitis frequently causes tearing, photophobia, eye pain, and vision loss. These symptoms are a result of the inflammatory processes and ciliary spasms to iris muscles and sphincter. The inflammatory process is usually managed with topical corticosteroids, while the ciliary spasm is blunted by dilating the pupils with topical mydriatic agents, an adjuvant therapy. However, the effectiveness of mydriatic agents has not been quantified in terms of reduction of ocular pain and visual acuity loss.\nObjectives\nTo evaluate the effectiveness and safety of topical mydriatics as adjunctive therapy to topical corticosteroids for traumatic iridocyclitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) which contains the Cochrane Eyes and Vision Trials Register (2019, issue 6); Ovid MEDLINE; Embase.com; Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus; PubMed; ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 12 June 2019.\nSelection criteria\nWe planned to include randomized controlled trials (RCTs) that compared topical mydriatic agents in conjunction with topical corticosteroid therapy versus topical corticosteroids alone, in participants with traumatic iridocyclitis.\nData collection and analysis\nTwo review authors (JH, MK) independently screened titles and abstracts, then full-text reports, against eligibility criteria. We planned to have two authors independently extract data from included studies. We resolved differences in opinion by discussion.\nMain results\nThere were no eligible RCTs that compared the interventions of interest in people with traumatic iridocyclitis.\nAuthors' conclusions\nWe did not find any evidence from RCTs about the efficacy of topical mydriatic agents as an adjunctive therapy with topical corticosteroids for treating traumatic iridocyclitis. In the absence of these types of studies, we cannot draw any firm conclusions. Controlled trials that compare the combined use of topical mydriatic agents and corticosteroid drops against standard corticosteroid drops alone, in people with traumatic iridocyclitis are required. These may provide evidence about the efficacy and risk of topical mydriatic drops as adjuvant therapy for traumatic iridocyclitis.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We last searched for evidence on 12 June 2019. This review covered research that was available up to that date, but did not consider any evidence that may have been produced since then."
}
] |
query-laysum
|
7111
|
[
{
"role": "user",
"content": "Abstract: Background\nAbout 10% of reproductive-aged women suffer from endometriosis which is a costly chronic disease that causes pelvic pain and subfertility. Laparoscopy is the 'gold standard' diagnostic test for endometriosis, but it is expensive and carries surgical risks. Currently, there are no simple non-invasive or minimally-invasive tests available in clinical practice that accurately diagnoses endometriosis.\nObjectives\n1. To provide summary estimates of the diagnostic accuracy of urinary biomarkers for the diagnosis of pelvic endometriosis compared to surgical diagnosis as a reference standard.\n2. To assess the diagnostic utility of biomarkers that could differentiate ovarian endometrioma from other ovarian masses.\nUrinary biomarkers were evaluated as replacement tests for surgical diagnosis and as triage tests to inform decisions to undertake surgery for endometriosis.\nSearch methods\nThe searches were not restricted to particular study design, language or publication dates. We searched the following databases to 20 April - 31 July 2015: CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, LILACS, OAIster, TRIP and ClinicalTrials.gov (trial register). MEDION, DARE, and PubMed were also searched to identify reviews and guidelines as reference sources of potentially relevant studies. Recently published papers not yet indexed in the major databases were also sought. The search strategy incorporated words in the title, abstract, text words across the record and the medical subject headings (MeSH) and was modified for each database.\nSelection criteria\nPublished peer-reviewed, randomised controlled or cross-sectional studies of any size were considered, which included prospectively collected samples from any population of reproductive-aged women suspected of having one or more of the following target conditions: ovarian, peritoneal or deep infiltrating endometriosis (DIE). We included studies comparing the diagnostic test accuracy of one or more urinary biomarkers with surgical visualisation of endometriotic lesions.\nData collection and analysis\nTwo authors independently collected and performed a quality assessment of the data from each study. For each diagnostic test, the data were classified as positive or negative for the surgical detection of endometriosis and sensitivity and specificity estimates were calculated. If two or more tests were evaluated in the same cohort, each was considered as a separate data set. The bivariate model was used to obtain pooled estimates of sensitivity and specificity whenever sufficient data sets were available. The predetermined criteria for a clinically useful urine test to replace diagnostic surgery was one with a sensitivity of 94% and a specificity of 79% to detect endometriosis. The criteria for triage tests were set at sensitivity of equal or greater than 95% and specificity of equal or greater than 50%, which in case of negative result rules out the diagnosis (SnOUT test) or sensitivity of equal or greater than 50% with specificity of equal or greater than 95%, which in case of positive result rules the diagnosis in (SpIN test).\nMain results\nWe included eight studies involving 646 participants, most of which were of poor methodological quality. The urinary biomarkers were evaluated either in a specific phase of menstrual cycle or irrespective of the cycle phase. Five studies evaluated the diagnostic performance of four urinary biomarkers for endometriosis, including three biomarkers distinguishing women with and without endometriosis (enolase 1 (NNE); vitamin D binding protein (VDBP); and urinary peptide profiling); and one biomarker (cytokeratin 19 (CK 19)) showing no significant difference between the two groups. All of these biomarkers were assessed in small individual studies and could not be statistically evaluated in a meaningful way. None of the biomarkers met the criteria for a replacement test or a triage test. Three studies evaluated three biomarkers that did not differentiate women with endometriosis from disease-free controls.\nAuthors' conclusions\nThere was insufficient evidence to recommend any urinary biomarker for use as a replacement or triage test in clinical practice for the diagnosis of endometriosis. Several urinary biomarkers may have diagnostic potential, but require further evaluation before being introduced into routine clinical practice. Laparoscopy remains the gold standard for the diagnosis of endometriosis, and diagnosis of endometriosis using urinary biomarkers should only be undertaken in a research setting.\n\nGiven the provided abstract, please respond to the following query: \"Future research\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "More high quality research trials are needed to accurately assess the diagnostic potential of urinary biomarkers identified in small numbers of studies as having value in detecting endometriosis."
}
] |
query-laysum
|
7112
|
[
{
"role": "user",
"content": "Abstract: Background\nMolluscum contagiosum is a common skin infection that is caused by a pox virus and occurs mainly in children. The infection usually resolves within months in people without immune deficiency, but treatment may be preferred for social and cosmetic reasons or to avoid spreading the infection. A clear evidence base supporting the various treatments is lacking.\nThis is an update of a Cochrane Review first published in 2006, and updated previously in 2009.\nObjectives\nTo assess the effects of specific treatments and management strategies, including waiting for natural resolution, for cutaneous, non-genital molluscum contagiosum in people without immune deficiency.\nSearch methods\nWe updated our searches of the following databases to July 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We searched six trial registers and checked the reference lists of included studies and review articles for further references to relevant randomised controlled trials. We contacted pharmaceutical companies and experts in the field to identify further relevant randomised controlled trials.\nSelection criteria\nRandomised controlled trials of any treatment of molluscum contagiosum in people without immune deficiency. We excluded trials on sexually transmitted molluscum contagiosum and in people with immune deficiency (including those with HIV infection).\nData collection and analysis\nTwo review authors independently selected studies, assessed methodological quality, and extracted data from selected studies. We obtained missing data from study authors where possible.\nMain results\nWe found 11 new studies for this update, resulting in 22 included studies with a total of 1650 participants. The studies examined the effects of topical (20 studies) and systemic interventions (2 studies).\nAmong the new included studies were the full trial reports of three large unpublished studies, brought to our attention by an expert in the field. They all provided moderate-quality evidence for a lack of effect of 5% imiquimod compared to vehicle (placebo) on short-term clinical cure (4 studies, 850 participants, 12 weeks after start of treatment, risk ratio (RR) 1.33, 95% confidence interval (CI) 0.92 to 1.93), medium-term clinical cure (2 studies, 702 participants, 18 weeks after start of treatment, RR 0.88, 95% CI 0.67 to 1.14), and long-term clinical cure (2 studies, 702 participants, 28 weeks after start of treatment, RR 0.97, 95% CI 0.79 to 1.17). We found similar but more certain results for short-term improvement (4 studies, 850 participants, 12 weeks after start of treatment, RR 1.14, 95% CI 0.89 to 1.47; high-quality evidence). For the outcome 'any adverse effect', we found high-quality evidence for little or no difference between topical 5% imiquimod and vehicle (3 studies, 827 participants, RR 0.97, 95% CI 0.88 to 1.07), but application site reactions were more frequent in the groups treated with imiquimod (moderate-quality evidence): any application site reaction (3 studies, 827 participants, RR 1.41, 95% CI 1.13 to 1.77, the number needed to treat for an additional harmful outcome (NNTH) was 11); severe application site reaction (3 studies, 827 participants, RR 4.33, 95% CI 1.16 to 16.19, NNTH over 40).\nFor the following 11 comparisons, there was limited evidence to show which treatment was superior in achieving short-term clinical cure (low-quality evidence): 5% imiquimod less effective than cryospray (1 study, 74 participants, RR 0.60, 95% CI 0.46 to 0.78) and 10% potassium hydroxide (2 studies, 67 participants, RR 0.65, 95% CI 0.46 to 0.93); 10% Australian lemon myrtle oil more effective than olive oil (1 study, 31 participants, RR 17.88, 95% CI 1.13 to 282.72); 10% benzoyl peroxide cream more effective than 0.05% tretinoin (1 study, 30 participants, RR 2.20, 95% CI 1.01 to 4.79); 5% sodium nitrite co-applied with 5% salicylic acid more effective than 5% salicylic acid alone (1 study, 30 participants, RR 3.50, 95% CI 1.23 to 9.92); and iodine plus tea tree oil more effective than tea tree oil (1 study, 37 participants, RR 0.20, 95% CI 0.07 to 0.57) or iodine alone (1 study, 37 participants, RR 0.07, 95% CI 0.01 to 0.50). Although there is some uncertainty, 10% potassium hydroxide appears to be more effective than saline (1 study, 20 participants, RR 3.50, 95% CI 0.95 to 12.90); homeopathic calcarea carbonica appears to be more effective than placebo (1 study, 20 participants, RR 5.57, 95% CI 0.93 to 33.54); 2.5% appears to be less effective than 5% solution of potassium hydroxide (1 study, 25 participants, RR 0.35, 95% CI 0.12 to 1.01); and 10% povidone iodine solution plus 50% salicylic acid plaster appears to be more effective than salicylic acid plaster alone (1 study, 30 participants, RR 1.43, 95% CI 0.95 to 2.16).\nWe found no statistically significant differences for other comparisons (most of which addressed two different topical treatments). We found no randomised controlled trial evidence for expressing lesions or topical hydrogen peroxide.\nStudy limitations included no blinding, many dropouts, and no intention-to-treat analysis. Except for the severe application site reactions of imiquimod, none of the evaluated treatments described above were associated with serious adverse effects (low-quality evidence). Among the most common adverse events were pain during application, erythema, and itching. Included studies of the following comparisons did not report adverse effects: calcarea carbonica versus placebo, 10% povidone iodine plus 50% salicylic acid plaster versus salicylic acid plaster, and 10% benzoyl peroxide versus 0.05% tretinoin.\nWe were unable to judge the risk of bias in most studies due to insufficient information, especially regarding concealment of allocation and possible selective reporting. We considered five studies to be at low risk of bias.\nAuthors' conclusions\nNo single intervention has been shown to be convincingly effective in the treatment of molluscum contagiosum. We found moderate-quality evidence that topical 5% imiquimod was no more effective than vehicle in terms of clinical cure, but led to more application site reactions, and high-quality evidence that there was no difference between the treatments in terms of short-term improvement. However, high-quality evidence showed a similar number of general side effects in both groups. As the evidence found did not favour any one treatment, the natural resolution of molluscum contagiosum remains a strong method for dealing with the condition.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Molluscum contagiosum in healthy people is a self limiting, relatively harmless viral skin infection. It mainly affects children and adolescents and is rare in adults. It occurs worldwide, but seems much more frequent in geographic areas with warm climates. Molluscum contagiosum usually presents as single or multiple pimples filled with an oily substance. People may seek treatment for social and cosmetic reasons and because of concerns about spreading the disease to others. Treatment is intended to speed up the healing process."
}
] |
query-laysum
|
7113
|
[
{
"role": "user",
"content": "Abstract: Background\nWhilst carrying out dental procedures under general anaesthesia (GA), practitioners routinely give local anaesthetics (LA) intraoperatively to children. Local anaesthetics are used to help manage postoperative pain and reduce bleeding and the physiological response to procedures. Studies of effectiveness of intraoperative LA to date have reported contradictory results.\nObjectives\nTo assess the effects of intraoperative local anaesthesia for reducing postoperative pain following general anaesthesia for dental treatment in children and young people aged 17 years or younger.\nSearch methods\nWe searched the following electronic databases: the Cochrane Oral Health Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2013, Issue 12), MEDLINE via OVID (1946 to 02 January 2014), EMBASE via OVID (1980 to 02 January 2014) and Web of Science Conference Proceedings (1990 to 02 January 2014). We searched for ongoing trials in the US National Institutes of Health Register, the metaRegister of Controlled Trials (mRCT) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Clinical Trials Portal. We did not place any restrictions on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials in which local anaesthetic was given intraoperatively under general anaesthesia for dental treatment of children and young people aged 17 years or younger.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration. We performed data extraction and assessment of risk of bias independently and in duplicate. We contacted authors to clarify omissions in trial reports. In the 'Summary of findings' tables, we elected to report the outcomes pain, distress, postoperative bleeding, and physiological parameters related to the general anaesthetic, as we considered these to be the outcomes of greatest importance to readers of the review.\nMain results\nWe included 14 trials in this review, with 1152 randomised participants. The studies were published between 1990 and 2009 and were conducted in the United Kingdom, Egypt, Saudi Arabia, and the United States. The age of participants ranged from 2 to 40 years. Three studies were at an overall high risk of bias, seven studies were at an unclear risk of bias, and we judged four studies to be at low risk of bias.\nThe clinical heterogeneity of the included studies precluded pooling of studies in terms of method of administration of LA (e.g., intraligamental injection, infiltration injection, or topical delivery) and variation in the use of supplementary analgesics and follow-up time.\nOf the seven studies where administration of LA was by infiltration injection, six studies (very low-quality body of evidence, 542 participants analysed, 1 study had overall high risk of bias, 4 studies had overall unclear risk of bias, 1 study had overall low risk of bias) measured postoperative pain. The results were equivocal. There was a decrease in bleeding and increase in soft tissue damage in the LA groups, but we did not judge this to be clinically significant.\nIn the 2 studies where administration of LA was by intraligamental injection, there was no difference in mean pain scores, and they did not report any soft tissue damage (very low-quality body of evidence, 115 participants analysed, 1 study had overall high risk of bias, 1 study had overall unclear risk of bias).\nOne 3-armed study (very low-quality body of evidence, 54 participants analysed, overall high risk of bias) compared the effects of intraligamental and infiltration LA injection with no treatment. There was no evidence of a mean difference in pain, distress, or postoperative anxiety among the three groups.\nFour studies (very low-quality body of evidence, 343 participants analysed, 2 studies had overall low risk of bias, 2 studies had overall unclear risk of bias) evaluated the effects of topical LA compared with no treatment or placebo. One study (overall unclear risk of bias) with a no-treatment comparator reported lower mean pain in the LA group; all other studies reported no difference in mean pain scores. Two studies reported on bleeding (overall unclear risk of bias): One study reported a clinically insignificant increase in bleeding with no treatment; the other reported no difference.\nNone of the studies reported on participant or child satisfaction.\nAuthors' conclusions\nIn this review, it was difficult to reach firm conclusions as to the benefit of using local anaesthetic for dental treatment under general anaesthesia. The information reported in the included studies was comprehensive and applicable to the review question, but ultimately it was not sufficient to address the objective of the review. We were unable to pool the included studies in a meta-analysis because of substantial variation in outcome measures, interventions, and treatment types. The use of supplementary analgesia further obscured the effect of local anaesthetics.\nBased on the literature review and the results of this review, we recommend further randomised controlled trials that minimise bias through adequate allocation concealment and blinding of participants and assessors, and assess the effect of intraoperative local anaesthetic on the volume and type of anaesthetic used and on the cardiovascular system in participants receiving supplementary analgesics as well. Researchers should give consideration to the impact of any changes on the health and well-being of the participant and report baseline measures of pain or distress, or both, and preoperative anxiety.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ".\nThe Cochrane Oral Health Group carried out this review and the evidence on which it is based was up-to-date on 2 January 2014. We included 14 studies, which took place from 1990 to 2009 in the UK, Egypt, Saudi Arabia, and the USA. These included 1152 participants aged from 2 to 40 years."
}
] |
query-laysum
|
7114
|
[
{
"role": "user",
"content": "Abstract: Background\nParenteral nutrition solutions, artificial formulas, and human breast milk contain insufficient iodine to meet recommended intakes for preterm infants. Iodine deficiency may exacerbate transient hypothyroxinaemia in preterm infants and this may be associated with adverse neonatal and longer-term outcomes.\nObjectives\nTo assess the evidence from randomised controlled trials that dietary supplementation with iodine reduces mortality and morbidity in preterm infants.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 1), Ovid MEDLINE, Ovid Embase, Ovid Maternity & Infant Care Database, and CINAHL to February 2018. We searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised or quasi-randomised controlled trials that compared supplementing enteral or parenteral feeds with iodine (as iodide salt) versus placebo or no supplementation in preterm infants.\nData collection and analysis\nTwo review authors independently assessed trial eligibility and risk of bias, and extracted data. We analysed treatment effects as described in the individual trials and reported risk ratios (RR) and risk differences for dichotomous data, and mean differences (MD) for continuous data, with 95% confidence intervals (CI). We used a fixed-effect model in meta-analyses and planned to explore potential causes of heterogeneity in sensitivity analyses. We used the GRADE approach to assess the quality of evidence.\nMain results\nTwo randomised controlled trials fulfilled the eligibility criteria. Both trials used methods to limit bias including allocation concealment and blinding of clinicians and investigators to the allocated intervention. The trials enrolled 1394 infants. One trial recruited 1273 participants. Most participants were born very preterm (less than 32 weeks' gestation) and about one-third were extremely preterm (less than 28 weeks' gestation). Analyses found no effect of iodine supplementation on mortality before hospital discharge (typical RR 1.01, 95% CI 0.72 to 1.42; typical RD 0.00, 95% CI -0.03 to 0.03; 2 studies, 1380 infants) or on neurodevelopmental assessments at two years post-term (Bayley Scales of Infant and Toddler Development, Third Edition main domain composite scores: cognitive: MD –0.30, 95% CI –2.44 to 1.84; motor: MD 0.20, 95% CI –2.15 to 2.55; language: MD –0.10, 95% CI –2.50 to 2.30; 1 study, 1259 infants). There were no differences in the proportion of infants who died or had a composite score less than 85 in any main Bayley domain (RR 1.05, 95% CI 0.94 to 1.17; RD 0.02 95% CI -0.03 to 0.08; 1 study, 1259 infants), or had visual impairment (RR 0.63, 95% CI 0.28 to 1.45; RD -0.01 95% CI -0.03 to 0.01; 1 study, 1092 infants) or auditory impairment (RR 1.05, 95% CI 0.51 to 2.16; RD 0.00 95% CI -0.02 to 0.02 1 study, 1093 infants). Using GRADE methods, we assessed the evidence for the effects on mortality and neurodevelopment outcomes as high-certainty.\nAuthors' conclusions\nThe available trial data, predominantly from one large, high-quality multicentre study published in 2017, do not show any evidence of beneficial effects of iodine supplementation for preterm infants. Given the high certainty of these estimates of effect, further trials of this intervention in this population are unlikely to be considered research priorities.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Does giving preterm infants iodine supplements reduce their risk of dying or improve their brain development?"
}
] |
query-laysum
|
7115
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic peripheral joint pain due to osteoarthritis (OA) is extremely prevalent and a major cause of physical dysfunction and psychosocial distress. Exercise is recommended to reduce joint pain and improve physical function, but the effect of exercise on psychosocial function (health beliefs, depression, anxiety and quality of life) in this population is unknown.\nObjectives\nTo improve our understanding of the complex inter-relationship between pain, psychosocial effects, physical function and exercise.\nSearch methods\nReview authors searched 23 clinical, public health, psychology and social care databases and 25 other relevant resources including trials registers up to March 2016. We checked reference lists of included studies for relevant studies. We contacted key experts about unpublished studies.\nSelection criteria\nTo be included in the quantitative synthesis, studies had to be randomised controlled trials of land- or water-based exercise programmes compared with a control group consisting of no treatment or non-exercise intervention (such as medication, patient education) that measured either pain or function and at least one psychosocial outcome (self-efficacy, depression, anxiety, quality of life). Participants had to be aged 45 years or older, with a clinical diagnosis of OA (as defined by the study) or self-reported chronic hip or knee (or both) pain (defined as more than six months' duration).\nTo be included in the qualitative synthesis, studies had to have reported people's opinions and experiences of exercise-based programmes (e.g. their views, understanding, experiences and beliefs about the utility of exercise in the management of chronic pain/OA).\nData collection and analysis\nWe used standard methodology recommended by Cochrane for the quantitative analysis. For the qualitative analysis, we extracted verbatim quotes from study participants and synthesised studies of patients' views using framework synthesis. We then conducted an integrative review, synthesising the quantitative and qualitative data together.\nMain results\nTwenty-one trials (2372 participants) met the inclusion criteria for quantitative synthesis. There were large variations in the exercise programme's content, mode of delivery, frequency and duration, participant's symptoms, duration of symptoms, outcomes measured, methodological quality and reporting. Comparator groups were varied and included normal care; education; and attention controls such as home visits, sham gel and wait list controls. Risk of bias was high in one and unclear risk in five studies regarding the randomisation process, high for 11 studies regarding allocation concealment, high for all 21 studies regarding blinding, and high for three studies and unclear for five studies regarding attrition. Studies did not provide information on adverse effects.\nThere was moderate quality evidence that exercise reduced pain by an absolute percent reduction of 6% (95% confidence interval (CI) -9% to -4%, (9 studies, 1058 participants), equivalent to reducing (improving) pain by 1.25 points from 6.5 to 5.3 on a 0 to 20 scale and moderate quality evidence that exercise improved physical function by an absolute percent of 5.6% (95% CI -7.6% to 2.0%; standardised mean difference (SMD) -0.27, 95% CI -0.37 to -0.17, equivalent to reducing (improving) WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) function on a 0 to 100 scale from 49.9 to 44.3) (13 studies, 1599 participants)). Self-efficacy was increased by an absolute percent of 1.66% (95% CI 1.08% to 2.20%), although evidence was low quality (SMD 0.46, 95% CI 0.34 to 0.58, equivalent to improving the ExBeliefs score on a 17 to 85 scale from 64.3 to 65.4), with small benefits for depression from moderate quality evidence indicating an absolute percent reduction of 2.4% (95% CI -0.47% to 0.5%) (SMD -0.16, 95% CI -0.29 to -0.02, equivalent to improving depression measured using HADS (Hospital Anxiety and Depression Scale) on a 0 to 21 scale from 3.5 to 3.0) but no clinically or statistically significant effect on anxiety (SMD -0.11, 95% CI -0.26 to 0.05, 2% absolute improvement, 95% CI -5% to 1% equivalent to improving HADS anxiety on a 0 to 21 scale from 5.8 to 5.4; moderate quality evidence). Five studies measured the effect of exercise on health-related quality of life using the 36-item Short Form (SF-36) with statistically significant benefits for social function, increasing it by an absolute percent of 7.9% (95% CI 4.1% to 11.6%), equivalent to increasing SF-36 social function on a 0 to 100 scale from 73.6 to 81.5, although the evidence was low quality. Evidence was downgraded due to heterogeneity of measures, limitations with blinding and lack of detail regarding interventions. For 20/21 studies, there was a high risk of bias with blinding as participants self-reported and were not blinded to their participation in an exercise intervention.\nTwelve studies (with 6 to 29 participants) met inclusion criteria for qualitative synthesis. Their methodological rigour and quality was generally good. From the patients' perspectives, ways to improve the delivery of exercise interventions included: provide better information and advice about the safety and value of exercise; provide exercise tailored to individual's preferences, abilities and needs; challenge inappropriate health beliefs and provide better support.\nAn integrative review, which compared the findings from quantitative trials with low risk of bias and the implications derived from the high-quality studies in the qualitative synthesis, confirmed the importance of these implications.\nAuthors' conclusions\nChronic hip and knee pain affects all domains of people's lives. People's beliefs about chronic pain shape their attitudes and behaviours about how to manage their pain. People are confused about the cause of their pain, and bewildered by its variability and randomness. Without adequate information and advice from healthcare professionals, people do not know what they should and should not do, and, as a consequence, avoid activity for fear of causing harm. Participation in exercise programmes may slightly improve physical function, depression and pain. It may slightly improve self-efficacy and social function, although there is probably little or no difference in anxiety. Providing reassurance and clear advice about the value of exercise in controlling symptoms, and opportunities to participate in exercise programmes that people regard as enjoyable and relevant, may encourage greater exercise participation, which brings a range of health benefits to a large population of people.\n\nGiven the provided abstract, please respond to the following query: \"What happens to people with chronic knee or hip pain who take part in exercise programmes?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A search of medical databases up to March 2016 found 21 studies with 2372 people which considered pain, movement or both alongside psychological and social outcomes when people with pain and stiffness in their knee, hip, or both took part in exercise. Participation in exercise programmes probably slightly improves pain, physical function, depression, and ability to connect with others, and little or no difference in anxiety. It may improve belief in one's own abilities, and social function.\nThe studies confirmed that:\n- people who exercised rated their pain to be 1.2 points lower on a scale of 0 to 20 after about 45 weeks (score: 5.3 with exercise compared with 6.5 with no exercise (control), an improvement of 6%).\n- physical function improved by about 5% over 41 weeks (exercise group improved by 5.6 points on a scale of 0 to 100 (44.3 with exercise compared with 49.9 with control)).\n- people's confidence in what they could do increased by 2% after 35 weeks (exercise group improved by 1.1 points on a scale of 17 to 85 (65.4 with exercise compared with 64.3 with control)).\n- people who exercised were 2% less depressed, or half a point on a scale of 0 to 21, after 35 weeks (3.0 points with exercise compared with 3.5 with control).\n- exercise made people feel less anxious about themselves by 2%, a 0.4 drop on a 0 to 21 scale, after 24 weeks (5.4 points with exercise compared with 5.8 with control).\n- exercise resulted in social interaction improving by 7.9 points over 36 weeks on a scale of 0 to 100, giving a change of 8% (81.5 with exercise compared with 73.6 with control).\nThe quality of the evidence was generally moderate, but low for confidence in ability, mental health and social function. This is mainly due to varied measures, making comparison more difficult, and because people taking part knew they were exercising so may have been influenced by expectations of improvement. The studies did not report side effects. Studies lasted for different durations, so we do not know if changes occurred quickly and were maintained, or whether improvements were gradual throughout the studies. Some studies took measurements later after the programme than others.\nAdditionally, 12 studies investigated people's opinions, beliefs and experiences of exercise, and whether exercise changed these. The quality of evidence was high overall. Initially people were confused about the characteristics of their pain, which shaped their feelings, behaviours and decisions about relieving pain. People thought movement and exercise was good for joints, but movement caused pain and they worried this might cause them harm. Lack of information from medical professionals meant people avoided physical activity and exercise for fear of causing damage.\nOverall, people who had taken part in exercise programmes had positive experiences, helping increase their beliefs that exercise could improve pain, physical and mental health, and general quality of life.\nProviding reassurance and exercise advice, challenging poor health beliefs, and providing enjoyable exercise programmes may encourage participation and benefit the health of many people."
}
] |
query-laysum
|
7116
|
[
{
"role": "user",
"content": "Abstract: Background\nMaternal pushing during the second stage of labour is an important and indispensable contributor to the involuntary expulsive force developed by uterine contraction. There is no consensus on an ideal strategy to facilitate these expulsive efforts and there are contradictory results about the influence on the mother and fetus.\nObjectives\nTo evaluate the benefits and possible disadvantages of different kinds of techniques regarding maternal pushing/breathing during the expulsive stage of labour on maternal and fetal outcomes.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (19 September 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs assessing the effects of pushing/bearing down techniques (type and/or timing) performed during the second stage of labour on maternal and neonatal outcomes. Cluster-RCTs were eligible for inclusion, but none were identified. Studies using a cross-over design and those published in abstract form only were not eligible for inclusion in this review.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. Data were checked for accuracy.\nMain results\nIn this updated review, we included 21 studies in total, eight (884 women) comparing spontaneous pushing versus directed pushing, with or without epidural analgesia and 13 (2879 women) comparing delayed pushing versus immediate pushing with epidural analgesia. Our GRADE assessments of evidence ranged from moderate to very low quality; the main reasons for downgrading were study design limitations and imprecision of effect estimates. Overall, the included studies varied in their risk of bias; most were judged to be at unclear risk of bias.\nComparison 1: types of pushing: spontaneous pushing versus directed pushing\nThere was no clear difference in the duration of the second stage of labour (mean difference (MD) 10.26 minutes; 95% confidence interval (CI) -1.12 to 21.64 minutes, six studies, 667 women, random-effects, I² = 81%) (very low-quality evidence). There was no clear difference in 3rd or 4th degree perineal laceration (risk ratio (RR) 0.87; 95% CI 0.45 to 1.66, one study, 320 women) (low-quality evidence), episiotomy (average RR 1.05; 95% CI 0.60 to 1.85, two studies, 420 women, random-effects, I² = 81%), duration of pushing (MD -9.76 minutes, 95% CI -19.54 to 0.02; two studies; 169 women; I² = 88%) (very low-quality evidence), or rate of spontaneous vaginal delivery (RR 1.01, 95% CI 0.97 to 1.05; five studies; 688 women; I² = 2%) (moderate-quality evidence). For primary neonatal outcomes such as five-minute Apgar score less than seven, there was no clear difference between groups (RR 0.35; 95% CI 0.01 to 8.43, one study, 320 infants) (very low-quality evidence), and the number of admissions to neonatal intensive care (RR 1.08; 95% CI 0.30 to 3.79, two studies, 393 infants) (very low-quality evidence) also showed no clear difference between spontaneous and directed pushing. No data were available on hypoxic ischaemic encephalopathy.\nComparison 2: timing of pushing: delayed pushing versus immediate pushing (all women with epidural)\nFor the primary maternal outcomes, delayed pushing was associated with an increase of 56 minutes in the duration of the second stage of labour (MD 56.40, 95% CI 42.05 to 70.76; 11 studies; 3049 women; I² = 91%) (very low-quality evidence), but no clear difference in third or 4th degree perineal laceration (RR 0.94; 95% CI 0.78 to 1.14, seven studies. 2775 women) (moderate-quality evidence) or episiotomy (RR 0.95; 95% CI 0.87 to 1.04, five studies, 2320 women). Delayed pushing was also associated with a 19-minute decrease in the duration of pushing (MD -19.05, 95% CI -32.27 to -5.83; 11 studies; 2932 women; I² = 95%) (very low-quality evidence) and an increase in spontaneous vaginal delivery (RR 1.07; 95% CI 1.02 to 1.11, 12 studies, 3114 women) (moderate-quality evidence).\nFor the primary neonatal outcomes, there was no clear difference between groups in admission to neonatal intensive care (RR 0.98; 95% CI 0.67 to 1.41, three studies, n = 2197) (low-quality evidence) and five-minute Apgar score less than seven (RR 0.15; 95% CI 0.01 to 3.00; three studies; 413 infants) (very low-quality evidence). There were no data on hypoxic ischaemic encephalopathy. Delayed pushing was associated with a greater incidence of low umbilical cord blood pH (RR 2.24; 95% CI 1.37 to 3.68, 4 studies, 2145 infants) and increased the cost of intrapartum care by CDN$ 68.22 (MD 68.22, 95% CI 55.37, 81.07, one study, 1862 women).\nAuthors' conclusions\nThis updated review is based on 21 included studies of moderate to very low quality of evidence (with evidence mainly downgraded due to study design limitations and imprecision of effect estimates).\nTiming of pushing with epidural is consistent in that delayed pushing leads to a shortening of the actual time pushing and increase of spontaneous vaginal delivery at the expense of an overall longer duration of the second stage of labour and an increased risk of a low umbilical cord pH (based only on one study). Nevertheless, there was no clear difference in serious perineal laceration and episiotomy, and in other neonatal outcomes (admission to neonatal intensive care, five-minute Apgar score less than seven and delivery room resuscitation) between delayed and immediate pushing.\nTherefore, for the type of pushing, with or without epidural, there is no conclusive evidence to support or refute any specific style as part of routine clinical practice, and in the absence of strong evidence supporting a specific method or timing of pushing, the woman's preference and comfort and clinical context should guide decisions.\nFurther properly well-designed RCTs, addressing clinically important maternal and neonatal outcomes are required to add evidence-based information to the current knowledge. Such trials will provide more complete data to be incorporated into a future update of this review.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are unable to say whether spontaneous pushing or directed pushing coaching methods are best. Until further high-quality studies are available, women should be encouraged to push and bear down according to their comfort and preference.\nDelaying pushing for women with epidural reduces the time spent pushing when giving birth, and increases the likelihood of a spontaneous vaginal birth. However, it increases the duration of the second stage. The possible effects on important neonatal outcomes and maternal perineal injury (serious tears) is still unclear. Therefore, the evidence is still insufficient and inconclusive to support any indication of specific timing of pushing as well as for the type of pushing once there is no conclusive evidence to indicate an adequate style of pushing to be used in the clinical practice.\nFurther properly well-designed randomised controlled trials are required to produce more evidence-based information. These trials should address clinically important maternal and neonatal outcomes and will provide more complete data to be incorporated into a future update of this review."
}
] |
query-laysum
|
7117
|
[
{
"role": "user",
"content": "Abstract: Background\nNicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). This is an update of a Cochrane Review first published in 2007.\nObjectives\nTo assess the effectiveness of nicotine receptor partial agonists, including varenicline and cytisine, for smoking cessation.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group's Specialised Register in April 2022 for trials, using relevant terms in the title or abstract, or as keywords. The register is compiled from searches of CENTRAL, MEDLINE, Embase, and PsycINFO.\nSelection criteria\nWe included randomised controlled trials that compared the treatment drug with placebo, another smoking cessation drug, e-cigarettes, or no medication. We excluded trials that did not report a minimum follow-up period of six months from baseline.\nData collection and analysis\nWe followed standard Cochrane methods. Our main outcome was abstinence from smoking at longest follow-up using the most rigorous definition of abstinence, preferring biochemically validated rates where reported. We pooled risk ratios (RRs), using the Mantel-Haenszel fixed-effect model. We also reported the number of people reporting serious adverse events (SAEs).\nMain results\nWe included 75 trials of 45,049 people; 45 were new for this update. We rated 22 at low risk of bias, 18 at high risk, and 35 at unclear risk.\nWe found moderate-certainty evidence (limited by heterogeneity) that cytisine helps more people to quit smoking than placebo (RR 1.30, 95% confidence interval (CI) 1.15 to 1.47; I2 = 83%; 4 studies, 4623 participants), and no evidence of a difference in the number reporting SAEs (RR 1.04, 95% CI 0.78 to 1.37; I2 = 0%; 3 studies, 3781 participants; low-certainty evidence). SAE evidence was limited by imprecision. We found no data on neuropsychiatric or cardiac SAEs.\nWe found high-certainty evidence that varenicline helps more people to quit than placebo (RR 2.32, 95% CI 2.15 to 2.51; I2 = 60%, 41 studies, 17,395 participants), and moderate-certainty evidence that people taking varenicline are more likely to report SAEs than those not taking it (RR 1.23, 95% CI 1.01 to 1.48; I2 = 0%; 26 studies, 14,356 participants). While point estimates suggested increased risk of cardiac SAEs (RR 1.20, 95% CI 0.79 to 1.84; I2 = 0%; 18 studies, 7151 participants; low-certainty evidence), and decreased risk of neuropsychiatric SAEs (RR 0.89, 95% CI 0.61 to 1.29; I2 = 0%; 22 studies, 7846 participants; low-certainty evidence), in both cases evidence was limited by imprecision, and confidence intervals were compatible with both benefit and harm.\nPooled results from studies that randomised people to receive cytisine or varenicline found no clear evidence of difference in quit rates (RR 1.00, 95% CI 0.79 to 1.26; I2 = 65%; 2 studies, 2131 participants; low-certainty evidence) and reported SAEs (RR 0.67, 95% CI 0.44 to 1.03; I2 = 45%; 2 studies, 2017 participants; low-certainty evidence). However, the evidence was limited by imprecision, and confidence intervals incorporated the potential for benefit from either cytisine or varenicline. We found no data on neuropsychiatric or cardiac SAEs.\nWe found high-certainty evidence that varenicline helps more people to quit than bupropion (RR 1.36, 95% CI 1.25 to 1.49; I2 = 0%; 9 studies, 7560 participants), and no clear evidence of difference in rates of SAEs (RR 0.89, 95% CI 0.61 to 1.31; I2 = 0%; 5 studies, 5317 participants), neuropsychiatric SAEs (RR 1.05, 95% CI 0.16 to 7.04; I2 = 10%; 2 studies, 866 participants), or cardiac SAEs (RR 3.17, 95% CI 0.33 to 30.18; I2 = 0%; 2 studies, 866 participants). Evidence of harms was of low certainty, limited by imprecision.\nWe found high-certainty evidence that varenicline helps more people to quit than a single form of nicotine replacement therapy (NRT) (RR 1.25, 95% CI 1.14 to 1.37; I2 = 28%; 11 studies, 7572 participants), and low-certainty evidence, limited by imprecision, of fewer reported SAEs (RR 0.70, 95% CI 0.50 to 0.99; I2 = 24%; 6 studies, 6535 participants). We found no data on neuropsychiatric or cardiac SAEs.\nWe found no clear evidence of a difference in quit rates between varenicline and dual-form NRT (RR 1.02, 95% CI 0.87 to 1.20; I2 = 0%; 5 studies, 2344 participants; low-certainty evidence, downgraded because of imprecision). While pooled point estimates suggested increased risk of SAEs (RR 2.15, 95% CI 0.49 to 9.46; I2 = 0%; 4 studies, 1852 participants) and neuropsychiatric SAEs (RR 4.69, 95% CI 0.23 to 96.50; I2 not estimable as events only in 1 study; 2 studies, 764 participants), and reduced risk of cardiac SAEs (RR 0.32, 95% CI 0.01 to 7.88; I2 not estimable as events only in 1 study; 2 studies, 819 participants), in all three cases evidence was of low certainty and confidence intervals were very wide, encompassing both substantial harm and benefit.\nAuthors' conclusions\nCytisine and varenicline both help more people to quit smoking than placebo or no medication. Varenicline is more effective at helping people to quit smoking than bupropion, or a single form of NRT, and may be as or more effective than dual-form NRT. People taking varenicline are probably more likely to experience SAEs than those not taking it, and while there may be increased risk of cardiac SAEs and decreased risk of neuropsychiatric SAEs, evidence was compatible with both benefit and harm. Cytisine may lead to fewer people reporting SAEs than varenicline. Based on studies that directly compared cytisine and varenicline, there may be no difference or a benefit from either medication for quitting smoking.\nFuture trials should test the effectiveness and safety of cytisine compared with varenicline and other pharmacotherapies, and should also test variations in dose and duration. There is limited benefit to be gained from more trials testing the effect of standard-dose varenicline compared with placebo for smoking cessation. Further trials on varenicline should test variations in dose and duration, and compare varenicline with e-cigarettes for smoking cessation.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 75 studies that compared NRPAs with:\n· placebo or no medicine;\n· nicotine replacement therapy, such as patches or gum;\n· bupropion (another medicine to help people stop smoking);\n· another NRPA;\n· e-cigarettes.\nThe USA hosted the most studies (28 studies). Other studies took place in a range of countries across the world, some in several countries."
}
] |
query-laysum
|
7118
|
[
{
"role": "user",
"content": "Abstract: Background\nThere are many accepted airway clearance techniques (ACTs) for managing the respiratory health of people with cystic fibrosis (CF); none of which demonstrate superiority. Other Cochrane Reviews have reported short-term effects related to mucus transport, but no evidence supporting long-term benefits. Exercise is an alternative ACT thought to produce shearing forces within the lung parenchyma, which enhances mucociliary clearance and the removal of viscous secretions.\nRecent evidence suggests that some people with CF are using exercise as a substitute for traditional ACTs, yet there is no agreed recommendation for this. Additionally, one of the top 10 research questions identified by people with CF is whether exercise can replace other ACTs.\nSystematically reviewing the evidence for exercise as a safe and effective ACT will help people with CF decide whether to incorporate this strategy into their treatment plans and potentially reduce their treatment burden. The timing of this review is especially pertinent given the shifting landscape of CF management with the advent of highly-effective small molecule therapies, which are changing the way people with CF are cared for.\nObjectives\nTo compare the effect of exercise to other ACTs for improving respiratory function and other clinical outcomes in people with CF and to assess the potential adverse effects associated with this ACT.\nSearch methods\nOn 28 February 2022, we searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews.\nWe searched online clinical trial registries on 15 February 2022.\nWe emailed authors of studies awaiting classification or potentially eligible abstracts for additional information on 1 February 2021.\nSelection criteria\nWe selected randomised controlled studies (RCTs) and quasi-RCTs comparing exercise to another ACT in people with CF for at least two treatment sessions.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias for the included studies. They assessed the certainty of the evidence using GRADE. Review authors contacted investigators for further relevant information regarding their publications.\nMain results\nWe included four RCTs. The 86 participants had a wide range of disease severity (forced expiratory volume in one second (FEV1) ranged from 54% to 95%) and were 7 to 41 years old. Two RCTs were cross-over and two were parallel in design. Participants in one RCT were hospitalised with an acute respiratory exacerbation, whilst the participants in three RCTs were clinically stable. All four RCTs compared exercise either alone or in combination with another ACT, but these were too diverse to allow us to combine results. The certainty of the evidence was very low; we downgraded it due to low participant numbers and high or unclear risks of bias across all domains.\nExercise versus active cycle of breathing technique (ACBT)\nOne cross-over trial (18 participants) compared exercise alone to ACBT. There was no change from baseline in our primary outcome FEV1, although it increased in the exercise group before returning to baseline after 30 minutes; we are unsure if exercise affected FEV1 as the evidence is very low-certainty. Similar results were seen for other measures of lung function. No adverse events occurred during the exercise sessions (very low-certainty evidence). We are unsure if ACBT was perceived to be more effective or was the preferred ACT (very low-certainty evidence). 24-hour sputum volume was less in the exercise group than with ACBT (secondary outcome). Exercise capacity, quality of life, adherence, hospitalisations and need for additional antibiotics were not reported.\nExercise plus postural drainage and percussion (PD&P) versus PD&P only\nTwo trials (55 participants) compared exercise and PD&P to PD&P alone. At two weeks, one trial narratively reported a greater increase in FEV1 % predicted with PD&P alone. At six months, the other trial reported a greater increase with exercise combined with PD&P, but did not provide data for the PD&P group. We are uncertain whether exercise with PD&P improves FEV1 as the certainty of evidence is very low. Other measures of lung function did not show clear evidence of effect. One trial reported no difference in exercise capacity (maximal work rate) after two weeks. No adverse events were reported (1 trial, 17 participants; very low-certainty evidence). Adherence was high, with all PD&P sessions and 96% of exercise sessions completed (1 trial, 17 participants; very low-certainty evidence). There was no difference between groups in 24-hour sputum volume or in the mean duration of hospitalisation, although the six-month trial reported fewer hospitalisations due to exacerbations in the exercise and PD&P group. Quality of life, ACT preference and need for antibiotics were not reported.\nExercise versus underwater positive expiratory pressure (uPEP)\nOne trial (13 participants) compared exercise to uPEP (also known as bubble PEP). No adverse events were recorded in either group (very low-certainty evidence). Trial investigators reported that participants perceived exercise as more fatiguing but also more enjoyable than bubble PEP (very low-certainty evidence). There were no differences found in the total weight of sputum collected during treatment sessions. The trial did not report the primary outcomes (FEV1, quality of life, exercise capacity) or the secondary outcomes (other measures of lung function, adherence, need for antibiotics or hospitalisations).\nAuthors' conclusions\nAs one of the top 10 research questions identified by clinicians and people with CF, it is important to systematically review the literature regarding whether or not exercise is an acceptable and effective ACT, and whether it can replace traditional methods. We identified an insufficient number of trials to conclude whether or not exercise is a suitable alternative ACT, and the diverse design of included trials did not allow for meta-analysis of results. The evidence is very low-certainty, so we are uncertain about the effectiveness of exercise as an ACT. Longer studies examining outcomes that are important to people with CF are required to answer this question.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Can exercise replace other methods of airway clearance for people with cystic fibrosis (CF)?"
}
] |
query-laysum
|
7119
|
[
{
"role": "user",
"content": "Abstract: Background\nMost ischaemic strokes are caused by blockage of a cerebral artery by a thrombus. Intravenous administration of recombinant tissue plasminogen activator given within 4.5 hours is now standard treatment for this condition. Percutaneous vascular interventions use an intra-arterial, mechanical approach for thrombus disruption or removal (thrombectomy). Recent randomised trials indicate that percutaneous vascular interventions are superior to usual care (usual care usually included intravenous thrombolysis). However, intravenous thrombolysis was usually given in both arms of the trial and there was a lack of direct comparison of percutaneous vascular interventions with intravenous thrombolysis.\nObjectives\nTo assess the effectiveness and safety of percutaneous vascular interventions compared with intravenous thrombolytic treatment for acute ischaemic stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last search: August 2018). In addition, in September 2017, we searched the following electronic databases: CENTRAL, MEDLINE, Embase, and Science Citation Index; and Stroke Trials Registry, and US National Institutes of Health Ongoing Trials Register, ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) that directly compared a percutaneous vascular intervention with intravenous thrombolytic treatment in people with acute ischaemic stroke.\nData collection and analysis\nTwo review authors applied the inclusion criteria, extracted data, and assessed risk of bias. We obtained both published and unpublished data. We assessed the quality of the evidence using the GRADE approach.\nMain results\nWe included four trials with 450 participants. Data on functional outcome and death at end of follow-up were available for 443 participants from three trials. Compared with intravenous thrombolytic therapy, percutaneous vascular intervention did not improve the proportion of participants with good functional outcome (modified Rankin Scale score 0 to 2, risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.25, P = 0.92). The quality of evidence was low (outcome assessment was blinded, but not the treating physician or participants). At the end of follow-up, there was a non-significant increase in the proportion of participants who died in the percutaneous vascular intervention group (RR 1.34, 95% CI 0.84 to 2.14, P = 0.21). The quality of evidence was low (wide confidence interval). There was no difference in the proportion of participants with symptomatic intracranial haemorrhages between the intervention and control groups (RR 0.99, 95% CI 0.50 to 1.95, P = 0.97). The quality of evidence was low (wide confidence interval). Data on vascular status (recanalisation rate) were only available for seven participants from one trial; we considered this inadequate for statistical analyses.\nAuthors' conclusions\nThe present review directly compared intravenous thrombolytic treatment with percutaneous vascular interventions for ischaemic stroke. We found no evidence from RCTs that percutaneous vascular interventions are superior to intravenous thrombolytic treatment with respect to functional outcome. Quality of evidence was low (outcome assessment was blinded, but not the treating physician or participants). New trials with adequate sample sizes are warranted because of the rapid development of new techniques and devices for such interventions.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current as of September 2017."
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query-laysum
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7120
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[
{
"role": "user",
"content": "Abstract: Background\nThe use of insulin-sensitising agents, such as metformin, in women with polycystic ovary syndrome (PCOS) who are undergoing ovulation induction or in vitro fertilisation (IVF) cycles has been widely studied. Metformin reduces hyperinsulinaemia and suppresses the excessive ovarian production of androgens. It is suggested that as a consequence metformin could improve assisted reproductive techniques (ART) outcomes, such as ovarian hyperstimulation syndrome (OHSS), pregnancy, and live birth rates.\nObjectives\nTo determine the effectiveness and safety of metformin as a co-treatment during IVF or intracytoplasmic sperm injection (ICSI) in achieving pregnancy or live birth in women with PCOS.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL via the Cochrane Register of Studies Online (CRSO), MEDLINE, Embase, PsycINFO, LILACS, the trial registries for ongoing trials, and reference lists of articles (from inception to 13 February 2020).\nSelection criteria\nTypes of studies: randomised controlled trials (RCTs) comparing metformin treatment with placebo or no treatment in women with PCOS who underwent IVF or ICSI treatment.\nTypes of participants: women of reproductive age with anovulation due to PCOS with or without co-existing infertility factors.\nTypes of interventions: metformin administered before and during IVF or ICSI treatment.\nPrimary outcome measures: live birth rate, incidence of ovarian hyperstimulation syndrome.\nData collection and analysis\nTwo review authors independently selected the studies, extracted the data according to the protocol, and assessed study quality. We assessed the overall quality of the evidence using the GRADE approach.\nMain results\nThis updated review includes 13 RCTs involving a total of 1132 women with PCOS undergoing IVF/ICSI treatments. We stratified the analysis by type of ovarian stimulation protocol used (long gonadotrophin-releasing hormone agonist (GnRH-agonist) or short gonadotrophin-releasing hormone antagonist (GnRH-antagonist)) to determine whether the type of stimulation used influenced the outcomes. We did not perform meta-analysis on the overall (both ovarian stimulation protocols combined) data for the outcomes of live birth and clinical pregnancy rates per woman because of substantial heterogeneity.\nIn the long protocol GnRH-agonist subgroup, the pooled evidence showed that we are uncertain of the effect of metformin on live birth rate per woman when compared with placebo/no treatment (risk ratio (RR) 1.30, 95% confidence interval (CI) 0.94 to 1.79; 6 RCTs; 651 women; I2 = 47%; low-quality evidence). This suggests that if the chance for live birth following placebo/no treatment is 28%, the chance following metformin would be between 27% and 51%. Only one study used short protocol GnRH-antagonist and reported live birth rate. Metformin may reduce live birth rate compared with placebo/no treatment (RR 0.48, 95% CI 0.29 to 0.79; 1 RCT; 153 women; low-quality evidence). This suggests that if the chance for live birth following placebo/no treatment is 43%, the chance following metformin would be between 13% and 34% (short GnRH-antagonist protocol). We found that metformin may reduce the incidence of OHSS (RR 0.46, 95% CI 0.29 to 0.72; 11 RCTs; 1091 women; I2 = 38%; low-quality evidence). This suggests that for a woman with a 20% risk of OHSS without metformin, the corresponding risk using metformin would be between 6% and 14%. Using long protocol GnRH-agonist stimulation, metformin may increase clinical pregnancy rate per woman compared with placebo/no treatment (RR 1.32, 95% CI 1.08 to 1.63; 10 RCTs; 915 women; I2 = 13%; low-quality evidence). Using short protocol GnRH-antagonist, we are uncertain of the effect of metformin on clinical pregnancy rate per woman compared with placebo/no treatment (RR 1.38, 95% CI 0.21 to 9.14; 2 RCTs; 177 women; I2 = 87%; very low-quality evidence).\nWe are uncertain of the effect of metformin on miscarriage rate per woman when compared with placebo/no treatment (RR 0.86, 95% CI 0.56 to 1.32; 8 RCTs; 821 women; I2 = 0%; low-quality evidence). Metformin may result in an increase in side effects compared with placebo/no treatment (RR 3.35, 95% CI 2.34 to 4.79; 8 RCTs; 748 women; I2 = 0%; low-quality evidence).\nThe overall quality of evidence ranged from very low to low. The main limitations were inconsistency, risk of bias, and imprecision.\nAuthors' conclusions\nThis updated review on metformin versus placebo/no treatment before or during IVF/ICSI treatment in women with PCOS found no conclusive evidence that metformin improves live birth rates. In a long GnRH-agonist protocol, we are uncertain whether metformin improves live birth rates, but metformin may increase the clinical pregnancy rate. In a short GnRH-antagonist protocol, metformin may reduce live birth rates, although we are uncertain about the effect of metformin on clinical pregnancy rate. Metformin may reduce the incidence of OHSS but may result in a higher incidence of side effects. We are uncertain of the effect of metformin on miscarriage rate per woman.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 13 randomised controlled trials (a type of study in which participants are assigned to one of two or more treatment groups using a random method) involving a total of 1132 women assigned to receive either metformin (570) or placebo (dummy treatment)/no treatment (563). The evidence is current to 13 February 2020."
}
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query-laysum
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7121
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[
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"role": "user",
"content": "Abstract: Background\nUpper endoscopy is the definitive treatment for upper gastrointestinal haemorrhage (UGIH). However, up to 13% of people who undergo upper endoscopy will have incomplete visualisation of the gastric mucosa at presentation. Erythromycin acts as a motilin receptor agonist in the upper gastrointestinal (GI) tract and increases gastric emptying, which may lead to better quality of visualisation and improved treatment effectiveness. However, there is uncertainty about the benefits and harms of erythromycin in UGIH.\nObjectives\nTo evaluate the benefits and harms of erythromycin before endoscopy in adults with acute upper gastrointestinal haemorrhage, compared with any other treatment or no treatment/placebo.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 15 October 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) that investigated erythromycin before endoscopy compared to any other treatment or no treatment/placebo before endoscopy in adults with acute UGIH.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. UGIH-related mortality and 2. serious adverse events. Our secondary outcomes were 1. all-cause mortality, 2. visualisation of gastric mucosa, 3. non-serious adverse events, 4. rebleeding, 5. blood transfusion, and 5. rescue invasive intervention. We used GRADE criteria to assess the certainty of the evidence for each outcome.\nMain results\nWe included 11 RCTs with 878 participants. The mean age ranged from 53.13 years to 64.5 years, and most participants were men (72.3%). One RCT included only non-variceal haemorrhage, one included only variceal haemorrhage, and eight included both aetiologies. We defined short-term outcomes as those occurring within one week of initial endoscopy.\nErythromycin versus placebo\nThree RCTs (255 participants) compared erythromycin with placebo. There were no UGIH-related deaths. The evidence is very uncertain about the short-term effects of erythromycin compared with placebo on serious adverse events (risk difference (RD) −0.01, 95% confidence interval (CI) −0.04 to 0.02; 3 studies, 255 participants; very low certainty), all-cause mortality (RD 0.00, 95% CI −0.03 to 0.03; 3 studies, 255 participants; very low certainty), non-serious adverse events (RD 0.01, 95% CI −0.03 to 0.05; 3 studies, 255 participants; very low certainty), and rebleeding (risk ratio (RR) 0.63, 95% CI 0.13 to 2.90; 2 studies, 195 participants; very low certainty). Erythromycin may improve gastric mucosa visualisation (mean difference (MD) 3.63 points on 16-point ordinal scale, 95% CI 2.20 to 5.05; higher MD means better visualisation; 2 studies, 195 participants; low certainty). Erythromycin may also result in a slight reduction in blood transfusion (MD −0.44 standard units of blood, 95% CI −0.86 to −0.01; 3 studies, 255 participants; low certainty).\nErythromycin plus nasogastric tube lavage versus no intervention/placebo plus nasogastric tube lavage\nSix RCTs (408 participants) compared erythromycin plus nasogastric tube lavage with no intervention/placebo plus nasogastric tube lavage. There were no UGIH-related deaths and no serious adverse events. The evidence is very uncertain about the short-term effects of erythromycin plus nasogastric tube lavage compared with no intervention/placebo plus nasogastric tube lavage on all-cause mortality (RD −0.02, 95% CI −0.08 to 0.03; 3 studies, 238 participants; very low certainty), visualisation of the gastric mucosa (standardised mean difference (SMD) 0.48 points on 10-point ordinal scale, 95% CI 0.10 to 0.85; higher SMD means better visualisation; 3 studies, 170 participants; very low certainty), non-serious adverse events (RD 0.00, 95% CI −0.05 to 0.05; 6 studies, 408 participants; very low certainty), rebleeding (RR 1.13, 95% CI 0.63 to 2.02; 1 study, 169 participants; very low certainty), and blood transfusion (MD −1.85 standard units of blood, 95% CI −4.34 to 0.64; 3 studies, 180 participants; very low certainty).\nErythromycin versus nasogastric tube lavage\nFour RCTs (287 participants) compared erythromycin with nasogastric tube lavage. There were no UGIH-related deaths and no serious adverse events. The evidence is very uncertain about the short-term effects of erythromycin compared with nasogastric tube lavage on all-cause mortality (RD 0.02, 95% CI −0.05 to 0.08; 3 studies, 213 participants; very low certainty), visualisation of the gastric mucosa (RR 1.19, 95% CI 0.79 to 1.79; 2 studies, 198 participants; very low certainty), non-serious adverse events (RD −0.10, 95% CI −0.34 to 0.13; 3 studies, 213 participants; very low certainty), rebleeding (RR 0.77, 95% CI 0.40 to 1.49; 1 study, 169 participants; very low certainty), and blood transfusion (median 2 standard units of blood, interquartile range 0 to 4 in both groups; 1 study, 169 participants; very low certainty).\nErythromycin plus nasogastric tube lavage versus metoclopramide plus nasogastric tube lavage\nOne RCT (30 participants) compared erythromycin plus nasogastric tube lavage with metoclopramide plus nasogastric tube lavage. The evidence is very uncertain about the effects of erythromycin plus nasogastric tube lavage on all the reported outcomes (serious adverse events, visualisation of gastric mucosa, non-serious adverse events, and blood transfusion).\nAuthors' conclusions\nWe are unsure if erythromycin before endoscopy in people with UGIH has any clinical benefits or harms. However, erythromycin compared with placebo may improve gastric mucosa visualisation and result in a slight reduction in blood transfusion.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Erythromycin compared with placebo\nThree studies (255 people) compared erythromycin with placebo. There were no deaths related to bleeding. We do not know if erythromycin has an effect on serious unwanted events, death by any cause, mild unwanted effects, or rebleeding. Erythromycin may make it easier to see the stomach during endoscopy and may reduce blood transfusion slightly.\nErythromycin plus nasogastric tube lavage versus no treatment/placebo plus nasogastric tube lavage\nSix studies (408 people) compared erythromycin plus nasogastric tube lavage with no treatment/placebo plus nasogastric tube lavage. There were no deaths related to bleeding and no serious unwanted events. We do not know if erythromycin plus nasogastric tube lavage compared to no treatment/placebo plus nasogastric tube lavage has an effect on death by any cause, ease of viewing the stomach, mild unwanted events, rebleeding, or blood transfusion.\nErythromycin versus nasogastric tube lavage\nFour studies (287 people) compared erythromycin with nasogastric tube lavage. There were no deaths related to bleeding and no severe unwanted events. We do not know if erythromycin compared with nasogastric tube lavage has any effect on death by any cause, ease of viewing the stomach, mild unwanted events, rebleeding, or blood transfusion.\nErythromycin plus nasogastric tube lavage versus metoclopramide plus nasogastric tube lavage\nOne study (30 people) compared erythromycin plus nasogastric tube lavage with metoclopramide plus nasogastric tube lavage. We do not know if erythromycin plus nasogastric tube lavage has an effect on any of the reported outcomes."
}
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query-laysum
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7122
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[
{
"role": "user",
"content": "Abstract: Background\nPrevious systematic reviews and randomised controlled trials have investigated the effect of post-stroke trunk training. Findings suggest that trunk training improves trunk function and activity or the execution of a task or action by an individual. But it is unclear what effect trunk training has on daily life activities, quality of life, and other outcomes.\nObjectives\nTo assess the effectiveness of trunk training after stroke on activities of daily living (ADL), trunk function, arm-hand function or activity, standing balance, leg function, walking ability, and quality of life when comparing with both dose-matched as non-dose-matched control groups.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, and five other databases to 25 October 2021. We searched trial registries to identify additional relevant published, unpublished, and ongoing trials. We hand searched the bibliographies of included studies.\nSelection criteria\nWe selected randomised controlled trials comparing trunk training versus non-dose-matched or dose-matched control therapy including adults (18 years or older) with either ischaemic or haemorrhagic stroke. Outcome measures of trials included ADL, trunk function, arm-hand function or activity, standing balance, leg function, walking ability, and quality of life.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nTwo main analyses were carried out. The first analysis included trials where the therapy duration of control intervention was non-dose-matched with the therapy duration of the experimental group and the second analysis where there was comparison with a dose-matched control intervention (equal therapy duration in both the control as in the experimental group).\nMain results\nWe included 68 trials with a total of 2585 participants.\nIn the analysis of the non-dose-matched groups (pooling of all trials with different training duration in the experimental as in the control intervention), we could see that trunk training had a positive effect on ADL (standardised mean difference (SMD) 0.96; 95% confidence interval (CI) 0.69 to 1.24; P < 0.001; 5 trials; 283 participants; very low-certainty evidence), trunk function (SMD 1.49, 95% CI 1.26 to 1.71; P < 0.001; 14 trials, 466 participants; very low-certainty evidence), arm-hand function (SMD 0.67, 95% CI 0.19 to 1.15; P = 0.006; 2 trials, 74 participants; low-certainty evidence), arm-hand activity (SMD 0.84, 95% CI 0.009 to 1.59; P = 0.03; 1 trial, 30 participants; very low-certainty evidence), standing balance (SMD 0.57, 95% CI 0.35 to 0.79; P < 0.001; 11 trials, 410 participants; very low-certainty evidence), leg function (SMD 1.10, 95% CI 0.57 to 1.63; P < 0.001; 1 trial, 64 participants; very low-certainty evidence), walking ability (SMD 0.73, 95% CI 0.52 to 0.94; P < 0.001; 11 trials, 383 participants; low-certainty evidence) and quality of life (SMD 0.50, 95% CI 0.11 to 0.89; P = 0.01; 2 trials, 108 participants; low-certainty evidence). Non-dose-matched trunk training led to no difference for the outcome serious adverse events (odds ratio: 7.94, 95% CI 0.16 to 400.89; 6 trials, 201 participants; very low-certainty evidence).\nIn the analysis of the dose-matched groups (pooling of all trials with equal training duration in the experimental as in the control intervention), we saw that trunk training had a positive effect on trunk function (SMD 1.03, 95% CI 0.91 to 1.16; P < 0.001; 36 trials, 1217 participants; very low-certainty evidence), standing balance (SMD 1.00, 95% CI 0.86 to 1.15; P < 0.001; 22 trials, 917 participants; very low-certainty evidence), leg function (SMD 1.57, 95% CI 1.28 to 1.87; P < 0.001; 4 trials, 254 participants; very low-certainty evidence), walking ability (SMD 0.69, 95% CI 0.51 to 0.87; P < 0.001; 19 trials, 535 participants; low-certainty evidence) and quality of life (SMD 0.70, 95% CI 0.29 to 1.11; P < 0.001; 2 trials, 111 participants; low-certainty evidence), but not for ADL (SMD 0.10; 95% confidence interval (CI) -0.17 to 0.37; P = 0.48; 9 trials; 229 participants; very low-certainty evidence), arm-hand function (SMD 0.76, 95% CI -0.18 to 1.70; P = 0.11; 1 trial, 19 participants; low-certainty evidence), arm-hand activity (SMD 0.17, 95% CI -0.21 to 0.56; P = 0.38; 3 trials, 112 participants; very low-certainty evidence). Trunk training also led to no difference for the outcome serious adverse events (odds ratio (OR): 7.39, 95% CI 0.15 to 372.38; 10 trials, 381 participants; very low-certainty evidence).\nTime post stroke led to a significant subgroup difference for standing balance (P < 0.001) in non-dose-matched therapy. In non-dose-matched therapy, different trunk therapy approaches had a significant effect on ADL (< 0.001), trunk function (P < 0.001) and standing balance (< 0.001).\nWhen participants received dose-matched therapy, analysis of subgroup differences showed that the trunk therapy approach had a significant effect on ADL (P = 0.001), trunk function (P < 0.001), arm-hand activity (P < 0.001), standing balance (P = 0.002), and leg function (P = 0.002). Also for dose-matched therapy, subgroup analysis for time post stroke resulted in a significant difference for the outcomes standing balance (P < 0.001), walking ability (P = 0.003) and leg function (P < 0.001), time post stroke significantly modified the effect of intervention.\nCore-stability trunk (15 trials), selective-trunk (14 trials) and unstable-trunk (16 trials) training approaches were mostly applied in the included trials.\nAuthors' conclusions\nThere is evidence to suggest that trunk training as part of rehabilitation improves ADL, trunk function, standing balance, walking ability, upper and lower limb function, and quality of life in people after stroke. Core-stability, selective-, and unstable-trunk training were the trunk training approaches mostly applied in the included trials. When considering only trials with a low risk of bias, results were mostly confirmed, with very low to moderate certainty, depending on the outcome.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched nine databases and hand searched the bibliographies of relevant studies published up to 25 October 2021."
}
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query-laysum
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7123
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[
{
"role": "user",
"content": "Abstract: Background\nPeripheral nerve block (infiltration of local anaesthetic around a nerve) is used for anaesthesia or analgesia. A limitation to its use for postoperative analgesia is that the analgesic effect lasts only a few hours, after which moderate to severe pain at the surgical site may result in the need for alternative analgesic therapy. Several adjuvants have been used to prolong the analgesic duration of peripheral nerve block, including perineural or intravenous dexamethasone.\nObjectives\nTo evaluate the comparative efficacy and safety of perineural dexamethasone versus placebo, intravenous dexamethasone versus placebo, and perineural dexamethasone versus intravenous dexamethasone when added to peripheral nerve block for postoperative pain control in people undergoing surgery.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, DARE, Web of Science and Scopus from inception to 25 April 2017. We also searched trial registry databases, Google Scholar and meeting abstracts from the American Society of Anesthesiologists, the Canadian Anesthesiologists' Society, the American Society of Regional Anesthesia, and the European Society of Regional Anaesthesia.\nSelection criteria\nWe included all randomized controlled trials (RCTs) comparing perineural dexamethasone with placebo, intravenous dexamethasone with placebo, or perineural dexamethasone with intravenous dexamethasone in participants receiving peripheral nerve block for upper or lower limb surgery.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 35 trials of 2702 participants aged 15 to 78 years; 33 studies enrolled participants undergoing upper limb surgery and two undergoing lower limb surgery. Risk of bias was low in 13 studies and high/unclear in 22.\nPerineural dexamethasone versus placebo\nDuration of sensory block was significantly longer in the perineural dexamethasone group compared with placebo (mean difference (MD) 6.70 hours, 95% confidence interval (CI) 5.54 to 7.85; participants1625; studies 27). Postoperative pain intensity at 12 and 24 hours was significantly lower in the perineural dexamethasone group compared with control (MD -2.08, 95% CI -2.63 to -1.53; participants 257; studies 5) and (MD -1.63, 95% CI -2.34 to -0.93; participants 469; studies 9), respectively. There was no significant difference at 48 hours (MD -0.61, 95% CI -1.24 to 0.03; participants 296; studies 4). The quality of evidence is very low for postoperative pain intensity at 12 hours and low for the remaining outcomes. Cumulative 24-hour postoperative opioid consumption was significantly lower in the perineural dexamethasone group compared with placebo (MD 19.25 mg, 95% CI 5.99 to 32.51; participants 380; studies 6).\nIntravenous dexamethasone versus placebo\nDuration of sensory block was significantly longer in the intravenous dexamethasone group compared with placebo (MD 6.21, 95% CI 3.53 to 8.88; participants 499; studies 8). Postoperative pain intensity at 12 and 24 hours was significantly lower in the intravenous dexamethasone group compared with placebo (MD -1.24, 95% CI -2.44 to -0.04; participants 162; studies 3) and (MD -1.26, 95% CI -2.23 to -0.29; participants 257; studies 5), respectively. There was no significant difference at 48 hours (MD -0.21, 95% CI -0.83 to 0.41; participants 172; studies 3). The quality of evidence is moderate for duration of sensory block and postoperative pain intensity at 24 hours, and low for the remaining outcomes. Cumulative 24-hour postoperative opioid consumption was significantly lower in the intravenous dexamethasone group compared with placebo (MD -6.58 mg, 95% CI -10.56 to -2.60; participants 287; studies 5).\nPerinerual versus intravenous dexamethasone\nDuration of sensory block was significantly longer in the perineural dexamethasone group compared with intravenous by three hours (MD 3.14 hours, 95% CI 1.68 to 4.59; participants 720; studies 9). We found that postoperative pain intensity at 12 hours and 24 hours was significantly lower in the perineural dexamethasone group compared with intravenous, however, the MD did not surpass our pre-determined minimally important difference of 1.2 on the Visual Analgue Scale/Numerical Rating Scale, therefore the results are not clinically significant (MD -1.01, 95% CI -1.51 to -0.50; participants 217; studies 3) and (MD -0.77, 95% CI -1.47 to -0.08; participants 309; studies 5), respectively. There was no significant difference in severity of postoperative pain at 48 hours (MD 0.13, 95% CI -0.35 to 0.61; participants 227; studies 3). The quality of evidence is moderate for duration of sensory block and postoperative pain intensity at 24 hours, and low for the remaining outcomes. There was no difference in cumulative postoperative 24-hour opioid consumption (MD -3.87 mg, 95% CI -9.93 to 2.19; participants 242; studies 4).\nIncidence of severe adverse events\nFive serious adverse events were reported. One block-related event (pneumothorax) occurred in one participant in a trial comparing perineural dexamethasone and placebo; however group allocation was not reported. Four non-block-related events occurred in two trials comparing perineural dexamethasone, intravenous dexamethasone and placebo. Two participants in the placebo group required hospitalization within one week of surgery; one for a fall and one for a bowel infection. One participant in the placebo group developed Complex Regional Pain Syndrome Type I and one in the intravenous dexamethasone group developed pneumonia. The quality of evidence is very low due to the sparse number of events.\nAuthors' conclusions\nLow- to moderate-quality evidence suggests that when used as an adjuvant to peripheral nerve block in upper limb surgery, both perineural and intravenous dexamethasone may prolong duration of sensory block and are effective in reducing postoperative pain intensity and opioid consumption. There is not enough evidence to determine the effectiveness of dexamethasone as an adjuvant to peripheral nerve block in lower limb surgeries and there is no evidence in children. The results of our review may not apply to participants at risk of dexamethasone-related adverse events for whom clinical trials would probably be unsafe.\nThere is not enough evidence to determine the effectiveness of dexamethasone as an adjuvant to peripheral nerve block in lower limb surgeries and there is no evidence in children. The results of our review may not be apply to participants who at risk of dexamethasone-related adverse events for whom clinical trials would probably be unsafe. The nine ongoing trials registered at ClinicalTrials.gov may change the results of this review.\n\nGiven the provided abstract, please respond to the following query: \"What did the researchers investigate?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We looked for randomized controlled trials that investigated whether perineural or intravenous dexamethasone prolongs the length of time people experience pain relief from the peripheral nerve block when undergoing upper and lower limb surgery and reduces the intensity of pain after surgery. We also investigated whether perineural or intravenous dexamethasone cause any side effects or harms. We searched the medical literature for articles that included either adults or children undergoing upper or lower limb surgery with peripheral nerve block published up until 25 April 2017. We also assessed the quality of evidence for each outcome."
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7124
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[
{
"role": "user",
"content": "Abstract: Background\nNon-alcohol related fatty liver disease (commonly called non-alcoholic fatty liver disease (NAFLD)) is liver steatosis in the absence of significant alcohol consumption, use of hepatotoxic medication, or other disorders affecting the liver such as hepatitis C virus infection, Wilson's disease, and starvation. NAFLD embraces the full spectrum of disease from pure steatosis (i.e. uncomplicated fatty liver) to non-alcoholic steatohepatitis (NASH), via NASH-cirrhosis to cirrhosis. The optimal pharmacological treatment for people with NAFLD remains uncertain.\nObjectives\nTo assess the comparative benefits and harms of different pharmacological interventions in the treatment of NAFLD through a network meta-analysis and to generate rankings of the available pharmacological treatments according to their safety and efficacy. However, it was not possible to assess whether the potential effect modifiers were similar across different comparisons. Therefore, we did not perform the network meta-analysis, and instead, assessed the comparative benefits and harms of different interventions using standard Cochrane methodology.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.com to August 2016.\nSelection criteria\nWe included only randomised clinical trials (irrespective of language, blinding, or publication status) in participants with NAFLD. We excluded trials which included participants who had previously undergone liver transplantation. We considered any of the various pharmacological interventions compared with each other or with placebo or no intervention.\nData collection and analysis\nWe calculated the odds ratio (OR) and rate ratio with 95% confidence intervals (CI) using both fixed-effect and random-effects models based on an available participant analysis with Review Manager. We assessed risk of bias according to the Cochrane risk of bias tool, controlled risk of random errors with Trial Sequential Analysis, and assessed the quality of the evidence using GRADE.\nMain results\nWe identified 77 trials including 6287 participants that met the inclusion criteria of this review. Forty-one trials (3829 participants) provided information for one or more outcomes. Only one trial was at low risk of bias in all domains. All other trials were at high risk of bias in one or more domains. Overall, all the evidence was very low quality. Thirty-five trials included only participants with non-alcohol related steatohepatitis (NASH) (based on biopsy confirmation). Five trials included only participants with diabetes mellitus; 14 trials included only participants without diabetes mellitus. The follow-up in the trials ranged from one month to 24 months.\nWe present here only the comparisons of active intervention versus no intervention in which two or more trials reported at least one of the following outcomes: mortality at maximal follow-up, serious adverse events, and health-related quality of life, the outcomes that determine whether a treatment should be used.\nAntioxidants versus no intervention\nThere was no mortality in either group (87 participants; 1 trial; very low quality evidence). None of the participants developed serious adverse events in the trial which reported the proportion of people with serious adverse events (87 participants; 1 trial; very low quality evidence). There was no evidence of difference in the number of serious adverse events between antioxidants and no intervention (rate ratio 0.89, 95% CI 0.36 to 2.19; 254 participants; 2 trials; very low quality evidence). None of the trials reported health-related quality of life.\nBile acids versus no intervention\nThere was no evidence of difference in mortality at maximal follow-up (OR 5.11, 95% CI 0.24 to 107.34; 659 participants; 4 trials; very low quality evidence), proportion of people with serious adverse events (OR 1.56, 95% CI 0.84 to 2.88; 404 participants; 3 trials; very low quality evidence), or the number of serious adverse events (rate ratio 1.01, 95% CI 0.66 to 1.54; 404 participants; 3 trials; very low quality evidence) between bile acids and no intervention. None of the trials reported health-related quality of life.\nThiazolidinediones versus no intervention\nThere was no mortality in either group (74 participants; 1 trial; very low quality evidence). None of the participants developed serious adverse events in the two trials which reported the proportion of people with serious adverse events (194 participants; 2 trials; very low quality evidence). There was no evidence of difference in the number of serious adverse events between thiazolidinediones and no intervention (rate ratio 0.25, 95% CI 0.06 to 1.05; 357 participants; 3 trials; very low quality evidence). None of the trials reported health-related quality of life.\nSource of funding\nTwenty-six trials were partially- or fully-funded by pharmaceutical companies that would benefit, based on the results of the trial. Twelve trials did not receive any additional funding or were funded by parties with no vested interest in the results. The source of funding was not provided in 39 trials.\nAuthors' conclusions\nDue to the very low quality evidence, we are very uncertain about the effectiveness of pharmacological treatments for people with NAFLD including those with steatohepatitis. Further well-designed randomised clinical trials with sufficiently large sample sizes are necessary.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Included trials compared drug treatments such as bile acids, antioxidants, phosphodiesterase type 4 inhibitor, glucocorticosteroid inhibitor, anti-cholesterol drugs and anti-diabetes drugs with a fake treatment (placebo) or no treatment."
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query-laysum
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7125
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[
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"role": "user",
"content": "Abstract: Background\nApproximately 10% of all newborns require resuscitation at birth. Training healthcare providers in standardised formal neonatal resuscitation training (SFNRT) programmes may improve neonatal outcomes. Substantial healthcare resources are expended on SFNRT.\nObjectives\nTo determine whether SFNRT programmes reduce neonatal mortality and morbidity, improve acquisition and retention of knowledge and skills, or change teamwork and resuscitation behaviour.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PREMEDLINE, EMBASE, CINAHL, Web of Science and the Oxford Database of Perinatal Trials, ongoing trials and conference proceedings in April 2014 and updated in March 2015.\nSelection criteria\nRandomised or quasi-randomised trials including cluster-randomised trials, comparing a SFNRT with no SFNRT, additions to SFNRT or types of SFNRT, and reporting at least one of our specified outcomes.\nData collection and analysis\nTwo authors extracted data independently and performed statistical analyses including typical risk ratio (RR), risk difference (RD), mean difference (MD), and number needed to treat for an additional beneficial outcome (NNTB) or an additional harmful outcome (NNTH) (all with 95% confidence intervals (CI)). We analysed cluster-randomised trials using the generic inverse variance and the approximate analysis methods.\nMain results\nWe identified two community-based and three manikin-based trials that assessed the effect of SFNRT compared with no SFNRT. Very low quality evidence from one study suggested improvement in acquisition of knowledge (RR 5.96, 95% CI 3.60 to 9.87) and skills (RR 170, 95% CI 10.8 to 2711) and retention of knowledge (RR 3.60, 95% CI 2.43 to 5.35) and the other study suggested improvement in resuscitation and behavioural scores.\nWe identified three community-based cluster-randomised trials in developing countries comparing SFNRT with basic resuscitation training (Early Newborn Care). In this setting, there was moderate quality evidence that SFNRT decreased early neonatal mortality (typical RR 0.88, 95% CI 0.78 to 1.00; 3 studies, 66,162 neonates) and when analysed by the approximate analysis method (typical RR 0.85, 95% CI 0.75 to 0.96; RD -0.0044, 95% CI -0.0082 to -0.0006; NNTB 227, 95% CI 122 to 1667). Low quality evidence from one trial showed that SFNRT may decrease 28-day mortality (typical RR 0.55, 95% CI 0.33 to 0.91) but the effect on late neonatal mortality was more uncertain (typical RR 0.47, 95% CI 0.20 to 1.11). None of our a priori defined neonatal morbidities were reported. We did not identify any randomised studies in the developed world.\nWe identified two trials that compared SFNRT with team training to SFNRT. Teamwork training of physician trainees with simulation may increase any teamwork behaviour (assessed by frequency) (MD 2.41, 95% CI 1.72 to 3.11) and decrease resuscitation duration (MD -149.54, 95% CI -214.73 to -84.34) but may lead to little or no difference in Neonatal Resuscitation Program (NRP) scores (MD 1.40, 95% CI -2.02 to 4.82; 98 participants, low quality evidence).\nWe identified two trials that compared SFNRT with booster courses to SFNRT. It is uncertain whether booster courses improve retention of resuscitation knowledge (84 participants, very low quality evidence) but may improve procedural and behavioural skills (40 participants, very low quality evidence).\nWe identified two trials on decision support tools, one on a cognitive aid that did not change resuscitation scores and the other on an electronic decision support tool that improved the frequency of correct decision making on positive pressure ventilation, cardiac compressions and frequency of fraction of inspired oxygen (FiO2) adjustments (97 participants, very low quality evidence).\nAuthors' conclusions\nSFNRT compared to basic newborn care or basic newborn resuscitation, in developing countries, results in a reduction of early neonatal and 28-day mortality. Randomised trials of SFNRT should report on neonatal morbidity including hypoxic ischaemic encephalopathy and neurodevelopmental outcomes. Innovative educational methods that enhance knowledge and skills and teamwork behaviour should be evaluated.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Does training healthcare providers in standardised formal neonatal resuscitation training (SFNRT) programmes reduce neonatal mortality and morbidity, improve acquisition and retention of knowledge and skills or change teamwork and resuscitation behaviour?"
}
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7126
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"content": "Abstract: Background\nTension-type headache (TTH) affects about 1 person in 5 worldwide. It is divided into infrequent episodic TTH (fewer than one headache per month), frequent episodic TTH (two to 14 headache days per month), and chronic TTH (15 headache days per month or more). Aspirin is one of a number of analgesics suggested for acute treatment of episodic TTH.\nObjectives\nTo assess the efficacy and safety of aspirin for acute treatment of episodic tension-type headache (TTH) in adults compared with placebo or any active comparator.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the Oxford Pain Relief Database from inception to September 2016, and also reference lists of relevant published studies and reviews. We sought unpublished studies by asking personal contacts and searching online clinical trial registers and manufacturers' websites.\nSelection criteria\nWe included randomised, double-blind, placebo-controlled studies (parallel-group or cross-over) using oral aspirin for symptomatic relief of an acute episode of TTH. Studies had to be prospective, with participants aged 18 years or over, and include at least 10 participants per treatment arm.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and extracted data. For various outcomes (predominantly those recommended by the International Headache Society (IHS)), we calculated the risk ratio (RR) and number needed to treat for one additional beneficial outcome (NNT), one additional harmful outcome (NNH), or to prevent one event (NNTp) for oral aspirin compared to placebo or an active intervention.\nWe assessed the evidence using GRADE and created a 'Summary of findings' table.\nMain results\nWe included five studies enrolling adults with frequent episodic TTH; 1812 participants took medication, of which 767 were included in comparisons of aspirin 1000 mg with placebo, and 405 in comparisons of aspirin 500 mg or 650 mg with placebo. Not all of these participants provided data for outcomes of interest in this review. Four studies specified using IHS diagnostic criteria; one predated commonly recognised criteria, but described comparable characteristics and excluded migraine. All participants treated headaches of at least moderate pain intensity.\nNone of the included studies were at low risk of bias across all domains considered, although for most studies and domains this was likely to be due to inadequate reporting rather than poor methods. We judged one study to be at high risk of bias due to small size.\nThere were no data for aspirin at any dose for the IHS preferred outcome of being pain free at two hours, or for being pain free at any other time, and only one study provided data equivalent to having no or mild pain at two hours (very low quality evidence). Use of rescue medication was lower with aspirin 1000 mg than with placebo (2 studies, 397 participants); 14% of participants used rescue medication with aspirin 1000 mg compared with 31% with placebo (NNTp 6.0, 95% confidence interval (CI) 4.1 to 12) (low quality evidence). Two studies (397 participants) reported a Patient Global Evaluation at the end of the study; we combined the top two categories for both studies to determine the number of participants who were 'satisfied' with treatment. Aspirin 1000 mg produced more satisfied participants (55%) than did placebo (37%) (NNT 5.7, 95% CI 3.7 to 12) (very low quality evidence).\nAdverse events were not different between aspirin 1000 mg and placebo (RR 1.1, 95% CI 0.8 to 1.5), or aspirin 500 mg or 650 mg and placebo (RR 1.3, 95% CI 0.8 to 2.0) (low quality evidence). Studies reported no serious adverse events.\nThe quality of the evidence using GRADE comparing aspirin doses between 500 mg and 1000 mg with placebo was low or very low. Evidence was downgraded because of the small number of studies and events, and because the most important measures of efficacy were not reported.\nThere were insufficient data to compare aspirin with any active comparator (paracetamol alone, paracetamol plus codeine, peppermint oil, or metamizole) at any of the doses tested.\nAuthors' conclusions\nA single dose of aspirin between 500 mg and 1000 mg provided some benefit in terms of less frequent use of rescue medication and more participants satisfied with treatment compared with placebo in adults with frequent episodic TTH who have an acute headache of moderate or severe intensity. There was no difference between a single dose of aspirin and placebo for the number of people experiencing adverse events. The amount and quality of the evidence was very limited and should be interpreted with caution.\n\nGiven the provided abstract, please respond to the following query: \"Bottom line\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review found only very low quality evidence that people with 2 to 14 tension-type headaches a month get good pain relief from taking aspirin 1000 mg or lower doses. There are questions about how studies of this type of headache are conducted. These questions involve the type of people chosen for the studies, and the types of outcomes reported. This limits the usefulness of the results, especially for people who just have an occasional headache."
}
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query-laysum
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7127
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[
{
"role": "user",
"content": "Abstract: Background\nThere is significant uncertainty in the treatment of intermediate-stage hepatocellular carcinoma which is defined by the Barcelona Clinic Liver Cancer (BCLC) as hepatocellular carcinoma stage B with large, multi-nodular, Child-Pugh status A to B, performance status 0 to 2, and without vascular occlusion or extrahepatic disease.\nObjectives\nTo assess the comparative benefits and harms of different interventions used in the treatment of intermediate-stage hepatocellular carcinoma (BCLC stage B) through a network meta-analysis and to generate rankings of the available interventions according to their safety and efficacy. However, we found only one comparison. Therefore, we did not perform the network meta-analysis, and we assessed the comparative benefits and harms of different interventions versus each other, or versus placebo, sham, or no intervention (supportive treatment only) using standard Cochrane methodology.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, World Health Organization International Clinical Trials Registry Platform, and randomised clinical trials registers to September 2016 to identify randomised clinical trials on hepatocellular carcinoma.\nSelection criteria\nWe included only randomised clinical trials, irrespective of language, blinding, or publication status, in participants with intermediate-stage hepatocellular carcinoma, irrespective of the presence of cirrhosis, size, or number of the tumours (provided they met the criteria of intermediate-stage hepatocellular carcinoma), of presence or absence of portal hypertension, of aetiology of hepatocellular carcinoma, and of the future remnant liver volume. We excluded trials which included participants who had previously undergone liver transplantation. We considered any of the various interventions compared with each other or with no active intervention (supportive treatment only). We excluded trials which compared variations of the same intervention: for example, different methods of performing transarterial chemoembolisation.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We calculated the hazard ratio (HR) with 95% confidence intervals (CI) using both fixed-effect and random-effects models based on available-participant analysis with Review Manager. We assessed risk of bias according to Cochrane, controlled risk of random errors with Trial Sequential Analysis using Stata, and assessed the quality of the evidence using GRADE.\nMain results\nThree randomised clinical trials, including 430 participants, met the inclusion criteria for this review; however, data from two trials with 412 participants could be included in only one primary outcome (i.e. mortality). All three trials were at high risk of bias. All three trials included supportive care as cointervention. The comparisons included in the two trials reporting on mortality were: systemic chemotherapy with sorafenib versus no active intervention; and transarterial chemoembolisation plus systemic chemotherapy with sorafenib versus transarterial chemoembolisation alone. The trials did not report the duration of follow-up; however, it appeared that the participants were followed up for a period of about 18 to 30 months. The majority of the participants in the trials had cirrhotic livers. The trials included participants with intermediate-stage hepatocellular carcinoma arising from viral and non-viral aetiologies. The trials did not report the portal hypertension status of the participants. The mortality was 50% to 70% over a median follow-up period of 18 to 30 months. There was no evidence of difference in mortality at maximal follow-up between systemic chemotherapy versus no chemotherapy (hazard ratio 0.85, 95% CI 0.60 to 1.18; participants = 412; studies = 2; I2 = 0%; very low quality evidence). A subgroup analysis performed by stratifying the analysis by the presence or absence of transarterial chemoembolisation as cointervention did not alter the results. None of the trials reported on serious adverse events other than mortality, health-related quality of life, recurrence of hepatocellular carcinoma, or length of hospital stay. One of the trials providing data was funded by the pharmaceutical industry, the other did not report the source of funding, and the trial with no data for the review was also funded by the pharmaceutical industry. We found two ongoing trials.\nAuthors' conclusions\nCurrently, there is no evidence from randomised clinical trials that people with intermediate-stage hepatocellular carcinoma would benefit from systemic chemotherapy with sorafenib either alone or when transarterial chemoembolisation was used as a cointervention (very low quality evidence). We need high-quality randomised clinical trials designed to measure differences in clinically important outcomes (e.g. all-cause mortality or health-related quality of life).\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The overall quality of evidence was low or very low and all the trials were at high risk of bias, which means that there is possibility of making the wrong conclusions, overestimating benefits, or underestimating harms of one treatment or the other because of the way that the trials were conducted."
}
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query-laysum
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7128
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[
{
"role": "user",
"content": "Abstract: Background\nEndoscopic assessment of mucosal disease activity is widely used to determine eligibility and response to therapy in clinical trials of treatment for Crohn’s disease. However, the operating properties of the currently available endoscopic indices remain unclear.\nObjectives\nA systematic review was undertaken to evaluate the development and operating characteristics of the Crohn’s Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Scale for Crohn’s Disease (SES-CD).\nSearch methods\nElectronic searches of the MEDLINE (1966 to December 2015), EMBASE (1980 to December 2015), and Cochrane CENTRAL Register of Controlled Trials (Issue 12, 2015) databases were supplemented by manual reviews of reference listings and conference proceedings (Digestive Disease Week, United European Gastroenterology Week, European Crohn’s and Colitis Organization).\nSelection criteria\nAny study design (e.g. randomized controlled trials, cohort studies, case series) that evaluated either or both the CDEIS or SES-CD in patients with Crohn’s disease was considered for inclusion. Eligible participants were adult patients (> 16 years), diagnosed with Crohn’s disease using conventional clinical, radiographic, and endoscopic criteria.\nData collection and analysis\nTwo authors (RK, JKM) independently reviewed the titles and abstracts of the studies identified from the literature search. The full texts of potentially relevant citations were reviewed for inclusion and the study investigators were contacted to clarify any unclear data. Any disagreements were resolved by discussion and consensus with a third author. A standardized form was used to assess eligibility of trials for inclusion in the study and for data extraction.\nTwo authors independently extracted and recorded data (RK, SAN). The number of patients enrolled; number of patients per treatment arm; patient characteristics including age and gender distribution; endoscopic index; and outcomes such as intra-rater reliability, inter-rater reliability responsiveness, validity, feasibility, construct validity, and criterion validity were recorded for each trial.\nMain results\nForty-three reports of 30 studies fulfilled the inclusion criteria.\nFor the SES-CD, inter-rater reliability was assessed in four studies. In the development study for the SES-CD (Daperno 2004), the overall ICC (0.9815, 95% CI 0.9705 to 0.9884) and the kappa for the regions is high; however the paired raters were in the same room which introduces the potential for bias.\nFor the CDEIS, inter-rater reliability was assessed in six studies. Daperno 2014 reported that the ICC for the CDEIS was 0.985 (95% CI 0.939-1.000) for average measures of video score and was 0.835 (95% CI 0.540-0.995) for single measures of video score.\nWith respect to validity, correlation between the CDEIS and clinical measures, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), was also reported. The estimates of correlation with CRP were r = 0.521 (Sipponen 2010b), r = 0.553 (Sipponen 2008a) and r = 0.608 (Sipponen 2008c). For the SES-CD, the corresponding values for correlation with CRP ranged from r = 0.46 (Jones 2008) to r = 0.68 (Green 2011).\nResponsiveness data for the CDEIS were available in nine studies. Seven studies demonstrated statistically significant decreases in the CDEIS score after administration of a treatment of known efficacy. Minimal responsiveness data were available for the SES-CD. Sipponen 2010a and Sipponen 2010b demonstrated statistically significant changes in the SES-CD score after subjects were administered a treatment of known efficacy.\nNo studies were identified that explicitly evaluated the feasibility for either the SES-CD or the CDEIS. The SES-CD requires fewer calculations and may therefore be easier to use than the CDEIS.\nAuthors' conclusions\nAlthough they are used in clinical trials, the CDEIS and SES-CD remain incompletely validated. Future research is required to determine the operating properties and to define the optimal index.\n\nGiven the provided abstract, please respond to the following query: \"What is an endoscopic scoring index?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "An endoscopic scoring index measures disease activity based on what a doctor sees during endoscopy. An endoscopy is a non-surgical procedure used to view the digestive tract using a camera. The doctor who performs the endoscopy can rate disease activity using the index, or this can be done by another off-site doctor if a video of the procedure was recorded.\nThe most commonly used endoscopic scoring indices are the Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score for Crohn's Disease (SES-CD)."
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query-laysum
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[
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"role": "user",
"content": "Abstract: Background\nCognitive impairments affect functional ability in people with dementia. Cognitive rehabilitation (CR) is a personalised, solution-focused approach that aims to enable people with mild-to-moderate dementia to manage everyday activities and maintain as much independence as possible.\nObjectives\nTo evaluate the effects of CR on everyday functioning and other outcomes for people with mild-to-moderate dementia, and on outcomes for care partners.\nTo identify and explore factors that may be associated with the efficacy of CR.\nSearch methods\nWe searched the Cochrane Dementia and Cognitive Improvement Group Specialised Register, which contains records from MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS, and other clinical trial databases, and grey literature sources. The most recent search was completed on 19 October 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing CR with control conditions and reporting relevant outcomes for the person with dementia and/or the care partner.\nData collection and analysis\nWe extracted relevant data from published manuscripts and contacted trial authors if necessary. Within each of the comparisons, we pooled data for each outcome of interest and conducted inverse-variance, random-effects meta-analyses. We evaluated the certainty of the evidence using GRADEpro GDT.\nMain results\nWe identified six eligible RCTs published in English between 2010 and 2022, which together included 1702 participants. The mean age of participants ranged from 76 to 80 and the proportion of male participants was between 29.4% and 79.3%. Most participants, in the studies where the type of dementia was reported, had a diagnosis of Alzheimer’s disease (AD; n = 1002, 58.9% of the whole sample, 81.2% of the participants for whom the specific diagnosis was reported).\nRisk of bias in the individual studies was relatively low. The exception was a high risk of bias in relation to blinding of participants and practitioners, which is not usually feasible with psychosocial interventions.\nOur primary outcome of everyday functioning was operationalised in the included studies as goal attainment in relation to activities targeted in the intervention. For our main comparison of CR with usual care, we pooled data for goal attainment evaluated from three perspectives (self-rating of performance, informant rating of performance, and self-rating of satisfaction with performance) at end of treatment and at medium-term follow-up (3 to 12 months). We could also pool data at these time points for 20 and 19 secondary outcomes respectively. The review findings were strongly driven by one large, high-quality RCT.\nWe found high-certainty evidence of large positive effects of CR on all three primary outcome perspectives at the end of treatment: participant self-ratings of goal attainment (standardised mean difference (SMD) 1.46, 95% confidence interval (CI) 1.26 to 1.66; I2 = 0%; 3 RCTs, 501 participants), informant ratings of goal attainment (SMD 1.61, 95% CI 1.01 to 2.21; I2 = 41%; 3 RCTs, 476 participants), and self-ratings of satisfaction with goal attainment (SMD 1.31, 95% CI 1.09 to 1.54; I2 = 5%; 3 RCTs, 501 participants), relative to an inactive control condition. At medium-term follow-up, we found high-certainty evidence showing a large positive effect of CR on all three primary outcome perspectives: participant self-ratings of goal attainment (SMD 1.46, 95% CI 1.25 to 1.68; I2 = 0%; 2 RCTs, 432 participants), informant ratings of goal attainment (SMD 1.25, 95% CI 0.78 to 1.72; I2 = 29%; 3 RCTs, 446 participants), and self-ratings of satisfaction with goal attainment (SMD 1.19, 95% CI 0.73 to 1.66; I2 = 28%; 2 RCTs, 432 participants), relative to an inactive control condition.\nFor participants at the end of treatment we found high-certainty evidence showing a small positive effect of CR on self-efficacy (2 RCTs, 456 participants) and immediate recall (2 RCTs, 459 participants).\nFor participants at medium-term follow-up we found moderate-certainty evidence showing a small positive effect of CR on auditory selective attention (2 RCTs, 386 participants), and a small negative effect on general functional ability (3 RCTs, 673 participants), and we found low-certainty evidence showing a small positive effect on sustained attention (2 RCTs, 413 participants), and a small negative effect on memory (2 RCTs, 51 participants) and anxiety (3 RCTs, 455 participants).\nWe found moderate- and low-certainty evidence indicating that at the end of treatment CR had negligible effects on participant anxiety, quality of life, sustained attention, memory, delayed recall, and general functional ability, and at medium-term follow-up on participant self-efficacy, depression, quality of life, immediate recall, and verbal fluency.\nFor care partners at the end of treatment we found low-certainty evidence showing a small positive effect on environmental aspects of quality of life (3 RCTs, 465 care partners), and small negative effects of CR on level of depression (2 RCTs, 32 care partners) and on psychological wellbeing (2 RCTs, 388 care partners).\nFor care partners at medium-term follow-up we found high-certainty evidence showing a small positive effect of CR on social aspects of quality of life (3 RCTs, 436 care partners) and moderate-certainty evidence showing a small positive effect on psychological aspects of quality of life (3 RCTs, 437 care partners).\nWe found moderate- and low-certainty evidence at the end of treatment that CR had negligible effects on care partners’ physical health, psychological and social aspects of quality of life, and stress, and at medium-term follow-up for the physical health aspect of care partners’ quality of life and psychological wellbeing.\nAuthors' conclusions\nCR is helpful in enabling people with mild or moderate dementia to improve their ability to manage the everyday activities targeted in the intervention. Confidence in these findings could be strengthened if more high-quality studies contributed to the observed effects. The available evidence suggests that CR can form a valuable part of a clinical toolkit to assist people with dementia in overcoming some of the everyday barriers imposed by cognitive and functional difficulties. Future research, including process evaluation studies, could help identify avenues to maximise CR effects and achieve wider impacts on functional ability and wellbeing.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched for studies that rigorously tested the effects of cognitive rehabilitation for people with mild-to-moderate dementia. In these studies, some people had their usual treatment and others had their usual treatment plus cognitive rehabilitation. This made it possible to see whether cognitive rehabilitation was more helpful than usual treatment alone. We compared and summarised the results of the studies. We rated our confidence in the evidence the studies provided, based on the methods used and the numbers of people involved."
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query-laysum
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[
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease (SCD), one of the commonest severe monogenic disorders, is caused by the inheritance of two abnormal haemoglobin (beta-globin) genes. SCD can cause severe pain, significant end-organ damage, pulmonary complications, and premature death. Kidney disease is a frequent and potentially severe complication in people with SCD.\nChronic kidney disease (CKD) is defined as abnormalities of kidney structure or function present for more than three months. Sickle cell nephropathy refers to the spectrum of kidney complications in SCD.\nGlomerular damage is a cause of microalbuminuria and can develop at an early age in children with SCD, with increased prevalence in adulthood. In people with sickle cell nephropathy, outcomes are poor as a result of the progression to proteinuria and chronic kidney insufficiency. Up to 12% of people who develop sickle cell nephropathy will develop end-stage renal disease.\nThis is an update of a review first published in 2017.\nObjectives\nTo assess the effectiveness of any intervention for preventing or reducing kidney complications or chronic kidney disease in people with sickle cell disease. Possible interventions include red blood cell transfusions, hydroxyurea, and angiotensin-converting enzyme inhibitors (ACEIs), either alone or in combination.\nSearch methods\nWe searched for relevant trials in the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, CENTRAL, MEDLINE, Embase, seven other databases, and two other trials registers.\nSelection criteria\nRandomised controlled trials (RCTs) comparing interventions to prevent or reduce kidney complications or CKD in people with SCD. We applied no restrictions related to outcomes examined, language, or publication status.\nData collection and analysis\nTwo review authors independently assessed trial eligibility, extracted data, assessed the risk of bias, and assessed the certainty of the evidence (GRADE).\nMain results\nWe included three RCTs with 385 participants.\nWe rated the certainty of the evidence as low to very low across different outcomes according to GRADE methodology, downgrading for risk of bias concerns, indirectness, and imprecision.\nHydroxyurea versus placebo\nOne RCT published in 2011 compared hydroxyurea to placebo in 193 children aged nine to 18 months. We are unsure if hydroxyurea compared to placebo reduces or prevents progression of kidney disease assessed by change in glomerular filtration rate (mean difference (MD) 0.58 mL/min /1.73 m2, 95% confidence interval (CI) −14.60 to 15.76; 142 participants; very low certainty). Hydroxyurea compared to placebo may improve the ability to concentrate urine (MD 42.23 mOsm/kg, 95% CI 12.14 to 72.32; 178 participants; low certainty), and may make little or no difference to SCD-related serious adverse events, including acute chest syndrome (risk ratio (RR) 0.39, 99% CI 0.13 to 1.16; 193 participants; low certainty), painful crisis (RR 0.68, 99% CI 0.45 to 1.02; 193 participants; low certainty); and hospitalisations (RR 0.83, 99% CI 0.68 to 1.01; 193 participants; low certainty).\nNo deaths occurred in either trial arm and the RCT did not report quality of life.\nAngiotensin-converting enzyme inhibitors versus placebo\nOne RCT published in 1998 compared an ACEI (captopril) to placebo in 22 adults with normal blood pressure and microalbuminuria. We are unsure if captopril compared to placebo reduces proteinuria (MD −49.00 mg/day, 95% CI −124.10 to 26.10; 22 participants; very low certainty). We are unsure if captopril reduces or prevents kidney disease as measured by creatinine clearance; the trial authors stated that creatinine clearance remained constant over six months in both groups, but provided no comparative data (very low certainty).\nThe RCT did not report serious adverse events, all-cause mortality, or quality of life.\nAngiotensin-converting enzyme inhibitors versus vitamin C\nOne RCT published in 2020 compared an ACEI (lisinopril) with vitamin C in 170 children aged one to 18 years with normal blood pressure and microalbuminuria. It reported no data we could analyse. We are unsure if lisinopril compared to vitamin C reduces proteinuria in this population: the large drop in microalbuminuria in both arms of the trial after only one month on treatment may have been due to an overestimation of microalbuminuria at baseline rather than a true effect.\nThe RCT did not report serious adverse events, all-cause mortality, or quality of life.\nAuthors' conclusions\nWe are unsure if hydroxyurea improves glomerular filtration rate or reduces hyperfiltration in children aged nine to 18 months, but it may improve their ability to concentrate urine and may make little or no difference to the incidence of acute chest syndrome, painful crises, and hospitalisations.\nWe are unsure if ACEI compared to placebo has any effect on preventing or reducing kidney complications in adults with normal blood pressure and microalbuminuria.\nWe are unsure if ACEI compared to vitamin C has any effect on preventing or reducing kidney complications in children with normal blood pressure and microalbuminuria.\nNo RCTs assessed red blood cell transfusions or any combined interventions to prevent or reduce kidney complications.\nDue to lack of evidence, we cannot comment on the management of children aged over 18 months or adults with any known genotype of SCD.\nWe have identified a lack of adequately designed and powered studies, although we found four ongoing trials since the last version of this review. Only one ongoing trial addresses renal function as a primary outcome in the short term, but such interventions have long-term effects. Trials of hydroxyurea, ACEIs or red blood cell transfusion in older children and adults are urgently needed to determine any effect on prevention or reduction of kidney complications in people with SCD.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found three randomised controlled trials, which enroled a total of 385 people. One trial, published in 2011, compared the drug hydroxyurea (which helps to maintain the shape and flexibility of red blood cells), to placebo (dummy treatment) in 193 children aged nine to 18 months. The second trial, published in 1998, compared captopril (a drug used to treat high blood pressure) to placebo in 22 adults with normal blood pressure and microalbuminuria (high levels of protein in the urine). The third trial, published in 2020, compared lisinopril (a drug used to treat high blood pressure) to vitamin C in 170 children aged one to 18 years.\nTwo trials received government funding; it was unclear how the third trial was funded."
}
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query-laysum
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7131
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[
{
"role": "user",
"content": "Abstract: Background\nMeningitis is inflammation of the meninges, the layers that protect the brain and spinal cord. Acute meningitis is an emergent disease that develops over the course of hours to several days. Delay in treatment can lead to serious outcomes.\nInflammation of the meninges is assessed by analysing cerebrospinal fluid. Identifying the pathogen in cerebrospinal fluid is another way to diagnose meningitis. Cerebrospinal fluid is collected by doing a lumbar puncture, which is an invasive test, and can be avoided if a physical examination excludes the diagnosis of meningitis. However, most physical examinations, such as nuchal rigidity, Kernig's test, and Brudzinski's test, are not sufficiently sensitive to exclude meningitis completely.\nJolt accentuation of headache is a new and less well-recognised physical examination, which assesses meningeal irritation. It is judged as positive if the headache is exacerbated by rotating the head horizontally two or three times per second. A 1991 observational study initially reported high sensitivity of this examination to predict pleocytosis. Pleocytosis, an abnormally high cerebrospinal fluid sample white cell count, is an accepted indicator of nervous system infection or inflammation. Jolt accentuation of headache may therefore accurately rule out meningitis without the use of lumbar puncture. However, more recent cross-sectional studies have reported variable diagnostic accuracy.\nObjectives\nTo estimate the diagnostic accuracy of jolt accentuation of headache for detecting acute meningitis in emergency settings. Secondary objectives: to investigate the sources of heterogeneity, including study population, patient condition, and types of meningitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), and Embase (Elsevier) to 27 April 2020. We searched ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, and Ichushi-Web Version 5.0 to 28 April 2020.\nSelection criteria\nWe included cross-sectional studies that assessed the diagnostic accuracy of jolt accentuation of headache for people with suspected meningitis in emergency settings. We included participants of any age and any severity of illness. Meningitis should be diagnosed with any reference standard, such as cerebrospinal fluid pleocytosis, proof of causative agents, or autopsy.\nData collection and analysis\nTwo review authors independently collated study data. We assessed methodological quality of studies using QUADAS-2 criteria. We used a bivariate random-effects model to determine summary estimates of sensitivity and specificity where meta-analysis was possible. We performed sensitivity analyses to validate the robustness of outcomes. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included nine studies (1161 participants). Five studies included only adults. Four studies included both adults and children; however, the proportion was not reported in three of these studies. The youngest child reported in the studies was aged 13 years. There was no study including only children.\nThe reference standard was pleocytosis in eight studies, and the combination of pleocytosis and increased protein in the cerebrospinal fluid in one study. Two studies also used smear or positive culture of cerebrospinal fluid.\nRisk of bias and concern about applicability was high in the participant selection domain for all included studies and the consciousness subgroup.\nOverall, pooled sensitivity was 65.3% (95% confidence interval (CI) 37.3 to 85.6), and pooled specificity was 70.4% (95% CI 47.7 to 86.1) (very low-certainty evidence). We established the possibility of heterogeneity from visual inspection of forest plots. However, we were unable to conduct further analysis for study population, types of meningitis, and participants' condition, other than disturbance of consciousness (a secondary outcome).\nAmongst participants whose consciousness was undisturbed (8 studies, 921 participants), pooled sensitivity and specificity were 75.2% (95% CI 54.3 to 88.6) and 60.8% (95% CI 43.4 to 75.9), respectively (very low-certainty evidence).\nAuthors' conclusions\nJolt accentuation for headache may exclude diagnoses of meningitis in emergency settings, but high-quality evidence to support use of this test is lacking. Even where jolt accentuation of headache is negative, there is still the possibility of acute meningitis. This review identified the possibility of heterogeneity. However, factors that contribute to heterogeneity are incompletely understood, and should be considered in future research.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We studied jolt accentuation of headache in people who presented with potential acute meningitis in emergency settings."
}
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query-laysum
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7132
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[
{
"role": "user",
"content": "Abstract: Background\nAsthma patients who continue to experience symptoms despite taking regular inhaled corticosteroids (ICS) represent a management challenge. Long-acting beta2-agonists (LABA) and anti-leukotrienes (LTRA) are two treatment options that could be considered as add-on therapy to ICS.\nObjectives\nTo compare the safety and efficacy of adding LABA versus LTRA to the treatment regimen for children and adults with asthma who remain symptomatic in spite of regular treatment with ICS. We specifically wished to examine the relative impact of the two agents on asthma exacerbations, lung function, symptoms, quality of life, adverse health events and withdrawals.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register until December 2012. We consulted reference lists of all included studies and contacted pharmaceutical manufacturers to ask about other published or unpublished studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) conducted in adults or children with recurrent asthma that was treated with ICS along with a fixed dose of a LABA or an LTRA for a minimum of four weeks.\nData collection and analysis\nTwo review authors independently assessed the risk of bias of included studies and extracted data. We sought unpublished data and further details of study design when necessary.\nMain results\nWe included 18 RCTs (7208 participants), of which 16 recruited adults and adolescents (6872) and two recruited children six to 17 years of age (336) with asthma and significant reversibility to bronchodilator at baseline. Fourteen (79%) trials were of high methodological quality.\nThe risk of exacerbations requiring systemic corticosteroids (primary outcome of the review) was significantly lower with the combination of LABA + ICS compared with LTRA + ICS—from 13% to 11% (eight studies, 5923 adults and 334 children; risk ratio (RR) 0.87, 95% confidence interval (CI) 0.76 to 0.99; high-quality evidence). The number needed to treat for an additional beneficial outcome (NNTB) with LABA compared with LTRA to prevent one additional exacerbation over four to 102 weeks was 62 (95% CI 34 to 794). The choice of LTRA, the dose of ICS and the participants' age group did not significantly influence the magnitude of effect. Although results were inconclusive, the effect appeared stronger in trials that used a single device rather than two devices to administer ICS and LABA and in trials of less than 12 weeks' duration.\nThe addition of LABA to ICS was associated with a statistically greater improvement from baseline in lung function, as well as in symptoms, rescue medication use and quality of life, although the latter effects were modest. LTRA was superior in the prevention of exercise-induced bronchospasm. More participants were satisfied with the combination of LABA + ICS than LTRA + ICS (three studies, 1625 adults; RR 1.12, 95% CI 1.04 to 1.20; moderate-quality evidence). The overall risk of withdrawal was significantly lower with LABA + ICS than with LTRA + ICS (13 studies, 6652 adults and 308 children; RR 0.84, 95% CI 0.74 to 0.96; moderate-quality evidence). Although the risk of overall adverse events was equivalent between the two groups, the risk of serious adverse events (SAE) approached statistical significance in disfavour of LABA compared with LTRA (nine studies, 5658 adults and 630 children; RR 1.33, 95% CI 0.99 to 1.79; P value 0.06; moderate-quality evidence), with no apparent impact of participants' age group.\nThe following adverse events were reported, but no significant differences were demonstrated between groups: headache (11 studies, N = 6538); cardiovascular events (five studies, N = 5163), osteopenia and osteoporosis (two studies, N = 2963), adverse events (10 studies, N = 5977 adults and 300 children). A significant difference in the risk of oral moniliasis was noted, but this represents a low occurrence rate.\nAuthors' conclusions\nIn adults with asthma that is inadequately controlled by predominantly low-dose ICS with significant bronchodilator reversibility, the addition of LABA to ICS is modestly superior to the addition of LTRA in reducing oral corticosteroid–treated exacerbations, with an absolute reduction of two percentage points. Differences favouring LABA over LTRA as adjunct therapy were observed in lung function and, to a lesser extend, in rescue medication use, symptoms and quality of life. The lower overall withdrawal rate and the higher proportion of participants satisfied with their therapy indirectly favour the combination of LABA + ICS over LTRA + ICS. Evidence showed a slightly increased risk of SAE with LABA compared with LTRA, with an absolute increase of one percentage point. Our findings modestly support the use of a single inhaler for the delivery of both LABA and low- or medium-dose ICS. Because of the paucity of paediatric trials, we are unable to draw firm conclusions about the best adjunct therapy in children.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In adults whose asthma is inadequately controlled with ICS, the addition of LABA to ICS was found to be modestly superior to LTRA + ICS. Although both options appeared safe, evidence suggests that slightly more serious adverse events (SAE) may be seen with LABA than with LTRA, particularly when separate devices are used to administer LABA + ICS. Because only two paediatric trials contributed data to the review, the best adjunct strategy to ICS remains uncertain for children."
}
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query-laysum
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7133
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[
{
"role": "user",
"content": "Abstract: Background\nOrganised inpatient (stroke unit) care is provided by multi-disciplinary teams that manage stroke patients. This can been provided in a ward dedicated to stroke patients (stroke ward), with a peripatetic stroke team (mobile stroke team), or within a generic disability service (mixed rehabilitation ward). Team members aim to provide co-ordinated multi-disciplinary care using standard approaches to manage common post-stroke problems.\nObjectives\n• To assess the effects of organised inpatient (stroke unit) care compared with an alternative service.\n• To use a network meta-analysis (NMA) approach to assess different types of organised inpatient (stroke unit) care for people admitted to hospital after a stroke (the standard comparator was care in a general ward).\nOriginally, we conducted this systematic review to clarify:\n• The characteristic features of organised inpatient (stroke unit) care?\n• Whether organised inpatient (stroke unit) care provide better patient outcomes than alternative forms of care?\n• If benefits are apparent across a range of patient groups and across different approaches to delivering organised stroke unit care?\nWithin the current version, we wished to establish whether previous conclusions were altered by the inclusion of new outcome data from recent trials and further analysis via NMA.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (2 April 2019); the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 4), in the Cochrane Library (searched 2 April 2019); MEDLINE Ovid (1946 to 1 April 2019); Embase Ovid (1974 to 1 April 2019); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 2 April 2019). In an effort to identify further published, unpublished, and ongoing trials, we searched seven trial registries (2 April 2019). We also performed citation tracking of included studies, checked reference lists of relevant articles, and contacted trialists.\nSelection criteria\nRandomised controlled clinical trials comparing organised inpatient stroke unit care with an alternative service (typically contemporary conventional care), including comparing different types of organised inpatient (stroke unit) care for people with stroke who are admitted to hospital.\nData collection and analysis\nTwo review authors assessed eligibility and trial quality. We checked descriptive details and trial data with co-ordinators of the original trials, assessed risk of bias, and applied GRADE. The primary outcome was poor outcome (death or dependency (Rankin score 3 to 5) or requiring institutional care) at the end of scheduled follow-up. Secondary outcomes included death, institutional care, dependency, subjective health status, satisfaction, and length of stay. We used direct (pairwise) comparisons to compare organised inpatient (stroke unit) care with an alternative service. We used an NMA to confirm the relative effects of different approaches.\nMain results\nWe included 29 trials (5902 participants) that compared organised inpatient (stroke unit) care with an alternative service: 20 trials (4127 participants) compared organised (stroke unit) care with a general ward, six trials (982 participants) compared different forms of organised (stroke unit) care, and three trials (793 participants) incorporated more than one comparison.\nCompared with the alternative service, organised inpatient (stroke unit) care was associated with improved outcomes at the end of scheduled follow-up (median one year): poor outcome (odds ratio (OR) 0.77, 95% confidence interval (CI) 0.69 to 0.87; moderate-quality evidence), death (OR 0.76, 95% CI 0.66 to 0.88; moderate-quality evidence), death or institutional care (OR 0.76, 95% CI 0.67 to 0.85; moderate-quality evidence), and death or dependency (OR 0.75, 95% CI 0.66 to 0.85; moderate-quality evidence). Evidence was of very low quality for subjective health status and was not available for patient satisfaction. Analysis of length of stay was complicated by variations in definition and measurement plus substantial statistical heterogeneity (I² = 85%). There was no indication that organised stroke unit care resulted in a longer hospital stay. Sensitivity analyses indicated that observed benefits remained when the analysis was restricted to securely randomised trials that used unequivocally blinded outcome assessment with a fixed period of follow-up. Outcomes appeared to be independent of patient age, sex, initial stroke severity, stroke type, and duration of follow-up. When calculated as the absolute risk difference for every 100 participants receiving stroke unit care, this equates to two extra survivors, six more living at home, and six more living independently.\nThe analysis of different types of organised (stroke unit) care used both direct pairwise comparisons and NMA.\nDirect comparison of stroke ward versus general ward: 15 trials (3523 participants) compared care in a stroke ward with care in general wards. Stroke ward care showed a reduction in the odds of a poor outcome at the end of follow-up (OR 0.78, 95% CI 0.68 to 0.91; moderate-quality evidence).\nDirect comparison of mobile stroke team versus general ward: two trials (438 participants) compared care from a mobile stroke team with care in general wards. Stroke team care may result in little difference in the odds of a poor outcome at the end of follow-up (OR 0.80, 95% CI 0.52 to 1.22; low-quality evidence).\nDirect comparison of mixed rehabilitation ward versus general ward: six trials (630 participants) compared care in a mixed rehabilitation ward with care in general wards. Mixed rehabilitation ward care showed a reduction in the odds of a poor outcome at the end of follow-up (OR 0.65, 95% CI 0.47 to 0.90; moderate-quality evidence).\nIn a NMA using care in a general ward as the comparator, the odds of a poor outcome were as follows: stroke ward - OR 0.74, 95% CI 0.62 to 0.89, moderate-quality evidence; mobile stroke team - OR 0.88, 95% CI 0.58 to 1.34, low-quality evidence; mixed rehabilitation ward - OR 0.70, 95% CI 0.52 to 0.95, low-quality evidence.\nAuthors' conclusions\nWe found moderate-quality evidence that stroke patients who receive organised inpatient (stroke unit) care are more likely to be alive, independent, and living at home one year after the stroke. The apparent benefits were independent of patient age, sex, initial stroke severity, or stroke type, and were most obvious in units based in a discrete stroke ward. We observed no systematic increase in the length of inpatient stay, but these findings had considerable uncertainty.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We downgraded the quality of evidence to 'moderate' for the main outcomes because it was impossible to hide the treating service from participants or healthcare workers. These conclusions were not dependent on trials judged to be of lower quality because of poor design or missing data. More information was missing for some of the other outcome measures and analyses, which we have downgraded to low-quality evidence."
}
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query-laysum
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7134
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[
{
"role": "user",
"content": "Abstract: Background\nOvarian hyperstimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in assisted reproduction technology (ART). It is characterised by enlarged ovaries and an acute fluid shift from the intravascular space to the third space, resulting in bloating, increased risk of venous thromboembolism, and decreased organ perfusion. Most cases are mild, but forms of moderate or severe OHSS appear in 3% to 8% of in vitro fertilisation (IVF) cycles. Dopamine agonists were introduced as a secondary prevention intervention for OHSS in women at high risk of OHSS undergoing ART treatment.\nObjectives\nTo assess the effectiveness and safety of dopamine agonists in preventing OHSS in women at high risk of developing OHSS when undergoing ART treatment.\nSearch methods\nWe searched the following databases from inception to 4 May 2020: Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and PsycINFO for randomised controlled trials (RCTs) assessing the effect of dopamine agonists on OHSS rates. We also handsearched reference lists and grey literature.\nSelection criteria\nWe considered RCTs for inclusion that compared dopamine agonists with placebo/no intervention or another intervention for preventing OHSS in ART. Primary outcome measures were incidence of moderate or severe OHSS and live birth rate. Secondary outcomes were rates of clinical pregnancy, multiple pregnancy, miscarriage, and adverse events.\nData collection and analysis\nTwo review authors independently screened titles, abstracts, and full texts of publications; selected studies; extracted data; and assessed risk of bias. We resolved disagreements by consensus. We reported pooled results as odds ratios (OR) and 95% confidence interval (CI) by the Mantel-Haenszel method. We applied GRADE criteria to judge overall quality of the evidence.\nMain results\nThe search identified six new RCTs, resulting in 22 included RCTs involving 3171 women at high risk of OHSS for this updated review. The dopamine agonists were cabergoline, quinagolide, and bromocriptine.\nDopamine agonists versus placebo or no intervention\nDopamine agonists probably lowered the risk of moderate or severe OHSS compared to placebo/no intervention (OR 0.32, 95% CI 0.23 to 0.44; 10 studies, 1202 participants; moderate-quality evidence). This suggests that if the risk of moderate or severe OHSS following placebo/no intervention is assumed to be 27%, the risk following dopamine agonists would be between 8% and 14%. We are uncertain of the effect of dopamine agonists on rates of live birth (OR 0.96, 95% CI 0.60 to 1.55; 3 studies, 362 participants; low-quality evidence). We are also uncertain of the effect of dopamine agonists on clinical pregnancy, multiple pregnancy, miscarriage or adverse events (very low to low-quality evidence).\nDopamine agonists plus co-intervention versus co-intervention\nDopamine agonist plus co-intervention (hydroxyethyl starch, human albumin, or withholding ovarian stimulation 'coasting') may decrease the risk of moderate or severe OHSS compared to co-intervention (OR 0.48, 95% CI 0.28 to 0.84; 4 studies, 748 participants; low-quality evidence). Dopamine agonists may improve rates of live birth (OR 1.21, 95% CI 0.81 to 1.80; 2 studies, 400 participants; low-quality evidence). Dopamine agonists may improve rates of clinical pregnancy and miscarriage, but we are uncertain if they improve rates of multiple pregnancy or adverse events (very low to low-quality evidence).\nDopamine agonists versus other active interventions\nWe are uncertain if cabergoline improves the risk of moderate or severe OHSS compared to human albumin (OR 0.21, 95% CI 0.12 to 0.38; 3 studies, 296 participants; very low-quality evidence), prednisolone (OR 0.27, 95% CI 0.05 to 1.33; 1 study; 150 participants; very low-quality evidence), hydroxyethyl starch (OR 2.69, 95% CI 0.48 to 15.10; 1 study, 61 participants; very low-quality evidence), coasting (OR 0.42, 95% CI 0.18 to 0.95; 3 studies, 320 participants; very low-quality evidence), calcium infusion (OR 1.83, 95% CI 0.88 to 3.81; I² = 81%; 2 studies, 400 participants; very low-quality evidence), or diosmin (OR 2.85, 95% CI 1.35 to 6.00; 1 study, 200 participants; very low-quality evidence). We are uncertain of the effect of dopamine agonists on rates of live birth (OR 1.08, 95% CI 0.73 to 1.59; 2 studies, 430 participants; low-quality evidence). We are uncertain of the effect of dopamine agonists on clinical pregnancy, multiple pregnancy or miscarriage (low to moderate-quality evidence). There were no adverse events reported.\nAuthors' conclusions\nDopamine agonists probably reduce the incidence of moderate or severe OHSS compared to placebo/no intervention, while we are uncertain of the effect on adverse events and pregnancy outcomes (live birth, clinical pregnancy, miscarriage). Dopamine agonists plus co-intervention may decrease moderate or severe OHSS rates compared to co-intervention only, but we are uncertain whether dopamine agonists affect pregnancy outcomes. When compared to other active interventions, we are uncertain of the effects of dopamine agonists on moderate or severe OHSS and pregnancy outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence ranged from very low to moderate. Limitations included poor reporting of study methods and imprecision (too few events, too few included studies) for some comparisons."
}
] |
query-laysum
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7135
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[
{
"role": "user",
"content": "Abstract: Background\nAvailable evidence on the effects of vitamin D on mortality has been inconclusive. In a recent systematic review, we found evidence that vitamin D3 may decrease mortality in mostly elderly women. The present systematic review updates and reassesses the benefits and harms of vitamin D supplementation used in primary and secondary prophylaxis of mortality.\nObjectives\nTo assess the beneficial and harmful effects of vitamin D supplementation for prevention of mortality in healthy adults and adults in a stable phase of disease.\nSearch methods\nWe searched The Cochrane Library, MEDLINE, EMBASE, LILACS, the Science Citation Index–Expanded and Conference Proceedings Citation Index–Science (all up to February 2012). We checked references of included trials and pharmaceutical companies for unidentified relevant trials.\nSelection criteria\nRandomised trials that compared any type of vitamin D in any dose with any duration and route of administration versus placebo or no intervention in adult participants. Participants could have been recruited from the general population or from patients diagnosed with a disease in a stable phase. Vitamin D could have been administered as supplemental vitamin D (vitamin D3 (cholecalciferol) or vitamin D2 (ergocalciferol)) or as an active form of vitamin D (1α-hydroxyvitamin D (alfacalcidol) or 1,25-dihydroxyvitamin D (calcitriol)).\nData collection and analysis\nSix review authors extracted data independently. Random-effects and fixed-effect meta-analyses were conducted. For dichotomous outcomes, we calculated the risk ratios (RRs). To account for trials with zero events, we performed meta-analyses of dichotomous data using risk differences (RDs) and empirical continuity corrections. We used published data and data obtained by contacting trial authors.\nTo minimise the risk of systematic error, we assessed the risk of bias of the included trials. Trial sequential analyses controlled the risk of random errors possibly caused by cumulative meta-analyses.\nMain results\nWe identified 159 randomised clinical trials. Ninety-four trials reported no mortality, and nine trials reported mortality but did not report in which intervention group the mortality occurred. Accordingly, 56 randomised trials with 95,286 participants provided usable data on mortality. The age of participants ranged from 18 to 107 years. Most trials included women older than 70 years. The mean proportion of women was 77%. Forty-eight of the trials randomly assigned 94,491 healthy participants. Of these, four trials included healthy volunteers, nine trials included postmenopausal women and 35 trials included older people living on their own or in institutional care. The remaining eight trials randomly assigned 795 participants with neurological, cardiovascular, respiratory or rheumatoid diseases. Vitamin D was administered for a weighted mean of 4.4 years. More than half of the trials had a low risk of bias. All trials were conducted in high-income countries. Forty-five trials (80%) reported the baseline vitamin D status of participants based on serum 25-hydroxyvitamin D levels. Participants in 19 trials had vitamin D adequacy (at or above 20 ng/mL). Participants in the remaining 26 trials had vitamin D insufficiency (less than 20 ng/mL).\nVitamin D decreased mortality in all 56 trials analysed together (5,920/47,472 (12.5%) vs 6,077/47,814 (12.7%); RR 0.97 (95% confidence interval (CI) 0.94 to 0.99); P = 0.02; I2 = 0%). More than 8% of participants dropped out. 'Worst-best case' and 'best-worst case' scenario analyses demonstrated that vitamin D could be associated with a dramatic increase or decrease in mortality. When different forms of vitamin D were assessed in separate analyses, only vitamin D3 decreased mortality (4,153/37,817 (11.0%) vs 4,340/38,110 (11.4%); RR 0.94 (95% CI 0.91 to 0.98); P = 0.002; I2 = 0%; 75,927 participants; 38 trials). Vitamin D2, alfacalcidol and calcitriol did not significantly affect mortality. A subgroup analysis of trials at high risk of bias suggested that vitamin D2 may even increase mortality, but this finding could be due to random errors. Trial sequential analysis supported our finding regarding vitamin D3, with the cumulative Z-score breaking the trial sequential monitoring boundary for benefit, corresponding to 150 people treated over five years to prevent one additional death. We did not observe any statistically significant differences in the effect of vitamin D on mortality in subgroup analyses of trials at low risk of bias compared with trials at high risk of bias; of trials using placebo compared with trials using no intervention in the control group; of trials with no risk of industry bias compared with trials with risk of industry bias; of trials assessing primary prevention compared with trials assessing secondary prevention; of trials including participants with vitamin D level below 20 ng/mL at entry compared with trials including participants with vitamin D levels equal to or greater than 20 ng/mL at entry; of trials including ambulatory participants compared with trials including institutionalised participants; of trials using concomitant calcium supplementation compared with trials without calcium; of trials using a dose below 800 IU per day compared with trials using doses above 800 IU per day; and of trials including only women compared with trials including both sexes or only men. Vitamin D3 statistically significantly decreased cancer mortality (RR 0.88 (95% CI 0.78 to 0.98); P = 0.02; I2 = 0%; 44,492 participants; 4 trials). Vitamin D3 combined with calcium increased the risk of nephrolithiasis (RR 1.17 (95% CI 1.02 to 1.34); P = 0.02; I2 = 0%; 42,876 participants; 4 trials). Alfacalcidol and calcitriol increased the risk of hypercalcaemia (RR 3.18 (95% CI 1.17 to 8.68); P = 0.02; I2 = 17%; 710 participants; 3 trials).\nAuthors' conclusions\nVitamin D3 seemed to decrease mortality in elderly people living independently or in institutional care. Vitamin D2, alfacalcidol and calcitriol had no statistically significant beneficial effects on mortality. Vitamin D3 combined with calcium increased nephrolithiasis. Both alfacalcidol and calcitriol increased hypercalcaemia. Because of risks of attrition bias originating from substantial dropout of participants and of outcome reporting bias due to a number of trials not reporting on mortality, as well as a number of other weaknesses in our evidence, further placebo-controlled randomised trials seem warranted.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In the 56 trials that provided data for the analyses, a total of 95,286 participants were randomly assigned to vitamin D versus no treatment or placebo. More than half of the trials were considered to have low risk of bias. All trials were conducted in high-income countries. The age of participants ranged from 18 to 107 years. The mean proportion of women was 77%. Vitamin D was administered for an average of 4.4 years.\nThis plain language summary is as current as of February 2012."
}
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query-laysum
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7136
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[
{
"role": "user",
"content": "Abstract: Background\nObstructive sleep-disordered breathing (oSDB) is a condition encompassing breathing problems when asleep due to upper airway obstruction. In children, hypertrophy of the tonsils and/or adenoids is thought to be the commonest cause. As such, (adeno)tonsillectomy has long been the treatment of choice. A rise in partial removal of the tonsils over the last decade is due to the hypothesis that tonsillotomy is associated with lower postoperative morbidity and fewer complications.\nObjectives\nTo assess whether partial removal of the tonsils (intracapsular tonsillotomy) is as effective as total removal of the tonsils (extracapsular tonsillectomy) in relieving signs and symptoms of oSDB in children, and has lower postoperative morbidity and fewer complications.\nSearch methods\nWe searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The search date was 22 July 2019.\nSelection criteria\nRandomised controlled trials (RCTs) comparing the effectiveness of (adeno)tonsillectomy with (adeno)tonsillotomy in children aged 2 to 16 years with oSDB.\nData collection and analysis\nWe used standard Cochrane methods and assessed the certainty of the evidence for our pre-defined outcomes using GRADE. Our primary outcomes were disease-specific quality of life, peri-operative blood loss and the proportion of children requiring postoperative medical intervention (with or without hospitalisation). Secondary outcomes included postoperative pain, return to normal activity, recurrence of oSDB symptoms as a result of tonsil regrowth and reoperation rates.\nMain results\nWe included 22 studies (1984 children), with predominantly unclear or high risk of bias. Three studies used polysomnography as part of their inclusion criteria. Follow-up duration ranged from six days to six years. Although 19 studies reported on some of our outcomes, we could only pool the results from a few due both to the variety of outcomes and the measurement instruments used, and an absence of combinable data.\nDisease-specific quality of life\nFour studies (540 children; 484 (90%) analysed) reported this outcome; data could not be pooled due to the different outcome measurement instruments used. It is very uncertain whether there is any difference in disease-specific quality of life between the two surgical procedures in the short (0 to 6 months; 3 studies, 410 children), medium (7 to 13 months; 2 studies, 117 children) and long term (13 to 24 months; 1 study, 67 children) (very low-certainty evidence).\nPeri-operative blood loss\nWe are uncertain whether tonsillotomy reduces peri-operative blood loss by a clinically meaningful amount (mean difference (MD) 14.06 mL, 95% CI 1.91 to 26.21 mL; 8 studies, 610 children; very low-certainty evidence). In sensitivity analysis (restricted to three studies with low risk of bias) there was no evidence of a difference between the groups.\nPostoperative complications requiring medical intervention (with or without hospitalisation)\nThe risk of postoperative complications in the first week after surgery was probably lower in children who underwent tonsillotomy (4.9% versus 2.6%, risk ratio (RR) 1.75, 95% CI 1.06 to 2.91; 16 studies, 1416 children; moderate-certainty evidence).\nPostoperative pain\nEleven studies (1017 children) reported this outcome. Pain was measured using various scales and scored by either children, parents, clinicians or study personnel.\nWhen considering postoperative pain there was little or no difference between tonsillectomy and tonsillotomy at 24 hours (10-point scale) (MD 1.09, 95% CI 0.88 to 1.29; 4 studies, 368 children); at two to three days (MD 0.93, 95% CI -0.14 to 2.00; 3 studies, 301 children); or at four to seven days (MD 1.07, 95% CI -0.40 to 2.53; 4 studies, 370 children) (all very low-certainty evidence). In sensitivity analysis (restricted to studies with low risk of bias), we found no evidence of a difference in mean pain scores between groups.\nReturn to normal activity\nTonsillotomy probably results in a faster return to normal activity. Children who underwent tonsillotomy were able to return to normal activity four days earlier (MD 3.84 days, 95% CI 0.23 to 7.44; 3 studies, 248 children; moderate-certainty evidence).\nRecurrence of oSDB and reoperation rates\nWe are uncertain whether there is a difference between the groups in the short (RR 0.26, 95% CI 0.03 to 2.22; 3 studies, 186 children), medium (RR 0.35, 95% CI 0.04 to 3.23; 4 studies, 206 children) or long term (RR 0.21 95% CI 0.01 to 4.13; 1 study, 65 children) (all very low-certainty evidence).\nAuthors' conclusions\nFor children with oSDB selected for tonsil surgery, tonsillotomy probably results in a faster return to normal activity (four days) and in a slight reduction in postoperative complications requiring medical intervention in the first week after surgery.\nThis should be balanced against the clinical effectiveness of one operation over the other. However, this is not possible to determine in this review as data on the long-term effects of the two operations on oSDB symptoms, quality of life, oSDB recurrence and need for reoperation are limited and the evidence is of very low quality leading to a high degree of uncertainty about the results.\nMore robust data from high-quality cohort studies, which may be more appropriate for detecting differences in less common events in the long term, are required to inform guidance on which tonsil surgery technique is best for children with oSDB requiring surgery.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The large majority of the studies included in this review had an unclear to high risk of bias and the evidence for most outcomes was of low to very low quality, meaning that the results are very uncertain. This means that we need more information from well-designed studies on the long-term outcomes of tonsillectomy and tonsillotomy to help parents and ENT surgeons choose which type of tonsil operation is best for children with obstructive sleep-disordered breathing who require surgery."
}
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query-laysum
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7137
|
[
{
"role": "user",
"content": "Abstract: Background\nStaphylococcus aureus causes pulmonary infection in young children with cystic fibrosis. Prophylactic antibiotics are prescribed hoping to prevent such infection and lung damage. Antibiotics have adverse effects and long-term use might lead to infection with Pseudomonas aeruginosa. This is an update of a previously published review.\nObjectives\nTo assess continuous oral antibiotic prophylaxis to prevent the acquisition of Staphylococcus aureus versus no prophylaxis in people with cystic fibrosis, we tested the following hypotheses to investigate whether prophylaxis:\n1. improves clinical status, lung function and survival;\n2. leads to fewer isolates of Staphylococcus aureus;\n3. causes adverse effects (e.g. diarrhoea, skin rash, candidiasis);\n4. leads to fewer isolates of other common pathogens from respiratory secretions;\n5. leads to the emergence of antibiotic resistance and colonisation of the respiratory tract with Pseudomonas aeruginosa.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. Companies manufacturing anti-staphylococcal antibiotics were contacted.\nMost recent search of the Group's Register: 27 February 2020.\nOnline trials registries were also searched. Most recent search of online trials registries: 15 September 2020.\nSelection criteria\nRandomised trials of continuous oral prophylactic antibiotics (given for at least one year) compared to intermittent antibiotics given 'as required', in people with cystic fibrosis of any disease severity.\nData collection and analysis\nThe authors assessed studies for eligibility and methodological quality and extracted data. The quality of the evidence was assessed using the GRADE criteria. The review's primary outcomes of interest were lung function by spirometry (forced expiratory volume in one second (FEV1)) and the number of people with one or more isolates of Staphylococcus aureus (sensitive strains).\nMain results\nWe included four studies, with a total of 401 randomised participants aged zero to seven years on enrolment; one study is ongoing. The two older included studies generally had a higher risk of bias across all domains, but in particular due to a lack of blinding and incomplete outcome data, than the two more recent studies. We only regarded the most recent study as being generally free of bias, although even here we were not certain of the effect of the per protocol analysis on the study results. Evidence quality was judged to be low for all outcomes assessed after being downgraded based on GRADE assessments. Downgrading decisions were due to limitations in study design (all outcomes), for imprecision and for inconsistency .\nProphylactic anti-staphylococcal antibiotics probably make little or no difference to lung function measured as FEV1 % predicted after six years (mean difference (MD) -2.30, 95% confidence interval (CI) -13.59 to 8.99, one study, n = 119, low-quality evidence); but may reduce the number of children having one or more isolates of Staphylococcus aureus at two years (odds ratio (OR) 0.21, 95% CI 0.13 to 0.35, three studies, n = 315, low-quality evidence). At the same time point, there may be little or no effect on nutrition as reported using weight z score (MD 0.06, 95% CI -0.33 to 0.45, two studies, n = 140, low-quality evidence), additional courses of antibiotics (OR 0.18, 95% CI 0.01 to 3.60, one study, n = 119, low-quality evidence) or adverse effects (low-quality evidence). There was no difference in the number of isolates of Pseudomonas aeruginosa between groups at two years (OR 0.74, 95% CI 0.45 to 1.23, three studies, n = 312, low-quality evidence), though there was a trend towards a lower cumulative isolation rate of Pseudomonas aeruginosa in the prophylaxis group at two and three years and towards a higher rate from four to six years. As the studies reviewed lasted six years or less, conclusions cannot be drawn about the long-term effects of prophylaxis.\nAuthors' conclusions\nAnti-staphylococcal antibiotic prophylaxis may lead to fewer children having isolates of Staphylococcus aureus, when commenced early in infancy and continued up to six years of age. The clinical importance of this finding is uncertain. Further research may establish whether the trend towards more children with CF with Pseudomonas aeruginosa, after four to six years of prophylaxis, is a chance finding and whether choice of antibiotic or duration of treatment might influence this.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to: 27 February 2020."
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query-laysum
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7138
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[
{
"role": "user",
"content": "Abstract: Background\nGraft thrombosis is a well-recognised complication of solid organ transplantation and is one of the leading causes of graft failure. Currently there are no standardised protocols for thromboprophylaxis. Many transplant units use unfractionated heparin (UFH) and fractionated heparins (low molecular weight heparin; LMWH) as prophylaxis for thrombosis. Antiplatelet agents such as aspirin are routinely used as prophylaxis of other thrombotic conditions and may have a role in preventing graft thrombosis. However, any pharmacological thromboprophylaxis comes with the theoretical risk of increasing the risk of major blood loss following transplant. This review looks at benefits and harms of thromboprophylaxis in patients undergoing solid organ transplantation.\nObjectives\nTo assess the benefits and harms of instituting thromboprophylaxis to patients undergoing solid organ transplantation.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 10 November 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and quasi-RCTs designed to examine interventions to prevent thrombosis in solid organ transplant recipients. All donor types were included (donor after circulatory (DCD) and brainstem death (DBD) and live transplantation). There was no upper age limit for recipients in our search.\nData collection and analysis\nThe results of the literature search were screened and data collected by two independent authors. Dichotomous outcome results were expressed as risk ratio (RR) with 95% confidence intervals (CI). Random effects models were used for data analysis. Risk of bias was independently assessed by two authors using the risk of bias assessment tool. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nWe identified nine studies (712 participants). Seven studies (544 participants) included kidney transplant recipients, and two studies (168 participants) included liver transplant recipients. We did not identify any study enrolling heart, lung, pancreas, bowel, or any other solid organ transplant recipient. Selection bias was high or unclear in eight of the nine studies; five studies were at high risk of bias for performance and/or detection bias; while attrition and reporting biases were in general low or unclear.\nThree studies (180 participants) primarily investigated heparinisation in kidney transplantation. Only two studies reported on graft vessel thrombosis in kidney transplantation (144 participants). These small studies were at high risk of bias in several domains and reported only two graft thromboses between them; it therefore remains unclear whether heparin decreases the risk of early graft thrombosis or non-graft thrombosis (very low certainty).\nUFH may make little or no difference versus placebo to the rate of major bleeding events in kidney transplantation (3 studies, 155 participants: RR 2.92, 95% CI 0.89 to 9.56; I² = 0%; low certainty evidence). Sensitivity analysis using a fixed-effect model suggested that UFH may increase the risk of haemorrhagic events compared to placebo (RR 3.33, 95% CI 1.04 to 10.67, P = 0.04). Compared to control, any heparin (including LMWH) may make little or no difference to the number of major bleeding events (3 studies, 180 participants: RR 2.70, 95% CI 0.89 to 8.19; I² = 0%; low certainty evidence) and had an unclear effect on risk of readmission to intensive care (3 studies, 180 participants: RR 0.68, 95% CI 0.12 to 3.90, I² = 45%; very low certainty evidence). The effect of heparin on our other outcomes (including death, patient and graft survival, transfusion requirements) remains unclear (very low certainty evidence).\nThree studies (144 participants) investigated antiplatelet interventions in kidney transplantation: aspirin versus dipyridamole (1), and Lipo-PGE1 plus low-dose heparin to \"control\" in patients who had a diagnosis of acute rejection (2). None of these reported on early graft thromboses. The effect of aspirin, dipyridamole and Lipo PGE1 plus low-dose heparin on any outcomes is unclear (very low certainty evidence).\nTwo studies (168 participants) assessed interventions in liver transplants. One compared warfarin versus aspirin in patients with pre-existing portal vein thrombosis and the other investigated plasmapheresis plus anticoagulation. Both studies were abstract-only publications, had high risk of bias in several domains, and no outcomes could be meta-analysed. Overall, the effect of any of these interventions on any of our outcomes remains unclear with no evidence to guide anti-thrombotic therapy in standard liver transplant recipients (very low certainty evidence).\nAuthors' conclusions\nOverall, there is a paucity of research in the field of graft thrombosis prevention. Due to a lack of high quality evidence, it remains unclear whether any therapy is able to reduce the rate of early graft thrombosis in any type of solid organ transplant. UFH may increase the risk of major bleeding in kidney transplant recipients, however this is based on low certainty evidence. There is no evidence from RCTs to guide anti-thrombotic strategies in liver, heart, lung, or other solid organ transplants. Further studies are required in comparing anticoagulants, antiplatelets to placebo in solid organ transplantation. These should focus on outcomes such as early graft thrombosis, major haemorrhagic complications, return to theatre, and patient/graft survival.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is a lack of evidence to guide the use of medications to prevent blood clots in transplanted organs. New research is needed to assess treatments to prevent blood clots, and also to investigate the risks of these treatments, such as major bleeding."
}
] |
query-laysum
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7139
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[
{
"role": "user",
"content": "Abstract: Background\nNonarteritic anterior ischemic optic neuropathy (NAION) is characterized by sudden and painless loss of vision in the eye, accompanied by pallid swelling of the optic disc. Its etiology is unknown and no medical therapy has been proven effective in treating this condition. Optic nerve decompression surgery, a proposed treatment for NAION, involves making two or more slits or a window in the tissue surrounding the optic nerve, thereby allowing cerebrospinal fluid to escape, and theoretically reducing the pressure surrounding the optic nerve.\nObjectives\nThe objective of this review was to assess the safety and efficacy of surgery compared with other treatment or no treatment in people with NAION.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 10), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2014), EMBASE (January 1980 to October 2014), PubMed (1948 to October 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 23 October 2014.\nSelection criteria\nAll randomized trials of surgical treatment of NAION were eligible for inclusion in this review.\nData collection and analysis\nFrom full-text copies of all reports from relevant trials, one author extracted data which were verified by another author. No data synthesis was required.\nMain results\nThe one included trial, in which 258 participants were randomized, was stopped early for futility. At the time of the 24-month report the follow-up rate was 95.3% for six months and 67.4% for 24 months (174 participants; 89 careful follow-up and 85 surgery). There was no evidence of a benefit of surgery on visual acuity. Measurements of visual acuity and visual fields were performed by a technician masked to the treatment received. At six months 32.0% of the surgery group had improved visual acuity by 3 or more lines compared with 42.6% of the careful follow-up group (unadjusted risk ratio (RR) 0.75, 95% confidence interval (CI) 0.54 to 1.04). At 24 months 29.4% of the surgery group had improved compared with 31.0% of the careful follow-up group (unadjusted RR 0.95, 95% CI 0.60 to 1.49). Participants who underwent surgery more often lost 3 or more lines of visual acuity in the study eye, although the increased risk was not statistically significant. At six months 18.9% in the surgery group had worsened visual acuity in the study eye compared with 14.8% in the careful follow-up group (RR 1.28; 95% CI 0.73 to 2.24). At 24 months 20.0% in the surgery group had worsened visual acuity in the study eye compared with 21.8% in the careful follow-up group (RR 0.92; 95% CI 0.51 to 1.64). Participants who received surgery experienced both intraoperative and postoperative adverse events, including central retinal artery occlusion during surgery and light perception vision at six months (one participant); and immediate loss of light perception following surgery and loss of vision that persisted to the 12-month visit (two participants). In the careful follow-up group, two participants had no light perception at the six-month follow-up visit; one of these had improved to light perception at 12 months. Pain was the most common adverse event in the surgery group (17% in surgery group versus 3% in the careful follow-up group at one week). Diplopia (double vision) was the next most common complication (8% in the surgery group versus 1% in the careful follow-up group at one week); at three months there was no statistically significant difference in proportion of participants with diplopia between the two groups.\nAuthors' conclusions\nThe only eligible trial provided no evidence of a beneficial effect of optic nerve decompression surgery for NAION. Future research should focus on increasing our understanding of the etiology and prognosis of NAION. New treatment options should be examined in the context of randomized clinical trials.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review looked at the evidence about the safety and effectiveness of surgery (optic nerve decompression surgery) compared with no treatment on the vision of people with nonarteritic anterior ischemic optic neuropathy (NAION)."
}
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query-laysum
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7140
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[
{
"role": "user",
"content": "Abstract: Background\nHysterosalpingography (HSG) is a method of testing for tubal patency. However, women struggle to tolerate the procedure, as it is associated with some discomfort. Various pharmacological strategies are available that may reduce pain during the procedure, though there is no consensus as to the best method.\nObjectives\nTo compare the effectiveness of different types of pharmacological interventions for pain relief in women undergoing HSG for investigation of subfertility.\nSearch methods\nThis review has drawn on the search strategy developed for the Cochrane Menstrual Disorders and Subfertility Group (MDSG). We searched the following databases to 15 April 2015: MDSG Specialised Register, CENTRAL, MEDLINE, EMBASE, CINAHL and PsycINFO.\nSelection criteria\nAll identified randomised controlled trials investigating pharmacological interventions for pain relief during HSG were investigated for selection.\nData collection and analysis\nFour review authors independently extracted data. We combined data to calculate mean differences (MDs) with 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I² statistic. We assessed the overall quality of the evidence for the main comparisons using GRADE methods.\nMain results\nThe search identified 23 trials (1272 women) that were eligible for inclusion into the study.\nOral opioid analgesia versus placebo/no treatment\nThere was no evidence of effect for oral opioid analgesia in reducing pain during the procedure (MD −0.91, 95% CI −1.88 to 0.06, 1 study, n = 128, low quality evidence) or more than 30 minutes after the procedure (MD −0.99, 95% CI −1.75 to −0.23, 1 study, n = 128, moderate quality evidence)\nNo studies reported on the effect of oral opioid analgesia, when taken prior to the procedure, in reducing pain within 30 minutes after the procedure\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nIntravenous opioid analgesia versus placebo/no treatment\nThere was evidence that intravenous opioids may improve pain relief during the procedure compared to no treatment (MD −3.53, 95% CI −4.29 to −2.77, 1 study, n = 62, moderate quality evidence)\nNo studies reported on the effect of intravenous opioid analgesia, when taken prior to the procedure, in reducing pain within 30 minutes and more than 30 minutes after the procedure\nIn terms of adverse effects, one trial reported 1/32 participants had apnoea with intravenous remifentanil. Recovery time was nearly 4 minutes longer in the remifentanil group compared to the control.\nOral non-opioid analgesia versus placebo/no treatment\nThere was no evidence of effect for oral non-opioid analgesia in reducing pain during the procedure (MD −0.13, 95% CI −0.48 to 0.23, 3 studies, n = 133, I² = 61%, low quality evidence), less than 30 minutes after the procedure (MD −0.30, 95% CI −1.03 to 0.43, 2 studies, n = 45, I² = 97%, very low quality evidence), or more than 30 minutes after the procedure (MD −0.36, 95% CI −1.06 to 0.34, 3 studies, n = 133, I² = 58%, low quality evidence).\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nTopical anaesthesia versus placebo/no treatment\nThere was evidence that topical anaesthetics may reduce pain during the procedure (MD −0.63, 95% CI −1.06 to −0.19, 9 studies, n = 613, I² = 66%, low quality evidence).\nThere was no evidence of effect for topical anaesthesia, when applied prior to the procedure, in reducing pain less than 30 minutes after the procedure (MD 0.42, 95% CI -0.03 to 0.86, 5 studies, n = 373, I² = 59%, very low quality evidence).\nThere was evidence of effect for topical anaesthesia, when applied prior to the procedure, in reducing pain more than 30 minutes after the procedure (MD −1.38, 95% CI -3.44 to −0.68, 2 studies, n = 166, I² = 92%, very low quality evidence).\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nLocally injected anaesthesia versus placebo/no treatment\nThere was evidence of effect that locally injected anaesthetic can reduce pain during the procedure (MD −1.31, 95% CI −1.55 to −1.07, 2 studies, n = 125, I² = 0%, very low quality evidence).\nThere was no evidence of effect for locally injected anaesthesia, when applied prior to the procedure, in reducing pain less than 30 minutes after the procedure (MD −1.31, 95% CI −2.14 to −0.49, 2 studies, n = 125, I² = 46%, low quality evidence).\nNo studies were included into the analysis of the effect of locally injected anaesthesia, when injected prior to the procedure, in reducing pain more than 30 minutes after the procedure.\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nAny analgesic versus any other analgesic\nThere was no evidence of a difference between the groups when oral non-opioid analgesia was compared to opioid analgesia for pain relief during the procedure (MD 1.10, 95% CI −0.26 to 2.46, 1 study, n = 91, low quality evidence); less than 30 minutes following the procedure (MD −0.30, 95% CI −1.00 to 0.40, 1 study, n = 91, low quality evidence); and more than 30 minutes following the procedure (MD −0.60, 95% CI −1.56 to 0.36, 1 study, n = 91, low quality evidence). Topical anaesthetics were found to be more effective than paracervical block for pain relief during HSG (MD −2.73, 95% CI −3.86 to −1.60, 1 study, n = 20, moderate quality evidence). This benefit did not extend to within 30 minutes following HSG (MD −1.03, 95% CI −2.52 to 0.46, 1 study, n = 20, low quality evidence); or 30 minutes or more after HSG (MD 0.31, 95% CI −0.87 to 1.49, 1 study, n = 20, low quality evidence).\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nAuthors' conclusions\nTopical anaesthetic applied before the procedure may be associated with effective pain relief during HSG, though the quality of this evidence is low. Intravenous opioids may also be effective in pain relief, though this must be weighed against their side effects and their effects on the recovery time. There is insufficient evidence to draw conclusions on the efficacy of other analgesics for HSG, or to reach any other conclusions regarding adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "\nTopical anaesthetic was associated with a mild reduction in the pain experienced during HSG (low quality evidence). However, it has no effect on the discomfort experienced by participants following the procedure (very low quality evidence).\nLocally injected anaesthetics, on the other hand, were not associated with any benefit. Only one study investigated this (moderate quality evidence).\nOne study directly compared locally injected anaesthetics to topical anaesthetics. This study found that topical anaesthesia was associated with improved pain relief during the procedure (moderate quality evidence)\nNo oral drug was found to be effective in reducing pain experienced during the procedure. This was true for both opioid (low quality evidence) and non-opioid (low quality evidence) analgesia. One trial however reported that tramadol may be of benefit in reducing the pain experienced more than 30 minutes after the procedure (moderate quality evidence)."
}
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query-laysum
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7141
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[
{
"role": "user",
"content": "Abstract: Background\nFor people with physical, sensory and cognitive limitations due to stroke, the routine practice of oral health care (OHC) may become a challenge. Evidence-based supported oral care intervention is essential for this patient group.\nObjectives\nTo compare the effectiveness of OHC interventions with usual care or other treatment options for ensuring oral health in people after a stroke.\nSearch methods\nWe searched the Cochrane Stroke Group and Cochrane Oral Health Group trials registers, CENTRAL, MEDLINE, Embase, and six other databases in February 2019. We scanned reference lists from relevant papers and contacted authors and researchers in the field. We handsearched the reference lists of relevant articles and contacted other researchers. There were no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated one or more interventions designed to improve the cleanliness and health of the mouth, tongue and teeth in people with a stroke who received assisted OHC led by healthcare staff. We included trials with a mixed population provided we could extract the stroke-specific data. The primary outcomes were dental plaque or denture plaque. Secondary outcomes included presence of oral disease, presence of related infection and oral opportunistic pathogens related to OHC and pneumonia, stroke survivor and providers' knowledge and attitudes to OHC, and patient satisfaction and quality of life.\nData collection and analysis\nTwo review authors independently screened abstracts and full-text articles according to prespecified selection criteria, extracted data and assessed the methodological quality using the Cochrane 'Risk of bias' tool. We sought clarification from investigators when required. Where suitable statistical data were available, we combined the selected outcome data in pooled meta-analyses. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nFifteen RCTs (22 randomised comparisons) involving 3631 participants with data for 1546 people with stroke met the selection criteria.\nOHC interventions compared with usual care\nSeven trials (2865 participants, with data for 903 participants with stroke, 1028 healthcare providers, 94 informal carers) investigated OHC interventions compared with usual care.\nMulti-component OHC interventions showed no evidence of a difference in the mean score (DMS) of dental plaque one month after the intervention was delivered (DMS –0.66, 95% CI –1.40 to 0.09; 2 trials, 83 participants; I2 = 83%; P = 0.08; very low-quality evidence).\nStroke survivors had less plaque on their dentures when staff had access to the multi-component OHC intervention (DMS –1.31, 95% CI –1.96 to –0.66; 1 trial, 38 participants; P < 0.0001; low-quality evidence).\nThere was no evidence of a difference in gingivitis (DMS –0.60, 95% CI –1.66 to 0.45; 2 trials, 83 participants; I2 = 93%; P = 0.26: very low-quality evidence) or denture-induced stomatitis (DMS –0.33, 95% CI –0.92 to 0.26; 1 trial, 38 participants; P = 0.69; low-quality evidence) among participants receiving the multi-component OHC protocol compared with usual care one month after the intervention. There was no difference in the incidence of pneumonia in participants receiving a multi-component OHC intervention (99 participants; 5 incidents of pneumonia) compared with those receiving usual care (105 participants; 1 incident of pneumonia) (OR 4.17, CI 95% 0.82 to 21.11; 1 trial, 204 participants; P = 0.08; low-quality evidence).\nOHC training for stroke survivors and healthcare providers significantly improved their OHC knowledge at one month after training (SMD 0.70, 95% CI 0.06 to 1.35; 3 trials, 728 participants; I2 = 94%; P = 0.03; very low-quality evidence). Pooled data one month after training also showed evidence of a difference between stroke survivor and providers' oral health attitudes (SMD 0.28, 95% CI 0.01 to 0.54; 3 trials, 728 participants; I2 = 65%; P = 0.06; very low-quality evidence).\nOHC interventions compared with placebo\nThree trials (394 participants, with data for 271 participants with stroke) compared an OHC intervention with placebo. There were no data for primary outcomes. There was no evidence of a difference in the incidence of pneumonia in participants receiving an OHC intervention compared with placebo (OR 0.39, CI 95% 0.14 to 1.09; 2 trials, 242 participants; I2 = 42%; P = 0.07; low-quality evidence). However, decontamination gel reduced the incidence of pneumonia among the intervention group compared with placebo gel group (OR 0.20, 95% CI 0.05 to 0.84; 1 trial, 203 participants; P = 0.028). There was no difference in the incidence of pneumonia in participants treated with povidone-iodine compared with a placebo (OR 0.81, 95% CI 0.18 to 3.51; 1 trial, 39 participants; P = 0.77).\nOne OHC intervention compared with another OHC intervention\nTwelve trials (372 participants with stroke) compared one OHC intervention with another OHC intervention. There was no difference in dental plaque scores between those participants that received an enhanced multi-component OHC intervention compared with conventional OHC interventions at three months (MD –0.04, 95% CI –0.33 to 0.25; 1 trial, 61 participants; P = 0.78; low-quality evidence). There were no data for denture plaque.\nAuthors' conclusions\nWe found low- to very low-quality evidence suggesting that OHC interventions can improve the cleanliness of patient's dentures and stroke survivor and providers' knowledge and attitudes. There is limited low-quality evidence that selective decontamination gel may be more beneficial than placebo at reducing the incidence of pneumonia. Improvements in the cleanliness of a patient's own teeth was limited. We judged the quality of the evidence included within meta-analyses to be low or very low quality, and this limits our confidence in the results. We still lack high-quality evidence of the optimal approach to providing OHC to people after stroke.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to know whether oral healthcare (OHC) interventions improve the oral health of people who have had a stroke, and if any one OHC intervention provided more benefit than another approach."
}
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query-laysum
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7142
|
[
{
"role": "user",
"content": "Abstract: Background\nOpioid-induced bowel dysfunction (OIBD) is characterised by constipation, incomplete evacuation, bloating, and gastric reflux. It is one of the major adverse events (AEs) of treatment for pain in cancer and palliative care, resulting in increased morbidity and reduced quality of life.\nThis review is a partial update of a 2008 review, and critiques as previous update (2018) trials only for people with cancer and people receiving palliative care.\nObjectives\nTo assess for OIBD in people with cancer and people receiving palliative care the effectiveness and safety of mu-opioid antagonists (MOAs) versus different doses of MOAs, alternative pharmacological/non-pharmacological interventions, placebo, or no treatment.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, and Web of Science (December 2021), clinical trial registries and regulatory websites. We sought contact with MOA manufacturers for further data.\nSelection criteria\nRandomised controlled trials (RCTs) assessing the effectiveness and safety of MOAs for OIBD in people with cancer and people at a palliative stage irrespective of the type of terminal disease.\nData collection and analysis\nTwo review authors assessed risk of bias and extracted data. The appropriateness of combining data from the trials depended upon sufficient homogeneity across trials. Our primary outcomes were laxation response, effect on analgesia, and AEs. We assessed the certainty of evidence using GRADE and created summary of findings tables.\nMain results\nWe included 10 studies (two new trials) randomising in-total 1343 adults with cancer irrespective of stage, or at palliative care stage of any disease. The MOAs were oral naldemedine and naloxone (alone or in combination with oxycodone), and subcutaneous methylnaltrexone. The trials compared MOAs with placebo, MOAs at different doses, or in combination with other drugs. Two trials of naldemedine and three of naloxone with oxycodone were in people with cancer irrespective of disease stage. The trial on naloxone alone was in people with advanced cancer. Four trials on methylnaltrexone were in palliative care where most participants had advanced cancer. All trials were vulnerable to biases; most commonly, blinding of the outcome assessor was not reported.\nOral naldemedine versus placebo\nRisk (i.e. chance) of spontaneous laxations in the medium term (over two weeks) for naldemedine was over threefold greater risk ratio (RR) 2.00, 95% confidence interval (CI) 1.59 to 2.52, 2 trials, 418 participants, I² = 0%. Number needed to treat for an additional beneficial outcome (NNTB) 3, 95% CI 3 to 4; moderate-certainty evidence). Earlier risk of spontaneous laxations and patient assessment of bowel change was not reported. Very low-certainty evidence showed naldemedine had little to no effect on opioid withdrawal symptoms. There was little to no difference in the risk of serious (non-fatal) AEs (RR 3.34, 95% CI 0.85 to 13.15: low-certainty evidence). Over double the risk of AEs (non-serious) reported with naldemedine (moderate-certainty evidence).\nLow-dose oral naldemedine versus higher dose\nRisk of spontaneous laxations was lower for the lower dose (medium term, 0.1 mg versus 0.4 mg: RR 0.69, 95% CI 0.53 to 0.89, 1 trial, 111 participants (low-certainty evidence)). Earlier risk of spontaneous laxations and patient assessment of bowel change not reported. Low-certainty evidence showed little to no difference on opioid withdrawal symptoms (0.1 mg versus 0.4 mg mean difference (MD) -0.30, 95% CI -0.85 to 0.25), and occurrences of serious AEs (0.1 mg versus 0.4 mg RR 0.25, 95% CI 0.03 to 2.17). Low-certainty evidence showed little to no difference on non-serious AEs.\nOral naloxone versus placebo\nRisk of spontaneous laxations and AEs not reported. Little to no difference in pain intensity (very low-certainty evidence). Full data not given. The trial reported that no serious AEs occurred.\nOral naloxone + oxycodone versus oxycodone\nRisk of spontaneous laxations within 24 hours and in the medium term not reported. Low-certainty evidence showed naloxone with oxycodone reduced the risk of opioid withdrawal symptoms. There was little to no difference in the risk of serious (non-fatal) AEs (RR 0.68, 95% CI 0.44 to 1.06), 3 trials, 362 participants, I² = 55%: very low-certainty evidence). There was little to no difference in risk of AEs (low-certainty evidence).\nSubcutaneous methylnaltrexone versus placebo\nRisk of spontaneous laxations within 24 hours with methylnaltrexone was fourfold greater than placebo (RR 2.97, 95% CI 2.13 to 4.13. 2 trials, 287 participants, I² = 31%. NNTB 3, 95% CI 2 to 3; low-certainty evidence). Risk of spontaneous laxations in the medium term was over tenfold greater with methylnaltrexone (RR 8.15, 95% CI 4.76 to 13.95, 2 trials, 305 participants, I² = 47%. NNTB 2, 95% CI 2 to 2; moderate-certainty evidence). Low-certainty evidence showed methylnaltrexone reduced the risk of opioid withdrawal symptoms, and did not increase risk of a serious AE (RR 0.59, 95% CI 0.38 to 0.93. I² = 0%; 2 trials, 364 participants). The risk of AEs was higher for methylnaltrexone (low-certainty evidence).\nLower-dose subcutaneous methylnaltrexone versus higher dose\nThere was little to no difference in risk of spontaneous laxations in the medium-term (1 mg versus 5 mg or greater: RR 2.91, 95% CI 0.82 to 10.39; 1 trial, 26 participants very low-certainty evidence), or in patient assessment of improvement in bowel status (RR 0.98, 95% CI 0.71 to 1.35, 1 trial, 102 participants; low-certainty evidence). Medium-term assessment of spontaneous laxations and serious AEs not reported. There was little to no difference in symptoms of opioid withdrawal (MD -0.25, 95% CI -0.84 to 0.34, 1 trial, 102 participants) or occurrence of AEs (low-certainty evidence).\nAuthors' conclusions\nThis update's findings for naldemedine and naloxone with oxycodone have been strengthened with two new trials, but conclusions have not changed. Moderate-certainty evidence for oral naldemedine on risk of spontaneous laxations and non-serious AEs suggests in people with cancer that naldemedine may improve bowel function over two weeks and increase the risk of AEs. There was low-certainty evidence on serious AEs. Moderate-certainty evidence for methylnaltrexone on spontaneous laxations over two weeks suggests subcutaneous methylnaltrexone may improve bowel function in people receiving palliative care, but certainty of evidence for AEs was low. More trials are needed, more evaluation of AEs, outcomes patients rate as important, and in children.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Opioids (morphine-like drugs) are used to treat severe pain, but they may cause bowel dysfunction including constipation, incomplete evacuation of the bowels, bloating, and increased reflux (flowing back) of stomach contents into the oesophagus (food pipe). This is because receptors for opioids are found in the gut. Opioid-induced bowel dysfunction may be so severe that people choose to limit pain relief to improve bowel function. Opioid-induced bowel dysfunction is common in people with cancer and those receiving palliative care (when a cure is no longer possible). Laxatives are often the first-choice treatment for opioid-induced bowel dysfunction. They may not always work. Mu-opioid antagonists are specific medicines for opioid-induced bowel dysfunction that have been developed to help reduce the effect of opioids (in the gut. A possible side effect of this treatment however, is reduced pain relief."
}
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query-laysum
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7143
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[
{
"role": "user",
"content": "Abstract: Background\nMonoclonal antibodies (mAbs) are laboratory-produced molecules derived from the B cells of an infected host. They are being investigated as potential prophylaxis to prevent coronavirus disease 2019 (COVID-19).\nObjectives\nTo assess the effects of SARS-CoV-2-neutralising mAbs, including mAb fragments, to prevent infection with SARS-CoV-2 causing COVID-19; and to maintain the currency of the evidence, using a living systematic review approach.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register, MEDLINE, Embase, and three other databases on 27 April 2022. We checked references, searched citations, and contacted study authors to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated SARS-CoV-2-neutralising mAbs, including mAb fragments, alone or combined, versus an active comparator, placebo, or no intervention, for pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) of COVID-19. We excluded studies of SARS-CoV-2-neutralising mAbs to treat COVID-19, as these are part of another review.\nData collection and analysis\nTwo review authors independently assessed search results, extracted data, and assessed risk of bias using Cochrane RoB 2. Prioritised outcomes were infection with SARS-CoV-2, development of clinical COVID-19 symptoms, all-cause mortality, admission to hospital, quality of life, adverse events (AEs), and serious adverse events (SAEs). We rated the certainty of evidence using GRADE.\nMain results\nWe included four RCTs of 9749 participants who were previously uninfected and unvaccinated at baseline. Median age was 42 to 76 years. Around 20% to 77.5% of participants in the PrEP studies and 35% to 100% in the PEP studies had at least one risk factor for severe COVID-19. At baseline, 72.8% to 82.2% were SARS-CoV-2 antibody seronegative.\nWe identified four ongoing studies, and two studies awaiting classification.\nPre-exposure prophylaxis\nTixagevimab/cilgavimab versus placebo\nOne study evaluated tixagevimab/cilgavimab versus placebo in participants exposed to SARS-CoV-2 wild-type, Alpha, Beta, and Delta variant. About 39.3% of participants were censored for efficacy due to unblinding and 13.8% due to vaccination. Within six months, tixagevimab/cilgavimab probably decreases infection with SARS-CoV-2 (risk ratio (RR) 0.45, 95% confidence interval (CI) 0.29 to 0.70; 4685 participants; moderate-certainty evidence), decreases development of clinical COVID-19 symptoms (RR 0.18, 95% CI 0.09 to 0.35; 5172 participants; high-certainty evidence), and may decrease admission to hospital (RR 0.03, 95% CI 0 to 0.59; 5197 participants; low-certainty evidence). Tixagevimab/cilgavimab may result in little to no difference on mortality within six months, all-grade AEs, and SAEs (low-certainty evidence). Quality of life was not reported.\nCasirivimab/imdevimab versus placebo\nOne study evaluated casirivimab/imdevimab versus placebo in participants who may have been exposed to SARS-CoV-2 wild-type, Alpha, and Delta variant. About 36.5% of participants opted for SARS-CoV-2 vaccination and had a mean of 66.1 days between last dose of intervention and vaccination. Within six months, casirivimab/imdevimab may decrease infection with SARS-CoV-2 (RR 0.01, 95% CI 0 to 0.14; 825 seronegative participants; low-certainty evidence) and may decrease development of clinical COVID-19 symptoms (RR 0.02, 95% CI 0 to 0.27; 969 participants; low-certainty evidence). We are uncertain whether casirivimab/imdevimab affects mortality regardless of the SARS-CoV-2 antibody serostatus. Casirivimab/imdevimab may increase all-grade AEs slightly (RR 1.14, 95% CI 0.98 to 1.31; 969 participants; low-certainty evidence). The evidence is very uncertain about the effects on grade 3 to 4 AEs and SAEs within six months. Admission to hospital and quality of life were not reported.\nPostexposure prophylaxis\nBamlanivimab versus placebo\nOne study evaluated bamlanivimab versus placebo in participants who may have been exposed to SARS-CoV-2 wild-type. Bamlanivimab probably decreases infection with SARS-CoV-2 versus placebo by day 29 (RR 0.76, 95% CI 0.59 to 0.98; 966 participants; moderate-certainty evidence), may result in little to no difference on all-cause mortality by day 60 (R 0.83, 95% CI 0.25 to 2.70; 966 participants; low-certainty evidence), may increase all-grade AEs by week eight (RR 1.12, 95% CI 0.86 to 1.46; 966 participants; low-certainty evidence), and may increase slightly SAEs (RR 1.46, 95% CI 0.73 to 2.91; 966 participants; low-certainty evidence). Development of clinical COVID-19 symptoms, admission to hospital within 30 days, and quality of life were not reported.\nCasirivimab/imdevimab versus placebo\nOne study evaluated casirivimab/imdevimab versus placebo in participants who may have been exposed to SARS-CoV-2 wild-type, Alpha, and potentially, but less likely to Delta variant. Within 30 days, casirivimab/imdevimab decreases infection with SARS-CoV-2 (RR 0.34, 95% CI 0.23 to 0.48; 1505 participants; high-certainty evidence), development of clinical COVID-19 symptoms (broad-term definition) (RR 0.19, 95% CI 0.10 to 0.35; 1505 participants; high-certainty evidence), may result in little to no difference on mortality (RR 3.00, 95% CI 0.12 to 73.43; 1505 participants; low-certainty evidence), and may result in little to no difference in admission to hospital. Casirivimab/imdevimab may slightly decrease grade 3 to 4 AEs (RR 0.50, 95% CI 0.24 to 1.02; 2617 participants; low-certainty evidence), decreases all-grade AEs (RR 0.70, 95% CI 0.61 to 0.80; 2617 participants; high-certainty evidence), and may result in little to no difference on SAEs in participants regardless of SARS-CoV-2 antibody serostatus. Quality of life was not reported.\nAuthors' conclusions\nFor PrEP, there is a decrease in development of clinical COVID-19 symptoms (high certainty), infection with SARS-CoV-2 (moderate certainty), and admission to hospital (low certainty) with tixagevimab/cilgavimab. There is low certainty of a decrease in infection with SARS-CoV-2, and development of clinical COVID-19 symptoms; and a higher rate for all-grade AEs with casirivimab/imdevimab.\nFor PEP, there is moderate certainty of a decrease in infection with SARS-CoV-2 and low certainty for a higher rate for all-grade AEs with bamlanivimab. There is high certainty of a decrease in infection with SARS-CoV-2, development of clinical COVID-19 symptoms, and a higher rate for all-grade AEs with casirivimab/imdevimab.\nAlthough there is high-to-moderate certainty evidence for some outcomes, it is insufficient to draw meaningful conclusions. These findings only apply to people unvaccinated against COVID-19. They are only applicable to the variants prevailing during the study and not other variants (e.g. Omicron). In vitro, tixagevimab/cilgavimab is effective against Omicron, but there are no clinical data. Bamlanivimab and casirivimab/imdevimab are ineffective against Omicron in vitro.\nFurther studies are needed and publication of four ongoing studies may resolve the uncertainties.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Four studies including 9749 people; two investigated people before being exposed to SARS-CoV-2 (pre-exposure prophylaxis) and two investigated people who were in contact with an infected person (postexposure prophylaxis). Studies were conducted before the emergence of the Omicron variant and before or during widespread vaccine roll-out. Participants were unvaccinated at baseline."
}
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query-laysum
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7144
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[
{
"role": "user",
"content": "Abstract: Background\nA significant number of women are diagnosed with minor cytological abnormalities on cervical screening. Many authorities recommend surveillance as spontaneous regression might occur. However, attendance for cytological follow-up decreases with time and might put some women at risk of developing invasive disease.\nObjectives\nTo assess the optimum management strategy for women with minor cervical cytological abnormalities (atypical squamous cells of undetermined significance - ASCUS or low-grade squamous intra-epithelial lesions - LSIL) at primary screening in the absence of HPV (human papillomavirus) DNA test.\nSearch methods\nWe searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL Issue 4, 2016), MEDLINE (1946 to April week 2 2016) and Embase (1980 to 2016 week 16).\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing immediate colposcopy to cytological surveillance in women with atypical squamous cells of undetermined significance (ASCUS/borderline) or low-grade squamous intra-epithelial lesions (LSIL/mild dyskaryosis).\nData collection and analysis\nThe primary outcome measure studied was the occurrence of cervical intra-epithelial neoplasia (CIN). The secondary outcome measures studied included default rate, clinically significant anxiety and depression, and other self-reported adverse effects.\nWe classified studies according to period of surveillance, at 6, 12, 24 or 36 months, as well as at 18 months, excluding a possible exit-examination. We calculated pooled risk ratios (RR) and 95% confidence intervals (CI) using a random-effects model with inverse variance weighting. Inter-study heterogeneity was assessed with I2 statistics.\nMain results\nWe identified five RCTs with 11,466 participants that fulfilled the inclusion criteria. There were 18 cases of invasive cervical cancer, seven in the immediate colposcopy and 11 in the cytological surveillance groups, respectively. Although immediate colposcopy detects CIN2+ and CIN3+ earlier than cytology, the differences were no longer observed at 24 months (CIN2+: 3 studies, 4331 women; 17.9% versus 18.3%, RR 1.14, CI 0.66 to 1.97; CIN3+: 3 studies, 4331 women; 10.3% versus 11.9%, RR 1.02, CI 0.53 to 1.97). The inter-study heterogeneity was considerable (I2 greater than 90%). Furthermore, the inclusion of the results of the exit examinations at 24 months, which could inflate the CIN detection rate of cytological surveillance, may have led to study design-derived bias; we therefore considered the evidence to be of low quality.\nWhen we excluded the exit examination, the detection rate of high-grade lesions at the 18-month follow-up was higher after immediate colposcopy (CIN2+: 2 studies, 4028 women; 14.3% versus 10.1%, RR 1.50, CI 1.12 to 2.01; CIN3+: 2 studies, 4028 women, 7.8% versus 6.9%, RR 1.24, CI 0.77 to 1.98) both had substantial inter-study heterogeneity (I2 greater than 60%) and we considered the evidence to be of moderate quality).\nThe meta-analysis revealed that immediate referral to colposcopy significantly increased the detection of clinically insignificant cervical abnormalities, as opposed to repeat cytology after 24 months of surveillance (occurrence of koilocytosis: 2 studies, 656 women; 32% versus 21%, RR 1.49, 95% CI 1.17 to 1.90; moderate-quality evidence) incidence of any CIN: 2 studies, 656 women; 64% versus 32%, RR 2.02, 95% CI 1.33 to 3.08, low-quality evidence; incidence of CIN1: 2 studies, 656 women; 21% versus 8%, RR 2.58, 95% CI 1.69 to 3.94, moderate-quality evidence).\nDue to differences in trial designs and settings, there was large variation in default rates between the included studies. The risk for default was higher for the repeat cytology group, with a four-fold increase at 6 months, a six-fold at 12 and a 19-fold at 24 months (6 months: 3 studies, 5117 women; 6.3% versus 13.3%, RR 3.85, 95% CI 1.27 to 11.63, moderate-quality evidence; 12 months: 3 studies, 5115 women; 6.3% versus 14.8%, RR 6.39, 95% CI 1.49 to 29.29, moderate-quality evidence; 24 months: 3 studies, 4331 women; 0.9% versus 16.1%, RR 19.1, 95% CI 9.02 to 40.43, moderate-quality evidence).\nAuthors' conclusions\nBased on low- or moderate-quality evidence using the GRADE approach and generally low risk of bias, the detection rate of CIN2+ or CIN3+ after two years does not appear to differ between immediate colposcopy and cytological surveillance in the absence of HPV testing, although women may default from follow-up. Immediate colposcopy probably leads to earlier detection of high-grade lesions, but also detects more clinically insignificant low-grade lesions. Colposcopy may therefore be the first choice when good compliance is not assured. These results emphasize the need for an accurate reflex HPV triage test to distinguish women who need diagnostic follow-up from those who can return safely to routine recall.\n\nGiven the provided abstract, please respond to the following query: \"What are the main findings?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included 5 randomised controlled trials including 11,466 participants with minor abnormalities on cervical cytology, treated either with immediate colposcopy or repetitive cytology. The included studies assessed differences in occurrence of cervical precancerous lesions between the two treatments.\nThe results suggested that women attending immediate colposcopy after a single low-grade abnormal cervical cytology test were more likely to have clinically insignificant findings detected than women who were managed with 'watchful waiting'.\nThere were 18 cases of invasive cervical cancer, seven in the immediate colposcopy and 11 in the cytological surveillance groups. The detection rate of clinically insignificant low-grade lesions was higher in the immediate colposcopy group, as was the detection rate of clinically more significant high-grade precancerous lesions (CIN2 or CIN2 or worse) at 18 months, but not by 24 months.\nThe risk of non-compliance was significantly greater for the repeat cytology arm and increased with the length of the follow-up."
}
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query-laysum
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7145
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[
{
"role": "user",
"content": "Abstract: Background\nThis review updates part of an earlier Cochrane review on 'Pregabalin for acute and chronic pain in adults' (Moore 2009), and considers only fibromyalgia pain.\nAntiepileptic drugs have been used in pain management since the 1960s. Pregabalin is an antiepileptic drug also used in management of chronic pain conditions, including fibromyalgia. Pain response with pregabalin is associated with major benefits for other symptoms, and improved quality of life and function in people with chronic painful conditions.\nObjectives\nTo assess the analgesic efficacy and adverse events of pregabalin for pain in fibromyalgia in adults, compared with placebo or any active comparator.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE for randomised controlled trials from inception to May 2009 for the original review and to 16 March 2016 for this update. We also searched the reference lists of retrieved studies and reviews, and online clinical trial registries.\nSelection criteria\nWe included randomised, double-blind trials of eight weeks' duration or longer, comparing pregabalin with placebo or another active treatment for relief of pain in fibromyalgia, and reporting on the analgesic effect of pregabalin, with subjective pain assessment by the participant.\nData collection and analysis\nTwo review authors independently extracted data and assessed trial quality and potential bias. Primary outcomes were participants with moderate pain relief (at least 30% pain relief over baseline or much or very much improved on Patient Global Impression of Change scale (PGIC)) or substantial pain relief (at least 50% pain relief over baseline or very much improved on PGIC). Where pooled analysis was possible, we used dichotomous data to calculate risk ratio and number needed to treat (NNT), using standard methods. We assessed the quality of the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) and created 'Summary of findings' tables.\nMain results\nOur searches identified two new published studies with classic design, and one new published study with an enriched enrolment randomised withdrawal (EERW) design.\nWe included eight studies. Five (3283 participants) had a classic design in which participants were randomised at the start of the study to pregabalin (150, 300, 450, or 600 mg daily) or placebo, with assessment after 8 to 13 weeks of stable treatment. No studies included active comparators. Studies had low risk of bias, except that the last observation carried forward (LOCF) imputation method used in analyses of the primary outcomes could overestimate treatment effect.\nPregabalin increased the number of participants experiencing substantial benefit (at least 50% pain intensity reduction after 12 or 13 weeks' stable treatment (450 mg: RR 1.8, 95% CI 1.4 to 2.1, 1874 participants, 5 studies, high quality evidence)). Substantial benefit with pregabalin 300 to 600 mg was experienced by about 14% of participants with placebo, but about 9% more with pregabalin 300 to 600 mg (22% to 24%) (high quality evidence). Pregabalin increased the number of participants experiencing moderate benefit (at least 30% pain intensity reduction after 12 or 13 weeks' stable treatment) (450 mg: RR 1.5, 95% CI (1.3 to 1.7), 1874 participants, 5 studies, high quality evidence). Moderate benefit with pregabalin 300 to 600 mg was experienced by about 28% of participants with placebo, but about 11% more with pregabalin 300 to 600 mg (39% to 43%) (high quality evidence). A similar magnitude of effect was found using PGIC of 'very much improved' and 'much or very much improved'. NNTs for these outcomes ranged between 7 and 14 (high quality evidence).\nA small study (177 participants) compared nightly with twice-daily pregabalin, and concluded there was no difference in effect.\nTwo studies (1492 participants began initial dose titration, 687 participants randomised) had an EERW design in which those with good pain relief after titration were randomised, double blind, to continuing the effective dose (300 to 600 mg pregabalin daily) or a short down-titration to placebo for 13 or 26 weeks. We calculated the outcome of maintained therapeutic response (MTR) without withdrawal, equivalent to a moderate benefit. Of those randomised, 40% had MTR with pregabalin and 20% with placebo (high quality evidence). The NNT was 5, but normalised to the starting population tested it was 12. About 10% of the initial population would have achieved the MTR outcome, similar to the result from studies of classic design. MTR had no imputation concerns.\nThe majority (70% to 90%) of participants in all treatment groups experienced adverse events. Specific adverse events were more common with pregabalin than placebo, in particular dizziness, somnolence, weight gain, and peripheral oedema, with number needed to harm of 3.7, 7.4, 18, and 19 respectively for all doses combined (high quality evidence). Serious adverse events did not differ between active treatment groups and placebo (very low quality evidence). Withdrawals for any reason were more common with pregabalin than placebo only with the 600 mg dose in studies of classic design. Withdrawals due to adverse events were about 10% higher with pregabalin than placebo, but withdrawals due to lack of efficacy were about 6% lower (high quality evidence).\nAuthors' conclusions\nPregabalin 300 to 600 mg produces a major reduction in pain intensity over 12 to 26 weeks with tolerable adverse events for a small proportion of people (about 10% more than placebo) with moderate or severe pain due to fibromyalgia. The degree of pain relief is known to be accompanied by improvements in other symptoms, quality of life, and function. These results are similar to other effective medicines in fibromyalgia (milnacipran, duloxetine).\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence was mostly of high quality, which means we are very confident that the true effect lies close to that of the estimate of the effect in this review. Concern about how information was handled when people left the studies was offset by other information showing that results were not impacted by this to any important degree."
}
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query-laysum
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7146
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[
{
"role": "user",
"content": "Abstract: Background\nFractures of the proximal humerus, often termed shoulder fractures, are common injuries, especially in older people. The management of these fractures varies widely, including in the use of surgery. This is an update of a Cochrane Review first published in 2001 and last updated in 2015.\nObjectives\nTo assess the effects (benefits and harms) of treatment and rehabilitation interventions for proximal humeral fractures in adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trial registries, and bibliographies of trial reports and systematic reviews to September 2020. We updated this search in November 2021, but have not yet incorporated these results.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials that compared non-pharmacological interventions for treating acute proximal humeral fractures in adults.\nData collection and analysis\nPairs of review authors independently selected studies, assessed risk of bias and extracted data. We pooled data where appropriate and used GRADE for assessing the certainty of evidence for each outcome. We prepared a brief economic commentary for one comparison.\nMain results\nWe included 47 trials (3179 participants, mostly women and mainly aged 60 years or over) that tested one of 26 comparisons. Six comparisons were tested by 2 to 10 trials, the others by small single-centre trials only. Twelve studies evaluated non-surgical treatments, 10 compared surgical with non-surgical treatments, 23 compared two methods of surgery, and two tested timing of mobilisation after surgery. Most trials were at high risk of bias, due mainly to lack of blinding. We summarise the findings for four key comparisons below.\nEarly (usually one week post injury) versus delayed (after three or more weeks) mobilisation for non-surgically-treated fractures\nFive trials (350 participants) made this comparison; however, the available data are very limited. Due to very low-certainty evidence from single trials, we are uncertain of the findings of better shoulder function at one year in the early mobilisation group, or the findings of little or no between-group difference in function at 3 or 24 months. Likewise, there is very low-certainty evidence of no important between-group difference in quality of life at one year. There was one reported death and five serious shoulder complications (1.9% of 259 participants), spread between the two groups, that would have required substantive treatment.\nSurgical versus non-surgical treatment\nTen trials (717 participants) evaluated surgical intervention for displaced fractures (66% were three- or four-part fractures). There is high-certainty evidence of no clinically important difference between surgical and non-surgical treatment in patient-reported shoulder function at one year (standardised mean difference (SMD) 0.10, 95% confidence interval (CI) -0.07 to 0.27; 7 studies, 552 participants) and two years (SMD 0.06, 95% CI -0.13 to 0.25; 5 studies, 423 participants). There is moderate-certainty evidence of no clinically important between-group difference in patient-reported shoulder function at six months (SMD 0.17, 95% CI -0.04 to 0.38; 3 studies, 347 participants). There is high-certainty evidence of no clinically important between-group difference in quality of life at one year (EQ-5D (0: dead to 1: best quality): mean difference (MD) 0.01, 95% CI -0.02 to 0.04; 6 studies, 502 participants). There is low-certainty evidence of little between-group difference in mortality: one of the 31 deaths was explicitly linked with surgery (risk ratio (RR) 1.35, 95% CI 0.70 to 2.62; 8 studies, 646 participants). There is low-certainty evidence of a higher risk of additional surgery in the surgery group (RR 2.06, 95% CI 1.21 to 3.51; 9 studies, 667 participants). Based on an illustrative risk of 35 subsequent operations per 1000 non-surgically-treated patients, this indicates an extra 38 subsequent operations per 1000 surgically-treated patients (95% CI 8 to 94 more). Although there was low-certainty evidence of a higher overall risk of adverse events after surgery, the 95% CI also includes a slightly increased risk of adverse events after non-surgical treatment (RR 1.46, 95% CI 0.92 to 2.31; 3 studies, 391 participants).\nOpen reduction and internal fixation with a locking plate versus a locking intramedullary nail\nFour trials (270 participants) evaluated surgical intervention for displaced fractures (63% were two-part fractures). There is low-certainty evidence of no clinically important between-group difference in shoulder function at one year (SMD 0.15, 95% CI -0.12 to 0.41; 4 studies, 227 participants), six months (Disability of the Arm, Shoulder, and Hand questionnaire (0 to 100: worst disability): MD -0.39, 95% CI -4.14 to 3.36; 3 studies, 174 participants), or two years (American Shoulder and Elbow Surgeons score (ASES) (0 to 100: best outcome): MD 3.06, 95% CI -0.05 to 6.17; 2 studies, 101 participants). There is very low-certainty evidence of no between-group difference in quality of life (1 study), and of little difference in adverse events (4 studies, 250 participants) and additional surgery (3 studies, 193 participants).\nReverse total shoulder arthroplasty (RTSA) versus hemiarthroplasty\nThere is very low-certainty evidence from two trials (161 participants with either three- or four-part fractures) of no or minimal between-group differences in self-reported shoulder function at one year (1 study) or at two to three years' follow-up (2 studies); or in quality of life at one year or at two or more years' follow-up (1 study). Function at six months was not reported. Of 10 deaths reported by one trial (99 participants), one appeared to be surgery-related. There is very low-certainty evidence of a lower risk of complications after RTSA (2 studies). Ten people (6.2% of 161 participants) had a reoperation; all eight cases in the hemiarthroplasty group received a RTSA (very low-certainty evidence).\nAuthors' conclusions\nThere is high- or moderate-certainty evidence that, compared with non-surgical treatment, surgery does not result in a better outcome at one and two years after injury for people with displaced proximal humeral fractures. It may increase the need for subsequent surgery. The evidence is absent or insufficient for people aged under 60 years, high-energy trauma, two-part tuberosity fractures or less common fractures, such as fracture dislocations and articular surface fractures.\nThere is insufficient evidence from randomised trials to inform the choices between different non-surgical, surgical or rehabilitation interventions for these fractures.\n\nGiven the provided abstract, please respond to the following query: \"What are proximal humeral fractures?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The proximal humerus is the top end of the upper arm bone. Fracture of the proximal humerus is a common and serious injury in older people. It is often called a broken (fractured) shoulder. It can take several months for people to recover the use of their arm. Some restrictions in movement and pain are common long-term problems."
}
] |
query-laysum
|
7147
|
[
{
"role": "user",
"content": "Abstract: Background\nThe presence and progression of hepatic (liver) fibrosis into cirrhosis is a prognostic variable having impact on survival in people with alcoholic liver disease. Liver biopsy, although an invasive method, is the recommended 'reference standard' for diagnosis and staging of hepatic fibrosis in people with liver diseases. Transient elastography is a non-invasive method for assessing and staging hepatic fibrosis.\nObjectives\nTo determine the diagnostic accuracy of transient elastography for diagnosis and staging hepatic fibrosis in people with alcoholic liver disease when compared with liver biopsy. To identify the optimal cut-off values for differentiating the five stages of hepatic fibrosis.\nSearch methods\nThe Cochrane Hepato-Biliary Group Controlled and Diagnostic Test Accuracy Studies Registers, The Cochrane Library, MEDLINE (OvidSP), EMBASE (OvidSP), and the Science Citation Index Expanded (last search August 2014).\nSelection criteria\nDiagnostic cohort and diagnostic case-control study designs that assessed hepatic fibrosis in participants with alcoholic liver disease with transient elastography and liver biopsy, irrespective of language or publication status. The study participants could be of any sex and ethnic origin, above 16 years old, hospitalised or managed as outpatients. We excluded participants with viral hepatitis, autoimmunity, metabolic diseases, and toxins.\nData collection and analysis\nWe followed the guidelines in the draft Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy.\nMain results\nFive retrospective and nine prospective cohort studies with 834 participants provided data for the review analyses. Authors of seven of those studies sent us individual participant data. The risk of bias in the included studies was high in all but three studies. We could identify no serious concerns regarding the applicability of the studies in answering the main study question of our review, namely to use transient elastography to diagnose hepatic fibrosis. We could not identify the optimal cut-off values for the fibrosis stages. The definition of the diagnosis of alcoholic liver disease was not provided in one study and was not clearly defined in two studies, but it was clear in the remaining 11 studies. The study authors used different liver stiffness cut-off values of transient elastography for the hepatic fibrosis stages.\nThere was only one study (103 participants) with data on hepatic fibrosis stage F1 or worse, with a cut-off of 5.9 kPa, and reporting sensitivity of 0.83 (95% confidence interval (CI) 0.74 to 0.90) and specificity of 0.88 (95% CI 0.47 to 1.00). The summary sensitivity and specificity of transient elastography for F2 or worse (seven studies with 338 participants and with cut-offs around 7.5 kPa (range 7.00 to 7.8 kPa)) were 0.94 and 0.89 with LR+ 8.2 and LR- 0.07, which suggests that transient elastography could be useful to rule out the presence of significant hepatic fibrosis, thus avoiding liver biopsy.\nDue to the wide range of cut-off values (from 8.0 to 17.0 kPa) found in the 10 studies with 760 participants with hepatic fibrosis F3 or worse, we fitted a hierarchical summary receiver operating characteristic (HSROC) model and estimated a summary ROC (SROC) curve. The sensitivity of the 10 studies varied from 72% to 100% and the specificity from 59% to 89%. We performed an additional analysis by including the studies with a cut-off value of around and equal to 9.5 kPa (range 8.0 to 11.0 kPa). The summary sensitivity and specificity of transient elastography (eight studies with 564 participants) were 0.92 and 0.70 with LR+ 3.1 and LR- 0.11, which suggests that transient elastography could also be useful to rule out the presence of severe hepatic fibrosis (F3 or worse), avoiding liver biopsy. We carried out a sensitivity analysis by considering only the studies with a cut-off value equal to 9.5 kPa and the result did not differ.\nWe performed an HSROC analysis and reported an SROC curve for hepatic fibrosis stage F4 (cirrhosis). The HSROC analysis suggested that when the cut-off value changes, there is a wide variation in specificity and a more limited variation in sensitivity. We performed an additional analysis with the studies with the most commonly used cut-off value of 12.5 kPa. The summary sensitivity and specificity of transient elastography (seven studies with 330 participants) were 0.95 and 0.71 with LR+ 3.3 and LR- 0.07, which again suggests that transient elastography could be useful to rule out the presence of cirrhosis, avoiding liver biopsy.\nAuthors' conclusions\nWe identified a small number of studies with a few participants and were unable to include several studies, which raises the risk of outcome reporting bias. With these caveats in mind, transient elastography may be used as a diagnostic method to rule out liver cirrhosis (F4) in people with alcoholic liver disease when the pre-test probability is about 51% (range 15% to 79%). Transient elastography may also help in ruling out severe fibrosis (F3 or worse). Liver biopsy investigation remains an option if the certainty to rule in or rule out the stage of hepatic fibrosis or cirrhosis remains insufficient after a clinical follow-up or any other non-invasive test considered useful by the clinician.\nThe proposed cut-off values for the different stages of hepatic fibrosis may be used in clinical practice, but caution is needed, as those values reported in this review are only the most common cut-off values used by the study authors. The best cut-off values for hepatic fibrosis in people with alcoholic liver disease could not be established yet.\nIn order to diagnose correctly the stage of hepatic fibrosis in people with alcoholic liver disease using transient elastography assessment, the studies should consider a single aetiology. Hepatic fibrosis should be diagnosed with both transient elastography and liver biopsy and in this sequence, and transient elastography cut-off values should be pre-specified and validated. The time interval between the two investigations should not exceed three months, which is the interval mainly valid for people without cirrhosis, and assessment of results should be properly blinded. Only studies with low risk of bias, fulfilling the Standards for Reporting of Diagnostic Accuracy may answer the review question.\n\nGiven the provided abstract, please respond to the following query: \"Aims\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To find out how well transient elastography may determine the presence or absence of fibrosis and if it can stage fibrosis in people with alcoholic liver disease when compared with liver biopsy."
}
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query-laysum
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7148
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[
{
"role": "user",
"content": "Abstract: Background\nDrugs used to treat psychotic illnesses may take weeks to be effective. In the interim, additional 'as required' doses of medication can be used to calm patients in psychiatric wards. The practice is widespread, with 20% to 50% of people on acute psychiatric wards receiving at least one 'as required' dose of psychotropic medication during their admission.\nObjectives\nTo compare the effects of 'as required' medication regimens with regular patterns of medication for the treatment of psychotic symptoms or behavioural disturbance, thought to be secondary to psychotic illness. These regimens may be given alone or in addition to any regular psychotropic medication for the long-term treatment of schizophrenia or schizophrenia-like illnesses.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Trials Register, which is based on regular searches of MEDLINE, EMBASE, PubMed, CINAHL, BIOSIS, AMED, PsycINFO and registries of clinical trials, in November 2001, March 2006, July 2012 andOctober 2013.\nSelection criteria\nWe aimed to include all relevant randomised controlled trials involving hospital inpatients with schizophrenia or schizophrenia-like illnesses, comparing any regimen of medication administered for the short-term relief of behavioural disturbance, or psychotic symptoms, to be given at the discretion of ward staff ('as required', 'prn') with fixed non-discretionary patterns of drug administration of the same drug(s). This was in addition to regular psychotropic medication for the long-term treatment of schizophrenia or schizophrenia-like illnesses where prescribed.\nData collection and analysis\nWe independently inspected abstracts and papers for inclusion. If trials had been found, we would have extracted data from the papers and quality assessed the data. For dichotomous data we would have calculated the risk ratios (RR), with the 95% confidence intervals (CI). We would have conducted analyses on an intention-to-treat basis. If data were available we would have completed a 'Summary of findings' table using GRADE.\nMain results\nWe have not been able to identify any randomised trials comparing 'as required' medication regimens to regular regimens of the same drug. Our main outcomes of interest were important changes in (i) mental state, (ii) behaviour, (iii) dose of medication used, (iv) adverse events, (v) satisfaction with care and (iv) cost of care.\nAuthors' conclusions\nThere is currently no evidence from within randomised trials to support this common practice. Current practice is based on clinical experience and habit rather than high quality evidence.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors found no trials that compared 'as required' with regular medication. 'As required' medication, though used widely, has not been evaluated scientifically. A well designed, conducted and reported randomised trial would help to gather more evidence.\nBen Gray, Senior Peer Researcher, McPin Foundation, http://mcpin.org/ (for the previous 'Plain language summary' please see Appendix 3)."
}
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query-laysum
|
7149
|
[
{
"role": "user",
"content": "Abstract: Background\nPosterior capsule opacification (PCO) is a clouding of the posterior part of the lens capsule, a skin-like transparent structure, which surrounds the crystalline lens in the human eye. PCO is the most common postoperative complication following modern cataract surgery with implantation of a posterior chamber intraocular lens (IOL). The main symptoms of PCO are a decrease in visual acuity, 'cloudy', blurred vision and reduced contrast sensitivity. PCO is treated with a neodymium:YAG (Nd:YAG) laser to create a small opening in the opaque capsule and regain a clear central visual axis. This capsulotomy might cause further ocular complications, such as raised intraocular pressure or swelling of the central retina (macular oedema). This procedure is also a significant financial burden for health care systems worldwide. In recent decades, there have been advances in the selection of IOL materials and optimisation of IOL designs to help prevent PCO formation after cataract surgery. These include changes to the side structures holding the lens in the centre of the lens capsule bag, called IOL haptics, and IOL optic edge designs.\nObjectives\nTo compare the effects of different IOL optic edge designs on PCO after cataract surgery.\nSearch methods\nWe searched CENTRAL, Ovid MEDLINE, Ovid Embase, Latin American and Caribbean Health Sciences Literature Database (LILACS), the ISRCTN registry, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) up to 17 November 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared different types of IOL optic edge design. Our prespecified primary outcome was the proportion of eyes with Nd:YAG capsulotomy one year after surgery. Secondary outcomes included PCO score, best-corrected distance visual acuity (BCDVA) and quality of life score at one year. Due to availability of important long-term data, we also presented data at longer-term follow-up which is a post hoc change to our protocol.\nData collection and analysis\nWe used standard methods expected by Cochrane and the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included 10 studies (1065 people, 1834 eyes) that compared sharp- and round-edged IOLs. Eight of these studies were within-person studies whereby one eye received a sharp-edged IOL and the fellow eye a round-edged IOL. The IOL materials were acrylic (2 studies), silicone (4 studies), polymethyl methacrylate (PMMA, 3 studies) and different materials (1 study). The studies were conducted in Austria, Germany, India, Japan, Sweden and the UK. Five studies were at high risk of bias in at least one domain. We judged two studies to be at low risk of bias in all domains.\nThere were few cases of Nd:YAG capsulotomy at one year (primary outcome): 1/371 in sharp-edged and 4/371 in round-edged groups. The effect estimate was in favour of sharp-edged IOLs but the confidence intervals were very wide and compatible with higher or lower chance of Nd:YAG capsulotomy in sharp-edged compared with round-edged lenses (Peto odds ratio (OR) 0.30, 95% CI 0.05 to 1.74; I2 = 0%; 6 studies, 742 eyes). This corresponds to seven fewer cases of Nd:YAG capsulotomy per 1000 sharp-edged IOLs inserted compared with round-edged IOLs (95% CI 9 fewer to 7 more). We judged this as low-certainty evidence, downgrading for imprecision and risk of bias.\nA similar reduced risk of Nd:YAG capsulotomy in sharp-edge compared with round-edge IOLs was seen at two, three and five years but as the number of Nd:YAG capsulotomy events increased with longer follow-up this effect was more precisely measured at longer follow-up: two years, risk ratio (RR) 0.35 (0.16 to 0.80); 703 eyes (6 studies); 89 fewer cases per 1000; three years, RR 0.21 (0.11 to 0.41); 538 eyes (6 studies); 170 fewer cases per 1000; five years, RR 0.21 (0.10 to 0.45); 306 eyes (4 studies); 331 fewer cases per 1000. Data at 9 years and 12 years were only available from one study.\nAll studies reported a PCO score. Four studies reported the AQUA (Automated Quantification of After-Cataract) score, four studies reported the EPCO (Evaluation of PCO) score and two studies reported another method of quantifying PCO. It was not possible to pool these data due to the way they were reported, but all studies consistently reported a statistically significant lower average PCO score (of the order of 0.5 to 3 units) with sharp-edged IOLs compared with round-edged IOLs. We judged this to be moderate-certainty evidence downgrading for risk of bias.\nThe logMAR visual acuity score was lower (better) in eyes that received a sharp-edged IOL but the difference was small and likely to be clinically unimportant at one year (mean difference (MD) -0.06 logMAR, 95% CI -0.12 to 0; 2 studies, 153 eyes; low-certainty evidence). Similar effects were seen at longer follow-up periods but non-statistically significant data were less fully reported: two years MD -0.01 logMAR (-0.05 to 0.02); 2 studies, 311 eyes; three years MD -0.09 logMAR (-0.22 to 0.03); 2 studies, 117 eyes; data at five years only available from one study.\nNone of the studies reported quality of life. Very low-certainty evidence on adverse events did not suggest any important differences between the groups.\nAuthors' conclusions\nThis review provides evidence that sharp-edged IOLs are likely to be associated with less PCO formation than round-edged IOLs, with less Nd:YAG capsulotomy. The effects on visual acuity were less certain. The impact of these lenses on quality of life has not been assessed and there are only very low-certainty comparative data on adverse events.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of our review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In all 10 studies, eyes given a sharp-edged lens showed less clouding on the lens, compared with eyes given a round-edged lens.\n- After two, three and five years, eyes given a sharp-edged lens may be less likely to need laser surgery than those given a round-edged lens (evidence from six studies involving 742 people). \n- After one year and three years, vision may be clearer in eyes given sharp-edged lenses compared with eyes given round-edged lenses (evidence from two studies involving 260 people). \n- At one year after surgery, it was not clear if the design of lens (sharp- or round-edged) affected how many people needed to have laser surgery to treat cloudy patches on the new lens. This might be because not many people in either group needed laser surgery after one year.\nWe are uncertain how the two designs of lens affected the numbers of any unwanted effects people experienced, because these were not consistently reported. We found no evidence of any important differences between the two lens types in the numbers of complications reported.\nNone of the studies measured people's well-being."
}
] |
query-laysum
|
7150
|
[
{
"role": "user",
"content": "Abstract: Background\nPancreatic cancer is the fourth-leading cause of cancer death for both, men and women. The standard treatment for resectable tumours consists of a classic Whipple (CW) operation or a pylorus-preserving pancreaticoduodenectomy (PPW). It is unclear which of these procedures is more favourable in terms of survival, postoperative mortality, complications, and quality of life.\nObjectives\nThe objective of this systematic review was to compare the effectiveness of CW and PPW techniques for surgical treatment of cancer of the pancreatic head and the periampullary region.\nSearch methods\nWe conducted searches on 28 March 2006, 11 January 2011, 9 January 2014, and 18 August 2015 to identify all randomised controlled trials (RCTs), while applying no language restrictions. We searched the following electronic databases on 18 August 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effects (DARE) from the Cochrane Library (2015, Issue 8); MEDLINE (1946 to August 2015); and EMBASE (1980 to August 2015). We also searched abstracts from Digestive Disease Week and United European Gastroenterology Week (1995 to 2010); we did not update this part of the search for the 2014 and 2015 updates because the prior searches did not contribute any additional information. We identified two additional trials through the updated search in 2015.\nSelection criteria\nRCTs comparing CW versus PPW including participants with periampullary or pancreatic carcinoma.\nData collection and analysis\nTwo review authors independently extracted data from the included trials. We used a random-effects model for pooling data. We compared binary outcomes using odds ratios (ORs), pooled continuous outcomes using mean differences (MDs), and used hazard ratios (HRs) for meta-analysis of survival. Two review authors independently evaluated the methodological quality and risk of bias of included trials according to the standards of The Cochrane Collaboration.\nMain results\nWe included eight RCTs with a total of 512 participants. Our critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. Postoperative mortality (OR 0.64, 95% confidence interval (CI) 0.26 to 1.54; P = 0.32), overall survival (HR 0.84, 95% CI 0.61 to 1.16; P = 0.29), and morbidity showed no significant differences, except of delayed gastric emptying, which significantly favoured CW (OR 3.03, 95% CI 1.05 to 8.70; P = 0.04). Furthermore, we noted that operating time (MD -45.22 minutes, 95% CI -74.67 to -15.78; P = 0.003), intraoperative blood loss (MD -0.32 L, 95% CI -0.62 to -0.03; P = 0.03), and red blood cell transfusion (MD -0.47 units, 95% CI -0.86 to -0.07; P = 0.02) were significantly reduced in the PPW group. All significant results were associated with low-quality evidence based on GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria.\nAuthors' conclusions\nCurrent evidence suggests no relevant differences in mortality, morbidity, and survival between the two operations. However, some perioperative outcome measures significantly favour the PPW procedure. Given obvious clinical and methodological heterogeneity, future high-quality RCTs of complex surgical interventions based on well-defined outcome parameters are required.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We could identify no relevant differences in terms of main complications, long-term survival, or death due to complications after the operation, but operating time, intraoperative blood loss, and need for blood transfusion seem to be less frequent in the group treated with the pylorus-preserving Whipple operation. Our conclusion is that, at present, no relevant difference is evident between the two surgical procedures for the treatment of pancreatic or periampullary cancer."
}
] |
query-laysum
|
7151
|
[
{
"role": "user",
"content": "Abstract: Background\nFungal infection of the toenails, also called onychomycosis, is a common problem that causes damage to the nail's structure and physical appearance. For those severely affected, it can interfere with normal daily activities. Treatment is taken orally or applied topically; however, traditionally topical treatments have low success rates due to the nail's physical properties. Oral treatments also appear to have shorter treatment times and better cure rates. Our review will assist those needing to make an evidence-based choice for treatment.\nObjectives\nTo assess the effects of oral antifungal treatments for toenail onychomycosis.\nSearch methods\nWe searched the following databases up to October 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials (RCTs). We sought to identify unpublished and ongoing trials by correspondence with authors and by contacting relevant pharmaceutical companies.\nSelection criteria\nRCTs comparing oral antifungal treatment to placebo or another oral antifungal treatment in participants with toenail onychomycosis, confirmed by one or more positive cultures, direct microscopy of fungal elements, or histological examination of the nail.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 48 studies involving 10,200 participants. Half the studies took place in more than one centre and were conducted in outpatient dermatology settings. The participants mainly had subungual fungal infection of the toenails. Study duration ranged from 4 months to 2 years.\nWe assessed one study as being at low risk of bias in all domains and 18 studies as being at high risk of bias in at least one domain. The most common high-risk domain was 'blinding of personnel and participants'.\nWe found high-quality evidence that terbinafine is more effective than placebo for achieving clinical cure (risk ratio (RR) 6.00, 95% confidence interval (CI) 3.96 to 9.08, 8 studies, 1006 participants) and mycological cure (RR 4.53, 95% CI 2.47 to 8.33, 8 studies, 1006 participants). Adverse events amongst terbinafine-treated participants included gastrointestinal symptoms, infections, and headache, but there was probably no significant difference in their risk between the groups (RR 1.13, 95% CI 0.87 to 1.47, 4 studies, 399 participants, moderate-quality evidence).\nThere was high-quality evidence that azoles were more effective than placebo for achieving clinical cure (RR 22.18, 95% CI 12.63 to 38.95, 9 studies, 3440 participants) and mycological cure (RR 5.86, 95% CI 3.23 to 10.62, 9 studies, 3440 participants). There were slightly more adverse events in the azole group (the most common being headache, flu-like symptoms, and nausea), but the difference was probably not significant (RR 1.04, 95% CI 0.97 to 1.12; 9 studies, 3441 participants, moderate-quality evidence).\nTerbinafine and azoles may lower the recurrence rate when compared, individually, to placebo (RR 0.05, 95% CI 0.01 to 0.38, 1 study, 35 participants; RR 0.55, 95% CI 0.29 to 1.07, 1 study, 26 participants, respectively; both low-quality evidence).\nThere is moderate-quality evidence that terbinafine was probably more effective than azoles for achieving clinical cure (RR 0.82, 95% CI 0.72 to 0.95, 15 studies, 2168 participants) and mycological cure (RR 0.77, 95% CI 0.68 to 0.88, 17 studies, 2544 participants). There was probably no difference in the risk of adverse events (RR 1.00, 95% CI 0.86 to 1.17; 9 studies, 1762 participants, moderate-quality evidence) between the two groups, and there may be no difference in recurrence rate (RR 1.11, 95% CI 0.68 to 1.79, 5 studies, 282 participants, low-quality evidence). Common adverse events in both groups included headache, viral infection, and nausea.\nModerate-quality evidence shows that azoles and griseofulvin probably had similar efficacy for achieving clinical cure (RR 0.94, 95% CI 0.45 to 1.96, 5 studies, 222 participants) and mycological cure (RR 0.87, 95% CI 0.50 to 1.51, 5 studies, 222 participants). However, the risk of adverse events was probably higher in the griseofulvin group (RR 2.41, 95% CI 1.56 to 3.73, 2 studies, 143 participants, moderate-quality evidence), with the most common being gastrointestinal disturbance and allergic reaction (in griseofulvin-treated participants) along with nausea and vomiting (in azole-treated participants). Very low-quality evidence means we are uncertain about this comparison's impact on recurrence rate (RR 4.00, 0.26 to 61.76, 1 study, 7 participants).\nThere is low-quality evidence that terbinafine may be more effective than griseofulvin in terms of clinical cure (RR 0.32, 95% CI 0.14 to 0.72, 4 studies, 270 participants) and mycological cure (RR 0.64, 95% CI 0.46 to 0.90, 5 studies, 465 participants), and griseofulvin was associated with a higher risk of adverse events, although this was based on low-quality evidence (RR 2.09, 95% CI 1.15 to 3.82, 2 studies, 100 participants). Common adverse events included headache and stomach problems (in griseofulvin-treated participants) as well as taste loss and nausea (in terbinafine-treated participants). No studies addressed recurrence rate for this comparison.\nNo study addressed quality of life.\nAuthors' conclusions\nWe found high-quality evidence that compared to placebo, terbinafine and azoles are effective treatments for the mycological and clinical cure of onychomycosis, with moderate-quality evidence of excess harm. However, terbinafine probably leads to better cure rates than azoles with the same risk of adverse events (moderate-quality evidence).\nAzole and griseofulvin were shown to probably have a similar effect on cure, but more adverse events appeared to occur with the latter (moderate-quality evidence). Terbinafine may improve cure and be associated with fewer adverse effects when compared to griseofulvin (low-quality evidence).\nOnly four comparisons assessed recurrence rate: low-quality evidence found that terbinafine or azoles may lower the recurrence rate when compared to placebo, but there may be no difference between them.\nOnly a limited number of studies reported adverse events, and the severity of the events was not taken into account.\nOverall, the quality of the evidence varied widely from high to very low depending on the outcome and comparison. The main reasons to downgrade evidence were limitations in study design, such as unclear allocation concealment and randomisation as well as lack of blinding.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified 48 studies with 10,200 participants of both sexes. The average age of the participants across studies ranged from 36 to 68; most studies included participants aged 18 and over. Our included studies compared the three main groups of medication against each other or to placebo. Most studies took place in outpatient dermatology settings in the USA and Europe. The participants mainly had fungal infection under the toenails. A small number of studies included a specific group of participants, such as those with diabetes. All but one study looked at fungal infections caused by dermatophyte, which are fungi that digest keratin. Study duration ranged from 4 months to 2 years, with most lasting 12 to 15 months."
}
] |
query-laysum
|
7152
|
[
{
"role": "user",
"content": "Abstract: Background\nMore than one in five patients who undergo treatment for breast cancer will develop breast cancer-related lymphedema (BCRL). BCRL can occur as a result of breast cancer surgery and/or radiation therapy. BCRL can negatively impact comfort, function, and quality of life (QoL). Manual lymphatic drainage (MLD), a type of hands-on therapy, is frequently used for BCRL and often as part of complex decongestive therapy (CDT). CDT is a fourfold conservative treatment which includes MLD, compression therapy (consisting of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises (LREs). Phase 1 of CDT is to reduce swelling; Phase 2 is to maintain the reduced swelling.\nObjectives\nTo assess the efficacy and safety of MLD in treating BCRL.\nSearch methods\nWe searched Medline, EMBASE, CENTRAL, WHO ICTRP (World Health Organization's International Clinical Trial Registry Platform), and Cochrane Breast Cancer Group's Specialised Register from root to 24 May 2013. No language restrictions were applied.\nSelection criteria\nWe included randomized controlled trials (RCTs) or quasi-RCTs of women with BCRL. The intervention was MLD. The primary outcomes were (1) volumetric changes, (2) adverse events. Secondary outcomes were (1) function, (2) subjective sensations, (3) QoL, (4) cost of care.\nData collection and analysis\nWe collected data on three volumetric outcomes. (1) LE (lymphedema) volume was defined as the amount of excess fluid left in the arm after treatment, calculated as volume in mL of affected arm post-treatment minus unaffected arm post-treatment. (2) Volume reduction was defined as the amount of fluid reduction in mL from before to after treatment calculated as the pretreatment LE volume of the affected arm minus the post-treatment LE volume of the affected arm. (3) Per cent reduction was defined as the proportion of fluid reduced relative to the baseline excess volume, calculated as volume reduction divided by baseline LE volume multiplied by 100. We entered trial data into Review Manger 5.2 (RevMan), pooled data using a fixed-effect model, and analyzed continuous data as mean differences (MDs) with 95% confidence intervals (CIs). We also explored subgroups to determine whether mild BCRL compared to moderate or severe BCRL, and BCRL less than a year compared to more than a year was associated with a better response to MLD.\nMain results\nSix trials were included. Based on similar designs, trials clustered in three categories.\n(1) MLD + standard physiotherapy versus standard physiotherapy (one trial) showed significant improvements in both groups from baseline but no significant between-groups differences for per cent reduction.\n(2) MLD + compression bandaging versus compression bandaging (two trials) showed significant per cent reductions of 30% to 38.6% for compression bandaging alone, and an additional 7.11% reduction for MLD (MD 7.11%, 95% CI 1.75% to 12.47%; two RCTs; 83 participants). Volume reduction was borderline significant (P = 0.06). LE volume was not significant. Subgroup analyses was significant showing that participants with mild-to-moderate BCRL were better responders to MLD than were moderate-to-severe participants.\n(3) MLD + compression therapy versus nonMLD treatment + compression therapy (three trials) were too varied to pool. One of the trials compared compression sleeve plus MLD to compression sleeve plus pneumatic pump. Volume reduction was statistically significant favoring MLD (MD 47.00 mL, 95% CI 15.25 mL to 78.75 mL; 1 RCT; 24 participants), per cent reduction was borderline significant (P=0.07), and LE volume was not significant. A second trial compared compression sleeve plus MLD to compression sleeve plus self-administered simple lymphatic drainage (SLD), and was significant for MLD for LE volume (MD -230.00 mL, 95% CI -450.84 mL to -9.16 mL; 1 RCT; 31 participants) but not for volume reduction or per cent reduction. A third trial of MLD + compression bandaging versus SLD + compression bandaging was not significant (P = 0.10) for per cent reduction, the only outcome measured (MD 11.80%, 95% CI -2.47% to 26.07%, 28 participants).\nMLD was well tolerated and safe in all trials.\nTwo trials measured function as range of motion with conflicting results. One trial reported significant within-groups gains for both groups, but no between-groups differences. The other trial reported there were no significant within-groups gains and did not report between-groups results. One trial measured strength and reported no significant changes in either group.\nTwo trials measured QoL, but results were not usable because one trial did not report any results, and the other trial did not report between-groups results.\nFour trials measured sensations such as pain and heaviness. Overall, the sensations were significantly reduced in both groups over baseline, but with no between-groups differences. No trials reported cost of care.\nTrials were small ranging from 24 to 45 participants. Most trials appeared to randomize participants adequately. However, in four trials the person measuring the swelling knew what treatment the participants were receiving, and this could have biased results.\nAuthors' conclusions\nMLD is safe and may offer additional benefit to compression bandaging for swelling reduction. Compared to individuals with moderate-to-severe BCRL, those with mild-to-moderate BCRL may be the ones who benefit from adding MLD to an intensive course of treatment with compression bandaging. This finding, however, needs to be confirmed by randomized data.\nIn trials where MLD and sleeve were compared with a nonMLD treatment and sleeve, volumetric outcomes were inconsistent within the same trial. Research is needed to identify the most clinically meaningful volumetric measurement, to incorporate newer technologies in LE assessment, and to assess other clinically relevant outcomes such as fibrotic tissue formation.\nFindings were contradictory for function (range of motion), and inconclusive for quality of life.\nFor symptoms such as pain and heaviness, 60% to 80% of participants reported feeling better regardless of which treatment they received.\nOne-year follow-up suggests that once swelling had been reduced, participants were likely to keep their swelling down if they continued to use a custom-made sleeve.\n\nGiven the provided abstract, please respond to the following query: \"Study Characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found six trials published through May, 2013, totaling 208 participants."
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7153
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"role": "user",
"content": "Abstract: Background\nPeople with hemophilia A or B with inhibitors are at high risk of bleeding complications. Infusion of bypassing agents, such as recombinant activated FVII (rFVIIa) and plasma-derived activated prothrombin complex concentrate, are suggested as alternative therapies to factor VIII (haemophilia A) or IX (haemophilia B) for individuals who no longer respond to these treatments because they develop inhibitory antibodies. The ultimate goal of treatment is to preserve the individual's joints, otherwise destroyed by recurrent bleeds.\nObjectives\nTo assess the effects of bypassing agent prophylaxis to prevent bleeding in people with hemophilia A or B and inhibitors.\nSearch methods\nWe searched for relevant studies from the Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, comprising of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched trial registries (16 February 2017) and bibliographic references of retrieved studies were reviewed for potential articles to be included in the review.\nDate of the last search of the Cochrane Cystic Fibrosis and Genetic Disorders Coagulopathies Trials Register: 12 December 2016.\nSelection criteria\nWe included randomized and quasi-randomized controlled studies (cross-over or parallel design) evaluating the effect of prophylaxis treatment with bypassing agents compared with on-demand treatment, or studies evaluating the effects of high-dose compared with low-dose prophylaxis in males of any age with hemophilia with inhibitors.\nData collection and analysis\nTwo authors independently selected studies and extracted data and assessed the risk of bias according to standard Cochrane criteria. They assessed the quality of the evidence using the GRADE criteria.\nMain results\nWe included four randomized studies (duration 7 to 15 months) involving 116 males. Risk of bias was judged to be high in two studies due to the open-label study design and in one study due to attrition bias.\nTwo studies compared on-demand treatment to prophylaxis with bypassing agents. In one study (34 males) prophylaxis significantly reduced mean overall bleeding rates, MD - 7.27 (95% CI -9.92 to -4.62) (low quality evidence), mean number of overall bleeding events per month, MD -1.10 (95% CI -1.54 to -0.66), mean number of hemarthrosis, MD -6.60 (95% CI -9.32 to -3.88) (low quality evidence) and mean number of joints that had hemarthrosis, MD -0.90 (95% CI -1.36 to -0.44). The meta-analysis did not conclusively demonstrate significant benefit of prophylaxis on health-related quality of life as measured by Haem-A-QoL score, EQ-5D total score and utility score, EQ-5D VAS and SF-36 physical summary and mental summary score (low quality evidence for all health-related quality of life analyses).\nThe remaining two studies compared dose regimens. The results from one study (22 males) did not conclusively demonstrate benefit or harm of high-dose versus low-dose recombinant activated factor VIIa (rFVIIa) as a prophylaxis for overall bleeding rate, MD -0.82 (95% CI -2.27 to 0.63) (moderate quality evidence), target joint bleeding rate, MD -3.20 (95% CI -7.23 to 0.83) (moderate quality evidence) and serious adverse events, RR 9.00 (95% CI, 0.54 to 149.50) (moderate quality evidence).\nThe overall quality of evidence was moderate to low due to imprecision from limited information provided by studies with small sample sizes and incomplete outcome data in one study.\nAuthors' conclusions\nThe evidence suggests that prophylaxis with bypassing agents may be effective in reducing bleeding in males with hemophilia with inhibitors. However, there is a lack of evidence for the superiority of one agent over the other or for the optimum dosage regimen. Further studies are needed to evaluate the benefits and harms of prophylaxis treatment on health-related quality of life, as well as the effects of dose of bypassing agents on the outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched the scientific databases for clinical studies evaluating the effects of bypassing agents in men with hemophilia A or B with inhibitors. We included four studies (duration 7 to 15 months), involving 116 individuals. Two studies compared the prophylactic infusion with bypassing agent to on-demand treatment (treatment given only after the bleeding occurred) and two studies compared high-dose to low-dose preventative therapies."
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"role": "user",
"content": "Abstract: Background\nOncoplastic breast-conserving surgery (O-BCS) involves removing the tumour in the breast and using plastic surgery techniques to reconstruct the breast. The adequacy of published evidence on the safety and efficacy of O-BCS for the treatment of breast cancer compared to other surgical options for breast cancer is still debatable. It is estimated that the local recurrence rate is similar to standard breast-conserving surgery (S-BCS) and also mastectomy, but the aesthetic and patient-reported outcomes may be improved with oncoplastic techniques.\nObjectives\nOur primary objective was to assess oncological control outcomes following O-BCS compared with other surgical options for women with breast cancer. Our secondary objective was to assess surgical complications, recall rates, need for further surgery to achieve adequate oncological resection, patient satisfaction through patient-reported outcomes, and cosmetic outcomes through objective measures or clinician-reported outcomes.\nSearch methods\nWe searched the Cochrane Breast Cancer Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL),\nMEDLINE (via OVID), Embase (via OVID), the World Health Organization's International Clinical Trials Registry\nPlatform and ClinicalTrials.gov on 7 August 2020. We did not apply any language restrictions.\nSelection criteria\nWe selected randomised controlled trials (RCTs) and non-randomised comparative studies (cohort and case-control studies). Studies evaluated any O-BCS technique, including volume displacement techniques and partial breast volume replacement techniques compared to any other surgical treatment (partial resection or mastectomy) for the treatment of breast cancer.\nData collection and analysis\nFour review authors performed data extraction and resolved disagreements. We used ROBINS-I to assess the risk of bias by outcome. We performed descriptive data analysis and meta-analysis and evaluated the quality of the evidence using GRADE criteria. The outcomes included local recurrence, breast cancer-specific disease-free survival, re-excision rates, complications, recall rates, and patient-reported outcome measures.\nMain results\nWe included 78 non-randomised cohort studies evaluating 178,813 women. Overall, we assessed the risk of bias per outcome as being at serious risk of bias due to confounding; where studies adjusted for confounding, we deemed these at moderate risk.\nComparison 1: oncoplastic breast-conserving surgery (O-BCS) versus standard-BCS (S-BCS)\nThe evidence in the review found that O-BCS when compared to S-BCS, may make little or no difference to local recurrence; either when measured as local recurrence-free survival (hazard ratio (HR) 0.90, 95% confidence interval (CI) 0.61 to 1.34; 4 studies, 7600 participants; very low-certainty evidence) or local recurrence rate (HR 1.33, 95% CI 0.96 to 1.83; 4 studies, 2433 participants; low-certainty evidence), but the evidence is very uncertain due to most studies not controlling for confounding clinicopathological factors. O-BCS compared to S-BCS may make little to no difference to disease-free survival (HR 1.06, 95% CI 0.89 to 1.26; 7 studies, 5532 participants; low-certainty evidence). O-BCS may reduce the rate of re-excisions needed for oncological resection (risk ratio (RR) 0.76, 95% CI 0.69 to 0.85; 38 studies, 13,341 participants; very low-certainty evidence), but the evidence is very uncertain. O-BCS may increase the number of women who have at least one complication (RR 1.19, 95% CI 1.10 to 1.27; 20 studies, 118,005 participants; very low-certainty evidence) and increase the recall to biopsy rate (RR 2.39, 95% CI 1.67 to 3.42; 6 studies, 715 participants; low-certainty evidence). Meta-analysis was not possible when assessing patient-reported outcomes or cosmetic evaluation; in general, O-BCS reported a similar or more favourable result, however, the evidence is very uncertain due to risk of bias in the measurement methods.\nComparison 2: oncoplastic breast-conserving surgery (O-BCS) versus mastectomy alone\nO-BCS may increase local recurrence-free survival compared to mastectomy but the evidence is very uncertain (HR 0.55, 95% CI 0.34 to 0.91; 2 studies, 4713 participants; very low-certainty evidence). The evidence is very uncertain about the effect of O-BCS on disease-free survival as there were only data from one study. O-BCS may reduce complications compared to mastectomy, but the evidence is very uncertain due to high risk of bias mainly resulting from confounding (RR 0.75, 95% CI 0.67 to 0.83; 4 studies, 4839 participants; very low-certainty evidence). Data on patient-reported outcome measures came from single studies; it was not possible to meta-analyse the data.\nComparison 3: oncoplastic breast-conserving surgery (O-BCS) versus mastectomy with reconstruction\nO-BCS may make little or no difference to local recurrence-free survival (HR 1.37, 95% CI 0.72 to 2.62; 1 study, 3785 participants; very low-certainty evidence) or disease-free survival (HR 0.45, 95% CI 0.09 to 2.22; 1 study, 317 participants; very low-certainty evidence) when compared to mastectomy with reconstruction, but the evidence is very uncertain. O-BCS may reduce the complication rate compared to mastectomy with reconstruction (RR 0.49, 95% CI 0.45 to 0.54; 5 studies, 4973 participants; very low-certainty evidence) but the evidence is very uncertain due to high risk of bias from confounding and inconsistency of results. The evidence is very uncertain for patient-reported outcome measures and cosmetic evaluation.\nAuthors' conclusions\nThe evidence is very uncertain regarding oncological outcomes following O-BCS compared to S-BCS, though O-BCS has not been shown to be inferior. O-BCS may result in less need for a second re-excision surgery but may result in more complications and a greater recall rate than S-BCS. It seems that O-BCS may give better patient satisfaction and surgeon rating for the look of the breast, but the evidence for this is of poor quality, and due to lack of numerical data, it was not possible to pool the results of different studies. It seems O-BCS results in fewer complications compared with surgeries involving mastectomy.\nBased on this review, no certain conclusions can be made to help inform policymakers. The surgical decision for what operation to proceed with should be made jointly between clinician and patient after an appropriate discussion about the risks and benefits of O-BCS personalised to the patient, taking into account clinicopathological factors. This review highlighted the deficiency of well-conducted studies to evaluate efficacy, safety and patient-reported outcomes following O-BCS.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The certainty of the evidence in this review was very low. The studies had several methodological flaws. Differences between groups in cancer stage and other cancer treatments that were used may have affected the results. This is likely to have an impact on the findings, and future research is needed to investigate the topic further."
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"role": "user",
"content": "Abstract: Background\nTargeting the immunoglobulin E pathway and the interleukin-5 pathway with specific monoclonal antibodies directed against the cytokines or their receptors is effective in patients with severe asthma. However, there are patients who have suboptimal responses to these biologics. Since interleukin-4 and interleukin-13, signalling through the interleukin-4 receptor, have multiple effects on the biology of asthma, therapies targeting interleukin-4 and -13 (both individually and combined) have been developed.\nObjectives\nTo assess the efficacy and safety of anti-interleukin-13 or anti-interleukin-4 agents, compared with placebo, anti-immunoglobulin E agents, or anti-interleukin-5 agents, for the treatment of children, adolescents, or adults with asthma.\nSearch methods\nWe identified studies from the Cochrane Airways Trials Register, which is maintained by the Information Specialist for the Group and through searches of the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. The search was carried out on the 16 October 2020.\nSelection criteria\nWe included parallel-group randomised controlled trials that compared anti-interleukin-13 or -4 agents (or agents that target both interleukin-13 and interleukin-4) with placebo in adolescents and adults (aged 16 years or older) or children (younger than 16 years), with a diagnosis of asthma; participants could receive their usual short- or long-acting medications (e.g. inhaled corticosteroids (ICS), long-acting beta adrenoceptor agonists (LABA), long-acting muscarinic antagonists (LAMA), and/or leukotriene receptor antagonists) provided that they were not part of the randomised treatment.\nData collection and analysis\nWe used standard methods expected by Cochrane.\nMain results\nWe identified and included 41 RCTs. Of these, 29 studies contributed data to the quantitative analyses, randomly assigning 10,604 people with asthma to receive an anti-interleukin-13 (intervention) or anti-interleukin-4 agent (intervention), or placebo (comparator). No relevant studies were identified where the comparator was an anti-immunoglobulin agent or an anti-interleukin-5 agent. Studies had a duration of between 2 and 52 (median 16) weeks. The mean age of participants across the included studies ranged from 22 to 55 years. Only five studies permitted enrolment of children and adolescents, accounting for less than 5% of the total participants contributing data to the present review. The majority of participants had moderate or severe uncontrolled asthma. Concomitant ICS use was permitted or required in the majority (21 of 29) of the included studies. The use of maintenance systemic corticosteroids was not permitted in 19 studies and was permitted or required in five studies (information not reported in five studies). Regarding the most commonly assessed anti-interleukin-13/-4 agents, four studies evaluated dupilumab (300 mg once every week (Q1W), 200 mg once every two weeks (Q2W), 300 mg Q2W, 200 mg once every four weeks (Q4W), 300 mg Q4W, each administered by subcutaneous (SC) injection); eight studies evaluated lebrikizumab (37.5 mg Q4W, 125 mg Q4W, 250 mg Q4W each administered by SC injection); and nine studies (3259 participants) evaluated tralokinumab (75 mg Q1W, 150 mg Q1W, 300 mg Q1W, 150 mg Q2W, 300 mg Q2W, 600 mg Q2W, 300 mg Q4W, each administered by SC injection; 1/5/10 mg/kg administered by intravenous (IV) injection); all anti-interleukin-13 or-4 agents were compared with placebo.\nThe risk of bias was generally considered to be low or unclear (insufficient detail provided); nine studies were considered to be at high risk for attrition bias and three studies were considered to be at high risk for reporting bias.\nThe following results relate to the primary outcomes. The rate of exacerbations requiring hospitalisation or emergency department (ED) visit was probably lower in participants receiving tralokinumab versus placebo (rate ratio 0.68, 95% CI 0.47 to 0.98; moderate-certainty evidence; data available for tralokinumab (anti-interleukin-13) only). In participants receiving an anti-interleukin-13/-4 agent, the mean improvement versus placebo in adjusted asthma quality of life questionnaire score was 0.18 units (95% CI 0.12 to 0.24; high-certainty evidence); however, this finding was deemed not to be a clinically relevant improvement. There was likely little or no difference between groups in the proportion of patients who reported all-cause serious adverse events (anti-interleukin-13/-4 agents versus placebo, OR 0.91, 95% CI 0.76 to 1.09; moderate-certainty evidence).\nIn terms of secondary outcomes, there may be little or no difference between groups in the proportion of patients who experienced exacerbations requiring oral corticosteroids (anti-interleukin-13/-4 agents versus placebo, rate ratio 0.98, 95% CI 0.72 to 1.32; low-certainty evidence). Anti-interleukin-13/-4 agents probably improve asthma control based on asthma control questionnaire score (anti-interleukin-13/-4 agents versus placebo, mean difference -0.19; 95% CI -0.24 to -0.14); however, the magnitude of this result was deemed not to be a clinically relevant improvement. The proportion of patients experiencing any adverse event was greater in those receiving anti-interleukin-13/-4 agents compared with those receiving placebo (OR 1.16, 95% CI 1.04 to 1.30; high-certainty evidence); the most commonly reported adverse events in participants treated with anti-interleukin-13/-4 agents were upper respiratory tract infection, nasopharyngitis, headache and injection site reaction. The pooled results for the exploratory outcome, the rate of exacerbations requiring oral corticosteroids (OCS) or hospitalisation or emergency department visit, may be lower in participants receiving anti-interleukin-13/-4 agents versus placebo (rate ratio 0.71, 95% CI 0.65 to 0.77; low-certainty evidence).\nResults were generally consistent across subgroups for different classes of agent (anti-interleukin-13 or anti-interleukin-4), durations of study and severity of disease. Subgroup analysis based on category of T helper 2 (TH2) inflammation suggested greater efficacy in patients with higher levels of inflammatory biomarkers (blood eosinophils, exhaled nitric oxide and serum periostin).\nAuthors' conclusions\nBased on the totality of the evidence, compared with placebo, anti-interleukin-13/-4 agents are probably associated with a reduction in exacerbations requiring hospitalisation or ED visit, at the cost of increased adverse events, in patients with asthma. No clinically relevant improvements in health-related quality of life or asthma control were identified. Therefore, anti-interleukin-13 or anti-interleukin-4 agents may be appropriate for adults with moderate-to-severe uncontrolled asthma who have not responded to other treatments. These conclusions are generally supported by moderate or high-certainty evidence based on studies with an observation period of up to one year.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We assessed the efficacy and safety of anti-interleukin-13 or anti-interleukin-4 agents, compared with placebo, anti-immunoglobulin E agents, or anti-interleukin-5 agents, for the treatment of children, adolescents, or adults with asthma."
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query-laysum
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7156
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"role": "user",
"content": "Abstract: Background\nAdvances in embryo culture media have led to a shift in in vitro fertilisation (IVF) practice from cleavage-stage embryo transfer to blastocyst-stage embryo transfer. The rationale for blastocyst-stage transfer is to improve both uterine and embryonic synchronicity and enable self selection of viable embryos, thus resulting in better live birth rates.\nObjectives\nTo determine whether blastocyst-stage (day 5 to 6) embryo transfer improves the live birth rate (LBR) per fresh transfer, and other associated outcomes, compared with cleavage-stage (day 2 to 3) embryo transfer.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL, from inception to October 2021. We also searched registers of ongoing trials and the reference lists of studies retrieved.\nSelection criteria\nWe included randomised controlled trials (RCTs) which compared the effectiveness of IVF with blastocyst-stage embryo transfer versus IVF with cleavage-stage embryo transfer.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Our primary outcomes were LBR per fresh transfer and cumulative clinical pregnancy rates (cCPR). Secondary outcomes were clinical pregnancy rate (CPR), multiple pregnancy, high-order multiple pregnancy, miscarriage (all following first embryo transfer), failure to transfer embryos, and whether supernumerary embryos were frozen for transfer at a later date (frozen-thawed embryo transfer). We assessed the overall quality of the evidence for the main comparisons using GRADE methods.\nMain results\nWe included 32 RCTs (5821 couples or women).\nThe live birth rate following fresh transfer was higher in the blastocyst-stage transfer group (odds ratio (OR) 1.27, 95% confidence interval (CI) 1.06 to 1.51; I2 = 53%; 15 studies, 2219 women; low-quality evidence). This suggests that if 31% of women achieve live birth after fresh cleavage-stage transfer, between 32% and 41% would do so after fresh blastocyst-stage transfer.\nWe are uncertain whether blastocyst-stage transfer improves the cCPR. A post hoc analysis showed that vitrification could increase the cCPR. This is an interesting finding that warrants further investigation when more studies using vitrification are published.\nThe CPR was also higher in the blastocyst-stage transfer group, following fresh transfer (OR 1.25, 95% CI 1.12 to 1.39; I2 = 51%; 32 studies, 5821 women; moderate-quality evidence). This suggests that if 39% of women achieve a clinical pregnancy after fresh cleavage-stage transfer, between 42% and 47% will probably do so after fresh blastocyst-stage transfer.\nWe are uncertain whether blastocyst-stage transfer increases multiple pregnancy (OR 1.05, 95% CI 0.83 to 1.33; I2 = 30%; 19 studies, 3019 women; low-quality evidence) or miscarriage rates (OR 1.12, 95% CI 0.90 to 1.38; I2 = 24%; 22 studies, 4208 women; low-quality evidence). This suggests that if 9% of women have a multiple pregnancy after fresh cleavage-stage transfer, between 8% and 12% would do so after fresh blastocyst-stage transfer. However, a sensitivity analysis restricted only to studies with low or 'some concerns' for risk of bias, in the subgroup of equal number of embryos transferred, showed that blastocyst transfer probably increases the multiple pregnancy rate.\nEmbryo freezing rates (when there are frozen supernumerary embryos for transfer at a later date) were lower in the blastocyst-stage transfer group (OR 0.48, 95% CI 0.40 to 0.57; I2 = 84%; 14 studies, 2292 women; low-quality evidence). This suggests that if 60% of women have embryos frozen after cleavage-stage transfer, between 37% and 46% would do so after blastocyst-stage transfer.\nFailure to transfer any embryos was higher in the blastocyst transfer group (OR 2.50, 95% CI 1.76 to 3.55; I2 = 36%; 17 studies, 2577 women; moderate-quality evidence). This suggests that if 1% of women have no embryos transferred in planned fresh cleavage-stage transfer, between 2% and 4% probably have no embryos transferred in planned fresh blastocyst-stage transfer.\nThe evidence was of low quality for most outcomes. The main limitations were serious imprecision and serious risk of bias, associated with failure to describe acceptable methods of randomisation.\nAuthors' conclusions\nThere is low-quality evidence for live birth and moderate-quality evidence for clinical pregnancy that fresh blastocyst-stage transfer is associated with higher rates of both than fresh cleavage-stage transfer. We are uncertain whether blastocyst-stage transfer improves the cCPR derived from fresh and frozen-thawed cycles following a single oocyte retrieval. Although there is a benefit favouring blastocyst-stage transfer in fresh cycles, more evidence is needed to know whether the stage of transfer impacts on cumulative live birth and pregnancy rates. Future RCTs should report rates of live birth, cumulative live birth, and miscarriage. They should also evaluate women with a poor prognosis to enable those undergoing assisted reproductive technology (ART) and service providers to make well-informed decisions on the best treatment option available.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "– Transferring 'fresh' embryos at the blastocyst stage (day 5 to 6) may lead to more live births than when 'fresh' embryos are transferred at the cleavage stage (day 2 to 3). This suggests that if 31% of women achieve live birth after 'fresh' cleavage-stage embryo transfer, between 32% and 41% would do so after 'fresh' blastocyst-stage transfer.\n– Transferring 'fresh' embryos at the blastocyst stage probably leads to more clinical pregnancies – defined as evidence of fetal heart activity on an ultrasound scan – than when 'fresh' embryos are transferred at the cleavage stage. This suggests that if 39% of women achieve a clinical pregnancy after 'fresh' cleavage-stage transfer, between 42% and 47% will probably do so after 'fresh' blastocyst-stage transfer.\n– We are uncertain whether blastocyst-stage transfer favors cumulative clinical pregnancy rates (i.e. pregnancies from both fresh and thawed cycles deriving from a single egg collection procedure).\n– We are uncertain whether blastocyst-stage transfer increases multiple pregnancy rates compared to cleavage-stage transfer, when we consider all the studies that reported information on this.\n– When we consider evidence only from higher-quality studies and studies that transferred the same number of embryos in both embryo stages, we found that multiple pregnancy rate is probably higher in the blastocyst-stage transfer group.\n– We are uncertain whether blastocyst-stage transfer increases miscarriage rates compared to cleavage-stage transfer.\nFuture studies should report rates of live birth, cumulative live birth, and miscarriage, to enable women, couples and their doctors to make well-informed decisions on the best treatment option available."
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"role": "user",
"content": "Abstract: Background\nThere are a number of ways of monitoring blood glucose in women with diabetes during pregnancy, with self-monitoring of blood glucose (SMBG) recommended as a key component of the management plan. No existing systematic reviews consider the benefits/effectiveness of different techniques of blood glucose monitoring on maternal and infant outcomes among pregnant women with pre-existing diabetes. The effectiveness of the various monitoring techniques is unclear. This review is an update of a review that was first published in 2014 and subsequently updated in 2017.\nObjectives\nTo compare techniques of blood glucose monitoring and their impact on maternal and infant outcomes among pregnant women with pre-existing diabetes.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 November 2018), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs comparing techniques of blood glucose monitoring including SMBG, continuous glucose monitoring (CGM), automated telemedicine monitoring or clinic monitoring among pregnant women with pre-existing diabetes mellitus (type 1 or type 2). Trials investigating timing and frequency of monitoring were also eligible for inclusion. RCTs using a cluster-randomised design were eligible for inclusion but none were identified.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were checked for accuracy. The quality of the evidence was assessed using the GRADE approach.\nMain results\nThis review update includes a total of 12 trials (944) women (type 1 diabetes: 660 women; type 2 diabetes: 113 women; type 1 or type 2 (unspecified): 171 women. The trials took place in Europe, the USA and Canada. Three of the 12 included studies are at low risk of bias, eight studies are at moderate risk of bias, and one study is at high risk of bias. Four trials reported that they were provided with the continuous glucose monitors free of charge or at a reduced cost by the manufacturer.\nContinuous glucose monitoring (CGM) versus intermittent glucose monitoring, (four studies, 609 women)\nCGM may reduce hypertensive disorders of pregnancy (pre-eclampsia and pregnancy-induced hypertension) (risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.85; 2 studies, 384 women; low-quality evidence), although it should be noted that only two of the four relevant studies reported data for this composite outcome. Conversely, this did not translate into a clear reduction for pre-eclampsia (RR 0.65, 95% CI 0.39 to 1.08; 4 studies, 609 women, moderate-quality evidence). There was also no clear reduction in caesarean section (average RR 0.94, 95% CI 0.75 to 1.18; 3 studies, 427 women; I2 = 41%; moderate-quality evidence) or large-for-gestational age (average RR 0.84, 95% CI 0.57 to 1.26; 3 studies, 421 women; I2 = 70%; low-quality evidence) with CGM. There was not enough evidence to assess perinatal mortality (RR 0.82, 95% CI 0.05 to 12.61, 71 infants, 1 study; low-quality evidence), or mortality or morbidity composite (RR 0.80, 95% CI 0.61 to 1.06; 1 study, 200 women) as the evidence was based on single studies of low quality. CGM appears to reduce neonatal hypoglycaemia (RR 0.66, 95% CI 0.48 to 0.93; 3 studies, 428 infants). Neurosensory disability was not reported.\nOther methods of glucose monitoring\nFor the following five comparisons, self-monitoring versus a different type of self-monitoring (two studies, 43 women); self-monitoring at home versus hospitalisation (one study, 100 women), pre-prandial versus post-prandial glucose monitoring (one study, 61 women), automated telemedicine monitoring versus conventional system (three studies, 84 women), and constant CGM versus intermittent CGM (one study, 25 women), it is uncertain whether any of the interventions has any impact on any of our GRADE outcomes (hypertensive disorders of pregnancy, caesarean section, large-for-gestational age) because the quality of the evidence was found to be very low. This was due to evidence largely being derived from single trials, with design limitations and limitations with imprecision (wide CIs, small sample sizes, and few events). There was not enough evidence to assess perinatal mortality and neonatal mortality and morbidity composite. Other important outcomes, such as neurosensory disability, were not reported in any of these comparisons.\nAuthors' conclusions\nTwo new studies (406 women) have been incorporated to one of the comparisons for this update. Although the evidence suggests that CGM in comparison to intermittent glucose monitoring may reduce hypertensive disorders of pregnancy, this did not translate into a clear reduction for pre-eclampsia, and so this result should be viewed with caution. There was no evidence of a difference for other primary outcomes for this comparison. The evidence base for the effectiveness of other monitoring techniques analysed in the other five comparisons is weak and based on mainly single studies with very low-quality evidence. Additional evidence from large well-designed randomised trials is required to inform choices of other glucose monitoring techniques and to confirm the effectiveness of CGM.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This is an update of a review first published in 2014, updated in 2017. We searched for evidence from randomised controlled studies in November 2018. We identified 12 studies involving 944 women (type 1 diabetes: 660 women; type 2 diabetes: 113 women; in two trials (171 women) there was a mix of type 1 and type 2 diabetes. The trials were from Europe, USA and Canada.\nThere were six comparisons. These were: continuous versus intermittent monitoring of blood glucose (four studies, 609 women); two different ways of self-monitoring (two studies, 43 women); self-monitoring at home versus hospitalisation to control blood glucose levels (one study, 100 women); blood glucose monitoring before a meal (pre-prandial) versus blood glucose monitoring after a meal (post-prandial) (one study, 61 women); automated telemedicine monitoring versus conventional care (three studies, 84 women); and constant continuous monitoring versus intermittent continuous monitoring (one study, 25 women),\nContinuous versus intermittent monitoring may reduce overall high blood pressure problems during pregnancy (two studies, 384 women, low-quality evidence). However, it should be noted that only two of four relevant studies reported data for this outcome. There was more evidence on high blood pressure and protein in their urine (pre-eclampsia), which showed no clear difference (four studies, 609 women). We also found no difference in the number of women having a caesarean section (three studies, 427 women; moderate-quality evidence). There was not enough evidence to assess infant deaths or the combined outcome of infant deaths and ill-health as these outcomes were based on single studies. Four studies received some support from commercial partners.\nThe other comparisons of different ways of monitoring blood glucose levels were based on very small studies or single studies with very low-quality evidence that did not show any clear differences in outcomes."
}
] |
query-laysum
|
7158
|
[
{
"role": "user",
"content": "Abstract: Background\nGastrointestinal paralysis, nausea and vomiting and pain are major clinical problems following abdominal surgery. Anaesthetic and analgesic techniques that reduce pain and postoperative nausea and vomiting (PONV), while preventing or reducing postoperative ileus, may reduce postoperative morbidity, duration of hospitalization and hospital costs. This review was first published in 2001 and was updated by new review authors in 2016.\nObjectives\nTo compare effects of postoperative epidural analgesia with local anaesthetics versus postoperative systemic or epidural opioids in terms of return of gastrointestinal transit, postoperative pain control, postoperative vomiting, incidence of anastomotic leak, length of hospital stay and costs after abdominal surgery.\nSearch methods\nWe identified trials by conducting computerized searches of the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 12), MEDLINE (from 1950 to December 2014) and EMBASE (from 1974 to December 2014) and by checking the reference lists of trials retained. When we reran the search in February 2016, we added 16 potential new studies of interest to the list of ‘Studies awaiting classification' and will incorporate these studies into formal review findings during the next review update.\nSelection criteria\nWe included parallel randomized controlled trials comparing effects of postoperative epidural local anaesthetic versus regimens based on systemic or epidural opioids.\nData collection and analysis\nWe rated the quality of studies by using the Cochrane 'Risk of bias' tool. Two review authors independently extracted data and judged the quality of evidence according to the GRADE (Grades of Recommendation, Assessment, Development and Evaluation Working Group) scale.\nMain results\nWe included 128 trials with 8754 participants in the review, and 94 trials with 5846 participants in the analysis. Trials included in the review were funded as follows: charity (n = 19), departmental resources (n = 8), governmental sources (n = 15) and industry (in part or in total) (n = 15). The source of funding was not specified for the other studies.\nResults of 22 trials including 1138 participants show that an epidural containing a local anaesthetic will decrease the time required for return of gastrointestinal transit as measured by time to first flatus after an abdominal surgery (standardized mean difference (SMD) -1.28, 95% confidence interval (CI) -1.71 to -0.86; high quality of evidence; equivalent to 17.5 hours). The effect is proportionate to the concentration of local anaesthetic used. A total of 28 trials including 1559 participants reported a decrease in time to first faeces (stool) (SMD -0.67, 95% CI -0.86 to -0.47; low quality of evidence; equivalent to 22 hours). Thirty-five trials including 2731 participants found that pain on movement at 24 hours after surgery was also reduced (SMD -0.89, 95% CI -1.08 to -0.70; moderate quality of evidence; equivalent to 2.5 on scale from 0 to 10). From findings of 22 trials including 1154 participants we did not find a difference in the incidence of vomiting within 24 hours (risk ratio (RR) 0.84, 95% CI 0.57 to 1.23; low quality of evidence). From investigators in 17 trials including 848 participants we did not find a difference in the incidence of gastrointestinal anastomotic leak (RR 0.74, 95% CI 0.41 to 1.32; low quality of evidence). Researchers in 30 trials including 2598 participants noted that epidural analgesia reduced length of hospital stay for an open surgery (SMD -0.20, 95% CI -0.35 to -0.04; very low quality of evidence; equivalent to one day). Data on costs were very limited.\nAuthors' conclusions\nAn epidural containing a local anaesthetic, with or without the addition of an opioid, accelerates the return of gastrointestinal transit (high quality of evidence). An epidural containing a local anaesthetic with an opioid decreases pain after abdominal surgery (moderate quality of evidence). We did not find a difference in the incidence of vomiting or anastomotic leak (low quality of evidence). For open surgery, an epidural containing a local anaesthetic would reduce the length of hospital stay (very low quality of evidence).\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that an epidural containing a local anaesthetic reduces the time required for return of gut function compared with an opioid-based regimen (equivalent to 17 hours). An epidural providing a local anaesthetic and an opioid also reduce pain (equivalent to a reduction of 2.5 on a scale from 0 to 10 for pain on movement at 24 hours after surgery) and time spent in hospital for open surgery (equivalent to one day). We found no evidence that an epidural with a local anaesthetic would affect the incidence of vomiting or poor healing of the gut."
}
] |
query-laysum
|
7159
|
[
{
"role": "user",
"content": "Abstract: Background\nThe increased birth rate of twins during recent decades and the improved prognosis of preterm infants have resulted in the need to explore measures that could optimize their growth and neurodevelopmental outcomes. It has been postulated that co-bedding simulates twins' intrauterine experiences in which co-regulatory behaviors between them are observed. These behaviors are proposed to benefit twins by reducing their stress, which may promote growth and development. However, in practice, uncertainty surrounds the benefit-risk profile of co-bedding.\nObjectives\nWe aimed to assess the effectiveness of co-bedding compared with separate (individual) care for stable preterm twins in the neonatal nursery in promoting growth and neurodevelopment and reducing short- and long-term morbidities, and to determine whether co-bedding is associated with significant adverse effects.\nAs secondary objectives, we sought to evaluate effects of co-bedding via the following subgroup analyses: twin pairs with different weight ranges (very low birth weight [VLBW] < 1500 grams vs non-VLBW), twins with versus without significant growth discordance at birth, preterm versus borderline preterm twins, twins co-bedded in incubator versus cot at study entry, and twins randomized by twin pair versus neonatal unit.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group (CNRG). We used keywords and medical subject headings (MeSH) to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2), MEDLINE (via PubMed), EMBASE (hosted by EBSCOHOST), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and references cited in our short-listed articles, up to February 29, 2016.\nSelection criteria\nWe included randomized controlled trials with randomization by twin pair and/or by neonatal unit. We excluded cross-over studies.\nData collection and analysis\nWe extracted data using standard methods of the CNRG. Two review authors independently assessed the relevance and risk of bias of retrieved records. We contacted the authors of included studies to request important information missing from their published papers. We expressed our results using risk ratios (RRs) and mean differences (MDs) when appropriate, along with 95% confidence intervals (95% CIs). We adjusted the unit of analysis from individual infants to twin pairs by averaging measurements for each twin pair (continuous outcomes) or by counting outcomes as positive if developed by either twin (dichotomous outcomes).\nMain results\nSix studies met the inclusion criteria; however, only five studies provided data for analysis. Four of the six included studies were small and had significant limitations in design. As each study reported outcomes differently, data for most outcomes were effectively contributed by a single study. Study authors reported no differences between co-bedded twins and twins receiving separate care in terms of rate of weight gain (MD 0.20 grams/kg/d, 95% CI -1.60 to 2.00; one study; 18 pairs of twins; evidence of low quality); apnea, bradycardia, and desaturation (A/B/D) episodes (RR 0.85, 95% CI 0.18 to 4.05; one study; 62 pairs of twins; evidence of low quality); episodes in co-regulated states (MD 0.96, 95% CI -3.44 to 5.36; one study; three pairs of twins; evidence of very low quality); suspected or proven infection (RR 0.84, 95% CI 0.30 to 2.31; three studies; 65 pairs of twins; evidence of very low quality); length of hospital stay (MD -4.90 days, 95% CI -35.23 to 25.43; one study; three pairs of twins; evidence of very low quality); and parental satisfaction measured on a scale of 0 to 55 (MD -0.38, 95% CI -4.49 to 3.73; one study; nine pairs of twins; evidence of moderate quality). Although co-bedded twins appeared to have lower pain scores 30 seconds after heel lance on a scale of 0 to 21 (MD -0.96, 95% CI -1.68 to -0.23; two studies; 117 pairs of twins; I2 = 75%; evidence of low quality), they had higher pain scores 90 seconds after the procedure (MD 1.00, 95% CI 0.14 to 1.86; one study; 62 pairs of twins). Substantial heterogeneity in the outcome of infant pain response after heel prick at 30 seconds post procedure and conflicting results at 30 and 90 seconds post procedure precluded clear conclusions.\nAuthors' conclusions\nEvidence on the benefits and harms of co-bedding for stable preterm twins was insufficient to permit recommendations for practice. Future studies must be adequately powered to detect clinically important differences in growth and neurodevelopment. Researchers should assess harms such as infection, along with medication errors and caregiver satisfaction.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed evidence on the benefits and harms of co-bedding stable preterm twins and found six relevant studies."
}
] |
query-laysum
|
7160
|
[
{
"role": "user",
"content": "Abstract: Background\nMénière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. First-line treatments often involve dietary or lifestyle changes, medication or local (intratympanic) treatments. However, surgery may also be considered for people with persistent or severe symptoms. The efficacy of different surgical interventions at preventing vertigo attacks, and their associated symptoms, is currently unclear.\nObjectives\nTo evaluate the benefits and harms of surgical interventions versus placebo or no treatment in people with Ménière's disease.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with definite or probable Ménière's disease comparing ventilation tubes, endolymphatic sac surgery, semi-circular canal plugging/obliteration, vestibular nerve section or labyrinthectomy with either placebo (sham surgery) or no treatment. We excluded studies with follow-up of less than three months, or with a cross-over design (unless data from the first phase of the study could be identified).\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) change in hearing, 6) change in tinnitus and 7) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included two studies with a total of 178 participants. One evaluated ventilation tubes compared to no treatment, the other evaluated endolymphatic sac decompression compared to sham surgery.\nVentilation tubes\nWe included a single RCT of 148 participants with definite Ménière's disease. It was conducted in a single centre in Japan from 2010 to 2013. Participants either received ventilation tubes with standard medical treatment, or standard medical treatment alone, and were followed up for two years. Some data were reported on the number of participants in whom vertigo resolved, and the effect of the intervention on hearing. Our other primary and secondary outcomes were not reported in this study. This is a single, small study and for all outcomes the certainty of evidence was low or very low. We are unable to draw meaningful conclusions from the numerical results.\nEndolymphatic sac decompression\nWe also included one RCT of 30 participants that compared endolymphatic sac decompression with sham surgery. This was a single-centre study conducted in Denmark during the 1980s. Follow-up was predominantly conducted at one year, but additional follow-up continued for up to nine years in some participants. Some data were reported on hearing and vertigo (both improvement in vertigo and change in vertigo), but our other outcomes of interest were not reported. Again, this is a single, very small study and we rated the certainty of the evidence as very low for all outcomes. We are therefore unable to draw meaningful conclusions from the numerical results.\nAuthors' conclusions\nWe are unable to draw clear conclusions about the efficacy of these surgical interventions for Ménière's disease. We identified evidence for only two of our five proposed comparisons, and we assessed all the evidence as low- or very low-certainty. This means that we have very low confidence that the effects reported are accurate estimates of the true effect of these interventions. Many of the outcomes that we planned to assess were not reported by the studies, such as the impact on quality of life, and adverse effects of the interventions. Consensus on the appropriate outcomes to measure in studies of Ménière's disease is needed (i.e. a core outcome set) in order to guide future studies in this area and enable meta-analyses of the results. This must include appropriate consideration of the potential harms of treatment, as well as the benefits.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Due to a lack of robust evidence, it is not clear whether any types of surgery used to treat Ménière's disease work to improve people's symptoms. There was no information regarding the potential for serious risks from these treatments.\nLarger, well-conducted studies are needed in order to identify whether surgery may be effective, and assess whether there are any harmful effects of treatment.\nFurther work also needs to be done to find out how best to measure the symptoms of people with Ménière's disease, in order to assess whether treatments are beneficial or not. This should include the development of a 'core outcome set' - a list of things that should be measured in all studies on Ménière's disease."
}
] |
query-laysum
|
7161
|
[
{
"role": "user",
"content": "Abstract: Background\nPosttraumatic stress disorder (PTSD) is a prevalent and disabling disorder. Evidence that PTSD is characterised by specific psychobiological dysfunctions has contributed to a growing interest in the use of medication in its treatment.\nObjectives\nTo assess the effects of medication for reducing PTSD symptoms in adults with PTSD.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 11, November 2020); MEDLINE (1946-), Embase (1974-), PsycINFO (1967-) and PTSDPubs (all available years) either directly or via the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR). We also searched international trial registers. The date of the latest search was 13 November 2020.\nSelection criteria\nAll randomised controlled trials (RCTs) of pharmacotherapy for adults with PTSD.\nData collection and analysis\nThree review authors (TW, JI, and NP) independently assessed RCTs for inclusion in the review, collated trial data, and assessed trial quality. We contacted investigators to obtain missing data. We stratified summary statistics by medication class, and by medication agent for all medications. We calculated dichotomous and continuous measures using a random-effects model, and assessed heterogeneity.\nMain results\nWe include 66 RCTs in the review (range: 13 days to 28 weeks; 7442 participants; age range 18 to 85 years) and 54 in the meta-analysis.\nFor the primary outcome of treatment response, we found evidence of beneficial effect for selective serotonin reuptake inhibitors (SSRIs) compared with placebo (risk ratio (RR) 0.66, 95% confidence interval (CI) 0.59 to 0.74; 8 studies, 1078 participants), which improved PTSD symptoms in 58% of SSRI participants compared with 35% of placebo participants, based on moderate-certainty evidence.\nFor this outcome we also found evidence of beneficial effect for the noradrenergic and specific serotonergic antidepressant (NaSSA) mirtazapine: (RR 0.45, 95% CI 0.22 to 0.94; 1 study, 26 participants) in 65% of people on mirtazapine compared with 22% of placebo participants, and for the tricyclic antidepressant (TCA) amitriptyline (RR 0.60, 95% CI 0.38 to 0.96; 1 study, 40 participants) in 50% of amitriptyline participants compared with 17% of placebo participants, which improved PTSD symptoms. These outcomes are based on low-certainty evidence. There was however no evidence of beneficial effect for the number of participants who improved with the antipsychotics (RR 0.51, 95% CI 0.16 to 1.67; 2 studies, 43 participants) compared to placebo, based on very low-certainty evidence.\nFor the outcome of treatment withdrawal, we found evidence of a harm for the individual SSRI agents compared with placebo (RR 1.41, 95% CI 1.07 to 1.87; 14 studies, 2399 participants). Withdrawals were also higher for the separate SSRI paroxetine group compared to the placebo group (RR 1.55, 95% CI 1.05 to 2.29; 5 studies, 1101 participants). Nonetheless, the absolute proportion of individuals dropping out from treatment due to adverse events in the SSRI groups was low (9%), based on moderate-certainty evidence. For the rest of the medications compared to placebo, we did not find evidence of harm for individuals dropping out from treatment due to adverse events.\nAuthors' conclusions\nThe findings of this review support the conclusion that SSRIs improve PTSD symptoms; they are first-line agents for the pharmacotherapy of PTSD, based on moderate-certainty evidence. The NaSSA mirtazapine and the TCA amitriptyline may also improve PTSD symptoms, but this is based on low-certainty evidence. In addition, we found no evidence of benefit for the number of participants who improved following treatment with the antipsychotic group compared to placebo, based on very low-certainty evidence. There remain important gaps in the evidence base, and a continued need for more effective agents in the management of PTSD.\n\nGiven the provided abstract, please respond to the following query: \"What should happen next?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most evidence for pharmacotherapy efficacy is related to SSRIs for acute treatment. There is an ongoing need to develop new pharmacotherapeutic treatments of PTSD."
}
] |
query-laysum
|
7162
|
[
{
"role": "user",
"content": "Abstract: Background\nVenous access is an essential part of caring for the sick neonate. However, problems such as contamination of fluids with bacteria, endotoxins and particulates have been associated with intravenous infusion therapy. Intravenous in-line filters claim to be an effective strategy for the removal of bacteria, endotoxins and particulates associated with intravenous therapy in adults and are increasingly being recommended for use in neonates.\nObjectives\nTo determine the effect of intravenous in-line filters on morbidity and mortality in neonates.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group. We searched the electronic databases MEDLINE (from 1966 to May, 2015), EMBASE (from 1980 to May, 2015), CINAHL (from 1982 to May 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 5). We did not impose any language restrictions. Further searching included cross references, abstracts, conferences, symposia proceedings, expert informants and journal handsearching.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs that compared the use of intravenous in-line filters with placebo or nothing in neonates.\nData collection and analysis\nWe followed the procedures of the Cochrane Neonatal Review Group throughout. We checked titles and abstracts identified from the search. We obtained the full text of all studies of possible relevance. We independently assessed the trials for their methodological quality and subsequent inclusion in the review. We contacted authors for further information as needed. Statistical analysis followed the procedures of the Cochrane Neonatal Review Group.\nMain results\nThere were four eligible studies that recruited a total of 704 neonates. This review of low to very low quality evidence found that the use of in-line filters compared with unfiltered fluids for intravenous infusion had no statistically significant difference in effectiveness on overall mortality (typical RR 0.87, 95% CI 0.52 to 1.47; typical RD -0.01, 95% CI -0.06 to 0.04; two studies, 530 infants), proven and suspect septicaemia (typical RR 0.86, 95% CI 0.59 to 1.27; typical RD -0.02, 95% CI -0.09 to 0.04; two studies, 530 infants), or other secondary outcomes (including local phlebitis and thrombus, necrotising enterocolitis, duration of cannula patency, length of stay in hospital, number of catheters inserted and financial costs).\nAuthors' conclusions\nThere is insufficient evidence to recommend the use of intravenous in-line filters to prevent morbidity and mortality in neonates.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Does the use of in-line filters on intravenous lines reduce morbidity and mortality in neonates?"
}
] |
query-laysum
|
7163
|
[
{
"role": "user",
"content": "Abstract: Background\nZinc deficiency is prevalent in low- and middle-income countries, and is considered a significant risk factor for morbidity, mortality, and linear growth failure. The effectiveness of preventive zinc supplementation in reducing prevalence of zinc deficiency needs to be assessed.\nObjectives\nTo assess the effects of zinc supplementation for preventing mortality and morbidity, and for promoting growth, in children aged 6 months to 12 years.\nSearch methods\nA previous version of this review was published in 2014. In this update, we searched CENTRAL, MEDLINE, Embase, five other databases, and one trials register up to February 2022, together with reference checking and contact with study authors to identify additional studies.\nSelection criteria\nRandomized controlled trials (RCTs) of preventive zinc supplementation in children aged 6 months to 12 years compared with no intervention, a placebo, or a waiting list control. We excluded hospitalized children and children with chronic diseases or conditions. We excluded food fortification or intake, sprinkles, and therapeutic interventions.\nData collection and analysis\nTwo review authors screened studies, extracted data, and assessed the risk of bias. We contacted study authors for missing information and used GRADE to assess the certainty of evidence. The primary outcomes of this review were all-cause mortality; and cause-specific mortality, due to all-cause diarrhea, lower respiratory tract infection (LRTI, including pneumonia), and malaria. We also collected information on a number of secondary outcomes, such as those related to diarrhea and LRTI morbidity, growth outcomes and serum levels of micronutrients, and adverse events.\nMain results\nWe included 16 new studies in this review, resulting in a total of 96 RCTs with 219,584 eligible participants. The included studies were conducted in 34 countries; 87 of them in low- or middle-income countries. Most of the children included in this review were under five years of age. The intervention was delivered most commonly in the form of syrup as zinc sulfate, and the most common dose was between 10 mg and 15 mg daily. The median duration of follow-up was 26 weeks. We did not consider that the evidence for the key analyses of morbidity and mortality outcomes was affected by risk of bias.\nHigh-certainty evidence showed little to no difference in all-cause mortality with preventive zinc supplementation compared to no zinc (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.84 to 1.03; 16 studies, 17 comparisons, 143,474 participants).\nModerate-certainty evidence showed that preventive zinc supplementation compared to no zinc likely results in little to no difference in mortality due to all-cause diarrhea (RR 0.95, 95% CI 0.69 to 1.31; 4 studies, 132,321 participants); but probably reduces mortality due to LRTI (RR 0.86, 95% CI 0.64 to 1.15; 3 studies, 132,063 participants) and mortality due to malaria (RR 0.90, 95% CI 0.77 to 1.06; 2 studies, 42,818 participants); however, the confidence intervals around the summary estimates for these outcomes were wide, and we could not rule out a possibility of increased risk of mortality.\nPreventive zinc supplementation likely reduces the incidence of all-cause diarrhea (RR 0.91, 95% CI 0.90 to 0.93; 39 studies, 19,468 participants; moderate-certainty evidence) but results in little to no difference in morbidity due to LRTI (RR 1.01, 95% CI 0.95 to 1.08; 19 studies, 10,555 participants; high-certainty evidence) compared to no zinc.\nThere was moderate-certainty evidence that preventive zinc supplementation likely leads to a slight increase in height (standardized mean difference (SMD) 0.12, 95% CI 0.09 to 0.14; 74 studies, 20,720 participants).\nZinc supplementation was associated with an increase in the number of participants with at least one vomiting episode (RR 1.29, 95% CI 1.14 to 1.46; 5 studies, 35,192 participants; high-certainty evidence). We report a number of other outcomes, including the effect of zinc supplementation on weight and serum markers such as zinc, hemoglobin, iron, copper, etc. We also performed a number of subgroup analyses and there was a consistent finding for a number of outcomes that co-supplementation of zinc with iron decreased the beneficial effect of zinc.\nAuthors' conclusions\nEven though we included 16 new studies in this update, the overall conclusions of the review remain unchanged. Zinc supplementation might help prevent episodes of diarrhea and improve growth slightly, particularly in children aged 6 months to 12 years of age. The benefits of preventive zinc supplementation may outweigh the harms in regions where the risk of zinc deficiency is relatively high.\n\nGiven the provided abstract, please respond to the following query: \"Why is it important to study zinc supplementation?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Zinc is an essential micronutrient. It is important to help children grow normally and to promote a healthy immune system. Lack of zinc may lead to diarrhea, pneumonia, malaria and even death. Low dietary zinc intake is often linked to poverty. As many as half of all children in low- and middle-income countries may have zinc deficiency. Meat, fish, eggs and dairy products are good natural sources of zinc, but are expensive. Lack of clean water and poor sanitation increases exposure to diseases, which zinc might help to fight. The human body cannot produce or store zinc, so giving dietary supplements is important."
}
] |
query-laysum
|
7164
|
[
{
"role": "user",
"content": "Abstract: Background\nPatients treated with mechanical ventilation in intensive care units (ICUs) have a high risk of developing respiratory tract infections (RTIs). Ventilator-associated pneumonia (VAP) has been estimated to affect 5% to 40% of patients treated with mechanical ventilation for at least 48 hours. The attributable mortality rate of VAP has been estimated at about 9%. Selective digestive decontamination (SDD), which consists of the topical application of non-absorbable antimicrobial agents to the oropharynx and gastroenteric tract during the whole period of mechanical ventilation, is often used to reduce the risk of VAP. A related treatment is selective oropharyngeal decontamination (SOD), in which topical antibiotics are applied to the oropharynx only. This is an update of a review first published in 1997 and updated in 2002, 2004, and 2009.\nObjectives\nTo assess the effect of topical antibiotic regimens (SDD and SOD), given alone or in combination with systemic antibiotics, to prevent mortality and respiratory infections in patients receiving mechanical ventilation for at least 48 hours in ICUs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Acute Respiratory Infections (ARI) Group's Specialised Register, PubMed, and Embase on 5 February 2020. We also searched the WHO ICTRP and ClinicalTrials.gov for ongoing and unpublished studies on 5 February 2020. All searches included non-English language literature. We handsearched references of topic-related systematic reviews and the included studies.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster-RCTs assessing the efficacy and safety of topical prophylactic antibiotic regimens in adults receiving intensive care and mechanical ventilation. The included studies compared topical plus systemic antibiotics versus placebo or no treatment; topical antibiotics versus no treatment; and topical plus systemic antibiotics versus systemic antibiotics.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included a total of 41 trials involving 11,004 participants (five new studies were added in this update). The minimum duration of mechanical ventilation ranged from 2 (19 studies) to 6 days (one study). Thirteen studies reported the mean length of ICU stay, ranging from 11 to 33 days. The percentage of immunocompromised patients ranged from 0% (10 studies) to 22% (1 study).\nThe reporting quality of the majority of included studies was very poor, so we judged more than 40% of the studies as at unclear risk of selection bias. We judged all studies to be at low risk of performance bias, though 47.6% were open-label, because hospitals usually have standardised infection control programmes, and possible subjective decisions on who should be tested for the presence or absence of RTIs are unlikely in an ICU setting. Regarding detection bias, we judged all included studies as at low risk for the outcome mortality. For the outcome RTIs, we judged all double-blind studies as at low risk of detection bias. We judged five open-label studies as at high risk of detection bias, as the diagnosis of RTI was not based on microbiological exams; we judged the remaining open-label studies as at low risk of detection bias, as a standardised set of diagnostic criteria, including results of microbiological exams, were used.\nTopical plus systemic antibiotic prophylaxis reduces overall mortality compared with placebo or no treatment (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.73 to 0.96; 18 studies; 5290 participants; high-certainty evidence). Based on an illustrative risk of 303 deaths in 1000 people this equates to 48 (95% CI 15 to 79) fewer deaths with topical plus systemic antibiotic prophylaxis. Topical plus systemic antibiotic prophylaxis probably reduces RTIs (RR 0.43, 95% CI 0.35 to 0.53; 17 studies; 2951 participants; moderate-certainty evidence). Based on an illustrative risk of 417 RTIs in 1000 people this equates to 238 (95% CI 196 to 271) fewer RTIs with topical plus systemic antibiotic prophylaxis.\nTopical antibiotic prophylaxis probably reduces overall mortality compared with no topical antibiotic prophylaxis (RR 0.96, 95% CI 0.87 to 1.05; 22 studies, 4213 participants; moderate-certainty evidence). Based on an illustrative risk of 290 deaths in 1000 people this equates to 19 (95% CI 37 fewer to 15 more) fewer deaths with topical antibiotic prophylaxis. Topical antibiotic prophylaxis may reduce RTIs (RR 0.57, 95% CI 0.44 to 0.74; 19 studies, 2698 participants; low-certainty evidence). Based on an illustrative risk of 318 RTIs in 1000 people this equates to 137 (95% CI 83 to 178) fewer RTIs with topical antibiotic prophylaxis.\nSixteen studies reported adverse events and dropouts due to adverse events, which were poorly reported with sparse data. The certainty of the evidence ranged from low to very low.\nAuthors' conclusions\nTreatments based on topical prophylaxis probably reduce respiratory infections, but not mortality, in adult patients receiving mechanical ventilation for at least 48 hours, whereas a combination of topical and systemic prophylactic antibiotics reduces both overall mortality and RTIs. However, we cannot rule out that the systemic component of the combined treatment provides a relevant contribution in the observed reduction of mortality. No conclusion can be drawn about adverse events as they were poorly reported with sparse data.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We judged the certainty of the evidence as high to moderate for deaths and respiratory tract infections and low to very low for adverse events."
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query-laysum
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7165
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[
{
"role": "user",
"content": "Abstract: Background\nGlaucoma is a leading cause of irreversible blindness worldwide and the second most common cause of blindness after cataracts. The primary treatment for glaucoma aims to lower intraocular pressure (IOP) with the use of topical medicines. Topical medication instillation techniques, such as eyelid closure and nasolacrimal occlusion when instilling drops, have been proposed as potential methods to increase ocular absorption and decrease systemic absorption of the drops.\nObjectives\nTo investigate the effectiveness of topical medication instillation techniques compared with usual care or another method of instillation of topical medication in the management of glaucoma or ocular hypertension.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 12), MEDLINE Ovid (1946 to 8 December 2016), Embase Ovid (1947 to 8 December 2016), PubMed (1948 to 8 December 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 8 December 2016), International Pharmaceutical Abstracts Database (1970 to 8 December 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 13 May 2013), ClinicalTrials.gov (www.clinicaltrials.gov) (searched 8 December 2016) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) (searched 8 December 2016). We did not use any date or language restrictions in the electronic searches for trials.\nSelection criteria\nWe included randomized controlled trials which had compared any topical medication instillation technique with usual care or a different method of instillation of topical medication.\nData collection and analysis\nTwo review authors independently screened records from the searches for eligibility, assessed the risk of bias, and extracted data. We followed methods recommended by Cochrane.\nMain results\nWe identified two trials (122 eyes of 61 participants) that had evaluated a topical medication instillation technique. We also identified two ongoing trials. Both included trials used a within-person design and administered prostaglandin monotherapy for glaucoma or ocular hypertension. Because the trials evaluated different instillation techniques and assessed different outcomes, we performed no meta-analysis.\nOne trial, conducted in the US, evaluated the effect of eyelid closure (one and three minutes) versus no eyelid closure on lowering IOP. At one to two weeks' follow-up, reduction in IOP was similar in the eyelid closure group and the no eyelid closure group (mean difference (MD) -0.33 mmHg, 95% confidence interval (CI) -0.8 to 1.5; 51 participants; moderate-certainty evidence).\nThe second trial, conducted in Italy, evaluated the effect of using an absorbent cloth to wipe excess fluid after instillation (fluid removal) versus not using an absorbent cloth (no removal) on reducing dermatologic adverse events. At four months' follow-up, eyelashes were shorter among eyes in the fluid removal group compared with the no fluid removal group (MD -1.70 mm, 95% CI -3.46 to 0.06; 10 participants; low-certainty evidence). Fewer eyes showed skin hyperpigmentation in the eyelid region towards the nose in the fluid removal group compared with the no removal group (RR 0.07, 95% CI 0.01 to 0.84; 10 participants; low-certainty evidence); however, the difference was uncertain in the eyelid region towards the temples (RR 0.44, 95% CI 0.07 to 2.66; 10 participants; low-certainty evidence). The effect hypertrichosis (excessive hair growth) was uncertain between groups (RR 1.00, 95% CI 0.17 to 5.98; 10 participants; low-certainty evidence).\nNeither trial reported other outcomes specified for this review, including the proportion of participants with IOP less than 21 mmHg; participant-reported outcomes related to the ease, convenience, and comfort of instillation techniques; physiologic measurements of systemic absorption; escalation of therapy; mean change in visual fields; optic nerve progression; mean change in best-corrected visual acuity; proportion in whom glaucoma developed; quality of life outcomes; or cost-effectiveness outcomes. Neither trial reported data at follow-up times of more than four months.\nAuthors' conclusions\nEvidence to evaluate the effectiveness of topical medication instillation techniques for treatment of glaucoma is lacking. It is unclear what, if any, effects instillation techniques have on topical medical therapy for glaucoma.\n\nGiven the provided abstract, please respond to the following query: \"What did this review study?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Glaucoma is a leading cause of blindness worldwide. In eyes with glaucoma, the ability to see may be lost because of damage to the optic nerve. The optic nerve is the part of the eye that sends visual information from the eye to the brain. Sometimes such damage occurs when there is too much pressure in the eye (called intraocular pressure or IOP). Sometimes eyes may have too much pressure without damage to the optic nerve (called ocular hypertension). The main goal of glaucoma and ocular hypertension treatment is to lower IOP. Topical medicines, such as eye drops, are most often used as the first treatment. Encouraging specific ways of applying the drops, such as closing your eyes or nasolacrimal occlusion (closing the eye and pressing a finger on the inside corner, by the nose) aims to increase how much medicine is absorbed into the eye and reduce how much medicine is absorbed into the body."
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query-laysum
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7166
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[
{
"role": "user",
"content": "Abstract: Background\nWork-related upper limb and neck musculoskeletal disorders (MSDs) are one of the most common occupational disorders worldwide. Studies have shown that the percentage of office workers that suffer from MSDs ranges from 20 to 60 per cent. The direct and indirect costs of work-related upper limb MSDs have been reported to be high in Europe, Australia, and the United States. Although ergonomic interventions are likely to reduce the risk of office workers developing work-related upper limb and neck MSDs, the evidence is unclear. This is an update of a Cochrane Review which was last published in 2012.\nObjectives\nTo assess the effects of physical, cognitive and organisational ergonomic interventions, or combinations of those interventions for the prevention of work-related upper limb and neck MSDs among office workers.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, Web of Science (Science Citation Index), SPORTDiscus, Embase, the US Centers for Disease Control and Prevention, the National Institute for Occupational Safety and Health database, and the World Health Organization's International Clinical Trials Registry Platform, to 10 October 2018.\nSelection criteria\nWe included randomised controlled trials (RCTs) of ergonomic interventions for preventing work-related upper limb or neck MSDs (or both) among office workers. We only included studies where the baseline prevalence of MSDs of the upper limb or neck, or both, was less than 25%.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias. We included studies with relevant data that we judged to be sufficiently homogeneous regarding the interventions and outcomes in the meta-analysis. We assessed the overall quality of the evidence for each comparison using the GRADE approach.\nMain results\nWe included 15 RCTs (2165 workers). We judged one study to have a low risk of bias and the remaining 14 studies to have a high risk of bias due to small numbers of participants and the potential for selection bias.\nPhysical ergonomic interventions\nThere is inconsistent evidence for arm supports and alternative computer mouse designs. There is moderate-quality evidence that an arm support with an alternative computer mouse (two studies) reduced the incidence of neck or shoulder MSDs (risk ratio (RR) 0.52; 95% confidence interval (CI) 0.27 to 0.99), but not the incidence of right upper limb MSDs (RR 0.73; 95% CI 0.32 to 1.66); and low-quality evidence that this intervention reduced neck or shoulder discomfort (standardised mean difference (SMD) −0.41; 95% CI −0.69 to −0.12) and right upper limb discomfort (SMD −0.34; 95% CI −0.63 to −0.06).\nThere is moderate-quality evidence that the incidence of neck or shoulder and right upper limb disorders were not considerably reduced when comparing an alternative computer mouse and a conventional mouse (two studies; neck or shoulder: RR 0.62; 95% CI 0.19 to 2.00; right upper limb: RR 0.91; 95% CI 0.48 to 1.72), and also when comparing an arm support with a conventional mouse and a conventional mouse alone (two studies) (neck or shoulder: RR 0.91; 95% CI 0.12 to 6.98; right upper limb: RR 1.07; 95% CI 0.58 to 1.96).\nWorkstation adjustment (one study) and sit-stand desks (one study) did not have an effect on upper limb pain or discomfort, compared to no intervention.\nOrganisational ergonomic interventions\nThere is very low-quality evidence that supplementary breaks (two studies) reduce discomfort of the neck (MD −0.25; 95% CI −0.40 to −0.11), right shoulder or upper arm (MD −0.33; 95% CI −0.46 to −0.19), and right forearm or wrist or hand (MD -0.18; 95% CI -0.29 to -0.08) among data entry workers.\nTraining in ergonomic interventions\nThere is low to very low-quality evidence in five studies that participatory and active training interventions may or may not prevent work-related MSDs of the upper limb or neck or both.\nMultifaceted ergonomic interventions\nFor multifaceted interventions there is one study (very low-quality evidence) that showed no effect on any of the six upper limb pain outcomes measured in that study.\nAuthors' conclusions\nWe found inconsistent evidence that the use of an arm support or an alternative mouse may or may not reduce the incidence of neck or shoulder MSDs. For other physical ergonomic interventions there is no evidence of an effect. For organisational interventions, in the form of supplementary breaks, there is very low-quality evidence of an effect on upper limb discomfort. For training and multifaceted interventions there is no evidence of an effect on upper limb pain or discomfort. Further high-quality studies are needed to determine the effectiveness of these interventions among office workers.\n\nGiven the provided abstract, please respond to the following query: \"Mutlifaceted ergonomic interventions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is no effect on pain or discomfort compared to no intervention in one study.\nThis means that there remains a need to conduct further studies to assess the effectiveness of ergonomic interventions."
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query-laysum
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7167
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[
{
"role": "user",
"content": "Abstract: Background\nThe role of gefitinib for the treatment of advanced non-small cell lung cancer (NSCLC) is evolving. We undertook a systematic review to evaluate the available evidence from all randomised trials.\nObjectives\nTo determine the effectiveness and safety of gefitinib as first-line, second-line or maintenance treatment for advanced NSCLC.\nSearch methods\nWe performed searches in CENTRAL, MEDLINE and Embase from inception to 17 February 2017. We handsearched relevant conference proceedings, clinical trial registries and references lists of retrieved articles.\nSelection criteria\nWe included trials assessing gefitinib, alone or in combination with other treatment, compared to placebo or other treatments in the first- or successive-line treatment of patients with NSCLC, excluding compassionate use.\nData collection and analysis\nWe used the standard Cochrane methodology. Two authors independently assessed the search results to select those with sound methodological quality. We carried out all analyses on an intention-to-treat basis. We recorded the following outcome data: overall survival, progression-free survival, toxicity, tumour response and quality of life. We also collected data for the following subgroups: Asian ethnicity and positive epidermal growth factor receptor (EGFR) mutation.\nMain results\nWe included 35 eligible randomised controlled trials (RCTs), which examined 12,089 patients.\nGeneral population\nGefitinib did not statistically improve overall survival when compared with placebo or chemotherapy in either first- or second-line settings. Second-line gefitinib prolonged time to treatment failure (TTF) (hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.75 to 0.90, P < 0.0001) when compared with placebo. Maintenance gefitinib improved progression-free survival (HR 0.70, 95% CI 0.53 to 0.91, P = 0.007) after first-line therapy.\nStudies in patients of Asian ethnicity or that conducted subgroup analyses\nSecond-line gefitinib prolonged overall survival over placebo (HR 0.66, 95% CI 0.48 to 0.91, P = 0.01). In the first-line setting, progression-free survival was improved with gefitinib over chemotherapy alone (HR 0.65, 95% CI 0.43 to 0.98, P = 0.04, moderate quality of evidence). Gefitinib given in combination with a chemotherapy regimen improved progression-free survival versus either gefitinib alone or chemotherapy alone (HR 0.69, 95% CI 0.49 to 0.96, P = 0.03; HR 0.69, 95% CI 0.62 to 0.77, P < 0.00001, respectively). In the second-line setting, progression-free survival was superior in patients given gefitinib over placebo or chemotherapy (HR 0.69, 95% CI 0.52 to 0.91, P = 0.009; HR 0.71, 95% CI 0.57 to 0.88, P = 0.002; moderate quality of evidence, respectively). Combining gefitinib with chemotherapy in the second-line setting was superior to gefitinib alone (HR 0.65, 95% CI 0.43 to 0.97, P = 0.04). As maintenance therapy, gefitinib improved progression-free survival when compared with placebo (HR 0.42, 95% CI 0.33 to 0.54, P < 0.00001).\nPatients with EGFR mutation-positive tumours\nStudies in patients with EGFR mutation-positive tumours showed an improvement in progression-free survival in favour of gefitinib over first-line and second-line chemotherapy (HR 0.47, 95% CI 0.36 to 0.61, P < 0.00001; HR 0.24, 95% CI 0.12 to 0.47, P < 0.0001, respectively). Gefitinib as maintenance therapy following chemotherapy improved overall and progression-free survival (HR 0.39, 95% CI 0.15 to 0.98, P = 0.05; HR 0.17, 95% CI 0.07 to 0.41, P < 0.0001, respectively) in one phase III study when compared to placebo.\nToxicities from gefitinib included skin rash, diarrhoea and liver transaminase derangements. Toxicities from chemotherapy included anaemia, neutropenia and neurotoxicity.\nIn terms of quality of life, gefitinib improved Functional Assessment of Cancer Therapy-Lung (FACT-L) (standardised mean difference (SMD) 10.50, 95% CI 9.55 to 11.45, P < 0.000001), lung cancer subscale (SMD 3.63, 95% CI 3.08 to 4.19, P < 0.00001) and Trial Outcome Index (SMD 9.87, 95% CI 1.26 to 18.48, P < 0.00001) scores when compared with chemotherapy.\nAuthors' conclusions\nThis systematic review shows that gefitinib, when compared with standard first- or second-line chemotherapy or maintenance therapy, probably has a beneficial effect on progression-free survival and quality of life in selected patient populations, particularly those with tumours bearing sensitising EGFR mutations.\nPatients with EGFR mutations lived longer when given maintenance gefitinib than those given placebo.\nOne study conducted subgroup analysis and showed that gefitinib improved overall survival over placebo in the second-line setting in patients of Asian ethnicity. All other studies did not detect any benefit on overall survival. The data analysed in this review were very heterogenous. We were limited in the amount of data that could be pooled, largely due to variations in study design. The risk of bias in most studies was moderate, with some studies not adequately addressing potential selection, attrition and reporting bias. This heterogeneity may have an impact on the applicability of the results\nCombining gefitinib with chemotherapy appears to be superior in improving progression-free survival to either gefitinib or chemotherapy alone, however further data and phase III studies in these settings are required.\nGefitinib has a favourable toxicity profile when compared with current chemotherapy regimens. Although there is no improvement in overall survival, gefitinib compares favourably with cytotoxic chemotherapy in patients with EGFR mutations with a prolongation of progression-free survival and a lesser side effect profile.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "When comparing gefitinib as a first- and second-line treatment with chemotherapy, we downgraded the quality of the evidence to moderate for the outcomes overall survival and progression-free survival because the results were not precise and they may not be applicable to all patients due to the inclusion of a population only over 70 years of age. However, the quality of the evidence when we compared toxicities from gefitinib with chemotherapy was high."
}
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query-laysum
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7168
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[
{
"role": "user",
"content": "Abstract: Background\nPermissive hypoxaemia describes a concept in which a lower level of arterial oxygenation (PaO2) than usual is accepted to avoid the detrimental effects of high fractional inspired oxygen and invasive mechanical ventilation. Currently however, no specific threshold is known that defines permissive hypoxaemia, and its use in adults remains formally untested. The importance of this systematic review is thus to determine whether any substantial evidence is available to support the notion that permissive hypoxaemia may improve clinical outcomes in mechanically ventilated critically ill patients.\nObjectives\nWe assessed whether permissive hypoxaemia (accepting a lower PaO2 than is current practice) in mechanically ventilated critically ill patients affects patient morbidity and mortality. We planned to conduct subgroup and sensitivity analyses and to examine the role of bias to determine the level of evidence provided.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2013, Issue 11, part of The Cochrane Library; MEDLINE (1954 to November 2013); EMBASE (1980 to November 2013); CINAHL (1982 to November 2013) and ISI Web of Science (1946 to November 2013). We combined the sensitive search strategies described in the Cochrane Handbook for Systematic Reviews of Interventions to search for randomized controlled trials (RCTs) in MEDLINE and EMBASE. For ongoing trials, we also searched the following databases: MetaRegister of ControlledTrials and the National Research Register. We applied no language restrictions.\nSelection criteria\nRCTs and quasi-RCTs that compared outcomes for mechanically ventilated critically ill participants, in which the intervention group was targeted to be hypoxaemic relative to the control group, and the control group was normoxaemic or was mildly hypoxaemic, were eligible for inclusion in this review. Exact values defining 'conventional' and 'permissive hypoxaemia' groupings were purposely not specified, and the manner in which these oxygenation goals were achieved also was not specified. We did state however that the intervention group required a target oxygenation level lower than that of the control group, and that the control group target levels should be in the range of normoxaemia or mild hypoxaemia (not hyperoxaemia).\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration. Using the results of the above searches, two review authors (EG-K and KM) independently screened all titles and abstracts for eligibility and duplication. No discrepancies were encountered, nor was it necessary for review authors to contact the first author of any trial to ask for additional information.\nMain results\nOur search strategy yielded a total of 2419 results. After exclusion of duplications, 1651 candidate studies were identified. Screening of titles and abstracts revealed that no studies met our inclusion criteria.\nAuthors' conclusions\nThis comprehensive review failed to identify any relevant studies evaluating permissive hypoxaemia versus normoxaemia in mechanically ventilated critically ill participants. Therefore we are unable to support or refute the hypothesis that this treatment strategy is of benefit to patients.\nGiven the substantial amount of provocative evidence derived from related clinical contexts (resuscitation, myocardial infarction, stroke), we believe that this review highlights an important unanswered question within critical care. In the presence of two competing harms (hypoxia and hyperoxia), it will be important to carefully evaluate the safety and feasibility of permissive hypoxaemia before proceeding to efficacy and effectiveness trials.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "As no studies were included in our review, we cannot comment on the quality of evidence. Given the lack of evidence related to safety issues regarding allowing for low, as opposed to normal, levels of blood oxygen, we recommend caution with respect to changing current medical practice in this area. We do believe however that future research into this question is necessary."
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query-laysum
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7169
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[
{
"role": "user",
"content": "Abstract: Background\nThe incidence of hip fracture is increasing and it is more common with increasing age. Surgery is used for almost all hip fractures. Blood loss occurs as a consequence of both the fracture and the surgery and thus red blood cell transfusion is frequently used. However, red blood cell transfusion is not without risks. Therefore, it is important to identify the evidence for the effective and safe use of red blood cell transfusion in people with hip fracture.\nObjectives\nTo assess the effects (benefits and harms) of red blood cell transfusion in people undergoing surgery for hip fracture.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (31 October 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2014, Issue 10), MEDLINE (January 1946 to 20 November 2014), EMBASE (January 1974 to 20 November 2014), CINAHL (January 1982 to 20 November 2014), British Nursing Index Database (January 1992 to 20 November 2014), the Systematic Review Initiative's Transfusion Evidence Library, PubMed for e-publications, various other databases and ongoing trial registers.\nSelection criteria\nRandomised controlled trials comparing red blood cell transfusion versus no transfusion or an alternative to transfusion, different transfusion protocols or different transfusion thresholds in people undergoing surgery for hip fracture.\nData collection and analysis\nThree review authors independently assessed each study's risk of bias and extracted data using a study-specific form. We pooled data where there was homogeneity in the trial comparisons and the timing of outcome measurement. We used GRADE criteria to assess the quality (low, moderate or high) of the evidence for each outcome.\nMain results\nWe included six trials (2722 participants): all compared two thresholds for red blood cell transfusion: a 'liberal' strategy to maintain a haemoglobin concentration of usually 10 g/dL versus a more 'restrictive' strategy based on symptoms of anaemia or a lower haemoglobin concentration, usually 8 g/dL. The exact nature of the transfusion interventions, types of surgery and participants varied between trials. The mean age of participants ranged from 81 to 87 years and approximately 24% of participants were men. The largest trial enrolled 2016 participants, over 60% of whom had a history of cardiovascular disease. The percentage of participants receiving a red blood cell transfusion ranged from 74% to 100% in the liberal transfusion threshold group and from 11% to 45% in the restrictive transfusion threshold group. There were no results available for the smallest trial (18 participants). All studies were at some risk of bias, in particular performance bias relating to the absence of blinding of personnel. We judged the evidence for all outcomes, except myocardial infarction, was low quality reflecting risk of bias primarily from imbalances in protocol violations in the largest trial and imprecision, often because of insufficient events. Thus, further research is likely to have an important impact on these results.\nThere was no evidence of a difference between a liberal versus restricted threshold transfusion in mortality, at 30 days post hip fracture surgery (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.67 to 1.26; five trials; 2683 participants; low quality evidence) or at 60 days post surgery (RR 1.08, 95% CI 0.80 to 1.44; three trials; 2283 participants; low quality evidence). Assuming an illustrative baseline risk of 50 deaths per 1000 participants in the restricted threshold group at 30 days, these data equate to four fewer (95% CI 17 fewer to 14 more) deaths per 1000 in the liberal threshold group at 30 days.\nThere was no evidence of a difference between a liberal versus restricted threshold transfusion in functional recovery at 60 days, assessed in terms of the inability to walk 10 feet (3 m) without human assistance (RR 1.00, 95% CI 0.87 to 1.15; two trials; 2083 participants; low quality evidence).\nThere was low quality evidence of no difference between the transfusion thresholds in postoperative morbidity for the following complications: thromboembolism (RR 1.15 favouring a restrictive threshold, 95% CI 0.56 to 2.37; four trials; 2416 participants), stroke (RR 2.40 favouring a restrictive threshold, 95% CI 0.85 to 6.79; four trials; 2416 participants), wound infection (RR 1.61 favouring a restrictive threshold, 95% CI 0.77 to 3.35; three trials; 2332 participants), respiratory infection (pneumonia) (RR 1.35 favouring a restrictive threshold, 95% CI 0.95 to 1.92; four trials; 2416 participants) and new diagnosis of congestive heart failure (RR 0.77 favouring a liberal threshold, 95% CI 0.48 to 1.23; three trials; 2332 participants). There was very low quality evidence of a lower risk of myocardial infarction in the liberal compared with the restrictive transfusion threshold group (RR 0.59, 95% CI 0.36 to 0.96; three trials; 2217 participants). Assuming an illustrative baseline risk of myocardial infarction of 24 per 1000 participants in the restricted threshold group, this result was compatible with between one and 15 fewer myocardial infarctions in the liberal threshold group.\nAuthors' conclusions\nWe found low quality evidence of no difference in mortality, functional recovery or postoperative morbidity between 'liberal' versus 'restrictive' thresholds for red blood cell transfusion in people undergoing surgery for hip fracture. Although further research may change the estimates of effect, the currently available evidence does not support the use of liberal red blood cell transfusion thresholds based on a 10 g/dL haemoglobin trigger in preference to more restrictive transfusion thresholds based on lower haemoglobin levels or symptoms of anaemia in these people. Future research needs to address the effectiveness of red blood cell transfusions at different time points in the surgical pathway, whether pre-operative, peri-operative or postoperative. In particular, such research would need to consider people who are symptomatic or haemodynamically unstable who were excluded from most of these trials.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The current evidence does not support the use of liberal red blood cell transfusion thresholds based on a 10 g/dL haemoglobin trigger in preference to more restrictive transfusion thresholds based on lower haemoglobin levels or symptoms of anaemia in people with a broken hip. Further research needs to address the use of red blood cell transfusions before, during and after hip fracture surgery, and the use of red blood cell transfusions especially in people who have symptoms that reflect impaired blood flow and function."
}
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query-laysum
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7170
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[
{
"role": "user",
"content": "Abstract: Background\nEmbryo transfer (ET) is a crucial step of in vitro fertilisation (IVF) treatment, and involves placing the embryo(s) in the woman’s uterus. There is a negative association between endometrial wave-like activity (contractile activities) at the time of ET and clinical pregnancy, but no specific treatment is currently used in clinical practice to counteract their effects. Oxytocin is a hormone produced by the hypothalamus and released by the posterior pituitary. Its main role involves generating uterine contractions during and after childbirth. Atosiban is the best known oxytocin antagonist (and is also a vasopressin antagonist), and it is commonly used to delay premature labour by halting uterine contractions. Other oxytocin antagonists include barusiban, nolasiban, epelsiban, and retosiban. Administration of oxytocin antagonists around the time of ET has been proposed as a means to reduce uterine contractions that may interfere with embryo implantation. The intervention involves administering the medication before, during, or after the ET (or a combination).\nObjectives\nTo evaluate the effectiveness and safety of oxytocin antagonists around the time of ET in women undergoing assisted reproduction.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two trials registers in March 2021; and checked references and contacted study authors and experts in the field to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of the use of oxytocin antagonists for women undergoing ET, compared with the non-use of this intervention, the use of placebo, or the use of another similar drug.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Primary review outcomes were live birth and miscarriage; secondary outcomes were clinical pregnancy and other adverse events.\nMain results\nWe included nine studies (including one comprising three separate trials, 3733 women analysed in total) investigating the role of three different oxytocin antagonists administered intravenously (atosiban), subcutaneously (barusiban), or orally (nolasiban). We found very low- to high-certainty evidence: the main limitations were serious risk of bias due to poor reporting of study methods, and serious or very serious imprecision.\nIntravenous atosiban versus normal saline or no intervention\nWe are uncertain of the effect of intravenous atosiban on live birth rate (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.88 to 1.24; 1 RCT, N = 800; low-certainty evidence). In a clinic with a live birth rate of 38% per cycle, the use of intravenous atosiban would be associated with a live birth rate ranging from 33.4% to 47.1%.\nWe are uncertain whether intravenous atosiban influences miscarriage rate (RR 1.08, 95% CI 0.75 to 1.56; 5 RCTs, N = 1424; I² = 0%; very low-certainty evidence). In a clinic with a miscarriage rate of 7.2% per cycle, the use of intravenous atosiban would be associated with a miscarriage rate ranging from 5.4% to 11.2%.\nIntravenous atosiban may increase clinical pregnancy rate (RR 1.50, 95% CI 1.18 to 1.89; 7 RCTs, N = 1646; I² = 69%; low-certainty evidence), and we are uncertain whether multiple or ectopic pregnancy and other complication rates were influenced by the use of intravenous atosiban (very low-certainty evidence).\nSubcutaneous barusiban versus placebo\nOne study investigated barusiban, but did not report on live birth or miscarriage.\nWe are uncertain whether subcutaneous barusiban influences clinical pregnancy rate (RR 0.96, 95% CI 0.69 to 1.35; 1 RCT, N = 255; very low-certainty evidence). Trialists reported more mild to moderate injection site reactions with barusiban than with placebo, but there was no difference in severe reactions. They reported no serious drug reactions; and comparable neonatal outcome between groups.\nOral nolasiban versus placebo\nNolasiban does not increase live birth rate (RR 1.13, 95% CI 0.99 to 1.28; 3 RCTs, N = 1832; I² = 0%; high-certainty evidence). In a clinic with a live birth rate of 33% per cycle, the use of oral nolasiban would be associated with a live birth rate ranging from 32.7% to 42.2%.\nWe are uncertain of the effect of oral nolasiban on miscarriage rate (RR 1.45, 95% CI 0.73 to 2.88; 3 RCTs, N = 1832; I² = 0%; low-certainty evidence). In a clinic with a miscarriage rate of 1.5% per cycle, the use of oral nolasiban would be associated with a miscarriage rate ranging from 1.1% to 4.3%.\nOral nolasiban improves clinical pregnancy rate (RR 1.15, 95% CI 1.02 to 1.30; 3 RCTs, N = 1832; I² = 0%; high-certainty evidence), and probably does not increase multiple or ectopic pregnancy, or other complication rates (moderate-certainty evidence).\nAuthors' conclusions\nWe are uncertain whether intravenous atosiban improves pregnancy outcomes for women undergoing assisted reproductive technology. This conclusion is based on currently available data from seven RCTs, which provided very low- to low-certainty evidence across studies.\nWe could draw no clear conclusions about subcutaneous barusiban, based on limited data from one RCT.\nFurther large well-designed RCTs reporting on live births and adverse clinical outcomes are still required to clarify the exact role of atosiban and barusiban before ET.\nOral nolasiban appears to improve clinical pregnancy rate but not live birth rate, with an uncertain effect on miscarriage and adverse events. This conclusion is based on a phased study comprising three trials that provided low- to high-certainty evidence. Further large, well-designed RCTs, reporting on live births and adverse clinical outcomes, should focus on identifying the subgroups of women who are likely to benefit from this intervention.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence was of very low to high certainty. The main limitations in the evidence were poor reporting of study methods, and lack of exactness due to small study numbers and few events."
}
] |
query-laysum
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7171
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[
{
"role": "user",
"content": "Abstract: Background\nHumidified high flow nasal cannula (HHFNC) delivers humidified gas at increased flow rates via binasal prongs and is becoming widely accepted as a method of non-invasive respiratory support for preterm infants. While indications for the use of (HHFNC) and its associated risks and benefits are being investigated, the best strategy for the discontinuation of HHFNC remains unknown. At what point an infant is considered stable enough to attempt to start withdrawing their HHFNC is not known. The criteria for a failed attempt at HHFNC discontinuation is also unclear.\nObjectives\nTo determine the risks and benefits of different strategies used for the discontinuation of HHFNC in preterm infants.\nSearch methods\nWe searched the Cochrane Neonatal Review Group Specialized Register, PubMed (1966 to March 2015), CINAHL (1982 to March 2015), EMBASE (1980 to March 2015), and the Cochrane Central Register of Controlled Trials (CENTRAL). Also, we checked previous reviews, including cross references. We searched for following web sites for ongoing trials: ClinicalTrials.gov and controlled-trials.com.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in which either individual newborn infants or clusters of infants (such as separate neonatal units) were randomised to different HHFNC withdrawal strategies (from the first time they come off HHFNC and any subsequent weaning, or withdrawal attempt, or both).\nData collection and analysis\nWe used standard methods of Cochrane and the Cochrane Neonatal Review Group.\nMain results\nWe identified no eligible studies examining the best strategy to wean or withdraw HHFNC once started as respiratory support in preterm infants\nAuthors' conclusions\nThere is currently no evidence available to suggest the best strategy for weaning and withdrawing HHFNC as a respiratory support in preterm infants. Research is required into the best strategy for withdrawal of HHFNC and to which subgroups this applies. Clear criteria for the definition of stability prior to attempting to withdraw HHFNC needs to be established. Furthermore, clear definitions are needed as to what constitutes failure of HHFNC.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Humidified high flow nasal cannula (HHFNC) is a form of respiratory support used in the treatment of preterm infants. Potential risks of HHFNC include damage to the nose and leaking of air from the lungs. Infants on HHFNC require more nursing care and the use of extra equipment (when compared to not being on any support). However, potential complications of removing HHFNC from babies too early include increased episodes of forgetting to breathe, increased oxygen needs, increased effort of breathing, the need to restart HHFNC, and the need for a breathing tube with mechanical ventilation. Any of these complications can be seen as a \"failure\" and are potentially distressing to staff and family. The best way to withdraw HHFNC once it has been started is unknown. Options include simply stopping, weaning the flow, increasing the time off HHFNC each day, or combinations of both."
}
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query-laysum
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7172
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[
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"role": "user",
"content": "Abstract: Background\nTo successfully initiate and maintain breastfeeding for a longer duration, the World Health Organization's Ten Steps to Successful Breastfeeding recommends total avoidance of artificial teats or pacifiers for breastfeeding infants. Concerns have been raised that offering the pacifier instead of the breast to calm the infant may lead to less frequent episodes of breastfeeding and as a consequence may reduce breast-milk production and shorten duration of breastfeeding.\nObjectives\nTo assess the effect of restricted versus unrestricted pacifier use in healthy full-term newborns whose mothers have initiated breastfeeding and intend to exclusively breastfeed, on the duration of breastfeeding, other breastfeeding outcomes and infant health.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised and quasi-randomised controlled trials comparing restricted versus unrestricted pacifier use in healthy full-term newborns who have initiated breastfeeding.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. The quality of the evidence was assessed using the GRADE approach.\nMain results\nWe found three trials (involving 1915 babies) for inclusion in the review, but have included only two trials (involving 1302 healthy full-term breastfeeding infants) in the analysis. Meta-analysis of the two combined studies showed that pacifier use in healthy breastfeeding infants had no significant effect on the proportion of infants exclusively breastfed at three months (risk ratio (RR) 1.01; 95% confidence interval (CI) 0.96 to 1.07, two studies, 1228 infants), and at four months of age (RR 1.01; 95% CI 0.94 to 1.09, one study, 970 infants, moderate-quality evidence), and also had no effect on the proportion of infants partially breastfed at three months (RR 1.00; 95% CI 0.98 to 1.02, two studies, 1228 infants), and at four months of age (RR 0.99; 95% CI 0.97 to 1.02, one study, 970 infants). None of the included trials reported data on the other primary outcomes, i.e. duration of partial or exclusive breastfeeding, or secondary outcomes: breastfeeding difficulties (mastitis, cracked nipples, breast engorgement); infant's health (dental malocclusion, otitis media, oral candidiasis; sudden infant death syndrome (SIDS)); maternal satisfaction and level of confidence in parenting. One study reported that avoidance of pacifiers had no effect on cry/fuss behavior at ages four, six, or nine weeks and also reported no effect on the risk of weaning before age three months, however the data were incomplete and so could not be included for analysis.\nAuthors' conclusions\nPacifier use in healthy term breastfeeding infants, started from birth or after lactation is established, did not significantly affect the prevalence or duration of exclusive and partial breastfeeding up to four months of age. Evidence to assess the short-term breastfeeding difficulties faced by mothers and long-term effect of pacifiers on infants' health is lacking.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In motivated mothers, there is moderate-quality evidence that pacifier use in healthy term breastfeeding infants before and after lactation is established does not reduce the duration of breastfeeding up to four months of age. However, there is insufficient information on the potential harms of pacifiers on infants and mothers. Until further information becomes available on the effects of pacifiers on the infant, mothers who are well-motivated to breastfeed should be encouraged to make a decision on the use of a pacifier based on personal preference."
}
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query-laysum
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7173
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[
{
"role": "user",
"content": "Abstract: Background\nClonidine is a presynaptic alpha-2-adrenergic receptor agonist that has been used for many years to treat hypertension and other conditions, including chronic pain. Adverse events associated with systemic use of the drug have limited its application. Topical use of drugs has been gaining interest since the beginning of the century, as it may limit adverse events without loss of analgesic efficacy. Topical clonidine (TC) formulations have been investigated for almost 20 years in clinical trials. This is an update of the original Cochrane Review published in Issue 8, 2015.\nObjectives\nThe objective of this review was to assess the analgesic efficacy and safety of TC compared with placebo or other drugs in adults aged 18 years or above with chronic neuropathic pain.\nSearch methods\nFor this update we searched the Cochrane Register of Studies Online (CRSO), MEDLINE (Ovid), and Embase (Ovid) databases, and reference lists of retrieved papers and trial registries. We also contacted experts in the field. The most recent search was performed on 27 October 2021.\nSelection criteria\nWe included randomised, double-blind studies of at least two weeks' duration comparing TC versus placebo or other active treatment in adults with chronic neuropathic pain.\nData collection and analysis\nTwo review authors independently screened references for eligibility, extracted data, and assessed risk of bias. Any discrepancies were resolved by discussion or by consulting a third review author if necessary. Where required, we contacted trial authors to request additional information.\nWe presented pooled estimates for dichotomous outcomes as risk ratios (RRs) with 95% confidence intervals (CIs), and continuous outcomes as mean differences (MDs) with P values. We used Review Manager Web software to perform the meta-analyses. We used a fixed-effect model if we considered heterogeneity as not important; otherwise, we used a random-effects model.\nThe review primary outcomes were: participant-reported pain relief of 50% or greater; participant-reported pain relief of 30% or greater; much or very much improved on Patient Global Impression of Change scale (PGIC); and very much improved on PGIC. Secondary outcomes included withdrawals due to adverse events; participants experiencing at least one adverse event; and withdrawals due to lack of efficacy. All outcomes were measured at the longest follow-up period.\nWe assessed the certainty of evidence using GRADE and created two summary of findings tables.\nMain results\nWe included four studies in the review (two new in this update), with a total of 743 participants with painful diabetic neuropathy (PDN). TC (0.1% or 0.2%) was applied in gel form to the painful area two to three times daily. The double-blind treatment phase of three studies lasted 8 weeks to 85 days and compared TC versus placebo. In the fourth study, the double-blind treatment phase lasted 12 weeks and compared TC versus topical capsaicin. We assessed the studies as at unclear or high risk of bias for most domains; all studies were at unclear risk of bias for allocation concealment and blinding of outcome assessment; one study was at high risk of bias for blinding of participants and personnel; two studies were at high risk of attrition bias; and three studies were at high risk of bias due to notable funding concerns. We judged the certainty of evidence (GRADE) to be moderate to very low, downgrading for study limitations, imprecision of results, and publication bias.\nTC compared to placebo\nThere was no evidence of a difference in number of participants with participant-reported pain relief of 50% or greater during longest follow-up period (12 weeks) between groups (risk ratio (RR) 1.21, 95% confidence interval (CI) 0.78 to 1.86; 179 participants; 1 study; low certainty evidence). However, the number of participants with participant-reported pain relief of 30% or greater during longest follow-up period (8 to 12 weeks) was higher in the TC group compared with placebo (RR 1.35, 95% CI 1.03 to 1.77; 344 participants; 2 studies, very low certainty evidence). The number needed to treat for an additional beneficial outcome (NNTB) for this comparison was 8.33 (95% CI 4.3 to 50.0). Also, there was no evidence of a difference between groups for the outcomes much or very much improved on the PGIC during longest follow-up period (12 weeks) or very much improved on PGIC during the longest follow-up period (12 weeks) (RR 1.06, 95% CI 0.76 to 1.49 and RR 1.82, 95% CI 0.89 to 3.72, respectively; 179 participants; 1 study; low certainty evidence). We observed no evidence of a difference between groups in withdrawals due to adverse events and withdrawals due to lack of efficacy during the longest follow-up period (12 weeks) (RR 0.34, 95% CI 0.04 to 3.18 and RR 1.01, 95% CI 0.06 to 15.92, respectively; 179 participants; 1 study; low certainty evidence) and participants experiencing at least one adverse event during longest follow-up period (12 weeks) (RR 0.65, 95% CI 0.14 to 3.05; 344 participants; 2 studies; low certainty evidence).\nTC compared to active comparator\nThere was no evidence of a difference in the number of participants with participant-reported pain relief of 50% or greater during longest follow-up period (12 weeks) between groups (RR 1.41, 95% CI 0.99 to 2.0; 139 participants; 1 study; low certainty evidence). Other outcomes were not reported.\nAuthors' conclusions\nThis is an update of a review published in 2015, for which our conclusions remain unchanged. Topical clonidine may provide some benefit to adults with painful diabetic neuropathy; however, the evidence is very uncertain. Additional trials are needed to assess TC in other neuropathic pain conditions and to determine whether it is possible to predict who or which groups of people will benefit from TC.\n\nGiven the provided abstract, please respond to the following query: \"Key message\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found no high certainty evidence to support the use of clonidine applied to the skin for painful diabetic neuropathy. We found no evidence for other chronic pain conditions."
}
] |
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