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query-laysum
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8387
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[
{
"role": "user",
"content": "Abstract: Background\nFibromyalgia is a clinically defined chronic condition of unknown etiology characterised by chronic widespread pain, sleep disturbance, cognitive dysfunction, and fatigue. Many patients report high disability levels and poor quality of life. Drug therapy aims to reduce key symptoms, especially pain, and improve quality of life. The tetracyclic antidepressant, mirtazapine, may help by increasing serotonin and noradrenaline in the central nervous system (CNS).\nObjectives\nTo assess the efficacy, tolerability and safety of the tetracyclic antidepressant, mirtazapine, compared with placebo or other active drug(s) in the treatment of fibromyalgia in adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, SCOPUS, the US National Institutes of Health, and the World Health Organization (WHO) International Clinical Trials Registry Platform for published and ongoing trials, and examined reference lists of reviewed articles, to 9 July 2018.\nSelection criteria\nRandomised controlled trials (RCTs) of any formulation of mirtazapine against placebo, or any other active treatment of fibromyalgia, in adults.\nData collection and analysis\nTwo review authors independently extracted study characteristics, outcomes of efficacy, tolerability and safety, examined issues of study quality, and assessed risk of bias, resolving discrepancies by discussion. Primary outcomes were participant-reported pain relief (at least 50% or 30% pain reduction), Patient Global Impression of Change (PGIC; much or very much improved), safety (serious adverse events), and tolerability (adverse event withdrawal). Other outcomes were health-related quality of life (HRQoL) improved by 20% or more, fatigue, sleep problems, mean pain intensity, negative mood and particular adverse events. We used a random-effects model to calculate risk difference (RD), standardised mean difference (SMD), and numbers needed to treat. We assessed the evidence using GRADE and created a 'Summary of findings' table.\nMain results\nThree studies with 606 participants compared mirtazapine with placebo (but not other drugs) over seven to 13 weeks. Two studies were at unclear or high risk of bias in six or seven of eight domains. We judged the evidence for all outcomes to be low- or very low-quality because of poor study quality, indirectness, imprecision, risk of publication bias, and sometimes low numbers of events.\nThere was no difference between mirtazapine and placebo for any primary outcome: participant-reported pain relief of 50% or greater (22% versus 16%; RD 0.05, 95% confidence interval (CI) -0.01 to 0.12; three studies with 591 participants; low-quality evidence); no data available for PGIC; only a single serious adverse event for evaluation of safety (RD -0.00, 95% CI -0.01 to 0.02; three studies with 606 participants; very low-quality evidence); and tolerability as frequency of dropouts due to adverse events (3% versus 2%; RD 0.00, 95% CI -0.02 to 0.03; three studies with 606 participants; low-quality evidence).\nMirtazapine showed a clinically-relevant benefit compared to placebo for some secondary outcomes: participant-reported pain relief of 30% or greater (47% versus 34%; RD 0.13, 95% CI 0.05 to 0.21; number needed to treat for an additional beneficial outcome (NNTB) 8, 95% CI 5 to 20; three studies with 591 participants; low-quality evidence); participant-reported mean pain intensity (SMD -0.29, 95% CI -0.46 to -0.13; three studies with 591 participants; low-quality evidence); and participant-reported sleep problems (SMD -0.23, 95% CI -0.39 to -0.06; three studies with 573 participants; low-quality evidence). There was no benefit for improvement of participant-reported improvement of HRQoL of 20% or greater (58% versus 50%; RD 0.08, 95% CI -0.01 to 0.16; three studies with 586 participants; low-quality evidence); participant-reported fatigue (SMD -0.02, 95% CI -0.19 to 0.16; two studies with 533 participants; low-quality evidence); participant-reported negative mood (SMD -0.67, 95% CI -1.44 to 0.10; three studies with 588 participants; low-quality evidence); or withdrawals due to lack of efficacy (1.5% versus 0.1%; RD 0.01, 95% CI -0.01 to 0.02; three studies with 605 participants; very low-quality evidence).\nThere was no difference between mirtazapine and placebo for participants reporting any adverse event (76% versus 59%; RD 0.12, 95 CI -0.01 to 0.26; three studies with 606 participants; low-quality evidence). There was a clinically-relevant harm with mirtazapine compared to placebo: in the number of participants with somnolence (42% versus 14%; RD 0.24, 95% CI 0.18 to 0.30; number needed to treat for an additional harmful outcome (NNTH) 5, 95% CI 3 to 6; three studies with 606 participants; low-quality evidence); weight gain (19% versus 1%; RD 0.17, 95% CI 0.11 to 0.23; NNTH 6, 95% CI 5 to 10; three studies with 606 participants; low-quality evidence); and elevated alanine aminotransferase (13% versus 2%; RD 0.13, 95% CI 0.04 to 0.22; NNTH 8, 95% CI 5 to 25; two studies with 566 participants; low-quality evidence).\nAuthors' conclusions\nStudies demonstrated no benefit of mirtazapine over placebo for pain relief of 50% or greater, PGIC, improvement of HRQoL of 20% or greater, or reduction of fatigue or negative mood. Clinically-relevant benefits were shown for pain relief of 30% or greater, reduction of mean pain intensity, and sleep problems. Somnolence, weight gain, and elevated alanine aminotransferase were more frequent with mirtazapine than placebo. The quality of evidence was low or very low, with two of three studies of questionable quality and issues over indirectness and risk of publication bias. On balance, any potential benefits of mirtazapine in fibromyalgia were outweighed by its potential harms, though, a small minority of people with fibromyalgia might experience substantial symptom relief without clinically-relevant adverse events.\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": "Two of the studies were of poor quality. We rated the quality of the evidence using four levels: very low, low, moderate, or high. Very low-quality evidence means that we are very uncertain about the results. High quality evidence means that we are very confident in the results. We judged that the evidence was mostly of low-quality, which means that while the research provides some indication of the likely effect, the true effect may be substantially different. The main issues were poor study quality, decisions about the types of people included in the studies, risk of important information not being published, and sometimes low numbers of events."
}
] |
query-laysum
|
8389
|
[
{
"role": "user",
"content": "Abstract: Background\nOxygen (O2) is widely used in people with acute myocardial infarction (AMI). Previous systematic reviews concluded that there was insufficient evidence to know whether oxygen reduced, increased or had no effect on heart ischaemia or infarct size. Our first Cochrane review in 2010 also concluded there was insufficient evidence to know whether oxygen should be used. Since 2010, the lack of evidence to support this widely used intervention has attracted considerable attention, prompting further trials of oxygen therapy in myocardial infarction patients. It is thus important to update this Cochrane review.\nObjectives\nTo assess the effects of routine use of inhaled oxygen for acute myocardial infarction (AMI).\nSearch methods\nWe searched the following bibliographic databases on 6 June 2015: the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE (OVID), Embase (OVID), CINAHL (EBSCO) and Web of Science (Thomson Reuters). LILACS (Latin American and Caribbean Health Sciences Literature) was last searched in September 2016. We also contacted experts to identify eligible studies. We applied no language restrictions.\nSelection criteria\nRandomised controlled trials in people with suspected or proven AMI (ST-segment elevation myocardial infarction (STEMI) or non-STEMI) within 24 hours after onset, in which the intervention was inhaled oxygen (at normal pressure) compared to air, regardless of co-therapies provided to participants in both arms of the trial.\nData collection and analysis\nTwo authors independently reviewed the titles and abstracts of identified studies to see if they met the inclusion criteria and independently undertook the data extraction. We assessed the quality of studies and the risk of bias according to guidance in the Cochrane Handbook for Systematic Reviews of Interventions. The primary outcome was death. The measure of effect used was the risk ratio (RR) with a 95% confidence interval (CI). We used the GRADE approach to evaluate the quality of the evidence and the GRADE profiler (GRADEpro) to import data from Review Manager 5 and create 'Summary of findings' tables.\nMain results\nThe updated search yielded one new trial, for a total of five included studies involving 1173 participants, 32 of whom died. The pooled risk ratio (RR) of all-cause mortality in the intention-to-treat analysis was 0.99 (95% CI 0.50 to 1.95; 4 studies, N = 1123; I2 = 46%; quality of evidence: very low) and 1.02 (95% CI 0.52 to 1.98; 4 studies, N = 871; I2 = 49%; quality of evidence: very low) when only analysing participants with confirmed AMI. One trial measured pain directly, and two others measured it by opiate usage. The trial showed no effect, with a pooled RR of 0.97 for the use of opiates (95% CI 0.78 to 1.20; 2 studies, N = 250). The result on mortality and pain are inconclusive. There is no clear effect for oxygen on infarct size (the evidence is inconsistent and low quality).\nAuthors' conclusions\nThere is no evidence from randomised controlled trials to support the routine use of inhaled oxygen in people with AMI, and we cannot rule out a harmful effect. Given the uncertainty surrounding the effect of oxygen therapy on all-cause mortality and on other outcomes critical for clinical decision, well-conducted, high quality randomised controlled trials are urgently required to inform guidelines in order to give definitive recommendations about the routine use of oxygen in AMI.\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 looked for the evidence to support this longstanding practice by searching for randomised controlled trials that compared the outcomes for people given oxygen versus normal air to breathe. We were primarily interested in seeing whether there was a difference in the number of people who died, but we also looked at whether administering oxygen reduced pain or other adverse outcomes."
}
] |
query-laysum
|
8390
|
[
{
"role": "user",
"content": "Abstract: Background\nDisseminated intravascular coagulation (DIC) is an acquired syndrome characterized by systemic intravascular activation of coagulation, leading to deposition of fibrin in the bloodstream. It may occur in patients with acute and chronic leukemia and is particularly associated with acute promyelocytic leukemia (a subtype of acute myeloid leukemia).\nObjectives\nTo assess the clinical benefits and harms of any pharmacological intervention for treating DIC in patients with acute or chronic leukemia.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2015, Issue 05), MEDLINE (1946 to 7 May 2015), LILACS (1982 to 7 May 2015) and African Index Medicus (7 May 2015). There was no language restrictions. We sought additional randomized controlled trials (RCTs) from the World Health Organization International Clinical Trials Registry Platform and the reference lists of primary studies identified.\nSelection criteria\nRCTs assessing the clinical benefits and harms of interventions for treating DIC in patients with acute and chronic leukemia.\nData collection and analysis\nTwo review authors independently performed trial selection, 'Risk of bias' assessment and data extraction. Primary outcomes were overall mortality, in-hospital mortality from any cause (15-day and 30-day) and adverse events.\nMain results\nIn this Cochrane Review update we did not include any new RCT compared with the first review version. Accordingly, four RCTs (388 participants) met the inclusion criteria. These trials evaluated the human activated protein C, recombinant human soluble thrombomodulin, tranexamic acid and dermatan sulphate. Included trials reported data on mortality and bleeding. The studies were conducted in Japan, Italy and the Netherlands. We classified the included trials as: 1) including patients with or without leukemia which did not report data for the leukemia subgroup (366 participants); and 2) only including patients with leukemia (22 participants). Overall, the risk of bias of the included trials was high, since the trial authors did not provide a detailed description about trial design and execution.\nAccording to the GRADE recommendations, we judged the overall quality of the body of evidence for all prefixed outcomes as 'very low', due to methodological limitations and very small sample size.\nOne trial, including 10 participants with leukemia and comparing dermatan sulphate with heparin, reported no deaths during trial treatment.\nIn terms of bleeding data, we were unable to pool results from two studies that were only conducted with leukemia patients due to the inconsistency in the measurement and reporting of this outcome. One trial, including 12 participants with leukemia, found very low quality evidence that tranexamic acid can reduce the cumulative hemorrhagic score in participants compared with those assigned to placebo (P = 0.0015, very low quality evidence). On the contrary, there is no evidence that dermatan sulphate compared with placebo reduces new events of hemorrhagic diathesis (1/5 (20%) versus 2/5 (40%); RR 0.50; 95% CI 0.06 to 3.91; P = 0.51, very low quality evidence).\nNo thromboembolic complications were reported in either trial that included patients with leukemia only (very low quality evidence). The safety profile was inconclusive.\nThe included trials did not assess overall mortality, resolution of respiratory failure, renal failure or shock.\nAuthors' conclusions\nDue to a lack of new RCTs, our conclusions in this Cochrane Review update are the same as the previous review version. We included four RCTs which reported mortality and bleeding data. It is not possible to determine whether human activated protein C, recombinant human soluble thrombomodulin, tranexamic acid and dermatan sulphate are effective or harmful for patients presenting with DIC related to acute or chronic leukemia. The quality of the evidence was low to very low. Therefore, prescription of these interventions for treating DIC in patients with acute and chronic leukemia can neither be supported nor rejected, unless new evidence from a large high-quality trial alters this conclusion.\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 four trials that had a limited number of patients (388) and assessed four different interventions: human activated protein C, recombinant human soluble thrombomodulin, tranexamic acid and dermatan sulphate with heparin or placebo. Two trials included patients either with or without leukemia. The other two trials only included patients with leukemia. The studies were published between 1989 and 2007, and were conducted in Japan, Italy and the Netherlands. All trials have a high risk of bias."
}
] |
query-laysum
|
8391
|
[
{
"role": "user",
"content": "Abstract: Background\nFluid restriction is often recommended as part of the management of infants with early or established bronchopulmonary dysplasia (BPD).\nObjectives\nTo determine whether fluid restriction as part of the therapeutic intervention for early or established BPD improves clinical outcomes.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1) in the Cochrane Library (searched 16 February 2016), MEDLINE via PubMed (1966 to 16 February 2016), Embase (1980 to 16 February 2016), and CINAHL (1982 to 16 February 2016). We also searched clinical trials' databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nProspective randomised clinical trials comparing two distinct fluid administration volumes in preterm infants with early or established BPD.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal. For the included trial, we extracted data and assessed the risk of bias, and used GRADE methods to assess the quality of the evidence. The outcomes considered in this review are effects on mortality or requirement for oxygen at 36 weeks' postmenstrual age (primary outcome measure), the duration of supplemental oxygen therapy, proportion of infants discharged from hospital on oxygen, duration of assisted ventilation, duration of hospitalisation, weight gain, feeding tolerance, apnoea, necrotizing enterocolitis, renal dysfunction or nephrocalcinosis, lung mechanics, and use of diuretic therapy (secondary outcome measures).\nMain results\nOne trial was found, including 60 preterm infants at 28 days of age with persistent oxygen requirements. Infants were randomised to either 180 mL/kg/day of standard formula or 145 mL/kg/day of concentrated formula. This single study did not provide data regarding our primary outcome. No effects of the intervention were found on any of our secondary outcomes. The quality of the evidence from this study was graded low.\nAuthors' conclusions\nThere is no evidence to support the practice of fluid restriction in infants with early or established BPD.\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": "Our search identified only one study comparing two volumes of fluid intake in preterm infants with early signs of chronic lung disease. Unfortunately, this study did not report progression to established chronic lung disease. Hence, no infant could be included in this analysis.\nOther outcomes, including days that the baby needed extra oxygen, proportion of infants discharged from hospital on oxygen, days of assisted ventilation, duration of hospital stay, weight gain and serious apnoeas were not affected by the volume of fluid received (from the evidence graded as low quality). The evidence is current to February 2016."
}
] |
query-laysum
|
8392
|
[
{
"role": "user",
"content": "Abstract: Background\nThere have been enormous advances in the screening, diagnosis, intervention and overall prognosis of abdominal aortic aneurysms (AAAs) in the last decade, but despite these, ruptured AAAs (rAAAs) still cause around 3500 to 6000 deaths in England and Wales each year. Open repair remains standard treatment for rAAA in most centres but increasingly endovascular aneurysm repair (EVAR) is being adopted. This has a 30-day postoperative mortality of 40%. This has remained static despite surgical, anaesthetic and critical care advances.\nOne significant change to current practice for elective repairs of AAAs, as opposed to emergency repairs of rAAAs, has been the introduction of intravenous heparin. This provides a protective effect against cardiac and thrombotic disease in the postoperative period. This practice has not gained widespread acceptance for emergency repairs of rAAA even though a reduction in mortality and morbidity has been demonstrated in elective repairs.\nObjectives\nThe primary objective was to assess the effect of intravenous heparin on all-cause mortality in ruptured abdominal aortic aneurysm (rAAA) management in people undergoing an emergency repair.\nThe secondary objectives were to assess the effect of intravenous heparin in rAAA management on the incidence of general arterial disease, for example, cardiovascular, cerebral, pulmonary and renal pathologies, in people undergoing emergency repair.\nSearch methods\nThe Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (December 2015). In addition the CIS searched CENTRAL;2015, Issue 11). The CIS searched clinical trials registries for details of ongoing or unpublished studies.\nSelection criteria\nWe sought all published and unpublished randomised controlled trials (RCTs) and controlled clinical trials (CCTs) of intravenous heparin in rAAA repairs (including parallel designs).\nData collection and analysis\nTwo review authors independently assessed studies identified for potential inclusion in the review. We used standard methodological procedures in accordance with the Cochrane Handbook for Systematic Review of Interventions.\nMain results\nWe identified no RCTs or CCTs that satisfied the inclusion criteria.\nAuthors' conclusions\nWe identified no RCTs or CCTs of intravenous heparin in rAAA repairs (including parallel designs). Therefore, we were unable to assess the effect of intravenous heparin on all-cause mortality and incidence of general arterial disease, for example, cardiovascular, cerebral, pulmonary and renal pathologies in rAAA management in people undergoing an emergency repair. It is clear that an RCT is needed to address this question in rAAA management as there is no high quality evidence.\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": "An abdominal aortic aneurysm (AAA) is a swelling (aneurysm) of the aorta, the main blood vessel that leads away from the heart down through the abdomen to the rest of the body, and can develop in both men and women. A growing aneurysm can lead to rupture. The rupture of an AAA leads to massive blood loss and is frequently fatal.\nThere have been enormous advances in managing AAAs in the last decade but ruptured AAAs (rAAAs) still have an unchanged high death rate. Intravenous heparin provides a protective effect against heart and blood clot problems. This practice has not gained widespread acceptance for emergency repairs of rAAA even though a reduction in death and morbidity has been demonstrated in surgical repair that is scheduled in advance because it does not involve a medical emergency (elective repair)."
}
] |
query-laysum
|
8393
|
[
{
"role": "user",
"content": "Abstract: Background\nDisease-related malnutrition has been reported in 10% to 55% of people in hospital and the community and is associated with significant health and social-care costs. Dietary advice (DA) encouraging consumption of energy- and nutrient-rich foods rather than oral nutritional supplements (ONS) may be an initial treatment.\nObjectives\nTo examine evidence that DA with/without ONS in adults with disease-related malnutrition improves survival, weight, anthropometry and quality of life (QoL).\nSearch methods\nWe identified relevant publications from comprehensive electronic database searches and handsearching.\nLast search: 01 March 2021.\nSelection criteria\nRandomised controlled trials (RCTs) of DA with/without ONS in adults with disease-related malnutrition in any healthcare setting compared with no advice, ONS or DA alone.\nData collection and analysis\nTwo authors independently assessed study eligibility, risk of bias, extracted data and graded evidence.\nMain results\nWe included 94, mostly parallel, RCTs (102 comparisons; 10,284 adults) across many conditions possibly explaining the high heterogeneity. Participants were mostly older people in hospital, residential care and the community, with limited reporting on their sex. Studies lasted from one month to 6.5 years.\nDA versus no advice - 24 RCTs (3523 participants)\nMost outcomes had low-certainty evidence. There may be little or no effect on mortality after three months, RR 0.87 (95% confidence interval (CI) 0.26 to 2.96), or at later time points. We had no three-month data, but advice may make little or no difference to hospitalisations, or days in hospital after four to six months and up to 12 months. A similar effect was seen for complications at up to three months, MD 0.00 (95% CI -0.32 to 0.32) and between four and six months. Advice may improve weight after three months, MD 0.97 kg (95% CI 0.06 to 1.87) continuing at four to six months and up to 12 months; and may result in a greater gain in fat-free mass (FFM) after 12 months, but not earlier. It may also improve global QoL at up to three months, MD 3.30 (95% CI 1.47 to 5.13), but not later.\nDA versus ONS - 12 RCTs (852 participants)\nAll outcomes had low-certainty evidence. There may be little or no effect on mortality after three months, RR 0.66 (95% CI 0.34 to 1.26), or at later time points. Either intervention may make little or no difference to hospitalisations at three months, RR 0.36 (95% CI 0.04 to 3.24), but ONS may reduce hospitalisations up to six months. There was little or no difference between groups in weight change at three months, MD -0.14 kg (95% CI -2.01 to 1.74), or between four to six months. Advice (one study) may lead to better global QoL scores but only after 12 months. No study reported days in hospital, complications or FFM.\nDA versus DA plus ONS - 22 RCTs (1286 participants)\nMost outcomes had low-certainty evidence. There may be little or no effect on mortality after three months, RR 0.92 (95% CI 0.47 to 1.80) or at later time points. At three months advice may lead to fewer hospitalisations, RR 1.70 (95% CI 1.04 to 2.77), but not at up to six months. There may be little or no effect on length of hospital stay at up to three months, MD -1.07 (95% CI -4.10 to 1.97). At three months DA plus ONS may lead to fewer complications, RR 0.75 (95% CI o.56 to 0.99); greater weight gain, MD 1.15 kg (95% CI 0.42 to 1.87); and better global QoL scores, MD 0.33 (95% CI 0.09 to 0.57), but this was not seen at other time points. There was no effect on FFM at three months.\nDA plus ONS if required versus no advice or ONS - 31 RCTs (3308 participants)\nEvidence was moderate- to low-certainty. There may be little or no effect on mortality at three months, RR 0.82 (95% CI 0.58 to 1.16) or at later time points. Similarly, little or no effect on hospitalisations at three months, RR 0.83 (95% CI 0.59 to 1.15), at four to six months and up to 12 months; on days in hospital at three months, MD -0.12 (95% CI -2.48 to 2.25) or for complications at any time point. At three months, advice plus ONS probably improve weight, MD 1.25 kg (95% CI 0.73 to 1.76) and may improve FFM, 0.82 (95% CI 0.35 to 1.29), but these effects were not seen later. There may be little or no effect of either intervention on global QoL scores at three months, but advice plus ONS may improve scores at up to 12 months.\nDA plus ONS versus no advice or ONS - 13 RCTs (1315 participants)\nEvidence was low- to very low-certainty. There may be little or no effect on mortality after three months, RR 0.91 (95% CI 0.55 to 1.52) or at later time points. No study reported hospitalisations and there may be little or no effect on days in hospital after three months, MD -1.81 (95% CI -3.65 to 0.04) or six months. Advice plus ONS may lead to fewer complications up to three months, MD 0.42 (95% CI 0.20 to 0.89) (one study). Interventions may make little or no difference to weight at three months, MD 1.08 kg (95% CI -0.17 to 2.33); however, advice plus ONS may improve weight at four to six months and up to 12 months. Interventions may make little or no difference in FFM or global QoL scores at any time point.\nAuthors' conclusions\nWe found no evidence of an effect of any intervention on mortality. There may be weight gain with DA and with DA plus ONS in the short term, but the benefits of DA when compared with ONS are uncertain. The size and direction of effect and the length of intervention and follow-up required for benefits to emerge were inconsistent for all other outcomes. There were too few data for many outcomes to allow meaningful conclusions. Studies focusing on both patient-centred and healthcare outcomes are needed to address the questions in this review.\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": "Overall we rated the certainty of the evidence as low for most results, which means that we cannot be confident about the findings we report. There were several reasons for this. Some of the treatment comparisons that we looked at had only a few studies and some of those had small numbers of participants. There were problems with the design of some studies that may have affected the results. Some people knew which treatment they were receiving. We think this may influence the way that they reported some changes, e.g. their energy and protein intake, body weight and quality of life. We think that the way the decision about which group a person went into at the start of the study may have affected the results for some outcomes, e.g. change in weight, change in muscle bulk and mortality.\nWe needed to see particular results to help us understand whether adults living with disease-related malnutrition can improve their survival, weight and general quality of life if they receive advice about diet with or without ONS. None of the studies reported all of the results that we needed to do this. We were not able to estimate whether participants gain any benefits from the treatments, such as shortening the length of hospital stay, lowering the risk of readmission to hospital or developing complications. The low certainty of evidence, with no evidence in many areas, means we cannot make statements about any benefits and the possible disadvantages of these treatments despite the fact they are being used extensively in clinical practice. We recommend that future studies should be designed to measure these important patient-centred and healthcare outcomes as well as any potential harms."
}
] |
query-laysum
|
8394
|
[
{
"role": "user",
"content": "Abstract: Background\nOvereating and harmful alcohol and tobacco use have been linked to the aetiology of various non-communicable diseases, which are among the leading global causes of morbidity and premature mortality. As people are repeatedly exposed to varying sizes and shapes of food, alcohol and tobacco products in environments such as shops, restaurants, bars and homes, this has stimulated public health policy interest in product size and shape as potential targets for intervention.\nObjectives\n1) To assess the effects of interventions involving exposure to different sizes or sets of physical dimensions of a portion, package, individual unit or item of tableware on unregulated selection or consumption of food, alcohol or tobacco products in adults and children.\n2) To assess the extent to which these effects may be modified by study, intervention and participant characteristics.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, PsycINFO, eight other published or grey literature databases, trial registries and key websites up to November 2012, followed by citation searches and contacts with study authors. This original search identified eligible studies published up to July 2013, which are fully incorporated into the review. We conducted an updated search up to 30 January 2015 but further eligible studies are not yet fully incorporated due to their minimal potential to change the conclusions.\nSelection criteria\nRandomised controlled trials with between-subjects (parallel-group) or within-subjects (cross-over) designs, conducted in laboratory or field settings, in adults or children. Eligible studies compared at least two groups of participants, each exposed to a different size or shape of a portion of a food (including non-alcoholic beverages), alcohol or tobacco product, its package or individual unit size, or of an item of tableware used to consume it, and included a measure of unregulated selection or consumption of food, alcohol or tobacco.\nData collection and analysis\nWe applied standard Cochrane methods to select eligible studies for inclusion and to collect data and assess risk of bias. We calculated study-level effect sizes as standardised mean differences (SMDs) between comparison groups, measured as quantities selected or consumed. We combined these results using random-effects meta-analysis models to estimate summary effect sizes (SMDs with 95% confidence intervals (CIs)) for each outcome for size and shape comparisons. We rated the overall quality of evidence using the GRADE system. Finally, we used meta-regression analysis to investigate statistical associations between summary effect sizes and variant study, intervention or participant characteristics.\nMain results\nThe current version of this review includes 72 studies, published between 1978 and July 2013, assessed as being at overall unclear or high risk of bias with respect to selection and consumption outcomes. Ninety-six per cent of included studies (69/72) manipulated food products and 4% (3/72) manipulated cigarettes. No included studies manipulated alcohol products. Forty-nine per cent (35/72) manipulated portion size, 14% (10/72) package size and 21% (15/72) tableware size or shape. More studies investigated effects among adults (76% (55/72)) than children and all studies were conducted in high-income countries - predominantly in the USA (81% (58/72)). Sources of funding were reported for the majority of studies, with no evidence of funding by agencies with possible commercial interests in their results.\nA meta-analysis of 86 independent comparisons from 58 studies (6603 participants) found a small to moderate effect of portion, package, individual unit or tableware size on consumption of food (SMD 0.38, 95% CI 0.29 to 0.46), providing moderate quality evidence that exposure to larger sizes increased quantities of food consumed among children (SMD 0.21, 95% CI 0.10 to 0.31) and adults (SMD 0.46, 95% CI 0.40 to 0.52). The size of this effect suggests that, if sustained reductions in exposure to larger-sized food portions, packages and tableware could be achieved across the whole diet, this could reduce average daily energy consumed from food by between 144 and 228 kcal (8.5% to 13.5% from a baseline of 1689 kcal) among UK children and adults. A meta-analysis of six independent comparisons from three studies (108 participants) found low quality evidence for no difference in the effect of cigarette length on consumption (SMD 0.25, 95% CI -0.14 to 0.65).\nOne included study (50 participants) estimated a large effect on consumption of exposure to differently shaped tableware (SMD 1.17, 95% CI 0.57 to 1.78), rated as very low quality evidence that exposure to shorter, wider bottles (versus taller, narrower bottles) increased quantities of water consumed by young adult participants.\nA meta-analysis of 13 independent comparisons from 10 studies (1164 participants) found a small to moderate effect of portion or tableware size on selection of food (SMD 0.42, 95% CI 0.24 to 0.59), rated as moderate quality evidence that exposure to larger sizes increased the quantities of food people selected for subsequent consumption. This effect was present among adults (SMD 0.55, 95% CI 0.35 to 0.75) but not children (SMD 0.14, 95% CI -0.06 to 0.34).\nIn addition, a meta-analysis of three independent comparisons from three studies (232 participants) found a very large effect of exposure to differently shaped tableware on selection of non-alcoholic beverages (SMD 1.47, 95% CI 0.52 to 2.43), rated as low quality evidence that exposure to shorter, wider (versus taller, narrower) glasses or bottles increased the quantities selected for subsequent consumption among adults (SMD 2.31, 95% CI 1.79 to 2.83) and children (SMD 1.03, 95% CI 0.41 to 1.65).\nAuthors' conclusions\nThis review found that people consistently consume more food and drink when offered larger-sized portions, packages or tableware than when offered smaller-sized versions. This suggests that policies and practices that successfully reduce the size, availability and appeal of larger-sized portions, packages, individual units and tableware can contribute to meaningful reductions in the quantities of food (including non-alcoholic beverages) people select and consume in the immediate and short term. However, it is uncertain whether reducing portions at the smaller end of the size range can be as effective in reducing food consumption as reductions at the larger end of the range. We are unable to highlight clear implications for tobacco or alcohol policy due to identified gaps in the current evidence base.\n\nGiven the provided abstract, please respond to the following query: \"Key findings and quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": ""
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query-laysum
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8395
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[
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"role": "user",
"content": "Abstract: Background\nBullous pemphigoid (BP) is the most common autoimmune blistering disease. Oral steroids are the standard treatment. We have updated this review, which was first published in 2002, because several new treatments have since been tried.\nObjectives\nTo assess the effects of treatments for bullous pemphigoid.\nSearch methods\nWe updated searches of the following databases to November 2021: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, and Embase. We searched five trial databases to January 2022, and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nRCTs of treatments for immunofluorescence-confirmed bullous pemphigoid.\nData collection and analysis\nAt least two review authors, working independently, evaluated the studies against the review's inclusion criteria and extracted data from included studies. Using GRADE methodology, we assessed the certainty of the evidence for each outcome in each comparison. Our primary outcomes were healing of skin lesions and mortality.\nMain results\nWe identified 14 RCTs (1442 participants). The main treatment modalities assessed were oral steroids, topical steroids, and the oral anti-inflammatory antibiotic doxycycline. Most studies reported mortality but adverse events and quality of life were not well reported. We decided to look at the primary outcomes 'disease control' and 'mortality'.\nAlmost all studies investigated different comparisons; two studies were placebo-controlled. The results are therefore based on a single study for each comparison except azathioprine. Most studies involved only small numbers of participants. We assessed the risk of bias for all key outcomes as having 'some concerns' or high risk, due to missing data, inappropriate analysis, or insufficient information.\nClobetasol propionate cream versus oral prednisone\nCompared to oral prednisone, clobetasol propionate cream applied over the whole body probably increases skin healing at day 21 (risk ratio (RR 1.08, 95% confidence interval (CI) 1.03 to 1.13; 1 study, 341 participants; moderate-certainty evidence). Skin healing at 21 days was seen in 99.8% of participants assigned to clobetasol and 92.4% of participants assigned to prednisone. Clobetasol propionate cream applied over the whole body compared to oral prednisone may reduce mortality at one year (RR 0.73, 95% CI 0.53 to 1.01; 1 study, 341 participants; low-certainty evidence). Death occurred in 26.5% (45/170) of participants assigned to clobetasol and 36.3% (62/171) of participants assigned to oral prednisone. This study did not measure quality of life. Clobetasol propionate cream may reduce risk of severe complications by day 21 compared with oral prednisone (RR 0.65, 95% CI 0.50 to 0.86; 1 study, 341 participants; low-certainty evidence).\nMild clobetasol propionate cream regimen (10 to 30 g/day) versus standard clobetasol propionate cream regimen (40 g/day)\nA mild regimen of topical clobetasol propionate applied over the whole body compared to the standard regimen probably does not change skin healing at day 21 (RR 1.00, 95% CI 0.97 to 1.03; 1 study, 312 participants; moderate-certainty evidence). Both groups showed complete healing of lesions at day 21 in 98% participants. A mild regimen of topical clobetasol propionate applied over the whole body compared to the standard regimen may not change mortality at one year (RR 1.00, 95% CI 0.75 to 1.32; 1 study, 312 participants; low-certainty evidence), which occurred in 118/312 (37.9%) participants. This study did not measure quality of life. A mild regimen of topical clobetasol propionate applied over the whole body compared to the standard regimen may not change adverse events at one year (RR 0.94, 95% CI 0.78 to 1.14; 1 study, 309 participants; low-certainty evidence).\nDoxycycline versus prednisolone\nCompared to prednisolone (0.5 mg/kg/day), doxycycline (200 mg/day) induces less skin healing at six weeks (RR 0.81, 95% CI 0.72 to 0.92; 1 study, 213 participants; high-certainty evidence). Complete skin healing was reported in 73.8% of participants assigned to doxycycline and 91.1% assigned to prednisolone. Doxycycline compared to prednisolone probably decreases mortality at one year (RR 0.25, 95% CI 0.07 to 0.89; number needed to treat for an additional beneficial outcome (NNTB) = 14; 1 study, 234 participants; moderate-certainty evidence). Mortality occurred in 2.4% (3/132) of participants with doxycycline and 9.7% (11/121) with prednisolone. Compared to prednisolone, doxycycline improved quality of life at one year (mean difference 1.8 points lower, which is more favourable on the Dermatology Life Quality Index, 95% CI 1.02 to 2.58 lower; 1 study, 234 participants; high-certainty evidence). Doxycycline compared to prednisolone probably reduces severe or life-threatening treatment-related adverse events at one year (RR 0.59, 95% CI 0.35 to 0.99; 1 study, 234 participants; moderate-certainty evidence).\nPrednisone plus azathioprine versus prednisone\nIt is unclear whether azathioprine plus prednisone compared to prednisone alone affects skin healing or mortality because there was only very low-certainty evidence from two trials (98 participants). These studies did not measure quality of life. Adverse events were reported in a total of 20/48 (42%) participants assigned to azathioprine plus prednisone and 15/44 (34%) participants assigned to prednisone.\nNicotinamide plus tetracycline versus prednisone\nIt is unclear whether nicotinamide plus tetracycline compared to prednisone affects skin healing or mortality because there was only very low-certainty evidence from one trial (18 participants). This study did not measure quality of life. Fewer adverse events were reported in the nicotinamide group.\nMethylprednisolone plus azathioprine versus methylprednisolone plus dapsone\nIt is unclear whether azathioprine plus methylprednisolone compared to dapsone plus methylprednisolone affects skin healing or mortality because there was only very low-certainty evidence from one trial (54 participants). This study did not measure quality of life. A total of 18 adverse events were reported in the azathioprine group and 13 in the dapsone group.\nAuthors' conclusions\nClobetasol propionate cream applied over the whole body is probably similarly effective as, and may cause less mortality than, oral prednisone for treating bullous pemphigoid. Lower-dose clobetasol propionate cream applied over the whole body is probably similarly effective as standard-dose clobetasol propionate cream and has similar mortality. Doxycycline is less effective but causes less mortality than prednisolone for treating bullous pemphigoid. Other treatments need further investigation.\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"
},
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"role": "assistant",
"content": "We found 14 studies including 1442 people with bullous pemphigoid. The main treatments assessed were oral steroids, topical steroids, and the oral anti-inflammatory antibiotic doxycycline. Other treatments tested were oral (i.e. taken by mouth) immunosuppressives (medicines that keep your immune system in check) and immunoglobulins (also called antibodies. Antibodies are proteins that your immune system makes to fight germs, for example).\n- Topical steroid cream, clobetasol propionate, applied over the whole body (40 grams of cream applied per day, with the amount decreased over 12 months) is an effective and safe treatment for bullous pemphigoid.\n- Treatment with a lower amount of clobetasol propionate cream (10 to 30 grams per day, decreased over 4 months) is equally effective and safe.\n- Prednisolone, an oral corticosteroid, in the dose of 0.5 mg/kg/day, may be adequate to control disease in most people and reduces adverse effects compared to higher doses of oral corticosteroid.\n- Initiating treatment with 200 mg/day of doxycycline leads to acceptable blister control compared to oral prednisolone (0.5 mg/kg/day) and is safer.\n- A study with 20 participants suggests that nicotinamide (a form of vitamin B3)and tetracycline (an antibiotic used to treat a wide variety of infections) may be an effective alternative to prednisone and may decrease treatment-associated death.\n- Adding azathioprine, a drug which suppresses the immune system, to an oral corticosteroid does not improve disease control; it may lead to a reduced need for oral corticosteroid.\n- Further research is needed to fully understand the effectiveness of alternatives to oral steroids (such as dapsone or immunoglobulins), as well as the effectiveness of giving other medicines alongside an oral steroid."
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query-laysum
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8396
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[
{
"role": "user",
"content": "Abstract: Background\nIn experimental studies, the outcome of bacterial meningitis has been related to the severity of inflammation in the subarachnoid space. Corticosteroids reduce this inflammatory response.\nObjectives\nTo examine the effect of adjuvant corticosteroid therapy versus placebo on mortality, hearing loss and neurological sequelae in people of all ages with acute bacterial meningitis.\nSearch methods\nWe searched CENTRAL (2015, Issue 1), MEDLINE (1966 to January week 4, 2015), Emabse (1974 to February 2015), Web of Science (2010 to February 2015), CINAHL (2010 to February 2015) and LILACS (2010 to February 2015).\nSelection criteria\nRandomised controlled trials (RCTs) of corticosteroids for acute bacterial meningitis.\nData collection and analysis\nWe scored RCTs for methodological quality. We collected outcomes and adverse effects. We performed subgroup analyses for children and adults, causative organisms, low-income versus high-income countries, time of steroid administration and study quality.\nMain results\nWe included 25 studies involving 4121 participants (2511 children and 1517 adults; 93 mixed population). Four studies were of high quality with no risk of bias, 14 of medium quality and seven of low quality, indicating a moderate risk of bias for the total analysis. Nine studies were performed in low-income countries and 16 in high-income countries.\nThere was insufficient evidence that corticosteroids caused a reduction in mortality overall (17.8% versus 19.9%; risk ratio (RR) 0.90, 95% confidence interval (CI) 0.80 to 1.01; P = 0.07), or for adults (RR 0.74, 95% CI 0.53 to 1.05; P = 0.09). However they caused lower rates of severe hearing loss (RR 0.67, 95% CI 0.51 to 0.88), any hearing loss (RR 0.74, 95% CI 0.63 to 0.87) and neurological sequelae (RR 0.83, 95% CI 0.69 to 1.00).\nSubgroup analyses for causative organisms showed that corticosteroids reduced mortality in Streptococcus pneumoniae (S pneumoniae) meningitis (RR 0.84, 95% CI 0.72 to 0.98), but not in Haemophilus influenzae (H influenzae) orNeisseria meningitidis (N meningitidis) meningitis. Corticosteroids reduced severe hearing loss in children with H influenzae meningitis (RR 0.34, 95% CI 0.20 to 0.59) but not in children with meningitis due to non-Haemophilus species.\nIn high-income countries, corticosteroids reduced severe hearing loss (RR 0.51, 95% CI 0.35 to 0.73), any hearing loss (RR 0.58, 95% CI 0.45 to 0.73) and short-term neurological sequelae (RR 0.64, 95% CI 0.48 to 0.85). There was no beneficial effect of corticosteroid therapy in low-income countries.\nSubgroup analysis for study quality showed no effect of corticosteroids on severe hearing loss in high-quality studies.\nCorticosteroid treatment was associated with an increase in recurrent fever (RR 1.27, 95% CI 1.09 to 1.47), but not with other adverse events.\nAuthors' conclusions\nCorticosteroids significantly reduced hearing loss and neurological sequelae, but did not reduce overall mortality. Data support the use of corticosteroids in patients with bacterial meningitis in high-income countries. We found no beneficial effect in low-income countries.\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"
},
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"role": "assistant",
"content": "Acute bacterial meningitis is an infection of the meninges (the system of membranes that envelops the brain and spinal cord), which often causes hearing loss. Bacterial meningitis is fatal in 5% to 40% of children and 20% to 50% of adults despite treatment with adequate antibiotics. It is caused by bacteria that usually spread from an ear or respiratory infection and is treated with antibiotics.\nCorticosteroids are drugs that can reduce the inflammation caused by infection. This inflammation has been shown to aggravate damage to the nervous system in experimental meningitis studies in animals. Research on the use of corticosteroids in addition to antibiotics has had conflicting results.\nWe wanted to discover whether use of corticosteroids was better of worse than placebo."
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query-laysum
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8397
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[
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"role": "user",
"content": "Abstract: Background\nAortic dissection is a separation of the aortic wall, caused by blood flowing through a tear in the inner layer of the aorta. Aortic dissection is an infrequent but life-threatening condition. The incidence of aortic dissection is 3 to 6 per 10,000 per year in the Western population, and can be up to 43 per 10,000 per year in the Eastern population. Over 20% of people with an aortic dissection do not reach a hospital alive. After admission, the mortality rates for people with an aortic dissection are between 10% and 20% for those who received endovascular treatment, and between 20% and 30% for those who had open surgery.\nThoracic endovascular aortic repair (TEVAR) is the standard endovascular method to treat complicated type B aortic dissection (aortic dissections without involvement of the ascending aorta). Although TEVAR is less invasive than open surgery and has a better long-term aortic remodeling effect than conservative medical treatment, favourable aortic remodelling is usually limited to the thoracic aortic segment. TEVAR cannot be extended into the abdominal aorta because it could cover the ostia of the reno-visceral arteries. Thus, the abdominal aorta is still at risk of progressive aneurysmal degeneration. The PETTICOAT (provisional extension to induce complete attachment) technique, with proximal endograft and distal bare metal stent, was proposed in 2006 to address this issue. The concept of this technique was to implant a distal bare metal stent into the aortic true lumen, distal to the proximal endograft, to stabilize the distal collapsed intimal flap, while allowing blood flow to reno-visceral arteries. Therefore, the PETTICOAT technique was considered to be related to a more extensive aortic remodelling for people with type B aortic dissection, especially in the area of the abdominal aorta. However, it is still unclear whether the PETTICOAT technique is superior to standard TEVAR.\nObjectives\nTo assess the effects of combined proximal descending aortic endografting plus distal bare metal stenting versus conventional proximal descending aortic stent graft repair for treating complicated type B aortic dissections.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 5 November 2018. We also undertook reference checking and citation searching to identify additional studies.\nSelection criteria\nWe considered all randomised controlled trials which compared the outcome of complicated type B aortic dissection, when treated by combined proximal descending aortic endografting plus distal bare metal stenting (PETTICOAT technique) versus conventional proximal descending aortic stent graft repair.\nData collection and analysis\nTwo independent review authors assessed all references identified by the Cochrane Vascular Information Specialist. We planned to undertake data collection and analysis in accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nWe found no trials that met the inclusion criteria for this review.\nAuthors' conclusions\nWe identified no randomised controlled trials and therefore cannot draw any definite conclusion on this topic. Evidence from non-randomised studies appears to be favourable in the short-term, for combined proximal descending aortic endografting plus distal bare metal stenting (PETTICOAT technique) to solve the problem of unfavourable distal aortic remodeling. Randomised controlled trials are warranted to provide solid evidence on this topic. Evidence from cohort studies with large sample sizes would also be helpful in guiding clinical practice.\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"
},
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"role": "assistant",
"content": "Randomised controlled trials are needed to provide solid evidence on this topic. Evidence from non-randomised studies with large sample sizes would also be helpful in guiding clinical practice."
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query-laysum
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8398
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[
{
"role": "user",
"content": "Abstract: Background\nPeriampullary cancer includes cancer of the head and neck of the pancreas, cancer of the distal end of the bile duct, cancer of the ampulla of Vater, and cancer of the second part of the duodenum. Surgical resection is the only established potentially curative treatment for pancreatic and periampullary cancer. A considerable proportion of patients undergo unnecessary laparotomy because of underestimation of the extent of the cancer on computed tomography (CT) scanning. Other imaging methods such as magnetic resonance imaging (MRI), positron emission tomography (PET), PET-CT, and endoscopic ultrasound (EUS) have been used to detect local invasion or distant metastases not visualised on CT scanning which could prevent unnecessary laparotomy. No systematic review or meta-analysis has examined the role of different imaging modalities in assessing the resectability with curative intent in patients with pancreatic and periampullary cancer.\nObjectives\nTo determine the diagnostic accuracy of MRI, PET scan, and EUS performed as an add-on test or PET-CT as a replacement test to CT scanning in detecting curative resectability in pancreatic and periampullary cancer.\nSearch methods\nWe searched MEDLINE, Embase, Science Citation Index Expanded, and Health Technology Assessment (HTA) databases up to 5 November 2015. Two review authors independently screened the references and selected the studies for inclusion. We also searched for articles related to the included studies by performing the \"related search\" function in MEDLINE (OvidSP) and Embase (OvidSP) and a \"citing reference\" search (by searching the articles that cite the included articles).\nSelection criteria\nWe included diagnostic accuracy studies of MRI, PET scan, PET-CT, and EUS in patients with potentially resectable pancreatic and periampullary cancer on CT scan. We accepted any criteria of resectability used in the studies. We included studies irrespective of language, publication status, or study design (prospective or retrospective). We excluded case-control studies.\nData collection and analysis\nTwo review authors independently performed data extraction and quality assessment using the QUADAS-2 (quality assessment of diagnostic accuracy studies - 2) tool. Although we planned to use bivariate methods for analysis of sensitivities and specificities, we were able to fit only the univariate fixed-effect models for both sensitivity and specificity because of the paucity of data. We calculated the probability of unresectability in patients who had a positive index test (post-test probability of unresectability in people with a positive test result) and in those with negative index test (post-test probability of unresectability in people with a positive test result) using the mean probability of unresectability (pre-test probability) from the included studies and the positive and negative likelihood ratios derived from the model. The difference between the pre-test and post-test probabilities gave the overall added value of the index test compared to the standard practice of CT scan staging alone.\nMain results\nOnly two studies (34 participants) met the inclusion criteria of this systematic review. Both studies evaluated the diagnostic test accuracy of EUS in assessing the resectability with curative intent in pancreatic cancers. There was low concerns about applicability for most domains in both studies. The overall risk of bias was low in one study and unclear or high in the second study. The mean probability of unresectable disease after CT scan across studies was 60.5% (that is 61 out of 100 patients who had resectable cancer after CT scan had unresectable disease on laparotomy). The summary estimate of sensitivity of EUS for unresectability was 0.87 (95% confidence interval (CI) 0.54 to 0.97) and the summary estimate of specificity for unresectability was 0.80 (95% CI 0.40 to 0.96). The positive likelihood ratio and negative likelihood ratio were 4.3 (95% CI 1.0 to 18.6) and 0.2 (95% CI 0.0 to 0.8) respectively. At the mean pre-test probability of 60.5%, the post-test probability of unresectable disease for people with a positive EUS (EUS indicating unresectability) was 86.9% (95% CI 60.9% to 96.6%) and the post-test probability of unresectable disease for people with a negative EUS (EUS indicating resectability) was 20.0% (5.1% to 53.7%). This means that 13% of people (95% CI 3% to 39%) with positive EUS have potentially resectable cancer and 20% (5% to 53%) of people with negative EUS have unresectable cancer.\nAuthors' conclusions\nBased on two small studies, there is significant uncertainty in the utility of EUS in people with pancreatic cancer found to have resectable disease on CT scan. No studies have assessed the utility of EUS in people with periampullary cancer.\nThere is no evidence to suggest that it should be performed routinely in people with pancreatic cancer or periampullary cancer found to have resectable disease on CT scan.\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": "The two included studies showed that in those people with pancreatic cancer in whom CT alone showed their cancer was capable of being fully surgically removed, 61% (61 out of 100) would prove to have cancer that was too fully spread to make this possible when a laparotomy was attempted. Due to the small sample size, there is significant uncertainty in the utility of EUS in people with pancreatic cancer found to have resectable disease on CT scan. There is no evidence to suggest that it should be performed routinely in people with pancreatic cancer found to have resectable disease on CT scan."
}
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query-laysum
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8399
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[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane review first published in 2012 (Cochrane Database of Systematic Reviews 2012, Issue 1).\nThe efficacy and safety of vigabatrin (VGB) as an add-on therapy for refractory epilepsy have been well established. However, this information needs to be weighed against the risk of development of visual field defects. Whether VGB monotherapy is an effective and safe treatment compared with the standard antiepileptic drug carbamazepine (CBZ) as monotherapy for epilepsy has not been systematically reviewed.\nObjectives\nTo investigate the efficacy and safety of VGB versus CBZ monotherapy for epilepsy in children and adults.\nSearch methods\nFor the latest update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 3 of 4), MEDLINE (1948 to July 2015), EMBASE (1974 to July 2015) and the Chinese Biomedical Database (CBM) (1979 to July 2015). We searched trial registers and contacted the manufacturer of VGB and authors of included studies for additional information. We applied no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) comparing VGB versus CBZ monotherapy for epilepsy.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. The primary outcome was time to treatment withdrawal. Secondary outcomes were time to achieve six-month and 12-month remission after randomisation, time to first seizure after randomisation and adverse events. We presented results as hazard ratios (HRs) with 95% confidence intervals (CIs) (time to event data) or as risk ratios (RRs) with 95% CIs (adverse events).\nMain results\nFive studies involving a total of 734 participants were eligible for inclusion. We assessed only one study as good quality and the other four as poor quality. However, it was difficult to perform a meta-analysis by extracting aggregate data to synthesise the results as originally planned, mainly because not all studies reported the same outcomes as those chosen for this review. No significant differences favoured VGB or CBZ in terms of time to treatment withdrawal and time to achieve six-month remission after dose stabilisation from randomisation, but results did show a disadvantage for VGB on time to first seizure after randomisation. Compared with CBZ, VGB was associated with more occurrences of weight gain and fewer occurrences of skin rash and drowsiness. No differences in visual field defects and visual disturbances were noted.\nAuthors' conclusions\nData are currently insufficient to address the risk-benefit balance of VGB versus CBZ monotherapy for epilepsy. Given the high prevalence of visual field defects reported in an existing systematic review of observational studies (Maguire 2010), VGB monotherapy should be prescribed with caution for epilepsy and should not be considered a first-line choice. If necessary, the visual field should be frequently assessed. Future research should focus on investigating the reasons for visual field defects and exploring potential prevention strategies. Moreover, future monotherapy studies of epilepsy should report results according to the recommendations of the International League Against Epilepsy (ILAE) Commission, and methodological quality should be improved.\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": "Results of this review show no significant differences between vigabatrin and carbamazepine in terms of time to treatment withdrawal and time to achieve six-month remission after dose stabilisation from randomisation, but they reveal some clinical disadvantage with vigabatrin on time to first seizure. Taking vigabatrin was more likely to result in weight gain. A safety concern was the high prevalence of visual field defects, as reported in a systematic review of observational studies (Maguire 2010)."
}
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query-laysum
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8400
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[
{
"role": "user",
"content": "Abstract: Background\nConcerns regarding the safety and availability of transfused donor blood have prompted research into a range of techniques to minimise allogeneic transfusion requirements. Cell salvage (CS) describes the recovery of blood from the surgical field, either during or after surgery, for reinfusion back to the patient.\nObjectives\nTo examine the effectiveness of CS in minimising perioperative allogeneic red blood cell transfusion and on other clinical outcomes in adults undergoing elective or non-urgent surgery.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, three other databases and two clinical trials registers for randomised controlled trials (RCTs) and systematic reviews from 2009 (date of previous search) to 19 January 2023, without restrictions on language or publication status.\nSelection criteria\nWe included RCTs assessing the use of CS compared to no CS in adults (participants aged 18 or over, or using the study's definition of adult) undergoing elective (non-urgent) surgery only.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 106 RCTs, incorporating data from 14,528 participants, reported in studies conducted in 24 countries. Results were published between 1978 and 2021. We analysed all data according to a single comparison: CS versus no CS. We separated analyses by type of surgery.\nThe certainty of the evidence varied from very low certainty to high certainty. Reasons for downgrading the certainty included imprecision (small sample sizes below the optimal information size required to detect a difference, and wide confidence intervals), inconsistency (high statistical heterogeneity), and risk of bias (high risk from domains including sequence generation, blinding, and baseline imbalances).\nAggregate analysis (all surgeries combined: primary outcome only)\nVery low-certainty evidence means we are uncertain if there is a reduction in the risk of allogeneic transfusion with CS (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.59 to 0.72; 82 RCTs, 12,520 participants).\nCancer: 2 RCTs (79 participants)\nVery low-certainty evidence means we are uncertain whether there is a difference for mortality, blood loss, infection, or deep vein thrombosis (DVT). There were no analysable data reported for the remaining outcomes.\nCardiovascular (vascular): 6 RCTs (384 participants)\nVery low- to low-certainty evidence means we are uncertain whether there is a difference for most outcomes. No data were reported for major adverse cardiovascular events (MACE).\nCardiovascular (no bypass): 6 RCTs (372 participants)\nModerate-certainty evidence suggests there is probably a reduction in risk of allogeneic transfusion with CS (RR 0.82, 95% CI 0.69 to 0.97; 3 RCTs, 169 participants).\nVery low- to low-certainty evidence means we are uncertain whether there is a difference for volume transfused, blood loss, mortality, re-operation for bleeding, infection, wound complication, myocardial infarction (MI), stroke, and hospital length of stay (LOS). There were no analysable data reported for thrombosis, DVT, pulmonary embolism (PE), and MACE.\nCardiovascular (with bypass): 29 RCTs (2936 participants)\nLow-certainty evidence suggests there may be a reduction in the risk of allogeneic transfusion with CS, and suggests there may be no difference in risk of infection and hospital LOS.\nVery low- to moderate-certainty evidence means we are uncertain whether there is a reduction in volume transfused because of CS, or if there is any difference for mortality, blood loss, re-operation for bleeding, wound complication, thrombosis, DVT, PE, MACE, and MI, and probably no difference in risk of stroke.\nObstetrics: 1 RCT (1356 participants)\nHigh-certainty evidence shows there is no difference between groups for mean volume of allogeneic blood transfused (mean difference (MD) -0.02 units, 95% CI -0.08 to 0.04; 1 RCT, 1349 participants).\nLow-certainty evidence suggests there may be no difference for risk of allogeneic transfusion. There were no analysable data reported for the remaining outcomes.\nOrthopaedic (hip only): 17 RCTs (2055 participants)\nVery low-certainty evidence means we are uncertain if CS reduces the risk of allogeneic transfusion, and the volume transfused, or if there is any difference between groups for mortality, blood loss, re-operation for bleeding, infection, wound complication, prosthetic joint infection (PJI), thrombosis, DVT, PE, stroke, and hospital LOS. There were no analysable data reported for MACE and MI.\nOrthopaedic (knee only): 26 RCTs (2568 participants)\nVery low- to low-certainty evidence means we are uncertain if CS reduces the risk of allogeneic transfusion, and the volume transfused, and whether there is a difference for blood loss, re-operation for bleeding, infection, wound complication, PJI, DVT, PE, MI, MACE, stroke, and hospital LOS. There were no analysable data reported for mortality and thrombosis.\nOrthopaedic (spine only): 6 RCTs (404 participants)\nModerate-certainty evidence suggests there is probably a reduction in the need for allogeneic transfusion with CS (RR 0.44, 95% CI 0.31 to 0.63; 3 RCTs, 194 participants).\nVery low- to moderate-certainty evidence suggests there may be no difference for volume transfused, blood loss, infection, wound complication, and PE. There were no analysable data reported for mortality, re-operation for bleeding, PJI, thrombosis, DVT, MACE, MI, stroke, and hospital LOS.\nOrthopaedic (mixed): 14 RCTs (4374 participants)\nVery low- to low-certainty evidence means we are uncertain if there is a reduction in the need for allogeneic transfusion with CS, or if there is any difference between groups for volume transfused, mortality, blood loss, infection, wound complication, PJI, thrombosis, DVT, MI, and hospital LOS. There were no analysable data reported for re-operation for bleeding, MACE, and stroke.\nAuthors' conclusions\nIn some types of elective surgery, cell salvage may reduce the need for and volume of allogeneic transfusion, alongside evidence of no difference in adverse events, when compared to no cell salvage. Further research is required to establish why other surgeries show no benefit from CS, through further analysis of the current evidence. More large RCTs in under-reported specialities are needed to expand the evidence base for exploring the impact of CS.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out if (1) using cell salvage reduces the need for a transfusion of donated blood, and (2) if people still needed a transfusion, did it reduce the amount of donated blood that they needed. We also wanted to check if people who have cell salvage have more complications than those who don't."
}
] |
query-laysum
|
8401
|
[
{
"role": "user",
"content": "Abstract: Background\nPremenstrual syndrome (PMS) is a common problem. Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome. Combined oral contraceptives (COC), which provide both progestin and oestrogen, have been examined for their ability to relieve premenstrual symptoms. A combined oral contraceptive containing drospirenone and a low oestrogen dose has been approved for treating PMDD in women who choose combined oral contraceptives for contraception.\nObjectives\nTo evaluate the effectiveness and safety of COCs containing drospirenone in women with PMS.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group trial register, CENTRAL (now containing output from two trials registers and CINAHL), MEDLINE, Embase, PsycINFO, LILACS, Google Scholar, and Epistemonikos on 29 June 2022. We checked included studies' reference lists and contacted study authors and experts in the field to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCT) that compared COCs containing drospirenone with placebo or with another COC for treatment of women with PMS.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary review outcomes were effects on premenstrual symptoms that were prospectively recorded, and withdrawal due to adverse events. Secondary outcomes included effects on mood, adverse events, and response rate to study medications.\nMain results\nWe included five RCTs (858 women analysed, most diagnosed with PMDD). The evidence was very low to moderate quality; the main limitations were serious risk of bias due to poor reporting of study methods, and serious inconsistency and imprecision.\nCOCs containing drospirenone and ethinylestradiol (EE) versus placebo\nCOCs containing drospirenone and EE may improve overall premenstrual symptoms (standardised mean difference (SMD) -0.41, 95% confidence interval (CI) -0.59 to -0.24; 2 RCTs, N = 514; I2 = 64%; low-quality evidence); and functional impairment due to premenstrual symptoms in terms of productivity (mean difference (MD) -0.31, 95% CI -0.55 to -0.08; 2 RCTs, N = 432; I2 = 47%; low-quality evidence), social activities (MD -0.29, 95% CI -0.54 to -0.04; 2 RCTs, N = 432; I2 = 53%; low-quality evidence), and relationships (MD -0.30, 95% CI -0.54 to -0.06; 2 RCTs, N = 432; I2 = 45%; low-quality evidence). The effects from COCs containing drospirenone may be small to moderate.\nCOCs containing drospirenone and EE may increase withdrawal from trials due to adverse effects (odds ratio (OR) 3.41, 95% CI 2.01 to 5.78; 4 RCT, N = 776; I2 = 0%; low-quality evidence). This suggests that if you assume the risk of withdrawal due to adverse effects from placebo is 3%, the risk from drospirenone plus EE will be between 6% and 16%.\nWe are uncertain of the effect of drospirenone plus EE on premenstrual mood symptoms, when measured by validated tools that were not developed to assess premenstrual symptoms.\nCOCs containing drospirenone may lead to more adverse effects in total (OR 2.31, 95% CI 1.71 to 3.11; 3 RCT, N = 739; I2 = 0%; low-quality evidence). This suggests that if you assume the risk of having adverse effects from placebo is 28%, the risk from drospirenone plus EE will be between 40% and 54%. It probably leads to more breast pain, and may lead to more nausea, intermenstrual bleeding, and menstrual disorder. Its effect on nervousness, headache, asthenia, and pain is uncertain. There was no report of any rare but serious adverse effects, such as venous thromboembolism in any of the included studies.\nCOCs containing drospirenone may improve response rate (OR 1.65, 95% CI 1.13 to 2.40; 1 RCT, N = 449; I2 not applicable; low-quality evidence). This suggests that if you assume the response rate from placebo is 36%, the risk from drospirenone plus EE will be between 39% and 58%.\nWe did not identify any studies that compared COCs containing drospirenone with other COCs.\nAuthors' conclusions\nCOCs containing drospirenone and EE may improve premenstrual symptoms that result in functional impairments in women with PMDD. The placebo also had a significant effect. COCs containing drospirenone and EE may lead to more adverse effects compared to placebo. We do not know whether it works after three cycles, helps women with less severe symptoms, or is better than other combined oral contraceptives that contain a different progestogen.\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": "PMS is a common problem. A severe form is called premenstrual dysphoric disorder (PMDD). Symptoms could include behaviour changes, and physical signs and symptoms that impact daily life. Birth control pills with the hormones progestin and oestrogen to treat these symptoms have been studied. A birth control pill with drospirenone combined with low-dose oestrogen was approved in the USA for treating PMDD."
}
] |
query-laysum
|
8402
|
[
{
"role": "user",
"content": "Abstract: Background\nEmergency contraception (EC) is using a drug or copper intrauterine device (Cu-IUD) to prevent pregnancy shortly after unprotected intercourse. Several interventions are available for EC. Information on the comparative effectiveness, safety and convenience of these methods is crucial for reproductive healthcare providers and the women they serve. This is an update of a review previously published in 2009 and 2012.\nObjectives\nTo determine which EC method following unprotected intercourse is the most effective, safe and convenient to prevent pregnancy.\nSearch methods\nIn February 2017 we searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Popline and PubMed, The Chinese biomedical databases and UNDP/UNFPA/WHO/World Bank Special Programme on Human Reproduction (HRP) emergency contraception database. We also searched ICTRP and ClinicalTrials.gov as well as contacting content experts and pharmaceutical companies, and searching reference lists of appropriate papers.\nSelection criteria\nRandomised controlled trials including women attending services for EC following a single act of unprotected intercourse were eligible.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary review outcome was observed number of pregnancies. Side effects and changes of menses were secondary outcomes.\nMain results\nWe included 115 trials with 60,479 women in this review. The quality of the evidence for the primary outcome ranged from moderate to high, and for other outcomes ranged from very low to high. The main limitations were risk of bias (associated with poor reporting of methods), imprecision and inconsistency.\nComparative effectiveness of different emergency contraceptive pills (ECP)\nLevonorgestrel was associated with fewer pregnancies than Yuzpe (estradiol-levonorgestrel combination) (RR 0.57, 95% CI 0.39 to 0.84, 6 RCTs, n = 4750, I2 = 23%, high-quality evidence). This suggests that if the chance of pregnancy using Yuzpe is assumed to be 29 women per 1000, the chance of pregnancy using levonorgestrel would be between 11 and 24 women per 1000.\nMifepristone (all doses) was associated with fewer pregnancies than Yuzpe (RR 0.14, 95% CI 0.05 to 0.41, 3 RCTs, n = 2144, I2 = 0%, high-quality evidence). This suggests that if the chance of pregnancy following Yuzpe is assumed to be 25 women per 1000 women, the chance following mifepristone would be between 1 and 10 women per 1000.\nBoth low-dose mifepristone (less than 25 mg) and mid-dose mifepristone (25 mg to 50 mg) were probably associated with fewer pregnancies than levonorgestrel (RR 0.72, 95% CI 0.52 to 0.99, 14 RCTs, n = 8752, I2 = 0%, high-quality evidence; RR 0.61, 95% CI 0.45 to 0.83, 27 RCTs, n = 6052, I2 = 0%, moderate-quality evidence; respectively). This suggests that if the chance of pregnancy following levonorgestrel is assumed to be 20 women per 1000, the chance of pregnancy following low-dose mifepristone would be between 10 and 20 women per 1000; and that if the chance of pregnancy following levonorgestrel is assumed to be 35 women per 1000, the chance of pregnancy following mid-dose mifepristone would be between 16 and 29 women per 1000.\nUlipristal acetate (UPA) was associated with fewer pregnancies than levonorgestrel (RR 0.59; 95% CI 0.35 to 0.99, 2 RCTs, n = 3448, I2 = 0%, high-quality evidence).\nComparative effectiveness of different ECP doses\nIt was unclear whether there was any difference in pregnancy rate between single-dose levonorgestrel (1.5 mg) and the standard two-dose regimen (0.75 mg 12 hours apart) (RR 0.84, 95% CI 0.53 to 1.33, 3 RCTs, n = 6653, I2 = 0%, moderate-quality evidence).\nMid-dose mifepristone was associated with fewer pregnancies than low-dose mifepristone (RR 0.73; 95% CI 0.55 to 0.97, 25 RCTs, n = 11,914, I2 = 0%, high-quality evidence).\nComparative effectiveness of Cu-IUD versus mifepristone\nThere was no conclusive evidence of a difference in the risk of pregnancy between the Cu-IUD and mifepristone (RR 0.33, 95% CI 0.04 to 2.74, 2 RCTs, n = 395, low-quality evidence).\nAdverse effects\nNausea and vomiting were the main adverse effects associated with emergency contraception. There is probably a lower risk of nausea (RR 0.63, 95% CI 0.53 to 0.76, 3 RCTs, n = 2186 , I2 = 59%, moderate-quality evidence) or vomiting (RR 0.12, 95% CI 0.07 to 0.20, 3 RCTs, n = 2186, I2 = 0%, high-quality evidence) associated with mifepristone than with Yuzpe. levonorgestrel is probably associated with a lower risk of nausea (RR 0.40, 95% CI 0.36 to 0.44, 6 RCTs, n = 4750, I2 = 82%, moderate-quality evidence), or vomiting (RR 0.29, 95% CI 0.24 to 0.35, 5 RCTs, n = 3640, I2 = 78%, moderate-quality evidence) than Yuzpe. Levonorgestrel users were less likely to have any side effects than Yuzpe users (RR 0.80, 95% CI 0.75 to 0.86; 1 RCT, n = 1955, high-quality evidence). UPA users were more likely than levonorgestrel users to have resumption of menstruation after the expected date (RR 1.65, 95% CI 1.42 to 1.92, 2 RCTs, n = 3593, I2 = 0%, high-quality evidence). Menstrual delay was more common with mifepristone than with any other intervention and appeared to be dose-related. Cu-IUD may be associated with higher risks of abdominal pain than mifepristone (18 events in 95 women using Cu-IUD versus no events in 190 women using mifepristone, low-quality evidence).\nAuthors' conclusions\nLevonorgestrel and mid-dose mifepristone (25 mg to 50 mg) were more effective than Yuzpe regimen. Both mid-dose (25 mg to 50 mg) and low-dose mifepristone(less than 25 mg) were probably more effective than levonorgestrel (1.5 mg). Mifepristone low dose (less than 25 mg) was less effective than mid-dose mifepristone. UPA may be more effective than levonorgestrel.\nLevonorgestrel users had fewer side effects than Yuzpe users, and appeared to be more likely to have a menstrual return before the expected date. UPA users were probably more likely to have a menstrual return after the expected date. Menstrual delay was probably the main adverse effect of mifepristone and seemed to be dose-related. Cu-IUD may be associated with higher risks of abdominal pain than ECPs.\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 quality of the evidence for the primary outcome (observed number of pregnancies) ranged from moderate to high, and for other outcomes ranged from very low to high. The main limitations were risk of bias (associated with poor reporting of methods), imprecision and inconsistency."
}
] |
query-laysum
|
8403
|
[
{
"role": "user",
"content": "Abstract: Background\nHealth services have traditionally been developed to focus on specific diseases or medical specialties. Involving consumers as partners in planning, delivering and evaluating health services may lead to services that are person-centred and so better able to meet the needs of and provide care for individuals. Globally, governments recommend consumer involvement in healthcare decision-making at the systems level, as a strategy for promoting person-centred health services. However, the effects of this 'working in partnership' approach to healthcare decision-making are unclear. Working in partnership is defined here as collaborative relationships between at least one consumer and health provider, meeting jointly and regularly in formal group formats, to equally contribute to and collaborate on health service-related decision-making in real time. In this review, the terms 'consumer' and 'health provider' refer to partnership participants, and 'health service user' and 'health service provider' refer to trial participants.\nThis review of effects of partnership interventions was undertaken concurrently with a Cochrane Qualitative Evidence Synthesis (QES) entitled Consumers and health providers working in partnership for the promotion of person-centred health services: a co-produced qualitative evidence synthesis.\nObjectives\nTo assess the effects of consumers and health providers working in partnership, as an intervention to promote person-centred health services.\nSearch methods\nWe searched the CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL databases from 2000 to April 2019; PROQUEST Dissertations and Theses Global from 2016 to April 2019; and grey literature and online trial registries from 2000 until September 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs of ‘working in partnership’ interventions meeting these three criteria: both consumer and provider participants meet; they meet jointly and regularly in formal group formats; and they make actual decisions that relate to the person-centredness of health service(s).\nData collection and analysis\nTwo review authors independently screened most titles and abstracts. One review author screened a subset of titles and abstracts (i.e. those identified through clinical trials registries searches, those classified by the Cochrane RCT Classifier as unlikely to be an RCT, and those identified through other sources). Two review authors independently screened all full texts of potentially eligible articles for inclusion. In case of disagreement, they consulted a third review author to reach consensus. One review author extracted data and assessed risk of bias for all included studies and a second review author independently cross-checked all data and assessments. Any discrepancies were resolved by discussion, or by consulting a third review author to reach consensus. Meta-analysis was not possible due to the small number of included trials and their heterogeneity; we synthesised results descriptively by comparison and outcome. We reported the following outcomes in GRADE ‘Summary of findings’ tables: health service alterations; the degree to which changed service reflects health service user priorities; health service users' ratings of health service performance; health service users' health service utilisation patterns; resources associated with the decision-making process; resources associated with implementing decisions; and adverse events.\nMain results\nWe included five trials (one RCT and four cluster-RCTs), with 16,257 health service users and more than 469 health service providers as trial participants. For two trials, the aims of the partnerships were to directly improve the person-centredness of health services (via health service planning, and discharge co-ordination). In the remaining trials, the aims were indirect (training first-year medical doctors on patient safety) or broader in focus (which could include person-centredness of health services that targeted the public/community, households or health service delivery to improve maternal and neonatal mortality). Three trials were conducted in high income-countries, one was in a middle-income country and one was in a low-income country. Two studies evaluated working in partnership interventions, compared to usual practice without partnership (Comparison 1); and three studies evaluated working in partnership as part of a multi-component intervention, compared to the same intervention without partnership (Comparison 2). No studies evaluated one form of working in partnership compared to another (Comparison 3).\nThe effects of consumers and health providers working in partnership compared to usual practice without partnership are uncertain: only one of the two studies that assessed this comparison measured health service alteration outcomes, and data were not usable, as only intervention group data were reported. Additionally, none of the included studies evaluating this comparison measured the other primary or secondary outcomes we sought for the 'Summary of findings' table.\nWe are also unsure about the effects of consumers and health providers working in partnership as part of a multi-component intervention compared to the same intervention without partnership. Very low-certainty evidence indicated there may be little or no difference on health service alterations or health service user health service performance ratings (two studies); or on health service user health service utilisation patterns and adverse events (one study each). No studies evaluating this comparison reported the degree to which health service alterations reflect health service user priorities, or resource use.\nOverall, our confidence in the findings about the effects of working in partnership interventions was very low due to indirectness, imprecision and publication bias, and serious concerns about risk of selection bias; performance bias, detection bias and reporting bias in most studies.\nAuthors' conclusions\nThe effects of consumers and providers working in partnership as an intervention, or as part of a multi-component intervention, are uncertain, due to a lack of high-quality evidence and/or due to a lack of studies. Further well-designed RCTs with a clear focus on assessing outcomes directly related to partnerships for patient-centred health services are needed in this area, which may also benefit from mixed-methods and qualitative research to build the evidence base.\n\nGiven the provided abstract, please respond to the following query: \"Why we did this Cochrane review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Governments worldwide recommend that healthcare providers work with consumers to promote person-centred health services. However, the effects of healthcare providers and consumers working together are unclear.\nWe reviewed the evidence from research studies to find out about the effects of healthcare providers and consumers working together to plan, deliver and evaluate health services.\nSpecifically, we wanted to know if consumers and healthcare providers working together in partnership – in the form of regular meetings in which consumers and providers were invited to contribute as equals to decisions about health services – had an impact on:\n- changes to health services;\n- the extent to which changes to health services reflected service users’ priorities;\n- users’ ratings of health services;\n- health service use; and\n- time and money needed to make or act on decisions about health services.\nWe also wanted to find out if there were any unwanted (adverse) effects."
}
] |
query-laysum
|
8404
|
[
{
"role": "user",
"content": "Abstract: Background\nCentral retinal vein occlusion (CRVO) is a common retinal vascular abnormality associated with conditions such as hypertension, diabetes, glaucoma, and a wide variety of hematologic disorders. Macular edema (ME) represents an important vision-threatening complication of CRVO. Intravitreal steroids (IVS), such as triamcinolone acetonide, have been utilized to treat macular edema stemming from a variety of etiologies and may be a treatment option for CRVO-ME.\nObjectives\nTo explore the effectiveness and safety of intravitreal steroids in the treatment of CRVO-ME.\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 November 2014), EMBASE (January 1980 to November 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). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 13 November 2014. For all included primary studies, we used The Science Citation Index (3 December 2014) and manually reviewed reference lists to identify other possible relevant trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared intravitreal steroids, of any dosage and duration of treatment of at least six months, with observation for the treatment of CRVO-ME.\nData collection and analysis\nTwo review authors independently screened titles and abstracts identified from the electronic searches and assessed full-text articles from potentially eligible trials. Two review authors independently assessed trial characteristics, risk of bias, and extracted data from included trials. We contacted investigators of included trials for desired data not provided in the trial reports.\nMain results\nWe included two RCTs that enrolled a total of 708 participants with CRVO-ME. SCORE compared triamcinolone acetonide intravitreal injections (n = 165) with observation (n = 72); GENEVA compared dexamethasone intravitreal implants (n = 290) with sham injections (n = 147). We observed characteristics indicative of high risk of bias due to incomplete outcome data in SCORE and selective outcome reporting in GENEVA. Loss to follow-up was high with 10% in the steroid groups and almost twice as much (17%) in the observation group. GENEVA enrolled participants with both branch and central retinal vein occlusion, but did not present subgroup data for the CRVO-ME population. A qualitative assessment of the results from GENEVA indicated that the dexamethasone implant was not associated with improvement in visual acuity after six months among participants with CRVO-ME. Although the SCORE investigators reported that participants treated with 1 mg (n = 82) or 4 mg (n = 83) triamcinolone intravitreal injections were five times more likely to have gained 15 letters or more in visual acuity compared with participants in the observation group (1 mg; risk ratio (RR): 5.27; 95% confidence interval (CI) 1.62 to 17.15; 4 mg RR 4.92; 95% CI 1.50 to 16.10) by the eighth-month follow-up examination, the average visual acuity decreased in all three groups. However, eyes treated with triamcinolone lost fewer letters than participants in the observation group at 8 months (1 mg mean difference (MD): 8.70 letters, 95% CI 1.86 to 15.54; 4 mg MD: 9.80 letters, 95% CI 3.32 to 16.28). A higher incidence of adverse events was noted with IVS therapy when compared with observation alone. As many as 20% to 35% of participants experienced an adverse event in the IVS groups compared with 8% of participants in the observation group of the SCORE study. The GENEVA investigators reported 63% in the treatment arm versus 43% in the observation arm experienced an adverse event. The most commonly encountered adverse events were elevated intraocular pressure, progression of cataracts, and retinal neovascularization. We graded the quality of evidence as low due to study limitations, imprecision of treatment estimates, and selective outcome reporting.\nAuthors' conclusions\nThe two RCTs reviewed herein provide insufficient evidence to determine the benefits of IVS for individuals with CRVO-ME. The improvement in visual acuity noted in the SCORE trial should be interpreted with caution as outcome data were missing for a large proportion of the observation group. Adverse events were observed more often with IVS treatment compared with observation/no treatment.\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 aimed to examine the benefits and harms of inserting steroids into the eye for treating macular edema secondary to central retinal vein occlusion (CRVO-ME)."
}
] |
query-laysum
|
8405
|
[
{
"role": "user",
"content": "Abstract: Background\nThe liver is affected by two of the most common groups of malignant tumours: primary liver tumours and liver metastases from colorectal carcinoma or other extrahepatic primary cancers. Liver metastases are significantly more common than primary liver cancer, and the reported long-term survival rate after radical surgical treatment is approximately 50%. However, R0 resection (resection for cure) is not feasible in the majority of patients; therefore, other treatments have to be considered. One of these is percutaneous ethanol injection (PEI), which causes dehydration and necrosis of tumour cells, accompanied by small-vessel thrombosis, leading to tumour ischaemia and destruction of the tumour.\nObjectives\nTo assess the beneficial and harmful effects of percutaneous ethanol injection (PEI) compared with no intervention, other ablation methods, or systemic treatments in people with liver metastases.\nSearch methods\nWe searched the following databases up to 10 September 2019: the Cochrane Hepato-Biliary Group Controlled Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE Ovid; Embase Ovid; Science Citation Index Expanded; Conference Proceedings Citation Index – Science; Latin American Caribbean Health Sciences Literature (LILACS); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). We also searched clinical trials registers such as ClinicalTrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the US Food and Drug Administration (FDA) (17 September 2019).\nSelection criteria\nRandomised clinical trials assessing beneficial and harmful effects of percutaneous ethanol injection and its comparators (no intervention, other ablation methods, systemic treatments) for liver metastases.\nData collection and analysis\nWe followed standard methodological procedures as outlined by Cochrane. We extracted information on participant characteristics, interventions, study outcomes, study design, and trial methods. Two review authors performed data extraction and assessed risk of bias independently. We assessed the certainty of evidence by using GRADE. We resolved disagreements by discussion.\nMain results\nWe identified only one randomised clinical trial comparing percutaneous intratumour ethanol injection (PEI) in addition to transcatheter arterial chemoembolisation (TACE) versus TACE alone. The trial was conducted in China and included 48 trial participants with liver metastases: 25 received PEI plus TACE, and 23 received TACE alone. The trial included 37 male and 11 female participants. Mean participant age was 49.3 years. Sites of primary tumours included colon (27 cases), stomach (12 cases), pancreas (3 cases), lung (3 cases), breast (2 cases), and ovary (1 case). Seven participants had a single tumour, 15 had two tumours, and 26 had three or more tumours in the liver. The bulk diameter of the tumour on average was 3.9 cm, ranging from 1.2 cm to 7.6 cm.\nParticipants were followed for 10 months to 43 months. The trial reported survival data after one, two, and three years. In the PEI + TACE group, 92%, 80%, and 64% of participants survived after one year, two years, and three years; in the TACE alone group, these percentages were 78.3%, 65.2%, and 47.8%, respectively. Upon conversion of these data to mortality rates, the calculated risk ratio (RR) for mortality at last follow-up when PEI plus TACE was compared with TACE alone was 0.69 (95% confidence interval (CI) 0.36 to 1.33; very low-certainty evidence) after three years of follow-up. Local recurrence was 16% in the PEI plus TACE group and 39.1% in the TACE group, resulting in an RR of 0.41 (95% CI 0.15 to 1.15; very low-certainty evidence). Forty-five out of a total of 68 tumours (66.2%) shrunk by at least 25% in the PEI plus TACE group versus 31 out of a total of 64 tumours (48.4%) in the TACE group. Trial authors reported some adverse events but provided very few details. We did not find data on time to mortality, failure to clear liver metastases, recurrence of liver metastases, health-related quality of life, or time to progression of liver metastases.\nThe single included trial did not provide information on funding nor on conflict of interest.\nAuthors' conclusions\nEvidence for the effectiveness of PEI plus TACE versus TACE in people with liver metastases is of very low certainty and is based on one small randomised clinical trial at high risk of bias. Currently, it cannot be determined whether adding PEI to TACE makes a difference in comparison to using TACE alone. Evidence for benefits or harms of PEI compared with no intervention, other ablation methods, or systemic treatments is lacking.\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": "Results of one small randomised clinical trial do not show beneficial or harmful effects of adding percutaneous intratumour ethanol injection to TACE in people with liver metastases with respect to mortality or local recurrence in comparison with TACE alone. Participants were followed for between 10 and 43 months. The tumour necrosis was larger in the combined treatment group. Trial authors reported some adverse events but gave very few details. We found no data on time to mortality, failure to clear liver metastases, recurrence of liver metastases, health-related quality of life, or time to progression of liver metastases."
}
] |
query-laysum
|
8406
|
[
{
"role": "user",
"content": "Abstract: Background\nGiant cell arteritis (GCA) is the most common form of systemic vasculitis in people older than 50 years of age. It causes granulomatous inflammation of medium- to large-sized vessels. Tocilizumab is a recombinant monoclonal antibody directed against interleukin-6 receptors (IL-6R).\nObjectives\nTo assess the effectiveness and safety of tocilizumab, given alone or with corticosteroids, compared with therapy without tocilizumab for treatment of GCA.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2020, Issue 1); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Science Information database (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). There were no date or language restrictions in the electronic search for trials. We last searched the electronic databases on 3 January 2020.\nSelection criteria\nWe included only randomized controlled trials (RCTs) that compared tocilizumab of any dosage regimen (alone or with corticosteroids) with therapy without tocilizumab that had a minimum follow-up of six months. Participants were at least 50 years of age, with biopsy-proven GCA or by large-vessel vasculitis by angiography, and met the American College of Rheumatology 1990 guidelines for GCA.\nData collection and analysis\nWe used standard Cochrane methodology.\nMain results\nMain results\nWe included two RCTs in the review. The studies were conducted in the USA, Canada, and Europe and enrolled a total of 281 participants with GCA, of whom 74% were women. The mean age of participants was 70 years, with new-onset or relapsing GCA, and fulfilled the 1990 American College of Rheumatology criteria with no uncontrolled comorbidities. Both studies were funded by F. Hoffmann-La Roche AG, the manufacturer of tocilizumab.\nFindings\nOne RCT (30 participants) compared tocilizumab administered every four weeks versus placebo. Point estimates at 12 months and beyond favored tocilizumab over placebo in terms of sustained remission (risk ratio (RR) 4.25, 95% confidence interval (CI) 1.21 to 14.88; moderate-certainty evidence). Point estimates suggest no evidence of a difference for all-cause mortality at 12 months or more (RR 0.17, 95% CI 0.01 to 3.94; moderate-certainty evidence). At 12 months, mean time to first relapse after induction of remission was 25 weeks in favor of participants receiving tocilizumab compared to placebo (mean difference (MD) 25, 95% CI 11.4 to 38.6; moderate-certainty evidence).\nThe second RCT (250 participants) randomized participants into two intervention and two comparator groups to receive tocilizumab weekly (100 participants), bi-weekly (49 participants), weekly placebo + 26-week taper (50 participants), or weekly placebo + 52-week taper (51 participants). At 12 months, point estimates from this study on proportion of participants with sustained remission favored participants who received tocilizumab weekly versus placebo + 52-week taper (RR 3.17, 95% CI 1.71 to 5.89; 151 participants); tocilizumab weekly versus placebo + 26-week taper (RR 4.00, 95% CI 1.97 to 8.12; 150 participants); tocilizumab every other week versus placebo + 52-week taper (RR 3.01, 95% CI 1.57 to 5.75; 100 participants); tocilizumab every other week versus placebo + 26-week taper (RR 3.79, 95% CI 1.82 to 7.91; 99 participants) (moderate-certainty evidence). Point estimates on proportion of participants who did not need escape therapy (defined by the study as the inability to keep to the protocol-defined prednisone taper) favored participants who received tocilizumab weekly versus placebo + 52-week taper (RR 1.71, 95% CI 1.24 to 2.35; 151 participants); tocilizumab weekly versus placebo + 26-week taper (RR 2.96, 95% CI 1.83 to 4.78; 150 participants); tocilizumab every other week versus placebo + 52-week taper (RR 1.49, 95% CI 1.04 to 2.14; 100 participants) but not tocilizumab every other week versus placebo + 26-week taper (RR 0.65, 95% CI 0.27 to 1.54; 99 participants) (moderate-certainty evidence). This study did not report mean time to first relapse after induction of remission or all-cause mortality.\nAcross comparison groups, the same study found no evidence of a difference in vision changes and inconsistent evidence with regard to quality of life. Evidence on quality of life as assessed by the physical (MD 8.17, 95% CI 4.44 to 11.90) and mental (MD 5.61, 95% CI 0.06 to 11.16) component score of the 36-Item Short Form Health Survey (SF-36) favored weekly tocilizumab versus placebo + 52-week taper but not bi-weekly tocillizumab versus placebo + 26-week taper (moderate-certainty evidence).\nAdverse events\nOne RCT reported a lower percentage of participants who experienced serious adverse events when receiving tocilizumab every four weeks versus placebo. The second RCT reported no evidence of a difference among groups with regard to adverse events; however, fewer participants reported serious adverse events in the tocilizumab weekly and tocilizumab biweekly interventions compared with the placebo + 26-week taper and placebo + 52-week taper comparators. Investigators in both studies reported that infection was the most frequently reported adverse event.\nAuthors' conclusions\nThis review indicates that tocilizumab therapy may be beneficial in terms of proportion of participants with sustained remission, relapse-free survival, and the need for escape therapy. While the evidence was of moderate certainty, only two studies were included in the review, suggesting that further research is required to corroborate these findings. Future trials should address issues related to the required duration of therapy, patient-reported outcomes such as quality of life and economic outcomes, as well as the clinical outcomes evaluated in this review.\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"
},
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"role": "assistant",
"content": "· People with giant cell arteritis who have an injection of tocilizumab every week or two weeks have an improved chance of being symptom-free after a year. People treated with tocilizumab every four weeks probably have an improved chance of being symptom-free after a year.\n· Tocilizumab probably causes similar numbers of adverse (unwanted) effects to a placebo (dummy treatment).\n· More studies are needed to strengthen the body of evidence and investigate whether duration of treatment affects the success of tocilizumab."
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query-laysum
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8407
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[
{
"role": "user",
"content": "Abstract: Background\nThe insertion of central venous catheters (CVCs) may be associated with peri- and post-procedural bleeding. People who require a central line often have disorders of coagulation as a result of their underlying illness, co-morbidities or the effects of treatment. Clinical practice in some institutions is to mitigate the risk of bleeding in these patients by prophylactically transfusing fresh frozen plasma (FFP) in order to correct clotting factor deficiencies prior to central line insertion. However, FFP transfusion is not without risk, and it remains unclear whether this intervention is associated with reduced rates of bleeding or other clinically-meaningful outcomes.\nObjectives\nTo assess the effect of different prophylactic plasma transfusion regimens prior to central line insertion in people with abnormal coagulation.\nSearch methods\nWe searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 3), PubMed (e-publications only), Ovid MEDLINE (from 1946), Ovid Embase (from 1974), the Transfusion Evidence Library (from 1950) and ongoing trial databases to 1 March 2016.\nSelection criteria\nWe included RCTs involving transfusions of plasma to prevent bleeding in people of any age with abnormal coagulation requiring insertion of a central venous catheter, published in English.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe identified four trials eligible for inclusion, of which three are ongoing. We did not exclude any studies because they were not published in English.\nThe included study randomised 81 adults in intensive care whose INR (International Normalised Ratio) was greater than or equal to 1.5 to no FFP or to a single dose of 12 mL/kg FFP prior to undergoing central venous catheterisation (58 participants) or other invasive procedure (23 participants). It is the subgroup of 58 adults undergoing CVC insertion that were included in this review, the study authors provided unpublished data for this review's outcomes.\nThe quality of the evidence was low or very low across different outcomes according to the GRADE methodology. The included study was at high risk of bias due to lack of blinding of participants and personnel and imbalance in the number of participants who had liver disease between study arms.\nThere was insufficient evidence to determine a difference in major procedure-related bleeding within 24 hours (one RCT; 58 participants; no events in either study arm, very low-quality evidence). We are very uncertain whether FFP reduces minor procedure-related bleeding within 24 hours of the study (one RCT; 58 participants, RR 0.67, 95% CI 0.12 to 3.70, very low-quality evidence).\nNo studies were found that looked at: all-cause mortality; the proportion of participants receiving plasma or red cell transfusions; serious adverse reactions (transfusion or line-related complications); number of days in hospital; change in INR; or quality of life.\nThe three ongoing studies are still recruiting participants (expected recruitment: up to 355 participants in total). and are due to be completed by February 2018.\nAuthors' conclusions\nThere is only very limited evidence from one RCT to inform the decision whether or not to administer prophylactic plasma prior to central venous catheterisation for people with abnormal coagulation. It is not possible from the current RCT evidence to recommend whether or not prophylactic plasma transfusion is beneficial or harmful in this situation. The three ongoing RCTs will not be able to answer this review’s questions, because they are small studies and do not address all of the comparisons included in this review (355 participants in total). To detect an increase in the proportion of participants who had major bleeding from 1 in 100 to 2 in 100 would require a study containing at least 4634 participants (80% power, 5% significance).\n\nGiven the provided abstract, please respond to the following query: \"Authors' conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The ongoing studies (expected to recruit 355 participants in total) will be unable to provide sufficient data for this review’s primary outcomes because major bleeding and mortality are uncommon. We would need to design a study with at least 4634 participants to be able to detect an increase in the number of people who had major bleeding from 1 in 100 to 2 in 100. It is not possible from the current randomised controlled trial evidence to recommend whether or not prophylactic plasma transfusion is beneficial or harmful in this situation."
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query-laysum
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8408
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[
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"role": "user",
"content": "Abstract: Background\nWendan decoction (WDD) is one of the classical Chinese herb formulas used for psychotic symptoms. It is thought to be safe, accessible and inexpensive.\nObjectives\nTo investigate the effects of WDD for treatment of people with schizophrenia or schizophrenia-like illness compared with placebo, antipsychotic drugs and other interventions for outcomes of clinical importance.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Trials Register (February 2016), which is based on regular searches of CINAHL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO, China biomedical databases group (SinoMed, CNKI, VIP, Wanfang) and clinical trials registries. There are no language, date, document type, or publication status limitations for inclusion of records in the register. We also inspected references of identified studies and contacted relevant authors for additional information.\nSelection criteria\nRandomised controlled trials with useable data comparing WDD with antipsychotics, placebo or other interventions for people with schizophrenia.\nData collection and analysis\nWe extracted data independently. For binary outcomes, we calculated risk ratios (RR) and 95% confidence intervals (CIs), on an intention-to-treat basis. For continuous data, we estimated mean differences (MD) between groups and their 95% CIs. We employed a random-effect model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE.\nMain results\nWe included 15 randomised trials (1437 participants) of WDD for schizophrenia. There was a high risk of performance bias within the trials but overall, risk for selection, attrition and reporting bias was low or unclear.\nData showed WDD improved the short-term global state of participants compared with placebo or no treatment (1 RCT n = 72, RR 0.53, 95% CI 0.39 to 0.73, low-quality evidence).\nWhen WDD was compared with antipsychotic drugs, such as chlorpromazine or risperidone, no difference in short-term global state of participants was observed (2 RCTs n = 140, RR 1.18 95% CI 0.98 to 1.43, moderate-quality evidence) and mental state (total endpoint Positive and Negative Syndrome Scale (PANSS): 2 RCTs, n = 140, MD 0.84, 95% CI -4.17 to 5.84, low-quality evidence). However, WDD was associated with fewer people experiencing extrapyramidal effects (EPS) compared with other treatments (2 RCTs 0/70 versus 47/70, n = 140, RR 0.02, 95% CI 0.00 to 0.15, moderate-quality evidence).\nWDD is often used as an add-on intervention alongside antipsychotics. When WDD + antipsychotic was compared to antipsychotic alone, the combination group had better global state (short-term results, 6 RCTs, n = 684, RR 0.60, 95% CI 0.50 to 0.72, moderate-quality evidence) and mental state (short-term total endpoint PANSS: 5 RCTs, n = 580, MD -11.64, 95% CI -13.33 to - 9.94, low-quality evidence), fewer people with EPS (2 RCTs n = 308, RR 0.46, 95% CI 0.30 to 0.70, moderate-quality evidence) and reduction of the mean use of risperidone (1 RCT n = 107, MD -0.70, 95% CI -0.87 to -0.53, low-quality evidence). But, there was no effect on weight gain (1 RCT n = 108, RR 0.50, 95% CI 0.20 to 1.24, low-quality evidence).\nWhen WDD + low-dose antipsychotic was compared with normal-dose antipsychotic alone, the combination again showed benefits for short-term global state (7 RCTs n = 522, RR 0.69, 95% CI 0.51 to 0.93, moderate-quality evidence), mental state (total endpoint PANSS: 4 RCTs n = 250, MD -9.53, 95% CI -17.82 to -1.24, low-quality evidence), and fewer participants with EPS (3 RCTS n = 280, RR 0.29, 95% CI 0.16 to 0.51, moderate-quality evidence).\nAcross all comparisons, we found no data on outcomes directly reporting quality of life, hospital service use and economics.\nAuthors' conclusions\nLimited evidence suggests that WDD may have some positive short-term antipsychotic global effects compared to placebo or no treatment. However when WDD was compared with other antipsychotics there was no effect on global or mental state, but WDD was associated with fewer adverse effects. When WDD was combined with an antipsychotic, positive effects were found for global and mental state and the combination caused fewer adverse effects. The available evidence is not high quality. Better designed large studies are needed to fully and fairly test the effects of WDD for people with schizophrenia.\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": "Is there trial-based evidence that a traditional Chinese herbal medicine, Wendan decoction (WDD) is effective for treatment of people with schizophrenia?"
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query-laysum
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8409
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[
{
"role": "user",
"content": "Abstract: Background\nThis is the first update of this review first published in 2009. When treating elevated blood pressure, doctors usually try to achieve a blood pressure target. That target is the blood pressure value below which the optimal clinical benefit is supposedly obtained. “The lower the better” approach that guided the treatment of elevated blood pressure for many years was challenged during the last decade due to lack of evidence from randomised trials supporting that strategy. For that reason, the standard blood pressure target in clinical practice during the last years has been less than 140/90 mm Hg for the general population of patients with elevated blood pressure. However, new trials published in recent years have reintroduced the idea of trying to achieve lower blood pressure targets. Therefore, it is important to know whether the benefits outweigh harms when attempting to achieve targets lower than the standard target.\nObjectives\nThe primary objective was to determine if lower blood pressure targets (any target less than or equal to 135/85 mm Hg) are associated with reduction in mortality and morbidity as compared with standard blood pressure targets (less than or equal to 140/ 90 mm Hg) for the treatment of patients with chronic arterial hypertension.\nThe secondary objectives were: to determine if there is a change in mean achieved systolic blood pressure (SBP) and diastolic blood pressure (DBP associated with \"lower targets\" as compared with \"standard targets\" in patients with chronic arterial hypertension; and to determine if there is a change in withdrawals due to adverse events with \"lower targets\" as compared with \"standard targets\", in patients with elevated blood pressure.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to May 2019: the Cochrane Hypertension Specialised Register, CENTRAL (2019, Issue 4), Ovid MEDLINE, Ovid Embase, the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. The searches had no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) comparing patients allocated to lower or to standard blood pressure targets (see above).\nData collection and analysis\nTwo review authors (JAA, VL) independently assessed the included trials and extracted data. Primary outcomes were total mortality; total serious adverse events; myocardial infarction, stroke, congestive heart failure, end stage renal disease, and other serious adverse events. Secondary outcomes were achieved mean SBP and DBP, withdrawals due to adverse effects, and mean number of antihypertensive drugs used. We assessed the risk of bias of each trial using the Cochrane risk of bias tool and the certainty of the evidence using the GRADE approach.\nMain results\nThis update includes 11 RCTs involving 38,688 participants with a mean follow-up of 3.7 years. This represents 7 new RCTs compared with the original version.\nAt baseline the mean weighted age was 63.1 years and the mean weighted blood pressure was 155/91 mm Hg.\nLower targets do not reduce total mortality (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.86 to 1.05; 11 trials, 38,688 participants; high-certainty evidence) and do not reduce total serious adverse events (RR 1.04, 95% CI 0.99 to 1.08; 6 trials, 18,165 participants; moderate-certainty evidence). This means that the benefits of lower targets do not outweigh the harms as compared to standard blood pressure targets. Lower targets may reduce myocardial infarction (RR 0.84, 95% CI 0.73 to 0.96; 6 trials, 18,938 participants, absolute risk reduction (ARR) 0.4%, number needed to treat to benefit (NNTB) 250 over 3.7 years) and congestive heart failure (RR 0.75, 95% CI 0.60 to 0.92; 5 trials, 15,859 participants, ARR 0.6%, NNTB 167 over 3.7 years) (low-certainty for both outcomes). Reduction in myocardial infarction and congestive heart failure was not reflected in total serious adverse events. This may be due to an increase in other serious adverse events (RR 1.44, 95% CI 1.32 to 1.59; 6 trials. 18,938 participants, absolute risk increase (ARI) 3%, number needed to treat to harm (NNTH) 33 over four years) (low-certainty evidence).\nParticipants assigned to a \"lower” target received one additional antihypertensive medication and achieved a significantly lower mean SBP (122.8 mm Hg versus 135.0 mm Hg, and a lower mean DBP (82.0 mm Hg versus 85.2 mm Hg, than those assigned to \"standard target\".\nAuthors' conclusions\nFor the general population of persons with elevated blood pressure, the benefits of trying to achieve a lower blood pressure target rather than a standard target (≤ 140/90 mm Hg) do not outweigh the harms associated with that intervention. Further research is needed to see if some groups of patients would benefit or be harmed by lower targets. The results of this review are primarily applicable to older people with moderate to high cardiovascular risk. They may not be applicable to other populations.\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": "The only significant benefits in the group assigned to 'lower' blood pressure targets was a small reduction in the incidence of heart attack and a small reduction in the incidence of congestive heart failure. However, the lower target group had an increase in the number of other serious adverse events. High-certainty evidence showed there was no difference in death from any cause or total serious adverse events with lower as compared to standard blood pressure targets. .\nFor the general population of persons with elevated blood pressure the small benefits of trying to achieve a lower blood pressure target rather than a standard target (≤ 140/90 mm Hg) do not outweigh the harms. Further research is needed to see if some groups of patients would benefit or be harmed by lower targets."
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query-laysum
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8410
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[
{
"role": "user",
"content": "Abstract: Background\nAtopic dermatitis (AD) (or atopic eczema) is a chronic inflammatory skin condition that affects children and adults and has an important impact on quality of life. Topical corticosteroids (TCS) are the first-line therapy for this condition; however, they can be associated with significant adverse effects when used chronically. Tacrolimus ointment (in its 2 manufactured strengths of 0.1% and 0.03%) might be an alternative treatment. Tacrolimus, together with pimecrolimus, are drugs called topical calcineurin inhibitors (TCIs).\nObjectives\nTo assess the efficacy and safety of topical tacrolimus for moderate and severe atopic dermatitis compared with other active treatments.\nSearch methods\nWe searched the following databases up to 3 June 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 5, 2015), MEDLINE (from 1946), EMBASE (from 1974), LILACS (from 1982), and the Global Resource of Eczema Trials (GREAT database). We searched six trials registers and checked the bibliographies of included studies for further references to relevant trials. We contacted specialists in the field for unpublished data.\nA separate search for adverse effects of topical tacrolimus was undertaken in MEDLINE and EMBASE on 30 July 2013. We also scrutinised the U.S. Food and Drug Administration (FDA) websites for adverse effects information.\nSelection criteria\nAll randomised controlled trials (RCTs) of participants with moderate to severe atopic dermatitis (both children and adults) using topical tacrolimus at any dose, course duration, and follow-up time compared with other active treatments.\nData collection and analysis\nTwo authors independently screened and examined the full text of selected studies for compliance with eligibility criteria, risk of bias, and data extraction. Our three prespecified primary outcomes were physician's assessment, participant's self-assessment of improvement, and adverse effects. Our secondary outcomes included assessment of improvement of the disease by validated or objective measures, such as SCORAD (SCORing Atopic Dermatitis), the EASI (Eczema Area and Severity Index), and BSA (Body Surface Area) scores.\nMain results\nWe included 20 studies, with 5885 participants. The variability of drug doses, outcomes, and follow-up periods made it difficult to carry out meta-analyses.\nA single trial showed that tacrolimus 0.1% was better than low-potency TCS by the physician's assessment (risk ratio (RR) 3.09, 95% confidence interval (CI) 2.14 to 4.45, 1 study, n = 371, moderate-quality evidence). It was also marginally better than low-potency TCS on face and neck areas and moderate-potency TCS on the trunk and extremities by the physician's assessment (RR 1.32, 95% CI 1.17 to 1.49, 1 study, n = 972, moderate level of evidence) and for some of the secondary outcomes. Compared with pimecrolimus 1%, people treated with tacrolimus were almost twice as likely to improve by the physician's assessment (RR 1.80, 95% CI 1.34 to 2.42, 2 studies, n = 506, moderate quality of evidence). Compared with the lower concentration of 0.03%, the tacrolimus 0.1% formulation reduced the risk of not having an improvement by 18% as evaluated by the physician's assessment (RR 0.82, 95% CI 0.72 to 0.92, 6 studies, n = 1640, high-quality evidence). Tacrolimus 0.1% compared with moderate-to-potent TCS showed no difference by the physician's assessment, and 2 secondary outcomes (1 study, 377 participants) and a marginal benefit favouring tacrolimus 0.1% was found by the participant's assessment (RR 1.21, 95% CI 1.13 to 1.29, 1 study, n = 974, low quality of evidence) and SCORAD.\nBased on data from 2 trials, tacrolimus 0.03% was superior to mild TCS for the physician's assessment (RR 2.58, 95% CI 1.96 to 3.38, 2 studies, n = 790, moderate-quality evidence) and the participant's self-assessment (RR 1.64, 95% CI 1.41 to 1.90, 1 study, n = 416, moderate quality of evidence). One trial showed moderate benefit of tacrolimus 0.03% compared with pimecrolimus 1% on the physician's assessment (RR 1.42, 95% CI 1.02 to 1.98, 1 study, n = 139, low-quality evidence), but the effects were equivocal when evaluating BSA. In the comparison of tacrolimus 0.03% with moderate-to-potent corticosteroids, no difference was found in most of the outcomes measured (including physician's and participant's assessment and also for the secondary outcomes), but in two studies, a marginal benefit favouring the corticosteroid group was found for the EASI and BSA scores.\nBurning was more frequent in those using calcineurin inhibitors than those using corticosteroid tacrolimus 0.03% (RR 2.48, 95% CI 1.96 to 3.14, 5 studies, 1883 participants, high-quality evidence), but no difference was found for skin infections. Symptoms observed were mild and transient. The comparison between the two calcineurin inhibitors (pimecrolimus and tacrolimus) showed the same overall incidence of adverse events, but with a small difference in the frequency of local effects.\nSerious adverse events were rare; occurred in both the tacrolimus and corticosteroid groups; and in most cases, were considered to be unrelated to the treatment. No cases of lymphoma were noted in the included studies nor in the non-comparative studies. Cases were only noted in spontaneous reports, cohorts, and case-control studies. Systemic absorption was rarely detectable, only in low levels, and this decreased with time. Exception is made for diseases with severe barrier defects, such as Netherton's syndrome, lamellar ichthyosis, and a few others, with case reports of a higher absorption. We evaluated clinical trials; case reports; and in vivo, in vitro, and animal studies; and didn't find any evidence that topical tacrolimus could cause skin atrophy.\nAuthors' conclusions\nTacrolimus 0.1% was better than low-potency corticosteroids, pimecrolimus 1%, and tacrolimus 0.03%. Results were equivocal when comparing both dose formulations to moderate-to-potent corticosteroids. Tacrolimus 0.03% was superior to mild corticosteroids and pimecrolimus. Both tacrolimus formulations seemed to be safe, and no evidence was found to support the possible increased risk of malignancies or skin atrophy with their use. The reliability and strength of the evidence was limited by the lack of data; thus, findings of this review should be interpreted with caution. We did not evaluate costs.\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 tacrolimus 0.1% to be better than low-potency TCS on the face and neck areas and moderate-potency TCS on the trunk and extremities. We evaluated the physician's assessment of pimecrolimus 1% and tacrolimus 0.03% in most of the studies. When compared with moderate-to-potent corticosteroids, there was a marginal benefit favouring tacrolimus 0.1% by the participant's self-assessment and SCORAD.\nCombined results of 2 studies indicated that tacrolimus 0.03% more than doubled the chance of achieving improvement by the physician's assessment compared with mild TCS. Another study found tacrolimus 0.03% to be better than pimecrolimus 1% for the same outcome, while no difference was found on the body surface area of skin affected with disease. For the comparison with moderate-to-potent corticosteroids, we found no significant difference in most of the results, but in two studies, we found a slight difference favouring the corticosteroids group.\nBurning and itching were more frequent in those using tacrolimus than TCS, but we found no difference in skin infection. Symptoms were mild and temporary. The comparison between pimecrolimus and tacrolimus showed the same overall frequency of side-effects, with local side-effects being more frequent in the tacrolimus groups. Tacrolimus also showed a longer duration of the local symptoms, between 30 minutes and 12 hours, while pimecrolimus users experienced symptoms for less than 30 minutes.\nSerious adverse events were rare, occurred both in tacrolimus and TCS groups, and were considered to be unrelated to treatment in most instances. No cases of lymphoma (a type of cancer of the lymph nodes) were noted in the included studies nor in the non-comparative studies. Cases were only noted retrospectively in studies and reports, with no confirmed relation to the drug.\nSystemic absorption (substance entering the bloodstream) was rarely detectable, only in low levels and decreased with time. Only in diseases with severe skin barrier problems, such as Netherton's syndrome, lamellar ichthyosis (rare genetic disorders), and a few others, were there case reports of systemic absorption.\nAfter evaluating clinical trials, case reports, human and animal studies, we found a lack of evidence associating the use of topical tacrolimus with skin thinning.\nIn summary, tacrolimus ointment seems to be safe and effective for moderate to severe atopic dermatitis in children and adults. It should be used with caution, though, in those having diseases with a severely damaged skin barrier. We found no risk of skin thinning with its use, even for longer periods. We did not find any evidence associating a risk of malignancies with the use of topical tacrolimus. We did not evaluate costs in this review."
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query-laysum
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8411
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[
{
"role": "user",
"content": "Abstract: Background\nVarious techniques have been employed for the early detection of perioperative cerebral ischaemia and hypoxia. Cerebral near-infrared spectroscopy (NIRS) is increasingly used in this clinical scenario to monitor brain oxygenation. However, it is unknown whether perioperative cerebral NIRS monitoring and the subsequent treatment strategies are of benefit to patients.\nObjectives\nTo assess the effects of perioperative cerebral NIRS monitoring and corresponding treatment strategies in adults and children, compared with blinded or no cerebral oxygenation monitoring, or cerebral oxygenation monitoring based on non-NIRS technologies, on the detection of cerebral oxygen desaturation events (CDEs), neurological outcomes, non-neurological outcomes and socioeconomic impact (including cost of hospitalization and length of hospital stay).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 12), Embase (1974 to 20 December 2016) and MEDLINE (PubMed) (1975 to 20 December 2016). We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform for ongoing studies on 20 December 2016. We updated this search in November 2017, but these results have not yet been incorporated in the review. We imposed no language restriction.\nSelection criteria\nWe included all relevant randomized controlled trials (RCTs) dealing with the use of cerebral NIRS in the perioperative setting (during the operation and within 72 hours after the operation), including the operating room, the postanaesthesia care unit and the intensive care unit.\nData collection and analysis\nTwo authors independently selected studies, assessed risk of bias and extracted data. For binary outcomes, we calculated the risk ratio (RR) and its 95% confidence interval (CI). For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. As we expected clinical and methodological heterogeneity between studies, we employed a random-effects model for analyses and we examined the data for heterogeneity (I2 statistic). We created a 'Summary of findings' table using GRADEpro.\nMain results\nWe included 15 studies in the review, comprising a total of 1822 adult participants. There are 12 studies awaiting classification, and eight ongoing studies.\nNone of the 15 included studies considered the paediatric population. Four studies were conducted in the abdominal and orthopaedic surgery setting (lumbar spine, or knee and hip replacement), one study in the carotid endarterectomy setting, and the remaining 10 studies in the aortic or cardiac surgery setting. The main sources of bias in the included studies related to potential conflict of interest from industry sponsorship, unclear blinding status or missing participant data.\nTwo studies with 312 participants considered postoperative neurological injury, however no pooled effect estimate could be calculated due to discordant direction of effect between studies (low-quality evidence). One study (N = 126) in participants undergoing major abdominal surgery reported that 4/66 participants experienced neurological injury with blinded monitoring versus 0/56 in the active monitoring group. A second study (N = 195) in participants having coronary artery bypass surgery reported that 1/96 participants experienced neurological injury in the blinded monitoring group compared with 4/94 participants in the active monitoring group.\nWe are uncertain whether active cerebral NIRS monitoring has an important effect on the risk of postoperative stroke because of the low number of events and wide confidence interval (RR 0.25, 95% CI 0.03 to 2.20; 2 studies, 240 participants; low-quality evidence).\nWe are uncertain whether active cerebral NIRS monitoring has an important effect on postoperative delirium because of the wide confidence interval (RR 0.63, 95% CI 0.27 to 1.45; 1 study, 190 participants; low-quality evidence).\nTwo studies with 126 participants showed that active cerebral NIRS monitoring may reduce the incidence of mild postoperative cognitive dysfunction (POCD) as defined by the original studies at one week after surgery (RR 0.53, 95% CI 0.30 to 0.95, I2 = 49%, low-quality evidence).\nBased on six studies with 962 participants, there was moderate-quality evidence that active cerebral oxygenation monitoring probably does not decrease the occurrence of POCD (decline in cognitive function) at one week after surgery (RR 0.62, 95% CI 0.37 to 1.04, I2 = 80%). The different type of monitoring equipment in one study could potentially be the cause of the heterogeneity.\nWe are uncertain whether active cerebral NIRS monitoring has an important effect on intraoperative mortality or postoperative mortality because of the low number of events and wide confidence interval (RR 0.63, 95% CI 0.08 to 5.03, I2= 0%; 3 studies, 390 participants; low-quality evidence). There was no evidence to determine whether routine use of NIRS-based cerebral oxygenation monitoring causes adverse effects.\nAuthors' conclusions\nThe effects of perioperative active cerebral NIRS monitoring of brain oxygenation in adults for reducing the occurrence of short-term, mild POCD are uncertain due to the low quality of the evidence. There is uncertainty as to whether active cerebral NIRS monitoring has an important effect on postoperative stroke, delirium or death because of the low number of events and wide confidence intervals. The conclusions of this review may change when the eight ongoing studies are published and the 12 studies awaiting assessment are classified. More RCTs performed in the paediatric population and high-risk patients undergoing non-cardiac surgery (e.g. neurosurgery, carotid endarterectomy and other surgery) are needed.\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": "The human brain needs a lot of oxygen (has a high oxygen consumption) and is very sensitive to reduced oxygen supply. Successful treatment for low levels of oxygen in the brain during or after surgery relies on early diagnosis of a lack of oxygen. Cerebral NIRS is increasingly used for the early detection of lack of oxygen to the brain. It uses near-infrared light (700 to 1000 nanometres) to penetrate through the superficial layers of the head, including the scalp and the skull, to show the cerebral tissue."
}
] |
query-laysum
|
8412
|
[
{
"role": "user",
"content": "Abstract: Background\nThe number of people with type 2 diabetes mellitus (T2DM) is increasing worldwide. The combination of metformin and sulphonylurea (M+S) is a widely used treatment. Whether M+S shows better or worse effects in comparison with other antidiabetic medications for people with T2DM is still controversial.\nObjectives\nTo assess the effects of metformin and sulphonylurea (second- or third-generation) combination therapy for adults with type 2 diabetes mellitus.\nSearch methods\nWe updated the search of a recent systematic review from the Agency for Healthcare Research and Quality (AHRQ). The updated search included CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and WHO ICTRP. The date of the last search was March 2018. We searched manufacturers' websites and reference lists of included trials, systematic reviews, meta-analyses and health technology assessment reports. We asked investigators of the included trials for information about additional trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) randomising participants 18 years old or more with T2DM to M+S compared with metformin plus another glucose-lowering intervention or metformin monotherapy with a treatment duration of 52 weeks or more.\nData collection and analysis\nTwo review authors read all abstracts and full-text articles and records, assessed risk of bias and extracted outcome data independently. We used a random-effects model to perform meta-analysis, and calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the certainty of the evidence using the GRADE instrument.\nMain results\nWe included 32 RCTs randomising 28,746 people. Treatment duration ranged between one to four years. We judged none of these trials as low risk of bias for all 'Risk of bias' domains. Most important events per person were all-cause and cardiovascular mortality, serious adverse events (SAE), non-fatal stroke (NFS), non-fatal myocardial infarction (MI) and microvascular complications. Most important comparisons were as follows:\nFive trials compared M+S (N = 1194) with metformin plus a glucagon-like peptide 1 analogue (N = 1675): all-cause mortality was 11/1057 (1%) versus 11/1537 (0.7%), risk ratio (RR) 1.15 (95% confidence interval (CI) 0.49 to 2.67); 3 trials; 2594 participants; low-certainty evidence; cardiovascular mortality 1/307 (0.3%) versus 1/302 (0.3%), low-certainty evidence; serious adverse events (SAE) 128/1057 (12.1%) versus 194/1537 (12.6%), RR 0.90 (95% CI 0.73 to 1.11); 3 trials; 2594 participants; very low-certainty evidence; non-fatal myocardial infarction (MI) 2/549 (0.4%) versus 6/1026 (0.6%), RR 0.57 (95% CI 0.12 to 2.82); 2 trials; 1575 participants; very low-certainty evidence.\nNine trials compared M+S (N = 5414) with metformin plus a dipeptidyl-peptidase 4 inhibitor (N = 6346): all-cause mortality was 33/5387 (0.6%) versus 26/6307 (0.4%), RR 1.32 (95% CI 0.76 to 2.28); 9 trials; 11,694 participants; low-certainty evidence; cardiovascular mortality 11/2989 (0.4%) versus 9/3885 (0.2%), RR 1.54 (95% CI 0.63 to 3.79); 6 trials; 6874 participants; low-certainty evidence; SAE 735/5387 (13.6%) versus 779/6307 (12.4%), RR 1.07 (95% CI 0.97 to 1.18); 9 trials; 11,694 participants; very low-certainty evidence; NFS 14/2098 (0.7%) versus 8/2995 (0.3%), RR 2.21 (95% CI 0.74 to 6.58); 4 trials; 5093 participants; very low-certainty evidence; non-fatal MI 15/2989 (0.5%) versus 13/3885 (0.3%), RR 1.45 (95% CI 0.69 to 3.07); 6 trials; 6874 participants; very low-certainty evidence; one trial in 64 participants reported no microvascular complications were observed (very low-certainty evidence).\nEleven trials compared M+S (N = 3626) with metformin plus a thiazolidinedione (N = 3685): all-cause mortality was 123/3300 (3.7%) versus 114/3354 (3.4%), RR 1.09 (95% CI 0.85 to 1.40); 6 trials; 6654 participants; low-certainty evidence; cardiovascular mortality 37/2946 (1.3%) versus 41/2994 (1.4%), RR 0.78 (95% CI 0.36 to 1.67); 4 trials; 5940 participants; low-certainty evidence; SAE 666/3300 (20.2%) versus 671/3354 (20%), RR 1.01 (95% CI 0.93 to 1.11); 6 trials; 6654 participants; very low-certainty evidence; NFS 20/1540 (1.3%) versus 16/1583 (1%), RR 1.29 (95% CI 0.67 to 2.47); P = 0.45; 2 trials; 3123 participants; very low-certainty evidence; non-fatal MI 25/1841 (1.4%) versus 21/1877 (1.1%), RR 1.21 (95% CI 0.68 to 2.14); P = 0.51; 3 trials; 3718 participants; very low-certainty evidence; three trials (3123 participants) reported no microvascular complications (very low-certainty evidence).\nThree trials compared M+S (N = 462) with metformin plus a glinide (N = 476): one person died in each intervention group (3 trials; 874 participants; low-certainty evidence); no cardiovascular mortality (2 trials; 446 participants; low-certainty evidence); SAE 34/424 (8%) versus 27/450 (6%), RR 1.68 (95% CI 0.54 to 5.21); P = 0.37; 3 trials; 874 participants; low-certainty evidence; no NFS (1 trial; 233 participants; very low-certainty evidence); non-fatal MI 2/215 (0.9%) participants in the M+S group; 2 trials; 446 participants; low-certainty evidence; no microvascular complications (1 trial; 233 participants; low-certainty evidence).\nFour trials compared M+S (N = 2109) with metformin plus a sodium-glucose co-transporter 2 inhibitor (N = 3032): all-cause mortality was 13/2107 (0.6%) versus 19/3027 (0.6%), RR 0.96 (95% CI 0.44 to 2.09); 4 trials; 5134 participants; very low-certainty evidence; cardiovascular mortality 4/1327 (0.3%) versus 6/2262 (0.3%), RR 1.22 (95% CI 0.33 to 4.41); 3 trials; 3589 participants; very low-certainty evidence; SAE 315/2107 (15.5%) versus 375/3027 (12.4%), RR 1.02 (95% CI 0.76 to 1.37); 4 trials; 5134 participants; very low-certainty evidence; NFS 3/919 (0.3%) versus 7/1856 (0.4%), RR 0.87 (95% CI 0.22 to 3.34); 2 trials; 2775 participants; very low-certainty evidence; non-fatal MI 7/890 (0.8%) versus 8/1374 (0.6%), RR 1.43 (95% CI 0.49 to 4.18; 2 trials); 2264 participants; very low-certainty evidence; amputation of lower extremity 1/437 (0.2%) versus 1/888 (0.1%); very low-certainty evidence.\nTrials reported more hypoglycaemic episodes with M+S combination compared to all other metformin-antidiabetic agent combinations. Results for M+S versus metformin monotherapy were inconclusive. There were no RCTs comparing M+S with metformin plus insulin. We identified nine ongoing trials and two trials are awaiting assessment. Together these trials will include approximately 16,631 participants.\nAuthors' conclusions\nThere is inconclusive evidence whether M+S combination therapy compared with metformin plus another glucose-lowering intervention results in benefit or harm for most patient-important outcomes (mortality, SAEs, macrovascular and microvascular complications) with the exception of hypoglycaemia (more harm for M+S combination). No RCT reported on health-related quality of life.\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": "Data on patient-important outcomes were few, and data were sparse for all comparisons of metformin plus sulphonylurea with other antidiabetic medications. The available data did not show firm differences between metformin plus sulphonylurea and other combinations of metformin with antidiabetic drugs or metformin only for most patient-important outcomes. There were more events with low blood sugar (hypoglycaemic episodes) with metformin plus sulphonylurea combination treatment compared to all other combinations of metformin with another antidiabetic compound.\nWe did not identify studies reporting on health-related quality of life. We identified nine ongoing studies and two yet unpublished studies are awaiting assessment. Together these studies will include around 16,631 participants. Once results are published these studies could significantly influence the findings of our review."
}
] |
query-laysum
|
8413
|
[
{
"role": "user",
"content": "Abstract: Background\nIntensive care unit (ICU) acquired or generalised weakness due to critical illness myopathy (CIM) and polyneuropathy (CIP) are major causes of chronically impaired motor function that can affect activities of daily living and quality of life. Physical rehabilitation of those affected might help to improve activities of daily living.\nObjectives\nOur primary objective was to assess the effects of physical rehabilitation therapies and interventions for people with CIP and CIM in improving activities of daily living such as walking, bathing, dressing and eating. Secondary objectives were to assess effects on muscle strength and quality of life, and to assess adverse effects of physical rehabilitation.\nSearch methods\nOn 16 July 2014 we searched the Cochrane Neuromuscular Disease Group Specialized Register and on 14 July 2014 we searched CENTRAL, MEDLINE, EMBASE and CINAHL Plus. In July 2014, we searched the Physiotherapy Evidence Database (PEDro, http://www.pedro.org.au/) and three trials registries for ongoing trials and further data about included studies. There were no language restrictions. We also handsearched relevant conference proceedings and screened reference lists to identify further trials.\nSelection criteria\nWe planned to include randomised controlled trials (RCTs), quasi-RCTs and randomised controlled cross-over trials of any rehabilitation intervention in people with acquired weakness syndrome due to CIP/CIM.\nData collection and analysis\nWe would have extracted data, assessed the risk of bias and classified the quality of evidence for outcomes in duplicate, according to the standard procedures of The Cochrane Collaboration. Outcome data collection would have been for activities of daily living (for example, mobility, walking, transfers and self care). Secondary outcomes included muscle strength, quality of life and adverse events.\nMain results\nThe search strategy retrieved 3587 references. After examination of titles and abstracts, we retrieved the full text of 24 potentially relevant studies. None of these studies met the inclusion criteria of our review. No data were suitable to be included in a meta-analysis.\nAuthors' conclusions\nThere are no published RCTs or quasi-RCTs that examine whether physical rehabilitation interventions improve activities of daily living for people with CIP and CIM. Large RCTs, which are feasible, need to be conducted to explore the role of physical rehabilitation interventions for people with CIP and CIM.\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": "Currently there are no RCTs that test whether physical rehabilitation improves activities of daily living for people with CIM/CIP. Well-conducted research is required to determine the effects of rehabilitation in CIM/CIP.\nThis evidence is up to date to July 2014."
}
] |
query-laysum
|
8414
|
[
{
"role": "user",
"content": "Abstract: Background\nAlthough research on non-surgical treatments for neck pain (NP) is progressing, there remains uncertainty about the efficacy of cognitive-behavioural therapy (CBT) for this population. Addressing cognitive and behavioural factors might reduce the clinical burden and the costs of NP in society.\nObjectives\nTo assess the effects of CBT among individuals with subacute and chronic NP. Specifically, the following comparisons were investigated: (1) cognitive-behavioural therapy versus placebo, no treatment, or waiting list controls; (2) cognitive-behavioural therapy versus other types of interventions; (3) cognitive-behavioural therapy in addition to another intervention (e.g. physiotherapy) versus the other intervention alone.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, SCOPUS, Web of Science, and PubMed, as well as ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform up to November 2014. Reference lists and citations of identified trials and relevant systematic reviews were screened.\nSelection criteria\nWe included randomised controlled trials that assessed the use of CBT in adults with subacute and chronic NP.\nData collection and analysis\nTwo review authors independently assessed the risk of bias in each study and extracted the data. If sufficient homogeneity existed among studies in the pre-defined comparisons, a meta-analysis was performed. We determined the quality of the evidence for each comparison with the GRADE approach.\nMain results\nWe included 10 randomised trials (836 participants) in this review. Four trials (40%) had low risk of bias, the remaining 60% of trials had a high risk of bias.\nThe quality of the evidence for the effects of CBT on patients with chronic NP was from very low to moderate. There was low quality evidence that CBT was better than no treatment for improving pain (standard mean difference (SMD) -0.58, 95% confidence interval (CI) -1.01 to -0.16), disability (SMD -0.61, 95% CI -1.21 to -0.01), and quality of life (SMD -0.93, 95% CI -1.54 to -0.31) at short-term follow-up, while there was from very low to low quality evidence of no effect on various psychological indicators at short-term follow-up. Both at short- and intermediate-term follow-up, CBT did not affect pain (SMD -0.06, 95% CI -0.33 to 0.21, low quality, at short-term follow-up; MD -0.89, 95% CI -2.73 to 0.94, low quality, at intermediate-term follow-up) or disability (SMD -0.10, 95% CI -0.40 to 0.20, moderate quality, at short-term follow-up; SMD -0.24, 95% CI-0.54 to 0.07, moderate quality, at intermediate-term follow-up) compared to other types of interventions. There was moderate quality evidence that CBT was better than other interventions for improving kinesiophobia at intermediate-term follow-up (SMD -0.39, 95% CI -0.69 to -0.08, I2 = 0%). Finally, there was very low quality evidence that CBT in addition to another intervention did not differ from the other intervention alone in terms of effect on pain (SMD -0.36, 95% CI -0.73 to 0.02) and disability (SMD -0.10, 95% CI -0.56 to 0.36) at short-term follow-up.\nFor patients with subacute NP, there was low quality evidence that CBT was better than other interventions at reducing pain at short-term follow-up (SMD -0.24, 95% CI -0.48 to 0.00), while no difference was found in terms of effect on disability (SMD -0.12, 95% CI -0.36 to 0.12) and kinesiophobia.\nNone of the included studies reported on adverse effects.\nAuthors' conclusions\nWith regard to chronic neck pain, CBT was found to be statistically significantly more effective for short-term pain reduction only when compared to no treatment, but these effects could not be considered clinically meaningful. When comparing both CBT to other types of interventions and CBT in addition to another intervention to the other intervention alone, no differences were found. For patients with subacute NP, CBT was significantly better than other types of interventions at reducing pain at short-term follow-up, while no difference was found for disability and kinesiophobia. Further research is recommended to investigate the long-term benefits and risks of CBT including for the different subgroups of subjects with NP.\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 examined the research published up to November 2014. We included 10 randomised trials (836 participants). Two studies included subjects with subacute NP (337 participants), while the other eight studies included participants with chronic NP (499 participants). CBTwas compared to no treatment (225 participants) or to other types of treatments (506 participants), or combined with another intervention (e.g. physiotherapy) and compared to the other intervention alone (200 participants). The interventions were carried out at primary and secondary health care centres."
}
] |
query-laysum
|
8415
|
[
{
"role": "user",
"content": "Abstract: Background\nPyrethroid long-lasting insecticidal nets (LLINs) have been important in the large reductions in malaria cases in Africa, but insecticide resistance in Anopheles mosquitoes threatens their impact. Insecticide synergists may help control insecticide-resistant populations. Piperonyl butoxide (PBO) is such a synergist; it has been incorporated into pyrethroid-LLINs to form pyrethroid-PBO nets, which are currently produced by five LLIN manufacturers and, following a recommendation from the World Health Organization (WHO) in 2017, are being included in distribution campaigns. This review examines epidemiological and entomological evidence on the addition of PBO to pyrethroid nets on their efficacy.\nObjectives\nTo compare effects of pyrethroid-PBO nets currently in commercial development or on the market with effects of their non-PBO equivalent in relation to:\n1. malaria parasite infection (prevalence or incidence); and\n2. entomological outcomes.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group (CIDG) Specialized Register, CENTRAL, MEDLINE, Embase, Web of Science, CAB Abstracts, and two clinical trial registers (ClinicalTrials.gov and WHO International Clinical Trials Registry Platform) up to 25 September 2020. We contacted organizations for unpublished data. We checked the reference lists of trials identified by these methods.\nSelection criteria\nWe included experimental hut trials, village trials, and randomized controlled trials (RCTs) with mosquitoes from the Anopheles gambiae complex or the Anopheles funestus group.\nData collection and analysis\nTwo review authors assessed each trial for eligibility, extracted data, and determined the risk of bias for included trials. We resolved disagreements through discussion with a third review author. We analysed data using Review Manager 5 and assessed the certainty of evidence using the GRADE approach.\nMain results\nSixteen trials met the inclusion criteria: 10 experimental hut trials, four village trials, and two cluster-RCTs (cRCTs). Three trials are awaiting classification, and four trials are ongoing.\nTwo cRCTs examined the effects of pyrethroid-PBO nets on parasite prevalence in people living in areas with highly pyrethroid-resistant mosquitoes (< 30% mosquito mortality in discriminating dose assays). At 21 to 25 months post intervention, parasite prevalence was lower in the intervention arm (odds ratio (OR) 0.79, 95% confidence interval (CI) 0.67 to 0.95; 2 trials, 2 comparisons; moderate-certainty evidence).\nIn highly pyrethroid-resistant areas, unwashed pyrethroid-PBO nets led to higher mosquito mortality compared to unwashed standard-LLINs (risk ratio (RR) 1.84, 95% CI 1.60 to 2.11; 14,620 mosquitoes, 5 trials, 9 comparisons; high-certainty evidence) and lower blood feeding success (RR 0.60, 95% CI 0.50 to 0.71; 14,000 mosquitoes, 4 trials, 8 comparisons; high-certainty evidence). However, in comparisons of washed pyrethroid-PBO nets to washed LLINs, we do not know if PBO nets had a greater effect on mosquito mortality (RR 1.20, 95% CI 0.88 to 1.63; 10,268 mosquitoes, 4 trials, 5 comparisons; very low-certainty evidence), although the washed pyrethroid-PBO nets did decrease blood-feeding success compared to standard-LLINs (RR 0.81, 95% CI 0.72 to 0.92; 9674 mosquitoes, 3 trials, 4 comparisons; high-certainty evidence).\nIn areas where pyrethroid resistance is moderate (31% to 60% mosquito mortality), mosquito mortality was higher with unwashed pyrethroid-PBO nets compared to unwashed standard-LLINs (RR 1.68, 95% CI 1.33 to 2.11; 1007 mosquitoes, 2 trials, 3 comparisons; moderate-certainty evidence), but there was little to no difference in effects on blood-feeding success (RR 0.90, 95% CI 0.72 to 1.11; 1006 mosquitoes, 2 trials, 3 comparisons; moderate-certainty evidence). For washed pyrethroid-PBO nets compared to washed standard-LLINs, we found little to no evidence for higher mosquito mortality or reduced blood feeding (mortality: RR 1.07, 95% CI 0.74 to 1.54; 329 mosquitoes, 1 trial, 1 comparison, low-certainty evidence; blood feeding success: RR 0.91, 95% CI 0.74 to 1.13; 329 mosquitoes, 1 trial, 1 comparison; low-certainty evidence).\nIn areas where pyrethroid resistance is low (61% to 90% mosquito mortality), studies reported little to no difference in the effects of unwashed pyrethroid-PBO nets compared to unwashed standard-LLINs on mosquito mortality (RR 1.25, 95% CI 0.99 to 1.57; 1580 mosquitoes, 2 trials, 3 comparisons; moderate-certainty evidence), and we do not know if there was any effect on blood-feeding success (RR 0.75, 95% CI 0.27 to 2.11; 1580 mosquitoes, 2 trials, 3 comparisons; very low-certainty evidence). For washed pyrethroid-PBO nets compared to washed standard-LLINs, we do not know if there was any difference in mosquito mortality (RR 1.39, 95% CI 0.95 to 2.04; 1774 mosquitoes, 2 trials, 3 comparisons; very low-certainty evidence) or on blood feeding (RR 1.07, 95% CI 0.49 to 2.33; 1774 mosquitoes, 2 trials, 3 comparisons; low-certainty evidence).\nIn areas where mosquito populations are susceptible to insecticides (> 90% mosquito mortality), there may be little to no difference in the effects of unwashed pyrethroid-PBO nets compared to unwashed standard-LLINs on mosquito mortality (RR 1.20, 95% CI 0.64 to 2.26; 2791 mosquitoes, 2 trials, 2 comparisons; low-certainty evidence). This is similar for washed nets (RR 1.07, 95% CI 0.92 to 1.25; 2644 mosquitoes, 2 trials, 2 comparisons; low-certainty evidence). We do not know if unwashed pyrethroid-PBO nets had any effect on the blood-feeding success of susceptible mosquitoes (RR 0.52, 95% CI 0.12 to 2.22; 2791 mosquitoes, 2 trials, 2 comparisons; very low-certainty evidence). The same applies to washed nets (RR 1.25, 95% CI 0.82 to 1.91; 2644 mosquitoes, 2 trials, 2 comparisons; low-certainty evidence).\nIn village trials comparing pyrethroid-PBO nets to LLINs, there was no difference in sporozoite rate (4 trials, 5 comparisons) nor in mosquito parity (3 trials, 4 comparisons).\nAuthors' conclusions\nIn areas of high insecticide resistance, pyrethroid-PBO nets have greater entomological and epidemiological efficacy compared to standard LLINs, with sustained reduction in parasite prevalence, higher mosquito mortality and reduction in mosquito blood feeding rates 21 to 25 months post intervention. Questions remain about the durability of PBO on nets, as the impact of pyrethroid-PBO nets on mosquito mortality was not sustained over 20 washes in experimental hut trials, and epidemiological data on pyrethroid-PBO nets for the full intended three-year life span of the nets is not available. Little evidence is available to support greater entomological efficacy of pyrethroid-PBO nets in areas where mosquitoes show lower levels of resistance to pyrethroids.\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": "Bed nets treated with pyrethroid insecticides are an effective way to reduce malaria transmission and have been deployed across Africa. However, mosquitoes that spread malaria are now developing resistance to this type of insecticide. One way to overcome this resistance is to add another chemical - piperonyl butoxide (PBO) - to the net. PBO is not an insecticide, but it blocks the substance (an enzyme) inside the mosquito that stops pyrethroids from working."
}
] |
query-laysum
|
8416
|
[
{
"role": "user",
"content": "Abstract: Background\nInterstitial lung disease (ILD) is characterised by reduced functional capacity, dyspnoea and exercise-induced hypoxia. Pulmonary rehabilitation is often used to improve symptoms, health-related quality of life and functional status in other chronic lung conditions. There is accumulating evidence for comparable effects of pulmonary rehabilitation in people with ILD. However, further information is needed to clarify the long-term benefit and to strengthen the rationale for pulmonary rehabilitation to be incorporated into standard clinical management of people with ILD. This review updates the results reported in 2014.\nObjectives\nTo determine whether pulmonary rehabilitation in people with ILD has beneficial effects on exercise capacity, symptoms, quality of life and survival compared with no pulmonary rehabilitation in people with ILD.\nTo assess the safety of pulmonary rehabilitation in people with ILD.\nSearch methods\nWe searched CENTRAL, MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCO) and PEDro from inception to April 2020. We searched the reference lists of relevant studies, international clinical trial registries and respiratory conference abstracts to look for qualifying studies.\nSelection criteria\nWe included randomised controlled trials and quasi-randomised controlled trials in which pulmonary rehabilitation was compared with no pulmonary rehabilitation or with other therapy in people with ILD of any origin.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data and assessed risk of bias. We contacted study authors to request missing data and information regarding adverse effects. We specified a priori subgroup analyses for participants with idiopathic pulmonary fibrosis (IPF) and participants with severe lung disease (low diffusing capacity or desaturation during exercise). There were insufficient data to perform the prespecified subgroup analysis for type of exercise training modality.\nMain results\nFor this update, we included an additional 12 studies resulting in a total of 21 studies. We included 16 studies in the meta-analysis (356 participants undertook pulmonary rehabilitation and 319 were control participants). The mean age of participants ranged from 36 to 72 years and included people with ILD of varying aetiology, sarcoidosis or IPF (with mean transfer factor of carbon dioxide (TLCO) % predicted ranging from 37% to 63%). Most pulmonary rehabilitation programmes were conducted in an outpatient setting, with a small number conducted in home-based, inpatient or tele-rehabilitation settings. The duration of pulmonary rehabilitation ranged from three to 48 weeks. There was a moderate risk of bias due to the absence of outcome assessor blinding and intention-to-treat analyses and the inadequate reporting of randomisation and allocation procedures in 60% of the studies.\nPulmonary rehabilitation probably improves the six-minute walk distance (6MWD) with mean difference (MD) of 40.07 metres, 95% confidence interval (CI) 32.70 to 47.44; 585 participants; moderate-certainty evidence). There may be improvements in peak workload (MD 9.04 watts, 95% CI 6.07 to 12.0; 159 participants; low-certainty evidence), peak oxygen consumption (MD 1.28 mL/kg/minute, 95% CI 0.51 to 2.05; 94 participants; low-certainty evidence) and maximum ventilation (MD 7.21 L/minute, 95% CI 4.10 to 10.32; 94 participants; low-certainty evidence). In the subgroup of participants with IPF, there were comparable improvements in 6MWD (MD 37.25 metres, 95% CI 26.16 to 48.33; 278 participants; moderate-certainty evidence), peak workload (MD 9.94 watts, 95% CI 6.39 to 13.49; low-certainty evidence), VO2 (oxygen uptake) peak (MD 1.45 mL/kg/minute, 95% CI 0.51 to 2.40; low-certainty evidence) and maximum ventilation (MD 9.80 L/minute, 95% CI 6.06 to 13.53; 62 participants; low-certainty evidence). The effect of pulmonary rehabilitation on maximum heart rate was uncertain.\nPulmonary rehabilitation may reduce dyspnoea in participants with ILD (standardised mean difference (SMD) –0.36, 95% CI –0.58 to –0.14; 348 participants; low-certainty evidence) and in the IPF subgroup (SMD –0.41, 95% CI –0.74 to –0.09; 155 participants; low-certainty evidence). Pulmonary rehabilitation probably improves health-related quality of life: there were improvements in all four domains of the Chronic Respiratory Disease Questionnaire (CRQ) and the St George's Respiratory Questionnaire (SGRQ) for participants with ILD and for the subgroup of people with IPF. The improvement in SGRQ Total score was –9.29 for participants with ILD (95% CI –11.06 to –7.52; 478 participants; moderate-certainty evidence) and –7.91 for participants with IPF (95% CI –10.55 to –5.26; 194 participants; moderate-certainty evidence). Five studies reported longer-term outcomes, with improvements in exercise capacity, dyspnoea and health-related quality of life still evident six to 12 months following the intervention period (6MWD: MD 32.43, 95% CI 15.58 to 49.28; 297 participants; moderate-certainty evidence; dyspnoea: MD –0.29, 95% CI –0.49 to –0.10; 335 participants; SGRQ Total score: MD –4.93, 95% CI –7.81 to –2.06; 240 participants; low-certainty evidence). In the subgroup of participants with IPF, there were improvements at six to 12 months following the intervention for dyspnoea and SGRQ Impact score. The effect of pulmonary rehabilitation on survival at long-term follow-up is uncertain. There were insufficient data to allow examination of the impact of disease severity or exercise training modality.\nTen studies provided information on adverse events; however, there were no adverse events reported during rehabilitation. Four studies reported the death of one pulmonary rehabilitation participant; however, all four studies indicated this death was unrelated to the intervention received.\nAuthors' conclusions\nPulmonary rehabilitation can be performed safely in people with ILD. Pulmonary rehabilitation probably improves functional exercise capacity, dyspnoea and quality of life in the short term, with benefits also probable in IPF. Improvements in functional exercise capacity, dyspnoea and quality of life were sustained longer term. Dyspnoea and quality of life may be sustained in people with IPF. The certainty of evidence was low to moderate, due to inadequate reporting of methods, the lack of outcome assessment blinding and heterogeneity in some results. Further well-designed randomised trials are needed to determine the optimal exercise prescription, and to investigate ways to promote longer-lasting improvements, particularly for people with IPF.\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 quality of evidence was generally low to moderate. This was mainly due to inadequate reporting of methods, assessors knowing which treatment had been given and the variability in some results."
}
] |
query-laysum
|
8417
|
[
{
"role": "user",
"content": "Abstract: Background\nMany women undergoing an assisted reproductive technology (ART) cycle will not achieve a live birth. Failure at the embryo transfer stage may be due to lack of good-quality embryo/s, lack of uterine receptivity, or the transfer technique itself. Numerous methods, including the use of ultrasound guidance for proper catheter placement in the endometrial cavity, have been suggested as more effective techniques of embryo transfer. This review evaluates the efficacy of ultrasound-guided embryo transfer (UGET) compared with 'clinical touch' (CTET), which is the traditional method of embryo transfer and relies on the clinician's tactile senses to judge when the transfer catheter is in the correct position.\nObjectives\nTo determine whether ultrasound guidance compared with clinical touch improves pregnancy outcomes in women undergoing embryo transfer during ART cycles.\nSearch methods\nFor the 2016 update of this review, we ran updated searches in the Cochrane Gynaecology and Fertility Group trials register (May 2015), the Cochrane Central Register of Controlled Trials (the Cochrane Library, May 2015), MEDLINE (2009 to May 2015), and EMBASE (2009 to May 2015). We also handsearched relevant conference proceedings: American Society for Reproductive Medicine (ASRM), European Society for Human Reproduction and Embryology (ESHRE), and International Federation of Gynecology and Obstetrics (FIGO). There were no language restrictions.\nSelection criteria\nWe included only randomised controlled trials.\nData collection and analysis\nTwo review authors independently assessed eligibility and quality of trials and extracted data from those selected. We calculated odds ratio (OR) and 95% confidence interval (CI) for dichotomous outcomes. No outcomes were reported using continuous data. We assessed the overall quality of the evidence for the main findings using the GRADE working group methods.\nMain results\nThis systematic review now has 21 included studies (four of which we added in the 2016 update), two studies awaiting assessment, and 47 excluded studies. In total, data for meta-analyses were available in 21 trials (n = 6218 women), of which only four reported live births.\nUGET was associated with an increased chance of a live birth/ongoing pregnancy compared with CTET (OR 1.47, 95% CI 1.30 to 1.65; 13 trials; n = 5859 women; I2 = 74%; low-quality evidence). Sensitivity analysis by including only trials with low risk of selection bias or by using a random-effects model did not alter the effect. We estimate that for women with a chance of a live birth/ongoing pregnancy of 23% using CTET, this would increase to between 28% and 33% using UGET. We considered the quality of the evidence using GRADE methodology to be low.\nUGET was associated with an increase in the chance of a clinical pregnancy (OR 1.31, 95% CI 1.17 to 1.45; 20 trials; n = 6711 women; I2 = 42%; moderate-quality evidence). We identified no differences between groups for the incidence of adverse events including multiple pregnancy, ectopic pregnancy, or miscarriage. These events were relatively rare, and sample sizes limited the ability to detect such differences.\nAuthors' conclusions\nThe evidence suggests ultrasound guidance improves the chance of live birth/ongoing and clinical pregnancies compared with clinical touch, without increasing the chance of multiple pregnancy, ectopic pregnancy, or miscarriage. Methodological limitations included: only four studies reporting details of both computerised randomisation techniques and adequate allocation concealment, only four studies reported on the outcome of live birth, and none of the nine studies that reported on ongoing pregnancy reported on live birth, suggesting possible reporting bias. Adequate reporting of randomisation and allocation concealment will improve the quality of future studies. The primary outcome measure of future studies should be the reporting of live births per woman randomised.\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": "Live birth/ongoing pregnancies were increased for the ultrasound-guided group compared with the clinical touch group, based on low-quality evidence. We estimate that for women with a chance of a live birth/ongoing pregnancy of 23% using clinical touch, this would increase to between 28% and 33% using UGET. Data for live birth should be interpreted carefully, as differences between the studies make drawing a conclusion difficult. The evidence suggests that in studies that used the same brand of transfer catheter in both the ultrasound-guided and the clinical touch groups, ultrasound guidance was linked to an increase in the chance of a live birth. There was no evidence that the risk of harm using UGET, including miscarriage, ectopic pregnancies, and multiple pregnancies, is any different than when clinical touch is used to guide the embryo transfer."
}
] |
query-laysum
|
8418
|
[
{
"role": "user",
"content": "Abstract: Background\nEarly discharge hospital at home is a service that provides active treatment by healthcare professionals in the patient's home for a condition that otherwise would require acute hospital inpatient care. This is an update of a Cochrane review.\nObjectives\nTo determine the effectiveness and cost of managing patients with early discharge hospital at home compared with inpatient hospital care.\nSearch methods\nWe searched the following databases to 9 January 2017: the Cochrane Effective Practice and Organisation of Care Group (EPOC) register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and EconLit. We searched clinical trials registries.\nSelection criteria\nRandomised trials comparing early discharge hospital at home with acute hospital inpatient care for adults. We excluded obstetric, paediatric and mental health hospital at home schemes.\nData collection and analysis\nWe followed the standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the body of evidence for the most important outcomes.\nMain results\nWe included 32 trials (N = 4746), six of them new for this update, mainly conducted in high-income countries. We judged most of the studies to have a low or unclear risk of bias. The intervention was delivered by hospital outreach services (17 trials), community-based services (11 trials), and was co-ordinated by a hospital-based stroke team or physician in conjunction with community-based services in four trials.\nStudies recruiting people recovering from stroke\nEarly discharge hospital at home probably makes little or no difference to mortality at three to six months (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.57 to 1.48, N = 1114, 11 trials, moderate-certainty evidence) and may make little or no difference to the risk of hospital readmission (RR 1.09, 95% CI 0.71 to 1.66, N = 345, 5 trials, low-certainty evidence). Hospital at home may lower the risk of living in institutional setting at six months (RR 0.63, 96% CI 0.40 to 0.98; N = 574, 4 trials, low-certainty evidence) and might slightly improve patient satisfaction (N = 795, low-certainty evidence). Hospital at home probably reduces hospital length of stay, as moderate-certainty evidence found that people assigned to hospital at home are discharged from the intervention about seven days earlier than people receiving inpatient care (95% CI 10.19 to 3.17 days earlier, N = 528, 4 trials). It is uncertain whether hospital at home has an effect on cost (very low-certainty evidence).\nStudies recruiting people with a mix of medical conditions\nEarly discharge hospital at home probably makes little or no difference to mortality (RR 1.07, 95% CI 0.76 to 1.49; N = 1247, 8 trials, moderate-certainty evidence). In people with chronic obstructive pulmonary disease (COPD) there was insufficient information to determine the effect of these two approaches on mortality (RR 0.53, 95% CI 0.25 to 1.12, N = 496, 5 trials, low-certainty evidence). The intervention probably increases the risk of hospital readmission in a mix of medical conditions, although the results are also compatible with no difference and a relatively large increase in the risk of readmission (RR 1.25, 95% CI 0.98 to 1.58, N = 1276, 9 trials, moderate-certainty evidence). Early discharge hospital at home may decrease the risk of readmission for people with COPD (RR 0.86, 95% CI 0.66 to 1.13, N = 496, 5 trials low-certainty evidence). Hospital at home may lower the risk of living in an institutional setting (RR 0.69, 0.48 to 0.99; N = 484, 3 trials, low-certainty evidence). The intervention might slightly improve patient satisfaction (N = 900, low-certainty evidence). The effect of early discharge hospital at home on hospital length of stay for older patients with a mix of conditions ranged from a reduction of 20 days to a reduction of less than half a day (moderate-certainty evidence, N = 767). It is uncertain whether hospital at home has an effect on cost (very low-certainty evidence).\nStudies recruiting people undergoing elective surgery\nThree studies did not report higher rates of mortality with hospital at home compared with inpatient care (data not pooled, N = 856, low-certainty evidence; mainly orthopaedic surgery). Hospital at home may lead to little or no difference in readmission to hospital for people who were mainly recovering from orthopaedic surgery (N = 1229, low-certainty evidence). We could not establish the effects of hospital at home on the risk of living in institutional care, due to a lack of data. The intervention might slightly improve patient satisfaction (N = 1229, low-certainty evidence). People recovering from orthopaedic surgery allocated to early discharge hospital at home were discharged from the intervention on average four days earlier than people allocated to usual inpatient care (4.44 days earlier, 95% CI 6.37 to 2.51 days earlier, , N = 411, 4 trials, moderate-certainty evidence). It is uncertain whether hospital at home has an effect on cost (very low-certainty evidence).\nAuthors' conclusions\nDespite increasing interest in the potential of early discharge hospital at home services as a less expensive alternative to inpatient care, this review provides insufficient evidence of economic benefit (through a reduction in hospital length of stay) or improved health outcomes.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors searched for studies that had been published up to 9 January 2017."
}
] |
query-laysum
|
8419
|
[
{
"role": "user",
"content": "Abstract: Background\nThe current paradigm for cardiovascular disease (CVD) emphasises absolute risk assessment to guide treatment decisions in primary prevention. Although the derivation and validation of multivariable risk assessment tools, or CVD risk scores, have attracted considerable attention, their effect on clinical outcomes is uncertain.\nObjectives\nTo assess the effects of evaluating and providing CVD risk scores in adults without prevalent CVD on cardiovascular outcomes, risk factor levels, preventive medication prescribing, and health behaviours.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (2016, Issue 2), MEDLINE Ovid (1946 to March week 1 2016), Embase (embase.com) (1974 to 15 March 2016), and Conference Proceedings Citation Index-Science (CPCI-S) (1990 to 15 March 2016). We imposed no language restrictions. We searched clinical trial registers in March 2016 and handsearched reference lists of primary studies to identify additional reports.\nSelection criteria\nWe included randomised and quasi-randomised trials comparing the systematic provision of CVD risk scores by a clinician, healthcare professional, or healthcare system compared with usual care (i.e. no systematic provision of CVD risk scores) in adults without CVD.\nData collection and analysis\nThree review authors independently selected studies, extracted data, and evaluated study quality. We used the Cochrane 'Risk of bias' tool to assess study limitations. The primary outcomes were: CVD events, change in CVD risk factor levels (total cholesterol, systolic blood pressure, and multivariable CVD risk), and adverse events. Secondary outcomes included: lipid-lowering and antihypertensive medication prescribing in higher-risk people. We calculated risk ratios (RR) for dichotomous data and mean differences (MD) or standardised mean differences (SMD) for continuous data using 95% confidence intervals. We used a fixed-effects model when heterogeneity (I²) was at least 50% and a random-effects model for substantial heterogeneity (I² > 50%). We evaluated the quality of evidence using the GRADE framework.\nMain results\nWe identified 41 randomised controlled trials (RCTs) involving 194,035 participants from 6422 reports. We assessed studies as having high or unclear risk of bias across multiple domains. Low-quality evidence evidence suggests that providing CVD risk scores may have little or no effect on CVD events compared with usual care (5.4% versus 5.3%; RR 1.01, 95% confidence interval (CI) 0.95 to 1.08; I² = 25%; 3 trials, N = 99,070). Providing CVD risk scores may reduce CVD risk factor levels by a small amount compared with usual care. Providing CVD risk scores reduced total cholesterol (MD −0.10 mmol/L, 95% CI −0.20 to 0.00; I² = 94%; 12 trials, N = 20,437, low-quality evidence), systolic blood pressure (MD −2.77 mmHg, 95% CI −4.16 to −1.38; I² = 93%; 16 trials, N = 32,954, low-quality evidence), and multivariable CVD risk (SMD −0.21, 95% CI −0.39 to −0.02; I² = 94%; 9 trials, N = 9549, low-quality evidence). Providing CVD risk scores may reduce adverse events compared with usual care, but results were imprecise (1.9% versus 2.7%; RR 0.72, 95% CI 0.49 to 1.04; I² = 0%; 4 trials, N = 4630, low-quality evidence). Compared with usual care, providing CVD risk scores may increase new or intensified lipid-lowering medications (15.7% versus 10.7%; RR 1.47, 95% CI 1.15 to 1.87; I² = 40%; 11 trials, N = 14,175, low-quality evidence) and increase new or increased antihypertensive medications (17.2% versus 11.4%; RR 1.51, 95% CI 1.08 to 2.11; I² = 53%; 8 trials, N = 13,255, low-quality evidence).\nAuthors' conclusions\nThere is uncertainty whether current strategies for providing CVD risk scores affect CVD events. Providing CVD risk scores may slightly reduce CVD risk factor levels and may increase preventive medication prescribing in higher-risk people without evidence of harm. There were multiple study limitations in the identified studies and substantial heterogeneity in the interventions, outcomes, and analyses, so readers should interpret results with caution. New models for implementing and evaluating CVD risk scores in adequately powered studies are needed to define the role of applying CVD risk scores in primary CVD prevention.\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": "There is low-quality evidence to guide the use of CVD risk scores in clinical practice. Studies had multiple limitations and used different methods to provide CVD risk scores. It is likely that further research will influence these results."
}
] |
query-laysum
|
8420
|
[
{
"role": "user",
"content": "Abstract: Background\nIn 2011 the World Health Organization (WHO) recommended parenteral artesunate in preference to quinine as first-line treatment for people with severe malaria. Prior to this recommendation many countries, particularly in Africa, had begun to use artemether, an alternative artemisinin derivative. This Cochrane Review evaluates intramuscular artemether compared with both quinine and artesunate.\nObjectives\nTo assess the efficacy and safety of intramuscular artemether versus any other parenteral medication in the treatment of severe malaria in adults and children.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (the Cochrane Library), MEDLINE, Embase, and LILACS, ISI Web of Science, conference proceedings, and reference lists of articles. We also searched the WHO International Clinical Trial Registry Platform, ClinicalTrials.gov, and the metaRegister of Controlled Trials (mRCT) for ongoing trials up to 7 September 2018. We checked the reference lists of all studies identified by the search. We examined references listed in review articles and previously compiled bibliographies to look for eligible studies.\nSelection criteria\nRandomized controlled trials (RCTs) comparing intramuscular artemether with intravenous/intramuscular quinine or artesunate for treating severe malaria.\nData collection and analysis\nThe primary outcome was all-cause death. Two review authors independently screened each article by title and abstract, and examined potentially relevant studies for inclusion using an eligibility form. Two review authors independently extracted data and assessed risk of bias of included studies. We summarized dichotomous outcomes using risk ratios (RRs) and continuous outcomes using mean differences (MDs), and have presented both measures with 95% confidence intervals (CIs). Where appropriate, we combined data in meta-analyses and used the GRADE approach to summarize the certainty of the evidence.\nMain results\nWe included 19 RCTs, enrolling 2874 adults and children with severe malaria, carried out in Africa (12 trials) and in Asia (7 trials).\nArtemether versus quinine\nFor children, there is probably little or no difference in the risk of death between intramuscular artemether and quinine (RR 0.97, 95% CI 0.77 to 1.21; 13 trials, 1659 participants, moderate-certainty evidence). Coma resolution time may be about five hours shorter with artemether (MD −5.45, 95% CI −7.90 to −3.00; six trials, 358 participants, low-certainty evidence). Artemether may make little difference to neurological sequelae (RR 0.84, 95% CI 0.66 to 1.07; seven trials, 968 participants, low-certainty evidence). Compared to quinine, artemether probably shortens the parasite clearance time by about nine hours (MD −9.03, 95% CI −11.43 to −6.63; seven trials, 420 participants, moderate-certainty evidence), and may shorten the fever clearance time by about three hours (MD −3.73, 95% CI −6.55 to −0.92; eight trials, 457 participants, low-certainty evidence).\nFor adults, treatment with intramuscular artemether probably results in fewer deaths than treatment with quinine (RR 0.59, 95% CI 0.42 to 0.83; four trials, 716 participants, moderate-certainty evidence).\nArtemether versus artesunate\nArtemether and artesunate have not been directly compared in randomized trials in children.\nFor adults, mortality is probably higher with intramuscular artemether (RR 1.80, 95% CI 1.09 to 2.97; two trials, 494 participants, moderate-certainty evidence).\nAuthors' conclusions\nArtemether appears to be more effective than quinine in children and adults. Artemether compared to artesunate has not been extensively studied, but in adults it appears inferior. These findings are consistent with the WHO recommendations that artesunate is the drug of choice, but artemether is acceptable when artesunate is not available.\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": "The review authors searched for studies up to 7 September 2018."
}
] |
query-laysum
|
8421
|
[
{
"role": "user",
"content": "Abstract: Background\nPlacental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes.\nObjectives\nTo assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials.\nSelection criteria\nRandomized, cluster randomized, or quasi-randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping.\nData collection and analysis\nAll review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information.\nMain results\nOne study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs.\nAuthors' conclusions\nThe results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful.\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 evidence was low, mainly because more infants need to be studied for definite conclusions."
}
] |
query-laysum
|
8422
|
[
{
"role": "user",
"content": "Abstract: Background\nPatients with head and neck cancer are often malnourished. Surgery for such cancers is complex and may be undertaken after a course of radiotherapy. As a result, patients may have postoperative complications such as fistulae and wound infections, as well as more generalised infections such as pneumonia. One possible way to enhance recovery, and reduce the incidence of these complications, is by improving nutrition. Nutritional formulas that deliver basic nutrients as well as amino acids (arginine and glutamine), ribonucleic acid (RNA) and/or lipids (omega-3 fatty acids) are known as immunonutrition.\nObjectives\nTo assess the effects of immunonutrition treatment, compared to standard feeding, on postoperative recovery in adult patients undergoing elective (non-emergency) surgery for head and neck cancer.\nSearch methods\nThe Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 February 2018.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing immunonutrition given either preoperatively, postoperatively or perioperatively to adult patients (18 years of age or older) undergoing an elective surgical procedure for head and neck cancer, compared with a control group receiving either standard polymeric nutritional supplements or no supplements.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. The primary outcomes were: length of hospital stay (days), wound infection, fistula formation and adverse events/tolerance of feeds, as defined by trial authors. Secondary outcomes were: all-cause mortality and postoperative complications (as defined by trial authors). We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included 19 RCTs (1099 participants). The mean age of participants ranged from 47 to 66 years. Most studies (12/19) had fewer than 25 patients in each treatment group. Most studies (16/19) used immunonutrition formulas containing arginine, but there was variation in the actual products and amounts used, and in the length of intervention postoperatively. Follow-up time for outcome measurement varied considerably across studies, ranging from five days to greater than or equal to 16 months.\nPrimary outcomes\nWe found no evidence of a difference in the length of hospital stay (mean difference -2.5 days, 95% confidence interval (CI) -5.11 to 0.12; 10 studies, 757 participants; low-quality evidence). Similarly, we found no evidence of an effect of immunonutrition on wound infection (risk ratio (RR) 0.94, 95% CI 0.70 to 1.26; 12 studies, 812 participants; very low-quality evidence). Fistula formation may be reduced with immunonutrition; the absolute risks were 11.3% and 5.4% in the standard care and immunonutrition groups, with a RR of 0.48 (95% CI 0.27 to 0.85; 10 studies, 747 participants; low-quality evidence). We found no evidence of a difference in terms of tolerance of feeds ('adverse events') between treatments (RR 1.33, 95% CI 0.86 to 2.06; 9 studies, 719 participants; very low-quality evidence).\nSecondary outcomes\nWe found no evidence of a difference between treatments in all-cause mortality (RR 1.33, 95% CI 0.48 to 3.66; 14 studies, 776 participants; low-quality evidence). Other postoperative complications such as pneumonia and urinary tract infections were not commonly reported.\nAuthors' conclusions\nThe risk of postoperative fistula formation may be reduced with immunonutrition, but we found no evidence of an effect of immunonutrition on any of the other outcomes that we assessed. The studies included in this review were generally small or at high risk of bias (or both). We judged the overall quality of the evidence to be low for the outcomes length of hospital stay and all-cause mortality, and very low for wound infection and adverse events. Further research should include larger, better quality studies.\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": "Head and neck cancer surgery usually means surgery to treat cancer of the mouth, throat or larynx (voice box). The surgery is complicated and people often experience problems such as wound infections and wound breakdown, as well as infections such as pneumonia. These can lead to a longer stay in hospital. Specific nutrients, for example amino acids (found in protein-based foods), omega-3 fatty acids (often found in fish oils) and nucleotides (found in many foods) have been investigated for their role in helping people recover from surgery. When any of these specific nutrients are added to the patient's feed it is called immunonutrition. We wanted to see whether feeding people immunonutrition improved recovery (for example, led to a shorter length of stay and fewer complications) when compared with a standard feed."
}
] |
query-laysum
|
8423
|
[
{
"role": "user",
"content": "Abstract: Background\nWe performed a systematic review, a standard meta-analysis and network meta-analysis (NMA), which updates the 2009 Cochrane Overview, 'Biologics for rheumatoid arthritis (RA)'. This review is focused on biologic monotherapy in people with RA in whom treatment with traditional disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) had failed (MTX/other DMARD-experienced).\nObjectives\nTo assess the benefits and harms of biologic monotherapy (includes anti-tumor necrosis factor (TNF) (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab) or non-TNF (abatacept, anakinra, rituximab, tocilizumab)) or tofacitinib monotherapy (oral small molecule) versus comparator (placebo or MTX/other DMARDs) in adults with RA who were MTX/other DMARD-experienced.\nMethods\nWe searched for randomized controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2015, Issue 6, June), MEDLINE (via OVID 1946 to June 2015), and Embase (via OVID 1947 to June 2015). Article selection, data extraction and risk of bias and GRADE assessments were done in duplicate. We calculated direct estimates with 95% confidence intervals (CI) using standard meta-analysis. We used a Bayesian mixed treatment comparisons (MTC) approach for NMA estimates with 95% credible intervals (CrI). We converted odds ratios (OR) to risk ratios (RR) for ease of understanding. We calculated absolute measures as risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB).\nMain results\nThis update includes 40 new RCTs for a total of 46 RCTs, of which 41 studies with 14,049 participants provided data. The comparator was placebo in 16 RCTs (4,532 patients), MTX or other DMARD in 13 RCTs (5,602 patients), and another biologic in 12 RCTs (3,915 patients).\nMonotherapy versus placebo\nBased on moderate-quality direct evidence, biologic monotherapy (without concurrent MTX/other DMARDs) was associated with a clinically meaningful and statistically significant improvement in American College of Rheumatology score (ACR50) and physical function, as measured by the Health Assessment Questionnaire (HAQ) versus placebo. RR was 4.68 for ACR50 (95% CI, 2.93 to 7.48); absolute benefit RD 23% (95% CI, 18% to 29%); and NNTB = 5 (95% CI, 3 to 8). The mean difference (MD) was -0.32 for HAQ (95% CI, -0.42 to -0.23; a negative sign represents greater HAQ improvement); absolute benefit of -10.7% (95% CI, -14% to -7.7%); and NNTB = 4 (95% CI, 3 to 5). Direct and NMA estimates for TNF biologic, non-TNF biologic or tofacitinib monotherapy showed similar results for ACR50 , downgraded to moderate-quality evidence. Direct and NMA estimates for TNF biologic, anakinra or tofacitinib monotherapy showed a similar results for HAQ versus placebo with mostly moderate quality evidence.\nBased on moderate-quality direct evidence, biologic monotherapy was associated with a clinically meaningful and statistically significant greater proportion of disease remission versus placebo with RR 1.12 (95% CI 1.03 to 1.22); absolute benefit 10% (95% CI, 3% to 17%; NNTB = 10 (95% CI, 8 to 21)).\nBased on low-quality direct evidence, results for biologic monotherapy for withdrawals due to adverse events and serious adverse events were inconclusive, with wide confidence intervals encompassing the null effect and evidence of an important increase. The direct estimate for TNF monotherapy for withdrawals due to adverse events showed a clinically meaningful and statistically significant result with RR 2.02 (95% CI, 1.08 to 3.78), absolute benefit RD 3% (95% CI,1% to 4%), based on moderate-quality evidence. The NMA estimates for TNF biologic, non-TNF biologic, anakinra, or tofacitinib monotherapy for withdrawals due to adverse events and for serious adverse events were all inconclusive and downgraded to low-quality evidence.\nMonotherapy versus active comparator (MTX/other DMARDs)\nBased on direct evidence of moderate quality, biologic monotherapy (without concurrent MTX/other DMARDs) was associated with a clinically meaningful and statistically significant improvement in ACR50 and HAQ scores versus MTX/other DMARDs with a RR of 1.54 (95% CI, 1.14 to 2.08); absolute benefit 13% (95% CI, 2% to 23%), NNTB = 7 (95% CI, 4 to 26) and a mean difference in HAQ of -0.27 (95% CI, -0.40 to -0.14); absolute benefit of -9% (95% CI, -13.3% to -4.7%), NNTB = 2 (95% CI, 2 to 4). Direct and NMA estimates for TNF monotherapy and NMA estimate for non-TNF biologic monotherapy for ACR50 showed similar results, based on moderate-quality evidence. Direct and NMA estimates for non-TNF biologic monotherapy, but not TNF monotherapy, showed similar HAQ improvements , based on mostly moderate-quality evidence.\nThere were no statistically significant or clinically meaningful differences for direct estimates of biologic monotherapy versus active comparator for RA disease remission. NMA estimates showed a statistically significant and clinically meaningful difference versus active comparator for TNF monotherapy (absolute improvement 7% (95% CI, 2% to 14%)) and non-TNF monotherapy (absolute improvement 19% (95% CrI, 7% to 36%)), both downgraded to moderate quality.\nBased on moderate-quality direct evidence from a single study, radiographic progression (scale 0 to 448) was statistically significantly reduced in those on biologic monotherapy versus active comparator, MD -4.34 (95% CI, -7.56 to -1.12), though the absolute reduction was small, -0.97% (95% CI, -1.69% to -0.25%). We are not sure of the clinical relevance of this reduction.\nDirect and NMA evidence (downgraded to low quality), showed inconclusive results for withdrawals due to adverse events, serious adverse events and cancer, with wide confidence intervals encompassing the null effect and evidence of an important increase.\nAuthors' conclusions\nBased mostly on RCTs of six to 12-month duration in people with RA who had previously experienced and failed treatment with MTX/other DMARDs, biologic monotherapy improved ACR50, function and RA remission rates compared to placebo or MTX/other DMARDs.\nRadiographic progression was reduced versus active comparator, although the clinical significance was unclear.\nResults were inconclusive for whether biologic monotherapy was associated with an increased risk of withdrawals due to adverse events, serious adverse events or cancer, versus placebo (no data on cancer) or MTX/other DMARDs.\n\nGiven the provided abstract, please respond to the following query: \"Serious Adverse Events\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "92 people out of 1000 who took biologic monotherapy had serious adverse events (most commonly infections) compared to 72 people out of 1000 who were on placebo, that is 20 more people out of 1000 (2% more withdrawals)."
}
] |
query-laysum
|
8424
|
[
{
"role": "user",
"content": "Abstract: Background\nOveractive bladder (OAB) is a common chronic and bothersome condition. Bladder training is widely prescribed as a first-line treatment for OAB, but the efficacy has been systematically evaluated for urinary incontinence rather than OAB alone.\nObjectives\nTo evaluate the benefits and harms of bladder training for treating adults with OAB compared to no treatment, anticholinergics, β3-adrenoceptor agonists, or pelvic floor muscle training (PFMT) alone or in combination.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 6 November 2022.\nSelection criteria\nWe included randomized controlled trials involving adults aged 18 years or older with non-neurogenic OAB. We excluded studies of participants whose symptoms were caused by factors outside the urinary tract (e.g. neurologic disorders, cognitive impairment, gynecologic diseases).\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. participant-reported cure or improvement, 2. symptom- and condition-related quality of life (QoL), and 3. adverse events. Secondary outcomes included 4. participant-reported satisfaction, 5. number of incontinence episodes, 6. number of urgency episodes, and 7. number of micturition episodes. For the purpose of this review, we considered two time points: immediately after the treatment (early phase) and at least two months after the treatment (late phase). We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included 15 trials with 2007 participants; participants in these trials were predominantly women (89.3%). We assessed the risk of bias of results for primary and secondary outcomes, which across all studies was similar and predominantly of high risk of bias, and none were at low risk of bias. The certainty of evidence was low to very low, with some moderate, across measured outcomes.\nBladder training versus no treatment: three studies involving 92 participants compared bladder training to no treatment. The evidence is very uncertain about the effects of bladder training on cure or improvement at the early phase (risk ratio (RR) 17.00, 95% confidence interval (CI) 1.13 to 256.56; 1 study, 18 participants; very low-certainty evidence). Bladder training may reduce the number of incontinence episodes (mean difference (MD) −1.86, 95% CI −3.47 to −0.25; 1 study, 14 participants; low-certainty evidence). No studies measured symptom- and condition-related QoL, number of adverse events, participant-reported satisfaction, number of urgency episodes, or number of micturition episodes in the early phase.\nBladder training versus anticholinergics: seven studies (602 participants) investigated the effects of bladder training versus anticholinergic therapy. Bladder training may be more effective than anticholinergics on cure or improvement at the early phase (RR 1.37, 95% CI 1.10 to 1.70; 4 studies, 258 participants; low-certainty evidence). The evidence is very uncertain about the effects of bladder training on symptom- and condition-related QoL (standardized mean difference (SMD) −0.06, 95% CI −0.89 to 0.77; 2 studies, 117 participants; very low-certainty evidence). Although the evidence is very uncertain, there were fewer adverse events in the bladder training group than in the anticholinergics group (RR 0.03, 95% CI 0.01 to 0.17; 3 studies, 187 participants; very low-certainty evidence). The evidence is very uncertain about the effects of the number of incontinence episodes per 24 hours (MD 0.36, 95% CI −0.27 to 1.00; 2 studies, 117 participants; very low-certainty evidence), the number of urgency episodes per 24 hours (MD 0.70, 95% CI −0.62 to 2.02; 2 studies, 92 participants; very low-certainty evidence), and the number of micturition episodes per 24 hours (MD −0.35, 95% CI −1.90 to 1.20; 3 studies, 175 participants; very low-certainty evidence). No studies measured participant-reported satisfaction in the early phase.\nBladder training versus PFMT: three studies involving 203 participants compared bladder training to PFMT. The evidence is very uncertain about the different effects between bladder training and PFMT on symptom- and condition-related QoL at the early phase (SMD 0.10, 95% CI −0.19 to 0.40; 2 studies, 178 participants; very low-certainty evidence). There were no adverse events in either group at the early phase (1 study, 97 participants; moderate-certainty evidence). The evidence is uncertain about the effects of the number of incontinence episodes per 24 hours (MD 0.02, 95% CI −0.35 to 0.39, 1 study, 81 participants; low-certainty evidence) and very uncertain about the number of micturition episodes per 24 hours (MD 0.10, 95% CI −1.44 to 1.64; 1 study, 81 participants; very low-certainty evidence). No studies measured cure or improvement, participant-reported satisfaction, or number of urgency episodes in the early phase.\nAlthough we were interested in studies examining bladder training versus β3-adrenoceptor agonists, in combination with β3-adrenoceptor agonists versus β3-adrenoceptor agonists alone, and in combination with PFMT versus PFMT alone, we did not identify any eligible studies for these comparisons.\nAuthors' conclusions\nThis review focused on the effect of bladder training to treat OAB. However, most of the evidence was low or very-low certainty. Based on the low- or very low-certainty evidence, bladder training may cure or improve OAB compared to no treatment. Bladder training may be more effective to cure or improve OAB than anticholinergics, and there may be fewer adverse events. There may be no difference in efficacy or safety between bladder training and PFMT. More well-designed trials are needed to reach a firm conclusion.\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": "OAB is a common chronic condition involving daytime frequent urination, urination during sleep, and sudden urge to urinate with or without urinary incontinence (unintentional passing of urine). The disorder reduces quality of life and results in a significant economic burden on society. Bladder training is a behavioral therapy that establishes treatment goals and uses techniques to modify inappropriate responses to urinary urgency. The aim is to improve OAB symptoms by minimizing the frequent urge to urinate. Although clinical guidelines recommend bladder training to treat OAB, there is no review to evaluate the efficacy systematically."
}
] |
query-laysum
|
8425
|
[
{
"role": "user",
"content": "Abstract: Background\nEndotracheal suctioning consists of the mechanical aspiration of pulmonary secretions from the endotracheal tube (ETT) to prevent obstruction. The optimal frequency of ETT suctioning has not been defined.\nObjectives\nTo determine the effect of specific ordered frequency of ETT suctioning ('as scheduled') versus ETT suctioning only in case of indications ('as needed') and of more frequent ETT suctioning versus less frequent ETT suctioning on respiratory morbidity in ventilated newborns.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 10), MEDLINE via PubMed (1966 to 31 October 2015), EMBASE (1980 to 31 October 2015), and CINAHL (1982 to 31 October 2015). We checked the reference lists of retrieved articles and contacted study authors to identify additional studies. We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials.\nSelection criteria\nRandomized, quasi-randomized, and cluster randomized controlled trials comparing different strategies regarding the frequency of ETT suctioning of newborn infants receiving ventilator support.\nData collection and analysis\nWe used the standard methods of the Cochrane Neonatal Review Group. Two review authors independently extracted data and assessed the risk of bias of trials. The primary outcome was bronchopulmonary dysplasia or chronic lung disease.\nMain results\nWe identified one randomized controlled study recruiting 97 low birthweight infants that met the inclusion criteria. The study was conducted in the UK in 1987 and 1988. Randomized infants received ETT suctioning every six or 12 hours during the first three days of life. The quality of reporting was limited and we rated the trial at high risk of bias. Furthermore, the trial lacked adequate power. There were no statistically significant differences in any of reported outcomes: bronchopulmonary dysplasia (defined as oxygen at more than 30 days; risk ratio (RR) 0.49, 95% confidence interval (CI) 0.20 to 1.20); incidence of pneumothorax (RR 0.70, 95% CI 0.24 to 2.05); intraventricular hemorrhage (RR 1.12, 95% CI 0.44 to 2.85); neonatal death (RR 1.40, 95% CI 0.58 to 3.37); and time on ventilation (median time 39 hours in the 12-hourly group and 28 hours in the six-hourly group; RD not applicable for this outcome as mean and standard deviation were not reported). Tests for heterogeneity were not applicable as only one study was included.\nAuthors' conclusions\nThere was insufficient evidence to identify the ideal frequency of ETT suctioning in ventilated neonates. Future research should focus on the effects in the very preterm newborns, that is, the most vulnerable population as concerns the risk of both lung and brain damage. Assessment should include the cases of prolonged ventilation, when more abundant, dense secretions are common. Clinical trials might include comparisons between 'as-scheduled' versus 'as-needed' endotracheal suctioning, that is, based on specific indications, as well frequent versus less frequent suctioning schedules.\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 medical databases for clinical studies comparing different strategies regarding the frequency of endotracheal tube suction in newborn babies on ventilators. We found only one study recruiting 97 newborns with bodyweights under 2.5 kg (these are called low birthweight infants). Suctioning was performed every six or 12 hours during the first three days of life."
}
] |
query-laysum
|
8426
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an updated review concerning 'Higher versus lower fractions of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit'.\nSupplementary oxygen is provided to most patients in intensive care units (ICUs) to prevent global and organ hypoxia (inadequate oxygen levels). Oxygen has been administered liberally, resulting in high proportions of patients with hyperoxemia (exposure of tissues to abnormally high concentrations of oxygen). This has been associated with increased mortality and morbidity in some settings, but not in others. Thus far, only limited data have been available to inform clinical practice guidelines, and the optimum oxygenation target for ICU patients is uncertain. Because of the publication of new trial evidence, we have updated this review.\nObjectives\nTo update the assessment of benefits and harms of higher versus lower fractions of inspired oxygen (FiO2) or targets of arterial oxygenation for adults admitted to the ICU.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, BIOSIS Previews, and LILACS. We searched for ongoing or unpublished trials in clinical trial registers and scanned the reference lists and citations of included trials. Literature searches for this updated review were conducted in November 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared higher versus lower FiO2 or targets of arterial oxygenation (partial pressure of oxygen (PaO2), peripheral or arterial oxygen saturation (SpO2 or SaO2)) for adults admitted to the ICU. We included trials irrespective of publication type, publication status, and language.\nWe excluded trials randomising participants to hypoxaemia (FiO2 below 0.21, SaO2/SpO2 below 80%, or PaO2 below 6 kPa) or to hyperbaric oxygen, and cross-over trials and quasi-randomised trials.\nData collection and analysis\nFour review authors independently, and in pairs, screened the references identified in the literature searches and extracted the data. Our primary outcomes were all-cause mortality, the proportion of participants with one or more serious adverse events (SAEs), and quality of life. We analysed all outcomes at maximum follow-up. Only three trials reported the proportion of participants with one or more SAEs as a composite outcome. However, most trials reported on events categorised as SAEs according to the International Conference on Harmonisation Good Clinical Practice (ICH-GCP) criteria. We, therefore, conducted two analyses of the effect of higher versus lower oxygenation strategies using 1) the single SAE with the highest reported proportion in each trial, and 2) the cumulated proportion of participants with an SAE in each trial. Two trials reported on quality of life.\nSecondary outcomes were lung injury, myocardial infarction, stroke, and sepsis. No trial reported on lung injury as a composite outcome, but four trials reported on the occurrence of acute respiratory distress syndrome (ARDS) and five on pneumonia. We, therefore, conducted two analyses of the effect of higher versus lower oxygenation strategies using 1) the single lung injury event with the highest reported proportion in each trial, and 2) the cumulated proportion of participants with ARDS or pneumonia in each trial.\nWe assessed the risk of systematic errors by evaluating the risk of bias in the included trials using the Risk of Bias 2 tool. We used the GRADEpro tool to assess the overall certainty of the evidence. We also evaluated the risk of publication bias for outcomes reported by 10b or more trials.\nMain results\nWe included 19 RCTs (10,385 participants), of which 17 reported relevant outcomes for this review (10,248 participants). For all-cause mortality, 10 trials were judged to be at overall low risk of bias, and six at overall high risk of bias. For the reported SAEs, 10 trials were judged to be at overall low risk of bias, and seven at overall high risk of bias. Two trials reported on quality of life, of which one was judged to be at overall low risk of bias and one at high risk of bias for this outcome.\nMeta-analysis of all trials, regardless of risk of bias, indicated no significant difference from higher or lower oxygenation strategies at maximum follow-up with regard to mortality (risk ratio (RR) 1.01, 95% confidence interval (C)I 0.96 to 1.06; I2 = 14%; 16 trials; 9408 participants; very low-certainty evidence); occurrence of SAEs: the highest proportion of any specific SAE in each trial RR 1.01 (95% CI 0.96 to 1.06; I2 = 36%; 9466 participants; 17 trials; very low-certainty evidence), or quality of life (mean difference (MD) 0.5 points in participants assigned to higher oxygenation strategies (95% CI -2.75 to 1.75; I2 = 34%, 1649 participants; 2 trials; very low-certainty evidence)). Meta-analysis of the cumulated number of SAEs suggested benefit of a lower oxygenation strategy (RR 1.04 (95% CI 1.02 to 1.07; I2 = 74%; 9489 participants; 17 trials; very low certainty evidence)). However, trial sequential analyses, with correction for sparse data and repetitive testing, could reject a relative risk increase or reduction of 10% for mortality and the highest proportion of SAEs, and 20% for both the cumulated number of SAEs and quality of life. Given the very low-certainty of evidence, it is necessary to interpret these findings with caution.\nMeta-analysis of all trials indicated no statistically significant evidence of a difference between higher or lower oxygenation strategies on the occurrence of lung injuries at maximum follow-up (the highest reported proportion of lung injury RR 1.08, 95% CI 0.85 to 1.38; I2 = 0%; 2048 participants; 8 trials; very low-certainty evidence).\nMeta-analysis of all trials indicated harm from higher oxygenation strategies as compared with lower on the occurrence of sepsis at maximum follow-up (RR 1.85, 95% CI 1.17 to 2.93; I2 = 0%; 752 participants; 3 trials; very low-certainty evidence). Meta-analysis indicated no differences regarding the occurrences of myocardial infarction or stroke.\nAuthors' conclusions\nIn adult ICU patients, it is still not possible to draw clear conclusions about the effects of higher versus lower oxygenation strategies on all-cause mortality, SAEs, quality of life, lung injuries, myocardial infarction, stroke, and sepsis at maximum follow-up. This is due to low or very low-certainty 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": "After this review update, we are still uncertain about the effects of higher versus lower levels of oxygen as our findings are based on low- or very low-certainty evidence.\nWe did not find evidence for a beneficial effect of higher compared with lower levels of oxygen for adult ICU patients, neither on the risk of death (16 trials; 9408 participants), the risk of SAEs (17 trials, 9466 participants), the quality of life (2 trial, 1649 participants), the risk of lung injury (8 trials; 2048 participants), the risk of heart attack (4 trials, 5002 participants), nor the risk of stroke (5 trials, 6110 participants). We found a potential reduction of the risk of developing new sepsis ('blood poisoning') during ICU admission with higher levels of oxygen (3 trials, 752 participants)."
}
] |
query-laysum
|
8427
|
[
{
"role": "user",
"content": "Abstract: Background\nPreterm infants are born with low skeletal stores of calcium and phosphorus. Preterm human milk provides insufficient calcium and phosphorus to meet the estimated needs of preterm infants for adequate growth. Supplementation of human milk with calcium and phosphorus may improve growth and development of preterm infants.\nObjectives\nTo determine whether addition of calcium and phosphorus supplements to human milk leads to improved growth and bone metabolism of preterm infants without significant adverse effects.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 3), MEDLINE via PubMed (1966 to 14 April 2016), Embase (1980 to 14 April 2016) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 14 April 2016). We also searched clinical trials databases (11 May 2016) and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised and quasi-randomised trials comparing supplementation of human milk with calcium and/or phosphorus versus no supplementation in hospitalised preterm infants were eligible for inclusion in this review.\nData collection and analysis\nTwo review authors (JB, JW) independently extracted data and assessed trial quality using standard methods of the Cochrane Neonatal Review Group. We reported dichotomous data as risk ratios (RRs) and continuous data as mean differences (MDs) with 95% confidence intervals (CIs). We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the quality of evidence.\nMain results\nThis is an update of a 2001 review that identified no eligible trials. One trial including 40 infants met the inclusion criteria for this review. Using GRADE criteria, we judged the quality of the evidence as low owing to risk of bias (inadequate reporting of methods of randomisation, allocation concealment and/or blinding) and imprecision (wide confidence intervals and data from a single small trial). We found no evidence of a difference between calcium and phosphorus supplementation versus no supplementation for neonatal growth outcomes (weight, length, head circumference) at any time point reported (two, four or six weeks postnatal age). At six weeks postnatal age, supplementation with calcium/phosphorus was associated with a decrease in serum alkaline phosphatase concentration (MD -56.85 IU/L, 95% CI -101.27 to -12.43; one randomised controlled trial (RCT); n = 40 infants). Investigators provided no data on growth at 12 to 18 months, neonatal fractures, feed intolerance, breastfeeding or any of the prespecified childhood outcomes for this review (fractures, growth, neurodevelopmental outcomes).\nAuthors' conclusions\nWe identified one small trial including only 40 infants that compared supplementation of human milk with calcium and phosphorus versus no supplementation in hospitalised preterm infants. We judged the evidence to be of low quality and found no evidence of differences between groups for clinically important outcomes including growth and fractures. Although serum alkaline phosphatase concentration was reduced in the group receiving supplementation at six weeks postnatal age, this difference is unlikely to be of clinical significance. We conclude that evidence is insufficient to determine whether benefit or harm ensues when human milk is supplemented with calcium and/or phosphorus for the hospitalised preterm infant. We see no advantage of conducting further trials of this intervention because with the advent of multi-component human milk fortifier, supplementation of human milk with calcium and/or phosphorus alone is no longer common practice. Future trials should consider assessing effects of multi-component fortifiers with different mineral compositions on clinically important outcomes during the neonatal period and in later childhood.\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": "Evidence is insufficient to allow a judgement as to whether extra calcium and/or phosphorus provided to preterm babies confers benefit for their bones and growth. It is no longer very common to give calcium and phosphorus supplements alone, as human milk fortifiers now available include many other components as well as minerals to support the growth and development of preterm babies. We therefore suggest that future trials conducted to examine effects of mineral supplements in preterm babies include them in multi-component human milk fortifiers and assess clinically important outcomes into childhood."
}
] |
query-laysum
|
8428
|
[
{
"role": "user",
"content": "Abstract: Background\nFibromyalgia (FM) is a clinically well-defined chronic condition of unknown aetiology characterized by chronic widespread pain that often co-exists with sleep disturbances, cognitive dysfunction and fatigue. Patients often report high disability levels and negative mood. Psychotherapies focus on reducing key symptoms, improving daily functioning, mood and sense of personal control over pain.\nObjectives\nTo assess the benefits and harms of cognitive behavioural therapies (CBTs) for treating FM at end of treatment and at long-term (at least six months) follow-up.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 8), MEDLINE (1966 to 28 August 2013), PsycINFO (1966 to 28 August 2013) and SCOPUS (1980 to 28 August 2013). We searched http://www.clinicaltrials.gov (web site of the US National Institutes of Health) and the World Health Organization Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/) for ongoing trials (last search 28 August,2013), and the reference lists of reviewed articles.\nSelection criteria\nWe selected randomised controlled trials of CBTs with children, adolescents and adults diagnosed with FM.\nData collection and analysis\nThe data of all included studies were extracted and the risks of bias of the studies were assessed independently by two review authors. Discrepancies were resolved by discussion.\nMain results\nTwenty-three studies with 24 study arms with CBTs were included. A total of 2031 patients were included; 1073 patients in CBT groups and 958 patients in control groups. Only two studies were without any risk of bias. The GRADE quality of evidence of the studies was low. CBTs were superior to controls in reducing pain at end of treatment by 0.5 points on a scale of 0 to 10 (standardised mean difference (SMD) - 0.29; 95% confidence interval (CI) -0.49 to -0.17) and by 0.6 points at long-term follow-up (median 6 months) (SMD -0.40; 95% CI -0.62 to -0.17); in reducing negative mood at end of treatment by 0.7 points on a scale of 0 to 10 (SMD - 0.33; 95% CI -0.49 to -0.17) and by 1.3 points at long-term follow-up (median 6 months) (SMD -0.43; 95% CI -0.75 to -0.11); and in reducing disability at end of treatment by 0.7 points on a scale of 0 to 10 (SMD - 0.30; 95% CI -0.51 to -0.08) and at long-term follow-up (median 6 months) by 1.2 points (SMD -0.52; 95% CI -0.86 to -0.18). There was no statistically significant difference in dropout rates for any reasons between CBTs and controls (risk ratio (RR) 0.94; 95% CI 0.65 to 1.35).\nAuthors' conclusions\nCBTs provided a small incremental benefit over control interventions in reducing pain, negative mood and disability at the end of treatment and at long-term follow-up. The dropout rates due to any reason did not differ between CBTs and controls.\n\nGiven the provided abstract, please respond to the following query: \"Disability\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "(higher scores mean more disability):\n- People who used CBTs rated their disability to be 0.7 points lower at the end of treatment (7.2% absolute improvement) and to be 1.2 points lower six months after the end of treatment on a scale of 0 to 10 (11.7% absolute improvement).\n- Peope who used CBTs rated their disability to be 2.0 points on a scale of 0 to 10.\n- People who used a control treatment rated their disability to be 2.8 points on a scale of 0 to 10."
}
] |
query-laysum
|
8429
|
[
{
"role": "user",
"content": "Abstract: Background\nHepatorenal syndrome is defined as severe renal failure occurring in people with cirrhosis and ascites. Systematic reviews of randomised clinical trials found that, compared with placebo, terlipressin may reduce mortality and improve renal function in people with hepatorenal syndrome, but we need current evidence from systematic reviews on the benefits and harms of terlipressin versus other vasoactive drugs.\nObjectives\nTo evaluate the beneficial and harmful effects of terlipressin versus other vasoactive drugs for people with hepatorenal syndrome.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, and Science Citation Index Expanded; conducted manual searches of references in relevant literature; and wrote to experts and pharmaceutical companies (date of last search November 2016).\nSelection criteria\nRandomised clinical trials comparing terlipressin versus any other type of vasoactive drugs for hepatorenal syndrome. We allowed albumin and other cointerventions if provided equally in the comparison groups.\nData collection and analysis\nThree authors independently extracted data. The primary outcomes were mortality, hepatorenal syndrome (persistent hepatorenal syndrome despite treatment), and serious adverse events. We conducted meta-analyses and present the results as risk ratios (RR) with 95% confidence intervals (CI). We performed sensitivity, subgroup, and Trial Sequential Analyses and evaluated bias control based on the Cochrane Hepato-Biliary Group domains.\nMain results\nWe included 10 randomised clinical trials with 474 participants. The trials compared terlipressin versus noradrenaline (seven trials), octreotide (one trial), midodrine and octreotide (one trial), or dopamine (one trial). All participants in both groups received albumin as cointervention. We classified two trials at low risk of bias and eight trials at high risk of bias in the assessment of mortality and all trials at high risk of bias for remaining outcomes. In five trials, investigators specifically stated that they did not receive funding from for-profit organisations. We had no information about the funding source from the remaining five trials.\nTerlipressin was not superior or inferior compared with other vasoactive drugs in regard to mortality when including the two trials with a low risk of bias (RR 0.92, 95% CI 0.63 to 1.36; 94 participants, very low quality evidence) or when including all 10 trials (RR 0.96, 95% CI 0.88 to 1.06; 474 participants; I² = 0%; very low quality evidence). One meta-analysis including nine trials suggested a beneficial effect of terlipressin on hepatorenal syndrome (RR 0.79, 95% CI 0.63 to 0.99; 394 participants; I² = 26%; very low quality evidence). Due to the high mortality of hepatorenal syndrome, the registration of other serious adverse events is uncertain, but comparing terlipressin and other vasoactive drugs we found no significant difference (RR 0.96, 95% CI 0.88 to 1.06; 474 participants; I² = 0%; very low quality evidence). Several trials did not report systematically of adverse events, but terlipressin seemed to increase the risks of diarrhoea or abdominal pain, or both (RR 3.50, 95% CI 1.19 to 10.27; 221 participants; 5 trials, I² = 0%). However, Trial Sequential Analyses found insufficient evidence to support or refute any differences between interventions for all outcomes. Considering reversal of hepatorenal syndrome, subgroup analyses on the type of other vasoactive drugs found that terlipressin was superior compared with midodrine and octreotide (RR 0.47, 95% CI 0.30 to 0.72) or octreotide alone (RR 0.56, 95% CI 0.33 to 0.96), but each subgroup only included one small trial. None of the remaining subgroup or sensitivity analyses found differences between terlipressin and other vasoactive drugs. We downgraded the evidence to very low quality because of the high risk of bias, imprecision, and the results of the Trial Sequential Analyses.\nAuthors' conclusions\nThis review found insufficient evidence to support or refute beneficial or harmful effects of terlipressin and albumin versus other vasoactive drugs and albumin. Additional research is needed to evaluate if clinically meaningful differences exist between interventions.\n\nGiven the provided abstract, please respond to the following query: \"Authors' conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We need additional large trials of a high quality to evaluate if terlipressin is more beneficial or safer than other vasoactive drugs."
}
] |
query-laysum
|
8430
|
[
{
"role": "user",
"content": "Abstract: Background\nThe ubiquity of mobile devices has made it possible for clinical decision-support systems (CDSS) to become available to healthcare providers on handheld devices at the point-of-care, including in low- and middle-income countries. The use of CDSS by providers can potentially improve adherence to treatment protocols and patient outcomes. However, the evidence on the effect of the use of CDSS on mobile devices needs to be synthesized. This review was carried out to support a World Health Organization (WHO) guideline that aimed to inform investments on the use of decision-support tools on digital devices to strengthen primary healthcare.\nObjectives\nTo assess the effects of digital clinical decision-support systems (CDSS) accessible via mobile devices by primary healthcare providers in the context of primary care settings.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Global Index Medicus, POPLINE, and two trial registries from 1 January 2000 to 9 October 2020. We conducted a grey literature search using mHealthevidence.org and issued a call for papers through popular digital health communities of practice. Finally, we conducted citation searches of included studies.\nSelection criteria\nStudy design: we included randomized trials, including full-text studies, conference abstracts, and unpublished data irrespective of publication status or language of publication.\nTypes of participants: we included studies of all cadres of healthcare providers, including lay health workers and other individuals (administrative, managerial, and supervisory staff) involved in the delivery of primary healthcare services using clinical decision-support tools; and studies of clients or patients receiving care from primary healthcare providers using digital decision-support tools.\nTypes of interventions: we included studies comparing digital CDSS accessible via mobile devices with non-digital CDSS or no intervention, in the context of primary care. CDSS could include clinical protocols, checklists, and other job-aids which supported risk prioritization of patients. Mobile devices included mobile phones of any type (but not analogue landline telephones), as well as tablets, personal digital assistants, and smartphones. We excluded studies where digital CDSS were used on laptops or integrated with electronic medical records or other types of longitudinal tracking of clients.\nData collection and analysis\nA machine learning classifier that gave each record a probability score of being a randomized trial screened all search results. Two review authors screened titles and abstracts of studies with more than 10% probability of being a randomized trial, and one review author screened those with less than 10% probability of being a randomized trial. We followed standard methodological procedures expected by Cochrane and the Effective Practice and Organisation of Care group. We used the GRADE approach to assess the certainty of the evidence for the most important outcomes.\nMain results\nEight randomized trials across varying healthcare contexts in the USA,. India, China, Guatemala, Ghana, and Kenya, met our inclusion criteria. A range of healthcare providers (facility and community-based, formally trained, and lay workers) used digital CDSS. Care was provided for the management of specific conditions such as cardiovascular disease, gastrointestinal risk assessment, and maternal and child health. The certainty of evidence ranged from very low to moderate, and we often downgraded evidence for risk of bias and imprecision.\nWe are uncertain of the effect of this intervention on providers' adherence to recommended practice due to the very low certainty evidence (2 studies, 185 participants). The effect of the intervention on patients' and clients' health behaviours such as smoking and treatment adherence is mixed, with substantial variation across outcomes for similar types of behaviour (2 studies, 2262 participants). The intervention probably makes little or no difference to smoking rates among people at risk of cardiovascular disease but probably increases other types of desired behaviour among patients, such as adherence to treatment. The effect of the intervention on patients'/clients' health status and well-being is also mixed (5 studies, 69,767 participants). It probably makes little or no difference to some types of health outcomes, but we are uncertain about other health outcomes, including maternal and neonatal deaths, due to very low-certainty evidence. The intervention may slightly improve patient or client acceptability and satisfaction (1 study, 187 participants). We found no studies that reported the time between the presentation of an illness and appropriate management, provider acceptability or satisfaction, resource use, or unintended consequences.\nAuthors' conclusions\nWe are uncertain about the effectiveness of mobile phone-based decision-support tools on several outcomes, including adherence to recommended practice. None of the studies had a quality of care framework and focused only on specific health areas. We need well-designed research that takes a systems lens to assess these issues.\n\nGiven the provided abstract, please respond to the following query: \"What were the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found eight relevant studies. Three studies were carried out in the USA and five studies in India, China, Guatemala, Ghana, and Kenya. These studies showed that when primary healthcare workers use decision-support tools on mobile phones:\n– we do not know if they are better at following recommended clinical practice, because the quality of this evidence was very low;\n– there was no clear pattern of a positive or negative effect on patients' or clients' behaviour and on their health;\n– this may slightly improve patients’ satisfaction with medical information;\n– we do not know if this approach led primary healthcare workers to manage people’s health issues more quickly because we found no studies that measured this. We also found no studies that explored the effect on healthcare worker satisfaction, resource use, or whether this approach had any unintended consequences (e.g. harms)."
}
] |
query-laysum
|
8431
|
[
{
"role": "user",
"content": "Abstract: Background\nThe detection and diagnosis of caries at the earliest opportunity is fundamental to the preservation of tooth tissue and maintenance of oral health. Radiographs have traditionally been used to supplement the conventional visual-tactile clinical examination. Accurate, timely detection and diagnosis of early signs of disease could afford patients the opportunity of less invasive treatment with less destruction of tooth tissue, reduce the need for treatment with aerosol-generating procedures, and potentially result in a reduced cost of care to the patient and to healthcare services.\nObjectives\nTo determine the diagnostic accuracy of different dental imaging methods to inform the detection and diagnosis of non-cavitated enamel only coronal dental caries.\nSearch methods\nCochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 31 December 2018); Embase Ovid (1980 to 31 December 2018); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 31 December 2018); and the World Health Organization International Clinical Trials Registry Platform (to 31 December 2018). We studied reference lists as well as published systematic review articles.\nSelection criteria\nWe included diagnostic accuracy study designs that compared a dental imaging method with a reference standard (histology, excavation, enhanced visual examination), studies that evaluated the diagnostic accuracy of single index tests, and studies that directly compared two or more index tests. Studies reporting at both the patient or tooth surface level were included. In vitro and in vivo studies were eligible for inclusion. Studies that explicitly recruited participants with more advanced lesions that were obviously into dentine or frankly cavitated were excluded. We also excluded studies that artificially created carious lesions and those that used an index test during the excavation of dental caries to ascertain the optimum depth of excavation.\nData collection and analysis\nTwo review authors extracted data independently and in duplicate using a standardised data extraction form and quality assessment based on QUADAS-2 specific to the clinical context. Estimates of diagnostic accuracy were determined using the bivariate hierarchical method to produce summary points of sensitivity and specificity with 95% confidence regions. Comparative accuracy of different radiograph methods was conducted based on indirect and direct comparisons between methods. Potential sources of heterogeneity were pre-specified and explored visually and more formally through meta-regression.\nMain results\nWe included 104 datasets from 77 studies reporting a total of 15,518 tooth sites or surfaces. The most frequently reported imaging methods were analogue radiographs (55 datasets from 51 studies) and digital radiographs (42 datasets from 40 studies) followed by cone beam computed tomography (CBCT) (7 datasets from 7 studies). Only 17 studies were of an in vivo study design, carried out in a clinical setting. No studies were considered to be at low risk of bias across all four domains but 16 studies were judged to have low concern for applicability across all domains. The patient selection domain had the largest number of studies judged to be at high risk of bias (43 studies); the index test, reference standard, and flow and timing domains were judged to be at high risk of bias in 30, 12, and 7 studies respectively.\nStudies were synthesised using a hierarchical bivariate method for meta-analysis. There was substantial variability in the results of the individual studies, with sensitivities that ranged from 0 to 0.96 and specificities from 0 to 1.00. For all imaging methods the estimated summary sensitivity and specificity point was 0.47 (95% confidence interval (CI) 0.40 to 0.53) and 0.88 (95% CI 0.84 to 0.92), respectively. In a cohort of 1000 tooth surfaces with a prevalence of enamel caries of 63%, this would result in 337 tooth surfaces being classified as disease free when enamel caries was truly present (false negatives), and 43 tooth surfaces being classified as diseased in the absence of enamel caries (false positives). Meta-regression indicated that measures of accuracy differed according to the imaging method (Chi2(4) = 32.44, P < 0.001), with the highest sensitivity observed for CBCT, and the highest specificity observed for analogue radiographs. None of the specified potential sources of heterogeneity were able to explain the variability in results. No studies included restored teeth in their sample or reported the inclusion of sealants.\nWe rated the certainty of the evidence as low for sensitivity and specificity and downgraded two levels in total for risk of bias due to limitations in the design and conduct of the included studies, indirectness arising from the in vitro studies, and the observed inconsistency of the results.\nAuthors' conclusions\nThe design and conduct of studies to determine the diagnostic accuracy of methods to detect and diagnose caries in situ are particularly challenging. Low-certainty evidence suggests that imaging for the detection or diagnosis of early caries may have poor sensitivity but acceptable specificity, resulting in a relatively high number of false-negative results with the potential for early disease to progress. If left untreated, the opportunity to provide professional or self-care practices to arrest or reverse early caries lesions will be missed. The specificity of lesion detection is however relatively high, and one could argue that initiation of non-invasive management (such as the use of topical fluoride), is probably of low risk.\nCBCT showed superior sensitivity to analogue or digital radiographs but has very limited applicability to the general dental practitioner. However, given the high-radiation dose, and potential for caries-like artefacts from existing restorations, its use cannot be justified in routine caries detection. Nonetheless, if early incidental carious lesions are detected in CBCT scans taken for other purposes, these should be reported. CBCT has the potential to be used as a reference standard in diagnostic studies of this type.\nDespite the robust methodology applied in this comprehensive review, the results should be interpreted with some caution due to shortcomings in the design and execution of many of the included studies. Future research should evaluate the comparative accuracy of different methods, be undertaken in a clinical setting, and focus on minimising bias arising from the use of imperfect reference standards in clinical studies.\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": "Three main types of dental imaging were studied in this review: analogue or digital radiographs (X-rays) and three-dimensional (3D) imaging (cone beam computed tomography (CBCT)). We studied decay on the occlusal surfaces (biting surfaces of the back teeth), the proximal surfaces (tooth surfaces that are next to each other), and smooth surfaces."
}
] |
query-laysum
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8432
|
[
{
"role": "user",
"content": "Abstract: Background\nAnaesthetic drugs during general anaesthesia are titrated according to sympathetic or somatic responses to surgical stimuli. It is now possible to measure depth of anaesthesia using electroencephalography (EEG). Entropy, an EEG-based monitor can be used to assess the depth of anaesthesia using a strip of electrodes applied to the forehead, and this can guide intraoperative anaesthetic drug administration.\nObjectives\nThe primary objective of this review was to assess the effectiveness of entropy monitoring in facilitating faster recovery from general anaesthesia. We also wanted to assess mortality at 24 hours, 30 days, and one year following general anaesthesia with entropy monitoring.\nThe secondary objectives were to assess the effectiveness of the entropy monitor in: preventing postoperative recall of intraoperative events (awareness) following general anaesthesia; reducing the amount of anaesthetic drugs used; reducing cost of the anaesthetic as well as in reducing time to readiness to leave the postanaesthesia care unit (PACU).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), MEDLINE via Ovid SP (1990 to September 2014) and EMBASE via Ovid SP (1990 to September 2014). We reran the search in CENTRAL, MEDLINE via Ovid SP and EMBASE via Ovid SP in January 2016. We added one potential new study of interest to the list of ‘Studies awaiting Classification' and we will incorporate this study into the formal review findings during the review update.\nSelection criteria\nWe included randomized controlled trials (RCTs) conducted in adults and children (aged greater than two years of age), where in one arm entropy monitoring was used for titrating anaesthesia, and in the other standard practice (increase in heart rate, mean arterial pressure, lacrimation, movement in response to noxious surgical stimuli) was used for titrating anaesthetic drug administration. We also included trials with an additional third arm, wherein another EEG monitor, the Bispectral index (BIS) monitor was used to assess anaesthetic depth.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently extracted details of trial methodology and outcome data from trials considered eligible for inclusion. All analyses were made on an intention-to-treat basis. We used a random-effect model where there was heterogeneity. For assessments of the overall quality of evidence for each outcome that included pooled data from RCTs, we downgraded evidence from 'high quality' by one level for serious (or by two for very serious) study limitations (risk of bias, indirectness of evidence, serious inconsistency, imprecision of effect or potential publication bias).\nMain results\nWe included 11 RCTs (962 participants). Eight RCTs (762 participants) were carried out on adults (18 to 80 years of age), two (128 participants) involved children (two to 16 years) and one RCT (72 participants) included patients aged 60 to 75 years. Of the 11 included studies, we judged three to be at low risk of bias, and the remaining eight RCTs at unclear or high risk of bias.\nSix RCTs (383 participants) estimated the primary outcome, time to awakening after stopping general anaesthesia, which was reduced in the entropy as compared to the standard practice group (mean difference (MD) -5.42 minutes, 95% confidence interval (CI) -8.77 to -2.08; moderate quality of evidence). We noted heterogeneity for this outcome; on performing subgroup analysis this was found to be due to studies that included participants undergoing major, long duration surgeries (off-pump coronary artery bypass grafting, major urological surgery). The MD for time to awakening with four studies on ambulatory procedures was -3.20 minutes (95% CI -3.94 to -2.45). No trial reported the second primary outcome, mortality at 24 hours, 30 days, and one year with the use of entropy monitoring.\nEight trials (797 participants) compared the secondary outcome, postoperative recall of intraoperative events (awareness) in the entropy and standard practice groups. Awareness was reported by only one patient in the standard practice group, making meaningful estimation of benefit of entropy monitoring difficult; moderate quality of evidence.\nAll 11 RCTs compared the amount of anaesthetic agent used between the entropy and standard practice groups. Six RCTs compared the amount of propofol, four compared the amount of sevoflurane and one the amount of isoflurane used between the groups. Analysis of three studies (166 participants) revealed that the MD of propofol consumption between the entropy group and control group was -11.56 mcg/kg/min (95% CI -24.05 to 0.92); low quality of evidence. Analysis of another two studies (156 participants) showed that the MD in sevoflurane consumption in the entropy group compared to the control group was -3.42 mL (95% CI -6.49 to -0.35); moderate quality of evidence.\nNo trial reported on the secondary outcome of the cost of general anaesthesia.\nThree trials (170 participants) estimated MD in time to readiness to leave the PACU of the entropy group as compared to the control group (MD -5.94 minutes, 95% CI -16.08 to 4.20; low quality of evidence). Heterogeneity was noted, which was due to the difference in anaesthetic technique (propofol-based general anaesthesia) in one study. The remaining two studies had used volatile-based general anaesthesia. The MD in time to readiness to leave the PACU was -4.17 minutes (95% CI -6.84 to -1.51) with these two studies.\nAuthors' conclusions\nThe evidence as regards time to awakening, recall of intraoperative awareness and reduction in inhalational anaesthetic agent use was of moderate quality. The quality of evidence of as regards reduction in intravenous anaesthetic agent (propofol) use, as well as time to readiness to leave the PACU was found to be of low quality. As the data are limited, further studies consisting of more participants will be required for ascertaining benefits of entropy monitoring.\nFurther studies are needed to assess the effect of entropy monitoring on focal issues such as short-term and long-term mortality, as well as cost of general anaesthesia.\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 studies that compared entropy monitoring to the standard practice of administering anaesthetic drugs according to changes in heart rate, blood pressure, tearing, sweating or movement in response to surgery. The evidence is current to September 2014. We included adults and children aged two to 16 years. The participants underwent all types of surgery, except brain surgery, under general anaesthesia. We reran the search in January 2016. We identified one potential new study of interest; we will incorporate it into the formal review findings during the review update."
}
] |
query-laysum
|
8433
|
[
{
"role": "user",
"content": "Abstract: Background\nMethotrexate, a folate antagonist, is an immunosuppressant drug that is effective for treating several inflammatory disorders including Crohn's disease. Ulcerative colitis, a related chronic inflammatory bowel disease, can be challenging to treat. T his updated systematic review summarizes the current evidence on the use of methotrexate for induction maintenance of remission in ulcerative colitis.\nObjectives\nThe objectives of this review were to assess the efficacy and safety of methotrexate for maintenance of remission in patients with ulcerative colitis.\nSearch methods\nWe searched MEDLINE, EMBASE, CENTRAL and the Cochrane IBD/FBD group specialized trials register from inception to June 26, 2014. Study references and review papers were also searched for additional trials. Abstracts from major gastroenterological meetings were searched to identify research published in abstract form only.\nSelection criteria\nRandomized controlled trials in which methotrexate was compared to placebo or an active comparator in patients with quiescent ulcerative were considered for inclusion.\nData collection and analysis\nTwo authors independently extracted data and assessed the risk of bias for each study. The primary outcome was the occurrence of clinical or endoscopic relapse as defined by the primary studies. Secondary outcomes included frequency and nature of adverse events, change of disease activity score and steroid-sparing effect. We calculated the risk ratio and corresponding 95% confidence interval for dichotomous outcomes. Data were analyzed on an intention-to-treat basis. The overall quality of the evidence supporting the outcomes was evaluated using the GRADE criteria.\nMain results\nThree trials (165 patients) fulfilled the inclusion criteria. One study compared oral methotrexate (12.5 mg/week) to placebo, another compared oral methotrexate (15 mg/week) to 6-mercaptopurine (6-MP, 1.5 mg/kg/day) or 5-aminosalicylic acid (5-ASA, 3 g/day) and the other compared methotrexate (15 mg/week) in combination sulfasalazine (3 g/day) to sulfasalazine. The placebo-controlled study was rated as low risk of bias. The study comparing methotrexate to 6-MP and 5-ASA was rated as high risk of bias and the study assessing methotrexate and sulfasalazine was rated as unclear risk of bias for sequence generation, allocation concealment and blinding. The placebo-controlled study found no statistically significant differences in the proportion of patients who maintained remission. At nine months, 36% (5/14) of methotrexate patients maintained remission compared to 54% (10/18) of placebo patients (RR 0.64, 95% CI 0.28 to 1.45). A GRADE analysis indicated that the overall quality of the evidence for this outcome was low due to very sparse data (15 events). The study comparing combination therapy to sulfasalazine found no statistically significant difference in the proportion of patients who maintained remission. At 12 months, 100% (14/14) of patients in the combination group maintained remission compared to 75% (9/12) of sulfasalazine patients (RR 1.32, 95% CI 0.94 to 0.86), A GRADE analysis indicated that the overall quality of the evidence for this outcome was very low due to unknown risk of bias and very sparse data (23 events). There were no statistically significant differences in maintenance of remission rates between methotrexate and 6-MP or between methotrexate and 5-ASA. At 76 weeks, 14% (1/7) of methotrexate patients maintained remission compared to 64% (7/11) of 6-MP patients (RR 0.22, 95% CI 0.03 to 1.45) and 0% (0/2) of 5-ASA patients (RR 1.13, 95% CI 0.06 to 20.71). A GRADE analysis indicated that the overall quality of the evidence from this study was very low due to high risk of bias and very sparse data. Adverse events reported in these studies included transient leucopenia, migraine, nausea and dyspepsia, mild alopecia, mild increase in aspartate aminotransferase levels, peritoneal abscess, hypoalbuminemia, severe rash and atypical pneumonia\nAuthors' conclusions\nThe results for efficacy and safety outcomes between methotrexate and placebo, methotrexate and sulfasalazine, methotrexate and 6-mercaptopurine and methotrexate and 5-aminosalicylic acid were uncertain. Whether a higher dose or parenteral administration of methotrexate would be effective in quiescent ulcerative colitis is unknown. At present there is no evidence supporting the use of methotrexate for maintenance of remission in ulcerative colitis. More studies are needed to determine the efficacy and safety of methotrexate maintenance therapy in patients with quiescent ulcerative colitis. Large scale methodologically rigorous randomized controlled trials are needed. These studies should investigate higher doses of methotrexate (e.g. 15 to 25 mg/week) and parenteral administration.\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 the evidence about the effects and safety of methotrexate for maintaining remission in patients with ulcerative colitis, with the medical literature up to June 26, 2014."
}
] |
query-laysum
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8434
|
[
{
"role": "user",
"content": "Abstract: Background\nThe majority of people with epilepsy have a good prognosis and their seizures are controlled by a single antiepileptic drug. However, up to 20% of patients from population-based studies, and up to 30% from clinical series (not population-based), develop drug-resistant epilepsy, especially those with focal-onset seizures. In this review, we summarise the current evidence regarding topiramate, an antiepileptic drug first marketed in 1996, when used as an add-on treatment for drug-resistant focal epilepsy.\nThis is an update of a Cochrane Review first published in 1999, and last updated in 2014.\nObjectives\nTo evaluate the efficacy and tolerability of topiramate when used as an add-on treatment for people with drug-resistant focal epilepsy.\nSearch methods\nFor the latest update of this review we searched the following databases on 2 July 2018: Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (Ovid, 1946- ); ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). We imposed no language restrictions. We also contacted the manufacturers of topiramate and researchers in the field to identify any ongoing or unpublished studies.\nSelection criteria\nRandomised, placebo-controlled add-on trials of topiramate, recruiting people with drug-resistant focal epilepsy.\nData collection and analysis\nTwo review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: (1) 50% or greater reduction in seizure frequency; (2) seizure freedom; (3) treatment withdrawal (any reason); (4) adverse effects. Primary analyses were intention-to-treat (ITT), and summary risk ratios (RRs) with 95% confidence intervals (95% CIs) are presented. We evaluated dose-response in regression models. We carried out a 'Risk of bias' assessment for each included study using the Cochrane 'Risk of bias' tool and assessed the overall certainty of evidence using the GRADE approach.\nMain results\nWe included 12 trials, representing 1650 participants. Baseline phases ranged from four to 12 weeks and double-blind phases ranged from 11 to 19 weeks. The RR for a 50% or greater reduction in seizure frequency with add-on topiramate compared to placebo was 2.71 (95% CI 2.05 to 3.59; 12 studies; high-certainty evidence). Dose regression analysis showed increasing effect with increasing topiramate dose demonstrated by an odds ratio (OR) of 1.45 (95% CI 1.28 to 1.64; P < 0.001) per 200 mg/d increase in topiramate dosage. The proportion of participants achieving seizure freedom was also significantly increased with add-on topiramate compared to placebo (RR 3.67, 95% CI 1.79 to 7.54; 8 studies; moderate-certainty evidence). Treatment withdrawal was significantly higher for add-on topiramate compared to placebo (RR 2.37, 95% CI 1.66 to 3.37; 12 studies; high-certainty evidence). The RRs for the following adverse effects indicate that they are significantly more prevalent with topiramate, compared to placebo: ataxia 2.29 (99% CI 1.10 to 4.77; 4 studies); concentration difficulties 7.81 (99% CI 2.08 to 29.29; 6 studies; moderate-certainty evidence); dizziness 1.52 (99% CI 1.07 to 2.16; 8 studies); fatigue 2.08 (99% CI 1.37 to 3.15; 10 studies); paraesthesia 3.65 (99% CI 1.58 to 8.39; 7 studies; moderate-certainty evidence); somnolence 2.44 (99% CI 1.61 to 3.68; 9 studies); 'thinking abnormally' 5.70 (99% CI 2.26 to 14.38; 4 studies; high-certainty evidence); and weight loss 3.99 (99% CI 1.82 to 8.72; 9 studies; low-certainty evidence). Evidence of publication bias for the primary outcome was found (Egger test, P = 0.001). We rated all studies included in the review as having either low or unclear risk of bias. Overall, we assessed the evidence as moderate to high certainty due to the evidence of publication bias, statistical heterogeneity and imprecision, which was partially compensated for by large effect sizes.\nAuthors' conclusions\nTopiramate has efficacy as an add-on treatment for drug-resistant focal epilepsy as it is almost three times more effective compared to a placebo in reducing seizures. The trials reviewed were of relatively short duration and provided no evidence for the long-term efficacy of topiramate. Short-term use of add-on topiramate was shown to be associated with several adverse events. The results of this review should only be applied to adult populations as only one study included children. Future research should consider further examining the effect of dose.\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": "We assessed the trials with regards to potential bias and certainty. Overall, we rated the certainty of the evidence as moderate to high which means that we are fairly certain that the findings that we have reported are accurate. The trials included in this review did not examine the long-term effects of topiramate as an add-on treatment and only one study investigated the use of add-on topiramate in children. The findings should, therefore, only be applied to adults with drug-resistant focal epilepsy. Future research should test which dose is most effective.\nThe evidence is current to July 2018."
}
] |
query-laysum
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8435
|
[
{
"role": "user",
"content": "Abstract: Background\nAsthma is one of the most common reasons for hospital admission among children and constitutes a significant economic burden. Use of non-invasive positive pressure ventilation (NPPV) in the care of children with acute asthma has increased even though evidence supporting the intervention has been considered weak and clinical guidelines do not recommend the intervention. NPPV might be an effective intervention for acute asthma, but no systematic review has been conducted to assess the effects of NPPV as an add-on therapy to usual care in children with acute asthma.\nObjectives\nTo assess the benefits and harms of NPPV as an add-on therapy to usual care (e.g. bronchodilators and corticosteroids) in children with acute asthma.\nSearch methods\nWe identified trials from the Cochrane Airways Group Specialised Register (CAGR). The Register contains trial reports identified through systematic searches of bibliographic databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, AMED and PsycINFO, and by handsearching of respiratory journals and meeting abstracts. We also conducted a search of ClinicalTrials.gov (www.ClinicalTrials.gov) and the WHO trials portal (www.who.int/ictrp/en/). We searched all databases from their inception to February 2016, with no restriction on language of publication.\nSelection criteria\nWe included randomised clinical trials (RCTs) assessing NPPV as add-on therapy to usual care versus usual care for children (age < 18 years) hospitalised for an acute asthma attack.\nData collection and analysis\nTwo review authors independently screened titles and abstracts. We retrieved all relevant full-text study reports, independently screened the full text, identified trials for inclusion and identified and recorded reasons for exclusion of ineligible trials. We resolved disagreements through discussion or, if required, consulted a third review author. We recorded the selection process in sufficient detail to complete a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) flow diagram and 'Characteristics of excluded studies' table. We identified the risk of bias of included studies to reduce the risk of systematic error. We contacted relevant study authors when data were missing.\nMain results\nWe included two RCTs that randomised 20 participants to NPPV and 20 participants to control. We assessed both studies as having high risk of bias; both trials assessed effects of bilateral positive airway pressure (BiPAP). Neither trial used continuous positive airway pressure (CPAP). Controls received standard care. Investigators reported no deaths and no serious adverse events (Grades of Recommendation, Assessment, Development and Evaluation (GRADE): very low quality of evidence due to serious risk of bias and serious imprecision of results). Both trials showed a statistically significant reduction in symptom score. One trial did not report a standard deviation (SD), but by using an estimated SD, we found a statistically significantly reduced asthma symptom score (mean difference (MD) -2.50, 95% confidence interval (CI) -4.70 to -0.30, P = 0.03, 19 participants, GRADE: very low quality of evidence). In the other trial, NPPV was associated with a lower total symptom score (5.6 vs 1.9, 16 participants, very low quality of evidence) before cross-over, but investigators did not report an SD, nor could it be estimated from the first phase of the trial, before the cross-over. These gains could be clinically relevant, as a reduction of three or more points in symptom score is considered a clinically meaningful change. Researchers documented five dropouts (12.5%), four of which were due to intolerance to NPPV, and one to respiratory failure requiring intubation. Owing to insufficient reporting in the latter trial and use of different scoring systems, it was not possible to conduct a meta-analysis nor a Trial Sequential Analysis.\nAuthors' conclusions\nCurrent evidence does not permit confirmation or rejection of the effects of NPPV for acute asthma in children. Large RCTs with low risk of bias are warranted.\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, we found that NPPV compared with no additional treatment, treatment as usual or placebo did not result in any benefit or harm regarding death from all causes, serious adverse events (i.e. major complications) or improvement in asthma symptoms. Five study participants did not tolerate the treatment, four because of discomfort and one because intubation was required. Current evidence cannot confirm or reject the effects of NPPV for treatment of children with acute asthma. Larger randomised clinical trials are warranted."
}
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query-laysum
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8436
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[
{
"role": "user",
"content": "Abstract: Background\nLipid emulsions (LE) form a vital component of infant nutrition for critically ill, late preterm or term infants, particularly for those with gastrointestinal failure. Conventionally used soybean oil-based LE (S-LE) have high polyunsaturated fatty acid (PUFA) content and phytosterols, which may contribute to adverse effects including parenteral nutrition-associated liver disease (PNALD).\nObjectives\nTo compare the safety and efficacy of all LE for parenteral nutrition (PN) in term and late preterm infants (between 34 weeks' gestation and 36 weeks' and six days' gestation) with or without surgical conditions or PNALD within first six months of life, using all possible direct comparisons.\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 (1946 to 18 June 2018), Embase (1974 to 18 June 2018), CINAHL (1982 to 18 June 2018), MIDRIS (1971 to 31 May 2018), conference proceedings, trial registries (ClinicalTrials.gov and the WHO's Trials Registry), and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised or quasi-randomised controlled studies in term and late preterm infants, with or without surgical conditions or PNALD.\nData collection and analysis\nData collection and analysis conformed to the methods of Cochrane Neonatal. We used the GRADE approach to assess the quality of evidence for important outcomes in addition to reporting the conventional statistical significance of results.\nMain results\nThe review included nine randomised studies (n = 273). LE were classified in three broad groups: 1. all fish oil-containing LE including pure fish oil (F-LE) and multisource LE (e.g. medium-chain triglycerides (MCT)-olive-fish-soybean oil-LE (MOFS-LE), MCT-fish-soy oil-LE (MFS-LE) and olive-fish-soy-LE (OFS-LE)); 2. conventional pure S-LE; 3. alternative-LE (e.g. MCT-soy-LE (MS-LE), olive-soy-LE (OS-LE) and borage oil-based LE).\nWe considered four broad comparisons: 1. all fish oil LE versus non-fish oil LE (6 studies; n = 182); 2. fish oil LE versus another fish oil LE (0 studies); 3. alternative-LE versus S-LE (3 studies; n = 91); 4. alternative-LE versus another alternative-LE (0 studies) in term and late preterm infants (0 studies), term and late preterm infants with surgical conditions (7 studies; n = 233) and term and late preterm infants with PNALD/cholestasis (2 studies; n = 40).\nPNALD/cholestasis was defined as conjugated bilirubin (Cbil) 2 mg/dL or greater and resolution of PNALD/cholestasis as Cbil less than 2 mg/dL. We put no restriction on timing of PNALD detection. There was heterogeneity in definitions and time points for detecting PNALD in the included studies.\nWe found one study each in surgical infants and in infants with cholestasis, showing no evidence of difference in incidence or resolution of PNALD/cholestasis (Cbil cut-off: 2 mg/dL) with use of fish oil-containing LE compared to S-LE.\nWe considered an outcome allowing for any definition of PNALD (different Cbil cut-off levels). In infants with surgical conditions and no pre-existing PNALD, meta-analysis showed no difference in the incidence of PNALD/cholestasis (any definition) with use of fish oil-containing LE compared to S-LE (typical risk ratio (RR) 1.20, 95% confidence interval (CI) 0.38 to 3.76; typical risk difference (RD) 0.03, 95% CI -0.14 to 0.20; 2 studies; n = 68; low-quality evidence). In infants with PNALD/cholestasis (any definition), use of fish oil-LEs was associated with significantly less cholestasis compared to the S-LE group (typical risk ratio (RR) 0.54, 95% confidence interval (CI) 0.32 to 0.91; typical risk difference (RD) –0.39, 95% CI –0.65 to –0.12; number needed to treat for additional beneficial outcome (NNTB) 3, 95% CI 2 to 9; 2 studies; n = 40; very low-quality evidence). This outcome had very low number of participants from two small studies with differences in study methodology and early termination in one study, which increased uncertainty about the effect estimates.\nOne study in infants with cholestasis reported significantly better weight gain with a pure fish oil LE compared to a 10% S-LE (45 g/week, 95% CI 15.0 to 75.0; n = 16; very low-quality evidence). There were no significant differences in growth parameters in studies with surgical populations.\nFor the secondary outcomes, in infants with cholestasis, one study (n = 24) reported significantly lower conjugated bilirubin levels but higher gamma glutamyl transferase levels with MOFS-LE (SMOFlipid) versus S-LE (Intralipid) and another study (n = 16), which was terminated early, reported significantly higher rates of rise in alanine aminotransferase (ALT) and conjugated bilirubin levels in the S-LE group compared to pure F-LE (Omegaven).\nIn surgical infants, two studies each reported on hypertriglyceridaemia and Cbil levels with one study in each outcome showing significant benefit with use of a F-LE and the other study showing no difference between the groups. Meta-analysis was not performed for either of these outcomes as there were only two studies showing conflicting results with high heterogeneity between the studies.\nThere was no evidence of differences in death, sepsis, alkaline phosphatase and ALT levels in infants with surgical conditions or cholestasis (very low-quality evidence).\nOne study reported neurodevelopmental outcomes at six and 24 months in infants with surgical conditions (n = 11) with no evidence of difference with use of pure F-LE versus S-LE. Another study in infants with cholestasis (n = 16) reported no difference in head growth velocity between pure F-LE versus S-LE.\nGRADE quality of evidence ranged from low to very low as the included studies were small single-centre studies. Three of the six studies that contributed data to the review were terminated early for various reasons.\nAuthors' conclusions\nBased on the current review, there is insufficient data from randomised studies to determine with any certainty, the potential benefit of any LE including fish oil-containing LEs over another LE, for prevention or resolution of PNALD/cholestasis or any other outcomes in term and late preterm infants with underlying surgical conditions or cholestasis. There were no studies in infants without surgical conditions or cholestasis.\nFurther research is required to establish role of fish oil or lipids from other sources in LEs to improve PNALD/cholestasis, and other clinical outcomes in parenterally fed term and late preterm infants.\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 review authors searched the medical literature and identified nine eligible studies (including 273 preterm infants). Evidence is up to date as of 18 June 2018."
}
] |
query-laysum
|
8437
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[
{
"role": "user",
"content": "Abstract: Background\nRisks of stillbirth or neonatal death increase as gestation continues beyond term (around 40 weeks' gestation). It is unclear whether a policy of labour induction can reduce these risks. This Cochrane Review is an update of a review that was originally published in 2006 and subsequently updated in 2012 and 2018.\nObjectives\nTo assess the effects of a policy of labour induction at or beyond 37 weeks' gestation compared with a policy of awaiting spontaneous labour indefinitely (or until a later gestational age, or until a maternal or fetal indication for induction of labour arises) on pregnancy outcomes for the infant and the mother.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (17 July 2019), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) conducted in pregnant women at or beyond 37 weeks, comparing a policy of labour induction with a policy of awaiting spontaneous onset of labour (expectant management). We also included trials published in abstract form only. Cluster-RCTs, quasi-RCTs and trials using a cross-over design were not eligible for inclusion in this review.\nWe included pregnant women at or beyond 37 weeks' gestation. Since risk factors at this stage of pregnancy would normally require intervention, only trials including women at low risk for complications, as defined by trialists, were eligible. The trials of induction of labour in women with prelabour rupture of membranes at or beyond term were not considered in this review but are considered in a separate Cochrane Review.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, assessed risk of bias and extracted data. Data were checked for accuracy. We assessed the certainty of evidence using the GRADE approach.\nMain results\nIn this updated review, we included 34 RCTs (reporting on over 21,000 women and infants) mostly conducted in high-income settings. The trials compared a policy to induce labour usually after 41 completed weeks of gestation (> 287 days) with waiting for labour to start and/or waiting for a period before inducing labour. The trials were generally at low to moderate risk of bias.\nCompared with a policy of expectant management, a policy of labour induction was associated with fewer (all-cause) perinatal deaths (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.15 to 0.64; 22 trials, 18,795 infants; high-certainty evidence). There were four perinatal deaths in the labour induction policy group compared with 25 perinatal deaths in the expectant management group. The number needed to treat for an additional beneficial outcome (NNTB) with induction of labour, in order to prevent one perinatal death, was 544 (95% CI 441 to 1042). There were also fewer stillbirths in the induction group (RR 0.30, 95% CI 0.12 to 0.75; 22 trials, 18,795 infants; high-certainty evidence); two in the induction policy group and 16 in the expectant management group.\nFor women in the policy of induction arms of trials, there were probably fewer caesarean sections compared with expectant management (RR 0.90, 95% CI 0.85 to 0.95; 31 trials, 21,030 women; moderate-certainty evidence); and probably little or no difference in operative vaginal births with induction (RR 1.03, 95% CI 0.96 to 1.10; 22 trials, 18,584 women; moderate-certainty evidence). Induction may make little or difference to perineal trauma (severe perineal tear: RR 1.04, 95% CI 0.85 to 1.26; 5 trials; 11,589 women; low-certainty evidence). Induction probably makes little or no difference to postpartum haemorrhage (RR 1.02, 95% CI 0.91 to 1.15, 9 trials; 12,609 women; moderate-certainty evidence), or breastfeeding at discharge (RR 1.00, 95% CI 0.96 to 1.04; 2 trials, 7487 women; moderate-certainty evidence). Very low certainty evidence means that we are uncertain about the effect of induction or expectant management on the length of maternal hospital stay (average mean difference (MD) -0.19 days, 95% CI -0.56 to 0.18; 7 trials; 4120 women; Tau² = 0.20; I² = 94%).\nRates of neonatal intensive care unit (NICU) admission were lower (RR 0.88, 95% CI 0.80 to 0.96; 17 trials, 17,826 infants; high-certainty evidence), and probably fewer babies had Apgar scores less than seven at five minutes in the induction groups compared with expectant management (RR 0.73, 95% CI 0.56 to 0.96; 20 trials, 18,345 infants; moderate-certainty evidence).\nInduction or expectant management may make little or no difference for neonatal encephalopathy (RR 0.69, 95% CI 0.37 to 1.31; 2 trials, 8851 infants; low-certainty evidence, and probably makes little or no difference for neonatal trauma (RR 0.97, 95% CI 0.63 to 1.49; 5 trials, 13,106 infants; moderate-certainty evidence) for induction compared with expectant management. Neurodevelopment at childhood follow-up and postnatal depression were not reported by any trials.\nIn subgroup analyses, no differences were seen for timing of induction (< 40 versus 40-41 versus ≥ 41 weeks' gestation), by parity (primiparous versus multiparous) or state of cervix for any of the main outcomes (perinatal death, stillbirth, NICU admission, caesarean section, operative vaginal birth, or perineal trauma).\nAuthors' conclusions\nThere is a clear reduction in perinatal death with a policy of labour induction at or beyond 37 weeks compared with expectant management, though absolute rates are small (0.4 versus 3 deaths per 1000). There were also lower caesarean rates without increasing rates of operative vaginal births and there were fewer NICU admissions with a policy of induction. Most of the important outcomes assessed using GRADE had high- or moderate-certainty ratings.\nWhile existing trials have not yet reported on childhood neurodevelopment, this is an important area for future research.\nThe optimal timing of offering induction of labour to women at or beyond 37 weeks' gestation needs further investigation, as does further exploration of risk profiles of women and their values and preferences. Offering women tailored counselling may help them make an informed choice between induction of labour for pregnancies, particularly those continuing beyond 41 weeks - or waiting for labour to start and/or waiting before inducing labour.\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": "A policy of labour induction compared with expectant management is associated with fewer deaths of babies and probably fewer caesarean sections; with probably little or no difference in assisted vaginal births. The best timing of when to offer induction of labour to women at or beyond 37 weeks' gestation warrants further investigation, as does further exploration of risk profiles of women and their values and preferences. Discussing the risks of labour induction, including benefits and harms, may help women make an informed choice between induction of labour for pregnancies, particularly those continuing beyond 41 weeks, or waiting for labour to start and/or waiting before inducing labour. Women's understanding of induction, the procedures, their risks and benefits, is important in influencing their choices and satisfaction."
}
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query-laysum
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8438
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[
{
"role": "user",
"content": "Abstract: Background\nClinical trials and observational data have variously shown a protective, harmful or neutral effect of antihypertensives on cognitive function. In theory, withdrawal of antihypertensives could improve cerebral perfusion and reduce or delay cognitive decline. However, it is also plausible that withdrawal of antihypertensives may have a detrimental effect on cognition through increased incidence of stroke or other vascular events.\nObjectives\nTo assess the effects of complete withdrawal of at least one antihypertensive medication on incidence of dementia, cognitive function, blood pressure and other safety outcomes in cognitively intact and cognitive impaired adults.\nSearch methods\nWe searched ALOIS, the specialised register of the Cochrane Dementia and Cognitive Improvement Group, with additional searches conducted in MEDLINE, Embase, PsycINFO, CINAHL, LILACS, Web of Science Core Collection, ClinicalTrials.gov and the World Health Organization Portal/ICTRP on 12 December 2015. There were no language or date restrictions applied to the electronic searches, and no methodological filters were used to restrict the search.\nSelection criteria\nWe included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) provided they compared withdrawal of antihypertensive medications with continuation of the medications and included an outcome measure assessing cognitive function or a clinical diagnosis of dementia. We included studies with healthy participants, but we also included studies with participants with all grades of severity of existing dementia or cognitive impairment.\nData collection and analysis\nTwo review authors examined titles and abstracts of citations identified by the search for eligibility, retrieving full texts where needed to identify studies for inclusion, with any disagreement resolved by involvement of a third author. Data were extracted independently on primary and secondary outcomes. We used standard methodological procedures expected by Cochrane.\nThe primary outcome measures of interest were changes in global and specific cognitive function and incidence of dementia; secondary outcomes included change in systolic and diastolic blood pressure, mortality, adverse events (including cardiovascular events, hospitalisation and falls) and adherence to withdrawal. The quality of the evidence was evaluated using the GRADE approach.\nMain results\nWe included two RCTs investigating withdrawal of antihypertensives in 2490 participants. There was substantial clinical heterogeneity between the included studies, therefore we did not combine data for our primary outcome. Overall, the quality of included studies was high and the risk of bias was low. Neither study investigated incident dementia.\nOne study assessed withholding previously prescribed antihypertensive drugs for seven days following acute stroke. Cognition was assessed using telephone Mini-Mental State Examination (t-MMSE) and Telephone Interview for Cognitive Status (TICS-M) at 90 days as a secondary outcome. The t-MMSE score was a mean of 1.0 point higher in participants who withdrew antihypertensive medications compared to participants who continued them (95% confidence interval (CI) 0.35 to 1.65; 1784 participants) and the TICS-M was a mean of 2.10 points higher (95% CI 0.69 to 3.51; 1784 participants). However, in both cases the evidence was of very low quality downgraded due to risk of bias, indirectness and evidence from a single study. The other study was community based and included participants with mild cognitive impairment. Drug withdrawal was for 16 weeks. Cognitive performance was assessed using a composite of at least five out of six cognitive tests. There was no evidence of a difference comparing participants who withdrew antihypertensive medications and participants who continued (mean difference 0.02 points, 95% CI -0.19 to 0.21; 351 participants). This evidence was of low quality and was downgraded due to risk of bias and evidence from single study.\nIn one study, the systolic blood pressure after seven days of withdrawal was 9.5 mmHg higher in the intervention compared to the control group (95% CI 7.43 to 11.57; 2095 participants) and diastolic blood pressure was 5.1 mmHg higher (95% CI 3.86 to 6.34; 2095 participants). This evidence was low quality, downgraded due to indirectness, because the data must be interpreted in the context of the wider study looking at glyceryl trinitrate administration or not, and evidence from a single study. In the other study, systolic blood pressure increased by 7.4 mmHg in the withdrawal group compared to the control group (95% CI 7.08 to 7.72; 356 participants) and diastolic blood pressure increased by 2.6 mmHg (95% CI 2.42 to 2.78; 356 participants). This was moderate quality evidence, downgraded as evidence was from a single study. We combined data for mortality and cardiovascular events. There was no clear evidence that antihypertensive medication withdrawal affected adverse events, although there was a possible trend to increased cardiovascular events in the large post-stroke study (pooled mortality risk ratio 0.88, 95% CI 0.72 to 1.08; 2485 participants; and cardiovascular events risk ratio 1.29, 95% CI 0.96 to 1.72). Certain prespecified outcomes of interest (falls, hospitalisation) were not reported.\nAuthors' conclusions\nThe effects of withdrawing antihypertensive medications on cognition or prevention of dementia are uncertain. There was a signal of a positive effect in one study looking at withdrawal after acute stroke but these results are unlikely to be generalisable to non-stroke settings and were not a primary outcome of the study. Withdrawing antihypertensive drugs was associated with increased blood pressure. It is unlikely to increase mortality at three to four months' follow-up, although there was a signal from one large study looking at withdrawal after stroke that withdrawal was associated an increase in cardiovascular events.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The two studies did not report new cases of dementia, rather they described performance on standardised tests of memory and thinking. The older-adult study did not find a difference between the participants who stopped and participants who continued medicine. The stroke study found better test scores in participants who stopped medicine, but this must be interpreted with caution since this was measured in such a specific patient population. As expected, blood pressure rose in both studies in the groups that stopped their blood pressure lowering medicines, but there was no short-term increase in heart attacks, strokes or death."
}
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query-laysum
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8439
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[
{
"role": "user",
"content": "Abstract: Background\nChild and adolescent overweight and obesity have increased globally and are associated with significant short- and long-term health consequences.\nObjectives\nTo assess the effects of surgery for treating obesity in childhood and adolescence.\nSearch methods\nFor this update, we searched Cochrane Central Register of Controlled Trials, MEDLINE, Latin American and Caribbean Health Science Information database (LILACS), World Health Organization International Clinical Trials Registry Platform (ICTRP)and ClinicalTrials.gov on 20 August 2021 (date of the last search for all databases). We did not apply language restrictions. We checked references of identified studies and systematic reviews.\nSelection criteria\nWe selected randomised controlled trials (RCTs) of surgical interventions for treating obesity in children and adolescents (age < 18 years) with a minimum of six months of follow-up. We excluded interventions that specifically dealt with the treatment of eating disorders or type 2 diabetes, or which included participants with a secondary or syndromic cause of obesity, or who were pregnant.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently extracted data and assessed the risk of bias using the Cochrane Risk of Bias 2.0 tool. Where necessary, we contacted authors for additional information.\nMain results\nWith this update, we did not find any new RCTs. Therefore, this updated review still includes a single RCT (a total of 50 participants, 25 in both the intervention and comparator groups). The intervention focused on laparoscopic adjustable gastric banding surgery, which was compared to a control group receiving a multi-component lifestyle programme. The participating population consisted of Australian adolescents (a higher proportion of girls than boys) aged 14 to 18 years, with a mean age of 16.5 and 16.6 years in the gastric banding and lifestyle groups, respectively. The trial was conducted in a private hospital, receiving funding from the gastric banding manufacturer. For most of the outcomes, we identified a high risk of bias, mainly due to bias due to missing outcome data.\nLaparoscopic gastric banding surgery may reduce BMI by a mean difference (MD) of -11.40 kg/m2 (95% CI -13.22 to -9.58) and weight by -31.60 kg (95% CI -36.66 to -26.54) compared to a multi-component lifestyle programme at two years follow-up. The evidence is very uncertain due to serious imprecision and a high risk of bias. Adverse events were reported in 12/25 (48%) participants in the intervention group compared to 11/25 (44%) in the control group. A total of 28% of the adolescents undergoing gastric banding required revisional surgery. The evidence is very uncertain due to serious imprecision and a high risk of bias. At two years of follow-up, laparoscopic gastric banding surgery may increase health-related quality of life in the physical functioning scores by an MD of 16.30 (95% CI 4.90 to 27.70) and change in health scores by an MD of 0.82 (95% CI 0.18 to 1.46) compared to the lifestyle group. The evidence is very uncertain due to serious imprecision and a high risk of bias. No data were reported for all-cause mortality, behaviour change, participants’ views of the intervention and socioeconomic effects.\nFinally, we have identified three ongoing RCTs that are evaluating the efficacy and safety of metabolic and bariatric surgery in children and adolescents.\nAuthors' conclusions\nLaparoscopic gastric banding led to greater body weight loss compared to a multi-component lifestyle program in one small study with 50 participants. These results have very limited application, primarily due to more recent recommendations derived from observation studies to avoid the use of banding in youth due to long-term reoperation rates. This systematic review update still highlights the lack of RCTs in this field. The authors are concerned that there may be ethical barriers to RTCs in this field, despite the lack of other effective therapies for severe obesity in children and adolescents and the significant morbidity and premature mortality caused by childhood obesity. Nevertheless, future studies, whether pre-registered and planned non-randomised or pragmatic randomised trials, should assess the impact of the surgical procedure and post-operative care to minimise adverse events, including the need for post-operative adjustments and revisional surgery. Long-term follow-up is also critical to comprehensively assess the impact of surgery as participants enter adulthood.\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": "Australian adolescents (higher proportion of girls than boys) with an average age of 16.5 and 16.6 years in the gastric banding and control group participated. The study authors reported an average reduction in weight of 34.6 kg at two years, representing a change in body mass index units (kg/m²) of 12.7 for the gastric banding group; and an average reduction in weight of 3.0 kg representing a change in body mass index units of 1.3 for the control intervention. Side effects were reported in 12 of 25 (48%) participants in the intervention group and in 11 of 25 (44%) in the control group. A total of 28% of the adolescents undergoing gastric banding required a 'revisional procedure' (surgery because of complications from the gastric banding surgery). No data were reported for all-cause mortality, behaviour change, participants’ views of the intervention and socioeconomic effects. At two years, the gastric banding participants performed better than the lifestyle participants in two of eight health-related quality of life concepts as measured by the Child Health Questionnaire (physical functioning score (94 versus 78, community norm 95) and change in health score (4.4 versus 3.6, community norm 3.5)."
}
] |
query-laysum
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8440
|
[
{
"role": "user",
"content": "Abstract: Background\nGlucocorticoid use in rheumatoid arthritis (RA) is widespread. Two Cochrane Reviews have been published examining the short term clinical benefit of low dose glucocorticoids compared to non-steroidal anti-inflammatory drugs and demonstrate good short term and medium term clinical benefits. The possibility that glucocorticoids may have a fundamental 'disease modifying' effect in RA, which would be seen by a reduction in the rate of radiological progression, has been raised by several authors.\nObjectives\nTo perform a systematic review of studies evaluating glucocorticoid efficacy in inhibiting the progression of radiological damage in rheumatoid arthritis.\nSearch methods\nA search of MEDLINE (from 1966 to 22 February 2005) and the Cochrane Central Register of Controlled Trials was undertaken, using the terms 'corticosteroids' and 'rheumatoid arthritis' expanded according to the Cochrane Collaboration recommendations. Identified abstracts were reviewed and appropriate reports obtained in full. Additional reports were identified from the reference lists and from expert knowledge.\nSelection criteria\nRandomized controlled or cross-over trials in adults with a diagnosis of rheumatoid arthritis in which prednisone or a similar glucocorticoid preparation was compared to either placebo controls or active controls (i.e. comparative studies) and where there was evaluation of radiographs of hands, or hands and feet, or feet by any standardised technique. Eligible studies had at least one treatment arm with glucocorticoids and one without glucocorticoids.\nData collection and analysis\nStandardised data extraction obtained the mean and standard deviation (SD) of change in erosion scores over 1 year or 2 years. (Where SD for change was not given a conservative estimate was taken from baseline data.) At least two authors selected the studies and extracted the data. Radiographic erosion scores were expressed as a percentage of the maximum possible score for the method used. The results were pooled after weighting in a random effects model to provide a standardised mean difference (SMD).\nMain results\nThe initial search produced 217 citations, and 15 were added from experts, abstracts and review of reference lists. Authors of 4 trials being prepared for publication (and subsequently published) kindly shared their data. After application of eligibility criteria 15 studies and 1,414 patients were included. The majority of trials studied early RA (disease duration up to 2 years), and the mean cumulative dose of glucocorticoid was 2,300 mg prednisone equivalent (range 270 mg - 5,800 mg) over the first year. Glucocorticoids were mostly added to other disease modifying anti-rheumatoid drug (DMARD) treatment. The standardised mean difference in progression was 0.40 in favour of glucocorticoids (95% CI 0.27, 0.54). In studies lasting 2 years (806 patients included), the standardised mean difference in progression in favour of glucocorticoids at 1 year was 0.45 (0.24, 0.66) and at 2 years was 0.42 (0.30, 0.55). All studies except one showed a numerical treatment effect in favour of glucocorticoids. The beneficial effects of glucocorticoids were generally achieved when used in conjunction with other DMARD treatment.\nAuthors' conclusions\nEven in the most conservative estimate, the evidence that glucocorticoids given in addition to standard therapy can substantially reduce the rate of erosion progression in rheumatoid arthritis is convincing. There remains concern about potential long-term adverse reactions to glucocorticoid therapy, such as increased cardiovascular risk, and this issue requires further research.\n\nGiven the provided abstract, please respond to the following query: \"What is rheumatoid arthritis and why use glucocorticoids?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Rheumatoid arthritis is a disease in which the body's immune system attacks its own healthy tissues. The attack happens mostly in the joints (especially in the hands and feet) and causes redness, pain, swelling and heat in the joint (inflammation). Glucocorticoids are also known as glucocorticosteroids, or sometimes just 'steroids', although there are many other types of steroids. They are taken as pills for up to 7 months and have already been shown to improve the symptoms of rheumatoid arthritis. There is however still some concern about the long term harms, such as heart problems, when taking glucocorticoids.\nRheumatoid arthritis also breaks down and erodes away the cartilage and bones in the affected joints. This erosion cannot be seen and is measured by x-rays. More erosion on an x-ray usually means that the disease is progressing or worsening. There is some debate about whether glucocorticoids can slow the erosion and the progression of the disease."
}
] |
query-laysum
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8442
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[
{
"role": "user",
"content": "Abstract: Background\nWithout a phase of retention after successful orthodontic treatment, teeth tend to 'relapse', that is, to return to their initial position. Retention is achieved by fitting fixed or removable retainers to provide stability to the teeth while avoiding damage to teeth and gums. Removable retainers can be worn full- or part-time. Retainers vary in shape, material, and the way they are made. Adjunctive procedures are sometimes used to try to improve retention, for example, reshaping teeth where they contact ('interproximal reduction'), or cutting fibres around teeth ('percision').\nThis review is an update of one originally published in 2004 and last updated in 2016.\nObjectives\nTo evaluate the effects of different retainers and retention strategies used to stabilise tooth position after orthodontic braces.\nSearch methods\nAn information specialist searched Cochrane Oral Health Trials Register, CENTRAL, MEDLINE, Embase and OpenGrey up to 27 April 2022 and used additional search methods to identify published, unpublished and ongoing studies.\nSelection criteria\nRandomised controlled trials (RCTs) involving children and adults who had retainers fitted or adjunctive procedures undertaken to prevent relapse following orthodontic treatment with braces. We excluded studies with aligners.\nData collection and analysis\nTwo review authors independently screened eligible studies, assessed risk of bias and extracted data. Outcomes were stability or relapse of tooth position, retainer failure (i.e. broken, detached, worn out, ill-fitting or lost), adverse effects on teeth and gums (i.e. plaque, gingival and bleeding indices), and participant satisfaction. We calculated mean differences (MD) for continuous data, risk ratios (RR) or risk differences (RD) for dichotomous data, and hazard ratios (HR) for survival data, all with 95% confidence intervals (CI). We conducted meta-analyses when similar studies reported outcomes at the same time point; otherwise results were reported as mean ranges. We prioritised reporting of Little's Irregularity Index (crookedness of anterior teeth) to measure relapse, judging the minimum important difference to be 1 mm.\nMain results\nWe included 47 studies, with 4377 participants. The studies evaluated: removable versus fixed retainers (8 studies); different types of fixed retainers (22 studies) or bonding materials (3 studies); and different types of removable retainers (16 studies). Four studies evaluated more than one comparison. We judged 28 studies to have high risk of bias, 11 to have low risk, and eight studies as unclear.\nWe focused on 12-month follow-up.\nThe evidence is low or very low certainty. Most comparisons and outcomes were evaluated in only one study at high risk of bias, and most studies measured outcomes after less than a year.\nRemovable versus fixed retainers\nRemovable (part-time) versus fixed\nOne study reported that participants wearing clear plastic retainers part-time in the lower arch had more relapse than participants with multistrand fixed retainers, but the amount was not clinically significant (Little's Irregularity Index (LII) MD 0.92 mm, 95% CI 0.23 to 1.61; 56 participants). Removable retainers were more likely to cause discomfort (RR 12.22; 95% CI 1.69 to 88.52; 57 participants), but were associated with less retainer failure (RR 0.44, 95% CI 0.20 to 0.98; 57 participants) and better periodontal health (Gingival Index (GI) MD −0.34, 95% CI −0.66 to −0.02; 59 participants).\nRemovable (full-time) versus fixed\nOne study reported that removable clear plastic retainers worn full-time in the lower arch did not provide any clinically significant benefit for tooth stability over fixed retainers (LII MD 0.60 mm, 95% CI 0.17 to 1.03; 84 participants). Participants with clear plastic retainers had better periodontal health (gingival bleeding RR 0.53, 95% CI 0.31 to 0.88; 84 participants), but higher risk of retainer failure (RR 3.42, 95% CI 1.38 to 8.47; 77 participants). The study found no difference between retainers for caries.\nDifferent types of fixed retainers\nComputer-aided design/computer-aided manufacturing (CAD/CAM) nitinol versus conventional/analogue multistrand\nOne study reported that CAD/CAM nitinol fixed retainers were better for tooth stability, but the difference was not clinically significant (LII MD −0.46 mm, 95% CI −0.72 to −0.21; 66 participants). There was no evidence of a difference between retainers for periodontal health (GI MD 0.00, 95% CI -0.16 to 0.16; 2 studies, 107 participants), or retainer survival (RR 1.29, 95% CI 0.67 to 2.49; 1 study, 41 participants).\nFibre-reinforced composite versus conventional multistrand/spiral wire\nOne study reported that fibre-reinforced composite fixed retainers provided better stability than multistrand retainers, but this was not of a clinically significant amount (LII MD −0.70 mm, 95% CI −1.17 to −0.23; 52 participants). The fibre-reinforced retainers had better patient satisfaction with aesthetics (MD 1.49 cm on a visual analogue scale, 95% CI 0.76 to 2.22; 1 study, 32 participants), and similar retainer survival rates (RR 1.01, 95% CI 0.84 to 1.21; 7 studies; 1337 participants) at 12 months. However, failures occurred earlier (MD −1.48 months, 95% CI −1.88 to −1.08; 2 studies, 103 participants; 24-month follow-up) and more gingival inflammation at six months, though bleeding on probing (BoP) was similar (GI MD 0.59, 95% CI 0.13 to 1.05; BoP MD 0.33, 95% CI −0.13 to 0.79; 1 study, 40 participants).\nDifferent types of removable retainers\nClear plastic versus Hawley\nWhen worn in the lower arch for six months full-time and six months part-time, clear plastic provided similar stability to Hawley retainers (LII MD 0.01 mm, 95% CI −0.65 to 0.67; 1 study, 30 participants). Hawley retainers had lower risk of failure (RR 0.60, 95% CI 0.43 to 0.83; 1 study, 111 participants), but were less comfortable at six months (VAS MD -1.86 cm, 95% CI -2.19 to -1.53; 1 study, 86 participants).\nPart-time versus full-time wear of Hawley\nThere was no evidence of a difference in stability between part-time and full-time use of Hawley retainers (MD 0.20 mm, 95% CI −0.28 to 0.68; 1 study, 52 participants).\nAuthors' conclusions\nThe evidence is low to very low certainty, so we cannot draw firm conclusions about any one approach to retention over another. More high-quality studies are needed that measure tooth stability over at least two years, and measure how long retainers last, patient satisfaction and negative side effects from wearing retainers, such as tooth decay and gum disease.\n\nGiven the provided abstract, please respond to the following query: \"Different types of removable retainers (16 studies)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The effects of Hawley removable retainers compared with clear plastic retainers on movement of the teeth may be similar, whether they are worn full- or part-time. Clear plastic retainers may provide better patient satisfaction but be less likely to last than Hawley retainers."
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"role": "user",
"content": "Abstract: Background\nDiarrhoeal disease accounts for millions of child deaths every year. Although the role of flies as vectors of infectious diarrhoea has been established, fly control is not often mentioned as an approach to decrease childhood diarrhoea. Theoretically, fly control for decreasing diarrhoea incidence can be achieved by intervening at four different levels: reduction or elimination of fly breeding sites; reduction of sources that attract houseflies; prevention of contact between flies and disease-causing organisms; and protection of people, food, and food utensils from contact with flies.\nObjectives\nTo assess the impact of various housefly control measures on the incidence of diarrhoea and its related morbidity and mortality in children under five years of age.\nSearch methods\nWe searched electronic databases including the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, CINAHL, and LILACS, from database inception to 24 May 2018. We also searched trial registries for relevant grey literature and ongoing trials. We checked the references of the identified studies and reviews. We did not apply any filters for language, publication status (published, unpublished, in press, and ongoing), or publication date.\nSelection criteria\nWe planned to include randomized controlled trials (RCTs), quasi-RCTs, and controlled before-and-after studies that studied the effect of fly control on diarrhoea in children under five years of age.\nData collection and analysis\nTwo review authors extracted the data and independently assessed the risk of bias in the included study. We planned to contact study authors for additional information, where necessary. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included one cluster-RCT (491 participants) conducted in Pakistan that evaluated insecticide spraying in the first two years and baited fly traps in the third year. Insecticide spraying reduced the fly population (house index) in the intervention group during the four months of the year when both flies and cases of diarrhoea were more common, but not at other times. On average, this was associated with a reduction in the incidence of diarrhoea in the first year (illustrative mean episodes per child-year in the intervention group was 6.3 while in the control group was 7.1) and second year of the intervention (illustrative mean episodes per child‒year in the intervention group was 4.4 while in the control group was 6.5; rate ratio (RaR) 0.77, 95% confidence interval (CI) 0.67 to 0.89, low-certainty evidence). In the third year of the intervention, the baited fly traps did not demonstrate an effect on the fly population or on diarrhoea incidence (RaR 1.15, 95% CI 0.90 to 1.47, low-certainty evidence).\nAuthors' conclusions\nThe trial, conducted in a setting where there were clear seasonal peaks in fly numbers and associated diarrhoea, shows insecticide spraying may reduce diarrhoea in children. Further research on whether this finding is applicable to other setting is required, as well as work on other fly control methods, their effects, feasibility, costs, and acceptability.\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"
},
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"role": "assistant",
"content": "The review authors searched for available studies up to 24 May 2018."
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"content": "Abstract: Background\nSupplemental oxygen is frequently administered to patients with acute respiratory distress syndrome (ARDS), including ARDS secondary to viral illness such as coronavirus disease 19 (COVID-19). An up-to-date understanding of how best to target this therapy (e.g. arterial partial pressure of oxygen (PaO2) or peripheral oxygen saturation (SpO2) aim) in these patients is urgently required.\nObjectives\nTo address how oxygen therapy should be targeted in adults with ARDS (particularly ARDS secondary to COVID-19 or other respiratory viruses) and requiring mechanical ventilation in an intensive care unit, and the impact oxygen therapy has on mortality, days ventilated, days of catecholamine use, requirement for renal replacement therapy, and quality of life.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register, CENTRAL, MEDLINE, and Embase from inception to 15 May 2020 for ongoing or completed randomized controlled trials (RCTs).\nSelection criteria\nTwo review authors independently assessed all records in accordance with standard Cochrane methodology for study selection.\nWe included RCTs comparing supplemental oxygen administration (i.e. different target PaO2 or SpO2 ranges) in adults with ARDS and receiving mechanical ventilation in an intensive care setting. We excluded studies exploring oxygen administration in patients with different underlying diagnoses or those receiving non-invasive ventilation, high-flow nasal oxygen, or oxygen via facemask.\nData collection and analysis\nOne review author performed data extraction, which a second review author checked. We assessed risk of bias in included studies using the Cochrane 'Risk of bias' tool. We used the GRADE approach to judge the certainty of the evidence for the following outcomes; mortality at longest follow-up, days ventilated, days of catecholamine use, and requirement for renal replacement therapy.\nMain results\nWe identified one completed RCT evaluating oxygen targets in patients with ARDS receiving mechanical ventilation in an intensive care setting. The study randomized 205 mechanically ventilated patients with ARDS to either conservative (PaO2 55 to 70 mmHg, or SpO2 88% to 92%) or liberal (PaO2 90 to 105 mmHg, or SpO2≥ 96%) oxygen therapy for seven days.\nOverall risk of bias was high (due to lack of blinding, small numbers of participants, and the trial stopping prematurely), and we assessed the certainty of the evidence as very low. The available data suggested that mortality at 90 days may be higher in those participants receiving a lower oxygen target (odds ratio (OR) 1.83, 95% confidence interval (CI) 1.03 to 3.27). There was no evidence of a difference between the lower and higher target groups in mean number of days ventilated (14.0, 95% CI 10.0 to 18.0 versus 14.5, 95% CI 11.8 to 17.1); number of days of catecholamine use (8.0, 95% CI 5.5 to 10.5 versus 7.2, 95% CI 5.9 to 8.4); or participants receiving renal replacement therapy (13.7%, 95% CI 5.8% to 21.6% versus 12.0%, 95% CI 5.0% to 19.1%). Quality of life was not reported.\nAuthors' conclusions\nWe are very uncertain as to whether a higher or lower oxygen target is more beneficial in patients with ARDS and receiving mechanical ventilation in an intensive care setting. We identified only one RCT with a total of 205 participants exploring this question, and rated the risk of bias as high and the certainty of the findings as very low. Further well-conducted studies are urgently needed to increase the certainty of the findings reported here. This review should be updated when more evidence is available.\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"
},
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"role": "assistant",
"content": "Acute respiratory distress syndrome (ARDS) is a very severe breathing problem with a high mortality rate (chance of dying). It has many potential causes, including viral infections such as COVID-19, and there are no specific treatments for it except for giving patients oxygen via a ventilator (artificial breathing machine) on an intensive care unit, often for long periods of time. However, large amounts of oxygen (either a high concentration of oxygen or oxygen administered for a long period of time) are associated with increased harm due to other illnesses (e.g. heart attack or stroke)."
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"role": "user",
"content": "Abstract: Background\nMany smokers give up smoking on their own, but materials that provide a structured programme for smokers to follow may increase the number who quit successfully.\nObjectives\nThe aims of this review were to determine the effectiveness of different forms of print-based self-help materials that provide a structured programme for smokers to follow, compared with no treatment and with other minimal contact strategies, and to determine the comparative effectiveness of different components and characteristics of print-based self-help, such as computer-generated feedback, additional materials, tailoring of materials to individuals, and targeting of materials at specific groups.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Trials Register, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP). The date of the most recent search was March 2018.\nSelection criteria\nWe included randomised trials of smoking cessation with follow-up of at least six months, where at least one arm tested print-based materials providing self-help compared with minimal print-based self-help (such as a short leaflet) or a lower-intensity control. We defined 'self-help' as structured programming for smokers trying to quit without intensive contact with a therapist.\nData collection and analysis\nWe extracted data in accordance with standard methodological procedures set out by Cochrane. The main outcome measure was abstinence from smoking after at least six months' follow-up in people smoking at baseline. We used the most rigorous definition of abstinence in each study and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a random-effects model.\nMain results\nWe identified 75 studies that met our inclusion criteria. Many study reports did not include sufficient detail to allow judgement of risk of bias for some domains. We judged 30 studies (40%) to be at high risk of bias for one or more domains.\nThirty-five studies evaluated the effects of standard, non-tailored self-help materials. Eleven studies compared self-help materials alone with no intervention and found a small effect in favour of the intervention (n = 13,241; risk ratio (RR) 1.19, 95% confidence interval (CI) 1.03 to 1.37; I² = 0%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for indirect relevance to populations in low- and middle-income countries because evidence for this comparison came from studies conducted solely in high-income countries and there is reason to believe the intervention might work differently in low- and middle-income countries. This analysis excluded two studies by the same author team with strongly positive outcomes that were clear outliers and introduced significant heterogeneity. Six further studies of structured self-help compared with brief leaflets did not show evidence of an effect of self-help materials on smoking cessation (n = 7023; RR 0.87, 95% CI 0.71 to 1.07; I² = 21%). We found evidence of benefit from standard self-help materials when there was brief contact that did not include smoking cessation advice (4 studies; n = 2822; RR 1.39, 95% CI 1.03 to 1.88; I² = 0%), but not when self-help was provided as an adjunct to face-to-face smoking cessation advice for all participants (11 studies; n = 5365; RR 0.99, 95% CI 0.76 to 1.28; I² = 32%).\nThirty-two studies tested materials tailored for the characteristics of individual smokers, with controls receiving no materials, or stage-matched or non-tailored materials. Most of these studies used more than one mailing. Pooling studies that compared tailored self-help with no self-help, either on its own or compared with advice, or as an adjunct to advice, showed a benefit of providing tailored self-help interventions (12 studies; n = 19,190; RR 1.34, 95% CI 1.20 to 1.49; I² = 0%) with little evidence of difference between subgroups (10 studies compared tailored with no materials, n = 14,359; RR 1.34, 95% CI 1.19 to 1.51; I² = 0%; two studies compared tailored materials with brief advice, n = 2992; RR 1.13, 95% CI 0.86 to 1.49; I² = 0%; and two studies evaluated tailored materials as an adjunct to brief advice, n = 1839; RR 1.72, 95% CI 1.17 to 2.53; I² = 10%). When studies compared tailored self-help with non-tailored self-help, results favoured tailored interventions when the tailored interventions involved more mailings than the non-tailored interventions (9 studies; n = 14,166; RR 1.42, 95% CI 1.20 to 1.68; I² = 0%), but not when the two conditions were contact-matched (10 studies; n = 11,024; RR 1.07, 95% CI 0.89 to 1.30; I² = 50%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for risk of bias.\nFive studies evaluated self-help materials as an adjunct to nicotine replacement therapy; pooling three of these provided no evidence of additional benefit (n = 1769; RR 1.05, 95% CI 0.86 to 1.30; I² = 0%). Four studies evaluating additional written materials favoured the intervention, but the lower confidence interval crossed the line of no effect (RR 1.20, 95% CI 0.91 to 1.58; I² = 73%). A small number of other studies did not detect benefit from using targeted materials, or find differences between different self-help programmes.\nAuthors' conclusions\nModerate-certainty evidence shows that when no other support is available, written self-help materials help more people to stop smoking than no intervention. When people receive advice from a health professional or are using nicotine replacement therapy, there is no evidence that self-help materials add to their effect. However, small benefits cannot be excluded. Moderate-certainty evidence shows that self-help materials that use data from participants to tailor the nature of the advice or support given are more effective than no intervention. However, when tailored self-help materials, which typically involve repeated assessment and mailing, were compared with untailored materials delivered similarly, there was no evidence of benefit.\nAvailable evidence tested self-help interventions in high-income countries, where more intensive support is often available. Further research is needed to investigate effects of these interventions in low- and middle-income countries, where more intensive support may not be available.\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"
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"role": "assistant",
"content": "When no other support is available, written self-help materials help more people to stop smoking compared with getting no help at all. People were more likely to make successful quit attempts when they were also given face-to-face support or nicotine replacement therapy, but printed self-help did not make these people more likely to quit.\nSelf-help materials that were tailored to help individual people are more effective than no help at all. However, tailoring these materials often involves more contact with the research team, and when we compared tailored self-help with regular self-help that involved the same amount of contact, we did not find a difference in quit rates.\nThe studies we found looked at self-help given to people in high-income countries, where more intensive support is often available. More research is needed to find out how well self-help works for people in low- and middle-income countries, where more intensive support is less available."
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"role": "user",
"content": "Abstract: Background\nBreastfeeding is important, however not all infants can feed at the breast and methods of expressing milk need evaluation.\nObjectives\nTo assess acceptability, effectiveness, safety, effect on milk composition, contamination and costs of methods of milk expression.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (21 March 2016), handsearched relevant journals and conference proceedings, and contacted experts in the field to seek additional published or unpublished studies. We also examined reference lists of all relevant retrieved papers.\nSelection criteria\nRandomised and quasi-randomised trials comparing methods at any time after birth.\nData collection and analysis\nThree review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.\nMain results\nThis updated review includes 41 trials involving 2293 participants, with 22 trials involving 1339 participants contributing data for analysis. Twenty-six of the trials referred to mothers of infants in neonatal units (n = 1547) and 14 to mothers of healthy infants at home (n = 730), with one trial containing mothers of both neonatal and healthy older infants (n = 16). Eleven trials compared one or more types of pump versus hand expression and 14 studies compared one type of pump versus another type of pump, with three of these studies comparing both hand expression and pump types. Twenty studies compared a specific protocol or adjunct behaviour including sequential versus simultaneous pumping protocols, pumping frequency, provision of an education and support intervention, relaxation, breast massage, combining hand expression with pumping and a breast cleansing protocol.\nDue to heterogeneity in participants, interventions, and outcomes measured or reported, we were unable to pool findings for most of the specified outcomes. It was not possible therefore to produce a 'Summary of findings' table in this update. Most of the included results were derived from single studies. Trials took place in 14 countries under a variety of circumstances and were published from 1982 to 2015. Sixteen of the 30 trials that evaluated pumps or products had support from the manufacturers. The risk of bias of the included studies was variable.\nPrimary outcomes\nOnly one of the 17 studies examining maternal satisfaction/acceptability with the method or adjunct behaviour provided data suitable for analysis. In this study, self-efficacy was assessed by asking mothers if they agreed or disagreed with the following statement: ‘I don't want anyone to see me (hand expressing/pumping)’. The study found that mothers who were using the electric pump were more likely to agree with the statement compared to mothers hand expressing, (mean difference (MD) 0.70, 95% confidence interval (CI) 0.15 to 1.25; P = 0.01, participants = 68). Mothers who were hand expressing reported that the instructions for expression were clearer compared to the electric pump, (MD -0.40, 95% CI -0.75 to -0.05; P = 0.02, participants = 68). Descriptive reporting of satisfaction in the other studies varied in the measures used, did not indicate a clear preference for one pump type, although there was satisfaction with some relaxation and support interventions.\nWe found no clinically significant differences between methods related to contamination of the milk that compared any type of pump to hand expression (risk ratio (RR) 1.13, 95% CI 0.79 to 1.61; P = 0.51, participants = 28), manual pump compared to hand expression, (MD 0.20, 95% CI -0.18 to 0.58; P = 0.30, participants = 142) a large electric pump compared to hand expression (MD 0.10, 95% CI -0.29 to 0.49; P = 0.61, participants = 123), or a large electric pump compared to a manual pump (MD -0.10, 95% CI -0.46 to 0.26; P = 0.59, participants = 141).\nThe level of maternal breast or nipple pain or damage was similar in comparisons of a large electric pump to hand expression (MD 0.02, 95% CI -0.67 to 0.71; P = 0.96, participants = 68). A study comparing a manual and large electric pump, reported sore nipples in 7% for both groups and engorgement in 4% using a manual pump versus 6% using an electric pump; and in one study no nipple damage was reported in the hand-expression group, and one case of nipple damage in each of the manual pump and the large electric pump groups.\nOne study examined adverse effects on infants, however as the infants did not all receive their mothers' expressed milk, we have not included the results.\nSecondary outcomes\nThe quantity of expressed milk obtained was increased, in some studies by a clinically significant amount, in interventions involving relaxation, music, warmth, massage, initiation of pumping, increased frequency of pumping and suitable breast shield size. Support programmes and simultaneous compared to sequential pumping did not show a difference in milk obtained. No pump consistently increased the milk volume obtained significantly.\nIn relation to nutrient quality, hand expression or a large electric pump were found to provide higher protein than a manual pump, and hand expression provided higher sodium and lower potassium compared to a large electric pump or a manual pump. Fat content was higher with breast massage when pumping; no evidence of difference was found for energy content between methods.\nNo consistent effect was found related to prolactin change or effect on oxytocin release with pump type or method. Economic aspects were not reported.\nAuthors' conclusions\nThe most suitable method for milk expression may depend on the time since birth, purpose of expression and the individual mother and infant. Low-cost interventions including initiation of milk expression sooner after birth when not feeding at the breast, relaxation, massage, warming the breasts, hand expression and lower cost pumps may be as effective, or more effective, than large electric pumps for some outcomes. Variation in nutrient content across methods may be relevant to some infants. Small sample sizes, large standard deviations, and the diversity of the interventions argue caution in applying these results beyond the specific method tested in the specific settings. Independently funded research is needed for more trials on hand expression, relaxation and other techniques that do not have a commercial potential.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Babies who do not receive human milk are more likely to suffer health problems both as newborns and later in life. Mothers may also want to express milk for their own comfort or to increase supply."
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"role": "user",
"content": "Abstract: Background\nSecond language (L2) learners are a heterogeneous group. Their L2 skills are highly varied due to internal factors (e.g. cognitive development) and external factors (e.g. cultural and linguistic contexts). As a group, their L2 vocabulary skills appear to be lower than their monolingual peers. This pattern tends to persist over time and may have negative consequences for social interaction and inclusion, learning, and academic achievement.\nObjectives\nTo examine the immediate and long-term effects of second language (L2) vocabulary interventions targeting L2 learners up to six years of age on vocabulary and social-emotional well-being.\nTo examine the associations between L2 vocabulary interventions and the general characteristics of L2 learners (e.g. age, L2 exposure, and L1 skills).\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was December 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing the effects of vocabulary interventions for L2 learners up to six years of age with standard care.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our primary outcomes were 1. receptive and 2. expressive L2 vocabulary (both proximal and distal), and 3. mean length of utterance (MLU; which is a measure of potential adverse effects). Our secondary outcomes were 4. L2 narrative skills, 5. L1 receptive vocabulary (both proximal and distal), 6. L1 expressive vocabulary (both proximal and distal), 7. L1 listening comprehension, 8. L2 grammatical knowledge, 9. L2 reading comprehension (long-term), and 10. socio-emotional well-being (measured with Strengths and Difficulties Questionnaire).\nMain results\nWe found 12 studies involving 1943 participants. Two studies were conducted in Norway, seven in the USA, and single studies conducted in Canada, China, and the Netherlands.\nTen studies were conducted in preschool settings, with a preschool teacher being the most common delivery agent for the intervention. The interventions were mainly organised as small-group sessions, with three or four children per group. The mean dosage per week was 80 minutes and ranged from 24 to 120 minutes.\nThe studies commonly applied shared book reading (reading aloud with the children), with target words embedded in the books.\nStandard care differed based on the setting and local conditions in each country or (pre)school. In some studies, the comparison groups received vocabulary instruction in preschool groups.\nCompared to standard care, the effect of L2 vocabulary interventions varied across outcome measures. For vocabulary measures including words that were taught in the intervention (proximal outcome measures), the intervention effects were large for both receptive L2 vocabulary (i.e. understanding of words; standardised mean difference (SMD) 0.97, 95% confidence interval (CI) 0.64 to 1.30; 4 studies, 1973 participants; very low-certainty evidence) and expressive L2 vocabulary (i.e. expressing or producing words; SMD 0.86, 95% CI 0.56 to 1.17; 6 studies, 1121 participants; very low-certainty evidence). However, due to some concerns in the overall risk of bias assessment, substantial heterogeneity, and wide CIs, we have limited confidence in these results.\nFor language measures that did not include taught vocabulary (distal outcome measures), the intervention effects were small for receptive vocabulary (SMD 0.29, 95% CI 0.02 to 0.55; 6 studies, 1074 participants; low-certainty evidence) and probably made little to no difference to expressive vocabulary (SMD 0.10, 95% CI −0.02 to 0.23; 7 studies, 960 participants; moderate-certainty evidence). There was little to no intervention effect on L2 listening comprehension (SMD 0.19, 95% CI −0.31 to 0.68; 2 studies, 294 participants; very low-certainty evidence), but the evidence was uncertain, and the interventions probably increased L2 narrative skills slightly (SMD 0.37, 95% CI 0.14 to 0.59; 2 studies, 487 participants; moderate-certainty evidence). Only one study reported data on MLU, and we were unable to examine the effect of intervention on this outcome. The level of certainty of the evidence was downgraded mainly due to inconsistency and imprecision.\nWe were unable to draw conclusions about socio-emotional well-being, or conduct the planned subgroup analyses to examine the second objective, due to lack of data.\nAuthors' conclusions\nFindings from this review suggest that, compared to standard care, vocabulary interventions may benefit children's L2 vocabulary learning but have little to no effect on their listening comprehension, though the evidence is uncertain. Vocabulary interventions probably improve the children's storytelling skills slightly.\nDue to the limited number of studies that met our inclusion criteria and the very low- to moderate-certainty evidence as a result of inconsistency and imprecision, implications for practice should be considered with caution.\nThis review highlights the need for more high-quality trials (e.g. RCTs) of vocabulary interventions for L2 learners, particularly studies of learners outside the USA.\n\nGiven the provided abstract, please respond to the following query: \"Why is this review important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Limited second language (L2) ability may have a negative impact on academic achievement, because vocabulary knowledge in the language of instruction is central to reading comprehension, classroom learning, and inclusion. In adulthood, proficiency in the community language (as well as continued competence in the first language (L1)) is predictive of employment, good relationships, and societal participation."
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query-laysum
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8448
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"role": "user",
"content": "Abstract: Background\nUnintentional injuries are the leading cause of death in children aged four to 18 years and are a major cause of ill health. The school setting offers the opportunity to deliver preventive interventions to a large number of children and has been used to address a range of public health problems. However, the effectiveness of the school setting for the prevention of different injury mechanisms in school-aged children is not well understood.\nObjectives\nTo assess the effects of school-based educational programmes for the prevention of injuries in children and evaluate their impact on improving children's safety skills, behaviour and practices, and knowledge, and assess their cost-effectiveness.\nSearch methods\nWe ran searches on the following electronic databases to 26 June 2015: PsycINFO, British Education Index (BEI), Education Resources Information Center (ERIC), Applied Social Sciences Index and Abstracts (ASSIA), International Bibliography of the Social Sciences (IBSS), Sociological Abstracts; Latin America and the Caribbean database (LILACS), together with several sources of grey literature. The Cochrane Injuries Information Specialist ran searches, to August 2013, on the Groups Specialised Register (SR-INJ), the Cochrane Central Register of Controlled Trials (CENTRAL) and other Cochrane Library databases, Ovid MEDLINE, Embase, CINAHL and the ISI Web of Science. In keeping with Cochrane standards, along with Cochrane Injuries' Information Specialist we ran an update search prior to publication (September and October 2016). We have screened the results and placed any relevant studies in the Characteristics of studies awaiting classification section of this review.These will be incorporated in the next version of this review, as appropriate.\nSelection criteria\nWe included randomised controlled trials (RCTs), non-randomised controlled trials (non-RCTs), and controlled before-and-after (CBA) studies that evaluated school-based educational programmes aimed at preventing a range of injury mechanisms. The primary outcome was self-reported or medically attended unintentional (or unspecified intent) injuries and secondary outcomes were observed safety skills, observed behaviour, self-reported behaviour and safety practices, safety knowledge, and health economic outcomes. The control groups received no intervention, a delayed injury-prevention intervention or alternative school-based curricular activities. We included studies that aimed interventions at primary or secondary prevention of injuries from more than one injury mechanism and were delivered, in part or in full, in schools catering for children aged four to 18 years.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors identified relevant trials from title and abstracts of studies identified in searches and two review authors extracted data from the included studies and assessed risk of bias. We grouped different types of interventions according to the outcome assessed and the injury mechanism targeted. Where data permitted, we performed random-effects meta-analyses to provide a summary of results across studies.\nMain results\nThe review included 27 studies reported in 30 articles. The studies had 73,557 participants with 12 studies from the US; four from China; two from each of Australia, Canada, the Netherlands and the UK; and one from each of Israel, Greece and Brazil. Thirteen studies were RCTs, six were non-RCTs and eight were CBAs. Of the included studies, 18 provided some element of the intervention in children aged four to 11 years, 17 studies included children aged 11 to 14 years and nine studies included children aged 14 to 18 years.\nThe overall quality of the results was poor, with the all studies assessed as being at high or unclear risks of bias across multiple domains, and varied interventions and data collection methods employed. Interventions comprised information-giving, peer education or were multi-component.\nSeven studies reported the primary outcome of injury occurrence and only three of these were similar enough to combine in a meta-analysis, with a pooled incidence rate ratio of 0.73 (95% confidence interval (CI) 0.49 to 1.08; 2073 children) and substantial statistical heterogeneity (I2 = 63%). However, this body of evidence was low certainty, due to concerns over this heterogeneity (inconsistency) and imprecision. This heterogeneity may be explained by the non-RCT study design of one of the studies, as a sensitivity analysis with this study removed found stronger evidence of an effect and no heterogeneity (I2 = 0%).\nTwo studies report an improvement in safety skills in the intervention group. Likewise, the four studies measuring observed safety behaviour reported an improvement in the intervention group relative to the control. Thirteen out of 19 studies describing self-reported behaviour and safety practices showed improvements, and of the 21 studies assessing changes in safety knowledge, 19 reported an improvement in at least one question domain in the intervention compared to the control group. However, we were unable to pool data for our secondary outcomes, so our conclusions were limited, as they were drawn from highly diverse single studies and the body of evidence was low (safety skills) or very low (behaviour, safety knowledge) certainty. Only one study reported intervention costs but did not undertake a full economic evaluation (very low certainty evidence).\nAuthors' conclusions\nThere is insufficient evidence to determine whether school-based educational programmes can prevent unintentional injuries. More high-quality studies are needed to evaluate the impact of educational programmes on injury occurrence. There is some weak evidence that such programmes improve safety skills, behaviour/practices and knowledge, although the evidence was of low or very low quality certainty. We found insufficient economic studies to assess cost-effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"About the review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We looked at the evidence on the effects of programmes in schools that aimed to prevent accidental injuries in children and young people. Preventing injuries in children is important because injuries are common in this age group and the effects on the child and the family can be severe and long-lasting. Schools are potentially a good setting within which to provide education programmes aimed at preventing such injuries occurring. However, it has not been examined in detail whether this works or not. We found 27 studies to help us address this question."
}
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query-laysum
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8449
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[
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"role": "user",
"content": "Abstract: Background\nBecause of poverty, children and families in low- and middle-income countries often face significant impediments to health and well-being. Centre-based day care services may influence the development of children and the economic situation of parents by providing good quality early childhood care and by freeing parents to participate in the labour force.\nObjectives\nTo assess the effects of centre-based day care without additional interventions (e.g. psychological or medical services, parent training) on the development, health and well-being of children and families in low- and middle-income countries (as defined by the World Bank 2011).\nSearch methods\nIn April 2014, we searched CENTRAL, Ovid MEDLINE, EMBASE, PsycINFO, ERIC and 16 other sources, including several World Health Organization (WHO) regional databases. We also searched two trials registers, websites of government and non-government agencies and reference lists of relevant studies.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials and prospective non-randomised studies with contemporaneous control groups and assessments both before and after intervention. We considered non-randomised controlled trials, as centre-based care in low- and middle-income countries is unlikely to be studied using randomised controlled trials (Higgins 2011). We included the following outcomes: child intellectual development, child psychosocial development, maternal and family outcomes and incidence of infectious diseases.\nData collection and analysis\nTwo review authors independently assessed risk of bias and extracted data from the single included study.\nMain results\nOnly one trial, involving 256 children, met the inclusion criteria for this review. This study was assessed as having high risk of bias because of non-random allocation, incomplete outcome data and insufficient control of confounding factors. Results from this study suggest that centre-based day care may have a positive effect on child cognitive ability compared with no treatment (care at home) (assessed using a modified version of the British Ability Scale-II (BAS-II) (standardised mean difference (SMD) 0.74, 95% confidence interval (CI) 0.48 to 1.00, 256 participants, 1 study, very low-quality evidence). This study did not measure other variables relevant to this review.\nAuthors' conclusions\nThe single study included in this review provides limited evidence on the effects of centre-based day care for children younger than five years of age in low- and middle-income countries. This study was at high risk of bias and may have limited generalisability to other low- and middle-income countries. Many of the studies excluded from this review paired day care attendance with co-interventions that are unlikely to be provided in normal day care centres. Effectiveness studies on centre-based day care without these co-interventions are few, and the need for such studies is significant. In future studies, comparisons might include home visits or alternative day care arrangements.\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"
},
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"role": "assistant",
"content": "This review includes only one trial. This study did not assign participants to the intervention by chance, so the comparison groups may have differed in important ways. Therefore results must be interpreted with caution. Although current studies do not now allow for conclusive judgements regarding the effects of centre-based day care on the development of children and the economic situation of parents, this does not imply that these services are not important in low- and middle-income countries. Effectiveness studies of centre-based day care without co-interventions are few, and the need for such studies is significant.\nThis review is one of a pair of reviews; researchers and practitioners may find evidence from the high-income country review to be informative also (Van Urk 2014)."
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query-laysum
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8450
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[
{
"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: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Evidence of moderate and high quality shows that supervised exercise therapy improves walking distance (maximal and pain-free) to a greater extent than home-based exercise therapy and walking advice, respectively. Trials show no clear differences in quality of life measures nor in self-reported functional impairment between supervised exercise therapy and home-based exercise therapy. However, evidence is of low and very low quality, respectively. Investigators detected some improvements in quality of life favoring supervised exercise therapy over walking advice, but analyses were limited by small numbers of studies and participants. More research is needed 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.\nAdhering to an exercise program is important because it leads to decreased leg pain and improved quality of life, as well as to likely improvement in general physical condition."
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query-laysum
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8451
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[
{
"role": "user",
"content": "Abstract: Background\nRecent cohort studies show that salt intake below 6 g is associated with increased mortality. These findings have not changed public recommendations to lower salt intake below 6 g, which are based on assumed blood pressure (BP) effects and no side-effects.\nObjectives\nTo assess the effects of sodium reduction on BP, and on potential side-effects (hormones and lipids)\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials up to April 2018 and a top-up search in March 2020: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. The searches had no language restrictions. The top-up search articles are recorded under \"awaiting assessment.\"\nSelection criteria\nStudies randomizing persons to low-sodium and high-sodium diets were included if they evaluated at least one of the outcome parameters (BP, renin, aldosterone, noradrenalin, adrenalin, cholesterol, high-density lipoprotein, low-density lipoprotein and triglyceride,.\nData collection and analysis\nTwo review authors independently collected data, which were analysed with Review Manager 5.3. Certainty of evidence was assessed using GRADE.\nMain results\nSince the first review in 2003 the number of included references has increased from 96 to 195 (174 were in white participants). As a previous study found different BP outcomes in black and white study populations, we stratified the BP outcomes by race.\nThe effect of sodium reduction (from 203 to 65 mmol/day) on BP in white participants was as follows: Normal blood pressure: SBP: mean difference (MD) -1.14 mmHg (95% confidence interval (CI): -1.65 to -0.63), 5982 participants, 95 trials; DBP: MD + 0.01 mmHg (95% CI: -0.37 to 0.39), 6276 participants, 96 trials. Hypertension: SBP: MD -5.71 mmHg (95% CI: -6.67 to -4.74), 3998 participants,88 trials; DBP: MD -2.87 mmHg (95% CI: -3.41 to -2.32), 4032 participants, 89 trials (all high-quality evidence).\nThe largest bias contrast across studies was recorded for the detection bias element. A comparison of detection bias low-risk studies versus high/unclear risk studies showed no differences.\nThe effect of sodium reduction (from 195 to 66 mmol/day) on BP in black participants was as follows: Normal blood pressure: SBP: mean difference (MD) -4.02 mmHg (95% CI:-7.37 to -0.68); DBP: MD -2.01 mmHg (95% CI:-4.37, 0.35), 253 participants, 7 trials. Hypertension: SBP: MD -6.64 mmHg (95% CI:-9.00, -4.27); DBP: MD -2.91 mmHg (95% CI:-4.52, -1.30), 398 participants, 8 trials (low-quality evidence).\nThe effect of sodium reduction (from 217 to 103 mmol/day) on BP in Asian participants was as follows: Normal blood pressure: SBP: mean difference (MD) -1.50 mmHg (95% CI: -3.09, 0.10); DBP: MD -1.06 mmHg (95% CI:-2.53 to 0.41), 950 participants, 5 trials. Hypertension: SBP: MD -7.75 mmHg (95% CI:-11.44, -4.07); DBP: MD -2.68 mmHg (95% CI: -4.21 to -1.15), 254 participants, 8 trials (moderate-low-quality evidence).\nDuring sodium reduction renin increased 1.56 ng/mL/hour (95%CI:1.39, 1.73) in 2904 participants (82 trials); aldosterone increased 104 pg/mL (95%CI:88.4,119.7) in 2506 participants (66 trials); noradrenalin increased 62.3 pg/mL: (95%CI: 41.9, 82.8) in 878 participants (35 trials); adrenalin increased 7.55 pg/mL (95%CI: 0.85, 14.26) in 331 participants (15 trials); cholesterol increased 5.19 mg/dL (95%CI:2.1, 8.3) in 917 participants (27 trials); triglyceride increased 7.10 mg/dL (95%CI: 3.1,11.1) in 712 participants (20 trials); LDL tended to increase 2.46 mg/dl (95%CI: -1, 5.9) in 696 participants (18 trials); HDL was unchanged -0.3 mg/dl (95%CI: -1.66,1.05) in 738 participants (20 trials) (All high-quality evidence except the evidence for adrenalin).\nAuthors' conclusions\nIn white participants, sodium reduction in accordance with the public recommendations resulted in mean arterial pressure (MAP) decrease of about 0.4 mmHg in participants with normal blood pressure and a MAP decrease of about 4 mmHg in participants with hypertension. Weak evidence indicated that these effects may be a little greater in black and Asian participants. The effects of sodium reduction on potential side effects (hormones and lipids) were more consistent than the effect on BP, especially in people with normal BP.\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": "In this 4th Cochrane update since 2003, studies in which participants were distributed by chance into groups with high and low salt intake were analysed to investigate the effect of reduced salt intake on blood pressure (BP) and potential side effects of salt reduction on some hormones and lipids."
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query-laysum
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8452
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[
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis is a life-limiting autosomal recessive genetic illness. A feeling of shortness of breath is common in cystic fibrosis, especially as the disease progresses. Reversing the underlying cause is the priority when treating breathlessness (dyspnoea), but when it is not feasible, palliation (easing) becomes the primary goal to improve an individual's quality of life. A range of drugs administered by various routes have been used, but no definite guidelines are available. A systematic review is needed to evaluate such treatments.\nObjectives\nTo assess the efficacy and safety of drugs used to ease breathlessness in people with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 18 November 2019.\nWe searched databases (clinicaltrials.gov, the ISRCTN registry, the Clinical Trials Registry India and WHO ICTRP) for ongoing trials. These searches were last run on 06 March 2020.\nSelection criteria\nWe planned to include randomised and quasi-randomised controlled trials in people with cystic fibrosis (diagnosed by a positive sweat chloride test or genetic testing) who have breathlessness. We considered studies comparing any drugs used for easing breathlessness to another drug administered by any route (inhaled (nebulised), intravenous, oral, subcutaneous, transmucosal (including buccal, sublingual and intra-nasal) and transdermal).\nData collection and analysis\nThe authors assessed the search results according to the pre-defined inclusion criteria.\nMain results\nThe new searches in 2020 yielded two ongoing studies that were not relevant to the review question. Previous searches had found only one study (cross-over in design), which did not fulfil the inclusion criteria as no data were available from the first treatment period alone.\nAuthors' conclusions\nDue to the lack of available evidence, this review cannot provide any information for clinical practice. The authors call for specific research in this area after taking into account relevant ethical considerations. The research should focus on the efficacy and safety of the drugs with efficacy being measured in terms of improvement in quality of life, dyspnoea scores and hospital stay.\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": "The evidence from the Cochrane Cystic Fibrosis Trials Register is current to 18 November 2019; the searches of ongoing trial registries are current to 06 March 2020."
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query-laysum
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8453
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[
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"role": "user",
"content": "Abstract: Background\nPain is a common side effect of orthodontic treatment. It increases in proportion to the amount of force applied to the teeth, and the type of orthodontic appliance used can affect the intensity of the pain. Pain during orthodontic treatment has been shown to be the most common reason for people wanting to discontinue treatment, and has been ranked as the worst aspect of treatment. Although pharmacological methods of pain relief have been investigated, there remains some uncertainty among orthodontists about which painkillers are most suitable and whether pre-emptive analgesia is beneficial. We conducted this Cochrane Review to assess and summarize the international evidence relating to the effectiveness of analgesics for preventing this unwanted side effect associated with orthodontic treatment.\nObjectives\nThe objectives of this review are to determine:\n- the effectiveness of drug interventions for pain relief during orthodontic treatment; and\n- whether there is a difference in the analgesic effect provided by different types, forms and doses of analgesia taken during orthodontic treatment.\nSearch methods\nCochrane Oral Health’s Information Specialist searched the following databases: the Cochrane Oral Health Trials Register (to 19 June 2017), the Cochrane Central Register of Controlled Trials (CENTRAL;the Cochrane Library 2016, Issue 7), MEDLINE Ovid (1946 to 19 June 2017), Embase Ovid (1980 to 19 June 2017) and CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to 19 June 2017). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched on the 19 June 2017 for ongoing studies. We placed no restrictions on language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomized controlled trials (RCTs) relating to pain control during orthodontic treatment. Pain could be measured on a visual analogue scale (VAS), numerical rating scale (NRS) or categorical scale.\nData collection and analysis\nTwo review authors independently screened the search results, agreed the studies to be included and extracted information from the included studies regarding methods, participants, interventions, outcomes, harms and results. We planned to resolve any discrepancies or disagreements through discussion. We used the Cochrane 'Risk of bias' tool to assess the risk of bias in the studies.\nMain results\nWe identified 32 relevant RCTs, which included 3110 participants aged 9 to 34 years, 2348 of whom we were able to include in our analyses. Seventeen of the studies had more than two arms. We were able to use data from 12 trials in meta-analyses that compared analgesics versus control (no treatment or a placebo); nine that compared non-steroidal anti-inflammatories (NSAIDs) versus paracetamol; and two that compared pre-emptive versus post-treatment ibuprofen for pain control following orthodontic treatment. One study provided data for the comparison of NSAIDs versus local anaesthetic.\nWe found moderate-quality evidence that analgesics effectively reduced pain following orthodontic treatment when compared to no treatment or a placebo at 2 hours (mean difference (MD) -11.66 mm on a 0 to 100 mm VAS, 95% confidence interval (CI) -16.15 to -7.17; 10 studies, 685 participants), 6 hours (MD -24.27 mm on a VAS, 95% CI -31.44 to -17.11; 9 studies, 535 participants) and 24 hours (MD -21.19 mm on a VAS, 95% CI -28.31 to -14.06; 12 studies, 1012 participants).\nWe did not find any evidence of a difference in efficacy between NSAID and paracetamol at 2, 6 or 24 hours (at 24 hours: MD -0.51, 95% CI -8.93 to 7.92; 9 studies, 734 participants; low-quality evidence).\nVery low-quality evidence suggested pre-emptive ibuprofen gave better pain relief at 2 hours than ibuprofen taken post treatment (MD -11.30, 95% CI -16.27 to -6.33; one study, 41 participants), however, the difference was no longer significant at 6 or 24 hours.\nA single study of 48 participants compared topical NSAIDs versus local anaesthetic and showed no evidence of a difference in the effectiveness of the interventions (very low-quality evidence).\nUse of rescue analgesia was poorly reported. The very low-quality evidence did not show evidence of a difference between participants taking ibuprofen and participants taking paracetamol (relative risk (RR) 1.5, 95% CI 0.6 to 3.6). Nor did we find evidence of a difference between groups in likelihood of requiring rescue analgesia when ibuprofen was taken pre-emptively compared to after treatment (RR 0.8, 95% CI 0.3 to 1.9).\nAdverse effects were identified in one study, with one participant developing a rash that required treatment with antihistamines. This was provisionally diagnosed as a hypersensitivity to paracetamol.\nAuthors' conclusions\nAnalgesics are more effective at reducing pain following orthodontic treatment than placebo or no treatment. Low-quality evidence did not show a difference in effectiveness between systemic NSAIDs compared with paracetamol, or topical NSAIDs compared with local anaesthetic. More high-quality research is needed to investigate these comparisons, and to evaluate pre-emptive versus post-treatment administration of analgesics.\n\nGiven the provided abstract, please respond to the following query: \"Analgesic versus placebo or no treatment\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found evidence that paracetamol, NSAIDs and local anaesthetic were effective at reducing pain intensity at 2 hours, 6 hours and 24 hours following orthodontic treatment when compared with either a placebo or no treatment group."
}
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query-laysum
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8454
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[
{
"role": "user",
"content": "Abstract: Background\nDementia is a worldwide concern. Its global prevalence is increasing. At present, there is no medication licensed to prevent or delay the onset of dementia. Inflammation has been suggested as a key factor in dementia pathogenesis. Therefore, medications with anti-inflammatory properties could be beneficial for dementia prevention.\nObjectives\nTo evaluate the effectiveness and adverse effects of aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) for the primary or secondary prevention of dementia.\nSearch methods\nWe searched ALOIS, the specialised register of the Cochrane Dementia and Cognitive Improvement Group up to 9 January 2020. ALOIS contains records of clinical trials identified from monthly searches of several major healthcare databases, trial registries and grey literature sources. We ran additional searches across MEDLINE (OvidSP), Embase (OvidSP) and six other databases to ensure that the searches were as comprehensive and up-to-date as possible. We also reviewed citations of reference lists of included studies.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing aspirin or other NSAIDs with placebo for the primary or secondary prevention of dementia. We included trials with cognitively healthy participants (primary prevention) or participants with mild cognitive impairment (MCI) or cognitive complaints (secondary prevention).\nData collection and analysis\nWe used standard methodological procedures according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the strength of evidence for each outcome using the GRADE approach.\nMain results\nWe included four RCTs with 23,187 participants. Because of the diversity of these trials, we did not combine data to give summary estimates, but presented a narrative description of the evidence.\nWe identified one trial (19,114 participants) comparing low-dose aspirin (100 mg once daily) to placebo. Participants were aged 70 years or older with no history of dementia, cardiovascular disease or physical disability. Interim analysis indicated no significant treatment effect and the trial was terminated slightly early after a median of 4.7 years' follow-up. There was no evidence of a difference in incidence of dementia between aspirin and placebo groups (risk ratio (RR) 0.98, 95% CI 0.83 to 1.15; high-certainty evidence). Participants allocated aspirin had higher rates of major bleeding (RR 1.37, 95% CI 1.17 to 1.60, high-certainty evidence) and slightly higher mortality (RR 1.14, 95% CI 1.01 to 1.28; high-certainty evidence). There was no evidence of a difference in activities of daily living between groups (RR 0.84, 95% CI 0.70 to 1.02; high-certainty evidence).\nWe identified three trials comparing non-aspirin NSAIDs to placebo. All three trials were terminated early due to adverse events associated with NSAIDs reported in other trials.\nOne trial (2528 participants) investigated the cyclo-oxygenase-2 (COX-2) inhibitor celecoxib (200 mg twice daily) and the non-selective NSAID naproxen (220 mg twice daily) for preventing dementia in cognitively healthy older adults with a family history of Alzheimer's disease (AD). Median follow-up was 734 days. Combining both NSAID treatment arms, there was no evidence of a difference in the incidence of AD between participants allocated NSAIDs and those allocated placebo (RR 1.91, 95% CI 0.89 to 4.10; moderate-certainty evidence). There was also no evidence of a difference in rates of myocardial infarction (RR 1.21, 95% CI 0.61 to 2.40), stroke (RR 1.82, 95% CI 0.76 to 4.37) or mortality (RR 1.37, 95% CI 0.78 to 2.43) between treatment groups (all moderate-certainty evidence).\nOne trial (88 participants) assessed the effectiveness of celecoxib (200 mg or 400 mg daily) in delaying cognitive decline in participants aged 40 to 81 years with mild age-related memory loss but normal memory performance scores. Mean duration of follow-up was 17.6 months in the celecoxib group and 18.1 months in the placebo group. There was no evidence of a difference between groups in test scores in any of six cognitive domains. Participants allocated celecoxib experienced more gastrointestinal adverse events than those allocated placebo (RR 2.66, 95% CI 1.05 to 6.75; low-certainty evidence).\nOne trial (1457 participants) assessed the effectiveness of the COX-2 inhibitor rofecoxib (25 mg once daily) in delaying or preventing a diagnosis of AD in participants with MCI. Median duration of study participation was 115 weeks in the rofecoxib group and 130 weeks in the placebo group. There was a higher incidence of AD in the rofecoxib than the placebo group (RR 1.32, 95% CI 1.01 to 1.72; moderate-certainty evidence). There was no evidence of a difference between groups in cardiovascular adverse events (RR 1.07, 95% CI 0.68 to 1.66; moderate-certainty evidence) or mortality (RR 1.62, 95% CI 0.85 to 3.05; moderate-certainty evidence). Participants allocated rofecoxib had more upper gastrointestinal adverse events (RR 3.53, 95% CI 1.17 to 10.68; moderate-certainty evidence). Reported annual mean difference scores showed no evidence of a difference between groups in activities of daily living (year 1: no data available; year 2: 0.0, 95% CI –0.1 to 0.2; year 3: 0.1, 95% CI –0.1 to 0.3; year 4: 0.1, 95% CI –0.1 to 0.4; moderate-certainty evidence).\nAuthors' conclusions\nThere is no evidence to support the use of low-dose aspirin or other NSAIDs of any class (celecoxib, rofecoxib or naproxen) for the prevention of dementia, but there was evidence of harm. Although there were limitations in the available evidence, it seems unlikely that there is any need for further trials of low-dose aspirin for dementia prevention. If future studies of NSAIDs for dementia prevention are planned, they will need to be cognisant of the safety concerns arising from the existing studies.\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": "Dementia is a worldwide healthcare concern. At present, there is no medicine that is proven to delay or prevent the onset of dementia. The biology of dementia is still poorly understood. However, there are reasons to believe that inflammation may be partly responsible for some of the brain changes seen in dementia. There are many medicines that have anti-inflammatory properties, including aspirin and NSAIDs that are often sold as pain killers. We wanted to see if these medicines had any effect on developing dementia. These medicines have a few potential side effects, including heart attack and bleeding, so we also assessed for any harmful effects of the medicines."
}
] |
query-laysum
|
8455
|
[
{
"role": "user",
"content": "Abstract: Background\nThere has been considerable development in the treatment of advanced prostate cancer over the last decade. A number of agents, including docetaxel, cabazitaxel, abiraterone acetate, enzalutamide and sipuleucel-T, have been reported to improve outcomes in men with castration-resistant disease and their use is being explored in hormone-sensitive prostate cancer.\nObjectives\nTo assess the effects of early taxane-based chemohormonal therapy for newly diagnosed, metastatic, hormone-sensitive prostate cancer.\nSearch methods\nWe performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Google Scholar, and Web of Science), trials registries, other sources of grey literature, and conference proceedings, up to 10 August 2018. We applied no restrictions on publication language or status.\nSelection criteria\nWe included randomized or quasi-randomized controlled trials in which participants were administered taxane-based chemotherapy with systemic androgen deprivation therapy (ADT) within 120 days of beginning ADT versus ADT alone at the time of diagnosis of metastatic disease.\nData collection and analysis\nTwo review authors independently classified studies and abstracted data from the included studies. We performed statistical analyses using a random-effects model. We rated the quality of evidence according to the GRADE approach.\nMain results\nThe search identified three studies in which 2,261 participants were randomized to receive either ADT alone, or taxane-based chemotherapy at a dose of 75mg per square meter of body surface area at three-weekly intervals for six or nine cycles in addition to ADT.\nPrimary outcomes\nEarly treatment with taxane-based chemotherapy in addition to ADT probably reduces death from any cause compared to ADT alone (hazard ratio (HR) 0.77, 95% confidence interval (CI) 0.68 to 0.87; moderate-certainty evidence); this would result in 94 fewer deaths per 1,000 men (95% CI 51 to 137 fewer deaths). We downgraded the certainty of evidence due to study limitations related to potential performance bias. Based on the results of one study with 375 participants, the addition of taxane-based chemotherapy to ADT may increase the incidence of Grade III to V adverse events compared to ADT alone (risk ratio (RR) 2.98, 95% CI 2.19 to 4.04; low-certainty evidence); this would result in 405 more Grade III to V adverse events per 1,000 men (95% CI 243 to 621 more events). We downgraded the certainty of evidence due to study limitations and imprecision.\nSecondary outcomes\nEarly taxane-based chemotherapy in addition to ADT probably reduces the risk of prostate cancer-specific death (RR 0.79, 95% CI 0.70 to 0.89; moderate-certainty evidence). We downgraded the certainty of evidence due to study limitations related to potential performance and detection bias. The addition of taxane-based chemotherapy also probably reduces disease progression compared to ADT alone (HR 0.63, 95% CI 0.56 to 0.71; moderate-certainty evidence). We downgraded the certainty of evidence because of study limitations related to potential performance bias. The addition of taxane-based chemotherapy to ADT may result in a large increase in the risk of treatment discontinuation due to adverse events (RR 79.41, 95% CI 4.92 to 1282.78; low-certainty evidence). We downgraded the certainty of evidence due to study limitations and imprecision. This estimate is derived from a single study with no events in the control arm but a discontinuation rate of 20% in the intervention arm. Taxane-based chemotherapy may increase the incidence of adverse events of any grade (RR 1.11, 95% CI 1.06 to 1.17; low-certainty evidence). We downgraded our assessment of the certainty of evidence due to very serious study limitations. There may be a small improvement, which may not be clinically important, in quality of life at 12 months with combination treatment (mean difference (MD) 2.85 on the Functional Assessment of Cancer Therapy—Prostate scale, 95% CI 0.13 higher to 5.57 higher; low-certainty evidence). We downgraded the certainty of evidence for study limitations related to potential performance, detection and attrition bias.\nAuthors' conclusions\nCompared to ADT alone, the early (within 120 days of beginning ADT) addition of taxane-based chemotherapy to ADT for hormone-sensitive prostate cancer probably prolongs both overall and disease-specific survival and delays disease progression. There may be an increase in toxicity with taxane-based chemotherapy in combination with ADT. There may also be a small, clinically unimportant improvement in quality of life at 12 months with taxane-based chemotherapy and ADT treatment.\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"
},
{
"role": "assistant",
"content": "We judged the certainty of the evidence to be moderate for time-to-death from any cause, risk of prostate cancer-specific death and the time to disease progression. This means that our estimates are likely to be close to the truth, but there were limitations in the studies that reduce our confidence in the results. The certainty of the evidence was low for Grade III to V adverse events (side effects), adverse events of all grades, people stopping treatment due to adverse events, and quality of life. This means that the true effect of the treatment may be substantially different from what this review shows, because of limitations in the studies and imprecision (variability in estimates)."
}
] |
query-laysum
|
8456
|
[
{
"role": "user",
"content": "Abstract: Background\nMeasles is an important cause of childhood morbidity and mortality globally, despite increasing vaccine coverage. Zinc plays a significant role in the maintenance of normal immunological functions, therefore supplements given to zinc-deficient children will increase the availability of zinc and could reduce measles-related morbidity and mortality. This is an update of a review first published in 2015.\nObjectives\nTo assess the effects of zinc supplementation in reducing morbidity and mortality in children with measles.\nSearch methods\nWe searched CENTRAL (03 February 2017, Issue 2), MEDLINE (1946 to 03 February 2017), Embase (1974 to 03 February 2017), CINAHL (1981 to 03 February 2017), LILACS (1982 to 03 February 2017), Web of Science (1985 to 03 February 2017), and BIOSIS Previews (1985 to 27 June 2014). We also searched ClinicalTrials.gov, the Australian New Zealand Clinical Trials Registry and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 03 February 2017 to identify unpublished and ongoing studies.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of zinc in reducing morbidity and mortality in children with measles.\nData collection and analysis\nTwo review authors independently assessed the studies for inclusion and extracted data on outcomes, details of the interventions, and other study characteristics using a standardised data extraction form. We used risk ratio (RR) and hazard ratio (HR) as measures of effect with 95% confidence intervals (CI). We included only one study, and did not conduct meta-analysis.\nMain results\nWe did not identify any new studies for inclusion in this update. One RCT met our inclusion criteria. The study was conducted in India and included 85 children diagnosed with measles and pneumonia. The trial showed no significant difference in mortality between children with measles and pneumonia who received zinc supplements and those who received placebo (RR 0.34, 95% CI 0.01 to 8.14). There was no significant difference in time to absence of fever between children who received zinc supplements and those who did not (HR 1.08, 95% CI 0.67 to 1.74). No treatment-related side effects were reported in either group. We assessed the overall quality of the evidence as very low.\nAuthors' conclusions\nWe could not draw any definitive conclusions from this review about the effects of zinc supplementation on clinical outcomes of children with measles due to the very low quality of the evidence available. There is insufficient evidence to confirm or refute the effect of zinc supplementation in children with measles.\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": "The included study was small and did not provide enough data to determine whether zinc had an effect on mortality when compared with placebo. Although no adverse effects were reported, there was insufficient evidence to draw any conclusions about the use of zinc supplements to improve measles symptoms in children. More research is needed to clarify any benefits or harms."
}
] |
query-laysum
|
8457
|
[
{
"role": "user",
"content": "Abstract: Background\nAntiplatelet agents may be useful for the treatment of deep venous thrombosis (DVT) when used in addition to best medical practice (BMP), which includes anticoagulation, compression stockings, and clinical care such as physical exercise, skin hydration, etc. Antiplatelet agents could minimise complications such as post-thrombotic syndrome (PTS) and pulmonary embolism (PE). They may also reduce the recurrence of the disease (recurrent venous thromboembolism (recurrent VTE)). However, antiplatelet agents may increase the likelihood of bleeding events.\nObjectives\nTo assess the effects of antiplatelet agents in addition to current BMP compared to current BMP (with or without placebo) for the treatment of DVT.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 7 December 2021. The review authors searched LILACS and IBECS databases (15 December 2021) and also checked the bibliographies of included trials for further references to relevant trials, and contacted specialists in the field, manufacturers and authors of the included trials.\nSelection criteria\nWe considered randomised controlled trials (RCTs) examining antiplatelet agents compared to BMP following initial standard anticoagulation treatment for DVT. We included studies where antiplatelet agents were given in addition to current BMP compared to current BMP (with or without placebo) for the treatment of DVT (acute: treatment started within 21 days of symptom onset; chronic: treatment started after 21 days of symptom onset). We evaluated only RCTs where the antiplatelet agents were the unique difference between the groups (intervention and control).\nData collection and analysis\nWe used standard Cochrane methodological procedures. Two review authors independently extracted data and assessed risk of bias of the trials. Any disagreements were resolved by discussion with a third review author. We calculated outcome effects using risk ratio (RR) or mean difference (MD) with a 95% confidence interval (CI) and the number needed to treat to benefit (NNTB).\nMain results\nWe included six studies with 1625 eligible participants, with data up to 37.2 months of follow-up. For one preplanned comparison (i.e. antiplatelet agents plus BMP versus BMP plus placebo) for acute DVT we identified no eligible studies for inclusion.\nIn acute DVT, antiplatelet agents plus BMP versus BMP alone was assessed by one study (500 participants), which reported on four outcomes until 6 months of follow-up. There were no deaths and no cases of major bleeding reported. The participants who received antiplatelet agents showed a lower risk of PTS (RR 0.74, 95% CI 0.61 to 0.91; 1 study, 500 participants; very low-certainty evidence). The control group presented a lower risk of adverse events compared to the intervention group (RR 2.88, 95% CI 1.06 to 7.80; 1 study, 500 participants; very low-certainty evidence). This study did not provide information for recurrent VTE or PE.\nIn chronic DVT, antiplatelet agents plus BMP versus BMP alone was assessed by one study (224 participants). The study authors reported four relevant outcomes, three of which (major bleeding, mortality and adverse events) showed no events during the 3 years of follow-up. Therefore, an effect estimate could only be reported for recurrent VTE, favouring antiplatelet agents plus BMP versus BMP alone (RR 0.12, 95% CI 0.05 to 0.34; 1 study, 224 participants; very low-certainty evidence). For the outcomes PE and PTS, this study did not present information which could be used for analysis.\nIn chronic DVT, antiplatelet agents plus BMP versus BMP plus placebo was assessed by four studies (901 participants). The meta-analysis of this pooled data showed a lower risk of recurrent VTE for the antiplatelet agents group (RR 0.65, 95%, CI 0.43 to 0.96; NNTB = 14; low-certainty evidence). For major bleeding, we found no clear difference between placebo and intervention groups until 37.2 months of follow-up (RR 0.98, 95% CI 0.29 to 3.34; 1 study, 583 participants; moderate-certainty evidence). In PE fatal/non-fatal outcome, we found no clear difference with the use of antiplatelet agents (RR 0.52, 95% CI 0.23 to 1.14; 1 study, 583 participants; moderate-certainty evidence). For all-cause mortality, the overall effect of antiplatelet agents did not differ from the placebo group (RR 0.48, 95% CI 0.21 to 1.06; 3 studies, 649 participants; moderate-certainty evidence). The adverse events outcome did not show a clear difference (RR 1.57, 95% CI 0.34 to 7.19; 2 studies, 621 participants; moderate-certainty evidence). There is no assessment of PTS in these studies.\nWe downgraded the certainty of evidence for risk of bias, indirectness, imprecision and publication bias.\nAuthors' conclusions\nIn chronic DVT settings, following the initial standard treatment with anticoagulants, there is low-certainty evidence that antiplatelet agents in addition to BMP may reduce recurrent VTE, (NNTB = 14) when compared to BMP plus placebo. Moderate-certainty evidence shows no clear difference in adverse events, major bleeding and PE when antiplatelet agents are used in addition to BMP compared to BMP plus placebo.\nIn acute and chronic DVT settings, following the initial standard treatment with anticoagulants, we can draw no conclusions for antiplatelet agents in addition to BMP compared to BMP alone due to very low-certainty evidence.\nTrials of high methodological quality, that are large and of sufficient duration to detect significant clinical outcomes are needed. Trials should ideally last more than 4 years in order to estimate the long-term effect of antiplatelet agents. Trials should include people with acute and chronic DVT and provide relevant individual data, such as the outcome for each index event (DVT or PE), the use of an inferior vena cava (IVC) filter, whether the DVT is provoked or unprovoked, and the age of participants.\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": "The results are based on six studies with 1625 participants from the USA, Canada, Europe, India, Argentina, Australia and New Zealand. Two large groups of participants were studied: participants with acute DVT (treatment started up to 21 days after symptoms), and participants with chronic DVT (treatment started after 21 days of symptoms). All studies used BMP as a comparison, or BMP plus placebo. Each comparison investigated the effects of antiplatelets on the recurrence of DVT, PE, death and side effects.\nWe have limited confidence that antiplatelets in addition to BMP may have an effect on reducing the risk of a new episode of VTE when compared to BMP with placebo in a chronic DVT setting. It is necessary to treat 14 patients to avoid one VTE event. When only PE was studied, however, antiplatelets did not achieve a difference between the groups. The use of antiplatelets as an additional treatment does not appear to add any harm or risks, such as death, bleeding, or other side effects.\nAlthough our confidence in the evidence is very limited, people who receive antiplatelets may have lower rates of recurrent VTE compared to those who did not receive antiplatelets in a chronic DVT setting. Similarly, although our confidence in the evidence is very limited, people who receive antiplatelets may have a lower rate of PTS and increased side effects in an acute DVT setting.\nWe can draw no conclusions from the very limited available evidence for using antiplatelets as an additional treatment to BMP compared with BMP alone in acute and chronic DVT settings."
}
] |
query-laysum
|
8458
|
[
{
"role": "user",
"content": "Abstract: Background\nThe accessibility of health services is an important factor that affects the health outcomes of populations. A mobile clinic provides a wide range of services but in most countries the main focus is on health services for women and children. It is anticipated that improvement of the accessibility of health services via mobile clinics will improve women's and children's health.\nObjectives\nTo evaluate the impact of mobile clinic services on women's and children's health.\nSearch methods\nFor related systematic reviews, we searched the Database of Abstracts of Reviews of Effectiveness (DARE), CRD; Health Technology Assessment Database (HTA), CRD; NHS Economic Evaluation Database (NHS EED), CRD (searched 20 February 2014).\nFor primary studies, we searched ISI Web of Science, for studies that have cited the included studies in this review (searched 18 January 2016); WHO ICTRP, and ClinicalTrials.gov (searched 23 May 2016); Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library.www.cochranelibrary.com (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register) (searched 7 April 2015); MEDLINE, OvidSP (searched 7 April 2015); Embase, OvidSP (searched 7 April 2015); CINAHL, EbscoHost (searched 7 April 2015); Global Health, OvidSP (searched 8 April 2015); POPLINE, K4Health (searched 8 April 2015); Science Citation Index and Social Sciences Citation Index, ISI Web of Science (searched 8 April 2015); Global Health Library, WHO (searched 8 April 2015); PAHO, VHL (searched 8 April 2015); WHOLIS, WHO (searched 8 April 2015); LILACS, VHL (searched 9 April 2015).\nSelection criteria\nWe included individual- and cluster-randomised controlled trials (RCTs) and non-RCTs. We included controlled before-and-after (CBA) studies provided they had at least two intervention sites and two control sites. Also, we included interrupted time series (ITS) studies if there was a clearly defined point in time when the intervention occurred and at least three data points before and three after the intervention. We defined the intervention of a mobile clinic as a clinic vehicle with a healthcare provider (with or without a nurse) and a driver that visited areas on a regular basis. The participants were women (18 years or older) and children (under the age of 18 years) in low-, middle-, and high-income countries.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts of studies identified by the search strategy, extracted data from the included studies using a specially-designed data extraction form based on the Cochrane EPOC Group data collection checklist, and assessed full-text articles for eligibility. All authors performed analyses, 'Risk of bias' assessments, and assessed the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nTwo cluster-RCTs met the inclusion criteria of this review. Both studies were conducted in the USA.\nOne study tested whether offering onsite mobile mammography combined with health education was more effective at increasing breast cancer screening rates than offering health education only, including reminders to attend a static clinic for mammography. Women in the group offered mobile mammography and health education may be more likely to undergo mammography within three months of the intervention than those in the comparison group (55% versus 40%; odds ratio (OR) 1.83, 95% CI 1.22 to 2.74; low certainty evidence).\nA cost-effectiveness analysis of mammography at mobile versus static units found that the total cost per patient screened may be higher for mobile units than for static units. The incremental costs per patient screened for a mobile over a stationary unit were USD 61 and USD 45 for a mobile full digital unit and a mobile film unit respectively.\nThe second study compared asthma outcomes for children aged two to six years who received asthma care from a mobile asthma clinic and children who received standard asthma care from the usual (static) primary provider. Children who receive asthma care from a mobile asthma clinic may experience little or no difference in symptom-free days, urgent care use and caregiver-reported medication use compared to children who receive care from their usual primary care provider. All of the evidence was of low certainty.\nAuthors' conclusions\nThe paucity of evidence and the restricted range of contexts from which evidence is available make it difficult to draw conclusions on the impacts of mobile clinics on women's and children's health compared to static clinics. Further rigorous studies are needed in low-, middle-, and high-income countries to evaluate the impacts of mobile clinics on women's and children's health.\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 only included two studies. One included study showed that mobile clinics may increase the number of women who use mammography services, although the cost of mammography screening may be higher. The other study showed that mobile clinics may make little or no difference to children’s asthma symptoms, their use of medication and urgent care, or their caregivers’ quality of life. More studies are needed, including studies that measure the effect of mobile clinics on cost and on people’s access to healthcare, their satisfaction, health, and well-being."
}
] |
query-laysum
|
8459
|
[
{
"role": "user",
"content": "Abstract: Background\nMany people with cancer experience moderate to severe pain that requires treatment with strong opioids, such as oxycodone and morphine. Strong opioids are, however, not effective for pain in all people, neither are they well tolerated by all people. The aim of this review was to assess whether oxycodone is associated with better pain relief and tolerability than other analgesic options for adults with cancer pain. This is an updated Cochrane review previously published in 2017.\nObjectives\nTo assess the effectiveness and tolerability of oxycodone by any route of administration for pain in adults with cancer.\nSearch methods\nFor this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE and MEDLINE In-Process (Ovid), Embase (Ovid), Science Citation Index, Conference Proceedings Citation Index - Science (ISI Web of Science), BIOSIS (ISI), and PsycINFO (Ovid) to November 2021. We also searched four trial registries, checked the bibliographic references of relevant studies, and contacted the authors of the included studies. We applied no language, date, or publication status restrictions.\nSelection criteria\nWe included randomised controlled trials (parallel-group or cross-over) comparing oxycodone (any formulation or route of administration) with placebo or an active drug (including oxycodone) for cancer background pain in adults by examining pain intensity/relief, adverse events, quality of life, and participant preference.\nData collection and analysis\nTwo review authors independently sifted the search, extracted data and assessed the included studies using standard Cochrane methodology. We meta-analysed pain intensity data using the generic inverse variance method, and pain relief and adverse events using the Mantel-Haenszel method, or summarised these data narratively along with the quality of life and participant preference data. We assessed the overall certainty of the evidence using GRADE.\nMain results\nFor this update, we identified 19 new studies (1836 participants) for inclusion. In total, we included 42 studies which enrolled/randomised 4485 participants, with 3945 of these analysed for efficacy and 4176 for safety. The studies examined a number of different drug comparisons.\nControlled-release (CR; typically taken every 12 hours) oxycodone versus immediate-release (IR; taken every 4-6 hours) oxycodone\nPooled analysis of three of the four studies comparing CR oxycodone to IR oxycodone suggest that there is little to no difference between CR and IR oxycodone in pain intensity (standardised mean difference (SMD) 0.12, 95% confidence interval (CI) -0.1 to 0.34; n = 319; very low-certainty evidence). The evidence is very uncertain about the effect on adverse events, including constipation (RR 0.71, 95% CI 0.45 to 1.13), drowsiness/somnolence (RR 1.03, 95% CI 0.69 to 1.54), nausea (RR 0.85, 95% CI 0.56 to 1.28), and vomiting (RR 0.66, 95% CI 0.38 to 1.15) (very low-certainty evidence). There were no data available for quality of life or participant preference, however, three studies suggested that treatment acceptability may be similar between groups (low-certainty evidence).\nCR oxycodone versus CR morphine\nThe majority of the 24 studies comparing CR oxycodone to CR morphine reported either pain intensity (continuous variable), pain relief (dichotomous variable), or both. Pooled analysis indicated that pain intensity may be lower (better) after treatment with CR morphine than CR oxycodone (SMD 0.14, 95% CI 0.01 to 0.27; n = 882 in 7 studies; low-certainty evidence). This SMD is equivalent to a difference of 0.27 points on the Brief Pain Inventory scale (0-10 numerical rating scale), which is not clinically significant. Pooled analyses also suggested that there may be little to no difference in the proportion of participants achieving complete or significant pain relief (RR 1.02, 95% CI 0.95 to 1.10; n = 1249 in 13 studies; low-certainty evidence).\nThe RR for constipation (RR 0.75, 95% CI 0.66 to 0.86) may be lower after treatment with CR oxycodone than after CR morphine. Pooled analyses showed that, for most of the adverse events, the CIs were wide, including no effect as well as potential benefit and harm: drowsiness/somnolence (RR 0.88, 95% CI 0.74 to 1.05), nausea (RR 0.93, 95% CI 0.77 to 1.12), and vomiting (RR 0.81, 95% CI 0.63 to 1.04) (low or very low-certainty evidence). No data were available for quality of life. The evidence is very uncertain about the treatment effects on treatment acceptability and participant preference.\nOther comparisons\nThe remaining studies either compared oxycodone in various formulations or compared oxycodone to different alternative opioids. None found any clear superiority or inferiority of oxycodone for cancer pain, neither as an analgesic agent nor in terms of adverse event rates and treatment acceptability. The certainty of this evidence base was limited by the high or unclear risk of bias of the studies and by imprecision due to low or very low event rates or participant numbers for many outcomes.\nAuthors' conclusions\nThe conclusions have not changed since the previous version of this review (in 2017). We found low-certainty evidence that there may be little to no difference in pain intensity, pain relief and adverse events between oxycodone and other strong opioids including morphine, commonly considered the gold standard strong opioid. Although we identified a benefit for pain relief in favour of CR morphine over CR oxycodone, this was not clinically significant and did not persist following sensitivity analysis and so we do not consider this important. However, we found that constipation and hallucinations occurred less often with CR oxycodone than with CR morphine; but the certainty of this evidence was either very low or the finding did not persist following sensitivity analysis, so these findings should be treated with utmost caution. Our conclusions are consistent with other reviews and suggest that, while the reliability of the evidence base is low, given the absence of important differences within this analysis, it seems unlikely that larger head-to-head studies of oxycodone versus morphine are justified, although well-designed trials comparing oxycodone to other strong analgesics may well be useful. For clinical purposes, oxycodone or morphine can be used as first-line oral opioids for relief of cancer pain in adults.\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": "We rated the certainty of the evidence from studies using four levels: very low, low, moderate, or high. Very low-certainty evidence means that we are very uncertain about the results. High-certainty evidence means that we are very confident in the results. Overall, the certainty of the evidence in this review was rated low or very low, meaning that we are not sure about the results because of problems with study quality and small size."
}
] |
query-laysum
|
8460
|
[
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization (WHO) recommends Artemisinin-based Combination Therapy (ACT) for treating uncomplicated Plasmodium falciparum malaria. This review aims to assist the decision-making of malaria control programmes by providing an overview of the relative effects of dihydroartemisinin-piperaquine (DHA-P) versus other recommended ACTs.\nObjectives\nTo evaluate the effectiveness and safety of DHA-P compared to other ACTs for treating uncomplicated P. falciparum malaria in adults and children.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL) published in The Cochrane Library; MEDLINE; EMBASE; LILACS, and the metaRegister of Controlled Trials (mRCT) up to July 2013.\nSelection criteria\nRandomized controlled trials comparing a three-day course of DHA-P to a three-day course of an alternative WHO recommended ACT in uncomplicated P. falciparum malaria.\nData collection and analysis\nTwo authors independently assessed trials for eligibility and risk of bias, and extracted data. We analysed primary outcomes in line with the WHO 'Protocol for assessing and monitoring antimalarial drug efficacy’ and compared drugs using risk ratios (RR) and 95% confidence intervals (CI). Secondary outcomes were effects on gametocytes, haemoglobin, and adverse events. We assessed the quality of evidence using the GRADE approach.\nMain results\nWe included 27 trials, enrolling 16,382 adults and children, and conducted between 2002 and 2010. Most trials excluded infants aged less than six months and pregnant women.\nDHA-P versus artemether-lumefantrine\nIn Africa, over 28 days follow-up, DHA-P is superior to artemether-lumefantrine at preventing further parasitaemia (PCR-unadjusted treatment failure: RR 0.34, 95% CI 0.30 to 0.39, nine trials, 6200 participants, high quality evidence), and although PCR-adjusted treatment failure was below 5% for both ACTs, it was consistently lower with DHA-P (PCR-adjusted treatment failure: RR 0.42, 95% CI 0.29 to 0.62, nine trials, 5417 participants, high quality evidence). DHA-P has a longer prophylactic effect on new infections which may last for up to 63 days (PCR-unadjusted treatment failure: RR 0.71, 95% CI 0.65 to 0.78, two trials, 3200 participants, high quality evidence).\nIn Asia and Oceania, no differences have been shown at day 28 (four trials, 1143 participants, moderate quality evidence), or day 63 (one trial, 323 participants, low quality evidence).\nCompared to artemether-lumefantrine, no difference was seen in prolonged QTc (low quality evidence), and no cardiac arrhythmias were reported. The frequency of other adverse events is probably similar with both combinations (moderate quality evidence).\nDHA-P versus artesunate plus mefloquine\nIn Asia, over 28 days follow-up, DHA-P is as effective as artesunate plus mefloquine at preventing further parasitaemia (PCR-unadjusted treatment failure: eight trials, 3487 participants, high quality evidence). Once adjusted by PCR to exclude new infections, treatment failure at day 28 was below 5% for both ACTs in all eight trials, but lower with DHA-P in two trials (PCR-adjusted treatment failure: RR 0.41 95% CI 0.21 to 0.80, eight trials, 3482 participants, high quality evidence). Both combinations contain partner drugs with very long half-lives and no consistent benefit in preventing new infections has been seen over 63 days follow-up (PCR-unadjusted treatment failure: five trials, 2715 participants, moderate quality evidence).\nIn the only trial from South America, there were fewer recurrent parastaemias over 63 days with artesunate plus mefloquine (PCR-unadjusted treatment failure: RR 6.19, 95% CI 1.40 to 27.35, one trial, 445 participants, low quality evidence), but no differences were seen once adjusted for new infections (PCR-adjusted treatment failure: one trial, 435 participants, low quality evidence).\nDHA-P is associated with less nausea, vomiting, dizziness, sleeplessness, and palpitations compared to artesunate plus mefloquine (moderate quality evidence). DHA-P was associated with more frequent prolongation of the QTc interval (low quality evidence), but no cardiac arrhythmias were reported.\nAuthors' conclusions\nIn Africa, dihydroartemisinin-piperaquine reduces overall treatment failure compared to artemether-lumefantrine, although both drugs have PCR-adjusted failure rates of less than 5%. In Asia, dihydroartemisinin-piperaquine is as effective as artesunate plus mefloquine, and is better tolerated.\n\nGiven the provided abstract, please respond to the following query: \"What is uncomplicated malaria and how might dihydroartemisinin-piperaquine work\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Uncomplicated malaria is the mild form of malaria which usually causes a fever, with or without headache, tiredness, muscle pains, abdominal pains, nausea, and vomiting. If left untreated, uncomplicated malaria can develop into severe malaria with kidney failure, breathing difficulties, fitting, unconsciousness, and eventually death.\nDHA-P is one of five artemisinin-based combination therapies the World Health Organization currently recommends to treat malaria. These combinations contain an artemisinin component (such as dihydroartemisinin) which works very quickly to clear the malaria parasite from the person's blood, and a longer acting drug (such as piperaquine) which clears the remaining parasites from the blood and may prevent new infections with malaria for several weeks."
}
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query-laysum
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8461
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[
{
"role": "user",
"content": "Abstract: Background\nAcute anterior shoulder dislocation, which is the most common type of dislocation, usually results from an injury. Subsequently, the shoulder is less stable and is more susceptible to re-dislocation or recurrent instability (e.g. subluxation), especially in active young adults. After closed reduction, most of these injuries are treated with immobilisation of the injured arm in a sling or brace for a few weeks, followed by exercises. This is an update of a Cochrane Review first published in 2006 and last updated in 2014.\nObjectives\nTo assess the effects (benefits and harms) of conservative interventions after closed reduction of traumatic anterior dislocation of the shoulder. These might include immobilisation, rehabilitative interventions or both.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, PEDro and trial registries. We also searched conference proceedings and reference lists of included studies. Date of last search: May 2018.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials comparing conservative interventions with no treatment, a different intervention or a variant of the intervention (e.g. a different duration) for treating people after closed reduction of a primary traumatic anterior shoulder dislocation. Inclusion was regardless of age, sex or mechanism of injury. Primary outcomes were re-dislocation, patient-reported shoulder instability measures and return to pre-injury activities. Secondary outcomes included participant satisfaction, health-related quality of life, any instability and adverse events.\nData collection and analysis\nBoth review authors independently selected studies, assessed risk of bias and extracted data. We contacted study authors for additional information. We pooled results of comparable groups of studies. We assessed risk of bias with the Cochrane 'Risk of bias' tool and the quality of the evidence with the GRADE approach.\nMain results\nWe included seven trials (six randomised controlled trials and one quasi-randomised controlled trial) with 704 participants; three of these trials (234 participants) are new to this update. The mean age across the trials was 29 years (range 12 to 90 years), and 82% of the participants were male. All trials compared immobilisation in external rotation (with or without an additional abduction component) versus internal rotation (the traditional method) following closed reduction. No trial evaluated any other interventions or comparisons, such as rehabilitation. All trials provided data for a follow-up of one year or longer; the commonest length was two years or longer.\nAll trials were at some risk of bias, commonly performance and detection biases given the lack of blinding. Two trials were at high risk of selection bias and some trials were affected by attrition bias for some outcomes. We rated the certainty of the evidence as very low for all outcomes.\nWe are uncertain whether immobilisation in external rotation makes a difference to the risk of re-dislocation after 12 months' or longer follow-up compared with immobilisation in internal rotation (55/245 versus 73/243; risk ratio (RR) 0.67, 95% confidence interval (CI) 0.38 to 1.19; 488 participants; 6 studies; I² = 61%; very low certainty evidence). In a moderate-risk population with an illustrative risk of 312 per 1000 people experiencing a dislocation in the internal rotation group, this equates to 103 fewer (95% CI 194 fewer to 60 more) re-dislocations after immobilisation in external rotation. Thus this result covers the possibility of a benefit for each intervention.\nIndividually, the four studies (380 participants) reporting on validated patient-reported outcome measures for shoulder instability at a minimum of 12 months' follow-up found no evidence of a clinically important difference between the two interventions.\nWe are uncertain of the relative effects of the two methods of immobilisation on resumption of pre-injury activities or sports. One study (169 participants) found no evidence of a difference between interventions in the return to pre-injury activity of the affected arm. Two studies (135 participants) found greater return to sports in the external rotation group in a subgroup of participants who had sustained their injury during sports activities.\nNone of the trials reported on participant satisfaction or health-related quality of life.\nWe are uncertain whether there is a difference between the two interventions in the number of participants experiencing instability, defined as either re-dislocation or subluxation (RR 0.84, 95% CI 0.62 to 1.14; 395 participants, 3 studies; very low certainty evidence).\nData on adverse events were collected only in an ad hoc way in the seven studies. Reported \"transient and resolved adverse events\" were nine cases of shoulder stiffness or rigidity in the external rotation group and two cases of axillary rash in the internal rotation group. There were three \"important\" adverse events: hyperaesthesia and moderate hand pain; eighth cervical dermatome paraesthesia; and major movement restriction between 6 and 12 months. It was unclear to what extent these three events could be attributed to the treatment.\nAuthors' conclusions\nThe available evidence from randomised trials is limited to that comparing immobilisation in external versus internal rotation. Overall, the evidence is insufficient to draw firm conclusions about whether immobilisation in external rotation confers any benefit over immobilisation in internal rotation.\nConsidering that there are several unpublished and ongoing trials evaluating immobilisation in external versus internal rotation, the main priority for research on this question consists of the publication of completed trials and the completion and publication of ongoing trials. Meanwhile, evaluation of other interventions, including rehabilitation, is warranted. There is a need for sufficiently large, good-quality, well-reported randomised controlled trials with long-term follow-up. Future research should aim to determine the optimal immobilisation duration, precise indications for immobilisation, optimal rehabilitation interventions, and the acceptability of these different 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": "We conducted the searches of healthcare literature for this review in May 2018."
}
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query-laysum
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8462
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[
{
"role": "user",
"content": "Abstract: Background\nPeople living with chronic kidney disease (CKD) experience a range of symptoms and often have complex comorbidities. Many pharmacological interventions for people with CKD have known risks of adverse events. Acupuncture is widely used for symptom management in patients with chronic diseases and in other palliative care settings. However, the safety and efficacy of acupuncture for people with CKD remains largely unknown.\nObjectives\nWe aimed to evaluate the benefits and harms of acupuncture, electro-acupuncture, acupressure, moxibustion and other acupuncture-related interventions (alone or combined with other acupuncture-related interventions) for symptoms of CKD. In particular, we planned to compare acupuncture and related interventions with conventional medicine, active non-pharmacological interventions, and routine care for symptoms of CKD.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register up to 28 January 2016 through contact with the Information Specialist using search terms relevant to this review. We also searched Korean medical databases (including Korean Studies Information, DBPIA, Korea Institute of Science and Technology Information, Research Information Centre for Health Database, KoreaMed, the National Assembly Library) and Chinese databases (including the China Academic Journal).\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs that investigated the effects of acupuncture and related point-stimulation interventions with or without needle penetration that involved six sessions or more in adults with CKD stage 3 to 5, regardless of the language and type of publication. We excluded studies that used herbal medicine or co-interventions administered unequally among the study groups.\nData collection and analysis\nTwo authors independently extracted data and assessed risk of bias. We calculated the mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) for continuous outcomes and risk ratio (RR) for dichotomous outcomes. Primary outcomes were changes in pain and depression, and occurrence of serious of adverse events.\nMain results\nWe included 24 studies that involved a total of 1787 participants. Studies reported on various types of acupuncture and related interventions including manual acupuncture and acupressure, ear acupressure, transcutaneous electrical acupuncture point stimulation, far-infrared radiation on acupuncture points and indirect moxibustion. CKD stages included pre-dialysis stage 3 or 4 and end-stage kidney disease on either haemodialysis or peritoneal dialysis.\nNone of the included studies assessed pain outcomes, nor formally addressed occurrence of serious adverse events, although three studies reported three participant deaths and three hospitalisations as reasons for attrition. Three studies reported minor acupuncture-related harms; the remainder did not report if those events occurred.\nAll studies were assessed at high or unclear risk of bias in terms of allocation concealment. Seventeen studies reported outcomes measured for only two months.\nThere was very low quality of evidence that compared with routine care, manual acupressure reduced scores of the Beck Depression Inventory score (scale from 0 to 63) (3 studies, 128 participants: MD -4.29, 95% CI -7.48 to -1.11, I2 = 0%), the revised Piper Fatigue Scale (scale from 0 to 10) (3 studies, 128 participants: MD -1.19, 95% CI -1.77 to -0.60, I2 = 0%), and the Pittsburgh Sleep Quality Index (scale from 0 to 21) (4 studies, 180 participants: MD -2.46, 95% CI -4.23 to -0.69, I2 = 50%).\nWe were unable to perform further meta-analyses because of the paucity of data and problems with clinical heterogeneity, such as different interventions, comparisons and timing of outcome measurements.\nAuthors' conclusions\nThere was very low quality of evidence of the short-term effects of manual acupressure as an adjuvant intervention for fatigue, depression, sleep disturbance and uraemic pruritus in patients undergoing regular haemodialysis. The paucity of evidence indicates that there is little evidence of the effects of other types of acupuncture for other outcomes, including pain, in patients with other stages of CKD. Overall high or unclear risk of bias distorts the validity of the reported benefit of acupuncture and makes the estimated effects uncertain. The incomplete reporting of acupuncture-related harm does not permit us to assess the safety of acupuncture and related interventions. Future studies should investigate the effects and safety of acupuncture for pain and other common symptoms in patients with CKD and those undergoing dialysis.\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": "Patients with chronic kidney disease experience various physical and psychological symptoms, but treatment options are limited because of reduced kidney function and other chronic health problems. Acupuncture is widely used to treat common symptoms such as pain, fatigue or depressive mood in patients with chronic conditions. This review aimed to investigate the current evidence and potential role for acupuncture in patients with chronic kidney disease (CKD)."
}
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query-laysum
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8463
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[
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD) is a chronic respiratory condition characterised by persistent respiratory symptoms and airflow limitation. Acute exacerbations punctuate the natural history of COPD and are associated with increased morbidity and mortality and disease progression. Chronic airflow limitation is caused by a combination of small airways (bronchitis) and parenchymal destruction (emphysema), which can impact day-to-day activities and overall quality of life. In carefully selected patients with COPD, long-term, prophylactic use of antibiotics may reduce bacterial load, inflammation of the airways, and the frequency of exacerbations.\nObjectives\nTo assess effects of different prophylactic antibiotics on exacerbations, quality of life, and serious adverse events in people with COPD in three separate network meta-analyses (NMAs), and to provide rankings of identified antibiotics.\nSearch methods\nTo identify eligible randomised controlled trials (RCTs), we searched the Cochrane Airways Group Specialised Register of trials and clinical trials registries. We conducted the most recent search on 22 January 2020.\nSelection criteria\nWe included RCTs with a parallel design of at least 12 weeks' duration evaluating long-term administration of antibiotics prophylactically compared with other antibiotics, or placebo, for patients with COPD.\nData collection and analysis\nThis Cochrane Review collected and updated pair-wise data from two previous Cochrane Reviews. Searches were updated and additional studies included. We conducted three separate network meta-analyses (NMAs) within a Bayesian framework to assess three outcomes: exacerbations, quality of life, and serious adverse events. For quality of life, we collected data from St George's Respiratory Questionnaire (SGRQ). Using previously validated methods, we selected the simplest model that could adequately fit the data for every analysis. We used threshold analysis to indicate which results were robust to potential biases, taking into account each study’s contributions to the overall results and network structure. Probability ranking was performed for each antibiotic class for exacerbations, quality of life, and serious adverse events.\nMain results\nCharacteristics of studies and participants\nEight trials were conducted at multiple sites that included hospital clinics or academic health centres. Seven were single-centre trials conducted in hospital clinics. Two trials did not report settings. Trials durations ranged from 12 to 52 weeks. Most participants had moderate to severe disease. Mean age ranged from 64 years to 73 years, and more males were recruited (51% to 100%). Forced expiratory volume in one second (FEV₁) ranged from 0.935 to 1.36 L. Most participants had previous exacerbations. Data from 12 studies were included in the NMAs (3405 participants; 16 treatment arms including placebo). Prophylactic antibiotics evaluated were macrolides (azithromycin and erythromycin), tetracyclines (doxycyclines), quinolones (moxifloxacin) and macrolides plus tetracyclines (roxithromycin plus doxycycline).\nRisk of bias and threshold analysis\nMost studies were at low risk across domains, except detection bias, for which only seven studies were judged at low risk. In the threshold analysis for exacerbations, all comparisons in which one antibiotic was compared with another were robust to sampling variation, especially macrolide comparisons. Comparisons of classes with placebo were sensitive to potential bias, especially macrolide versus placebo, therefore, any bias in the comparison was likely to favour the active class, so any adjustment would bring the estimated relative effect closer to the null value, thus quinolone may become the best class to prevent exacerbations.\nExacerbations\nNine studies were included (2732 participants) in this NMA (exacerbations analysed as time to first exacerbation or people with one or more exacerbations). Macrolides and quinolones reduced exacerbations. Macrolides had a greater effect in reducing exacerbations compared with placebo (macrolides: hazard ratio (HR) 0.67, 95% credible interval (CrI) 0.60 to 0.75; quinolones: HR 0.89, 95% CrI 0.75 to 1.04), resulting in 127 fewer people per 1000 experiencing exacerbations on macrolides. The difference in exacerbations between tetracyclines and placebo was uncertain (HR 1.29, 95% CrI 0.66 to 2.41). Macrolides ranked first (95% CrI first to second), with quinolones ranked second (95% CrI second to third). Tetracyclines ranked fourth, which was lower than placebo (ranked third). Contributing studies were considered as low risk of bias in a threshold analysis.\nQuality of life (SGRQ)\nSeven studies were included (2237 participants) in this NMA. SGRQ scores improved with macrolide treatment compared with placebo (fixed effect-fixed class effect: mean difference (MD) -2.30, 95% CrI -3.61 to -0.99), but the mean difference did not reach the minimally clinical important difference (MCID) of 4 points. Tetracyclines and quinolones did not improve quality of life any more than placebo, and we did not detect a difference between antibiotic classes.\nSerious adverse events\nNine studies were included (3180 participants) in the NMA. Macrolides reduced the odds of a serious adverse event compared with placebo (fixed effect-fixed class effect: odds ratio (OR) 0.76, 95% CrI 0.62 to 0.93). There was probably little to no difference in the effect of quinolone compared with placebo or tetracycline plus macrolide compared with placebo. There was probably little to no difference in serious adverse events between quinolones or tetracycline plus macrolide. With macrolide treatment 49 fewer people per 1000 experienced a serious adverse event compared with those given placebo. Macrolides ranked first, followed by quinolones. Tetracycline did not rank better than placebo.\nDrug resistance\nTen studies reported drug resistance. Results were not combined due to variation in outcome measures. All studies concluded that prophylactic antibiotic administration was associated with the development of antimicrobial resistance.\nAuthors' conclusions\nThis NMA evaluated the safety and efficacy of different antibiotics used prophylactically for COPD patients. Compared to placebo, prolonged administration of macrolides (ranked first) appeared beneficial in prolonging the time to next exacerbation, improving quality of life, and reducing serious adverse events. No clear benefits were associated with use of quinolones or tetracyclines. In addition, antibiotic resistance was a concern and could not be thoroughly assessed in this review. Given the trade-off between effectiveness, safety, and risk of antibiotic resistance, prophylactic administration of antibiotics may be best reserved for selected patients, such as those experiencing frequent exacerbations. However, none of the eligible studies excluded patients with previously isolated non-tuberculous mycobacteria, which would contraindicate prophylactic administration of antibiotics, due to the risk of developing resistant non-tuberculous mycobacteria.\n\nGiven the provided abstract, please respond to the following query: \"Why did we do this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out if one type of preventative antibiotic was better than another in reducing exacerbations, improving quality of life, and reducing side effects. We did this by using information from two previous reviews and comparing different antibiotics with each other, and with a control treatment (called placebo), by creating networks. As information was limited, the networks allowed us to combine information and determine the best preventative antibiotics by ranking them in order of ability to reduce exacerbations, improve quality of life, and reduce serious side effects."
}
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query-laysum
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8464
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[
{
"role": "user",
"content": "Abstract: Background\nSexual dysfunction following stroke is common but often is poorly managed. As awareness of sexual dysfunction following stroke increases as an important issue, a clearer evidence base for interventions for sexual dysfunction is needed to optimise management.\nObjectives\nTo evaluate the effectiveness of interventions to reduce sexual dysfunction following stroke, and to assess adverse events associated with interventions for sexual dysfunction following stroke.\nSearch methods\nWe conducted the search on 27 November 2019. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; from June 2014), in the Cochrane Library; MEDLINE (from 1950); Embase (from 1980); the Cumulative Index to Nursing and Allied Health Literature (CINAHL; from 1982); the Allied and Complementary Medicine Database (AMED; from 1985); PsycINFO (from 1806); the Physiotherapy Evidence Database (PEDro; from 1999); and 10 additional bibliographic databases and ongoing trial registers.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared pharmacological treatments, mechanical devices, or complementary medicine interventions versus placebo. We also included other non-pharmacological interventions (such as education or therapy), which were compared against usual care or different forms of intervention (such as different intensities) for treating sexual dysfunction in stroke survivors.\nData collection and analysis\nTwo review authors independently selected eligible studies, extracted data, and assessed study quality. We determined the risk of bias for each study and performed a 'best evidence' synthesis using the GRADE approach.\nMain results\nWe identified three RCTs with a total of 212 participants. We noted significant heterogeneity in interventions (one pharmacological, one physiotherapy-based, and one psycho-educational), and all RCTs were small and of 'low' or 'very low' quality. Based on these RCTs, data are insufficient to provide any reliable indication of benefit or risk to guide clinical practice in terms of the use of sertraline, specific pelvic floor muscle training, or individualised sexual rehabilitation.\nAuthors' conclusions\nUse of sertraline to treat premature ejaculation needs to be tested in further RCTs. The lack of benefit with structured sexual rehabilitation and pelvic floor physiotherapy should not be interpreted as proof of ineffectiveness. Well-designed, randomised, double-blinded, placebo-controlled trials of long-term duration are needed to determine the effectiveness of various types of interventions for sexual dysfunction. It should be noted, however, that it may not be possible to double-blind trials of complex interventions.\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 find out whether some treatments are better or worse than alternatives."
}
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query-laysum
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8465
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[
{
"role": "user",
"content": "Abstract: Background\nA hordeolum is a common, painful inflammation of the eyelid margin that is usually caused by a bacterial infection. The infection affects oil glands of the eyelid and can be either internal or external. In many cases, the lesion drains spontaneously and resolves without treatment; however, the inflammation can spread to other ocular glands or tissues, and recurrences are common. If unresolved, an acute internal hordeolum can become chronic, or can develop into a chalazion. External hordeola, also known as styes, were not included in the scope of this review.\nObjectives\nThe objective of this review was to investigate the effectiveness, and when possible, the safety, of non-surgical treatments for acute internal hordeola compared with observation or placebo.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register (2016; Issue 12)), MEDLINE Ovid, MEDLINE Ovid Epub Ahead of Print, MEDLINE Ovid In-Process & Other Non-Indexed Citations, MEDLINE(R) Ovid Daily (January 1946 to December 2016), Embase (January 1947 to December 2016), PubMed (1948 to December 2016), Latin American and Caribbean Literature on Health Sciences (LILACS (January 1982 to December 2016)), the metaRegister of Controlled Trials (mRCT; www.controlled-trials.com (last searched 26 July 2012)), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We used no date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 2 December 2016.\nSelection criteria\nThe selection criteria for this review included randomized or quasi-randomized clinical trials of participants diagnosed with an acute internal hordeolum. Studies of participants with external hordeola (styes), chronic hordeola, or chalazia were excluded. Non-surgical interventions of interest included the use of hot or warm compresses, lid scrubs, antibiotics, or steroids compared with observation, placebo, or other active interventions.\nData collection and analysis\nTwo review authors independently assessed the references identified by electronic searches for inclusion in this review. No relevant studies were found. The reasons for exclusion were documented.\nMain results\nNo trials were identified for this review. Most of the references identified through our search reported on external hordeola or chronic internal hordeola. The few references specific to acute internal hordeola reported recommendations for treatment, were reports of interventional case series, case studies, or other types of observational study designs, and were published more than 20 years ago.\nAuthors' conclusions\nWe did not find any evidence for or against the effectiveness of non-surgical interventions for the treatment of an internal hordeolum. Controlled clinical trials would be useful to determine which interventions are effective for the treatment of acute internal hordeola.\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": "A hordeolum is a common, painful lump in the eyelid that is usually caused by a bacterial infection. The infection affects the oil glands in the eyelid and results in a lump. Often, the infected lump drains and heals by itself, with no treatment. However, the infection can sometimes spread to other glands in the eyes, and can become long lasting. It can also turn into a cyst (known as a chalazion). Hordeola can be internal (on the inside of the eyelid), or external (on the outside of the eyelid near the eyelashes). A hordeolum on the outside of the eyelid is known as a stye. Hordeola can also be acute (appearing suddenly and healing in a short time), or chronic (long lasting). Common treatments for hordeola include warm compresses applied at home, topical medications and lid scrubs available over-the-counter, prescribed antibiotics or steroids, and lid massages."
}
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query-laysum
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8466
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[
{
"role": "user",
"content": "Abstract: Background\nChronic suppurative otitis media (CSOM) is a chronic inflammation and infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss.\nSystemic antibiotics are a commonly used treatment option for CSOM, which act to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be used alone or in addition to other treatments for CSOM.\nObjectives\nTo assess the effects of systemic antibiotics for people with CSOM.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 March 2020.\nSelection criteria\nWe included randomised controlled trials comparing systemic antibiotics (oral, injection) against placebo/no treatment or other systemic antibiotics with at least a one-week follow-up period, involving patients with chronic (at least two weeks) ear discharge of unknown cause or due to CSOM. Other treatments were allowed if both treatment and control arms also received it.\nData collection and analysis\nWe used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome.\nOur primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not, measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks); health-related quality of life using a validated instrument; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.\nMain results\nWe included 18 studies (2135 participants) with unclear or high risk of bias.\n1. Systemic antibiotics versus no treatment/placebo\nIt is very uncertain if there is a difference between systemic (intravenous) antibiotics and placebo in the resolution of ear discharge at between one and two weeks (risk ratio (RR) 8.47, 95% confidence interval (CI) 1.88 to 38.21; 33 participants; 1 study; very low-certainty evidence). The study did not report results for resolution of ear discharge after two weeks. Health-related quality of life was not reported. The evidence is very uncertain for hearing and serious (intracranial) complications. Ear pain and suspected ototoxicity were not reported.\n2. Systemic antibiotics versus no treatment/placebo (both study arms received topical antibiotics)\nSix studies were included of which five presented useable data. There may be little or no difference in the resolution of ear discharge at between one to two weeks for oral ciprofloxacin compared to placebo or no treatment when ciprofloxacin ear drops were used in both intervention arms (RR 1.02, 95% CI 0.93 to 1.12; 390 participants; low-certainty evidence). No results after two weeks were reported. Health-related quality of life was not reported. The evidence is very uncertain for ear pain, serious complications and suspected ototoxicity.\n3. Systemic antibiotics versus no treatment/placebo (both study arms received other background treatments)\nTwo studies used topical antibiotics plus steroids as background treatment in both arms. It is very uncertain if there is a difference in resolution of ear discharge between metronidazole and placebo at four weeks (RR 0.91, 95% CI 0.51 to 1.65; 40 participants; 1 study; very low-certainty evidence). This study did not report other outcomes. It is also very uncertain if resolution of ear discharge at six weeks was improved with co-trimoxazole compared to placebo (RR 1.54, 95% CI 1.09 to 2.16; 98 participants; 1 study; very low-certainty evidence). Resolution of ear discharge was not reported at other time points. From the narrative report there was no evidence of a difference between groups for health-related quality of life, hearing or serious complications (very low-certainty evidence).\nOne study (136 participants) used topical antiseptics as background treatment in both arms and found similar resolution of ear discharge between the amoxicillin and no treatment groups at three to four months (RR 1.03, 95% CI 0.75 to 1.41; 136 participants; 1 study; very low-certainty evidence). The narrative report indicated no evidence of differences in hearing or suspected ototoxicity (both very low-certainty evidence). No other outcomes were reported.\n4. Different types of systemic antibiotics\nThis is a summary of four comparisons, where different antibiotics were compared to each other. Eight studies compared different types of systemic antibiotics against each other: quinolones against beta-lactams (four studies), lincosamides against nitroimidazoles (one study) and comparisons of different types of beta-lactams (three studies). It was not possible to conclude if there was one class or type of systemic antibiotic that was better in terms of resolution of ear discharge. The studies did not report adverse events well.\nAuthors' conclusions\nThere was a limited amount of evidence available to examine whether systemic antibiotics are effective in achieving resolution of ear discharge for people with CSOM. When used alone (with or without aural toileting), we are very uncertain if systemic antibiotics are more effective than placebo or no treatment. When added to an effective intervention such as topical antibiotics, there seems to be little or no difference in resolution of ear discharge (low-certainty evidence). Data were only available for certain classes of antibiotics and it is very uncertain whether one class of systemic antibiotic may be more effective than another. Adverse effects of systemic antibiotics were poorly reported in the studies included. As we found very sparse evidence for their efficacy, the possibility of adverse events may detract from their use for CSOM.\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": "There is insufficient robust evidence to determine whether systemic antibiotics are effective treatments for CSOM, and whether they lead to side effects. Evidence about side effects is particularly limited. When added to topical antibiotics, systemic antibiotics may make little to no difference to whether discharge resolves after one to two weeks. We do not know if some systemic antibiotics are better than others."
}
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query-laysum
|
8467
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[
{
"role": "user",
"content": "Abstract: Background\nOlder people taking multiple medications represent a large and growing proportion of the population. Managing multiple medications can be challenging, and this is especially the case for older people, who have higher rates of comorbidity and physical and cognitive impairment than younger adults. Good medication-taking ability and medication adherence are necessary to ensure safe and effective use of medications.\nObjectives\nTo evaluate the effectiveness of interventions designed to improve medication-taking ability and/or medication adherence in older community-dwelling adults prescribed multiple long-term medications.\nSearch methods\nWe searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL Plus, and International Pharmaceutical Abstracts from inception until June 2019. We also searched grey literature, online trial registries, and reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs. Eligible studies tested interventions aimed at improving medication-taking ability and/or medication adherence among people aged ≥ 65 years (or of mean/median age > 65 years), living in the community or being discharged from hospital back into the community, and taking four or more regular prescription medications (or with group mean/median of more than four medications). Interventions targeting carers of older people who met these criteria were also included.\nData collection and analysis\nTwo review authors independently reviewed abstracts and full texts of eligible studies, extracted data, and assessed risk of bias of included studies. We conducted meta-analyses when possible and used a random-effects model to yield summary estimates of effect, risk ratios (RRs) for dichotomous outcomes, and mean differences (MDs) or standardised mean differences (SMDs) for continuous outcomes, along with 95% confidence intervals (CIs). Narrative synthesis was performed when meta-analysis was not possible. We assessed overall certainty of evidence for each outcome using Grades of Recommendation, Assessment, Development and Evaluation (GRADE). Primary outcomes were medication-taking ability and medication adherence. Secondary outcomes included health-related quality of life (HRQoL), emergency department (ED)/hospital admissions, and mortality.\nMain results\nWe identified 50 studies (14,269 participants) comprising 40 RCTs, six cluster-RCTs, and four quasi-RCTs. All included studies evaluated interventions versus usual care; six studies also reported a comparison between two interventions as part of a three-arm RCT design.\nInterventions were grouped on the basis of their educational and/or behavioural components: 14 involved educational components only, 7 used behavioural strategies only, and 29 provided mixed educational and behavioural interventions. Overall, our confidence in results regarding the effectiveness of interventions was low to very low due to a high degree of heterogeneity of included studies and high or unclear risk of bias across multiple domains in most studies.\nFive studies evaluated interventions for improving medication-taking ability, and 48 evaluated interventions for improving medication adherence (three studies evaluated both outcomes).\nNo studies involved educational or behavioural interventions alone for improving medication-taking ability. Low-quality evidence from five studies, each using a different measure of medication-taking ability, meant that we were unable to determine the effects of mixed interventions on medication-taking ability.\nLow-quality evidence suggests that behavioural only interventions (RR 1.22, 95% CI 1.07 to 1.38; 4 studies) and mixed interventions (RR 1.22, 95% CI 1.08 to 1.37; 12 studies) may increase the proportions of people who are adherent compared with usual care. We could not include in the meta-analysis results from two studies involving mixed interventions: one had a positive effect on adherence, and the other had little or no effect. Very low-quality evidence means that we are uncertain of the effects of educational only interventions (5 studies) on the proportions of people who are adherent.\nLow-quality evidence suggests that educational only interventions (SMD 0.16, 95% CI -0.12 to 0.43; 5 studies) and mixed interventions (SMD 0.47, 95% CI -0.08 to 1.02; 7 studies) may have little or no impact on medication adherence assessed through continuous measures of adherence. We excluded 10 studies (4 educational only and 6 mixed interventions) from the meta-analysis including four studies with unclear or no available results. Very low-quality evidence means that we are uncertain of the effects of behavioural only interventions (3 studies) on medication adherence when assessed through continuous outcomes.\nLow-quality evidence suggests that mixed interventions may reduce the number of ED/hospital admissions (RR 0.67, 95% CI 0.50 to 0.90; 11 studies) compared with usual care, although results from six further studies that we were unable to include in meta-analyses indicate that the intervention may have a smaller, or even no, effect on these outcomes. Similarly, low-quality evidence suggests that mixed interventions may lead to little or no change in HRQoL (7 studies), and very low-quality evidence means that we are uncertain of the effects on mortality (RR 0.93, 95% CI 0.67 to 1.30; 7 studies).\nModerate-quality evidence shows that educational interventions alone probably have little or no effect on HRQoL (6 studies) or on ED/hospital admissions (4 studies) when compared with usual care. Very low-quality evidence means that we are uncertain of the effects of behavioural interventions on HRQoL (1 study) or on ED/hospital admissions (2 studies). We identified no studies evaluating effects of educational or behavioural interventions alone on mortality.\nSix studies reported a comparison between two interventions; however due to the limited number of studies assessing the same types of interventions and comparisons, we are unable to draw firm conclusions for any outcomes.\nAuthors' conclusions\nBehavioural only or mixed educational and behavioural interventions may improve the proportion of people who satisfactorily adhere to their prescribed medications, but we are uncertain of the effects of educational only interventions. No type of intervention was found to improve adherence when it was measured as a continuous variable, with educational only and mixed interventions having little or no impact and evidence of insufficient quality to determine the effects of behavioural only interventions. We were unable to determine the impact of interventions on medication-taking ability. The quality of evidence for these findings is low due to heterogeneity and methodological limitations of studies included in the review. Further well-designed RCTs are needed to investigate the effects of interventions for improving medication-taking ability and medication adherence in older adults prescribed multiple medications.\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": "Older people are often prescribed multiple medications, which can be challenging to manage. Medication-taking errors and non-adherence (under-use or over-use of medication) can lead to negative health outcomes. Assisting older people to better use and adhere to their medications could reduce adverse medication events, such as medication-related hospital admissions, and could improve health outcomes."
}
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query-laysum
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8468
|
[
{
"role": "user",
"content": "Abstract: Background\nThe role of inhaled corticosteroids (ICS) in chronic obstructive pulmonary disease (COPD) has been the subject of much uncertainty. COPD clinical guidelines currently recommend selective use of ICS. ICS are not recommended as monotherapy for people with COPD, and are only given in combination with long-acting bronchodilators due to greater efficacy of combination therapy. Incorporating and critiquing newly published placebo-controlled trials into the monotherapy evidence base may help to resolve ongoing uncertainties and conflicting findings about their role in this population.\nObjectives\nTo evaluate the benefits and harms of inhaled corticosteroids, used as monotherapy versus placebo, in people with stable COPD, in terms of objective and subjective outcomes.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was October 2022.\nSelection criteria\nWe included randomised trials comparing any dose of any type of ICS, given as monotherapy, with a placebo control in people with stable COPD. We excluded studies of less than 12 weeks' duration and studies of populations with known bronchial hyper-responsiveness (BHR) or bronchodilator reversibility.\nData collection and analysis\nWe used standard Cochrane methods. Our a priori primary outcomes were 1. exacerbations of COPD and 2. quality of life. Our secondary outcomes were 3. all-cause mortality, 4. lung function (rate of decline of forced expiratory volume in one second (FEV1)), 5. rescue bronchodilator use, 6. exercise capacity, 7. pneumonia and 8. adverse events including pneumonia. ]. We used GRADE to assess certainty of evidence.\nMain results\nThirty-six primary studies with 23,139 participants met the inclusion criteria. Mean age ranged from 52 to 67 years, and females were 0% to 46% of participants. Studies recruited across the severities of COPD. Seventeen studies were of duration longer than three months and up to six months and 19 studies were of duration longer than six months. We judged the overall risk of bias as low.\nLong-term (more than six months) use of ICS as monotherapy reduced the mean rate of exacerbations in those studies where pooling of data was possible (generic inverse variance analysis: rate ratio 0.88 exacerbations per participant per year, 95% confidence interval (CI) 0.82 to 0.94; I2 = 48%, 5 studies, 10,097 participants; moderate-certainty evidence; pooled means analysis: mean difference (MD) −0.05 exacerbations per participant per year, 95% CI −0.07 to −0.02; I2 = 78%, 5 studies, 10,316 participants; moderate-certainty evidence). ICS slowed the rate of decline in quality of life, as measured by the St George's Respiratory Questionnaire (MD −1.22 units/year, 95% CI −1.83 to −0.60; I2 = 0%; 5 studies, 2507 participants; moderate-certainty evidence; minimal clinically importance difference 4 points). There was no evidence of a difference in all-cause mortality in people with COPD (odds ratio (OR) 0.94, 95% CI 0.84 to 1.07; I2 = 0%; 10 studies, 16,636 participants; moderate-certainty evidence). Long-term use of ICS reduced the rate of decline in FEV1 in people with COPD (generic inverse variance analysis: MD 6.31 mL/year benefit, 95% CI 1.76 to 10.85; I2 = 0%; 6 studies, 9829 participants; moderate-certainty evidence; pooled means analysis: 7.28 mL/year, 95% CI 3.21 to 11.35; I2 = 0%; 6 studies, 12,502 participants; moderate-certainty evidence).\nAdverse events: in the long-term studies, the rate of pneumonia was increased in the ICS group, compared to placebo, in studies that reported pneumonia as an adverse event (OR 1.38, 95% CI 1.02 to 1.88; I2 = 55%; 9 studies, 14,831 participants; low-certainty evidence). There was an increased risk of oropharyngeal candidiasis (OR 2.66, 95% CI 1.91 to 3.68; 5547 participants) and hoarseness (OR 1.98, 95% CI 1.44 to 2.74; 3523 participants). The long-term studies that measured bone effects generally showed no major effect on fractures or bone mineral density over three years. We downgraded the certainty of evidence to moderate for imprecision and low for imprecision and inconsistency.\nAuthors' conclusions\nThis systematic review updates the evidence base for ICS monotherapy with newly published trials to aid the ongoing assessment of their role for people with COPD. Use of ICS alone for COPD likely results in a reduction of exacerbation rates of clinical relevance, probably results in a reduction in the rate of decline of FEV1 of uncertain clinical relevance and likely results in a small improvement in health-related quality of life not meeting the threshold for a minimally clinically important difference. These potential benefits should be weighed up against adverse events (likely to increase local oropharyngeal adverse effects and may increase the risk of pneumonia) and probably no reduction in mortality. Though not recommended as monotherapy, the probable benefits of ICS highlighted in this review support their continued consideration in combination with long-acting bronchodilators. Future research and evidence syntheses should be focused in that area.\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 medical databases for studies comparing inhaled corticosteroids versus inhaled placebo (pretend treatment) in people with stable COPD."
}
] |
query-laysum
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8469
|
[
{
"role": "user",
"content": "Abstract: Background\nMirror therapy is used to improve motor function after stroke. During mirror therapy, a mirror is placed in the person's midsagittal plane, thus reflecting movements of the non-paretic side as if it were the affected side.\nObjectives\nTo summarise the effectiveness of mirror therapy compared with no treatment, placebo or sham therapy, or other treatments for improving motor function and motor impairment after stroke. We also aimed to assess the effects of mirror therapy on activities of daily living, pain, and visuospatial neglect.\nSearch methods\nWe searched the Cochrane Stroke Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, AMED, PsycINFO and PEDro (last searched 16 August 2017). We also handsearched relevant conference proceedings, trials and research registers, checked reference lists, and contacted trialists, researchers and experts in our field of study.\nSelection criteria\nWe included randomised controlled trials (RCTs) and randomised cross-over trials comparing mirror therapy with any control intervention for people after stroke.\nData collection and analysis\nTwo review authors independently selected trials based on the inclusion criteria, documented the methodological quality, assessed risks of bias in the included studies, and extracted data. We assessed the quality of the evidence using the GRADE approach. We analysed the results as standardised mean differences (SMDs) or mean differences (MDs) for continuous variables, and as odds ratios (ORs) for dichotomous variables.\nMain results\nWe included 62 studies with a total of 1982 participants that compared mirror therapy with other interventions. Of these, 57 were randomised controlled trials and five randomised cross-over trials. Participants had a mean age of 59 years (30 to 73 years). Mirror therapy was provided three to seven times a week, between 15 and 60 minutes for each session for two to eight weeks (on average five times a week, 30 minutes a session for four weeks).When compared with all other interventions, we found moderate-quality evidence that mirror therapy has a significant positive effect on motor function (SMD 0.47, 95% CI 0.27 to 0.67; 1173 participants; 36 studies) and motor impairment (SMD 0.49, 95% CI 0.32 to 0.66; 1292 participants; 39 studies). However, effects on motor function are influenced by the type of control intervention. Additionally, based on moderate-quality evidence, mirror therapy may improve activities of daily living (SMD 0.48, 95% CI 0.30 to 0.65; 622 participants; 19 studies). We found low-quality evidence for a significant positive effect on pain (SMD −0.89, 95% CI −1.67 to −0.11; 248 participants; 6 studies) and no clear effect for improving visuospatial neglect (SMD 1.06, 95% CI −0.10 to 2.23; 175 participants; 5 studies). No adverse effects were reported.\nAuthors' conclusions\nThe results indicate evidence for the effectiveness of mirror therapy for improving upper extremity motor function, motor impairment, activities of daily living, and pain, at least as an adjunct to conventional rehabilitation for people after stroke. Major limitations are small sample sizes and lack of reporting of methodological details, resulting in uncertain evidence quality.\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 62 relevant studies, of which 57 randomly allocated participants to receive either MT or a control therapy (randomised controlled trials) and five provided both therapies to all participants, but in random order (cross-over trials). The studies involved a total of 1982 participants with a mean age of 59 years (30 to 73 years) after stroke. Mirror therapy was provided three to seven times a week, between 15 and 60 minutes for each session for two to eight weeks (on average five times a week, 30 minutes a session for four weeks)."
}
] |
query-laysum
|
8470
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[
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization (WHO) recommends Xpert MTB/RIF in place of smear microscopy to diagnose tuberculosis (TB), and many countries have adopted it into their diagnostic algorithms. However, it is not clear whether the greater accuracy of the test translates into improved health outcomes.\nObjectives\nTo assess the impact of Xpert MTB/RIF on patient outcomes in people being investigated for tuberculosis.\nSearch methods\nWe searched the following databases, without language restriction, from 2007 to 24 July 2020: Cochrane Infectious Disease Group (CIDG) Specialized Register; CENTRAL; MEDLINE OVID; Embase OVID; CINAHL EBSCO; LILACS BIREME; Science Citation Index Expanded (Web of Science), Social Sciences citation index (Web of Science), and Conference Proceedings Citation Index - Social Science & Humanities (Web of Science). We also searched the WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Pan African Clinical Trials Registry for ongoing trials.\nSelection criteria\nWe included individual- and cluster-randomized trials, and before-after studies, in participants being investigated for tuberculosis. We analysed the randomized and non-randomized studies separately.\nData collection and analysis\nFor each study, two review authors independently extracted data, using a piloted data extraction tool. We assessed the risk of bias using Cochrane and Effective Practice and Organisation of Care (EPOC) tools. We used random effects meta-analysis to allow for heterogeneity between studies in setting and design. The certainty of the evidence in the randomized trials was assessed by GRADE.\nMain results\nWe included 12 studies: eight were randomized controlled trials (RCTs), and four were before-and-after studies. Most included RCTs had a low risk of bias in most domains of the Cochrane 'Risk of bias' tool.\nThere was inconclusive evidence of an effect of Xpert MTB/RIF on all-cause mortality, both overall (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.75 to 1.05; 5 RCTs, 9932 participants, moderate-certainty evidence), and restricted to studies with six-month follow-up (RR 0.98, 95% CI 0.78 to 1.22; 3 RCTs, 8143 participants; moderate-certainty evidence). There was probably a reduction in mortality in participants known to be infected with HIV (odds ratio (OR) 0.80, 95% CI 0.67 to 0.96; 5 RCTs, 5855 participants; moderate-certainty evidence).\nIt is uncertain whether Xpert MTB/RIF has no or a modest effect on the proportion of participants starting tuberculosis treatment who had a successful treatment outcome (OR) 1.10, 95% CI 0.96 to 1.26; 3RCTs, 4802 participants; moderate-certainty evidence).\nThere was also inconclusive evidence of an effect on the proportion of participants who were treated for tuberculosis (RR 1.10, 95% CI 0.98 to 1.23; 5 RCTs, 8793 participants; moderate-certainty evidence).\nThe proportion of participants treated for tuberculosis who had bacteriological confirmation was probably higher in the Xpert MTB/RIF group (RR 1.44, 95% CI 1.29 to 1.61; 6 RCTs, 2068 participants; moderate-certainty evidence). The proportion of participants with bacteriological confirmation who were lost to follow-up pre-treatment was probably reduced (RR 0.59, 95% CI 0.41 to 0.85; 3 RCTs, 1217 participants; moderate-certainty evidence).\nAuthors' conclusions\nWe were unable to confidently rule in or rule out the effect on all-cause mortality of using Xpert MTB/RIF rather than smear microscopy. Xpert MTB/RIF probably reduces mortality among participants known to be infected with HIV. We are uncertain whether Xpert MTB/RIF has a modest effect or not on the proportion treated or, among those treated, on the proportion with a successful outcome. It probably does not have a substantial effect on these outcomes. Xpert MTB/RIF probably increases both the proportion of treated participants who had bacteriological confirmation, and the proportion with a laboratory-confirmed diagnosis who were treated. These findings may inform decisions about uptake alongside evidence on cost-effectiveness and implementation.\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": "A rapid, accurate diagnosis of tuberculosis ensures people who are ill start taking the right antibiotics as soon as possible. This might reduce the number of people dying, but also, if rifampicin-resistant tuberculosis is detected early, they are more likely to get appropriate treatment. It also helps ensure people who do not have tuberculosis are not treated unnecessarily.\nThe Xpert MTB/RIF test is an automated molecular test, commonly used to identify tuberculosis and rifampicin resistance at the same time, in less than two hours. The World Health Organization (WHO) recommends using the Xpert MTB/RIF test to diagnose tuberculosis instead of smear microscopy – using a microscope to look for bacteria in samples of sputum (a mixture of saliva and mucus, coughed up from the lungs). This review investigates whether using Xpert MTB/RIF instead of microscopy improves health outcomes."
}
] |
query-laysum
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8471
|
[
{
"role": "user",
"content": "Abstract: Background\nRespiratory failure or respiratory distress in infants is the most common reason for non-elective admission to hospitals and neonatal intensive care units. Non-invasive methods of respiratory support have become the preferred mode of treating respiratory problems as they avoid some of the complications associated with intubation and mechanical ventilation. High flow nasal cannula (HFNC) therapy is increasingly being used as a method of non-invasive respiratory support. However, the evidence pertaining to its use in term infants (defined as infants ≥ 37 weeks gestational age to the end of the neonatal period (up to one month postnatal age)) is limited and there is no consensus of opinion regarding the safety and efficacy HFNC in this population.\nObjectives\nTo assess the safety and efficacy of high flow nasal cannula oxygen therapy for respiratory support in term infants when compared with other forms of non-invasive respiratory support.\nSearch methods\nWe searched the following databases in December 2022: Cochrane CENTRAL; PubMed; Embase; CINAHL; LILACS; Web of Science; Scopus. We also searched the reference lists of retrieved studies and performed a supplementary search of Google Scholar.\nSelection criteria\nWe included randomised controlled trials (RCTs) that investigated the use of high flow nasal cannula oxygen therapy in infants ≥ 37 weeks gestational age up to one month postnatal age (the end of the neonatal period).\nData collection and analysis\nTwo review authors independently assessed trial eligibility, performed data extraction, and assessed risk of bias in the included studies. Where studies were sufficiently similar, we performed a meta-analysis using mean differences (MD) for continuous data and risk ratios (RR) for dichotomous data, with their respective 95% confidence intervals (CIs). For statistically significant RRs, we calculated the number needed to treat for an additional beneficial outcome (NNTB). We used the GRADE approach to evaluate the certainty of the evidence for clinically important outcomes.\nMain results\nWe included eight studies (654 participants) in this review. Six of these studies (625 participants) contributed data to our primary analyses.\nFour studies contributed to our comparison of high flow nasal cannula (HFNC) oxygen therapy versus continuous positive airway pressure (CPAP) for respiratory support in term infants. The outcome of death was reported in two studies (439 infants) but there were no events in either group. HFNC may have little to no effect on treatment failure, but the evidence is very uncertain (RR 0.98, 95% CI 0.47 to 2.04; 3 trials, 452 infants; very low-certainty evidence). The outcome of chronic lung disease (need for supplemental oxygen at 28 days of life) was reported in one study (375 participants) but there were no events in either group. HFNC may have little to no effect on the duration of respiratory support (any form of non-invasive respiratory support with or without supplemental oxygen), but the evidence is very uncertain (MD 0.17 days, 95% CI -0.28 to 0.61; 4 trials, 530 infants; very low-certainty evidence). HFNC likely results in little to no difference in the length of stay at the intensive care unit (ICU) (MD 0.90 days, 95% CI -0.31 to 2.12; 3 trials, 452 infants; moderate-certainty evidence). HFNC may reduce the incidence of nasal trauma (RR 0.16, 95% CI 0.04 to 0.66; 1 trial, 78 infants; very low-certainty evidence) and abdominal overdistension (RR 0.22, 95% CI 0.07 to 0.71; 1 trial, 78 infants; very low-certainty evidence), but the evidence is very uncertain.\nTwo studies contributed to our analysis of HFNC versus low flow nasal cannula oxygen therapy (LFNC) (supplemental oxygen up to a maximum flow rate of 2 L/min). The outcome of death was reported in both studies (95 infants) but there were no events in either group. The evidence suggests that HFNC may reduce treatment failure slightly (RR 0.44, 95% CI 0.21 to 0.92; 2 trials, 95 infants; low-certainty evidence). Neither study reported results for the outcome of chronic lung disease (need for supplemental oxygen at 28 days of life). HFNC may have little to no effect on the duration of respiratory support (MD -0.07 days, 95% CI -0.83 to 0.69; 1 trial, 74 infants; very low-certainty evidence), length of stay at the ICU (MD 0.49 days, 95% CI -0.83 to 1.81; 1 trial, 74 infants; very low-certainty evidence), or hospital length of stay (MD -0.60 days, 95% CI -2.07 to 0.86; 2 trials, 95 infants; very low-certainty evidence), but the evidence is very uncertain. Adverse events was an outcome reported in both studies (95 infants) but there were no events in either group.\nThe risk of bias across outcomes was generally low, although there were some concerns of bias. The certainty of evidence across outcomes ranged from moderate to very low, downgraded due to risk of bias, imprecision, indirectness, and inconsistency.\nAuthors' conclusions\nWhen compared with CPAP, HFNC may result in little to no difference in treatment failure. HFNC may have little to no effect on the duration of respiratory support, but the evidence is very uncertain. HFNC likely results in little to no difference in the length of stay at the intensive care unit. HFNC may reduce the incidence of nasal trauma and abdominal overdistension, but the evidence is very uncertain.\nWhen compared with LFNC, HFNC may reduce treatment failure slightly. HFNC may have little to no effect on the duration of respiratory support, length of stay at the ICU, or hospital length of stay, but the evidence is very uncertain.\nThere is insufficient evidence to enable the formulation of evidence-based guidelines on the use of HFNC for respiratory support in term infants. Larger, methodologically robust trials are required to further evaluate the possible health benefits or harms of HFNC in this patient population.\n\nGiven the provided abstract, please respond to the following query: \"What is high flow nasal cannula (HFNC) oxygen therapy?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "HFNC oxygen therapy is one form of non-invasive respiratory support. It delivers heated, humidified oxygen gas at flow rates greater than 2 litres per minute via tubes positioned just inside the nostrils and is proposed to provide advantages over alternative oxygen therapies. However, in term infants (babies born after 37 weeks of pregnancy are completed) during their first month of life (the neonatal period) the evidence regarding the safety and effectiveness of HFNC is limited, and there is no consensus of opinion regarding its use in this population."
}
] |
query-laysum
|
8472
|
[
{
"role": "user",
"content": "Abstract: Background\nPeople with end-stage renal disease (ESRD) often require either the formation of an arteriovenous fistula (AVF) or an interposition prosthetic arteriovenous graft (AVG) for haemodialysis. These access sites should ideally have a long life and a low rate of complications (e.g. thrombosis, infection, stenosis, aneurysm formation and distal limb ischaemia). Although some of the complications may be unavoidable, any adjuvant technique or medical treatment aimed at decreasing complications would be welcome. This is the fourth update of the review first published in 2003.\nObjectives\nTo assess the effects of adjuvant drug treatment in people with ESRD on haemodialysis via autologous AVFs or prosthetic interposition AVGs.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and ClinicalTrials.gov trials register to 6 August 2020.\nSelection criteria\nRandomised controlled trials of active drug versus placebo in people with ESRD undergoing haemodialysis via an AVF or prosthetic interposition AVG.\nData collection and analysis\nFor this update, two review authors (IM, MFAK) independently selected trials for inclusion, extracted data, assessed risk of bias and assessed the certainty of the evidence according to GRADE. We resolved disagreements by discussion or consultation with another review author (ADS). The primary outcome was the long-term fistula or graft patency rate. Secondary outcomes included duration of hospital stay; complications such as infection, aneurysm formation, stenosis and distal limb ischaemia; and number of related surgical or radiological interventions.\nMain results\nFor this update, one additional study was suitable for inclusion, making a total of 13 trials with 2080 participants. Overall the certainty of the evidence was low or moderate due to short follow-up periods, heterogeneity between trials, small sample sizes, and risk of bias due to incomplete reporting. Medical adjuvant treatments used in the included trials were aspirin, ticlopidine, dipyridamole, dipyridamole plus aspirin, warfarin, fish oil, clopidogrel, sulphinpyrazone and glyceryl trinitrate (GTN) patch.\nAll included studies reported on graft patency by measuring graft thrombosis. There was insufficient evidence to determine if there was a difference in graft patency in studies comparing aspirin versus placebo (odds ratio (OR) 0.40, 95% confidence interval (CI) 0.07 to 2.25; 3 studies, 175 participants; low-certainty evidence). The meta-analysis for graft patency comparing ticlopidine versus placebo favoured ticlopidine (OR 0.45, 95% CI 0.25 to 0.82; 3 studies, 339 participants; moderate-certainty evidence).\nThere was insufficient evidence to determine if there was a difference in graft patency in studies comparing fish oil versus placebo (OR 0.24, 95% CI 0.03 to 1.95; 2 studies, 220 participants; low-certainty evidence); and studies comparing clopidogrel and placebo (OR 0.40, 95% CI 0.13 to 1.19; 2 studies, 959 participants; moderate-certainty evidence). Similarly, there was insufficient evidence to determine if there was a difference in graft patency comparing the effect of dipyridamole versus placebo (OR 0.46, 95% CI 0.11 to 1.94; 1 study, 42 participants, moderate-certainty evidence) and dipyridamole plus aspirin versus placebo (OR 0.64, CI 0.16 to 2.56; 1 study, 41 participants; moderate-certainty evidence); comparing low-intensity warfarin with placebo (OR 1.76, 95% CI 0.78 to 3.99; 1 study, 107 participants; low-certainty evidence); comparing sulphinpyrazone versus placebo (OR 0.43, 95% CI 0.03 to 5.98; 1 study, 16 participants; low-certainty evidence) and comparing GTN patch and placebo (OR 1.26, 95% CI 0.63 to 2.54; 1 study, 167 participants; moderate-certainty evidence). The single trial evaluating warfarin was terminated early because of major bleeding events in the warfarin group.\nOnly two studies published data on the secondary outcome of related interventions (surgical or radiological); there was insufficient evidence to determine if there was a difference in related interventions between placebo and treatment groups. None of the included studies reported on the duration of hospital stay. Most studies reported complications ranging from mortality to nausea. However, data on complications were limited and reporting varied between studies.\nAuthors' conclusions\nThe meta-analyses of three studies for ticlopidine (an antiplatelet treatment), which all used the same dose of treatment but with a short follow-up of only one month, suggest ticlopidine may have a beneficial effect as an adjuvant treatment to increase the patency of AVFs and AVGs in the short term. There was insufficient evidence to determine if there was a difference in graft patency between placebo and other treatments such as aspirin, fish oil, clopidogrel, dipyridamole, dipyridamole plus aspirin, warfarin, sulphinpyrazone and GTN patch. The certainty of the evidence was low to moderate due to short follow-up periods, the small number of studies for each comparison, small sample sizes, heterogeneity between trials and risk of bias due to incomplete reporting. Therefore, it appears reasonable to suggest further prospective studies be undertaken to assess the use of these antiplatelet drugs in renal patients with an AVF or AVG.\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": "Overall the certainty of the evidence was low to moderate, meaning that results may change with more research. This is because there were mostly one or two small studies comparing each medication to a placebo. In some studies, using the same medication, they had a different dosage (strength) or were of different study lengths, making them difficult to compare. We also had concerns with the lack of detail reported by studies."
}
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query-laysum
|
8473
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[
{
"role": "user",
"content": "Abstract: Background\nA giant retinal tear (GRT) is a full-thickness neurosensory retinal break extending for 90° or more in the presence of a posterior vitreous detachment.\nObjectives\nTo evaluate the effectiveness and safety of pars plana vitrectomy combined with scleral buckle versus pars plana vitrectomy alone for eyes with giant retinal tear.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 8), which contains the Cochrane Eyes and Vision Trials Register; Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Literature on Health Sciences (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in our electronic search. We last searched the electronic databases on 16 August 2018.\nSelection criteria\nWe included only randomized controlled trials (RCTs) comparing pars plana vitrectomy combined with scleral buckle versus pars plana vitrectomy alone for giant retinal tear regardless of age, gender, lens status (e.g. phakic or pseudophakic eyes) of the affected eye(s), or etiology of GRT among participants enrolled in these trials.\nData collection and analysis\nTwo review authors independently assessed titles and abstracts, then full-text articles, using Covidence. Any differences in classification between the two review authors were resolved through discussion. Two review authors independently abstracted data and assessed risk of bias of included trials.\nMain results\nWe found two RCTs in abstract format (105 participants randomized). Neither RCT was published in full. Based on the data presented in the abstracts, scleral buckling might be beneficial (relative risk of re-attachement ranged from 3.0 to 4.4), but the findings are inconclusive due to a lack of peer reviewed publication and insufficient information for assessing risk of bias.\nAuthors' conclusions\nWe found no conclusive evidence from RCTs on which to base clinical recommendations for scleral buckle combined with pars plana vitrectomy for giant retinal tear. RCTs are clearly needed to address this evidence gap. Such trials should be randomized, and patients should be classified by giant retinal tear characteristics (extension (90º, 90º to 180º, > 180º), location (oral, anterior, posterior to equator)), proliferative vitreoretinopathy stage, and endotamponade. Analysis should include both short-term (three months and six months) and long-term (one year to two years) outcomes for primary retinal reattachment, mean change in best corrected visual acuity, study eyes that required second surgery for retinal reattachment, and adverse events such as elevation of intraocular pressure above 21 mmHg, choroidal detachment, cystoid macular edema, macular pucker, proliferative vitreoretinopathy, and progression of cataract in initially phakic eyes.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To find out the effectiveness and safety of vitrectomy combined with scleral buckle versus vitrectomy alone for eyes with giant retinal tear."
}
] |
query-laysum
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8474
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[
{
"role": "user",
"content": "Abstract: Background\nChronic pain is common and can be challenging to manage. Despite increased utilisation of opioids, the safety and efficacy of long-term use of these compounds for chronic non-cancer pain (CNCP) remains controversial. This overview of Cochrane Reviews complements the overview entitled 'High-dose opioids for chronic non-cancer pain: an overview of Cochrane Reviews'.\nObjectives\nTo provide an overview of the occurrence and nature of adverse events associated with any opioid agent (any dose, frequency, or route of administration) used on a medium- or long-term basis for the treatment of CNCP in adults.\nMethods\nWe searched the Cochrane Database of Systematic Reviews (the Cochrane Library) Issue 3, 2017 on 8 March 2017 to identify all Cochrane Reviews of studies of medium- or long-term opioid use (2 weeks or more) for CNCP in adults aged 18 and over. We assessed the quality of the reviews using the AMSTAR criteria (Assessing the Methodological Quality of Systematic Reviews) as adapted for Cochrane Overviews. We assessed the quality of the evidence for the outcomes using the GRADE framework.\nMain results\nWe included a total of 16 reviews in our overview, of which 14 presented unique quantitative data. These 14 Cochrane Reviews investigated 14 different opioid agents that were administered for time periods of two weeks or longer. The longest study was 13 months in duration, with most in the 6- to 16-week range. The quality of the included reviews was high using AMSTAR criteria, with 11 reviews meeting all 10 criteria, and 5 of the reviews meeting 9 out of 10, not scoring a point for either duplicate study selection and data extraction, or searching for articles irrespective of language and publication type. The quality of the evidence for the generic adverse event outcomes according to GRADE ranged from very low to moderate, with risk of bias and imprecision being identified for the following generic adverse event outcomes: any adverse event, any serious adverse event, and withdrawals due to adverse events. A GRADE assessment of the quality of the evidence for specific adverse events led to a downgrading to very low- to moderate-quality evidence due to risk of bias, indirectness, and imprecision.\nWe calculated the equivalent milligrams of morphine per 24 hours for each opioid studied (buprenorphine, codeine, dextropropoxyphene, dihydrocodeine, fentanyl, hydromorphone, levorphanol, methadone, morphine, oxycodone, oxymorphone, tapentadol, tilidine, and tramadol). In the 14 Cochrane Reviews providing unique quantitative data, there were 61 studies with a total of 18,679 randomised participants; 12 of these studies had a cross-over design with two to four arms and a total of 796 participants. Based on the 14 selected Cochrane Reviews, there was a significantly increased risk of experiencing any adverse event with opioids compared to placebo (risk ratio (RR) 1.42, 95% confidence interval (CI) 1.22 to 1.66) as well as with opioids compared to a non-opioid active pharmacological comparator, with a similar risk ratio (RR 1.21, 95% CI 1.10 to 1.33). There was also a significantly increased risk of experiencing a serious adverse event with opioids compared to placebo (RR 2.75, 95% CI 2.06 to 3.67). Furthermore, we found significantly increased risk ratios with opioids compared to placebo for a number of specific adverse events: constipation, dizziness, drowsiness, fatigue, hot flushes, increased sweating, nausea, pruritus, and vomiting.\nThere was no data on any of the following prespecified adverse events of interest in any of the included reviews in this overview of Cochrane Reviews: addiction, cognitive dysfunction, depressive symptoms or mood disturbances, hypogonadism or other endocrine dysfunction, respiratory depression, sexual dysfunction, and sleep apnoea or sleep-disordered breathing. We found no data for adverse events analysed by sex or ethnicity.\nAuthors' conclusions\nA number of adverse events, including serious adverse events, are associated with the medium- and long-term use of opioids for CNCP. The absolute event rate for any adverse event with opioids in trials using a placebo as comparison was 78%, with an absolute event rate of 7.5% for any serious adverse event. Based on the adverse events identified, clinically relevant benefit would need to be clearly demonstrated before long-term use could be considered in people with CNCP in clinical practice. A number of adverse events that we would have expected to occur with opioid use were not reported in the included Cochrane Reviews. Going forward, we recommend more rigorous identification and reporting of all adverse events in randomised controlled trials and systematic reviews on opioid therapy. The absence of data for many adverse events represents a serious limitation of the evidence on opioids. We also recommend extending study follow-up, as a latency of onset may exist for some adverse events.\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": "There is good-quality evidence showing that side effects can occur in people with chronic non-cancer pain who use opioid medicines for longer than two weeks."
}
] |
query-laysum
|
8475
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[
{
"role": "user",
"content": "Abstract: Background\nNutritional support is an essential component of critical care. Malnutrition has been associated with poor outcomes among patients in intensive care units (ICUs). Evidence suggests that in patients with a functional gut, nutrition should be administered through the enteral route. One of the main concerns regarding use of the enteral route is the reduction in gastric motility that is often responsible for limited caloric intake. This increases the risk of aspiration pneumonia as well. Post-pyloric feeding, in which the feed is delivered directly into the duodenum or the jejunum, could solve these issues and provide additional benefits over routine gastric administration of the feed.\nObjectives\nTo evaluate the effectiveness and safety of post-pyloric feeding versus gastric feeding for critically ill adults who require enteral tube feeding.\nSearch methods\nWe searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL;2013 Issue 10), MEDLINE (Ovid) (1950 to October 2013), EMBASE (Ovid) (1980 to October 2013) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) via EBSCO host (1982 to October 2013). We reran the search on 4 February 2015 and will deal with the one study of interest when we update the review.\nSelection criteria\nRandomized or quasi-randomized controlled trials comparing post-pyloric versus gastric tube feeding in critically ill adults.\nData collection and analysis\nWe extracted data using the standard methods of the Cochrane Anaesthesia, Critical and Emergency Care Group and separately evaluated trial quality and data extraction as performed by each review author. We contacted trials authors to request missing data.\nMain results\nWe pooled data from 14 trials of 1109 participants in a meta-analysis. Moderate quality evidence suggests that post-pyloric feeding is associated with low rates of pneumonia compared with gastric tube feeding (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.51 to 0.84). Low-quality evidence shows an increase in the percentage of total nutrient delivered to the patient by post-pyloric feeding (mean difference (MD) 7.8%, 95% CI 1.43 to 14.18).\nEvidence of moderate quality revealed no differences in duration of mechanical ventilation or in mortality. Intensive care unit (ICU) length of stay was similar between the two groups. The effect on the time required to achieve the full nutrition target was uncertain (MD -1.99 hours 95% CI -10.97 to 6.99) (very low-quality evidence). We found no evidence suggesting an increase in the rate of complications during insertion or maintenance of the tube in the post-pyloric group (RR 0.51, 95% CI 0.19 to 1.364; RR1.63, 95% CI 0.93 to 2.86, respectively); evidence was assessed as being of low quality for both.\nRisk of bias was generally low in most studies, and review authors expressed concern regarding lack of blinding of the caregiver in most trials.\nAuthors' conclusions\nWe found moderate-quality evidence of a 30% lower rate of pneumonia associated with post-pyloric feeding and low-quality evidence suggesting an increase in the amount of nutrition delivered to these participants. We do not have sufficient evidence to show that other clinically important outcomes such as duration of mechanical ventilation, mortality and length of stay were affected by the site of tube feeding.\nLow-quality evidence suggests that insertion of a post-pyloric feeding tube appears to be safe and was not associated with increased complications when compared with gastric tube insertion. Placement of the post-pyloric tube can present challenges; the procedure is technically difficult, requiring expertise and sophisticated radiological or endoscopic assistance.\nWe recommend that use of a post-pyloric feeding tube may be preferred for ICU patients for whom placement of the post-pyloric feeding tube is feasible. Findings of this review preclude recommendations regarding the best method for placing the post-pyloric feeding tube. The clinician is left with this decision, which should be based on the policies of institutional facilities and should be made on a case-by-case basis. Protocols and training for bedside placement by physicians or nurses should be evaluated.\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 found evidence of moderate quality for the outcomes of rate of pneumonia, duration of dependency on a breathing machine and rate of death, mainly because identified studies were poorly conducted. With regard to the total quantity of nutrients that can be delivered to patients and complications related to insertion and maintenance of the tube, the quality of evidence was assessed as low. Evidence for the time required to reach the target amount of feeding was very low in that results were not similar across studies and study design issues hindered assessment.\nWe recommend that a post-pyloric feeding tube should be used routinely for all ICU patients, when this approach is feasible."
}
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query-laysum
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8476
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[
{
"role": "user",
"content": "Abstract: Background\nMechanical chest compression devices have been proposed to improve the effectiveness of cardiopulmonary resuscitation (CPR).\nObjectives\nTo assess the effectiveness of resuscitation strategies using mechanical chest compressions versus resuscitation strategies using standard manual chest compressions with respect to neurologically intact survival in patients who suffer cardiac arrest.\nSearch methods\nOn 19 August 2017 we searched the Cochrane Central Register of Controlled Studies (CENTRAL), MEDLINE, Embase, Science Citation Index-Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index–Science databases. Biotechnology and Bioengineering Abstracts and Science Citation abstracts had been searched up to November 2009 for prior versions of this review. We also searched two clinical trials registries for any ongoing trials not captured by our search of databases containing published works: Clinicaltrials.gov (August 2017) and the World Health Organization International Clinical Trials Registry Platform portal (January 2018). We applied no language restrictions. We contacted experts in the field of mechanical chest compression devices and manufacturers.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-RCTs and quasi-randomised studies comparing mechanical chest compressions versus manual chest compressions during CPR for patients with cardiac arrest.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included five new studies in this update. In total, we included 11 trials in the review, including data from 12,944 adult participants, who suffered either out-of-hospital cardiac arrest (OHCA) or in-hospital cardiac arrest (IHCA). We excluded studies explicitly including patients with cardiac arrest caused by trauma, drowning, hypothermia and toxic substances. These conditions are routinely excluded from cardiac arrest intervention studies because they have a different underlying pathophysiology, require a variety of interventions specific to the underlying condition and are known to have a prognosis different from that of cardiac arrest with no obvious cause. The exclusions were meant to reduce heterogeneity in the population while maintaining generalisability to most patients with sudden cardiac death.\nThe overall quality of evidence for the outcomes of included studies was moderate to low due to considerable risk of bias. Three studies (N = 7587) reported on the designated primary outcome of survival to hospital discharge with good neurologic function (defined as a Cerebral Performance Category (CPC) score of one or two), which had moderate quality evidence. One study showed no difference with mechanical chest compressions (risk ratio (RR) 1.07, 95% confidence interval (CI) 0.82 to 1.39), one study demonstrated equivalence (RR 0.79, 95% CI 0.60 to 1.04), and one study demonstrated reduced survival (RR 0.41, CI 0.21 to 0.79). Two other secondary outcomes, survival to hospital admission (N = 7224) and survival to hospital discharge (N = 8067), also had moderate quality level of evidence. No studies reported a difference in survival to hospital admission. For survival to hospital discharge, two studies showed benefit, four studies showed no difference, and one study showed harm associated with mechanical compressions. No studies demonstrated a difference in adverse events or injury patterns between comparison groups but the quality of data was low. Marked clinical and statistical heterogeneity between studies precluded any pooled estimates of effect.\nAuthors' conclusions\nThe evidence does not suggest that CPR protocols involving mechanical chest compression devices are superior to conventional therapy involving manual chest compressions only. We conclude on the balance of evidence that mechanical chest compression devices used by trained individuals are a reasonable alternative to manual chest compressions in settings where consistent, high-quality manual chest compressions are not possible or dangerous for the provider (eg, limited rescuers available, prolonged CPR, during hypothermic cardiac arrest, in a moving ambulance, in the angiography suite, during preparation for extracorporeal CPR [ECPR], etc.). Systems choosing to incorporate mechanical chest compression devices should be closely monitored because some data identified in this review suggested harm. Special attention should be paid to minimising time without compressions and delays to defibrillation during device deployment.\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": "'Sudden cardiac arrest' occurs when someone's heart stops beating unexpectedly. Cardiopulmonary resuscitation, referred to as CPR, involves rhythmical pushing on the chest of a cardiac arrest victim to provide forward blood flow. This can keep blood flowing to the victim's vital organs while the heart is not pumping. CPR has been shown to improve the chance that the heart will restart and the victim will survive. Machines have been developed to take over this chest pumping action using automated pistons, pneumatic vests, or band-like mechanisms. The theory is that these machines should be able to provide a more effective pumping action than is seen in humans because the machines do not pause or get tired. Furthermore, they provide consistent pressure and timing of each chest compression in line with latest evidenced-based practice. Some preliminary studies using these machines have shown that they are easy to use and can save people with cardiac arrest. This is an update of the Cochrane Review on mechanical chest compression devices originally published in 2011 and updated last in 2014."
}
] |
query-laysum
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8477
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[
{
"role": "user",
"content": "Abstract: Background\nWork-related upper limb disorder (WRULD), repetitive strain injury (RSI), occupational overuse syndrome (OOS) and work-related complaints of the arm, neck or shoulder (CANS) are the most frequently used umbrella terms for disorders that develop as a result of repetitive movements, awkward postures and impact of external forces such as those associated with operating vibrating tools. Work-related CANS, which is the term we use in this review, severely hampers the working population.\nObjectives\nTo assess the effects of conservative interventions for work-related complaints of the arm, neck or shoulder (CANS) in adults on pain, function and work-related outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, 31 May 2013), MEDLINE (1950 to 31 May 2013), EMBASE (1988 to 31 May 2013), CINAHL (1982 to 31 May 2013), AMED (1985 to 31 May 2013), PsycINFO (1806 to 31 May 2013), the Physiotherapy Evidence Database (PEDro; inception to 31 May 2013) and the Occupational Therapy Systematic Evaluation of Evidence Database (OTseeker; inception to 31 May 2013). We did not apply any language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-randomised controlled trials evaluating conservative interventions for work-related complaints of the arm, neck or shoulder in adults. We excluded trials undertaken to test injections and surgery. We included studies that evaluated effects on pain, functional status or work ability.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data and assessed risk of bias of the included studies. When studies were sufficiently similar, we performed statistical pooling of reported results.\nMain results\nWe included 44 studies (62 publications) with 6,580 participants that evaluated 25 different interventions. We categorised these interventions according to their working mechanisms into exercises, ergonomics, behavioural and other interventions.\nOverall, we judged 35 studies as having a high risk of bias mainly because of an unknown randomisation procedure, lack of a concealed allocation procedure, unblinded trial participants or lack of an intention-to-treat analysis.\nWe found very low-quality evidence showing that exercises did not improve pain in comparison with no treatment (five studies, standardised mean difference (SMD) -0.52, 95% confidence interval (CI) -1.08 to 0.03), or minor intervention controls (three studies, SMD -0.25, 95% CI -0.87 to 0.37) or when provided as additional treatment (two studies, inconsistent results) at short-term follow-up or at long-term follow-up. Results were similar for recovery, disability and sick leave. Specific exercises led to increased pain at short-term follow-up when compared with general exercises (four studies, SMD 0.45, 95% CI 0.14 to 0.75)\nWe found very low-quality evidence indicating that ergonomic interventions did not lead to a decrease in pain when compared with no intervention at short-term follow-up (three studies, SMD -0.07, 95% CI -0.36 to 0.22) but did decrease pain at long-term follow-up (four studies, SMD -0.76, 95% CI -1.35 to -0.16). There was no effect on disability but sick leave decreased in two studies (risk ratio (RR) 0.48, 95% CI 0.32 to 0.76). None of the ergonomic interventions was more beneficial for any outcome measures when compared with another treatment or with no treatment or with placebo.\nBehavioural interventions had inconsistent effects on pain and disability, with some subgroups showing benefit and others showing no significant improvement when compared with no treatment, minor intervention controls or other behavioural interventions.\nIn the eight studies that evaluated various other interventions, there was no evidence of a clear beneficial effect of any of the interventions provided.\nAuthors' conclusions\nWe found very low-quality evidence indicating that pain, recovery, disability and sick leave are similar after exercises when compared with no treatment, with minor intervention controls or with exercises provided as additional treatment to people with work-related complaints of the arm, neck or shoulder. Low-quality evidence also showed that ergonomic interventions did not decrease pain at short-term follow-up but did decrease pain at long-term follow-up. There was no evidence of an effect on other outcomes. For behavioural and other interventions, there was no evidence of a consistent effect on any of the outcomes.\nStudies are needed that include more participants, that are clear about the diagnosis of work-relatedness and that report findings according to current guidelines.\n\nGiven the provided abstract, please respond to the following query: \"Studies included in the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included randomised controlled studies of all possible treatments such as exercises, ergonomic adjustments at the workplace, massage and manual therapy. These treatments aim to reduce pain and improve functioning, and they can be provided by general practitioners or physiotherapists. We excluded injections and surgical procedures that invade the body and require more special skills. We included studies only if the authors wrote that the people they studied had complaints that were work-related. We searched electronic databases up until May 2013."
}
] |
query-laysum
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8478
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[
{
"role": "user",
"content": "Abstract: Background\nKeratoconus is the most common corneal dystrophy. It can cause loss of uncorrected and best-corrected visual acuity through ectasia (thinning) of the central or paracentral cornea, irregular corneal scarring, or corneal perforation. Disease onset usually occurs in the second to fourth decade of life, periods of peak educational attainment or career development. The condition is lifelong and sight-threatening.\nCorneal collagen crosslinking (CXL) using ultraviolet A (UVA) light applied to the cornea is the only treatment that has been shown to slow progression of disease. The original, more widely known technique involves application of UVA light to de-epithelialized cornea, to which a photosensitizer (riboflavin) is added topically throughout the irradiation process.\nTransepithelial CXL is a recently advocated alternative to the standard CXL procedure, in that the epithelium is kept intact during CXL. Retention of the epithelium offers the putative advantages of faster healing, less patient discomfort, faster visual rehabilitation, and less risk of corneal haze.\nObjectives\nTo assess the short- and long-term effectiveness and safety of transepithelial CXL compared with epithelium-off CXL for progressive keratoconus.\nSearch methods\nTo identify potentially eligible studies, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2020, Issue 1); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature database (LILACS); ClinicalTrials.gov; and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not impose any date or language restrictions. We last searched the electronic databases on 15 January 2020.\nSelection criteria\nWe included randomized controlled trials (RCTs) in which transepithelial CXL had been compared with epithelium-off CXL in participants with progressive keratoconus.\nData collection and analysis\nWe used standard Cochrane methodology.\nMain results\nWe included 13 studies with 661 eyes of 567 participants enrolled; 13 to 119 participants were enrolled per study. Seven studies were conducted in Europe, three in the Middle East, and one each in India, Russia, and Turkey. Seven studies were parallel-group RCTs, one study was an RCT with a paired-eyes design, and five studies were RCTs in which both eyes of some or all participants were assigned to the same intervention.\nEleven studies compared transepithelial CXL with epithelium-off CXL in participants with progressive keratoconus. There was no evidence of an important difference between intervention groups in maximum keratometry (denoted 'maximum K' or 'Kmax'; also known as steepest keratometry measurement) at 12 months or later (mean difference (MD) 0.99 diopters (D), 95% CI −0.11 to 2.09; 5 studies; 177 eyes; I2 = 41%; very low certainty evidence). Few studies described other outcomes of interest. The evidence is very uncertain that epithelium-off CXL may have a small (data from two studies were not pooled due to considerable heterogeneity (I2 = 92%)) or no effect on stabilization of progressive keratoconus compared with transepithelial CXL; comparison of the estimated proportions of eyes with decreases or increases of 2 or more diopters in maximum K at 12 months from one study with 61 eyes was RR 0.32 (95% CI 0.09 to 1.12) and RR (non-event) 0.86 (95% CI 0.74 to 1.00), respectively (very low certainty). We did not estimate an overall effect on corrected-distance visual acuity (CDVA) because substantial heterogeneity was detected (I2 = 70%). No study evaluated CDVA gain or loss of 10 or more letters on a logarithm of the minimum angle of resolution (logMAR) chart. Transepithelial CXL may result in little to no difference in CDVA at 12 months or beyond. Four studies reported that either no adverse events or no serious adverse events had been observed. Another study noted no change in endothelial cell count after either procedure. Moderate certainty evidence from 4 studies (221 eyes) found that epithelium-off CXL resulted in a slight increase in corneal haze or scarring when compared to transepithelial CXL (RR (non-event) 1.07, 95% CI 1.01 to 1.14).\nThree studies, one of which had three arms, compared outcomes among participants assigned to transepithelial CXL using iontophoresis versus those assigned to epithelium-off CXL. No conclusive evidence was found for either keratometry or visual acuity outcomes at 12 months or later after surgery. Low certainty evidence suggests that transepithelial CXL using iontophoresis results in no difference in logMAR CDVA (MD 0.00 letter, 95% CI −0.04 to 0.04; 2 studies; 51 eyes). Only one study examined gain or loss of 10 or more logMAR letters. In terms of adverse events, one case of subepithelial infiltrate was reported after transepithelial CXL with iontophoresis, whereas two cases of faint corneal scars and four cases of permanent haze were observed after epithelium-off CXL. Vogt's striae were found in one eye after each intervention. The certainty of the evidence was low or very low for the outcomes in this comparison due to imprecision of estimates for all outcomes and risk of bias in the studies from which data have been reported.\nAuthors' conclusions\nBecause of lack of precision, frequent indeterminate risk of bias due to inadequate reporting, and inconsistency in outcomes measured and reported among studies in this systematic review, it remains unknown whether transepithelial CXL, or any other approach, may confer an advantage over epithelium-off CXL for patients with progressive keratoconus with respect to further progression of keratoconus, visual acuity outcomes, and patient-reported outcomes (PROs). Arrest of the progression of keratoconus should be the primary outcome of interest in future trials of CXL, particularly when comparing the effectiveness of different approaches to CXL. Furthermore, methods of assessing and defining progressive keratoconus should be standardized. Trials with longer follow-up are required in order to assure that outcomes are measured after corneal wound-healing and stabilization of keratoconus. In addition, perioperative, intraoperative, and postoperative care should be standardized to permit meaningful comparisons of CXL methods. Methods to increase penetration of riboflavin through intact epithelium as well as delivery of increased dose of UVA may be needed to improve outcomes. PROs should be measured and reported. The visual significance of adverse outcomes, such as corneal haze, should be assessed and correlated with other outcomes, including PROs.\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": "Keratoconus is a disease that affects the thin, clear outer layer of the eye, known as the cornea. Normally, the cornea is dome-shaped. In people with keratoconus, the cornea slowly thins, and a cone-shaped bulge develops in the center of the cornea. The disease usually begins between the ages of teens and 40, and persists throughout life. It causes blurry or distorted vision that may not be improved by wearing glasses and may result in perforation of the cornea and other visual problems.\nTreatments such as glasses and contact lenses can be used to improve the vision of people with keratoconus. However, these do not slow the progression of the disease. The only treatment known to slow disease progression is ‘corneal collagen crosslinking’ (CXL).\nCXL is a surgical procedure that aims to strengthen the cornea and prevent further thinning. It involves shining ultraviolet A (invisible) light rays onto eyes that have been treated with eye drops containing riboflavin (a vitamin). When the light rays meet the riboflavin, new links form between the fibers that make up the cornea.\nThere are two types of CXL. One type requires the removal of the cells on surface of the cornea, to make it easier for the riboflavin to reach the cornea. This procedure is called ‘epithelium-off CXL’. The other type does not require the removal of these cells. This procedure is called ‘transepithelial CXL’. Surgeons who carry out this procedure can use chemicals to help riboflavin penetrate the cells on the surface of the cornea. They can also deliver riboflavin to the cornea using a small electrical current (iontophoresis).\nEpithelium-off CXL is the more commonly used procedure. However, transepithelial CXL could have advantages, such as faster healing and less patient discomfort. We reviewed the evidence to find out which of these two procedures is more beneficial and less risky for people with keratoconus."
}
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query-laysum
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8479
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[
{
"role": "user",
"content": "Abstract: Background\nPelvic radiotherapy is a treatment delivered to an estimated 150,000 to 300,000 people annually across high-income countries. Fractures due to normal stresses on weakened bone due to radiotherapy are termed insufficiency fractures. Pelvic radiotherapy-related interruption of the blood supply to the hip is termed avascular necrosis and is another recognised complication. The reported incidences of insufficiency fractures are 2.7% to 89% and risk of developing avascular necrosis is 0.5%. These complications lead to significant morbidity in terms of pain, immobility and consequently risk of infections, pressure sores and mortality.\nObjectives\nTo assess the effects of pharmacological interventions for preventing insufficiency fractures and avascular necrosis in adults over 18 years of age undergoing pelvic radiotherapy.\nSearch methods\nWe performed electronic literature searches in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and DARE to 19 April 2017. We also searched trial registries. Further relevant studies were identified through handsearching of citation lists of included studies.\nSelection criteria\nRandomised controlled trials (RCTs) or non RCTs with concurrent comparison groups including quasi-RCTs, cluster RCTs, prospective cohort studies and case series of 30 or more participants were screened. We included studies assessing the effect of pharmacological interventions in adults over 18 years of age undergoing radical pelvic radiotherapy as part of anticancer treatment for a primary pelvic malignancy. We excluded studies involving radiotherapy for bone metastases. We assessed use of pharmacological interventions at any stage before or during pelvic radiotherapy. Interventions included calcium or vitamin D (or both) supplementation, bisphosphonates, selective oestrogen receptor modulators, hormone replacement therapy (oestrogen or testosterone), denosumab and calcitonin.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We contacted study authors to obtain missing data. Data were to be pooled using the random-effects model if study comparisons were similar, otherwise results were to be reported narratively.\nMain results\nWe included two RCTs (1167 participants). The first RCT compared zoledronic acid with placebo in 96 men undergoing pelvic radiotherapy for non-metastatic prostate cancer.\nThe second RCT had four treatment arms, two of which evaluated zoledronic acid plus adjuvant androgen suppression compared with androgen suppression only in 1071 men undergoing pelvic radiotherapy for non-metastatic prostate cancer.\nBoth studies were at a moderate to high risk of bias and all evidence was judged to be of very low certainty.\nThe studies provided no evidence on the primary outcomes of the review and provided limited data in relation to secondary outcomes, such that meta-analyses were not possible. Both studies focused on interventions to improve bone health in relation to androgen deprivation rather than radiation-related insufficiency fractures and avascular necrosis. Few fractures were described in each study and those described were not specific to insufficiency fractures secondary to radiotherapy. Both studies reported that zoledronic acid in addition to androgen deprivation and pelvic radiotherapy led to improvements in BMD; however, the changes in BMD were measured and reported differently. There was no available evidence regarding adverse effects.\nAuthors' conclusions\nThe evidence relating to interventions to prevent insufficiency fractures and avascular necrosis associated with pelvic radiotherapy in adults is of very low certainty. This review highlights the need for prospective clinical trials using interventions prior to and during radiotherapy to prevent radiation-related bone morbidity, insufficiency fractures and avascular necrosis. Future trials could involve prospective assessment of bone health including BMD and bone turnover markers prior to pelvic radiotherapy. The interventions for investigation could begin as radiotherapy commences and remain ongoing for 12 to 24 months. Bone turnover markers and BMD could be used as surrogate markers for bone health in addition to radiographic imaging to report on presence of insufficiency fractures and development of avascular necrosis. Clinical assessments and patient reported outcomes would help to identify any associated adverse effects of treatment and quality of life outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Research shows that pelvic radiotherapy can cause changes in pelvic bones, which may lead to fractures occurring from minimal trauma (called insufficiency fractures) and permanent damage to bone from interrupted blood supply (called avascular necrosis). These conditions can result in pain, problems with mobility, hospitalisation, need for surgery and death. This review looked at the literature for medicines which may be given prior to or during pelvic radiotherapy, to determine if these could reduce the incidence of insufficiency fractures and avascular necrosis, and improve bone health and quality of life."
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query-laysum
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8480
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[
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease is one of the most common and severe genetic disorders in the world. It can be broadly divided into two distinct clinical phenotypes characterized by either haemolysis or vaso-occlusion. Pain is the most prominent symptom of vaso-occlusion, and hypercoagulability is a well-established pathogenic phenomenon in people with sickle cell disease. Low-molecular-weight heparins might control this hypercoagulable state through their anticoagulant effect. This is an update of a previously published version of this review.\nObjectives\nTo assess the effects of low-molecular-weight heparins for managing vaso-occlusive crises in people with sickle cell disease.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register comprising references identified from comprehensive electronic database searches. We also searched abstract books of conference proceedings and several online trials registries for ongoing trials.\nDate of the last search of the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register: 28 September 2015.\nSelection criteria\nRandomised controlled clinical trials and controlled clinical trials that assessed the effects of low-molecular-weight heparins in the management of vaso-occlusive crises in people with sickle cell disease.\nData collection and analysis\nStudy selection, data extraction, assessment of risk of bias and analyses were carried out independently by the two review authors.\nMain results\nTwo studies comprising 287 participants were included. One study (with an overall unclear to high risk of bias) involved 253 participants and the quality of the evidence for most outcomes was very low. This study, reported that pain severity at day two and day three was lower in the tinzaparin group than in the placebo group (P < 0.01, analysis of variance (ANOVA)) and additionally at day 4 (P < 0.05 (ANOVA)). Thus tinzaparin resulted in more rapid resolution of pain, as measured with a numerical pain scale. The mean difference in duration of painful crises was statistically significant at -1.78 days in favour of the tinzaparin group (95% confidence interval -1.94 to -1.62). Participants treated with tinzaparin had statistically significantly fewer hospitalisation days than participants in the group treated with placebo, with a mean difference of -4.98 days (95% confidence interval -5.48 to -4.48). Two minor bleeding events were reported as adverse events in the tinzaparin group, and none were reported in the placebo group. The second study (unclear risk of bias) including 34 participants and was a conference abstract with limited data and only addressed one of the predefined outcomes of the review; i.e. pain intensity. After one day pain intensity reduced more, as reported on a visual analogue scale, in the dalteparin group than in the placebo group, mean difference -1.30 (95% confidence interval -1.60 to -1.00), with the quality of evidence rated very low. The most important reasons for downgrading the quality of evidence were serious risk of bias and imprecision (due to low sample size or low occurrence of events).\nAuthors' conclusions\nBased on the results of two studies, evidence is incomplete to support or refute the effectiveness of low-molecular-weight heparins in people with sickle cell disease. Vaso-occlusive crises are extremely debilitating for sufferers of sickle cell disease; therefore well-designed placebo-controlled studies with other types of low-molecular-weight heparins, and in participants with different genotypes of sickle cell disease, still need to be carried out to confirm or dismiss the results of this single study.\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 review included two studies that lasted seven days with a total of 287 people. One study involved 253 people (aged approximately 22 years) with sickle cell disease and compared tinzaparin with placebo and people were selected for one treatment or the other randomly. The other study was smaller with 34 participants (aged approximately 27 years) and compared dalteparin versus placebo."
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query-laysum
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8481
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[
{
"role": "user",
"content": "Abstract: Background\nThis is the fourth update of a Cochrane Review first published in 2002 and last updated in 2016.\nIt is common clinical practice to follow patients with colorectal cancer for several years following their curative surgery or adjuvant therapy, or both. Despite this widespread practice, there is considerable controversy about how often patients should be seen, what tests should be performed, and whether these varying strategies have any significant impact on patient outcomes.\nObjectives\nTo assess the effect of follow-up programmes (follow-up versus no follow-up, follow-up strategies of varying intensity, and follow-up in different healthcare settings) on overall survival for patients with colorectal cancer treated with curative intent. Secondary objectives are to assess relapse-free survival, salvage surgery, interval recurrences, quality of life, and the harms and costs of surveillance and investigations.\nSearch methods\nFor this update, on 5 April 2109 we searched CENTRAL, MEDLINE, Embase, CINAHL, and Science Citation Index. We also searched reference lists of articles, and handsearched the Proceedings of the American Society for Radiation Oncology. In addition, we searched the following trials registries: ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We contacted study authors. We applied no language or publication restrictions to the search strategies.\nSelection criteria\nWe included only randomised controlled trials comparing different follow-up strategies for participants with non-metastatic colorectal cancer treated with curative intent.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently determined study eligibility, performed data extraction, and assessed risk of bias and methodological quality. We used GRADE to assess evidence quality.\nMain results\nWe identified 19 studies, which enrolled 13,216 participants (we included four new studies in this second update). Sixteen out of the 19 studies were eligible for quantitative synthesis. Although the studies varied in setting (general practitioner (GP)-led, nurse-led, or surgeon-led) and 'intensity' of follow-up, there was very little inconsistency in the results.\nOverall survival: we found intensive follow-up made little or no difference (hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.80 to 1.04: I² = 18%; high-quality evidence). There were 1453 deaths among 12,528 participants in 15 studies. In absolute terms, the average effect of intensive follow-up on overall survival was 24 fewer deaths per 1000 patients, but the true effect could lie between 60 fewer to 9 more per 1000 patients.\nColorectal cancer-specific survival: we found intensive follow-up probably made little or no difference (HR 0.93, 95% CI 0.81 to 1.07: I² = 0%; moderate-quality evidence). There were 925 colorectal cancer deaths among 11,771 participants enrolled in 11 studies. In absolute terms, the average effect of intensive follow-up on colorectal cancer-specific survival was 15 fewer colorectal cancer-specific survival deaths per 1000 patients, but the true effect could lie between 47 fewer to 12 more per 1000 patients.\nRelapse-free survival: we found intensive follow-up made little or no difference (HR 1.05, 95% CI 0.92 to 1.21; I² = 41%; high-quality evidence). There were 2254 relapses among 8047 participants enrolled in 16 studies. The average effect of intensive follow-up on relapse-free survival was 17 more relapses per 1000 patients, but the true effect could lie between 30 fewer and 66 more per 1000 patients.\nSalvage surgery with curative intent: this was more frequent with intensive follow-up (risk ratio (RR) 1.98, 95% CI 1.53 to 2.56; I² = 31%; high-quality evidence). There were 457 episodes of salvage surgery in 5157 participants enrolled in 13 studies. In absolute terms, the effect of intensive follow-up on salvage surgery was 60 more episodes of salvage surgery per 1000 patients, but the true effect could lie between 33 to 96 more episodes per 1000 patients.\nInterval (symptomatic) recurrences: these were less frequent with intensive follow-up (RR 0.59, 95% CI 0.41 to 0.86; I² = 66%; moderate-quality evidence). There were 376 interval recurrences reported in 3933 participants enrolled in seven studies. Intensive follow-up was associated with fewer interval recurrences (52 fewer per 1000 patients); the true effect is between 18 and 75 fewer per 1000 patients.\nIntensive follow-up probably makes little or no difference to quality of life, anxiety, or depression (reported in 7 studies; moderate-quality evidence). The data were not available in a form that allowed analysis.\nIntensive follow-up may increase the complications (perforation or haemorrhage) from colonoscopies (OR 7.30, 95% CI 0.75 to 70.69; 1 study, 326 participants; very low-quality evidence). Two studies reported seven colonoscopic complications in 2292 colonoscopies, three perforations and four gastrointestinal haemorrhages requiring transfusion. We could not combine the data, as they were not reported by study arm in one study.\nThe limited data on costs suggests that the cost of more intensive follow-up may be increased in comparison with less intense follow-up (low-quality evidence). The data were not available in a form that allowed analysis.\nAuthors' conclusions\nThe results of our review suggest that there is no overall survival benefit for intensifying the follow-up of patients after curative surgery for colorectal cancer. Although more participants were treated with salvage surgery with curative intent in the intensive follow-up groups, this was not associated with improved survival. Harms related to intensive follow-up and salvage therapy were not well reported.\n\nGiven the provided abstract, please respond to the following query: \"This means...\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The information we have now suggests that there is little benefit from intensifying follow-up, but there is also little evidence about quality of life, harms, and costs. We do not know what is the best way to follow patients treated for non-metastatic (no secondaries) colorectal cancer, or if we should at all. We know little about the costs of follow-up in this setting. Consumer needs and concerns with respect to the value of follow-up require further research."
}
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query-laysum
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8482
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[
{
"role": "user",
"content": "Abstract: Background\nFetal growth restriction (FGR) is a condition of poor growth of the fetus in utero. One of the causes of FGR is placental insufficiency. Severe early-onset FGR at < 32 weeks of gestation occurs in an estimated 0.4% of pregnancies. This extreme phenotype is associated with a high risk of fetal death, neonatal mortality, and neonatal morbidity. Currently, there is no causal treatment, and management is focused on indicated preterm birth to prevent fetal death. Interest has risen in interventions that aim to improve placental function by administration of pharmacological agents affecting the nitric oxide pathway causing vasodilatation.\nObjectives\nThe objective of this systematic review and aggregate data meta-analysis is to assess the beneficial and harmful effects of interventions affecting the nitric oxide pathway compared with placebo, no therapy, or different drugs affecting this pathway against each other, in pregnant women with severe early-onset FGR.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (16 July 2022), and reference lists of retrieved studies.\nSelection criteria\nWe considered all randomised controlled comparisons of interventions affecting the nitric oxide pathway compared with placebo, no therapy, or another drug affecting this pathway in pregnant women with severe early-onset FGR of placental origin, for inclusion in this review.\nData collection and analysis\nWe used standard Cochrane Pregnancy and Childbirth methods for data collection and analysis.\nMain results\nWe included a total of eight studies (679 women) in this review, all of which contributed to the data and analysis. The identified studies report on five different comparisons: sildenafil compared with placebo or no therapy, tadalafil compared with placebo or no therapy, L-arginine compared with placebo or no therapy, nitroglycerin compared with placebo or no therapy and sildenafil compared with nitroglycerin.\nThe risk of bias of included studies was judged as low or unclear. In two studies the intervention was not blinded. The certainty of evidence for our primary outcomes was judged as moderate for the intervention sildenafil and low for tadalafil and nitroglycerine (due to low number of participants and low number of events). For the intervention L-arginine, our primary outcomes were not reported.\nSildenafil citrate compared to placebo or no therapy (5 studies, 516 women)\nFive studies (Canada, Australia and New Zealand, the Netherlands, the UK and Brazil) involving 516 pregnant women with FGR were included. We assessed the certainty of the evidence as moderate.\nCompared with placebo or no therapy, sildenafil probably has little or no effect on all-cause mortality (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.80 to 1.27, 5 studies, 516 women); may reduce fetal mortality (RR 0.82, 95% CI 0.60 to 1.12, 5 studies, 516 women), and increase neonatal mortality (RR 1.45, 95% CI 0.90 to 2.33, 5 studies, 397 women), although the results are uncertain for fetal and neonatal mortality as 95% confidence intervals are wide crossing the line of no effect.\nTadalafil compared with placebo or no therapy (1 study, 87 women)\nOne study (Japan) involving 87 pregnant women with FGR was included. We assessed the certainty of the evidence as low.\nCompared with placebo or no therapy, tadalafil may have little or no effect on all-cause mortality (risk ratio 0.20, 95% CI 0.02 to 1.60, one study, 87 women); fetal mortality (RR 0.11, 95% CI 0.01 to 1.96, one study, 87 women); and neonatal mortality (RR 0.89, 95% CI 0.06 to 13.70, one study, 83 women).\nL-Arginine compared with placebo or no therapy (1 study, 43 women)\nOne study (France) involving 43 pregnant women with FGR was included. This study did not assess our primary outcomes.\nNitroglycerin compared to placebo or no therapy (1 studies, 23 women)\nOne study (Brazil) involving 23 pregnant women with FGR was included. We assessed the certainty of the evidence as low. The effect on the primary outcomes is not estimable due to no events in women participating in both groups.\nSildenafil citrate compared to nitroglycerin (1 study, 23 women)\nOne study (Brazil) involving 23 pregnant women with FGR was included. We assessed the certainty of the evidence as low.\nThe effect on the primary outcomes is not estimable due to no events in women participating in both groups.\nAuthors' conclusions\nInterventions affecting the nitric oxide pathway probably do not seem to influence all-cause (fetal and neonatal) mortality in pregnant women carrying a baby with FGR, although more evidence is needed. The certainty of this evidence is moderate for sildenafil and low for tadalafil and nitroglycerin.\nFor sildenafil a fair amount of data are available from randomised clinical trials, but with low numbers of participants. Therefore, the certainty of evidence is moderate. For the other interventions investigated in this review there are insufficient data, meaning we do not know whether these interventions improve perinatal and maternal outcomes in pregnant women with FGR.\n\nGiven the provided abstract, please respond to the following query: \"L-Arginine compared with placebo or no therapy (1 study, 43 women)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One study (France) involving 43 pregnant women with fetal growth restriction. This study did not assess our primary outcomes."
}
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query-laysum
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8483
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[
{
"role": "user",
"content": "Abstract: Background\nDepression and anxiety are the most frequent indication for which antidepressants are prescribed. Long-term antidepressant use is driving much of the internationally observed rise in antidepressant consumption. Surveys of antidepressant users suggest that 30% to 50% of long-term antidepressant prescriptions had no evidence-based indication. Unnecessary use of antidepressants puts people at risk of adverse events. However, high-certainty evidence is lacking regarding the effectiveness and safety of approaches to discontinuing long-term antidepressants.\nObjectives\nTo assess the effectiveness and safety of approaches for discontinuation versus continuation of long-term antidepressant use for depressive and anxiety disorders in adults.\nSearch methods\nWe searched all databases for randomised controlled trials (RCTs) until January 2020.\nSelection criteria\nWe included RCTs comparing approaches to discontinuation with continuation of antidepressants (or usual care) for people with depression or anxiety who are prescribed antidepressants for at least six months. Interventions included discontinuation alone (abrupt or taper), discontinuation with psychological therapy support, and discontinuation with minimal intervention. Primary outcomes were successful discontinuation rate,relapse (as defined by authors of the original study), withdrawal symptoms, and adverse events. Secondary outcomes were depressive symptoms, anxiety symptoms, quality of life, social and occupational functioning, and severity of illness.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane.\nMain results\nWe included 33 studies involving 4995 participants. Nearly all studies were conducted in a specialist mental healthcare service and included participants with recurrent depression (i.e. two or more episodes of depression prior to discontinuation). All included trials were at high risk of bias. The main limitation of the review is bias due to confounding withdrawal symptoms with symptoms of relapse of depression. Withdrawal symptoms (such as low mood, dizziness) may have an effect on almost every outcome including adverse events, quality of life, social functioning, and severity of illness.\nAbrupt discontinuation\nThirteen studies reported abrupt discontinuation of antidepressant.\nVery low-certainty evidence suggests that abrupt discontinuation without psychological support may increase risk of relapse (hazard ratio (HR) 2.09, 95% confidence interval (CI) 1.59 to 2.74; 1373 participants, 10 studies) and there is insufficient evidence of its effect on adverse events (odds ratio (OR) 1.11, 95% CI 0.62 to 1.99; 1012 participants, 7 studies; I² = 37%) compared to continuation of antidepressants, without specific assessment of withdrawal symptoms. Evidence about the effects of abrupt discontinuation on withdrawal symptoms (1 study) is very uncertain.\nNone of these studies included successful discontinuation rate as a primary endpoint.\nDiscontinuation by \"taper\"\nEighteen studies examined discontinuation by \"tapering\" (one week or longer). Most tapering regimens lasted four weeks or less.\nVery low-certainty evidence suggests that \"tapered\" discontinuation may lead to higher risk of relapse (HR 2.97, 95% CI 2.24 to 3.93; 1546 participants, 13 studies) with no or little difference in adverse events (OR 1.06, 95% CI 0.82 to 1.38; 1479 participants, 7 studies; I² = 0%) compared to continuation of antidepressants, without specific assessment of withdrawal symptoms. Evidence about the effects of discontinuation on withdrawal symptoms (1 study) is very uncertain.\nDiscontinuation with psychological support\nFour studies reported discontinuation with psychological support. Very low-certainty evidence suggests that initiation of preventive cognitive therapy (PCT), or MBCT, combined with \"tapering\" may result in successful discontinuation rates of 40% to 75% in the discontinuation group (690 participants, 3 studies). Data from control groups in these studies were requested but are not yet available.\nLow-certainty evidence suggests that discontinuation combined with psychological intervention may result in no or little effect on relapse (HR 0.89, 95% CI 0.66 to 1.19; 690 participants, 3 studies) compared to continuation of antidepressants. Withdrawal symptoms were not measured. Pooling data on adverse events was not possible due to insufficient information (3 studies).\nDiscontinuation with minimal intervention\nLow-certainty evidence from one study suggests that a letter to the general practitioner (GP) to review antidepressant treatment may result in no or little effect on successful discontinuation rate compared to usual care (6% versus 8%; 146 participants, 1 study) or on relapse (relapse rate 26% vs 13%; 146 participants, 1 study). No data on withdrawal symptoms nor adverse events were provided.\nNone of the studies used low-intensity psychological interventions such as online support or a changed pharmaceutical formulation that allows tapering with low doses over several months. Insufficient data were available for the majority of people taking antidepressants in the community (i.e. those with only one or no prior episode of depression), for people aged 65 years and older, and for people taking antidepressants for anxiety.\nAuthors' conclusions\nCurrently, relatively few studies have focused on approaches to discontinuation of long-term antidepressants. We cannot make any firm conclusions about effects and safety of the approaches studied to date. The true effect and safety are likely to be substantially different from the data presented due to assessment of relapse of depression that is confounded by withdrawal symptoms. All other outcomes are confounded with withdrawal symptoms. Most tapering regimens were limited to four weeks or less. In the studies with rapid tapering schemes the risk of withdrawal symptoms may be similar to studies using abrupt discontinuation which may influence the effectiveness of the interventions. Nearly all data come from people with recurrent depression.\nThere is an urgent need for trials that adequately address withdrawal confounding bias, and carefully distinguish relapse from withdrawal symptoms. Future studies should report key outcomes such as successful discontinuation rate and should include populations with one or no prior depression episodes in primary care, older people, and people taking antidepressants for anxiety and use tapering schemes longer than 4 weeks.\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"
},
{
"role": "assistant",
"content": "Overall, the certainty of evidence was low to very low. This means we have limited or little confidence in the results, and new research is likely to change our conclusions. The main reasons for this assessment of evidence certainty were that trials did not distinguish between symptoms of relapse of depression and symptoms of withdrawal. Also, most studies used no tapering or very \"rapid\" tapering schedules (four weeks or less), and nearly all studies included people with recurrent depression (more than two episodes)."
}
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query-laysum
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8484
|
[
{
"role": "user",
"content": "Abstract: Background\nDespite major advances in medical technology, the incidence of preterm birth remains high. The use of antenatal corticosteroid administered transplacentally, by intramuscular injection to women at risk of preterm birth, has reduced the incidence of respiratory distress syndrome and increased the survival rates of preterm infants. However, this intervention also comes with its own risks and side effects. Animal studies and early studies in pregnant women at risk of preterm birth have reported the use of an alternative route of administration, by direct intramuscular injection of corticosteroid into the fetus under ultrasound guidance, in an attempt to minimise the side-effect profile. Direct fetal corticosteroid administration may have benefits over maternal administration in terms of safety and efficacy.\nObjectives\nTo assess if different routes of corticosteroid administration (maternal versus direct fetal) have effects on health outcomes for women and their babies.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (25 October 2017), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (25 October 2017) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials comparing maternal with direct fetal routes of antenatal corticosteroid administration in women at risk of preterm birth.\nData collection and analysis\nThe two review authors independently assessed study eligibility. In future updates of this review, at least two review authors will extract data and assess the risks of bias in included studies. We will also assess the quality of the evidence using the GRADE approach.\nMain results\nWe did not identify any eligible randomised controlled trials to include in this review.\nAuthors' conclusions\nThe available clinical studies carried out so far on animals and human have shown that direct intramuscular injection of corticosteroid into the fetus under ultrasound guidance is feasible, but data on health outcomes are lacking. Uncertainty therefore persists as to which method could provide better efficacy and safety. Randomised controlled trials are required focusing on the benefits and harms of transplacental versus direct fetal corticosteroid treatment. Until the uncertainties have been addressed, it is advisable to stay with the current standard of antenatal transplacental maternally-administered corticosteroid treatment.\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 need further studies to assess the effects of injecting corticosteroid directly to the fetus compared with injecting into the mother's muscles. The babies in these trials need to be followed up over a long period so that we can monitor the effects of corticosteroids on childhood development, including impairments or disabilities such as cerebral palsy. We need good-quality randomised trials, to establish if one method is better than the other."
}
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query-laysum
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8485
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[
{
"role": "user",
"content": "Abstract: Background\nA large number of people are employed in sedentary occupations. Physical inactivity and excessive sitting at workplaces have been linked to increased risk of cardiovascular disease, obesity, and all-cause mortality.\nObjectives\nTo evaluate the effectiveness of workplace interventions to reduce sitting at work compared to no intervention or alternative interventions.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, OSH UPDATE, PsycINFO, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal up to 9 August 2017. We also screened reference lists of articles and contacted authors to find more studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), cross-over RCTs, cluster-randomised controlled trials (cluster-RCTs), and quasi-RCTs of interventions to reduce sitting at work. For changes of workplace arrangements, we also included controlled before-and-after studies. The primary outcome was time spent sitting at work per day, either self-reported or measured using devices such as an accelerometer-inclinometer and duration and number of sitting bouts lasting 30 minutes or more. We considered energy expenditure, total time spent sitting (including sitting at and outside work), time spent standing at work, work productivity and adverse events as secondary outcomes.\nData collection and analysis\nTwo review authors independently screened titles, abstracts and full-text articles for study eligibility. Two review authors independently extracted data and assessed risk of bias. We contacted authors for additional data where required.\nMain results\nWe found 34 studies — including two cross-over RCTs, 17 RCTs, seven cluster-RCTs, and eight controlled before-and-after studies — with a total of 3,397 participants, all from high-income countries. The studies evaluated physical workplace changes (16 studies), workplace policy changes (four studies), information and counselling (11 studies), and multi-component interventions (four studies). One study included both physical workplace changes and information and counselling components. We did not find any studies that specifically investigated the effects of standing meetings or walking meetings on sitting time.\nPhysical workplace changes\nInterventions using sit-stand desks, either alone or in combination with information and counselling, reduced sitting time at work on average by 100 minutes per workday at short-term follow-up (up to three months) compared to sit-desks (95% confidence interval (CI) −116 to −84, 10 studies, low-quality evidence). The pooled effect of two studies showed sit-stand desks reduced sitting time at medium-term follow-up (3 to 12 months) by an average of 57 minutes per day (95% CI −99 to −15) compared to sit-desks. Total sitting time (including sitting at and outside work) also decreased with sit-stand desks compared to sit-desks (mean difference (MD) −82 minutes/day, 95% CI −124 to −39, two studies) as did the duration of sitting bouts lasting 30 minutes or more (MD −53 minutes/day, 95% CI −79 to −26, two studies, very low-quality evidence).\nWe found no significant difference between the effects of standing desks and sit-stand desks on reducing sitting at work. Active workstations, such as treadmill desks or cycling desks, had unclear or inconsistent effects on sitting time.\nWorkplace policy changes\nWe found no significant effects for implementing walking strategies on workplace sitting time at short-term (MD −15 minutes per day, 95% CI −50 to 19, low-quality evidence, one study) and medium-term (MD −17 minutes/day, 95% CI −61 to 28, one study) follow-up. Short breaks (one to two minutes every half hour) reduced time spent sitting at work on average by 40 minutes per day (95% CI −66 to −15, one study, low-quality evidence) compared to long breaks (two 15-minute breaks per workday) at short-term follow-up.\nInformation and counselling\nProviding information, feedback, counselling, or all of these resulted in no significant change in time spent sitting at work at short-term follow-up (MD −19 minutes per day, 95% CI −57 to 19, two studies, low-quality evidence). However, the reduction was significant at medium-term follow-up (MD −28 minutes per day, 95% CI −51 to −5, two studies, low-quality evidence).\nComputer prompts combined with information resulted in no significant change in sitting time at work at short-term follow-up (MD −14 minutes per day, 95% CI −39 to 10, three studies, low-quality evidence), but at medium-term follow-up they produced a significant reduction (MD −55 minutes per day, 95% CI −96 to −14, one study). Furthermore, computer prompting resulted in a significant decrease in the average number (MD −1.1, 95% CI −1.9 to −0.3, one study) and duration (MD -74 minutes per day, 95% CI −124 to −24, one study) of sitting bouts lasting 30 minutes or more.\nComputer prompts with instruction to stand reduced sitting at work on average by 14 minutes per day (95% CI 10 to 19, one study) more than computer prompts with instruction to walk at least 100 steps at short-term follow-up.\nWe found no significant reduction in workplace sitting time at medium-term follow-up following mindfulness training (MD −23 minutes per day, 95% CI −63 to 17, one study, low-quality evidence). Similarly a single study reported no change in sitting time at work following provision of highly personalised or contextualised information and less personalised or contextualised information. One study found no significant effects of activity trackers on sitting time at work.\nMulti-component interventions\nCombining multiple interventions had significant but heterogeneous effects on sitting time at work (573 participants, three studies, very low-quality evidence) and on time spent in prolonged sitting bouts (two studies, very low-quality evidence) at short-term follow-up.\nAuthors' conclusions\nAt present there is low-quality evidence that the use of sit-stand desks reduce workplace sitting at short-term and medium-term follow-ups. However, there is no evidence on their effects on sitting over longer follow-up periods. Effects of other types of interventions, including workplace policy changes, provision of information and counselling, and multi-component interventions, are mostly inconsistent. The quality of evidence is low to very low for most interventions, mainly because of limitations in study protocols and small sample sizes. There is a need for larger cluster-RCTs with longer-term follow-ups to determine the effectiveness of different types of interventions to reduce sitting time at work.\n\nGiven the provided abstract, please respond to the following query: \"Effect of information and counselling\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Providing information, feedback, counselling, or all of these reduces sitting time at medium-term follow-up (3 to 12 months after the intervention) on average by 5 to 51 minutes per day. The available evidence is insufficient to draw conclusions about the effects at short-term follow-up (up to three months after the intervention). The use of computer prompts combined with providing information reduces sitting time in the medium-term on average by 14 to 96 minutes per day. The available evidence is insufficient to draw conclusions about the effects in the short-term.\nOne study found that prompts to stand reduce sitting time more than prompts to step, on average by 10 to 19 minutes per day.\nThe available evidence is insufficient to conclude whether providing highly personalised or contextualised information is more or less effective than providing less personalised or contextualised information in reducing siting time at work. The available evidence is also insufficient to draw conclusions about the effect of mindfulness training and the use of activity trackers on sitting at work."
}
] |
query-laysum
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8486
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[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a previously published version of the review (Issue 10, 2011).\nEpithelial ovarian cancer (EOC) is the seventh most common cause of cancer death among women worldwide. Treatment consists of a combination of surgical debulking and platinum-based chemotherapy. Between 55% and 75% of women who respond to first-line therapy experience relapse within two years. Second-line chemotherapy is palliative and aims to reduce symptoms and prolong survival. Improved understanding about the molecular basis of EOC has led to the development of novel agents, such as epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors and anti-EGFR antibodies.\nObjectives\nTo compare the effectiveness and harmful effects of interventions that target the epidermal growth factor receptor in the treatment of epithelial ovarian cancer (EOC).\nSearch methods\nWe searched the Cochrane Gynaecological Cancer Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2010, Issue 4), MEDLINE, and Embase up to October 2010. We also searched registers of clinical trials, abstracts of scientific meetings, and reference lists of included studies, and we contacted experts in the field. This update includes further searches up to September 2017.\nSelection criteria\nRandomised controlled trials (RCTs) comparing anti-EGFR agents with or without conventional chemotherapy versus conventional chemotherapy alone or no treatment in women with histologically proven EOC.\nData collection and analysis\nTwo review authors independently abstracted data, assessed risk of bias, and performed GRADE assessment.\nMain results\nFrom 6105 references obtained through the literature search and an additional 15 references derived from grey literature searches, we identified seven RCTs that met our inclusion criteria and included 1725 participants. Trial results show that after first-line chemotherapy is provided, maintenance treatment with erlotinib (EGFR tyrosine kinase inhibitor (TKI)) probably makes little or no difference in overall survival (hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.81 to 1.20; one study; 835 participants; low-certainty evidence) and may make little or no difference in progression-free survival (HR 1.05, 95% CI 0.90 to 1.23; one study; 835 participants; very low-certainty evidence). Less than 50% of participants provided quality of life data, and study authors reported these results incompletely. The certainty of evidence is very low, but treatment may reduce quality of life compared to observation.\nTreatment with an EGFR TKI (vandetanib) for women with relapsed EOC may make little or no difference in overall survival (HR 1.25, 95% CI 0.80 to 1.95; one study; 129 participants; low-certainty evidence) and may make little or no difference in progression-free survival (HR 0.99, 95% CI 0.69 to 1.42; one study; 129 participants; very low-certainty evidence). In treating patients with relapse, giving EGFR TKI may slightly increase some toxicities, such as severe rash (risk ratio (RR) 13.63, 95% CI 0.78 to 236.87; one study; 125 participants; very low-certainty evidence). Quality of life data were not available for meta-analysis.\nAnti-EGFR antibody treatment in relapsed EOC may or may not make a difference to overall survival (HR 0.93, 95% CI 0.74 to 1.18; four studies; 658 participants; moderate-certainty evidence) and may or may not have any effect on progression-free survival (HR 0.90, 95% CI 0.70 to 1.16; four studies; 658 participants; low-certainty evidence). Anti-EGFR antibody treatment may or may not increase side effects, including severe nausea and/or vomiting (RR 1.27, 95% CI 0.56 to 2.89; three studies; 503 participants; low-certainty evidence), severe fatigue (RR 1.06, 95% CI 0.66 to 1.73; I² = 0%; four studies; 652 participants; low-certainty evidence), and hypokalaemia (RR 2.01, 95% CI 0.80 to 5.06; I² = 0%; three studies; 522 participants; low-certainty evidence). Severe diarrhoea rates were heterogeneous across studies (RR 2.87, 95% CI 0.59 to 13.89; four studies; 652 participants; low-certainty evidence), and subgroup analysis revealed that severe diarrhoea was more likely with pertuzumab (RR 6.37, 95% CI 1.89 to 21.45; I² = 0%; three studies; 432 participants; low-certainty evidence) than with seribantumab treatment (RR 0.38, 95% CI 0.07 to 2.23; I² = 0%; one study; 220 participants; very low-certainty evidence). Quality of life data were incompletely reported, and we were unable to combine them in a meta-analysis.\nAuthors' conclusions\nCurrent evidence suggests that an anti-EGFR single-agent biological treatment (EGFR TKI or anti-EGFR antibody) makes little or no difference to survival, either as maintenance treatment after first-line chemotherapy or in association with chemotherapy in recurrent cancer. Anti-EGFR therapy may increase some side effects and may or may not reduce quality of life.\n\nGiven the provided abstract, please respond to the following query: \"What are the key messages of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Limited evidence suggests that there is little or no benefit from taking anti-EGFR agents either alongside chemotherapy at relapse, or as maintenance treatment after first-line chemotherapy for EOC, and that some side effects may be increased."
}
] |
query-laysum
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8487
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[
{
"role": "user",
"content": "Abstract: Background\nThe United Nations' Sustainable Development Goals (SDGs) include reducing the global maternal mortality rate to less than 70 per 100,000 live births and ending preventable deaths of newborns and children under five years of age, in every country, by 2030. Maternal and perinatal death audit and review is widely recommended as an intervention to reduce maternal and perinatal mortality, and to improve quality of care, and could be key to attaining the SDGs. However, there is uncertainty over the most cost-effective way of auditing and reviewing deaths: community-based audit (verbal and social autopsy), facility-based audits (significant event analysis (SEA)) or a combination of both (confidential enquiry).\nObjectives\nTo assess the impact and cost-effectiveness of different types of death audits and reviews in reducing maternal, perinatal and child mortality.\nSearch methods\nWe searched the following from inception to 16 January 2019: CENTRAL, Ovid MEDLINE, Embase OvidSP, and five other databases. We identified ongoing studies using ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform, and searched reference lists of included articles.\nSelection criteria\nCluster-randomised trials, cluster non-randomised trials, controlled before-and-after studies and interrupted time series studies of any form of death audit or review that involved reviewing individual cases of maternal, perinatal or child deaths, identifying avoidable factors, and making recommendations. To be included in the review, a study needed to report at least one of the following outcomes: perinatal mortality rate; stillbirth rate; neonatal mortality rate; mortality rate in children under five years of age or maternal mortality rate.\nData collection and analysis\nWe used standard Cochrane Effective Practice and Organisation of Care (EPOC) group methodological procedures. Two review authors independently extracted data, assessed risk of bias and assessed the certainty of the evidence using GRADE. We planned to perform a meta-analysis using a random-effects model but included studies were not homogeneous enough to make pooling their results meaningful.\nMain results\nWe included two cluster-randomised trials. Both introduced death review and audit as part of a multicomponent intervention, and compared this to current care. The QUARITE study (QUAlity of care, RIsk management, and TEchnology) concerned maternal death reviews in hospitals in West Africa, which had very high maternal and perinatal mortality rates. In contrast, the OPERA trial studied perinatal morbidity/mortality conferences (MMCs) in maternity units in France, which already had very low perinatal mortality rates at baseline.\nThe OPERA intervention in France started with an outreach visit to brief obstetricians, midwives and anaesthetists on the national guidelines on morbidity/mortality case management, and was followed by a series of perinatal MMCs. Half of the intervention units were randomised to receive additional support from a clinical psychologist during these meetings. The OPERA intervention may make little or no difference to overall perinatal mortality (low certainty evidence), however we are uncertain about the effect of the intervention on perinatal mortality related to suboptimal care (very low certainty evidence).The intervention probably reduces perinatal morbidity related to suboptimal care (unadjusted odds ratio (OR) 0.62, 95% confidence interval (CI) 0.40 to 0.95; 165,353 births; moderate-certainty evidence). The effect of the intervention on stillbirth rate, neonatal mortality, mortality rate in children under five years of age, maternal mortality or adverse effects was not reported.\nThe QUARITE intervention in West Africa focused on training leaders of hospital obstetric teams using the ALARM (Advances in Labour And Risk Management) course, which included one day of training about conducting maternal death reviews. The leaders returned to their hospitals, established a multidisciplinary committee and started auditing maternal deaths, with the support of external facilitators. The intervention probably reduces inpatient maternal deaths (adjusted OR 0.85, 95% CI 0.73 to 0.98; 191,167 deliveries; moderate certainty evidence) and probably also reduces inpatient neonatal mortality within 24 hours following birth (adjusted OR 0.74, 95% CI 0.61 to 0.90; moderate certainty evidence). However, QUARITE probably makes little or no difference to the inpatient stillbirth rate (moderate certainty evidence) and may make little or no difference to the inpatient neonatal mortality rate after 24 hours, although the 95% confidence interval includes both benefit and harm (low certainty evidence). The QUARITE intervention probably increases the percent of women receiving high quality of care (OR 1.87, 95% CI 1.35 - 2.57, moderate-certainty evidence). The effect of the intervention on perinatal mortality, mortality rate in children under five years of age, or adverse effects was not reported.\nWe did not find any studies that evaluated child death audit and review or community-based death reviews or costs.\nAuthors' conclusions\nA complex intervention including maternal death audit and review, as well as development of local leadership and training, probably reduces inpatient maternal mortality in low-income country district hospitals, and probably slightly improves quality of care. Perinatal death audit and review, as part of a complex intervention with training, probably improves quality of care, as measured by perinatal morbidity related to suboptimal care, in a high-income setting where mortality was already very low.\nThe WHO recommends that maternal and perinatal death reviews should be conducted in all hospitals globally. However, conducting death reviews in isolation may not be sufficient to achieve the reductions in mortality observed in the QUARITE trial. This review suggests that maternal death audit and review may need to be implemented as part of an intervention package which also includes elements such as training of a leading doctor and midwife in each hospital, annual recertification, and quarterly outreach visits by external facilitators to provide supervision and mentorship. The same may also apply to perinatal and child death reviews. More operational research is needed on the most cost-effective ways of implementing maternal, perinatal and paediatric death reviews in low- and middle-income countries.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date was this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors searched for studies that had been published up to 16 January 2019."
}
] |
query-laysum
|
8488
|
[
{
"role": "user",
"content": "Abstract: Background\nSystemic lupus erythematosus (SLE) is a chronic inflammatory, multisystem autoimmune condition. Dehydroepiandrosterone (DHEA) is a naturally occurring inactive steroid which may possess disease activity modifying properties as well as the ability to reduce flares and steroid requirements.\nObjectives\nTo assess the effectiveness and safety of dehydroepiandrosterone compared to placebo in the treatment of people with systemic lupus erythematosus.\nSearch methods\nWe searched The Cochrane Library (Issue 2, 2006), MEDLINE, Pub Med, EMBASE, Science Citation Index and ISI Proceedings as well as searching web sites of Genelabs, FDA and EMEA. (Searches undertaken in June 2006 unless otherwise specified).\nSelection criteria\nWe included randomised controlled trials of at least three months duration comparing DHEA to a placebo in people with SLE.\nData collection and analysis\nTwo review authors assessed quality and extracted data.\nMain results\nFrom the seven RCTs identified (842 participants) to date there is 'gold' ranking evidence (www.cochranemsk.org) that DHEA:\nhad little clinical effect on disease activity in those with mild/moderate disease (measured by SLEDAI or SLAM) but one study demonstrated evidence of stabilisation or improvement in 8.3% more patients than those treated with placebo; \nhad a modest but clinically significant improvement in health related quality of life measured by Patient Global Assessment, estimated as 11.5% (11.5 mm on a 100 mm scale) by meta-analysis; \nresulted in a greater number of patients experiencing adverse events, particularly androgenic effects such as acne where patients risk was doubled when compared to placebo (RR 2.2; 95% CI 1.65 to 2.83)\nAuthors' conclusions\nStudying effectiveness of DHEA for SLE is difficult, reflecting the problems of studying any treatment for a disease as complex as SLE. From the seven RCTs to date, there was evidence that DHEA had a modest but clinically significant impact on health related quality of life in the short term. Impact on disease activity was inconsistent, with DHEA showing no benefit over placebo in terms of change in SLEDAI in all but one of the 6 studies reporting this outcome. Long term outcomes and safety remain unstudied.\n\nGiven the provided abstract, please respond to the following query: \"What are the effects of DHEA (dehydroepiandrosterone)?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
] |
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