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query-laysum
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23854
|
[
{
"role": "user",
"content": "Abstract: Background\nMost people who are newly diagnosed with non-small cell lung cancer (NSCLC) have advanced disease. For these people, survival is determined by various patient- and tumor-related factors, of which the performance status (PS) is the most important prognostic factor. People with PS 0 or 1 are usually treated with systemic therapies, whereas people with PS 3 or 4 most often receive supportive care. However, treatment for people with PS 2 without a targetable mutation remains unclear. Historically, people with a PS 2 cancer are frequently excluded from (important) clinical trials because of poorer outcomes and increased toxicity. We aim to address this knowledge gap, as this group of people represents a significant proportion (20% to 30%) of the total population with newly diagnosed lung cancer.\nObjectives\nTo identify the best first-line therapy for advanced lung cancer in people with performance status 2 without a targetable mutation or with an unknown mutation status.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 17 June 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared different chemotherapy (with or without angiogenesis inhibitor) or immunotherapy regimens, specifically designed for people with PS 2 only or studies including a subgroup of these people.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. overall survival (OS), 2. health-related quality of life (HRQoL), and 3. toxicity/adverse events. Our secondary outcomes were 4. tumor response rate, 5. progression-free survival, and 6. survival rates at six and 12 months' treatment. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included 22 trials in this review and identified one ongoing trial. Twenty studies compared chemotherapy with different regimens, of which 11 compared non-platinum therapy (monotherapy or doublet) versus platinum doublet. We found no studies comparing best supportive care with chemotherapy and only two abstracts analyzing chemotherapy versus immunotherapy.\nWe found that platinum doublet therapy showed superior OS compared to non-platinum therapy (hazard ratio [HR] 0.67, 95% confidence interval [CI] 0.57 to 0.78; 7 trials, 697 participants; moderate-certainty evidence). There were no differences in six-month survival rates (risk ratio [RR] 1.00, 95% CI 0.72 to 1.41; 6 trials, 632 participants; moderate-certainty evidence), whereas 12-month survival rates were improved for treatment with platinum doublet therapy (RR 0.92, 95% CI 0.87 to 0.97; 11 trials, 1567 participants; moderate-certainty evidence). PFS and tumor response rate were also better for people treated with platinum doublet therapy, with moderate-certainty evidence (PFS: HR 0.57, 95% CI 0.42 to 0.77; 5 trials, 487 participants; tumor response rate: RR 2.25, 95% CI 1.67 to 3.05; 9 trials, 964 participants).\nWhen analyzing toxicity rates, we found that platinum doublet therapy increased grade 3 to 5 hematologic toxicities, all with low-certainty evidence (anemia: RR 1.98, 95% CI 1.00 to 3.92; neutropenia: RR 2.75, 95% CI 1.30 to 5.82; thrombocytopenia: RR 3.96, 95% CI 1.73 to 9.06; all 8 trials, 935 participants).\nOnly four trials reported HRQoL data; however, the methodology was different per trial and we were unable to perform a meta-analysis.\nAlthough evidence is limited, there were no differences in 12-month survival rates or tumor response rates between carboplatin and cisplatin regimens. With an indirect comparison, carboplatin seemed to have better 12-month survival rates than cisplatin compared to non-platinum therapy.\nThe assessment of the efficacy of immunotherapy in people with PS 2 was limited. There might be a place for single-agent immunotherapy, but the data provided by the included studies did not encourage the use of double-agent immunotherapy.\nAuthors' conclusions\nThis review showed that as a first-line treatment for people with PS 2 with advanced NSCLC, platinum doublet therapy seems to be preferred over non-platinum therapy, with a higher response rate, PFS, and OS. Although the risk for grade 3 to 5 hematologic toxicity is higher, these events are often relatively mild and easy to treat. Since trials using checkpoint inhibitors in people with PS 2 are scarce, we identified an important knowledge gap regarding their role in people with advanced NSCLC and PS 2.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are moderately confident in our results that chemotherapies with a platinum-based medicine increases survival. We are also moderately confident in the evidence evaluating the time to progression of disease because in all included studies, both investigators and trial participants were fully aware of which treatment the participants received. This might lead to substantial bias. In addition, we have little confidence in the evidence regarding toxicities because the evidence is based on a small number of studies with conflicting outcomes."
}
] |
query-laysum
|
23855
|
[
{
"role": "user",
"content": "Abstract: Background\nA huge clinical research database on adjuvant cancer treatment has verified improvements in breast cancer outcomes such as recurrence and mortality rates. On the other hand, adjuvant and neoadjuvant therapy with chemotherapy and radiotherapy impacts on quality of life due to substantial short- and long-term side effects. A number of studies have evaluated the effect of exercise interventions on those side effects. This is an updated version of the original Cochrane review published in 2006. The original review identified some benefits of physical activity on physical fitness and the resulting capacity for performing activities of daily life. It also identified a lack of evidence for other outcomes, providing clear justification for an updated review.\nObjectives\nTo assess the effect of aerobic or resistance exercise interventions during adjuvant treatment for breast cancer on treatment-related side effects such as physical deterioration, fatigue, diminished quality of life, depression, and cognitive dysfunction.\nSearch methods\nWe carried out an updated search in the Cochrane Breast Cancer Group Specialised Register (30 March 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2015), MEDLINE (1966 to 30 March 2015), and EMBASE (1966 to 30 March 2015). We did not update the original searches in CINAHL (1982 to 2004), SPORTDiscus (1975 to 2004), PsycINFO (1872 to 2003), SIGLE (1880 to 2004), and ProQuest Digital Dissertations (1861 to 2004). We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov for ongoing trials on 30 March 2015. We screened references in relevant reviews and published clinical trials.\nSelection criteria\nWe included randomised controlled trials that examined aerobic or resistance exercise or both in women undergoing adjuvant treatment for breast cancer. Published and unpublished trials were eligible.\nData collection and analysis\nTwo review authors independently performed data extraction, assessed trials, and graded the methodological quality using Cochrane's 'Risk of bias' tool. Any disagreements were resolved through discussion or by consulting the third review author. We entered data into Review Manager for analysis. For outcomes assessed with a variety of instruments, we used the standardised mean difference (SMD) as a summary statistic for meta-analysis; for those assessed with the same instrument, we used the mean difference (MD).\nMain results\nFor this 2015 update we included a total of 32 studies with 2626 randomised women, 8 studies from the original search and 24 studies from the updated search. We found evidence that physical exercise during adjuvant treatment for breast cancer probably improves physical fitness (SMD 0.42, 95% confidence interval (CI) 0.25 to 0.59; 15 studies; 1310 women; moderate-quality evidence) and slightly reduces fatigue (SMD -0.28, 95% CI -0.41 to -0.16; 19 studies; 1698 women; moderate-quality evidence). Exercise may lead to little or no improvement in health-related quality of life (MD 1.10, 95% CI -5.28 to 7.48; 1 study; 68 women; low-quality evidence), a slight improvement in cancer site-specific quality of life (MD 4.24, 95% CI -1.81 to 10.29; 4 studies; 262 women; low-quality evidence), and an improvement in cognitive function (MD -11.55, 95% CI -22.06 to -1.05; 2 studies; 213 women; low-quality evidence). Exercise probably leads to little or no difference in cancer-specific quality of life (SMD 0.12, 95% CI 0.00 to 0.25; 12 studies; 1012 women; moderate-quality evidence) and little or no difference in depression (SMD -0.15, 95% CI -0.30 to 0.01; 5 studies; 674 women; moderate-quality evidence). Evidence for other outcomes ranged from low to moderate quality. Seven trials reported a very small number of adverse events.\nAuthors' conclusions\nExercise during adjuvant treatment for breast cancer can be regarded as a supportive self care intervention that probably results in less fatigue, improved physical fitness, and little or no difference in cancer-specific quality of life and depression. Exercise may also slightly improve cancer site-specific quality of life and cognitive function, while it may result in little or no difference in health-related quality of life. This review is based on trials with a considerable degree of clinical heterogeneity regarding adjuvant cancer treatments and exercise interventions. Due to the difficulty of blinding exercise trials, all included trials were at high risk for performance bias. Furthermore, the majority of trials were at high risk for detection bias, largely due to most outcomes being self reported.\nThe findings of the updated review have enabled us to make a more precise conclusion that both aerobic and resistance exercise can be regarded as beneficial for individuals with adjuvant therapy-related side effects. Further research is required to determine the optimal type, intensity, and timing of an exercise intervention. Furthermore, long-term evaluation is required due to possible long-term side effects of adjuvant treatment.\n\nGiven the provided abstract, please respond to the following query: \"Why does it matter?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The side effects of breast cancer treatment can interfere with daily activities and return to work. It is important to learn of ways to reduce these side effects."
}
] |
query-laysum
|
23856
|
[
{
"role": "user",
"content": "Abstract: Background\nHip fractures are a major healthcare problem, presenting a challenge and burden to individuals and healthcare systems. The number of hip fractures globally is rising. The majority of extracapsular hip fractures are treated surgically.\nObjectives\nTo assess the relative effects (benefits and harms) of all surgical treatments used in the management of extracapsular hip fractures in older adults, using a network meta-analysis of randomised trials, and to generate a hierarchy of interventions according to their outcomes.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Web of Science and five other databases in July 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing different treatments for fragility extracapsular hip fractures in older adults. We included internal and external fixation, arthroplasties and non-operative treatment. We excluded studies of hip fractures with specific pathologies other than osteoporosis or resulting from high-energy trauma.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion. One review author completed data extraction which was checked by a second review author. We collected data for three outcomes at different time points: mortality and health-related quality of life (HRQoL) - both reported within 4 months, at 12 months and after 24 months of surgery, and unplanned return to theatre (at end of study follow-up).\nWe performed a network meta-analysis (NMA) with Stata software, using frequentist methods, and calculated the differences between treatments using risk ratios (RRs) and standardised mean differences (SMDs) and their corresponding 95% confidence intervals (CIs). We also performed direct comparisons using the same codes.\nMain results\nWe included 184 studies (160 RCTs and 24 quasi-RCTs) with 26,073 participants with 26,086 extracapsular hip fractures in the review. The mean age in most studies ranged from 60 to 93 years, and 69% were women.\nAfter discussion with clinical experts, we selected nine nodes that represented the best balance between clinical plausibility and efficiency of the networks: fixed angle plate (dynamic and static), cephalomedullary nail (short and long), condylocephalic nail, external fixation, hemiarthroplasty, total hip arthroplasty (THA) and non-operative treatment. Seventy-three studies (with 11,126 participants) with data for at least two of these treatments contributed to the NMA.\nWe selected the dynamic fixed angle plate as a reference treatment against which other treatments were compared. This was a common treatment in the networks, providing a clinically appropriate comparison.\nWe downgraded the certainty of the evidence for serious and very serious risks of bias, and because some of the estimates included the possibility of transitivity owing to the proportion of stable and unstable fractures between treatment comparisons. We also downgraded if we noted evidence of inconsistency in direct or indirect estimates from which the network estimate was derived. Most estimates included the possibility of benefits and harms, and we downgraded the evidence for these treatments for imprecision.\nOverall, 20.2% of participants who received the reference treatment had died by 12 months after surgery. We noted no evidence of any differences in mortality at this time point between the treatments compared. Effect estimates of all treatments included plausible benefits as well as harms. Short cephalomedullary nails had the narrowest confidence interval (CI), with 7 fewer deaths (26 fewer to 15 more) per 1000 participants, compared to the reference treatment (risk ratio (RR) 0.97, 95% CI 0.87 to 1.07). THA had the widest CI, with 62 fewer deaths (177 fewer to 610 more) per 1000 participants, compared to the reference treatment (RR 0.69, 95% CI 0.12 to 4.03). The certainty of the evidence for all treatments was low to very low. Although we ranked the treatments, this ranking should be interpreted cautiously because of the imprecision in all the network estimates for these treatments.\nOverall, 4.3% of participants who received the reference treatment had unplanned return to theatre. Compared to this treatment, we found very low-certainty evidence that 58 more participants (14 to 137 more) per 1000 participants returned to theatre if they were treated with a static fixed angle plate (RR 2.48, 95% CI 1.36 to 4.50), and 91 more participants (37 to 182 more) per 1000 participants returned to theatre if treated with a condylocephalic nail (RR 3.33, 95% CI 1.95 to 5.68). We also found that these treatments were ranked as having the highest probability of unplanned return to theatre. In the remaining treatments, we noted no evidence of any differences in unplanned return to theatre, with effect estimates including benefits as well as harms. The certainty of the evidence for these other treatments ranged from low to very low.\nWe did not use GRADE to assess the certainty of the evidence for early mortality, but our findings were similar to those for 12-month mortality, with no evidence of any differences in treatments when compared to dynamic fixed angle plate. Very few studies reported HRQoL and we were unable to build networks from these studies and perform network meta-analysis.\nAuthors' conclusions\nAcross the networks, we found that there was considerable variability in the ranking of each treatment such that there was no one outstanding, or subset of outstanding, superior treatments. However, static implants such as condylocephalic nails and static fixed angle plates did yield a higher risk of unplanned return to theatre. We had insufficient evidence to determine the effects of any treatments on HRQoL, and this review includes data for only two outcomes. More detailed pairwise comparisons of some of the included treatments are reported in other Cochrane Reviews in this series. Short cephalomedullary nails versus dynamic fixed angle plates contributed the most evidence to each network, and our findings indicate that there may be no difference between these treatments. These data included people with both stable and unstable extracapsular fractures. At this time, there are too few studies to draw any conclusions regarding the benefits or harms of arthroplasty or external fixation for extracapsular fracture in older adults.\nFuture research could focus on the benefits and harms of arthroplasty interventions compared with internal fixation using a dynamic implant.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- There is no 'best treatment' for this type of broken hip.\n- More people needed additional surgery on their broken hip after treatment with condylocephalic nails (where a nail is inserted upwards from the knee towards the hip joint) or static fixed angle plates (where pins or screws attach a plate to the broken bone).\n- There may be no difference between a short cephalomedullary nail (where a nail is inserted downwards from the hip joint towards the knee) and a dynamic fixed angle plate (where the pins or screws attaching a plate to the broken bone are able to slide in a sleeve).\n- We found too few studies to know whether any of these treatments were better at improving people's quality of life after surgery."
}
] |
query-laysum
|
23857
|
[
{
"role": "user",
"content": "Abstract: Background\nNeonates are at higher risk of infection due to immuno-incompetence. Maternal transport of immunoglobulins to the fetus mainly occurs after 32 weeks' gestation, and endogenous synthesis begins several months after birth. Administration of intravenous immunoglobulin (IVIG) provides immunoglobulin G (IgG) that can bind to cell surface receptors, provide opsonic activity, activate complement, promote antibody-dependent cytotoxicity and improve neutrophilic chemo-luminescence. Theoretically, infectious morbidity and mortality could be reduced by the administration of IVIG.\nObjectives\nTo assess the effects of IVIG on mortality and morbidity caused by suspected or proven infection at study entry in neonates. To assess in a subgroup analysis the effects of IgM-enriched IVIG on mortality from suspected infection.\nSearch methods\nFor this update, MEDLINE, EMBASE, The Cochrane Library, CINAHL, trial registries, Web of Science, reference lists of identified studies, meta-analyses and personal files were searched in 2013. No language restrictions were applied.\nSelection criteria\nRandomised or quasi-randomised controlled trials involving newborn infants (< 28 days old); IVIG for treatment of suspected or proven bacterial or fungal infection compared with placebo or no intervention; and where one of the following outcomes was reported, mortality, length of hospital stay or psychomotor development at follow-up.\nData collection and analysis\nStatistical analyses included typical risk ratio (RR), risk difference (RD), weighted mean difference (WMD), number needed to treat for an additional beneficial outcome (NNTB) or an additional harmful outcome (NNTH), all with 95% confidence intervals (CIs), and the I2 statistic to examine for statistical heterogeneity.\nMain results\nThe updated search identified one published study that was previously ongoing. A total of 9 studies evaluating 3973 infants were included in this review. Mortality during hospital stay in infants with clinically suspected infection was not significantly different after IVIG treatment (9 studies (n = 2527); typical RR 0.95, 95% CI 0.80 to 1.13; typical RD -0.01, 95% CI - 0.04 to 0.02; I2 = 23% for RR and 29% for RD). Death or major disability at 2 years corrected age was not significantly different in infants with suspected infection after IVIG treatment (1 study (n = 1985); RR 0.98, 95% CI 0.88 to 1.09; RD -0.01, 95% CI -0.05 to 0.03). Mortality during hospital stay was not significantly different after IVIG treatment in infants with proven infection at trial entry (1 trial (n = 1446); RR 0.95, 95% CI 0.74 to 1.21; RD -0.01, 95% CI -0.04 to 0.03). Death or major disability at 2 years corrected age was not significantly different after IVIG treatment in infants with proven infection at trial entry (1 trial (n = 1393); RR 1.03, 95% CI 0.91 to 1.18; RD 0.01, 95% CI -0.04 to 0.06). Mortality during hospital stay in infants with clinically suspected or proven infection at trial entry was not significantly different after IVIG treatment (1 study (n = 3493); RR 1.00, 95% CI 0.86 to 1.16; RD 0.00, 95% CI - 0.02 to 0.03). Death or major disability at 2 years corrected age was not significantly different after IVIG treatment in infants with suspected or proven infection at trial entry (1 study (n = 3493); RR 1.00, 95% CI 0.92 to 1.09; RD -0.00, 95% CI -0.03 to 0.03). Length of hospital stay was not reduced for infants with suspected or proven infection at trial entry (1 study (n = 3493); mean difference (MD) 0.00 days, 95% CI -0.61 to 0.61). No significant difference in mortality during hospital stay after administration of IgM-enriched IVIG for suspected infection at trial entry was reported in 4 studies (n = 266) (typical RR 0.68, 95% CI 0.39 to 1.20; RD -0.06, 95% CI -0.14 to 0.02; I2 = 17% for RR and 53% for RD).\nAuthors' conclusions\nThe undisputable results of the INIS trial, which enrolled 3493 infants, and our meta-analyses (n = 3973) showed no reduction in mortality during hospital stay, or death or major disability at two years of age in infants with suspected or proven infection. Although based on a small sample size (n = 266), this update provides additional evidence that IgM-enriched IVIG does not significantly reduce mortality during hospital stay in infants with suspected infection. Routine administration of IVIG or IgM-enriched IVIG to prevent mortality in infants with suspected or proven neonatal infection is not recommended. No further research is recommended.\n\nGiven the provided abstract, please respond to the following query: \"Our review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
] |
query-laysum
|
23858
|
[
{
"role": "user",
"content": "Abstract: Background\nShift work is associated with insufficient sleep, which can compromise worker alertness with ultimate effects on occupational health and safety. Adapting shift work schedules may reduce adverse occupational outcomes.\nObjectives\nTo assess the effects of shift schedule adaptation on sleep quality, sleep duration, and sleepiness among shift workers.\nSearch methods\nWe searched CENTRAL, PubMed, Embase, and eight other databases on 13 December 2020, and again on 20 April 2022, applying no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) and non-RCTs, including controlled before-after (CBA) trials, interrupted time series, and cross-over trials. Eligible trials evaluated any of the following shift schedule components.\n• Permanency of shifts\n• Regularity of shift changes\n• Direction of shift rotation\n• Speed of rotation\n• Shift duration\n• Timing of start of shifts\n• Distribution of shift schedule\n• Time off between shifts\n• Split shifts\n• Protected sleep\n• Worker participation\nWe included studies that assessed sleep quality off-shift, sleep duration off-shift, or sleepiness during shifts.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts of the records recovered by the search, read through the full-text articles of potentially eligible studies, and extracted data. We assessed the risk of bias of included studies using the Cochrane risk of bias tool, with specific additional domains for non-randomised and cluster-randomised studies. For all stages, we resolved any disagreements by consulting a third review author. We presented the results by study design and combined clinically homogeneous studies in meta-analyses using random-effects models. We assessed the certainty of the evidence with GRADE.\nMain results\nWe included 11 studies with a total of 2125 participants. One study was conducted in a laboratory setting and was not considered for drawing conclusions on intervention effects. The included studies investigated different and often multiple changes to shift schedule, and were heterogeneous with respect to outcome measurement.\nForward versus backward rotation\nThree CBA trials (561 participants) investigated the effects of forward rotation versus backward rotation. Only one CBA trial provided sufficient data for the quantitative analysis; it provided very low-certainty evidence that forward rotation compared with backward rotation did not affect sleep quality measured with the Basic Nordic Sleep Questionnaire (BNSQ; mean difference (MD) −0.20 points, 95% confidence interval (CI) −2.28 to 1.89; 62 participants) or sleep duration off-shift (MD −0.21 hours, 95% CI −3.29 to 2.88; 62 participants). However, there was also very low-certainty evidence that forward rotation reduced sleepiness during shifts measured with the BNSQ (MD −1.24 points, 95% CI −2.24 to −0.24; 62 participants).\nFaster versus slower rotation\nTwo CBA trials and one non-randomised cross-over trial (341 participants) evaluated faster versus slower shift rotation. We were able to meta-analyse data from two studies. There was low-certainty evidence of no difference in sleep quality off-shift (standardised mean difference (SMD) −0.01, 95% CI −0.26 to 0.23) and very low-certainty evidence that faster shift rotation reduced sleep duration off-shift (SMD −0.26, 95% CI −0.51 to −0.01; 2 studies, 282 participants). The SMD for sleep duration translated to an MD of 0.38 hours' less sleep per day (95% CI −0.74 to −0.01). One study provided very low-certainty evidence that faster rotations decreased sleepiness during shifts measured with the BNSQ (MD −1.24 points, 95% CI −2.24 to −0.24; 62 participants).\nLimited shift duration (16 hours) versus unlimited shift duration\nTwo RCTs (760 participants) evaluated 80-hour workweeks with maximum daily shift duration of 16 hours versus workweeks without any daily shift duration limits. There was low-certainty evidence that the 16-hour limit increased sleep duration off-shift (SMD 0.50, 95% CI 0.21 to 0.78; which translated to an MD of 0.73 hours' more sleep per day, 95% CI 0.30 to 1.13; 2 RCTs, 760 participants) and moderate-certainty evidence that the 16-hour limit reduced sleepiness during shifts, measured with the Karolinska Sleepiness Scale (SMD −0.29, 95% CI −0.44 to −0.14; which translated to an MD of 0.37 fewer points, 95% CI −0.55 to −0.17; 2 RCTs, 716 participants).\nShorter versus longer shifts\nOne RCT, one CBA trial, and one non-randomised cross-over trial (692 participants) evaluated shorter shift duration (eight to 10 hours) versus longer shift duration (two to three hours longer). There was very low-certainty evidence of no difference in sleep quality (SMD −0.23, 95% CI −0.61 to 0.15; which translated to an MD of 0.13 points lower on a scale of 1 to 5; 2 studies, 111 participants) or sleep duration off-shift (SMD 0.18, 95% CI −0.17 to 0.54; which translated to an MD of 0.26 hours' less sleep per day; 2 studies, 121 participants). The RCT and the non-randomised cross-over study found that shorter shifts reduced sleepiness during shifts, while the CBA study found no effect on sleepiness.\nMore compressed versus more spread out shift schedules\nOne RCT and one CBA trial (346 participants) evaluated more compressed versus more spread out shift schedules. The CBA trial provided very low-certainty evidence of no difference between the groups in sleep quality off-shift (MD 0.31 points, 95% CI −0.53 to 1.15) and sleep duration off-shift (MD 0.52 hours, 95% CI −0.52 to 1.56).\nAuthors' conclusions\nForward and faster rotation may reduce sleepiness during shifts, and may make no difference to sleep quality, but the evidence is very uncertain. Very low-certainty evidence indicated that sleep duration off-shift decreases with faster rotation. Low-certainty evidence indicated that on-duty workweeks with shift duration limited to 16 hours increases sleep duration, with moderate-certainty evidence for minimal reductions in sleepiness. Changes in shift duration and compression of workweeks had no effect on sleep or sleepiness, but the evidence was of very low-certainty. No evidence is available for other shift schedule changes. There is a need for more high-quality studies (preferably RCTs) for all shift schedule interventions to draw conclusions on the effects of shift schedule adaptations on sleep and sleepiness in shift workers.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that evaluated the following features of shift schedules.\n• Whether shift schedules changed (rotated) or stayed the same\n• Whether shift changes were regular or irregular\n• Direction of shift rotation (morning to afternoon to night or night to afternoon to morning)\n• Speed of rotation\n• Shift duration\n• Timing of start of shifts\n• Distribution of shift schedule (fewer shifts with more hours or more shifts with fewer hours)\n• Time off between shifts\n• Split (interrupted) shifts\n• Whether workers had on-call shifts\n• Whether workers were involved in organising the shift schedule"
}
] |
query-laysum
|
23859
|
[
{
"role": "user",
"content": "Abstract: Background\nCutaneous leishmaniasis, caused by a parasitic infection, is considered one of the most serious skin diseases in many low- and middle-income countries. Old World cutaneous leishmaniasis (OWCL) is caused by species found in Africa, Asia, the Middle East, the Mediterranean, and India. The most commonly prescribed treatments are antimonials, but other drugs have been used with varying success. As OWCL tends to heal spontaneously, it is necessary to justify the use of systemic and topical treatments. This is an update of a Cochrane Review first published in 2008.\nObjectives\nTo assess the effects of therapeutic interventions for the localised form of Old World cutaneous leishmaniasis.\nSearch methods\nWe updated our searches of the following databases to November 2016: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs). We wrote to national programme managers, general co-ordinators, directors, clinicians, WHO-EMRO regional officers of endemic countries, pharmaceutical companies, tropical medicine centres, and authors of relevant papers for further information about relevant unpublished and ongoing trials. We undertook a separate search for adverse effects of interventions for Old World cutaneous leishmaniasis in September 2015 using MEDLINE.\nSelection criteria\nRandomised controlled trials of either single or combination treatments in immunocompetent people with OWCL confirmed by smear, histology, culture, or polymerase chain reaction. The comparators were either no treatment, placebo/vehicle, and/or another active compound.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias and extracted data. We only synthesised data when we were able to identify at least two studies investigating similar treatments and reporting data amenable to pooling. We also recorded data about adverse effects from the corresponding search.\nMain results\nWe included 89 studies (of which 40 were new to this update) in 10,583 people with OWCL. The studies included were conducted mainly in the Far or Middle East at regional hospitals, local healthcare clinics, and skin disease research centres. Women accounted for 41.5% of the participants (range: 23% to 80%). The overall mean age of participants was 25 years (range 12 to 56). Most studies lasted between two to six months, with the longest lasting two years; average duration was four months. Most studies were at unclear or high risk for most bias domains. A lack of blinding and reporting bias were present in almost 40% of studies. Two trials were at low risk of bias for all domains. Trials reported the causative species poorly.\nHere we provide results for the two main comparisons identified: itraconazole (200 mg for six to eight weeks) versus placebo; and paromomycin ointment (15% plus 10% urea, twice daily for 14 days) versus vehicle.\nIn the comparison of oral itraconazole versus placebo, at 2.5 months' follow up, 85/125 participants in the itraconazole group achieved complete cure compared to 54/119 in the placebo group (RR 3.70, 95% CI 0.35 to 38.99; 3 studies; 244 participants). In one study, microbiological or histopathological cure of skin lesions only occurred in the itraconazole group after a mean follow-up of 2.5 months (RR 17.00, 95% CI 0.47 to 612.21; 20 participants). However, although the analyses favour oral itraconazole for these outcomes, we cannot be confident in the results due to the very low certainty evidence. More side effects of mild abdominal pain and nausea (RR 2.36, 95% CI 0.74 to 7.47; 3 studies; 204 participants) and mild abnormal liver function (RR 3.08, 95% CI 0.53 to 17.98; 3 studies; 84 participants) occurred in the itraconazole group (as well as reports of headaches and dizziness), compared with the placebo group, but again we rated the certainty of evidence as very low so are unsure of the results.\nWhen comparing paromomycin with vehicle, there was no difference in the number of participants who achieved complete cure (RR of 1.00, 95% CI 0.86, 1.17; 383 participants, 2 studies) and microbiological or histopathological cure of skin lesions after a mean follow-up of 2.5 months (RR 1.03, CI 0.88 to 1.20; 383 participants, 2 studies), but the paromomycin group had more skin/local reactions (such as inflammation, vesiculation, pain, redness, or itch) (RR 1.42, 95% CI 0.67 to 3.01; 4 studies; 713 participants). For all of these outcomes, the certainty of evidence was very low, meaning we are unsure about these results.\nTrial authors did not report the percentage of lesions cured after the end of treatment or speed of healing for either of these key comparisons.\nAuthors' conclusions\nThere was very low-certainty evidence to support the effectiveness of itraconazole and paromomycin ointment for OWCL in terms of cure (i.e. microbiological or histopathological cure and percentage of participants completely cured). Both of these interventions incited more adverse effects, which were mild in nature, than their comparisons, but we could draw no conclusions regarding safety due to the very low certainty of the evidence for this outcome.\nWe downgraded the key outcomes in these two comparisons due to high risk of bias, inconsistency between the results, and imprecision. There is a need for large, well-designed international studies that evaluate long-term effects of current therapies and enable a reliable conclusion about treatments. Future trials should specify the species of leishmaniasis; trials on types caused by Leishmania infantum, L aethiopica, andL donovani are lacking. Research into the effects of treating women of childbearing age, children, people with comorbid conditions, and those who are immunocompromised would also be helpful.\nIt was difficult to evaluate the overall efficacy of any of the numerous treatments due to the variable treatment regimens examined and because RCTs evaluated different Leishmania species and took place in different geographical areas. Some outcomes we looked for but did not find were degree of functional and aesthetic impairment, change in ability to detect Leishmania, quality of life, and emergence of resistance. There were only limited data on prevention of scarring.\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 overall certainty of the evidence for the different outcomes in the two main comparisons was very low. Important reasons for this were that studies were not blinded, or had a small sample size, making the results less precise. Some of the evidence only focused on young people, and the results greatly varied between each study.\nWe need more research to fill in the following research gaps: 1) trials of OWCL caused by other types of infection such as L. infantum, L. aethiopica,or L. donovani; 2) involving specific subgroups of people such as children; 3) assessing effectiveness and safety of different anti-Leishmania drugs compared with placebo in self-healing forms of leishmaniasis or with traditional first-choice antimonial treatment in complicated form (defined as more than four lesions over 4 cm in size, located close to an opening or small joints, for which previous treatment has failed); and 4) assessing areas such as wound healing and patient-reported outcomes, such as quality of life. In addition, few studies assessed relevant issues such as drug resistance. International collaboration is required to improve the quality and standardisation of future trials in order to develop a better evidence-based approach."
}
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query-laysum
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23860
|
[
{
"role": "user",
"content": "Abstract: Background\nAlcohol use in young people is a risk factor for a range of short- and long-term harms and is a cause of concern for health services, policy-makers, youth workers, teachers, and parents.\nObjectives\nTo assess the effectiveness of universal, selective, and indicated family-based prevention programmes in preventing alcohol use or problem drinking in school-aged children (up to 18 years of age).\nSpecifically, on these outcomes, the review aimed:\n• to assess the effectiveness of universal family-based prevention programmes for all children up to 18 years (‘universal interventions’);\n• to assess the effectiveness of selective family-based prevention programmes for children up to 18 years at elevated risk of alcohol use or problem drinking (‘selective interventions’); and\n• to assess the effectiveness of indicated family-based prevention programmes for children up to 18 years who are currently consuming alcohol, or who have initiated use or regular use (‘indicated interventions’).\nSearch methods\nWe identified relevant evidence from the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, MEDLINE (Ovid 1966 to June 2018), Embase (1988 to June 2018), Education Resource Information Center (ERIC; EBSCOhost; 1966 to June 2018), PsycINFO (Ovid 1806 to June 2018), and Google Scholar. We also searched clinical trial registers and handsearched references of topic-related systematic reviews and the included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and cluster RCTs (C-RCTs) involving the parents of school-aged children who were part of the general population with no known risk factors (universal interventions), were at elevated risk of alcohol use or problem drinking (selective interventions), or were already consuming alcohol (indicated interventions). Psychosocial or educational interventions involving parents with or without involvement of children were compared with no intervention, or with alternate (e.g. child only) interventions, allowing experimental isolation of parent components.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 46 studies (39,822 participants), with 27 classified as universal, 12 as selective, and seven as indicated. We performed meta-analyses according to outcome, including studies reporting on the prevalence, frequency, or volume of alcohol use. The overall quality of evidence was low or very low, and there was high, unexplained heterogeneity.\nUpon comparing any family intervention to no intervention/standard care, we found no intervention effect on the prevalence (standardised mean difference (SMD) 0.00, 95% confidence interval (CI) -0.08 to 0.08; studies = 12; participants = 7490; I² = 57%; low-quality evidence) or frequency (SMD -0.31, 95% CI -0.83 to 0.21; studies = 8; participants = 1835; I² = 96%; very low-quality evidence) of alcohol use in comparison with no intervention/standard care. The effect of any parent/family interventions on alcohol consumption volume compared with no intervention/standard care was very small (SMD -0.14, 95% CI -0.27 to 0.00; studies = 5; participants = 1825; I² = 42%; low-quality evidence).\nWhen comparing parent/family and adolescent interventions versus interventions with young people alone, we found no difference in alcohol use prevalence (SMD -0.39, 95% CI -0.91 to 0.14; studies = 4; participants = 5640; I² = 99%; very low-quality evidence) or frequency (SMD -0.16, 95% CI -0.42 to 0.09; studies = 4; participants = 915; I² = 73%; very low-quality evidence). For this comparison, no trials reporting on the volume of alcohol use could be pooled in meta-analysis.\nIn general, the results remained consistent in separate subgroup analyses of universal, selective, and indicated interventions. No adverse effects were reported.\nAuthors' conclusions\nThe results of this review indicate that there are no clear benefits of family-based programmes for alcohol use among young people. Patterns differ slightly across outcomes, but overall, the variation, heterogeneity, and number of analyses performed preclude any conclusions about intervention effects. Additional independent studies are required to strengthen the evidence and clarify the marginal effects observed.\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 46 randomised controlled trials (studies where participants were randomly allocated to one of two or more intervention or control groups) that compared family-based interventions versus no intervention or an adolescent component alone. We included studies targeting general populations of parents and children (universal interventions), those targeting parents of children at increased risk of alcohol use (selective interventions), and studies targeting parents of children already using alcohol (indicated interventions). We were interested in studies following participants up to four years post intervention.\nMost studies were conducted in the United States or in European countries (the Netherlands, Sweden, Poland, and Germany). One study was conducted in India. Interventions were delivered in various settings including the child's school or family home and via the Internet or print material. Interventions varied in intensity, duration, and approach, but all targeted alcohol or other drug use by promoting positive parenting approaches or enhancing parent-child relationships. The interventions focused on communication, family dynamics, rule-setting, and risk management.\nThe total number of participants in the included studies was 39,822, and the young people targeted ranged from 5 to 17 years of age. Participant ethnicity was mixed, with 12 studies targeting ethnic minority groups specifically."
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query-laysum
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23861
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[
{
"role": "user",
"content": "Abstract: Background\nAround 1 in 1000 adolescents aged 12 to 17 years old display problematic or harmful sexual behaviour (HSB). Examples include behaviours occurring more frequently than would be considered developmentally appropriate; accompanied by coercion; involving children of different ages or stages of development; or associated with emotional distress. Some, but not all, young people engaging in HSB come to the attention of authorities for investigation, prosecution or treatment. Depending on policy context, young people with HSB are those whose behaviour has resulted in a formal reprimand or warning, conviction for a sexual offence, or civil measures. Cognitive-behavioural therapy (CBT) interventions are based on the idea that by changing the way a person thinks, and helping them to develop new coping skills, it is possible to change behaviour.\nObjectives\nTo evaluate the effects of CBT for young people aged 10 to 18 years who have exhibited HSB.\nSearch methods\nIn June 2019, we searched CENTRAL, MEDLINE, Embase, 12 other databases and three trials registers. We also examined relevant websites, checked reference lists and contacted authors of relevant articles.\nSelection criteria\nWe included all relevant randomised controlled trials (RCTs) using parallel groups. We evaluated CBT treatments compared with no treatment, waiting list or standard care, irrespective of mode of delivery or setting, given to young people aged 10 to 18 years, who had been convicted of a sexual offence or who exhibited HSB.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe found four eligible RCTs (115 participants). Participants in two studies were adolescent males aged 12 to 18 years old. In two studies participants were males simply described as \"adolescents.\"\nThree studies took place in the USA and one in South Africa. The four studies were of short duration: one lasted two months; two lasted three months; and one lasted six months. No information was available on funding sources.\nTwo studies compared group-based CBT respectively to no treatment (18 participants) or treatment as usual (21 participants). The third compared CBT with sexual education (16 participants). The fourth compared CBT (19 participants) with mode-deactivation therapy (21 participants) and social skills training (20 participants). Three interventions delivered treatment in a residential setting by someone working there, and one in a community setting by licensed therapist undertaking a PhD.\nCBT compared with no treatment or treatment as usual\nPrimary outcomes\nNo study in this comparison reported the impact of CBT on any measure of primary outcomes (recidivism, and adverse events such as self-harm or suicidal behaviour).\nSecondary outcomes\nThere was little to no difference between CBT and treatment as usual on cognitive distortions in general (mean difference (MD) 1.56, 95% confidence interval (CI) -11.54 to 14.66, 1 study, 18 participants; very low-certainty evidence), assessed with Abel and Becker Cognition Scale (higher scores indicate more problematic distortions); and specific cognitive distortions about rape (MD 8.75, 95% CI 2.83 to 14.67, 1 study, 21 participants; very low-certainty evidence), measured with the Bumby Cardsort Rape Scale (higher scores indicate more justifications, minimisations, rationalisations and excuses for HSB).\nOne study (18 participants) reported very low-certainty evidence that CBT may result in greater improvements in victim empathy (MD 5.56, 95% CI 0.94 to 10.18), measured with the Attitudes Towards Women Scale, compared with no treatment. One additional study also measured this, but provided no usable data.\nCBT compared with alternative interventions\nPrimary outcomes\nOne study (59 participants) found little to no difference between CBT and alternative treatments on post-treatment sexual aggression scores (MD 0.09, 95% CI -0.18 to 0.37, very low-certainty evidence), assessed using Daily Behaviour Reports and Behaviour Incidence Report Forms. No study in this comparison reported the impact of CBT on any measure of our remaining primary outcomes.\nSecondary outcomes\nOne study (16 participants) provided very low-certainty evidence that, compared to sexual education, mean cognitive distortions pertaining to justification or taking responsibility for actions (MD 3.27, 95% CI −4.77 to −1.77) and apprehension confidence (MD 2.47 95% CI −3.85 to −1.09) may be lower in the CBT group. The same study indicated that mean cognitive distortions pertaining to social-sexual desirability may be lower in the CBT group, and there may be little to no difference between the groups for cognitive distortions pertaining to inappropriate sexual fantasies measured with the Multiphasic Sex Inventory.\nAuthors' conclusions\nIt is uncertain whether CBT reduces HSB in male adolescents compared to other treatments. All studies had insufficient detail in what they reported to allow for full assessment of risk of bias. 'Risk of bias' judgements were predominantly rated as unclear or high. Sample sizes were very small, and the imprecision of results was significant. There is very low-certainty evidence that group-based CBT may improve victim empathy when compared to no treatment, and may improve cognitive distortions when compared to sexual education, but not treatment as usual. Further research is likely to change the estimate. More robust evaluations of both individual and group-based CBT are required, particularly outside North America, and which look at the effects of CBT on diverse participants.\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": "One study (59 participants) examined whether CBT reduced harmful sexual behaviour, or made participants less likely to offend. It provided very low-certainty evidence showing CBT reduced sexual aggression at post-intervention. This was similar to other treatments of mode deactivation therapy and social skills training. No studies examined whether it had unintended consequences such as self-harm.\nOne study (59 participants) found little to no difference in how CBT improved psychological well-being compared with other treatments (very low-certainty evidence). One study (18 participants) showed CBT meant the young men understood how their behaviour had effected their victims, compared to the no-treatment group (very low-certainty evidence). One study (21 participants) measured this, but reported no usable data.\nTwo studies examined whether CBT improved the kind of thinking associated with harmful sexual behaviour (sexual attitudes and behaviour). One of these (21 participants) compared CBT with treatment as usual. It found no evidence that it made a difference. Another study (16 participants) compared CBT with sexual education. It found CBT improved some types of cognitive distortions. One study (18 participants) reported no significant difference between CBT and receiving no treatment on general cognitive distortions about sexual behaviour (very low-certainty evidence)."
}
] |
query-laysum
|
23862
|
[
{
"role": "user",
"content": "Abstract: Background\nNeonatal sepsis and necrotizing enterocolitis (NEC) cause significant neonatal mortality and morbidity despite appropriate antibiotic therapy. Enhancing host defense and modulating inflammation by using lactoferrin as an adjunct to antibiotics in the treatment of sepsis, NEC, or both, may improve clinical outcomes.\nObjectives\nThe primary objective was to assess safety and efficacy of oral lactoferrin as an adjunct to antibiotics in the treatment of neonates with suspected or confirmed sepsis, NEC, or both.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 9), MEDLINE via PubMed, PREMEDLINE, (1966 to 20 September 2018) Embase (1980 to 20 September 2018), and CINAHL (1982 to 20 September 2018). We also searched clinical trial databases, conference proceedings, the reference lists of retried articles and clinical trials, and the authors' personal files.\nSelection criteria\nWe included randomized or quasi-randomized controlled trials evaluating enteral lactoferrin (at any dose or duration), used as an adjunct to antibiotic therapy, compared with antibiotic therapy alone (with or without placebo) or other adjuncts to antibiotic therapy to treat neonates at any gestational age up to 44 weeks' postmenstrual age with confirmed or suspected sepsis or necrotizing enterocolitis (Bell's Stage II or III).\nData collection and analysis\nWe used the standardized methods of Cochrane Neonatal for conducting a systematic review and for assessing the methodological quality of studies (neonatal.cochrane.org/en/index.html). The titles and the abstracts of studies identified by the search strategy were independently assessed by the two review authors and full text versions were obtained for assessment if necessary. Forms were designed to record trial inclusion/exclusion and data extraction. We used the GRADE approach to assess the quality of evidence.\nMain results\nWe did not identify any eligible trials evaluating lactoferrin for the treatment of neonatal sepsis or NEC.\nAuthors' conclusions\nImplications for practice: currently there is no evidence to support or refute the use of enteral lactoferrin, as an adjunct to antibiotic therapy, for the treatment of neonatal sepsis or necrotizing enterocolitis.\nImplications for research: given the lack of efficacy of enteral lactoferrin for preventing late-onset sepsis and necrotizing enterocolitis, evaluation of enteral lactoferrin as an adjunctive agent for treatment of sepsis or necrotizing enterocolitis does not appear to be a research priority.\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": "Newborn babies, especially those born preterm, are at risk from infections in the blood (sepsis), gastrointestinal inflammation and injury (necrotizing enterocolitis), or both these conditions. A number of babies with sepsis or necrotizing enterocolitis die or suffer from long-term brain and lung damage, despite treatment with antibiotics. Lactoferrin, a substance normally present in human milk, may be effective against infections and gastrointestinal injury."
}
] |
query-laysum
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23863
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[
{
"role": "user",
"content": "Abstract: Background\nOtitis media with effusion (OME) is an accumulation of fluid in the middle ear cavity, common amongst young children. The fluid may cause hearing loss. When persistent, it may lead to developmental delay, social difficulty and poor quality of life. Management of OME includes watchful waiting, autoinflation, medical and surgical treatment. Antibiotics are sometimes used to treat any bacteria present in the effusion, or associated biofilms.\nObjectives\nTo assess the effects (benefits and harms) of oral antibiotics for otitis media with effusion (OME) in children.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register, CENTRAL, Ovid MEDLINE, Ovid Embase, Web of Science, ClinicalTrials.gov, ICTRP and additional sources for published and unpublished studies to 20 January 2023.\nSelection criteria\nWe included randomised controlled trials and quasi-randomised trials in children aged 6 months to 12 years with unilateral or bilateral OME. We included studies that compared oral antibiotics with either placebo or no treatment.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were determined following a multi-stakeholder prioritisation exercise and were: 1) hearing, 2) otitis media-specific quality of life and 3) anaphylaxis. Secondary outcomes were: 1) persistence of OME, 2) adverse effects, 3) receptive language skills, 4) speech development, 5) cognitive development, 6) psychosocial skills, 7) listening skills, 8) generic health-related quality of life, 9) parental stress, 10) vestibular function and 11) episodes of acute otitis media. We used GRADE to assess the certainty of evidence for each outcome.\nAlthough we included all measures of hearing assessment, the proportion of children who returned to normal hearing was our preferred method to assess hearing, due to challenges in interpreting the results of mean hearing thresholds.\nMain results\nWe identified 19 completed studies that met our inclusion criteria (2581 participants). They assessed a variety of oral antibiotics (including penicillins, cephalosporins, macrolides and trimethoprim), with most studies using a 10- to 14-day treatment course. We had some concerns about the risk of bias in all studies included in this review. Here we report our primary outcomes and main secondary outcome, at the longest reported follow-up time.\nAntibiotics versus placebo\nWe included 11 studies for this comparison, but none reported all of our outcomes of interest and limited meta-analysis was possible.\nHearing\nOne study found that more children may return to normal hearing by two months (resolution of the air-bone gap) after receiving antibiotics as compared with placebo, but the evidence is very uncertain (Peto odds ratio (OR) 9.59, 95% confidence interval (CI) 3.51 to 26.18; 20/49 children who received antibiotics returned to normal hearing versus 0/37 who received placebo; 1 study, 86 participants; very low-certainty evidence).\nDisease-specific quality of life\nNo studies assessed this outcome.\nPresence/persistence of OME\nAt 6 to 12 months of follow-up, the use of antibiotics compared with placebo may slightly reduce the number of children with persistent OME, but the confidence intervals were wide, and the evidence is very uncertain (risk ratio (RR) 0.89, 95% CI 0.68 to 1.17; 48% versus 54%; number needed to treat (NNT) 17; 2 studies, 324 participants; very low-certainty evidence).\nAdverse event: anaphylaxis\nNo studies provided specific data on anaphylaxis. Three of the included studies (448 children) did report adverse events in sufficient detail to assume that no anaphylactic reactions occurred, but the evidence is very uncertain (very low-certainty evidence).\nAntibiotics versus no treatment\nWe included eight studies for this comparison, but very limited meta-analysis was possible.\nHearing\nOne study found that the use of antibiotics compared to no treatment may result in little to no difference in final hearing threshold at three months (mean difference (MD) -5.38 dB HL, 95% CI -9.12 to -1.64; 1 study, 73 participants; low-certainty evidence). The only data identified on the return to normal hearing were reported at 10 days of follow-up, which we considered to be too short to accurately reflect the efficacy of antibiotics.\nDisease-specific quality of life\nNo studies assessed this outcome.\nPresence/persistence of OME\nAntibiotics may reduce the proportion of children who have persistent OME at up to three months of follow-up, when compared with no treatment (RR 0.64, 95% CI 0.50 to 0.80; 6 studies, 542 participants; low-certainty evidence).\nAdverse event: anaphylaxis\nNo studies provided specific data on anaphylaxis. Two of the included studies (180 children) did report adverse events in sufficient detail to assume that no anaphylactic reactions occurred, but the evidence is very uncertain (very low-certainty evidence).\nAuthors' conclusions\nThe evidence for the use of antibiotics for OME is of low to very low certainty. Although the use of antibiotics compared to no treatment may have a slight beneficial effect on the resolution of OME at up to three months, the overall impact on hearing is very uncertain. The long-term effects of antibiotics are unclear and few of the studies included in this review reported on potential harms. These important endpoints should be considered when weighing up the potential short- and long-term benefits and harms of antibiotic treatment in a condition with a high spontaneous resolution rate.\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": "We are uncertain whether the use of antibiotics improves hearing for children with glue ear, due to a lack of robust evidence.\nThe use of antibiotics compared to no treatment might slightly reduce the number of children who have glue ear at three months of follow-up. It is unclear whether this is a long-lasting effect, as few studies followed up children for more than three months.\nThe studies included in this review did not report serious harms from treatment with antibiotics. However, there is some suggestion that antibiotics may cause unpleasant side effects such as skin rash."
}
] |
query-laysum
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23864
|
[
{
"role": "user",
"content": "Abstract: Background\nMost cancer survivors receive follow-up care after completion of treatment with the primary aim of detecting recurrence. Traditional follow-up consisting of fixed visits to a cancer specialist for examinations and tests are expensive and may be burdensome for the patient. Follow-up strategies involving non-specialist care providers, different intensity of procedures, or addition of survivorship care packages have been developed and tested, however their effectiveness remains unclear.\nObjectives\nThe objective of this review is to compare the effect of different follow-up strategies in adult cancer survivors, following completion of primary cancer treatment, on the primary outcomes of overall survival and time to detection of recurrence. Secondary outcomes are health-related quality of life, anxiety (including fear of recurrence), depression and cost.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, four other databases and two trials registries on 11 December 2018 together with reference checking, citation searching and contact with study authors to identify additional studies.\nSelection criteria\nWe included all randomised trials comparing different follow-up strategies for adult cancer survivors following completion of curatively-intended primary cancer treatment, which included at least one of the outcomes listed above. We compared the effectiveness of: 1) non-specialist-led follow-up (i.e. general practitioner (GP)-led, nurse-led, patient-initiated or shared care) versus specialist-led follow-up; 2) less intensive versus more intensive follow-up (based on clinical visits, examinations and diagnostic procedures) and 3) follow-up integrating additional care components relevant for detection of recurrence (e.g. patient symptom education or monitoring, or survivorship care plans) versus usual care.\nData collection and analysis\nWe used the standard methodological guidelines by Cochrane and Cochrane Effective Practice and Organisation of Care (EPOC). We assessed the certainty of the evidence using the GRADE approach. For each comparison, we present synthesised findings for overall survival and time to detection of recurrence as hazard ratios (HR) and for health-related quality of life, anxiety and depression as mean differences (MD), with 95% confidence intervals (CI). When meta-analysis was not possible, we reported the results from individual studies. For survival and recurrence, we used meta-regression analysis where possible to investigate whether the effects varied with regards to cancer site, publication year and study quality.\nMain results\nWe included 53 trials involving 20,832 participants across 12 cancer sites and 15 countries, mainly in Europe, North America and Australia. All the studies were carried out in either a hospital or general practice setting. Seventeen studies compared non-specialist-led follow-up with specialist-led follow-up, 24 studies compared intensity of follow-up and 12 studies compared patient symptom education or monitoring, or survivorship care plans with usual care. Risk of bias was generally low or unclear in most of the studies, with a higher risk of bias in the smaller trials.\nNon-specialist-led follow-up compared with specialist-led follow-up\nIt is uncertain how this strategy affects overall survival (HR 1.21, 95% CI 0.68 to 2.15; 2 studies; 603 participants), time to detection of recurrence (4 studies, 1691 participants) or cost (8 studies, 1756 participants) because the certainty of the evidence is very low.\nNon-specialist- versus specialist-led follow up may make little or no difference to health-related quality of life at 12 months (MD 1.06, 95% CI −1.83 to 3.95; 4 studies; 605 participants; low-certainty evidence); and probably makes little or no difference to anxiety at 12 months (MD −0.03, 95% CI −0.73 to 0.67; 5 studies; 1266 participants; moderate-certainty evidence). We are more certain that it has little or no effect on depression at 12 months (MD 0.03, 95% CI −0.35 to 0.42; 5 studies; 1266 participants; high-certainty evidence).\nLess intensive follow-up compared with more intensive follow-up\nLess intensive versus more intensive follow-up may make little or no difference to overall survival (HR 1.05, 95% CI 0.96 to 1.14; 13 studies; 10,726 participants; low-certainty evidence) and probably increases time to detection of recurrence (HR 0.85, 95% CI 0.79 to 0.92; 12 studies; 11,276 participants; moderate-certainty evidence). Meta-regression analysis showed little or no difference in the intervention effects by cancer site, publication year or study quality.\nIt is uncertain whether this strategy has an effect on health-related quality of life (3 studies, 2742 participants), anxiety (1 study, 180 participants) or cost (6 studies, 1412 participants) because the certainty of evidence is very low. None of the studies reported on depression.\nFollow-up strategies integrating additional patient symptom education or monitoring, or survivorship care plans compared with usual care:\nNone of the studies reported on overall survival or time to detection of recurrence.\nIt is uncertain whether this strategy makes a difference to health-related quality of life (12 studies, 2846 participants), anxiety (1 study, 470 participants), depression (8 studies, 2351 participants) or cost (1 studies, 408 participants), as the certainty of evidence is very low.\nAuthors' conclusions\nEvidence regarding the effectiveness of the different follow-up strategies varies substantially. Less intensive follow-up may make little or no difference to overall survival but probably delays detection of recurrence. However, as we did not analyse the two outcomes together, we cannot make direct conclusions about the effect of interventions on survival after detection of recurrence. The effects of non-specialist-led follow-up on survival and detection of recurrence, and how intensity of follow-up affects health-related quality of life, anxiety and depression, are uncertain. There was little evidence for the effects of follow-up integrating additional patient symptom education/monitoring and survivorship care plans.\n\nGiven the provided abstract, please respond to the following query: \"When cancer survivors receive aftercare led by non-specialists, such as GPs and nurses\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- We are not sure if overall survival is affected or if cancer recurrence is detected earlier;\n- It probably makes little or no difference to health-related quality of life and anxiety and it makes no difference for depression at 12 months of follow-up;\n- We are not sure there is a difference in costs between these two types of follow-up strategies."
}
] |
query-laysum
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23865
|
[
{
"role": "user",
"content": "Abstract: Background\nRotavirus is a common cause of diarrhoea, diarrhoea-related hospital admissions, and diarrhoea-related deaths worldwide. Rotavirus vaccines prequalified by the World Health Organization (WHO) include Rotarix (GlaxoSmithKline), RotaTeq (Merck), and, more recently, Rotasiil (Serum Institute of India Ltd.), and Rotavac (Bharat Biotech Ltd.).\nObjectives\nTo evaluate rotavirus vaccines prequalified by the WHO for their efficacy and safety in children.\nSearch methods\nOn 30 November 2020, we searched PubMed, the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in the Cochrane Library), Embase, LILACS, Science Citation Index Expanded, Social Sciences Citation Index, Conference Proceedings Citation Index-Science, Conference Proceedings Citation Index-Social Science & Humanities. We also searched the WHO ICTRP, ClinicalTrials.gov, clinical trial reports from manufacturers' websites, and reference lists of included studies, and relevant systematic reviews.\nSelection criteria\nWe selected randomized controlled trials (RCTs) conducted in children that compared rotavirus vaccines prequalified for use by the WHO with either placebo or no intervention.\nData collection and analysis\nTwo authors independently assessed trial eligibility and assessed risk of bias. One author extracted data and a second author cross-checked them. We combined dichotomous data using the risk ratio (RR) and 95% confidence interval (CI). We stratified the analyses by under-five country mortality rate and used GRADE to evaluate evidence certainty.\nMain results\nSixty trials met the inclusion criteria and enrolled a total of 228,233 participants. Thirty-six trials (119,114 participants) assessed Rotarix, 15 trials RotaTeq (88,934 participants), five trials Rotasiil (11,753 participants), and four trials Rotavac (8432 participants).\nRotarix\nInfants vaccinated and followed up for the first year of life\nIn low-mortality countries, Rotarix prevented 93% of severe rotavirus diarrhoea cases (14,976 participants, 4 trials; high-certainty evidence), and 52% of severe all-cause diarrhoea cases (3874 participants, 1 trial; moderate-certainty evidence).\nIn medium-mortality countries, Rotarix prevented 79% of severe rotavirus diarrhoea cases (31,671 participants, 4 trials; high-certainty evidence), and 36% of severe all-cause diarrhoea cases (26,479 participants, 2 trials; high-certainty evidence).\nIn high-mortality countries, Rotarix prevented 58% of severe rotavirus diarrhoea cases (15,882 participants, 4 trials; high-certainty evidence), and 27% of severe all-cause diarrhoea cases (5639 participants, 2 trials; high-certainty evidence).\nChildren vaccinated and followed up for two years\nIn low-mortality countries, Rotarix prevented 90% of severe rotavirus diarrhoea cases (18,145 participants, 6 trials; high-certainty evidence), and 51% of severe all-cause diarrhoea episodes (6269 participants, 2 trials; moderate-certainty evidence).\nIn medium-mortality countries, Rotarix prevented 77% of severe rotavirus diarrhoea cases (28,834 participants, 3 trials; high-certainty evidence), and 26% of severe all-cause diarrhoea cases (23,317 participants, 2 trials; moderate-certainty evidence).\nIn high-mortality countries, Rotarix prevented 35% of severe rotavirus diarrhoea cases (13,768 participants, 2 trials; moderate-certainty evidence), and 17% of severe all-cause diarrhoea cases (2764 participants, 1 trial; high-certainty evidence).\nRotaTeq\nInfants vaccinated and followed up for the first year of life\nIn low-mortality countries, RotaTeq prevented 97% of severe rotavirus diarrhoea cases (5442 participants, 2 trials; high-certainty evidence).\nIn medium-mortality countries, RotaTeq prevented 79% of severe rotavirus diarrhoea cases (3863 participants, 1 trial; low-certainty evidence).\nIn high-mortality countries, RotaTeq prevented 57% of severe rotavirus diarrhoea cases (6775 participants, 2 trials; high-certainty evidence), but there is probably little or no difference between vaccine and placebo for severe all-cause diarrhoea (1 trial, 4085 participants; moderate-certainty evidence).\nChildren vaccinated and followed up for two years\nIn low-mortality countries, RotaTeq prevented 96% of severe rotavirus diarrhoea cases (5442 participants, 2 trials; high-certainty evidence).\nIn medium-mortality countries, RotaTeq prevented 79% of severe rotavirus diarrhoea cases (3863 participants, 1 trial; low-certainty evidence).\nIn high-mortality countries, RotaTeq prevented 44% of severe rotavirus diarrhoea cases (6744 participants, 2 trials; high-certainty evidence), and 15% of severe all-cause diarrhoea cases (5977 participants, 2 trials; high-certainty evidence).\nWe did not identify RotaTeq studies reporting on severe all-cause diarrhoea in low- or medium-mortality countries.\nRotasiil\nRotasiil has not been assessed in any RCT in countries with low or medium child mortality.\nInfants vaccinated and followed up for the first year of life\nIn high-mortality countries, Rotasiil prevented 48% of severe rotavirus diarrhoea cases (11,008 participants, 2 trials; high-certainty evidence), and resulted in little to no difference in severe all-cause diarrhoea cases (11,008 participants, 2 trials; high-certainty evidence).\nChildren vaccinated and followed up for two years\nIn high-mortality countries, Rotasiil prevented 44% of severe rotavirus diarrhoea cases (11,008 participants, 2 trials; high-certainty evidence), and resulted in little to no difference in severe all-cause diarrhoea cases (11,008 participants, 2 trials; high-certainty evidence).\nRotavac\nRotavac has not been assessed in any RCT in countries with low or medium child mortality.\nInfants vaccinated and followed up for the first year of life\nIn high-mortality countries, Rotavac prevented 57% of severe rotavirus diarrhoea cases (6799 participants, 1 trial; moderate-certainty evidence), and 16% of severe all-cause diarrhoea cases (6799 participants, 1 trial; moderate-certainty evidence).\nChildren vaccinated and followed up for two years\nIn high-mortality countries, Rotavac prevented 54% of severe rotavirus diarrhoea cases (6541 participants, 1 trial; moderate-certainty evidence); no Rotavac studies have reported on severe all-cause diarrhoea at two-years follow-up.\nSafety\nNo increased risk of serious adverse events (SAEs) was detected with Rotarix (103,714 participants, 31 trials; high-certainty evidence), RotaTeq (82,502 participants, 14 trials; moderate to high-certainty evidence), Rotasiil (11,646 participants, 3 trials; high-certainty evidence), or Rotavac (8210 participants, 3 trials; moderate-certainty evidence).\nDeaths were infrequent and the analysis had insufficient evidence to show an effect on all-cause mortality. Intussusception was rare.\nAuthors' conclusions\nRotarix, RotaTeq, Rotasiil, and Rotavac prevent episodes of rotavirus diarrhoea. The relative effect estimate is smaller in high-mortality than in low-mortality countries, but more episodes are prevented in high-mortality settings as the baseline risk is higher. In high-mortality countries some results suggest lower efficacy in the second year. We found no increased risk of serious adverse events, including intussusception, from any of the prequalified rotavirus vaccines.\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": "The aim of this Cochrane Review was to find out if rotavirus vaccines are effective in preventing diarrhoea and deaths in infants and young children. We also aimed to find out if the rotavirus vaccines are safe. We collected and analysed all relevant studies to answer these questions."
}
] |
query-laysum
|
23866
|
[
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is a life-limiting genetic condition affecting various organ systems including the gastrointestinal tract, endocrine system and especially the respiratory tract. Pulmonary exacerbations in CF result in increased symptoms, an acceleration in the rate of lung decline and an increased need for treatment. Early detection of infections or clinical worsening provides an opportunity for proactive treatment that may affect clinical outcomes.\nObjectives\nTo evaluate whether digital technology can effectively predict pulmonary exacerbations to allow earlier intervention and improved health outcomes without increasing the burden of treatment in people with CF.\nSearch methods\nWe used standard, extensive Cochrane search methods. We searched the Cochrane Cystic Fibrosis Trials Register and the reference lists of relevant articles and reviews on 13 October 2022. We searched Embase and the clinical trial registries on 3 January 2023.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs in people with CF looking at whether digital technology can effectively predict pulmonary exacerbations to allow earlier intervention and improved health outcomes without increasing the burden of treatment.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. pulmonary exacerbations and 2. quality of life (QoL). Our secondary outcomes were 3. lung function, 4. hospitalisations, 5. intravenous (IV) antibiotics, 6. microbiology, 7. cost-effectiveness and 8. adverse events. We used GRADE to assess certainty of evidence.\nMain results\nWe included three studies (415 participants) in people with CF aged 15 to 41 years over a 12-month period. One was a multicentre RCT, whilst two were single-centre RCTs.\nThe three studies were mostly similar in their risk of bias, having low or unclear risk of selection bias but a high risk of detection bias, due to the unblinded design of these studies. The studies used a variety of digital technologies to monitor symptoms such as a digital symptom diary either with or without home spirometry monitoring. As the trials only included adults and older children, we are not certain that the results would apply to younger children.\nOne of our primary outcomes was to assess time to detection of pulmonary exacerbation and number of pulmonary exacerbations identified between the intervention and routine care groups. We were largely unable to pool results in a meta-analysis due to the variety of methodologies and ways of reporting data. Two studies noted a shorter time to detection of exacerbations in the intervention group and one of these also reported that the intervention group had a shorter time to first exacerbation (hazard ratio for time to first exacerbation 1.45, 95% confidence interval (CI) 1.09 to 1.93), whilst a further study reported a shorter time to detection of exacerbations in the intervention group requiring oral or IV antibiotics compared to the control group (median: 70 (interquartile range (IQR) 123) days with intervention versus 141 (IQR 140) days with control; P = 0.02). However, all three studies were concordant in finding no probable effect on spirometry in the intervention groups when compared with their routine care groups over a 12-month period.\nWe found that there is probably no difference between groups with regard to QoL scores across most domains except for Weight and Body Image, which favoured the usual care group. There is also probably no difference in the number of days of additional IV antibiotics needed or newly detected pathogens.\nNo studies reported serious adverse events directly linked to the intervention and one study reported their smartphone application was generally well received.\nAuthors' conclusions\nPulmonary exacerbations are universally accepted to be detrimental to progression of CF-related lung disease, therefore, it is intuitive that early detection and intervention would help to improve outcomes. Digital technology provides an opportunity to detect physiological and symptomatic changes to identify exacerbations early.\nOur review found that digital technologies based on recording physiological change (spirometry) and symptoms probably allow earlier identification of exacerbations as a group. However, this may not reduce the number of exacerbations warranting IV antibiotics and there is probably no effect on lung function. This may be partly due to inconsistent definitions of pulmonary exacerbations and discrepancy in the management strategies for pulmonary exacerbations. Overall, the intervention may make little or no difference to QoL scores.\nThe adherence to and uptake of digital technologies, especially those which include physiological measurements, are not well sustained and the costs of these need to be balanced against the clinical efficacy.\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 well-designed clinical trials in people with CF. People taking part in the studies had the same chance of being in either the treatment group (who used the digital technology) or the usual care group."
}
] |
query-laysum
|
23867
|
[
{
"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: \"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 if controlling flies can prevent diarrhoea in children under the age of five years."
}
] |
query-laysum
|
23868
|
[
{
"role": "user",
"content": "Abstract: Background\n30% of people with anogenital warts (AGW) have spontaneous regression of lesions but there is no way to determine whether a specific lesion will remain. There are a wide range of options available for treating people with AGW and selection is based on clinician's experience, patient preferences and adverse effects. The imiquimod could offer the advantages of patient-applied therapies without incurring the limitations of provider-administered treatments.\nObjectives\nTo assess the effectiveness and safety of imiquimod for the treatment of AGW in non-immunocompromised adults.\nSearch methods\nWe searched the Cochrane Sexually Transmitted Infections Group Specialized Register (15 April 2014), CENTRAL (1991 to 15 April 2014), MEDLINE (1946 to 15 April 2014), EMBASE (1947 to 15 April 2014), LILACS (1982 to 15 April 2014), World Health Organization International Clinical Trials Registry (ICTRP) (15 April 2014), ClinicalTrials.gov (15 April 2014), Web of Science (2001 to 15 April 2014) and OpenGrey (15 April 2014). We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies.\nSelection criteria\nRandomized controlled trials (RCTs) comparing the use of imiquimod with placebo, any other patient-applied or any other provider-administered treatment (excluding interferon and 5-fluorouracil which are assessed in other Cochrane Reviews) for the treatment of AGW in non-immunocompromised adults.\nData collection and analysis\nThree review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We resolved any disagreements through consensus. The quality of the evidence was assessed using the GRADE approach.\nMain results\nTen RCTs (1734 participants) met our inclusion criteria of which six were funded by industry. We judged the risk of bias of the included trials as high. Six trials (1294 participants) compared the use of imiquimod versus placebo. There was very low quality evidence that imiquimod was superior to placebo in achieving complete and partial regression (RR 4.03, 95% CI 2.03 to 7.99; RR 2.56, 95% CI 2.05 to 3.20, respectively). When compared with placebo, the effects of imiquimod on recurrence (RR 2.76, 95% CI 0.70 to 10.91), appearance of new warts (RR 0.76, 95% CI 0.58 to 1.00) and frequency of systemic adverse reactions (RR 0.91, 95% CI 0.63 to 1.32) were imprecise. We downgraded the quality of evidence to low or very low. There was low quality evidence that imiquimod led to more local adverse reactions (RR 1.73, 95% CI 1.18 to 2.53) and pain (RR 11.84, 95% CI 3.36 to 41.63).\nTwo trials (105 participants) compared the use of imiquimod versus any other patient-applied treatment (podophyllotoxin and podophyllin). The estimated effects of imiquimod on complete regression (RR 1.09, 95% CI 0.80 to 1.48), partial regression (RR 0.77, 95% CI 0.40 to 1.47), recurrence (RR 0.49, 95% CI 0.21 to 1.11) or the presence of local adverse reactions (RR 1.24, 95% CI 1.00 to 1.54) were imprecise (very low quality evidence). There was low quality evidence that systemic adverse reactions were less frequent with imiquimod (RR 0.30, 95% CI 0.09 to 0.98).\nFinally, two trials (335 participants) compared imiquimod with any other provider-administered treatment (ablative methods and cryotherapy). There was very low quality of evidence that imiquimod did not have a lower frequency of complete regression (RR 0.84, 95% CI 0.56 to 1.28). There was very low quality evidence that imiquimod led to a lower rate of recurrence during six-month follow-up (RR 0.24, 95% CI 0.10 to 0.56) but this did not translate in to a lower recurrence from six to 12 months (RR 0.71, 95% CI 0.40 to 1.25; very low quality evidence). There was very low quality evidence that imiquimod was associated with less pain (RR 0.30, 95% CI 0.17 to 0.54) and fewer local reactions (RR 0.55, 95% CI 0.40 to 0.74).\nAuthors' conclusions\nThe benefits and harms of imiquimod compared with placebo should be regarded with caution due to the risk of bias, imprecision and inconsistency for many of the outcomes we assessed in this Cochrane Review. The evidence for many of the outcomes that show imiquimod and patient-applied treatment (podophyllotoxin or podophyllin) confer similar benefits but fewer systematic reactions with the Imiquimod, is of low or very low quality. The quality of evidence for the outcomes assessing imiquimod and other provider-administered treatment were of very low quality.\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": "Compared with placebo, imiquimod was superior to achieve complete and partial regression but not in the rate of recurrence, appearance of new warts or the frequency of systemic reactions. The patients allocated to imiquimod treatment had a higher frequency of pain and local adverse reactions. When imiquimod was compared with any other patient-applied treatment, we were unable to determine whether it led to differences in the rate of complete or partial regression, recurrence or the presence of local reactions, although systemic adverse reactions were lower in the imiquimod group. Finally, when imiquimod use was compared with any other provider-administered treatment it was unclear whether there were differences in terms of complete regression. Imiquimod was associated with a lower rate of recurrence during the first six months after treatment and with less pain or local reactions."
}
] |
query-laysum
|
23869
|
[
{
"role": "user",
"content": "Abstract: Background\nOsteogenesis imperfecta is caused by a genetic defect resulting in an abnormal type I collagen bone matrix which typically results in multiple fractures with little or no trauma. Bisphosphonates are used in an attempt to increase bone mineral density and reduce these fractures in people with osteogenesis imperfecta. This is an update of a previously published Cochrane Review.\nObjectives\nTo assess the effectiveness and safety of bisphosphonates in increasing bone mineral density, reducing fractures and improving clinical function in people with osteogenesis imperfecta.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Inborn Errors of Metabolism Trials Register which comprises references identified from comprehensive electronic database searches, handsearches of journals and conference proceedings. We additionally searched PubMed and major conference proceedings.\nDate of the most recent search of the Cochrane Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Register: 28 April 2016.\nSelection criteria\nRandomised and quasi-randomised controlled trials comparing bisphosphonates to placebo, no treatment, or comparator interventions in all types of osteogenesis imperfecta.\nData collection and analysis\nTwo authors independently extracted data and assessed the risk of bias of the included trials.\nMain results\nFourteen trials (819 participants) were included. Overall, the trials were mainly at a low risk of bias, although selective reporting was an issue in several of the trials. Data for oral bisphosphonates versus placebo could not be aggregated; a statistically significant difference favouring oral bisphosphonates in fracture risk reduction and number of fractures was noted in two trials. No differences were reported in the remaining three trials which commented on fracture incidence. Five trials reported data for spine bone mineral density; all found statistically significant increased lumbar spine density z scores for at least one time point studied. For intravenous bisphosphonates versus placebo, aggregated data from two trials showed no statistically significant difference for the number of participants with at least one fracture, risk ratio 0.56 (95% confidence interval 0.30 to 1.06). In the remaining trial no statistically significant difference was noted in fracture incidence. For spine bone mineral density, no statistically significant difference was noted in the aggregated data from two trials, mean difference 9.96 (95% confidence interval -2.51 to 22.43). In the remaining trial a statistically significant difference in mean per cent change in spine bone mineral density z score favoured intravenous bisphosphonates at six and 12 months. Data describing growth, bone pain, and functional outcomes after oral or intravenous bisphosphonate therapy, or both, as compared to placebo were incomplete among all studies, but do not show consistent improvements in these outcomes. Two studies compared different doses of bisphosphonates. No differences were found between doses when bone mineral density, fractures, and height or length z score were assessed. One trial compared oral versus intravenous bisphosphonates and found no differences in primary outcomes. Two studies compared the intravenous bisphosphonates zoledronic acid and pamidronate. There were no significant differences in primary outcome. However, the studies were at odds as to the relative benefit of zoledronic acid over pamidronate for lumbosacral bone mineral density at 12 months.\nAuthors' conclusions\nBisphophonates are commonly prescribed to individuals with osteogenesis imperfecta. Current evidence, albeit limited, demonstrates oral or intravenous bisphosphonates increase bone mineral density in children and adults with this condition. These were not shown to be different in their ability to increase bone mineral density. It is unclear whether oral or intravenous bisphosphonate treatment consistently decreases fractures, though multiple studies report this independently and no studies report an increased fracture rate with treatment. The studies included here do not show bisphosphonates conclusively improve clinical status (reduce pain; improve growth and functional mobility) in people with osteogenesis imperfecta. Given their current widespread and expected continued use, the optimal method, duration of therapy and long-term safety of bisphosphonate therapy require further investigation. In addition, attention should be given to long-term fracture reduction and improvement in quality of life indicators.\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": "Osteogenesis imperfecta is also known as brittle bone disease. It is a genetic condition which can be passed on from a parent to child or occur in the child without any other family history. An affected person is at risk for frequent breaks of the long bones or collapse of the bones of the spine. There is no cure for osteogenesis imperfecta and treatment is mostly supportive."
}
] |
query-laysum
|
23870
|
[
{
"role": "user",
"content": "Abstract: Background\nDonor site wounds of split-thickness skin grafts can be a major cause of morbidity. Choosing the appropriate dressing for these wounds is crucial to successful healing. Various types of dressing are available, including hydrogel dressings. A review of current evidence is required to guide clinical decision-making on the choice of dressing for the treatment of donor sites of split-thickness skin grafts.\nObjectives\nTo assess the effects of hydrogel dressings on donor site wounds following split-thickness skin grafts for wound healing.\nSearch methods\nIn July 2022 we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL EBSCO Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication, or study setting.\nSelection criteria\nRandomised controlled trials (RCTs) comparing hydrogel dressings with other types of dressing, topical treatments or no dressing, or with different types of hydrogel dressings in managing donor site wounds irrespective of language and publication status.\nData collection and analysis\nTwo review authors independently carried out data extraction, risk of bias assessment using the Cochrane risk of bias tool, RoB 1, and quality assessment according to GRADE methodology.\nMain results\nWe included two studies (162 participants) in this review. One study with three arms and 101 participants (15 months' duration) was conducted in a children's hospital, and compared hydrogel dressings in the form of Sorbact with Algisite, an alginate dressing and Cuticerin, a smooth acetate gauze impregnated with water-repellent ointment. Another study with two arms and 61 participants (19 months' duration) was conducted in three surgery departments and compared an octenidine-containing hydrogel dressing with an identical non-antimicrobial hydrogel dressing. We identified no studies that compared hydrogel dressings with another therapy such as a topical agent (a topical agent is a cream, an ointment or a solution that is applied directly to the wound), or no dressing, or a combination of hydrogel dressings and another therapy versus another therapy alone. Both studies were at high risk of attrition bias and the second study was also at unclear risk of selection bias.\nAmorphous hydrogel dressings versus other types of dressings\nAmorphous hydrogel dressings may increase time to wound healing when compared with alginate (mean difference (MD) 1.67 days, 95% confidence interval (CI) 0.56 to 2.78; 1 study, 69 participants; low-certainty evidence) or Cuticerin dressings (MD 1.67 days, 95% CI 0.55 to 2.79; 1 study, 68 participants; low-certainty evidence). The effect of amorphous hydrogel dressings compared with other types of dressings is uncertain for pain at the donor site and wound complications, including scarring and itching (very low-certainty evidence). No adverse events were reported in any of the groups. The study did not report health-related quality of life or wound infection.\nOctenidine-based hydrogel dressing versus octenidine-free hydrogel dressing\nThe effect of octenidine-based hydrogel dressings versus octenidine-free hydrogel dressings is uncertain for time to wound healing (MD 0.40, 95% CI 0.28 to 0.52; 1 study, 41 participants) and wound infection, as the certainty of the evidence is very low. The certainty of the evidence is also very low for adverse events, with two participants in the intervention group and one participant in the comparison group reporting adverse events (risk ratio (RR) 0.58, 95% CI 0.06 to 5.89; 1 study, 41 participants). The study did not report donor site pain, health-related quality of life, or wound complications.\nAuthors' conclusions\nThere is insufficient evidence to determine the effect of hydrogel dressings on donor site wounds of split thickness skin grafts compared with other types of dressings. There is a need for adequately powered and well-designed RCTs, with adequate sample sizes, types of populations and subgroups, types of interventions, and outcomes, that compare hydrogel dressings with other treatment options in the treatment of donor site wounds of split-thickness skin grafts.\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": "- We do not know if hydrogel dressings (designed to keep wounds moist) are better than other dressings for helping donor site wounds to heal after split-thickness skin grafts (skin taken from another part of the body).\n- We did not find any studies comparing hydrogel dressings with creams, ointments, or other solutions applied directly to the wound.\n- More and better designed studies are needed to answer this question."
}
] |
query-laysum
|
23871
|
[
{
"role": "user",
"content": "Abstract: Background\nAcute exacerbations of chronic obstructive pulmonary disease (COPD) are a major cause of hospital admission and mortality. They contribute to long-term decline in lung function, physical capacity and quality of life. The most common causes are infective, and treatment includes antibiotics, bronchodilators and systemic corticosteroids as anti-inflammatory agents.\nObjectives\nTo assess the effects of corticosteroids administered orally or parenterally for treatment of acute exacerbations of COPD, and to compare the efficacy of parenteral versus oral administration.\nSearch methods\nWe carried out searches using the Cochrane Airways Group Specialised Register of Trials, MEDLINE and CENTRAL (Cochrane Central Register of Controlled Trials), and checked references of included studies and trials registries. We conducted the last search in May 2014.\nSelection criteria\nRandomised controlled trials comparing corticosteroids administered orally or parenterally with an appropriate placebo, or comparing oral corticosteroids with parenteral corticosteroids in the treatment of people with acute exacerbations of COPD. Other interventions (e.g. bronchodilators and antibiotics) were standardised for both groups. We excluded clinical studies of acute asthma.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nSixteen studies (n = 1787) met inclusion criteria for the comparison systemic corticosteroid versus placebo and 13 studies contributed data (n = 1620). Four studies (n = 298) met inclusion criteria for the comparison oral corticosteroid versus parenteral corticosteroid and three studies contributed data (n = 239). The mean age of participants with COPD was 68 years, median proportion of males 82% and mean forced expiratory volume in one second (FEV1) per cent predicted at study admission was 40% (6 studies; n = 633). We judged risk of selection, detection, attrition and reporting bias as low or unclear in all studies. We judged risk of performance bias high in one study comparing systemic corticosteroid with control and in two studies comparing intravenous corticosteroid versus oral corticosteroid.\nSystemic corticosteroids reduced the risk of treatment failure by over half compared with placebo in nine studies (n = 917) with median treatment duration 14 days, odds ratio (OR) 0.48 (95% confidence interval (CI) 0.35 to 0.67). The evidence was graded as high quality and it would have been necessary to treat nine people (95% CI 7 to 14) with systemic corticosteroids to avoid one treatment failure. There was moderate-quality evidence for a lower rate of relapse by one month for treatment with systemic corticosteroid in two studies (n = 415) (hazard ratio (HR) 0.78; 95% CI 0.63 to 0.97). Mortality up to 30 days was not reduced by treatment with systemic corticosteroid compared with control in 12 studies (n = 1319; OR 1.00; 95% CI 0.60 to 1.66).\nFEV1, measured up to 72 hours, showed significant treatment benefits (7 studies; n = 649; mean difference (MD) 140 mL; 95% CI 90 to 200); however, this benefit was not observed at later time points. The likelihood of adverse events increased with corticosteroid treatment (OR 2.33; 95% CI 1.59 to 3.43). Overall, one extra adverse effect occurred for every six people treated (95% CI 4 to 10). The risk of hyperglycaemia was significantly increased (OR 2.79; 95% CI 1.86 to 4.19). For general inpatient treatment, duration of hospitalisation was significantly shorter with corticosteroid treatment (MD -1.22 days; 95% CI -2.26 to -0.18), with no difference in length of stay the intensive care unit (ICU) setting.\nComparison of parenteral versus oral treatment showed no significant difference in the primary outcomes of treatment failure, relapse or mortality or for any secondary outcomes. There was a significantly increased rate of hyperglycaemia in one study (OR 4.89; 95% CI 1.20 to 19.94).\nAuthors' conclusions\nThere is high-quality evidence to support treatment of exacerbations of COPD with systemic corticosteroid by the oral or parenteral route in reducing the likelihood of treatment failure and relapse by one month, shortening length of stay in hospital inpatients not requiring assisted ventilation in ICU and giving earlier improvement in lung function and symptoms. There is no evidence of benefit for parenteral treatment compared with oral treatment with corticosteroid on treatment failure, relapse or mortality. There is an increase in adverse drug effects with corticosteroid treatment, which is greater with parenteral administration compared with oral treatment.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 16 studies including over 1700 people with COPD who experienced a flare-up that required additional medical treatment that compared corticosteroid given by injections or tablets with dummy treatment. Four studies with nearly 300 people compared corticosteroid injections with corticosteroid tablets. More men than women took part in the studies and they were usually in their late 60s, with moderately severe symptoms of COPD. Most studies took place in hospitals, two in intensive care units with people who needed breathing support, and three studies involved people who were treated at home. The last search for studies to include in the review was done in May 2014.\nThere were three studies where people knew which treatment they were getting, but otherwise studies were generally well designed.\nPeople treated with either corticosteroid injections or tablets compared with dummy treatment were less likely to experience treatment failure, 122 fewer people per 1000 treated, with a lower rate of relapse by one month. They had shorter stays in hospital if they did not require assisted ventilation in an intensive care unit, and their lung function and breathlessness improved more quickly during treatment. However, they had more adverse events while taking treatment, especially a temporary increase in glucose levels in blood. Corticosteroid treatment did not reduce the number of people who died within one month of their flare-up.\nIn studies comparing two ways of giving corticosteroid, either by injections or tablets, there were no differences in treatment failure, the time in hospital or number of deaths after discharge; however, a temporary increase in glucose levels in blood was more likely with injections than tablets."
}
] |
query-laysum
|
23872
|
[
{
"role": "user",
"content": "Abstract: Background\nThis review is an update of 'Topical capsaicin (high concentration) for chronic neuropathic pain in adults' last updated in Issue 2, 2013. Topical creams with capsaicin are used to treat peripheral neuropathic pain. Following application to the skin, capsaicin causes enhanced sensitivity, followed by a period with reduced sensitivity and, after repeated applications, persistent desensitisation. High-concentration (8%) capsaicin patches were developed to increase the amount of capsaicin delivered; rapid delivery was thought to improve tolerability because cutaneous nociceptors are 'defunctionalised' quickly. The single application avoids noncompliance. Only the 8% patch formulation of capsaicin is available, with a capsaicin concentration about 100 times greater than conventional creams. High-concentration topical capsaicin is given as a single patch application to the affected part. It must be applied under highly controlled conditions, often following local anaesthetic, due to the initial intense burning sensation it causes. The benefits are expected to last for about 12 weeks, when another application might be made.\nObjectives\nTo review the evidence from controlled trials on the efficacy and tolerability of topically applied, high-concentration (8%) capsaicin in chronic neuropathic pain in adults.\nSearch methods\nFor this update, we searched CENTRAL, MEDLINE, Embase, two clinical trials registries, and a pharmaceutical company's website to 10 June 2016.\nSelection criteria\nRandomised, double-blind, placebo-controlled studies of at least 6 weeks' duration, using high-concentration (5% or more) topical capsaicin to treat neuropathic pain.\nData collection and analysis\nTwo review authors independently searched for studies, extracted efficacy and adverse event data, and examined issues of study quality and potential bias. Where pooled analysis was possible, we used dichotomous data to calculate risk ratio and numbers needed to treat for one additional event, using standard methods.\nEfficacy outcomes reflecting long-duration pain relief after a single drug application were from the Patient Global Impression of Change (PGIC) at specific points, usually 8 and 12 weeks. We also assessed average pain scores over weeks 2 to 8 and 2 to 12 and the number of participants with pain intensity reduction of at least 30% or at least 50% over baseline, and information on adverse events and withdrawals.\nWe assessed the quality of the evidence using GRADE and created a 'Summary of findings' table.\nMain results\nWe included eight studies, involving 2488 participants, two more studies and 415 more participants than the previous version of this review. Studies were of generally good methodological quality; we judged only one study at high risk of bias, due to small size. Two studies used a placebo control and six used 0.04% topical capsaicin as an 'active' placebo to help maintain blinding. Efficacy outcomes were inconsistently reported, resulting in analyses for most outcomes being based on less than complete data.\nFor postherpetic neuralgia, we found four studies (1272 participants). At both 8 and 12 weeks about 10% more participants reported themselves much or very much improved with high-concentration capsaicin than with 'active' placebo; the point estimates of numbers needed to treat for an additional beneficial outcome (NNTs) were 8.8 (95% confidence interval (CI) 5.3 to 26) at 8 weeks and 7.0 (95% CI 4.6 to 15) at 12 weeks (2 studies, 571 participants; moderate quality evidence). More participants (about 10%) had average 2 to 8-week and 2 to 12-week pain intensity reductions over baseline of at least 30% and at least 50% with capsaicin than control, with NNT values between 10 and 12 (2 to 4 studies, 571 to 1272 participants; very low quality evidence).\nFor painful HIV-neuropathy, we found two studies (801 participants). One study reported the proportion of participants who were much or very much improved at 12 weeks (27% with high-concentration capsaicin and 10% with 'active' placebo). For both studies, more participants (about 10%) had average 2 to 12-week pain intensity reductions over baseline of at least 30% with capsaicin than control, with an NNT of 11 (very low quality evidence).\nFor peripheral diabetic neuropathy, we found one study (369 participants). It reported about 10% more participants who were much or very much improved at 8 and 12 weeks. One small study of 46 participants with persistent pain following inguinal herniorrhaphy did not show a difference between capsaicin and placebo for pain reduction (very low quality evidence).\nWe downgraded the quality of the evidence for efficacy outcomes by one to three levels due to sparse data, imprecision, possible effects of imputation methods, and susceptibility to publication bias.\nLocal adverse events were common, but not consistently reported. Serious adverse events were no more common with active treatment (3.5%) than control (3.2%). Adverse event withdrawals did not differ between groups, but lack of efficacy withdrawals were somewhat more common with control than active treatment, based on small numbers of events (six to eight studies, 21 to 67 events; moderate quality evidence, downgraded due to few events). No deaths were judged to be related to study medication.\nAuthors' conclusions\nHigh-concentration topical capsaicin used to treat postherpetic neuralgia, HIV-neuropathy, and painful diabetic neuropathy generated more participants with moderate or substantial levels of pain relief than control treatment using a much lower concentration of capsaicin. These results should be interpreted with caution as the quality of the evidence was moderate or very low. The additional proportion who benefited over control was not large, but for those who did obtain high levels of pain relief, there were usually additional improvements in sleep, fatigue, depression, and quality of life. High-concentration topical capsaicin is similar in its effects to other therapies for chronic pain.\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": "In seven studies, involving 2442 participants, we found that the treatment gave good levels of pain relief to a small number of participants with some types of neuropathic pain (pain after shingles, and nerve injury pain associated with HIV infection), and probably also in another type (painful feet because of damaged nerves caused by diabetes). About 4 in 10 people had at least moderate pain relief with capsaicin compared with 3 in 10 with control. The control was a treatment that looked the same but did not contain high levels of capsaicin, with either nothing added, or very small amounts of capsaicin added. In one small study (46 participants) in people with persistent pain after hernia surgery, it did not seem better than control.\nIn all people who have this treatment there can be short-lived localised skin problems such as redness, burning, or pain. Serious problems seem to be uncommon, and were no more frequent in these trials with high-concentration capsaicin than with control using very low-concentration capsaicin or placebo.\nSlightly more people treated with control rather than capsaicin dropped out of the studies because of lack of benefit, but there was no difference between the groups for drop-outs because of side effects."
}
] |
query-laysum
|
23873
|
[
{
"role": "user",
"content": "Abstract: Background\nIndwelling urethral catheters are often used for bladder drainage in hospital. Urinary tract infection is the most common hospital-acquired infection, and a common complication of urinary catheterisation. Pain, ease of use and quality of life are important to consider, as well as formal economic analysis. Suprapubic catheterisation can also result in bowel perforation and death.\nObjectives\nTo determine the advantages and disadvantages of alternative routes of short-term bladder catheterisation in adults in terms of infection, adverse events, replacement, duration of use, participant satisfaction and cost effectiveness. For the purpose of this review, we define 'short-term' as intended duration of catheterisation for 14 days or less.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 26 February 2015), CINAHL (searched 27 January 2015) and the reference lists of relevant articles.\nSelection criteria\nWe included all randomised and quasi-randomised trials comparing different routes of catheterisation for short-term use in hospitalised adults.\nData collection and analysis\nAt least two review authors extracted data and performed 'Risk of bias' assessment of the included trials. We sought clarification from the trialists if further information was required.\nMain results\nIn this systematic review, we included 42 trials.\nTwenty-five trials compared indwelling urethral and suprapubic catheterisation. There was insufficient evidence for symptomatic urinary tract infection (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.61 to 1.69; 5 trials, 575 participants; very low-quality evidence). Participants with indwelling catheters had more cases of asymptomatic bacteriuria (RR 2.25, 95% CI 1.63 to 3.10; 19 trials, 1894 participants; very low quality evidence) and more participants reported pain (RR 5.62, 95% CI 3.31 to 9.55; 4 trials, 535 participants; low-quality evidence). Duration of catheterisation was shorter in the indwelling urethral catheter group (MD -1.73, 95% CI -2.42 to -1.05; 2 trials, 274 participants).\nFourteen trials compared indwelling urethral catheterisation with intermittent catheterisation. Two trials had data for symptomatic UTI which were suitable for meta-analysis. Due to evidence of significant clinical and statistical heterogeneity, we did not pool the results, which were inconclusive and the quality of evidence was very low. The main source of heterogeneity was the reason for hospitalisation as Hakvoort and colleagues recruited participants undergoing urogenital surgery; whereas in the trial conducted by Tang and colleagues elderly women in geriatric rehabilitation ward were recruited. The evidence was also inconclusive for asymptomatic bacteriuria (RR 1.04; 95% CI 0.85 to 1.28; 13 trials, 1333 participants; very low quality evidence). Almost three times as many people developed acute urinary retention with the intermittent catheter (16% with urethral versus 45% with intermittent); RR 0.45, 95% CI 0.22 to 0.91; 4 trials, 384 participants.\nThree trials compared intermittent catheterisation with suprapubic catheterisation, with only female participants. The evidence was inconclusive for symptomatic urinary tract infection, asymptomatic bacteriuria, pain or cost.\nNone of the trials reported the following critical outcomes: quality of life; ease of use, and cost utility analysis.\nAuthors' conclusions\nSuprapubic catheters reduced the number of participants with asymptomatic bacteriuria, recatheterisation and pain compared with indwelling urethral. The evidence for symptomatic urinary tract infection was inconclusive.\nFor indwelling versus intermittent urethral catheterisation, the evidence was inconclusive for symptomatic urinary tract infection and asymptomatic bacteriuria. No trials reported pain.\nThe evidence was inconclusive for suprapubic versus intermittent urethral catheterisation. Trials should use a standardised definition for symptomatic urinary tract infection. Further adequately-powered trials comparing all catheters are required, particularly suprapubic and intermittent urethral catheterisation.\n\nGiven the provided abstract, please respond to the following query: \"Number of trials: 42\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
] |
query-laysum
|
23874
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic non-invasive ventilation (NIV) is increasingly being used to treat people with COPD who have respiratory failure, but the evidence supporting this treatment has been conflicting.\nObjectives\nTo assess the effects of chronic non-invasive ventilation at home via a facial mask in people with COPD, using a pooled analysis of IPD and meta-analysis.\nSearch methods\nWe searched the Cochrane Airways Register of Trials, MEDLINE, Embase, PsycINFO, CINAHL, AMED, proceedings of respiratory conferences, clinical trial registries and bibliographies of relevant studies. We conducted the latest search on 21 December 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing chronic NIV for at least five hours per night for three consecutive weeks or more (in addition to standard care) versus standard care alone, in people with COPD. Studies investigating people initiated on NIV in a stable phase and studies investigating NIV commenced after a severe COPD exacerbation were eligible, but we reported and analysed them separately. The primary outcomes were arterial blood gases, health-related quality of life (HRQL), exercise capacity (stable COPD) and admission-free survival (post-exacerbation COPD). Secondary outcomes for both populations were: lung function, COPD exacerbations and admissions, and all-cause mortality. For stable COPD, we also reported respiratory muscle strength, dyspnoea and sleep efficiency.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. After inclusion of a study, we requested the IPD. We analysed continuous and time-to-event data using linear- and cox-regression mixed-effect models with a random effect on study level. We analysed dichotomous IPD using generalised estimating equations. We adjusted all models for age and sex. We assessed changes in outcomes after three and 12 months. We also conducted a meta-analysis on aggregated trial data.\nMain results\nWe included 14 new RCTs in this review update, in addition to the seven previously included. Seventeen studies investigated chronic NIV in stable COPD and four studies investigated chronic NIV commenced after a severe COPD exacerbation. Three studies compared NIV to sham continuous positive airway pressure (2 to 4 cmH2O). Seven studies used a nasal mask, one study used an oronasal mask and eight studies used both interfaces. Five studies did not report the interface. The majority of trials (20/21) were at high risk of performance bias due to an unblinded design. We considered 11 studies to have a low risk of selection bias and 13 to have a low risk of attrition bias. We collected and analysed the IPD from 13 stable COPD studies (n = 778, 68% of the participants included) and from three post-exacerbation studies (n = 364, 96% of the participants included).\nIn the stable COPD group, NIV probably results in a minor benefit on the arterial partial pressure of oxygen (PaO2) after three months (adjusted mean difference (AMD) 0.27 kPa, 95% CI 0.04 to 0.49; 9 studies, 271 participants; moderate-certainty evidence), but there was little to no benefit at 12 months (AMD 0.09 kPa, 95% CI -0.23 to 0.42; 3 studies, 171 participants; low-certainty evidence). The arterial partial pressure of carbon dioxide (PaCO2) was reduced in participants allocated to NIV after three months (AMD -0.61 kPa, 95% CI -0.77 to -0.45; 11 studies, 475 participants; high-certainty evidence) and persisted up to 12 months (AMD -0.42 kPa, 95% CI -0.68 to -0.16; 4 studies, 232 participants; high-certainty evidence).\nExercise capacity was measured with the 6-minute walking distance (minimal clinical important difference: 26 m). There was no clinically relevant effect of NIV on exercise capacity (3 months: AMD 15.5 m, 95% CI -0.8 to 31.7; 8 studies, 330 participants; low-certainty evidence; 12 months: AMD 26.4 m, 95% CI -7.6 to 60.5; 3 studies, 134 participants; very low-certainty evidence). HRQL was measured with the Severe Respiratory Insufficiency and the St. Georges's Respiratory Questionnaire and may be improved by NIV, but only after three months (3 months: standardised mean difference (SMD) 0.39, 95% CI 0.15 to 0.62; 5 studies, 259 participants; very low-certainty evidence; 12 months: SMD 0.15, 95% CI -0.13 to 0.43; 4 studies, 200 participants; very low-certainty evidence). Lastly, the risk for all-cause mortality is likely reduced by NIV (adjusted hazard ratio (AHR) 0.75, 95% CI 0.58 to 0.97; 3 studies, 405 participants; moderate-certainty evidence).\nIn the post-exacerbation COPD group, there was little to no benefit on the PaO2 after three months, but there may be a slight decrease after 12 months (3 months: AMD -0.10 kPa, 95% CI -0.65 to 0.45; 3 studies, 234 participants; low-certainty evidence; 12 months: -0.27 kPa, 95% CI -0.86 to 0.32, 3 studies; 170 participants; low-certainty evidence). The PaCO2 was reduced by NIV at both three months (AMD -0.40 kPa, 95% CI -0.70 to -0.09; 3 studies, 241 participants; moderate-certainty evidence) and 12 months (AMD -0.52 kPa, 95% CI -0.87 to -0.18; 3 studies, 175 participants; high-certainty evidence). NIV may have little to no benefit on HRQL (3 months: SMD 0.25, 95% CI -0.01 to 0.51; 2 studies, 219 participants; very low-certainty evidence; 12 months: SMD 0.25, 95% -0.06 to 0.55; 2 studies, 164 participants; very low-certainty evidence). Admission-free survival seems improved with NIV (AHR 0.71, 95% CI 0.54 to 0.94; 2 studies, 317 participants; low-certainty evidence), but the risk for all-cause mortality does not seem to improve (AHR 0.97, 95% CI 0.74 to 1.28; 2 studies, 317 participants; low-certainty evidence).\nAuthors' conclusions\nRegardless of the timing of initiation, chronic NIV improves daytime hypercapnia. In addition, in stable COPD, survival seems to be improved and there might be a short term HRQL benefit. In people with persistent hypercapnia after a COPD exacerbation, chronic NIV might prolong admission-free survival without a beneficial effect on HRQL.\nIn stable COPD, future RCTs comparing NIV to a control group receiving standard care might no longer be warranted, but research should focus on identifying participant characteristics that would define treatment success. Furthermore, the optimal timing for initiation of NIV after a severe COPD exacerbation is still unknown.\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": "In all people with COPD who had raised levels of carbon dioxide, chronic NIV for three and 12 months improved blood gases. In stable COPD, chronic NIV also might have improved quality of life, and survival seemed to be better compared to people who were treated with standard care only. There was no relevant benefit of NIV on exercise capacity. People using chronic NIV after a COPD admission experienced less benefit; carbon dioxide levels decreased, the time to the next hospital admission might have been longer when treated with NIV but quality of life and survival were not affected by chronic NIV."
}
] |
query-laysum
|
23875
|
[
{
"role": "user",
"content": "Abstract: Background\nHeart failure is the end stage of heart disease, and the prevalence and incidence of the condition is rapidly increasing. Although heart transplantation is one type of surgical treatment for people with end-stage heart failure, donor availability is limited. Implantable ventricular assist devices (VADs) therefore offer an alternative treatment to heart transplantation. Although two studies reported the beneficial effects of exercise-based cardiac rehabilitation (CR) on functional capacity and quality of life (QOL) by performing systematic reviews and meta-analyses, both systematic reviews included studies with limited design (e.g. non-randomised, retrospective studies) or participants with implantable or extracorporeal VADs.\nObjectives\nTo determine the benefits and harms of exercise-based CR for people with implantable VADs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, PsycINFO, Conference Proceedings Citation Index-Science (CPCI-S) on Web of Science, CINAHL, and LILACS on 3 October 2017 with no limitations on date, language, or publication status. We also searched two clinical trials registers on 10 August 2017 and checked the reference lists of primary studies and review articles.\nSelection criteria\nRandomised controlled trials (RCTs) regardless of cluster or individual randomisation, and full-text studies, those published as abstract only, and unpublished data were eligible. However, only individually RCTs and full-text publications were included.\nData collection and analysis\nTwo review authors independently extracted outcome data from the included studies. We double-checked that data were entered correctly by comparing the data presented in the systematic review with the study reports. We had no dichotomous data to analyse and used mean difference or standardised mean difference with 95% confidence intervals (CIs) for continuous data. Furthermore, we assessed the quality of evidence as it relates to those studies that contribute data to the meta-analyses for the prespecified outcomes, using GRADEpro software.\nMain results\nWe included two studies with a total of 40 participants in the review. Exercise-based CR consisted of aerobic or resistance training or both three times per week for six to eight weeks. Exercise intensity was 50% of oxygen consumption (VO2) reserve, or ranged from 60% to 80% of heart rate reserve. Two serious adverse events were observed in one trial, in which participants did not complete the study due to infections. Furthermore, a total of four participants in each group required visits to the emergency department, although these participants did complete the study. Summary scores from the 36-item Short Form Health Survey (SF-36) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) were measured as quality of life. One trial reported that the KCCQ summary score improved by 14.4 points in the exercise group compared with 0.5 points in the usual care group. The other trial reported that the SF-36 total score improved by 29.2 points in the exercise group compared with 16.3 points in the usual care group. A large difference in quality of life was observed between groups at the end of follow-up (standardised mean difference 0.88, 95% CI -0.12 to 1.88; 37 participants; 2 studies; very low-quality of evidence). However, there was no evidence for the effectiveness of exercise-based CR due to the young age of the participants, high risk of performance bias, very small sample size, and wide confidence intervals, which resulted in very low-quality evidence. Furthermore, we were not able to determine the effect of exercise-based CR on mortality, rehospitalisation, heart transplantation, and cost, as these outcomes were not reported.\nAuthors' conclusions\nThe evidence is currently inadequate to assess the safety and efficacy of exercise-based CR for people with implantable VADs compared with usual care. The amount of RCT evidence was very limited and of very low quality. In addition, the training duration was very short term, that is from six to eight weeks. Further high-quality and well-reported RCTs of exercise-based CR for people with implantable VADs are needed. Such trials need to collect data on events (mortality and rehospitalisation), patient-related outcomes (including quality of life), and cost-effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Methods\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the scientific literature for randomised controlled trials that assessed the effectiveness of exercise in people with heart failure who have implantable VADs by comparing participants receiving the exercise intervention with those receiving usual care, where the intervention consisted of a single type of exercise or more. We excluded participants with total artificial hearts. The evidence is current to 3 October 2017."
}
] |
query-laysum
|
23876
|
[
{
"role": "user",
"content": "Abstract: Background\nAnkylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause and affects mainly the spine, but can also affect other joints. Disease progression may result in loss of mobility and function. Sulfasalazine is a disease-modifying antirheumatic drug used in the treatment of AS. However, its efficacy remains unclear. This is an update of a Cochrane review first published in 2005.\nObjectives\nTo evaluate the benefits and harms of sulfasalazine for the treatment of ankylosing spondylitis (AS).\nSearch methods\nWe searched for relevant randomized and quasi-randomized trials in any language, using the following sources: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 11); MEDLINE (2003 to 28 November 2013); EMBASE (2003 to 27 November 2013); CINAHL (2003 to 28 November 2013); Ovid MEDLINE data, World Health Organization International Clinical Trials Registry Platform (28 November 2013); and the reference sections of retrieved articles.\nSelection criteria\nWe evaluated randomized and quasi-randomized trials examining the benefits and harms of sulfasalazine on AS.\nData collection and analysis\nTwo review authors independently reviewed unblinded trial reports according to the selection criteria. Disagreements on the inclusion of the studies were resolved, when necessary, by recourse to a third review author. The same authors independently assessed the risk of bias of included trials and entered the data extracted from the included trials. We combined results using mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data.\nWe restructured outcome measures for this update based on recommendations from the editorial group. Major outcomes included: pain, Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis function index (BASFI), Bath ankylosing spondylitis metrology index (BASMI), radiographic progression, total number of withdrawals due to adverse events, and serious adverse events.\nMain results\nWe did not add any new studies to this review following the updated search. In the original review, we included 11 studies in the analysis, involving 895 participants in total. All included studies compared sulfasalazine with placebo. We judged most of the studies as low risk of bias or unclear risk of bias in five domains (random sequence generation, allocation concealment, blinding of outcome assessment, selective reporting, and other sources of bias). However, for incomplete outcome data, we only judged one trial at low risk of bias.\nNone of the included trials assessed BASDAI, BASFI, BASMI or radiographic progression. Different parameters were used to assess pain. The pooled MD for back pain measured on a 0 to 100 mm visual analogue scale was -2.96 (95% confidence interval (CI) -6.33 to 0.41; absolute risk difference 3%, 95% CI 1% to 6%; 6 trials). Compared to placebo, a significantly higher rate of withdrawals due to adverse effects (RR 1.50, 95% CI 1.04 to 2.15; absolute risk difference 4%, 95% CI 0.4% to 8.8%; 11 trials) was found in the sulfasalazine group. A serious adverse reaction was reported in one patient taking sulfasalazine (Peto odds ratio 7.50, 95% CI 0.15 to 378.16).\nAuthors' conclusions\nThere is not enough evidence to support any benefit of sulfasalazine in reducing pain, disease activity, radiographic progression, or improving physical function and spinal mobility in the treatment of AS. A statistically significant benefit in reducing the erythrocyte sedimentation rate and easing spinal stiffness was mentioned in the previous version. However, the effect size was very small and not clinically meaningful. More withdrawals because of side effects occurred with sulfasalazine. Further studies, with larger sample sizes, longer duration, and using validated outcome measures are needed to verify the uncertainty of sulfasalazine in AS.\n\nGiven the provided abstract, please respond to the following query: \"Bath ankylosing spondylitis function index (BASFI)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This outcome was not measured in the studies."
}
] |
query-laysum
|
23877
|
[
{
"role": "user",
"content": "Abstract: Background\nMechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods. Potential advantages of mechanical methods, compared with pharmacological methods may include reduction in side effects that could improve neonatal outcomes. This is an update of a review first published in 2001, last updated in 2012.\nObjectives\nTo determine the effectiveness and safety of mechanical methods for third trimester (> 24 weeks' gestation) induction of labour in comparison with prostaglandin E2 (PGE2) (vaginal and intracervical), low-dose misoprostol (oral and vaginal), amniotomy or oxytocin.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies (9 January 2018). We updated the search in March 2019 and added the search results to the awaiting classification section of the review.\nSelection criteria\nClinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with pharmacological methods.\nMechanical methods include: (1) the introduction of a catheter through the cervix into the extra-amniotic space with balloon insufflation; (2) introduction of laminaria tents, or their synthetic equivalent (Dilapan), into the cervical canal; (3) use of a catheter to inject fluid into the extra-amniotic space (EASI).\nThis review includes the following comparisons: (1) specific mechanical methods (balloon catheter, laminaria tents or EASI) compared with prostaglandins (different types, different routes) or with oxytocin; (2) single balloon compared to a double balloon; (3) addition of prostaglandins or oxytocin to mechanical methods compared with prostaglandins or oxytocin alone.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors independently extracted data and assessed the quality of the evidence using the GRADE approach.\nMain results\nThis review includes a total of 112 trials, with 104 studies contributing data (22,055 women; 21 comparisons). Risk of bias of trials varied. Overall, the evidence was graded from very-low to moderate quality. All evidence was downgraded for lack of blinding and, for many comparisons, the effect estimates were too imprecise to make a valid judgement.\nBalloon versus vaginal PGE2: there may be little or no difference in vaginal deliveries not achieved within 24 hours (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.26; 7 studies; 1685 women; low-quality evidence) and there probably is little or no difference in caesarean sections (RR 1.00, 95% CI 0.92 to 1.09; 28 studies; 6619 women; moderate-quality evidence) between induction of labour with a balloon catheter and vaginal PGE2. A balloon catheter probably reduces the risk of uterine hyperstimulation with fetal heart rate (FHR) changes (RR 0.35, 95% CI 0.18 to 0.67; 6 studies; 1966 women; moderate-quality evidence), serious neonatal morbidity or perinatal death (RR 0.48, 95% CI 0.25 to 0.93; 8 studies; 2757 women; moderate-quality evidence) and may slightly reduce the risk of aneonatal intensive care unit (NICU) admission (RR 0.82, 95% CI 0.65 to 1.04; 3647 women; 12 studies; low-quality evidence). It is uncertain whether there is a difference in serious maternal morbidity or death (RR 0.20, 95% CI 0.01 to 4.12; 4 studies; 1481 women) or five-minute Apgar score < 7 (RR 0.74, 95% CI 0.49 to 1.14; 4271 women; 14 studies) because the quality of the evidence was found to be very low and low, respectively.\nBalloon versus low-dose vaginal misoprostol: it is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between induction of labour with a balloon catheter and vaginal misoprostol (RR 1.09, 95% CI 0.85 to 1.39; 340 women; 2 studies; low-quality evidence). A balloon catheter probably reduces the risk of uterine hyperstimulation with FHR changes (RR 0.39, 95% CI 0.18 to 0.85; 1322 women; 8 studies; moderate-quality evidence) but may increase the risk of a caesarean section (RR 1.28, 95% CI 1.02 to 1.60; 1756 women; 12 studies; low-quality evidence). It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death (RR 0.58, 95% CI 0.12 to 2.66; 381 women; 3 studies), serious maternal morbidity or death (no events; 4 studies, 464 women), both very low-quality evidence, and five-minute Apgar score < 7 (RR 1.00, 95% CI 0.50 to 1.97; 941 women; 7 studies) and NICU admissions (RR 1.00, 95% CI 0.61 to 1.63; 1302 women; 9 studies) both low-quality evidence.\nBalloon versus low-dose oral misoprostol: a balloon catheter probably increases the risk of a vaginal delivery not achieved within 24 hours (RR 1.28, 95% CI 1.13 to 1.46; 782 women, 2 studies, and probably slightly increases the risk of a caesarean section (RR 1.17, 95% CI 1.04 to 1.32; 3178 women; 7 studies; both moderate-quality evidence) when compared to oral misoprostol. It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes (RR 0.81, 95% CI 0.48 to 1.38; 2033 women; 2 studies), serious neonatal morbidity or perinatal death (RR 1.11, 95% CI 0.60 to 2.06; 2627 women; 3 studies), both low-quality evidence, serious maternal morbidity or death (RR 0.50, 95% CI 0.05 to 5.52; 2627 women; 3 studies), very low-quality evidence, five-minute Apgar scores < 7 (RR 0.71, 95% CI 0.38 to 1.32; 2693 women; 4 studies) and NICU admissions (RR 0.82, 95% CI 0.58 to 1.17; 2873 women; 5 studies) both low-quality evidence.\nAuthors' conclusions\nLow- to moderate-quality evidence shows mechanical induction with a balloon is probably as effective as induction of labour with vaginal PGE2. However, a balloon seems to have a more favourable safety profile. More research on this comparison does not seem warranted.\nModerate-quality evidence shows a balloon catheter may be slightly less effective as oral misoprostol, but it remains unclear if there is a difference in safety outcomes for the neonate. When compared to low-dose vaginal misoprostol, low-quality evidence shows a balloon may be less effective, but probably has a better safety profile.\nFuture research could be focused more on safety aspects for the neonate and maternal satisfaction.\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": "Mechanical induction with a balloon is probably as effective as induction of labour with vaginal PGE2. However, a balloon seems to have a more favourable safety profile for the baby. More research on this comparison does not seem warranted.\nA balloon catheter may be slightly less effective as oral misoprostol, but It remains unclear if there is a difference in safety outcomes for the baby. When compared to low-dose vaginal misoprostol, a balloon catheter may be less effective, but probably has a better safety profile for the baby.\nFuture research could focus more on safety aspects for the baby and maternal satisfaction."
}
] |
query-laysum
|
23878
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD; including chronic bronchitis and emphysema) is a chronic respiratory condition characterised by shortness of breath, cough and recurrent exacerbations. Long-term antibiotic use may reduce both bacterial load and inflammation in the airways. Studies have shown a reduction of exacerbations with antibiotics in comparison to placebo in people with COPD, but there are concerns about antibiotic resistance and safety.\nObjectives\nTo compare the safety and efficacy of different classes of antibiotics (continuous, intermittent or pulsed) for prophylaxis of exacerbations in patients with COPD.\nSearch methods\nWe searched the Cochrane Airways Group Trials Register and bibliographies of relevant studies. The latest literature search was conducted on 6 February 2019.\nSelection criteria\nRandomised controlled trials (RCTs) were selected that compared one prophylactic antibiotic with another in patients with COPD.\nData collection and analysis\nWe used the standard Cochrane methods. Two independent review authors selected trials for inclusion, extracted data and assessed risk of bias. Discrepancies were resolved by involving a third review author.\nMain results\nWe included two RCTs, both published in 2015 involving a total of 391 participants with treatment duration of 12 to 13 weeks. One RCT compared a quinolone (moxifloxacin pulsed, for 5 days every 4 weeks), with a tetracycline (doxycycline continuous) or a macrolide (azithromycin intermittent).\nThe second RCT compared a tetracycline (doxycycline continuous) plus a macrolide (roxithromycin continuous), with roxithromycin (continuous) alone.\nThe trials recruited participants with a mean age of 68 years, with moderate-severity COPD. Both trials included participants who had between two and five exacerbations in the previous one to two years. In one trial, 17% of patients had previously been using inhaled corticosteroids. In the other study, all patients were positive for Chlamydophila pneumoniae (C pneumoniae).\nOverall, we judged the evidence presented to be of very low-certainty, mainly due to imprecision, but we also had concerns about indirectness and methodological quality of the included studies. The primary outcome measures for this review included exacerbations, quality of life, drug resistance and serious adverse events.\nMacrolide + tetracycline versus macrolide\nThere was no clear difference between treatments in improvement in quality of life as assessed by the Chronic Respiratory Questionnaire (CRQ). The CRQ scale ranges from 0 to 10 and higher scores on the scale indicate better quality of life. CRQ sub-scales for dyspnoea (mean difference (MD) 0.58, 95% confidence interval (CI) -0.84 to 2.00; 187 participants; very low-certainty evidence), fatigue (MD 0.02, 95% CI -1.08 to 1.12; 187 participants; very low-certainty evidence), emotional function (MD -0.37, 95% CI -1.74 to 1.00; 187 participants; very low-certainty evidence), or mastery (MD -0.79, 95% CI -1.86 to 0.28; 187 participants; very low-certainty evidence) at 12 weeks. For serious adverse events, it was uncertain if there was a difference between combined roxithromycin and doxycycline versus roxithromycin alone at 48 weeks follow-up after active treatment of 12 weeks (odds ratio (OR) 1.00, 95% CI 0.52 to 1.93; 198 participants; very low-certainty evidence). There were five deaths reported in the combined treatment arm, versus three in the single treatment arm at 48 weeks follow-up after active treatment of 12 weeks (OR 1.63, 95% CI 0.38 to 7.02; 198 participants; very low-certainty evidence).\nQuinolone versus tetracycline\nThere was no clear difference between moxifloxacin and doxycycline for the number of participants experiencing one or more exacerbations (OR 0.44, 95% CI 0.14 to 1.38; 50 participants, very low-certainty evidence) at 13 weeks. There were no serious adverse events or deaths reported in either treatment groups. We did not identify any evidence for our other primary outcomes.\nQuinolone versus macrolide\nThere was no clear difference between moxifloxacin and azithromycin for the number of participants experiencing one or more exacerbations (OR 1.00, 95% CI 0.32 to 3.10; 50 participants; very low-certainty evidence) at 13 weeks. There were no serious adverse events or deaths reported in either treatment groups. We did not identify any evidence for our other primary outcomes.\nMarcolide versus tetracycline\nThere was no clear difference between azithromycin and doxycycline for the number of participants experiencing one or more exacerbations (OR 0.44, 95% CI 0.14 to 1.38; 50 participants; very low-certainty evidence) at 13 weeks. There were no serious adverse events or deaths reported in either treatment groups. We did not identify any evidence for our other primary outcomes.\nWe did not find head-to-head evidence for impact of antibiotics on drug resistance.\nAuthors' conclusions\nIt is not clear from the evidence included in this review whether there is a difference in efficacy or safety between different classes or regimens of prophylactic antibiotic, given for 12 to 13 weeks to people with COPD. Whilst no head-to-head comparisons of antibiotic resistance were identified, concerns about this continue. The sample size in this review is small and both included studies are of short duration. Thus, there is considerable uncertainty in effects observed and the effects of different prophylactic antibiotics requires further research.\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 were very uncertain about the results due to finding only two small studies that gave people with COPD antibiotics for only 12 or 13 weeks. The studies only looked at four different antibiotics and did not measure all the things we were interested in."
}
] |
query-laysum
|
23879
|
[
{
"role": "user",
"content": "Abstract: Background\nTumour necrosis factor (TNF)-alpha inhibitors are beneficial for the treatment of rheumatoid arthritis (RA) for reducing the risk of joint damage, improving physical function and improving the quality of life. This review is an update of the 2014 Cochrane Review of the treatment of RA with certolizumab pegol.\nObjectives\nTo assess the clinical benefits and harms of certolizumab pegol (CZP) in people with RA who have not responded well to conventional disease-modifying anti-rheumatic drugs (DMARDs).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL: Cochrane Library 2016, Issue 9), MEDLINE, Embase, Web of Knowledge, reference lists of articles, clinicaltrials.gov and ICTRP of WHO. The searches were updated from 2014 (date of the last search for the previous version) to 26 September 2016.\nSelection criteria\nRandomised controlled trials that compared certolizumab pegol with any other agent, including placebo or methotrexate (MTX), in adults with active RA, regardless of current or prior treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs), such as MTX.\nData collection and analysis\nTwo review authors independently checked search results, extracted data and assessed trial quality. We resolved disagreements by discussion or referral to a third review author.\nMain results\nWe included 14 trials in this update, three more than previously. Twelve trials (5422 participants) included measures of benefit. We pooled 11 of them, two more than previously. Thirteen trials included information on harms, (5273 participants). The duration of follow-up varied from 12 to 52 weeks and the range of doses of certolizumab pegol varied from 50 to 400 mg given subcutaneously. In Phase III trials, the comparator was placebo plus MTX in seven trials and placebo in five. In the two Phase II trials the comparator was only placebo.\nThe approved dose of certolizumab pegol, 200 mg every other week, produced clinically important improvements at 24 weeks for the following outcomes:\n- American College of Rheumatology (ACR) 50% improvement (pain, function and other symptoms of RA): 25% absolute improvement (95% confidence interval (CI) 20% to 33%); number need to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 5); risk ratio (RR) 3.80 (95% CI 2.42 to 5.95), 1445 participants, 5 studies.\n- The Health Assessment Questionnaire (HAQ): -12% absolute improvement (95% CI -9% to -14%); NNTB of 8 (95% CI 7 to 11); mean difference (MD) - 0.35 (95% CI -0.43 to -0.26; 1268 participants, 4 studies) (scale 0 to 3; lower scores mean better function).\n- Proportion of participants achieving remission (Disease Activity Score (DAS) < 2.6) absolute improvement 10% (95% CI 8% to 16%); NNTB of 8 (95% CI 6 to 12); risk ratio (RR) 2.94 (95% CI 1.64 to 5.28), 2420 participants, six studies.\n- Radiological changes: erosion score (ES) absolute improvement -0.29% (95% CI -0.42% to -0.17%); NNTB of 6 (95% CI 4 to 10); MD -0.67 (95% CI -0.96 to -0.38); 714 participants, two studies (scale 0 to 230), but not a clinically important difference.\n-Serious adverse events (SAEs) were statistically but not clinically significantly more frequent for certolizumab pegol (200 mg every other week) with an absolute rate difference of 3% (95% CI 1% to 4%); number needed to treat for an additional harmful outcome (NNTH) of 33 (95% CI 25 to 100); Peto odds ratio (OR) 1.47 (95% CI 1.13 to 1.91); 3927 participants, nine studies.\nThere was a clinically significant increase in all withdrawals in the placebo groups (for all doses and at all follow-ups) with an absolute rate difference of -29% (95% CI -16% to -42%), NNTH of 3 (95% CI 2 to 6), RR 0.47 (95% CI 0.39 to 0.56); and there was a clinically significant increase in withdrawals due to adverse events in the certolizumab groups (for all doses and at all follow-ups) with an absolute rate difference of 2% (95% CI 0% to 3%); NNTH of 58 (95% CI 28 to 329); Peto OR 1.45 (95% CI 1.09 to 1.94) 5236 participants Twelve studies.\nWe judged the quality of evidence to be high for ACR50, DAS remission, SAEs and withdrawals due to adverse events, and moderate for HAQ and radiological changes, due to concerns about attrition bias. For all withdrawals we judged the quality of evidence to be moderate, due to inconsistency.\nAuthors' conclusions\nThe results and conclusions did not change from the previous review. There is a moderate to high certainty of evidence from randomised controlled trials that certolizumab pegol, alone or combined with methotrexate, is beneficial in the treatment of RA for improved ACR50 and health-related quality of life, an increased chance of remission of RA, and reduced joint damage as seen on x-ray. Fewer people stopped taking their treatment, but most of these who did stopped due to serious adverse events. Adverse events were more frequent with active treatment. We found a clinically but not statistically significant risk of serious adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Radiological changes (x-rays of the joints, measured on a 0 to 230 unit scale)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- the joint damage in people who took certolizumab pegol was 0.67 units less (absolute improvement -0.29%).\n- the damage to joints in people who took certolizumab pegol was 0.04 units less compared to people who took a placebo, whose joint damage was 0.7 units more.\nWe rate the quality of evidence for the findings in the radiological changes as moderate, downgraded, due to concerns about the high number of people dropping out of the studies."
}
] |
query-laysum
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23880
|
[
{
"role": "user",
"content": "Abstract: Background\nRepetitive peripheral magnetic stimulation (rPMS) is a non-invasive treatment method that can penetrate to deeper structures with painless stimulation to improve motor function in people with physical impairment due to brain or nerve disorders. rPMS for people after stroke has proved to be a feasible approach to improving activities of daily living and functional ability. However, the effectiveness and safety of this intervention for people after stroke remain uncertain. This is an update of the review published in 2019.\nObjectives\nTo assess the effects of rPMS for improving activities of daily living and functional ability in people after stroke.\nSearch methods\nWe searched the Cochrane Stroke Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; Embase; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); PsycINFO; the Allied and Complementary Medicine Database (AMED); OTseeker: Occupational Therapy Systematic Evaluation of Evidence; the Physiotherapy Evidence Database (PEDro); Ichushi-Web; and six ongoing trial registries on 5 October 2021. We screened reference lists and contacted experts in the field. We placed no restrictions on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomised controlled trials (RCTs) conducted to assess the therapeutic effect of rPMS for people after stroke. The following comparisons were eligible for inclusion: 1) active rPMS only compared with 'sham' rPMS (a very weak form of stimulation or a sound only); 2) active rPMS only compared with no intervention; 3) active rPMS plus rehabilitation compared with sham rPMS plus rehabilitation; and 4) active rPMS plus rehabilitation compared with rehabilitation only.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion in the review. The same review authors assessed methods and risk of bias, undertook data extraction, and evaluated the certainty of the evidence using the GRADE approach. We contacted trial authors to request unpublished information if necessary. Any disagreements were resolved through discussion.\nMain results\nWe included four trials (three parallel-group RCTs and one cross-over trial) involving a total of 139 participants. This result was unchanged from the review published in 2019. Blinding of participants and physicians was well reported in three trials, with no information on whether personnel were blinded in one trial. We judged the overall risk of bias across trials as low. Only two trials (with 63 and 18 participants, respectively) provided sufficient information to be included in the meta-analysis. We found no clear effect of rPMS on activities of daily living at the end of treatment (mean difference (MD) −3.00, 95% confidence interval (CI) −16.35 to 10.35; P = 0.66; 1 trial; 63 participants; low-certainty evidence) and at the end of follow-up (MD −2.00, 95% CI −14.86 to 10.86; P = 0.76; 1 trial; 63 participants; low-certainty evidence) when comparing rPMS plus rehabilitation versus sham rPMS plus rehabilitation. We found no statistical difference in improvement of upper limb function at the end of treatment (MD 2.00, 95% CI −4.91 to 8.91; P = 0.57; 1 trial; 63 participants; low-certainty evidence) and at the end of follow-up (MD 4.00, 95% CI −2.92 to 10.92; P = 0.26; 1 trial; 63 participants; low-certainty evidence) when comparing rPMS plus rehabilitation versus sham rPMS plus rehabilitation. We observed a decrease in spasticity of the elbow at the end of follow-up (MD −0.41, 95% CI −0.89 to 0.07; 1 trial; 63 participants; low-certainty evidence) when comparing rPMS plus rehabilitation versus sham rPMS plus rehabilitation. In terms of muscle strength, rPMS treatment was not associated with improved muscle strength of the ankle dorsiflexors at the end of treatment (MD 3.00, 95% CI −2.44 to 8.44; P = 0.28; 1 trial; 18 participants; low-certainty evidence) when compared with sham rPMS. No studies provided information on lower limb function or adverse events, including death. Based on the GRADE approach, we judged the certainty of evidence related to the primary outcome as low, owing to the small sample size of the studies.\nAuthors' conclusions\nThere is insufficient evidence to permit the drawing of any conclusions about routine use of rPMS for people after stroke. Additional trials with large sample sizes are needed to provide robust evidence for rPMS after stroke.\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": "It remains unclear whether rPMS is useful in improving activities of daily living and functional ability in people after stroke. More trials involving larger numbers of participants are needed to determine the effects of rPMS."
}
] |
query-laysum
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23881
|
[
{
"role": "user",
"content": "Abstract: Background\nTinnitus is described as the perception of sound or noise in the absence of real acoustic stimulation. In the current absence of a cure for tinnitus, clinical management typically focuses on reducing the effects of co-morbid symptoms such as distress or hearing loss. Hearing loss is commonly co-morbid with tinnitus and so logic implies that amplification of external sounds by hearing aids will reduce perception of the tinnitus sound and the distress associated with it.\nObjectives\nTo assess the effects of hearing aids specifically in terms of tinnitus benefit in patients with tinnitus and co-existing hearing loss.\nSearch methods\nWe searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 19 August 2013.\nSelection criteria\nRandomised controlled trials and non-randomised controlled trials recruiting adults with subjective tinnitus and some degree of hearing loss, where the intervention involves amplification with hearing aids and this is compared to interventions involving other medical devices, other forms of standard or complementary therapy, or combinations of therapies, no intervention or placebo interventions.\nData collection and analysis\nThree authors independently screened all selected abstracts. Two authors independently extracted data and assessed those potentially suitable studies for risk of bias. For studies meeting the inclusion criteria, we used the mean difference (MD) to compare hearing aids with other interventions and controls.\nMain results\nOne randomised controlled trial (91 participants) was included in this review. We judged the trial to have a low risk of bias for method of randomisation and outcome reporting, and an unclear risk of bias for other criteria. No non-randomised controlled trials meeting our inclusion criteria were identified. The included study measured change in tinnitus severity (primary measure of interest) using a tinnitus questionnaire measure, and change in tinnitus loudness (secondary measure of interest) on a visual analogue scale. Other secondary outcome measures of interest, namely change in the psychoacoustic characteristics of tinnitus, change in self reported anxiety, depression and quality of life, and change in neurophysiological measures, were not investigated in this study. The included study compared hearing aid use to sound generator use. The estimated effect on change in tinnitus loudness or severity as measured by the Tinnitus Handicap Inventory score was compatible with benefits for both hearing aids or sound generators but no difference was found between the two alternative treatments (MD -0.90, 95% confidence interval (CI) -7.92 to 6.12) (100-point scale); moderate quality evidence. No negative or adverse events were reported.\nAuthors' conclusions\nThe current evidence base for hearing aid prescription for tinnitus is limited. To be useful, future studies should make appropriate use of blinding and be consistent in their use of outcome measures. Whilst hearing aids are sometimes prescribed as part of tinnitus management, there is currently no evidence to support or refute their use as a more routine intervention for tinnitus.\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 just one randomised controlled trial which evaluated 91 participants who had tinnitus for at least six months and some degree of hearing loss. It compared those receiving hearing aids to those receiving sound generators. The average age of the patients was 38 and there were 40 women and 51 men. The study took place in two centres in Italy and the USA."
}
] |
query-laysum
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23882
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[
{
"role": "user",
"content": "Abstract: Background\nSurgical options for treating stress urinary incontinence (SUI) are usually explored after conservative interventions have failed. Surgeries fall into two categories: traditional techniques (open surgery) and minimally invasive procedures, such as laparoscopic procedures, midurethral sling and injections with urethral bulking agents. Postsurgery infections, such as infections of the surgical site or urinary tract, are common complications. To minimise the risk of postoperative bacterial infections, prophylactic antibiotics may be given before or during surgery.\nObjectives\nTo assess the effects of prophylactic antibiotics for preventing infection following continence surgery in women with stress urinary incontinence.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register, which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov and WHO ICTRP; and handsearched journals and conference proceedings to 18 March 2021. We also searched the reference lists of relevant articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs assessing prophylactic antibiotics in women undergoing continence surgery to treat SUI.\nData collection and analysis\nTwo review authors selected potentially eligible trials, extracted data and assessed risk of bias. We expressed results as risk ratios (RR) for dichotomous outcomes and as mean differences (MD) for continuous outcomes, both with 95% confidence intervals (CIs). We assessed the certainty of evidence using the GRADE approach.\nMain results\nWe identified one quasi-RCT and two RCTs, involving a total of 390 women. One study performed retropubic urethropexy surgery requiring a transverse suprapubic incision, while the other two studies performed midurethral sling surgery. It should be noted that none of the included studies clearly specified the timing of outcome assessment.\nWe are very uncertain whether prophylactic antibiotics (cefazolin) have an effect on surgical site infections (RR 0.56, 95% CI 0.03 to 12.35; 2 studies, 85 women; very low-certainty evidence) or urinary tract infections or bacteriuria (RR 0.84, 95% CI 0.05 to 13.24; 2 studies, 85 women; very low-certainty evidence). The effect of prophylactic antibiotics (cefazolin) on febrile morbidity is also uncertain (RR 0.08, 95% CI 0.00 to 1.29; 2 studies, 85 women; very low-certainty evidence). We are very uncertain whether prophylactic antibiotics (cefazolin) have any effect on mesh exposure (RR 0.32, 95% CI 0.01 to 7.61; 1 study, 59 women; very low-certainty evidence). None of the three included studies described the assessment of adverse events from antibiotic use, sepsis or bacteraemia in their reports.\nAuthors' conclusions\nOnly limited data are available from the three included studies and, overall, the certainty of evidence was very low. Moreover, the three included studies evaluated different surgical procedures and dosages of antibiotic administration.\nThus, there is insufficient evidence to support or refute the use of prophylactic antibiotics to prevent infection following anti-incontinence surgery. In addition, there were no data regarding adverse effects of prophylactic antibiotics. More RCTs are required.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for randomised controlled trials (RCTs; everyone has the same chance of receiving the treatment being tested), and quasi-RCTs (a treatment is being tested but not everyone has the same chance of receiving it) up to 18 March 2021."
}
] |
query-laysum
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23883
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[
{
"role": "user",
"content": "Abstract: Background\nDementia is a chronic condition which progressively affects memory and other cognitive functions, social behaviour, and ability to carry out daily activities. To date, no treatment is clearly effective in preventing progression of the disease, and most treatments are symptomatic, often aiming to improve people's psychological symptoms or behaviours which are challenging for carers. A range of new therapeutic strategies has been evaluated in research, and the use of trained animals in therapy sessions, termed animal-assisted therapy (AAT), is receiving increasing attention.\nObjectives\nTo evaluate the efficacy and safety of animal-assisted therapy for people with dementia.\nSearch methods\nWe searched ALOIS: the Cochrane Dementia and Cognitive Improvement Group's Specialised Register on 5 September 2019. ALOIS contains records of clinical trials identified from monthly searches of major healthcare databases, trial registries, and grey literature sources. We also searched MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), ISI Web of Science, ClinicalTrials.gov, and the WHO's trial registry portal.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-randomised trials, and randomised cross-over trials that compared AAT versus no AAT, AAT using live animals versus alternatives such as robots or toys, or AAT versus any other active intervention.\nData collection and analysis\nWe extracted data using the standard methods of Cochrane Dementia. Two review authors independently assessed the eligibility and risk of bias of the retrieved records. We expressed our results using mean difference (MD), standardised mean difference (SMD), and risk ratio (RR) with their 95% confidence intervals (CIs) where appropriate.\nMain results\nWe included nine RCTs from 10 reports. All nine studies were conducted in Europe and the US. Six studies were parallel-group, individually randomised RCTs; one was a randomised cross-over trial; and two were cluster-RCTs that were possibly related where randomisation took place at the level of the day care and nursing home. We identified two ongoing trials from trial registries.\nThere were three comparisons: AAT versus no AAT (standard care or various non-animal-related activities), AAT using live animals versus robotic animals, and AAT using live animals versus the use of a soft animal toy. The studies evaluated 305 participants with dementia. One study used horses and the remainder used dogs as the therapy animal. The duration of the intervention ranged from six weeks to six months, and the therapy sessions lasted between 10 and 90 minutes each, with a frequency ranging from one session every two weeks to two sessions per week. There was a wide variety of instruments used to measure the outcomes. All studies were at high risk of performance bias and unclear risk of selection bias. Our certainty about the results for all major outcomes was very low to moderate.\nComparing AAT versus no AAT, participants who received AAT may be slightly less depressed after the intervention (MD –2.87, 95% CI –5.24 to –0.50; 2 studies, 83 participants; low-certainty evidence), but they did not appear to have improved quality of life (MD 0.45, 95% CI –1.28 to 2.18; 3 studies, 164 participants; moderate-certainty evidence). There were no clear differences in all other major outcomes, including social functioning (MD –0.40, 95% CI –3.41 to 2.61; 1 study, 58 participants; low-certainty evidence), problematic behaviour (SMD –0.34, 95% CI –0.98 to 0.30; 3 studies, 142 participants; very-low-certainty evidence), agitation (SMD –0.39, 95% CI –0.89 to 0.10; 3 studies, 143 participants; very-low-certainty evidence), activities of daily living (MD 4.65, 95% CI –16.05 to 25.35; 1 study, 37 participants; low-certainty evidence), and self-care ability (MD 2.20, 95% CI –1.23 to 5.63; 1 study, 58 participants; low-certainty evidence). There were no data on adverse events.\nComparing AAT using live animals versus robotic animals, one study (68 participants) found mixed effects on social function, with longer duration of physical contact but shorter duration of talking in participants who received AAT using live animals versus robotic animals (median: 93 seconds with live versus 28 seconds with robotic for physical contact; 164 seconds with live versus 206 seconds with robotic for talk directed at a person; 263 seconds with live versus 307 seconds with robotic for talk in total). Another study showed no clear differences between groups in behaviour measured using the Neuropsychiatric Inventory (MD –6.96, 95% CI –14.58 to 0.66; 78 participants; low-certainty evidence) or quality of life (MD –2.42, 95% CI –5.71 to 0.87; 78 participants; low-certainty evidence). There were no data on the other outcomes.\nComparing AAT using live animals versus a soft toy cat, one study (64 participants) evaluated only social functioning, in the form of duration of contact and talking. The data were expressed as median and interquartile ranges. Duration of contact was slightly longer in participants in the AAT group and duration of talking slightly longer in those exposed to the toy cat. This was low-certainty evidence.\nAuthors' conclusions\nWe found low-certainty evidence that AAT may slightly reduce depressive symptoms in people with dementia. We found no clear evidence that AAT affects other outcomes in this population, with our certainty in the evidence ranging from very-low to moderate depending on the outcome. We found no evidence on safety or effects on the animals. Therefore, clear conclusions cannot yet be drawn about the overall benefits and risks of AAT in people with dementia. Further well-conducted RCTs are needed to improve the certainty of the evidence. In view of the difficulty in achieving blinding of participants and personnel in such trials, future RCTs should work on blinding outcome assessors, document allocation methods clearly, and include major patient-important outcomes such as affect, emotional and social functioning, quality of life, adverse events, and outcomes for animals.\n\nGiven the provided abstract, please respond to the following query: \"Key characteristics of included studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included nine randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups), involving 305 people with dementia, which compared AAT to a control treatment (either usual care or an alternative treatment). All studies took place in Europe or the US. Seven studies compared AAT to usual care or to another activity which had nothing to do with animals. Two studies compared AAT (using live animals) to the use of robotic animals. One study compared AAT to the use of a soft toy cat. There were some features of the studies which could have biased the results. Study participants and care staff knew what treatment a person was receiving and this might have affected some results. Also, it was not always clear that the randomisation to treatments had been done as well as possible."
}
] |
query-laysum
|
23884
|
[
{
"role": "user",
"content": "Abstract: Background\nMaternal antenatal transfers provide better neonatal outcomes. However, there will inevitably be some infants who require acute transport to a neonatal intensive care unit (NICU). Because of this, many institutions develop services to provide neonatal transport by specially trained health personnel. However, few studies report on relevant clinical outcomes in infants requiring transport to NICU.\nObjectives\nTo determine the effects of specialist transport teams compared with non-specialist transport teams on the risk of neonatal mortality and morbidity among high-risk newborn infants requiring transport to neonatal intensive care.\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 7), MEDLINE (1966 to 31 July 2015), EMBASE (1980 to 31 July 2015), CINAHL (1982 to 31 July 2015), conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nStudy design: randomised, quasi-randomised or cluster randomised controlled trials.\nPopulation: neonates requiring transport to a neonatal intensive care unit.\nIntervention: transport by a specialist team compared to a non-specialist team.\nOutcomes: any of the following outcomes — death; adverse events during transport leading to respiratory compromise; and condition on admission to the neonatal intensive care unit.\nData collection and analysis\nThe methodological quality of the trials was assessed using the information provided in the studies and by personal communication with the author. Data on relevant outcomes were extracted and the effect size estimated and reported as risk ratio (RR), risk difference (RD), number needed to treat for an additional beneficial outcome (NNTB) or number needed to treat for an additional harmful outcome (NNTH) and mean difference (MD) for continuous outcomes. Data from cluster randomised trials were not combined for analysis.\nMain results\nOne trial met the inclusion criteria of this review but was considered ineligible owing to serious bias in the reporting of the results.\nAuthors' conclusions\nThere is no reliable evidence from randomised trials to support or refute the effects of specialist neonatal transport teams for neonatal retrieval on infant morbidity and mortality. Cluster randomised trial study designs may be best suited to provide us with answers on effectiveness and clinical outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "No eligible trials were identified for inclusion in this review."
}
] |
query-laysum
|
23885
|
[
{
"role": "user",
"content": "Abstract: Background\nWhile cigarette smoking has declined globally, waterpipe smoking is rising, especially among youth. The impact of this rise is amplified by mounting evidence of its addictive and harmful nature. Waterpipe smoking is influenced by multiple factors, including appealing flavors, marketing, use in social settings, and misperceptions that waterpipe is less harmful or addictive than cigarettes. People who use waterpipes are interested in quitting, but are often unsuccessful at doing so on their own. Therefore, developing and testing waterpipe cessation interventions to help people quit was identified as a priority for global tobacco control efforts.\nObjectives\nTo evaluate the effectiveness of tobacco cessation interventions for people who smoke waterpipes.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Review Group Specialized Register from database inception to 29 July 2022, using variant terms and spellings ('waterpipe' or 'narghile' or 'arghile' or 'shisha' or 'goza' or 'narkeela' or 'hookah' or 'hubble bubble'). We searched for trials, published or unpublished, in any language.\nSelection criteria\nWe sought randomized controlled trials (RCTs), quasi-RCTs, or cluster-RCTs of any smoking cessation interventions for people who use waterpipes, of any age or gender. In order to be included, studies had to measure waterpipe abstinence at a three-month follow-up or longer.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcome was abstinence from waterpipe use at least three months after baseline. We also collected data on adverse events. Individual study effects and pooled effects were summarized as risk ratios (RR) and 95% confidence intervals (95% CI), using Mantel-Haenszel random-effects models to combine studies, where appropriate. We assessed statistical heterogeneity with the I2 statistic. We summarized secondary outcomes narratively. We used the five GRADE considerations (risk of bias, inconsistency of effect, imprecision, indirectness, and publication bias) to assess the certainty of the body of evidence for our primary outcome in four categories high, moderate, low, or very low.\nMain results\nThis review included nine studies, involving 2841 participants. All studies were conducted in adults, and were carried out in Iran, Vietnam, Syria, Lebanon, Egypt, Pakistan, and the USA. Studies were conducted in several settings, including colleges/universities, community healthcare centers, tuberculosis hospitals, and cancer treatment centers, while two studies tested e-health interventions (online web-based educational intervention, text message intervention). Overall, we judged three studies to be at low risk of bias, and six studies at high risk of bias.\nWe pooled data from five studies (1030 participants) that tested intensive face-to-face behavioral interventions compared with brief behavioral intervention (e.g. one behavioral counseling session), usual care (e.g. self-help materials), or no intervention. In our meta-analysis, we included people who used waterpipe exclusively, or with another form of tobacco. Overall, we found low-certainty evidence of a benefit of behavioral support for waterpipe abstinence (RR 3.19 95% CI 2.17 to 4.69; I2 = 41%; 5 studies, N = 1030). We downgraded the evidence because of imprecision and risk of bias.\nWe pooled data from two studies (N = 662 participants) that tested varenicline combined with behavioral intervention compared with placebo combined with behavioral intervention. Although the point estimate favored varenicline, 95% CIs were imprecise, and incorporated the potential for no difference and lower quit rates in the varenicline groups, as well as a benefit as large as that found in cigarette smoking cessation (RR 1.24, 95% CI 0.69 to 2.24; I2 = 0%; 2 studies, N = 662; low-certainty evidence). We downgraded the evidence because of imprecision. We found no clear evidence of a difference in the number of participants experiencing adverse events (RR 0.98, 95% CI 0.67 to 1.44; I2 = 31%; 2 studies, N = 662). The studies did not report serious adverse events.\nOne study tested the efficacy of seven weeks of bupropion therapy combined with behavioral intervention. There was no clear evidence of benefit for waterpipe cessation when compared with behavioral support alone (RR 0.77, 95% CI 0.42 to 1.41; 1 study, N = 121; very low-certainty evidence), or with self-help (RR 1.94, 95% CI 0.94 to 4.00; 1 study, N = 86; very low-certainty evidence).\nTwo studies tested e-health interventions. One study reported higher waterpipe quit rates among participants randomized to either a tailored mobile phone or untailored mobile phone intervention compared with those randomized to no intervention (RR 1.48, 95% CI 1.07 to 2.05; 2 studies, N = 319; very low-certainty evidence). Another study reported higher waterpipe abstinence rates following an intensive online educational intervention compared with a brief online educational intervention (RR 1.86, 95% CI 1.08 to 3.21; 1 study, N = 70; very low-certainty evidence).\nAuthors' conclusions\nWe found low-certainty evidence that behavioral waterpipe cessation interventions can increase waterpipe quit rates among waterpipe smokers. We found insufficient evidence to assess whether varenicline or bupropion increased waterpipe abstinence; available evidence is compatible with effect sizes similar to those seen for cigarette smoking cessation.\nGiven e-health interventions' potential reach and effectiveness for waterpipe cessation, trials with large samples and long follow-up periods are needed. Future studies should use biochemical validation of abstinence to prevent the risk of detection bias. Finally, there has been limited attention given to high-risk groups for waterpipe smoking, such as youth, young adults, pregnant women, and dual or poly tobacco users. These groups would benefit from targeted studies.\n\nGiven the provided abstract, please respond to the following query: \"Why did we do this Cochrane Review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Waterpipe smoking has increased dramatically, becoming a global public health problem, especially among young people. Current evidence suggests that waterpipe smoking is as addictive as cigarettes, and that users will experience similar risks to their health as cigarette smokers. Therefore, developing and testing waterpipe-specific quitting interventions is important."
}
] |
query-laysum
|
23886
|
[
{
"role": "user",
"content": "Abstract: Background\nShift work results in sleep-wake disturbances, which cause sleepiness during night shifts and reduce sleep length and quality in daytime sleep after the night shift. In its serious form it is also called shift work sleep disorder. Various pharmacological products are used to ameliorate symptoms of sleepiness or poor sleep length and quality.\nObjectives\nTo evaluate the effects of pharmacological interventions to reduce sleepiness or to improve alertness at work and decrease sleep disturbances whilst off work, or both, in workers undertaking shift work in their present job and to assess their cost-effectiveness.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, PubMed and PsycINFO up to 20 September 2013 and ClinicalTrials.gov up to July 2013. We also screened reference lists of included trials and relevant reviews.\nSelection criteria\nWe included all eligible randomised controlled trials (RCTs), including cross-over RCTs, of pharmacological products among workers who were engaged in shift work (including night shifts) in their present jobs and who may or may not have had sleep problems. Primary outcomes were sleep length and sleep quality while off work, alertness and sleepiness, or fatigue at work.\nData collection and analysis\nTwo authors independently selected studies, extracted data and assessed risk of bias in included trials. We performed meta-analyses where appropriate.\nMain results\nWe included 15 randomised placebo-controlled trials with 718 participants. Nine trials evaluated the effect of melatonin and two the effect of hypnotics for improving sleep problems. One trial assessed the effect of modafinil, two of armodafinil and one examined caffeine plus naps to decrease sleepiness or to increase alertness.\nMelatonin (1 to 10 mg) after the night shift may increase sleep length during daytime sleep (mean difference (MD) 24 minutes, 95% confidence interval (CI) 9.8 to 38.9; seven trials, 263 participants, low quality evidence) and night-time sleep (MD 17 minutes, 95% CI 3.71 to 30.22; three trials, 234 participants, low quality evidence) compared to placebo. We did not find a dose-response effect. Melatonin may lead to similar sleep latency times as placebo (MD 0.37minutes, 95% CI - 1.55 to 2.29; five trials, 74 participants, low quality evidence).\nHypnotic medication, zopiclone, did not result in significantly longer daytime sleep length compared to placebo in one low quality trial and we could not use the data from the study on lormetazepam.\nArmodafinil taken before the night shift probably reduces sleepiness by one point on the Karolinska Sleepiness Scale (KSS) (MD -0.99, 95% CI -1.32 to -0.67; range 1 to 10; two trials, 572 participants, moderate quality evidence) and increases alertness by 50 ms in a simple reaction time test (MD -50.0, 95% CI -85.5 to -15.5) at three months' follow-up in shift work sleep disorder patients. Modafinil probably has similar effects on sleepiness (KSS) (MD -0.90, 95% CI -1.45 to -0.35; one trial, 183 participants, moderate quality evidence) and alertness in the psychomotor vigilance test in the same patient group. Post-marketing, severe skin reactions have been reported. Adverse effects reported by trial participants were headache, nausea and a rise in blood pressure. There were no trials in non-patient shift workers.\nBased on one trial, caffeine plus pre-shift naps taken before the night shift decreased sleepiness (KSS) (MD -0.63, 95% CI -1.09 to -0.17).\nWe judged most trials to have a low risk of bias even though the randomisation method and allocation concealment were often not described.\nAuthors' conclusions\nThere is low quality evidence that melatonin improves sleep length after a night shift but not other sleep quality parameters. Both modafinil and armodafinil increase alertness and reduce sleepiness to some extent in employees who suffer from shift work sleep disorder but they are associated with adverse events. Caffeine plus naps reduces sleepiness during the night shift, but the quality of evidence is low. Based on one low quality trial, hypnotics did not improve sleep length and quality after a night shift.\nWe need more and better quality trials on the beneficial and adverse effects and costs of all pharmacological agents that induce sleep or promote alertness in shift workers both with and without a diagnosis of shift work sleep disorder. We also need systematic reviews of their adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"What do we still need to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence was of low quality and mostly from small trials. Both sleep and alertness promoting agents have potentially serious adverse effects. Therefore, we need more trials to determine the beneficial and harmful effects of these drugs."
}
] |
query-laysum
|
23887
|
[
{
"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 are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, we have low to moderate confidence in the evidence underlying these findings. We have moderate confidence in the evidence for the findings related to COPD exacerbations, quality of life, breathing capacity, death rates and side effects. This was due to some variation in the data across these studies. We have low confidence in the evidence for pneumonia risk due to variable results across a number of studies."
}
] |
query-laysum
|
23888
|
[
{
"role": "user",
"content": "Abstract: Background\nNon-absorbable disaccharides (lactulose and lactitol) are recommended as first-line treatment for hepatic encephalopathy. The previous (second) version of this review included 10 randomised clinical trials (RCTs) evaluating non-absorbable disaccharides versus placebo/no intervention and eight RCTs evaluating lactulose versus lactitol for people with cirrhosis and hepatic encephalopathy. The review found no evidence to either support or refute the use of the non-absorbable disaccharides and no differences between lactulose versus lactitol.\nObjectives\nTo assess the beneficial and harmful effects of i) non-absorbable disaccharides versus placebo/no intervention and ii) lactulose versus lactitol in people with cirrhosis and hepatic encephalopathy.\nSearch methods\nWe carried out electronic searches of the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 10), MEDLINE, EMBASE, and Science Citation Index Expanded to 19 October 2015; manual searches of meetings and conference proceedings; checks of bibliographies; and correspondence with investigators and pharmaceutical companies.\nSelection criteria\nWe included RCTs, irrespective of publication status, language, or blinding.\nData collection and analysis\nTwo review authors, working independently, retrieved data from published reports and correspondence with investigators. The primary outcomes were mortality, hepatic encephalopathy, and serious adverse events. We presented the results of meta-analyses as risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CI). We assessed the quality of the evidence using 'Grading of Recommendations Assessment Development and Evaluation' (GRADE) and bias control using the Cochrane Hepato-Biliary Group domains. Our analyses included regression analyses of publication bias and other small study effects, Trial Sequential Analyses to detect type 1 and type 2 errors, and subgroup and sensitivity analyses.\nMain results\nWe included 38 RCTs with a total of 1828 participants. Eight RCTs had a low risk of bias in the assessment of mortality. All trials had a high risk of bias in the assessment of the remaining outcomes. Random-effects meta-analysis showed a beneficial effect of non-absorbable disaccharides versus placebo/no intervention on mortality when including all RCTs with extractable data (RR 0.59, 95% CI 0.40 to 0.87; 1487 participants; 24 RCTs; I2 = 0%; moderate quality evidence) and in the eight RCTs with a low risk of bias (RR 0.63, 95% CI 0.41 to 0.97; 705 participants). The Trial Sequential Analysis with the relative risk reduction (RRR) reduced to 30% confirmed the findings when including all RCTs, but not when including only RCTs with a low risk of bias or when we reduced the RRR to 22%. Compared with placebo/no intervention, the non-absorbable disaccharides were associated with beneficial effects on hepatic encephalopathy (RR 0.58, 95% CI 0.50 to 0.69; 1415 participants; 22 RCTs; I2 = 32%; moderate quality evidence). Additional analyses showed that non-absorbable disaccharides can help to reduce serious adverse events associated with the underlying liver disease including liver failure, hepatorenal syndrome, and variceal bleeding (RR 0.47, 95% CI 0.36 to 0.60; 1487 participants; 24 RCTs; I2 = 0%; moderate quality evidence). We confirmed the results in Trial Sequential Analysis. Tests for subgroup differences showed no statistical differences between RCTs evaluating prevention, overt, or minimal hepatic encephalopathy. The evaluation of secondary outcomes showed a potential beneficial effect of the non-absorbable disaccharides on quality of life, but we were not able to include the data in an overall meta-analysis (very low quality evidence). Non-absorbable disaccharides were associated with non-serious (mainly gastrointestinal) adverse events (very low quality evidence). None of the RCTs comparing lactulose versus lactitol evaluated quality of life. The review found no differences between lactulose and lactitol for the remaining outcomes (very low quality evidence).\nAuthors' conclusions\nThis review includes a large number of RCTs evaluating the prevention or treatment of hepatic encephalopathy. The analyses found evidence that non-absorbable disaccharides may be associated with a beneficial effect on clinically relevant outcomes compared with placebo/no intervention.\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": "Cirrhosis is a chronic disorder of the liver. People with cirrhosis may develop hepatic encephalopathy, a condition that results in poor brain functioning. Hepatic encephalopathy may be clinically obvious (overt) with changes including poor concentration, tremor, and alterations in consciousness. Others have no obvious clinical changes (minimal) but, when tested, some aspects of brain function such as attention and the ability to perform complex tasks are impaired.\nThe reason why people develop hepatic encephalopathy is complex. The accumulation of ammonia plays a key role. The non-absorbable disaccharides, lactulose and lactitol, are indigestible sugars that reduce the levels of ammonia in the blood."
}
] |
query-laysum
|
23889
|
[
{
"role": "user",
"content": "Abstract: Background\nSchizophrenia is frequently a chronic and disabling illness with a heterogeneous range of symptoms. The positive symptoms usually respond to antipsychotics but the cognitive and negative symptoms of schizophrenia are difficult to treat with conventional antipsychotics and significantly impact on quality of life and social outcomes. Selective noradrenaline reuptake inhibitors (NRIs) increase prefrontal dopamine and noradrenaline levels without significantly affecting subcortical dopamine levels, making them an attractive candidate for treating cognitive and negative symptoms.\nObjectives\nTo investigate the effects of selective noradrenaline reuptake inhibitors (NRIs), compared with a placebo or control treatment, for people with schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group’s Trials Register (up to 7 February 2017) which is based on regular searches of MEDLINE, Embase, CINAHL, BIOSIS, AMED, PubMed, PsycINFO, and registries of clinical trials. There are no language, date, document type, or publication status limitation for inclusion of records into the register. We inspected references of all included studies for further relevant studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing NRIs with either a control treatment or placebo for people with schizophrenia or related disorders (such as schizoaffective disorder) by any means of diagnosis. We included trials that met our selection criteria and provided useable information.\nData collection and analysis\nWe independently inspected all citations from searches, identified relevant abstracts, and independently extracted data from all included studies. For binary data we calculated risk ratio (RR), for continuous data we calculated mean difference (MD), and for cognitive outcomes we derived standardised mean difference (SMD) effect sizes, all with 95% confidence intervals (CI) and using a random-effects model. We assessed risk of bias for the included studies and used the GRADE approach to produce a 'Summary of findings' table which included our prespecified main outcomes of interest.\nMain results\nSearching identified 113 records. We obtained the full text of 48 of these records for closer inspection. Sixteen trials, randomising a total of 919 participants are included. The majority of trials included adults with schizophrenia or similar illness who were inpatients, and while they were poorly characterised, most appeared to include patients with a chronic presentation. The intervention NRI in nine of the 16 trials was reboxetine, with atomoxetine and viloxazine used in the remaining trials. 14 trials compared NRIs with placebo. Only two trials provided data to compare NRIs against an active control and both compared reboxetine to citalopram but at 4 weeks and 24 weeks respectively so they could not be combined in a meta-analysis.\nOne trial was described as 'open' and we considered it to be at high risk of bias for randomisation and blinding, three trials were at high risk of bias for attrition, six for reporting, and two for other sources of bias. Our main outcomes of interest were significant response or improvement in positive/negative mental state, global state and cognitive functioning, average cognitive functioning scores, significant response or improvement in quality of life and incidence of nausea. All data for main outcomes were short term.\nNRIs versus placebo\nMental state results showed significantly greater rates of improvement in negative symptoms scores (1 RCT, n = 50; RR 3.17, 95% CI 1.52 to 6.58; very low quality evidence) with NRIs on the PANSS negative. No data were reported for significant response or improvement in positive symptoms, but average endpoint PANSS positive scores were available and showed no difference between NRIs and placebo (5 RCTs, n = 294; MD −0.16, 95% CI −0.96 to 0.63; low-quality evidence). Improvement in clinical global status was similar between groups (1 RCT, n = 28; RR 0.99, 95% CI 0.45 to 2.20; very low quality evidence). Significant response or improvement in cognitive functioning data were not reported. Average composite cognitive scores showed no difference between NRIs and placebo (4 RCTs, n = 180; SMD 0.04, 95% CI −0.28 to 0.36; low-quality evidence). Significant response or improvement in quality of life data were not reported, however average endpoint scores from the GQOLI-74 were reported. Those receiving NRIs had better quality of life scores compared to placebo (1 RCT, n = 114; MD 9.36, 95% CI 7.89 to 10.83; very low quality evidence). All-cause withdrawals did not differ between the treatment groups (8 RCTs, n = 401, RR 0.94 95% CI 0.63 to 1.39; moderate-quality evidence). Rates of nausea were not greater with NRIs (3 RCTs, n = 176; RR 0.49, 95% CI 0.10 to 2.41; low-quality evidence).\nAuthors' conclusions\nOur results provide tentative very low quality evidence that compared to placebo, NRIs (specifically reboxetine) may have a benefit on the negative symptoms of schizophrenia. Limited evidence also suggests that NRIs have no effect on the positive symptoms of schizophrenia or cognitive functioning. NRIs appear generally well tolerated with no real differences in adverse effects such as nausea noted between NRIs and placebo. However, these results are based on short-term follow-up and are poor quality — there is need for more good-quality evidence. A large RCT of reboxetine over a longer period of time, focusing specifically on negative and cognitive symptoms as well as more detailed and comprehensive reporting of outcomes, including adverse events, is required.\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": "Are selective noradrenaline reuptake inhibitors (NRIs) effective for treating the symptoms, particularly the negative symptoms, of schizophrenia?"
}
] |
query-laysum
|
23890
|
[
{
"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: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results of this review are limited as we included only a single study, which suggested fly control through insecticide spraying may reduce diarrhoea in children during ‘fly seasons' when both flies and diarrhoea incidence peak. Further research on the effects in other settings is required, as well as research on fly control methods, their implementation, effects, costs, and acceptability.."
}
] |
query-laysum
|
23891
|
[
{
"role": "user",
"content": "Abstract: Background\nBronchiectasis is a chronic inflammatory disease characterised by a recurrent cycle of respiratory bacterial infections associated with cough, sputum production and impaired quality of life. Antibiotics are the main therapeutic option for managing bronchiectasis exacerbations. Evidence suggests that inhaled antibiotics may be associated with more effective eradication of infective organisms and a lower risk of developing antibiotic resistance when compared with orally administered antibiotics. However, it is currently unclear whether antibiotics are more effective when administered orally or by inhalation.\nObjectives\nTo determine the comparative efficacy and safety of oral versus inhaled antibiotics in the treatment of adults and children with bronchiectasis.\nSearch methods\nWe identified studies through searches of the Cochrane Airways Group's Specialised Register (CAGR), which is maintained by the Information Specialist for the group. 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 handsearching of respiratory journals and meeting abstracts. We also searched ClinicalTrials.gov and the WHO trials portal. We searched all databases in March 2018 and imposed no restrictions on language of publication.\nSelection criteria\nWe planned to include studies which compared oral antibiotics with inhaled antibiotics. We would have considered short-term use (less than four weeks) for treating acute exacerbations separately from longer-term use as a prophylactic (4 weeks or more). We would have considered both intraclass and interclass comparisons. We planned to exclude studies if the participants received continuous or high-dose antibiotics immediately before the start of the trial, or if they have received a diagnosis of cystic fibrosis (CF), sarcoidosis, active allergic bronchopulmonary aspergillosis or active non-tuberculous Mycobacterial infection.\nData collection and analysis\nTwo review authors independently applied study inclusion criteria to the searches and we planned for two authors to independently extract data, assess risk of bias and assess overall quality of the evidence using GRADE criteria. We also planned to obtain missing data from the authors where possible and to report results with 95% confidence intervals (CIs).\nMain results\nWe identified 313 unique records through database searches and a further 21 records from trial registers. We excluded 307 on the basis of title and abstract alone and a further 27 after examining full-text reports. No studies were identified for inclusion in the review.\nAuthors' conclusions\nThere is currently no evidence indicating whether orally administered antibiotics are more beneficial compared to inhaled antibiotics. The recent ERS bronchiectasis guidelines provide a practical approach to the use of long-term antibiotics. New research is needed comparing inhaled versus oral antibiotic therapies for bronchiectasis patients with a history of frequent exacerbations, to establish which approach is the most effective in terms of exacerbation prevention, quality of life, treatment burden, and antibiotic resistance.\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 wished to know whether oral antibiotics (taken by mouth) or inhaled antibiotics are more effective for reducing the duration and frequency of infective episodes of bronchiectasis, admissions to hospital and side effects, as well as reducing the risk of chest infections not responding to treatment with antibiotics."
}
] |
query-laysum
|
23892
|
[
{
"role": "user",
"content": "Abstract: Background\nAround a third of people with schizophrenia or related serious mental illness will be a parent. Both the parents and the children in this population are at increased risk of adverse outcomes due to parental mental illness. Parenting interventions are known to improve parenting skills and decrease child disruptive behaviour. This systematic review aimed to synthesise the evidence base for parenting interventions designed specifically for parents who have schizophrenia or related serious mental illness.\nObjectives\nTo assess the effects of parenting interventions for people with schizophrenia or related serious mental illness.\nSearch methods\nOn 10 February 2021 we searched the Cochrane Schizophrenia Group's Study-Based Register of Trials, which is based on the following: Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), ClinicalTrials.Gov, Embase, International Standard Randomised Controlled Trial Number (ISRCTN), MEDLINE, PsycINFO, PubMed, and the World Health Organization International Clinical Trials Registry Platform.\nSelection criteria\nEligible studies were randomised controlled trials (RCTs) that compared parenting interventions with a control condition for people with schizophrenia or related serious mental illness with a child between the ages of 0 and 18 years.\nData collection and analysis\nWe independently inspected citations, selected studies, extracted data and appraised study quality. We assessed risk of bias for included studies.\nMain results\nWe only included one trial (n = 50), and it was not possible to extract any data because the authors did not provide any means and standard deviations for our outcomes of interest; they only reported whether outcomes were significant or not at the 0.05 level. Three domains of the trial were rated as having a high risk of bias.\nAuthors' conclusions\nThe only included trial provided inconclusive evidence. There is insufficient evidence to make recommendations to people with schizophrenia (or related serious mental illness) or clinicians, or for policy changes. Although there is no RCT evidence, parenting interventions for people with schizophrenia or related serious mental illness have been developed. Future research should test these in RCTs in order to improve the evidence base for this population.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is not enough evidence to make recommendations about parenting programmes for people with schizophrenia or related serious mental illness. Future research should conduct rigorous studies to test the effectiveness of parenting programmes that have already been designed."
}
] |
query-laysum
|
23893
|
[
{
"role": "user",
"content": "Abstract: Background\nThoracic aortic arch aneurysms (TAAs) can be a life-threatening condition due to the potential risk of rupture. Treatment is recommended when the risk of rupture is greater than the risk of surgical complications. Depending on the cause, size and growth rate of the TAA, treatment may vary from close observation to emergency surgery. Aneurysms of the thoracic aorta can be managed by a number of surgical techniques. Open surgical repair (OSR) of aneurysms involves either partial or total replacement of the aorta, which is dependent on the extent of the diseased segment of the aorta. During OSR, the aneurysm is replaced with a synthetic graft. Hybrid repair (HR) involves a combination of open surgery with endovascular aortic stent graft placement. Hybrid repair requires varying degrees of invasiveness, depending on the number of supra-aortic branches that require debranching. The hybrid technique that combines supra-aortic vascular debranching with stent grafting of the aortic arch has been introduced as a therapeutic alternative. However, the short- and long-term outcomes of HR remain unclear, due to technical difficulties and complications as a result of the angulation of the aortic arch as well as handling of the arch during surgery.\nObjectives\nTo assess the effectiveness and safety of HR versus conventional OSR for the treatment of TAAs.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 22 March 2021. We also searched references of relevant articles retrieved from the electronic search for additional citations.\nSelection criteria\nWe considered for inclusion in the review all published and unpublished randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing HR to OSR for TAAs.\nData collection and analysis\nTwo review authors independently screened all titles and abstracts obtained from the literature search to identify those that met the inclusion criteria. We retrieved the full text of studies deemed as potentially relevant by at least one review author. The same review authors screened the full-text articles independently for inclusion or exclusion.\nMain results\nNo RCTs or CCTs met the inclusion criteria for this review.\nAuthors' conclusions\nDue to the lack of RCTs or CCTs, we were unable to determine the safety and effectiveness of HR compared to OSR in people with TAAs, and we are unable to provide high-certainty evidence on the optimal surgical intervention for this cohort of patients. High-quality RCTs or CCTs are necessary, addressing the objective of 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": "We found no RCTs and CCTs that addressed the review objective."
}
] |
query-laysum
|
23894
|
[
{
"role": "user",
"content": "Abstract: Background\nUnilateral ureteric-pelvic junction obstruction (UPJO) is the most common cause of obstructive uropathy and may lead to renal impairment and loss of renal function. The current diagnostic approach with renal imaging cannot reliably determine which newborns and infants less than two years of age have a significant obstruction and are at risk for permanent kidney damage. There is therefore no consensus on optimal therapeutic management of unilateral UPJO.\nObjectives\nTo assess the effects of surgical versus non-surgical treatment options for newborns and infants less than two years of age with unilateral UPJO.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 6, 2016), MEDLINE/Ovid, and EMBASE/Ovid databases from their inception to 13 June 2016. We searched the reference lists of potentially relevant studies without using any language restriction. We also searched the following trial registers for relevant registered studies: www.clinicaltrials.gov/; ISRCTN registry (controlled-trials.com/); www.trialscentral.org/; apps.who.int/trialsearch/; www.drks.de/; and www.anzctr.org.au/trialSearch.aspx.\nSelection criteria\nWe selected randomised and quasi-randomised controlled trials comparing surgical with non-surgical interventions for the treatment of unilateral UPJO.\nData collection and analysis\nTwo review authors independently assessed study eligibility and risk of bias of included studies and extracted data. In case of disagreements we consulted a third review author. The data reported in the two included studies did not allow us to perform a meta-analysis.\nMain results\nWe found only two studies at high risk of bias that were eligible for inclusion in this review. The total sample size, including both trials, was small (n = 107 participants less than six months of age from the UK and USA), and not all prespecified outcome measures were assessed. Reported measures only accounted for the short-term follow-ups. The mean split renal function was not statistically different between the surgical and non-surgical group at the six-month or one-year time point (very low-quality evidence). The surgical group showed a significantly less obstructed drainage pattern and a lower urinary tract dilatation than the non-surgical group (very low-quality evidence). Transfer from the non-surgical group to the surgical group was reported for about one out of five participants. Split renal function after secondary surgical intervention was reported with variable results, but most of the participants reverted to pre-deteriorated values. The studies either provided no or insufficient data on the following outcome measures: postoperative complications, UPJO-associated clinical symptoms, costs of interventions, radiation exposure, quality of life, and adverse effects.\nAuthors' conclusions\nWe found limited evidence assessing the benefits and harms of surgical compared to non-surgical treatment options for newborns and infants less than two years of age with unilateral UPJO. The majority of participants in the non-surgical treatment group did not experience any significant deterioration of split renal function, and only about 20% of them underwent secondary surgical intervention, with minor risk of permanent deteriorated split renal function. The study follow-up period was too short to assess the long-term effects on split renal function in both treatment groups. We need further randomised controlled trials with sufficient statistical power and an adequate follow-up period to determine the optimal therapy for newborns and infants less than two years of age with unilateral UPJO.\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": "Some newborn and infants less than two years of age are shown using ultrasound to have an enlargement of the pelvis of the kidney. This is the anatomical structure where the urine collects before it is transported down the ureter to the bladder. Enlargement of the pelvis of the kidney is a concern due to possible blockage of urine flow, not unlike how a river widens in front of a dam.\nLonger-term blockage of the urine flow for months and years may damage the kidney and lead to other problems such as urinary tract infections or kidney stones. Surgery can remove a blockage if it occurs, but it also has downsides including risks of complications. It is unclear whether these operations are necessary."
}
] |
query-laysum
|
23895
|
[
{
"role": "user",
"content": "Abstract: Background\nAlthough pain is common in osteoarthritis, most people fail to achieve adequate analgesia. Increasing acknowledgement of the contribution of pain sensitisation has resulted in the investigation of medications affecting pain processing with central effects. Antidepressants contribute to pain management in other conditions where pain sensitisation is present.\nObjectives\nTo assess the benefits and harms of antidepressants for the treatment of symptomatic knee and hip osteoarthritis in adults.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was January 2021.\nSelection criteria\nWe included randomised controlled trials of adults with osteoarthritis that compared use of antidepressants to placebo or alternative comparator. We included trials that focused on efficacy (pain and function), treatment-related adverse effects and had documentation regarding discontinuation of participants. We excluded trials of less than six weeks of duration or had participants with concurrent mental health disorders.\nData collection and analysis\nWe used standard Cochrane methods. Major outcomes were pain; responder rate; physical function; quality of life; and proportion of participants who withdrew due to adverse events, experienced any adverse events or had serious adverse events. Minor outcomes were proportion meeting the OARSI (Osteoarthritis Research Society International) Response Criteria, radiographic joint structure changes and proportion of participants who dropped out of the study for any reason. We used GRADE to assess certainty of evidence.\nMain results\nNine trials (2122 participants) met the inclusion criteria. Seven trials examined only knee osteoarthritis. Two also included participants with hip osteoarthritis. All trials compared antidepressants to placebo, with or without non-steroidal anti-inflammatory drugs. Trial sizes were 36 to 388 participants. Most participants were female, with mean ages of 54.5 to 65.9 years. Trial durations were 8 to 16 weeks. Six trials examined duloxetine. We combined data from nine trials in meta-analyses for knee and hip osteoarthritis.\nOne trial was at low risk of bias in all domains. Five trials were at risk of attrition and reporting bias.\nHigh-certainty evidence found that antidepressants resulted in a clinically unimportant improvement in pain compared to placebo. Mean reduction in pain (0 to 10 scale, 0 = no pain) was 1.7 points with placebo and 2.3 points with antidepressants (mean difference (MD) −0.59, 95% confidence interval (CI) −0.88 to −0.31; 9 trials, 2122 participants).\nClinical response was defined as achieving a 50% or greater reduction in 24-hour mean pain. High-certainty evidence demonstrated that 45% of participants receiving antidepressants had a clinical response compared to 28.6% receiving placebo (RR 1.55, 95% CI 1.32 to 1.82; 6 RCTs, 1904 participants). This corresponded to an absolute improvement in pain of 16% more responders with antidepressants (8.9% more to 26% more) and a number needed to treat for an additional beneficial effect (NNTB) of 6 (95% CI 4 to 11).\nHigh-certainty evidence showed that the mean improvement in function (on 0 to 100 Western Ontario and McMaster Universities Arthritis Index, 0 = best function) was 10.51 points with placebo and 16.16 points with antidepressants (MD −5.65 points, 95% CI −7.08 to −4.23; 6 RCTs, 1909 participants). This demonstrates a small, clinically unimportant response.\nModerate-certainty evidence (downgraded for imprecision) showed that quality of life measured using the EuroQol 5-Dimension scale (−0.11 to 1.0, 1.0 = perfect health) improved by 0.07 points with placebo and 0.11 points with antidepressants (MD 0.04, 95% CI 0.01 to 0.07; 3 RCTs, 815 participants). This is clinically unimportant.\nHigh-certainty evidence showed that total adverse events increased in the antidepressant group (64%) compared to the placebo group (49%) (RR 1.27, 95% CI 1.15 to 1.41; 9 RCTs, 2102 participants). The number needed to treat for an additional harmful outcome (NNTH) was 7 (95% CI 5 to 11).\nLow-certainty evidence (downgraded twice for imprecision for very low numbers of events) found no evidence of a difference in serious adverse events between groups (RR 0.94, 95% CI 0.46 to 1.94; 9 RCTs, 2101 participants). The NNTH was 1000.\nModerate-certainty evidence (downgraded for imprecision) showed that 11% of participants receiving antidepressants withdrew from trials due to an adverse event compared to 5% receiving placebo (RR 2.15, 95% CI 1.56 to 2.97; 6 RCTs, 1977 participants). The NNTH was 17 (95% CI 10 to 35).\nAuthors' conclusions\nThere is high-certainty evidence that use of antidepressants for knee osteoarthritis leads to a non-clinically important improvement in mean pain and function. However, a small number of people will have a 50% or greater important improvement in pain and function. This finding was consistent across all trials. Pain in osteoarthritis may be due to a variety of causes that differ between individuals. It may be that the cause of pain that responds to this therapy is only present in a small number of people. There is moderate-certainty evidence that antidepressants have a small positive effect on quality of life with heterogeneity between trials.\nHigh-certainty evidence indicates antidepressants result in more adverse events and moderate-certainty evidence indicates more withdrawal due to adverse events. There was little to no difference in serious adverse events (low-certainty evidence due to low numbers of events). This suggests that if antidepressants were being considered, there needs to be careful patient selection to optimise clinical benefit given the known propensity for adverse events with antidepressant use. Future trials should include alternative antidepressant agents or phenotyping of pain in people with osteoarthritis, or both.\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": "Compared with a placebo, antidepressants resulted in a small benefit.\nPain\nPain reduced by 0.59 points more on a 0- to 10-point scale with antidepressants compared to placebo.\n– The placebo group had a pain reduction of 1.73 points.\n– The antidepressant group had a pain reduction of 2.32 points.\nResponse\nA clinical response is considered a 50% or greater reduction in pain. About 16% more people taking an antidepressant had a reduction compared to placebo (that is, one in six people).\n– 28.65% of people taking placebo had a clinical response.\n– 45.2% of people taking antidepressants had a clinical response.\nFunction\nPhysical function is measured using walking, stair climbing and domestic duties. It improved 6% more with antidepressants compared to placebo. With antidepressants, the function score reduced by 5.65 on a 0- to 100-point scale (lower score = better function), compared to placebo. This is a small improvement.\n– The placebo group had an improvement in function of 10.51 points.\n– The antidepressant group had an improvement in function of 16.16 points.\nQuality of life\nQuality of life improved by 4% more with antidepressants compared to placebo. This was 0.04 points higher on a −0.11 to 1 scale in people taking antidepressants compared to placebo (higher score = better quality of life).\n– In the placebo group, quality of life improved by 0.07 points.\n– In the antidepressant group, quality of life improved by 0.11 points.\nWithdrawals due to side effects\nThe risk of stopping treatment was 2.15 more in the antidepressant group compared to placebo. This means that 1 in 17 people stopped taking the antidepressant because of side effects.\n– 5.1% of the placebo group withdrew because of side effects.\n– 10.9% of the antidepressant group withdrew because of side effects.\nTotal side effects\nThe risk of having any side effects was 1.27 more in the antidepressant group compared to the placebo group. About 14.8% more people reported a side effect in the antidepressant group. This is equivalent to 1 in every 7 people having a side effect.\n– 49.3% of the placebo group had a side effect.\n– 64.1% of the antidepressant group had a side effect.\nSerious side effects\nThere was no difference in serious side effects between groups.\n– 1.7% of the placebo group had serious side effects.\n– 1.6% of the antidepressant group had serious side effects."
}
] |
query-laysum
|
23896
|
[
{
"role": "user",
"content": "Abstract: Background\nBipolar disorder is a severe and common mental disorder where patients experience recurrent symptoms of elevated or irritable mood, depression, or a combination of both. Treatment is usually with psychiatric medication, including mood stabilisers, antidepressants and antipsychotics. Valproate is an effective maintenance treatment for bipolar disorder. However, evidence assessing the efficacy of valproate in the treatment of acute mania is less robust, especially when comparing it to some of the newer antipsychotic agents. This review is an update of a previous Cochrane Review (last published 2003) on the role of valproate in acute mania.\nObjectives\nTo assess the efficacy and tolerability of valproate for acute manic episodes in bipolar disorder compared to placebo, alternative pharmacological treatments, or a combination pharmacological treatments, as measured by the treatment of symptoms on specific rating scales for individual episodes in paediatric, adolescent and adult populations.\nSearch methods\nWe searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 28 September 2018. We had also conducted an earlier search of these databases in the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR) (all years to 6 June 2016). We also searched the World Health Organization (WHO) trials portal (ICTRP) and clinicaltrials.gov in September 2018, to identify any additional unpublished or ongoing studies.\nSelection criteria\nSingle- and double-blind, randomised controlled trials comparing valproate with placebo, alternative antimanic treatments, or a combination of pharmacological treatments. We also considered studies where valproate was used as an adjunctive treatment in combination with another agent separately from studies where it was used in monotherapy. We included male and female patients of all ages and ethnicity with bipolar disorder.\nData collection and analysis\nTwo review authors independently performed data extraction and methodological quality assessment. For analysis, we used the odds ratio (OR) for binary efficacy outcomes and the mean difference (MD) or standardised mean difference (SMD) for continuously distributed outcomes.\nMain results\nTwenty-five trials (3252 participants) compared valproate with either placebo or alternative antimanic treatments to alleviate the symptoms of acute mania. For efficacy, our primary outcome was response rate. For tolerability, our primary outcome was the number of participants with any adverse effect. This meta-analysis included studies focusing on children, adolescents, as well as adults with a range of severity of manic symptoms. The majority of studies focused on adult men and women (aged 18 and above), were conducted in inpatient settings and completed in the US. Five studies in this review focused on children and adolescents (aged 18 and under) so that the review covers an age range from 3 - 82 years. Seven studies contained outpatient participants in some form. Nine studies included data that has been collected outside the US, namely Iran (4 studies), India (3 studies), China (1 study), or across several international countries (1 study).\nIn adults, high-quality evidence found that valproate induces a slightly higher response compared to placebo (45% vs 29%, OR 2.05, 95% CI 1.32 to 3.20; 4 studies, 869 participants). Moderate-quality evidence found there was probably little or no difference in response rates between valproate and lithium (56% vs 62%, OR 0.80, 95% CI 0.48 to 1.35; 3 studies, 356 participants). In adults, low-quality evidence found there may be little or no difference in response rate between valproate and olanzapine (38% vs 44%, OR 0.77, 95% CI 0.48 to 1.25; 2 studies, 667 participants).\nIn the children and adolescent population, the evidence regarding any difference in response rates between valproate and placebo was uncertain (23% vs 22%, OR 1.11, 95% CI 0.51 to 2.38; 1 study, 151 participants, very low-quality evidence). Low-quality evidence found that the response rate of participants receiving valproate may be lower compared to risperidone (23% vs 66%, OR 0.16, 95% CI 0.08 to 0.29; 1 study, 197 participants). The evidence regarding any difference in response rates between valproate and lithium was uncertain (23% vs 34%, OR 0.57, 95% CI 0.31 to 1.07; 1 study, 197 participants, very low-quality evidence).\nIn terms of tolerability in adults, moderate-quality evidence found that there are probably more participants receiving valproate who experienced any adverse events compared to placebo (83% vs 75%, OR 1.63, 95% CI 1.13 to 2.36; 3 studies, 745 participants). Low-quality evidence found there may be little or no difference in tolerability between valproate and lithium (78% vs 86%, OR 0.61, 95% CI 0.25 to 1.50; 2 studies, 164 participants). We did not obtain primary tolerability outcome data on the olanzapine comparison.\nWithin the children and adolescent population, the evidence regarding any difference between valproate or placebo was uncertain (67% vs 60%, OR 1.39, 95% CI 0.71 to 2.71; 1 study, 150 participants, very low-quality evidence). We did not obtain primary tolerability outcome data on the lithium or risperidone comparisons.\nAuthors' conclusions\nThere is evidence that valproate is an efficacious treatment for acute mania in adults when compared to placebo. By contrast, there is no evidence of a difference in efficacy between valproate and placebo for children and adolescents. Valproate may be less efficacious than olanzapine in adults, and may also be inferior to risperidone as a monotherapy treatment for paediatric mania. Generally, there is uncertain evidence regarding whether valproate causes more or less side effects than the other main antimanic therapies. However, evidence suggests that valproate causes less weight gain and sedation than olanzapine.\n\nGiven the provided abstract, please respond to the following query: \"Who may be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with bipolar disorder and their healthcare providers."
}
] |
query-laysum
|
23897
|
[
{
"role": "user",
"content": "Abstract: Background\nAcute respiratory tract infections (ARTIs) are common and may lead to complications. Most children experience between three and six ARTIs annually. Although most infections are self-limiting, symptoms can be distressing. Many treatments are used to control symptoms and shorten illness duration. Most treatments have minimal benefit and may lead to adverse events. Oral homeopathic medicinal products could play a role in childhood ARTI management if evidence for their effectiveness is established. This is an update of a review first published in 2018.\nObjectives\nTo assess the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat ARTIs in children.\nSearch methods\nWe searched CENTRAL (2022, Issue 3), including the Cochrane Acute Respiratory Infections Specialised Register, MEDLINE (1946 to 16 March 2022), Embase (2010 to 16 March 2022), CINAHL (1981 to 16 March 2022), AMED (1985 to 16 March 2022), CAMbase (searched 16 March 2022), and British Homeopathic Library (searched 26 June 2013 - no longer operating). We also searched the WHO ICTRP and ClinicalTrials.gov (16 March 2022), checked references, and contacted study authors to identify additional studies.\nSelection criteria\nWe included double-blind randomised controlled trials (RCTs) or double-blind cluster-RCTs comparing oral homeopathy medicinal products with identical placebo or self-selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nIn this 2022 update, we identified three new RCTs involving 251 children, for a total of 11 included RCTs with 1813 children receiving oral homeopathic medicinal products or a control treatment (placebo or conventional treatment) for ARTIs. All studies focused on upper respiratory tract infections (URTIs), with only one study including some lower respiratory tract infections (LRTIs). Six treatment studies examined the effect on URTI recovery, and five studies investigated the effect on preventing URTIs after one to four months of treatment. Two treatment and three prevention studies involved homeopaths individualising treatment. The other studies used predetermined, non-individualised treatments. All studies involved highly diluted homeopathic medicinal products, with dilutions ranging from 1 x 10-4 to 1 x 10-200.\nWe identified several limitations to the included studies, in particular methodological inconsistencies and high attrition rates, failure to conduct intention-to-treat analysis, selective reporting, and apparent protocol deviations. We assessed three studies as at high risk of bias in at least one domain, and many studies had additional domains with unclear risk of bias. Four studies received funding from homeopathy manufacturers; one study support from a non-government organisation; two studies government support; one study was co-sponsored by a university; and three studies did not report funding support.\nMethodological inconsistencies and significant clinical and statistical heterogeneity precluded robust quantitative meta-analysis. Only four outcomes were common to more than one study and could be combined for analysis. Odds ratios (OR) were generally small with wide confidence intervals (CI), and the contributing studies found conflicting effects, so there was little certainty that the efficacy of the intervention could be ascertained. All studies assessed as at low risk of bias showed no benefit from oral homeopathic medicinal products, whilst trials at unclear or high risk of bias reported beneficial effects.\nFor the comparison of individualised homeopathy versus placebo or usual care for the prevention of ARTIs, two trials reported on disease severity; due to heterogeneity the data were not combined, but neither study demonstrated a clinically significant difference. We combined data from two trials for the outcome need for antibiotics (OR 0.79, 95% CI 0.35 to 1.76; low-certainty evidence).\nFor the comparison of non-individualised homeopathy versus placebo or usual care for the prevention of ARTIs, only the outcome recurrence of ARTI was reported by more than one trial; data from three studies were combined for this outcome (OR 0.60, 95% CI 0.21 to 1.72; low-certainty evidence).\nFor the comparison of both individualised and non-individualised homeopathy versus placebo or usual care for the treatment of ARTIs, two studies provided data on short-term cure (OR 1.31, 95% CI 0.09 to 19.54) and long-term cure (OR 1.01, 95% CI 0.10 to 9.96; very low-certainty evidence). The studies demonstrated an opposite direction of effect for both outcomes.\nSix studies reported on disease severity but were not combined as they used different scoring systems and scales. Three studies reported adverse events (OR 0.79, 95% CI 0.16 to 4.03; low-certainty evidence).\nAuthors' conclusions\nPooling of five prevention and six treatment studies did not show any consistent benefit of homeopathic medicinal products compared to placebo on ARTI recurrence or cure rates in children. We assessed the certainty of the evidence as low to very low for the majority of outcomes. We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children. Adverse events were poorly reported, and we could not draw conclusions regarding safety.\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 know whether homeopathic medicines help children with ARTIs. We were interested in the effect of homeopathic medicines compared to placebo (a 'dummy' treatment that does not contain any medicine but looks or tastes identical to the medicine being tested) or to usual care therapies for ARTIs.\nWe were also interested in the effect of homeopathic medicines on improvement in the severity or symptoms of infection, the need for antibiotics, duration of illness (that would affect days off school or days off work for parents), symptom reappearance, and any medicine adverse effects."
}
] |
query-laysum
|
23898
|
[
{
"role": "user",
"content": "Abstract: Background\nGestational diabetes mellitus (GDM) is a form of diabetes occurring during pregnancy which can result in short- and long-term adverse outcomes for women and babies. With an increasing prevalence worldwide, there is a need to assess strategies, including dietary advice interventions, that might prevent GDM.\nObjectives\nTo assess the effects of dietary advice interventions for preventing GDM and associated adverse health outcomes for women and their babies.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (3 January 2016) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs assessing the effects of dietary advice interventions compared with no intervention (standard care), or to different dietary advice interventions. Cluster-RCTs were eligible for inclusion but none were identified.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included studies. Data were checked for accuracy. The quality of the evidence was assessed using the GRADE approach.\nMain results\nWe included 11 trials involving 2786 women and their babies, with an overall unclear to moderate risk of bias. Six trials compared dietary advice interventions with standard care; four compared low glycaemic index (GI) with moderate- to high-GI dietary advice; one compared specific (high-fibre focused) with standard dietary advice.\nDietary advice interventions versus standard care (six trials)\nConsidering primary outcomes, a trend towards a reduction in GDM was observed for women receiving dietary advice compared with standard care (average risk ratio (RR) 0.60, 95% confidence interval (CI) 0.35 to 1.04; five trials, 1279 women; Tau² = 0.20; I² = 56%; P = 0.07; GRADE: very low-quality evidence); subgroup analysis suggested a greater treatment effect for overweight and obese women receiving dietary advice. While no clear difference was observed for pre-eclampsia (RR 0.61, 95% CI 0.25 to 1.46; two trials, 282 women; GRADE: low-quality evidence) a reduction in pregnancy-induced hypertension was observed for women receiving dietary advice (RR 0.30, 95% CI 0.10 to 0.88; two trials, 282 women; GRADE: low-quality evidence). One trial reported on perinatal mortality, and no deaths were observed (GRADE: very low-quality evidence). None of the trials reported on large-for-gestational age or neonatal mortality and morbidity.\nFor secondary outcomes, no clear differences were seen for caesarean section (average RR 0.98, 95% CI 0.78 to 1.24; four trials, 1194 women; Tau² = 0.02; I² = 36%; GRADE: low-quality evidence) or perineal trauma (RR 0.83, 95% CI 0.23 to 3.08; one trial, 759 women; GRADE: very low-quality evidence). Women who received dietary advice gained less weight during pregnancy (mean difference (MD) -4.70 kg, 95% CI -8.07 to -1.34; five trials, 1336 women; Tau² = 13.64; I² = 96%; GRADE: low-quality evidence); the result should be interpreted with some caution due to considerable heterogeneity. No clear differences were seen for the majority of secondary outcomes reported, including childhood/adulthood adiposity (skin-fold thickness at six months) (MD -0.10 mm, 95% CI -0.71 to 0.51; one trial, 132 children; GRADE: low-quality evidence). Women receiving dietary advice had a lower well-being score between 14 and 28 weeks, more weight loss at three months, and were less likely to have glucose intolerance (one trial).\nThe trials did not report on other secondary outcomes, particularly those related to long-term health and health service use and costs. We were not able to assess the following outcomes using GRADE: postnatal depression; maternal type 2 diabetes; neonatal hypoglycaemia; childhood/adulthood type 2 diabetes; and neurosensory disability.\nLow-GI dietary advice versus moderate- to high-GI dietary advice (four trials)\nConsidering primary outcomes, no clear differences were shown in the risks of GDM (RR 0.91, 95% CI 0.63 to 1.31; four trials, 912 women; GRADE: low-quality evidence) or large-for-gestational age (average RR 0.60, 95% CI 0.19 to 1.86; three trials, 777 babies; Tau² = 0.61; P = 0.07; I² = 62%; GRADE: very low-quality evidence) between the low-GI and moderate- to high-GI dietary advice groups. The trials did not report on: hypertensive disorders of pregnancy; perinatal mortality; neonatal mortality and morbidity.\nNo clear differences were shown for caesarean birth (RR 1.27, 95% CI 0.79 to 2.04; two trials, 201 women; GRADE: very low-quality evidence) and gestational weight gain (MD -1.23 kg, 95% CI -4.08 to 1.61; four trials, 787 women; Tau² = 7.31; I² = 90%; GRADE: very low-quality evidence), or for other reported secondary outcomes.\nThe trials did not report the majority of secondary outcomes including those related to long-term health and health service use and costs. We were not able to assess the following outcomes using GRADE: perineal trauma; postnatal depression; maternal type 2 diabetes; neonatal hypoglycaemia; childhood/adulthood adiposity; type 2 diabetes; and neurosensory disability.\nHigh-fibre dietary advice versus standard dietary advice (one trial)\nThe one trial in this comparison reported on two secondary outcomes. No clear difference between the high-fibre and standard dietary advice groups observed for mean blood glucose (following an oral glucose tolerance test at 35 weeks), and birthweight.\nAuthors' conclusions\nVery low-quality evidence from five trials suggests a possible reduction in GDM risk for women receiving dietary advice versus standard care, and low-quality evidence from four trials suggests no clear difference for women receiving low- versus moderate- to high-GI dietary advice. A possible reduction in pregnancy-induced hypertension for women receiving dietary advice was observed and no clear differences were seen for other reported primary outcomes. There were few outcome data for secondary outcomes.\nFor outcomes assessed using GRADE, evidence was considered to be low to very low quality, with downgrading based on study limitations (risk of bias), imprecision, and inconsistency.\nMore high-quality evidence is needed to determine the effects of dietary advice interventions in pregnancy. Future trials should be designed to monitor adherence, women's views and preferences, and powered to evaluate effects on short- and long-term outcomes; there is a need for such trials to collect and report on core outcomes for GDM research. We have identified five ongoing studies and four are awaiting classification. We will consider these in the next review update.\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"
},
{
"role": "assistant",
"content": "Women with GDM have an increased risk of developing high blood pressure and protein in their urine during pregnancy (pre-eclampsia), and of having a caesarean section birth. Their babies may grow large and, as a result, be injured at birth, or cause injury to their mothers during birth. Additionally, there can be long-term health problems for women and their babies, including an increased risk of cardiovascular disease or type 2 diabetes. The number of women being diagnosed with GDM is increasing around the world, so finding simple and cost-effective ways to prevent women developing GDM is important.\nCarbohydrates are the main nutrient affecting blood glucose after meals. The glycaemic index (GI) can be used to characterise the capability of carbohydrate-based foods to raise these levels. Some diets, for example, those with low-fibre and high-GI foods, can increase the risk of developing GDM. It has been suggested that dietary advice interventions in pregnancy may help to prevent women developing GDM."
}
] |
query-laysum
|
23899
|
[
{
"role": "user",
"content": "Abstract: Background\nDecisions in clinical medicine can be associated with ethical challenges. Ethical case interventions (e.g. ethics committee, moral case deliberation) identify and analyse ethical conflicts which occur within the context of care for patients. Ethical case interventions involve ethical experts, different health professionals as well as the patient and his/her family. The aim is to support decision-making in clinical practice. This systematic review gathered and critically appraised the available evidence of controlled studies on the effectiveness of ethical case interventions.\nObjectives\nTo determine whether ethical case interventions result in reduced decisional conflict or moral distress of those affected by an ethical conflict in clinical practice; improved patient involvement in decision-making and a higher quality of life in adult patients. To determine the most effective models of ethical case interventions and to analyse the use and appropriateness of the outcomes in experimental studies.\nSearch methods\nWe searched the following electronic databases for primary studies to September 2018: CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO. We also searched CDSR and DARE for related reviews. Furthermore, we searched Clinicaltrials.gov, International Clinical Trials Registry Platform Search Portal and conducted a cited reference search for all included studies in ISI WEB of Science. We also searched the references of the included studies.\nSelection criteria\nWe included randomised trials, non-randomised trials, controlled before-after studies and interrupted time series studies which compared ethical case interventions with usual care or an active control in any language. The included population were adult patients. However, studies with mixed populations consisting of adults and children were included, if a subgroup or sensitivity analysis (or both) was performed for the adult population.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and the Effective Practice and Organisation of Care review group. We used meta-analysis based on a random-effects model for treatment costs and structured analysis for the remaining outcomes, because these were heterogeneously reported. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included four randomised trials published in six articles. The publication dates ranged from 2000 to 2014. Three studies were conducted in the USA, and one study in Taiwan. All studies were conducted on intensive care units and included 1165 patients. We judged the included studies to be of moderate or high risk of bias. It was not possible to compare different models of the intervention regarding effectiveness due to the diverse character of the interventions and the small number of studies. Included studies did not directly measure the main outcomes. All studies received public funding and one received additional funding from private sources.\nWe identified two models of ethical case interventions: proactive and request-based ethics consultation. Three studies evaluated proactive ethics consultation (n = 1103) of which one study reported findings on one key outcome criterion. The studies did not report data on decisional conflict, moral distress of participants of ethical case interventions, patient involvement in decision-making, quality of life or ethical competency for proactive ethics consultation. One study assessed satisfaction with care on a 5-point Likert scale (1 = lowest rating, 5 = highest rating). The healthcare providers (nurses and physicians, n = 365) scored a value of 4 or 5 for 81.4% in the control group and 86.1% in the intervention group (P > 0.05). The patients or their surrogates (n = 275) scored a value of 4 or 5 for 83.6% in the control group and for 74.8% in the intervention group (P > 0.05). It was uncertain whether proactive ethics consultation led to high satisfaction with care, because the certainty of evidence was very low.\nOne study evaluated request-based ethics consultation (n = 62). The study indirectly measured decisional conflict by assessing consensus regarding patient care. The risk (increase in consensus, reduction in decisional conflict) increased by 80% as a result of the intervention. The risk ratio was 0.20 (95% confidence interval 0.09 to 0.46; P < 0.01). It was uncertain whether request-based ethics consultation reduced decisional conflict, because the certainty of evidence was very low. The study did not report data on moral distress of participants of ethical case interventions, patient involvement in decision-making, quality of life, or ethical competency or satisfaction with care for request-based ethics consultation.\nAuthors' conclusions\nIt is not possible to determine the effectiveness of ethical case interventions with certainty due to the low certainty of the evidence of included studies in this review. The effectiveness of ethical case interventions should be investigated in light of the outcomes reported in this systematic review. In addition, there is need for further research to identify and measure outcomes which reflect the goals of different types of ethical case intervention.\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": "It was uncertain whether ethical case intervention reduced the decisional conflict of those who need to make decisions about treatment, because the certainty of evidence was very low. We found no studies reporting effects of ethical case interventions on moral distress, patient involvement in decision-making, patients' quality of life or ethical competency. It was uncertain whether ethical case intervention increased satisfaction with care, because the certainty of evidence was very low. We need more high-quality studies to evaluate ethical case intervention."
}
] |
query-laysum
|
23900
|
[
{
"role": "user",
"content": "Abstract: Background\nTheoretically, autologous serum eye drops (AS) offer a potential advantage over traditional therapies on the assumption that AS not only serve as a lacrimal substitute to provide lubrication but contain other biochemical components that allow them to mimic natural tears more closely. Application of AS has gained popularity as second-line therapy for patients with dry eye. Published studies on this subject indicate that autologous serum could be an effective treatment for dry eye.\nObjectives\nWe conducted this review to evaluate the efficacy and safety of AS given alone or in combination with artificial tears as compared with artificial tears alone, saline, placebo, or no treatment for adults with dry eye.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 5), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2016), Embase (January 1980 to July 2016), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to July 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We also searched the Science Citation Index Expanded database (December 2016) and reference lists of included studies. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 5 July 2016.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared AS versus artificial tears for treatment of adults with dry eye.\nData collection and analysis\nTwo review authors independently screened all titles and abstracts and assessed full-text reports of potentially eligible trials. Two review authors extracted data and assessed risk of bias and characteristics of included trials. We contacted investigators to ask for missing data. For both primary and secondary outcomes, we reported mean differences with corresponding 95% confidence intervals (CIs) for continuous outcomes. We did not perform meta-analysis owing to differences in outcome assessments across trials.\nMain results\nWe identified five eligible RCTs (92 participants) that compared AS versus artificial tears or saline in individuals with dry eye of various origins (Sjögren's syndrome-related dry eye, non-Sjögren's syndrome dry eye, and postoperative dry eye induced by laser-assisted in situ keratomileusis (LASIK)). We assessed the certainty of evidence as low or very low because of lack of reporting of quantitative data for most outcomes and unclear or high risk of bias among trials. We judged most risk of bias domains to have unclear risk in two trials owing to insufficient reporting of trial characteristics, and we considered one trial to have high risk of bias for most domains. We judged the remaining two trials to have low risk of bias; however, these trials used a cross-over design and did not report data in a way that could be used to compare outcomes between treatment groups appropriately. Incomplete outcome reporting and heterogeneity among outcomes and follow-up periods prevented inclusion of these trials in a summary meta-analysis.\nThree trials compared AS with artificial tears; however, only one trial reported quantitative data for analysis. Low-certainty evidence from one trial suggested that AS might provide some improvement in participant-reported symptoms compared with artificial tears after two weeks of treatment; the mean difference in mean change in symptom score measured on a visual analogue scale (range 0 to 100, with higher scores representing worse symptoms) was -12.0 (95% confidence interval (CI) -20.16 to -3.84; 20 participants). This same trial found mixed results with respect to ocular surface outcomes; the mean difference in mean change in scores between AS and artificial tears was -0.9 (95% CI -1.47 to -0.33; 20 participants; low-certainty evidence) for fluorescein staining and -2.2 (95% CI -2.73 to -1.67; 20 participants; low-certainty evidence) for Rose Bengal staining. Both staining scales range from 0 to 9, with higher scores indicating worse results. The mean change in tear film break-up time was 2.00 seconds longer (95% CI 0.99 to 3.01; 20 participants; low-certainty evidence) in the AS group than in the artificial tears group. Investigators reported no clinically meaningful differences in Schirmer’s test scores between groups (mean difference -0.40 mm, 95% CI -2.91 to 2.11; 20 participants; low-certainty evidence). None of these three trials reported tear hyperosmolarity and adverse events.\nTwo trials compared AS versus saline; however, only one trial reported quantitative data for analysis of only one outcome (Rose Bengal staining). Trial investigators of the two studies reported no differences in symptom scores, fluorescein staining scores, tear film break-up times, or Schirmer's test scores between groups at two to four weeks' follow-up. Very low-certainty evidence from one trial suggested that AS might provide some improvement in Rose Bengal staining scores compared with saline after four weeks of treatment; the mean difference in Rose Bengal staining score (range from 0 to 9, with higher scores showing worse results) was -0.60 (95% CI -1.11 to -0.09; 35 participants). Neither trial reported tear hyperosmolarity outcomes. One trial reported adverse events; two of 12 participants had signs of conjunctivitis with negative culture that did resolve.\nAuthors' conclusions\nOverall, investigators reported inconsistency in possible benefits of AS for improving participant-reported symptoms and other objective clinical measures. There might be some benefit in symptoms with AS compared with artificial tears in the short-term, but we found no evidence of an effect after two weeks of treatment. Well-planned, large, high-quality RCTs are warranted to examine participants with dry eye of different severities by using standardized questionnaires to measure participant-reported outcomes, as well as objective clinical tests and objective biomarkers to assess the benefit of AS therapy for dry eye.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found five studies in people with dry eye from Australia, Chile, Japan, and Turkey. These studies compared autologous serum eye drops versus traditional artificial tears or saline solution for treatment of dry eye. We could not combine results of the five studies in analysis owing to differences in what each study evaluated. In one study, people who received autologous serum eye drops showed better improvement in symptoms after two weeks than those who received artificial tears. However, results after longer treatment (four weeks or more) and for other outcomes had problems that prevent us from saying whether autologous serum is truly better than artifical tears or saline. The authors of this review conclude that autologous serum versus artificial tears might provide benefit for treatment of dry eye in the short term. However, the overall benefit seems unclear at this time, and much more research is needed in this area."
}
] |
query-laysum
|
23901
|
[
{
"role": "user",
"content": "Abstract: Background\nHealthcare professionals, including nurses, frequently advise people to improve their health by stopping smoking. Such advice may be brief, or part of more intensive interventions.\nObjectives\nTo determine the effectiveness of nursing-delivered smoking cessation interventions in adults. To establish whether nursing-delivered smoking cessation interventions are more effective than no intervention; are more effective if the intervention is more intensive; differ in effectiveness with health state and setting of the participants; are more effective if they include follow-ups; are more effective if they include aids that demonstrate the pathophysiological effect of smoking.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialized Register and CINAHL in January 2017.\nSelection criteria\nRandomized trials of smoking cessation interventions delivered by nurses or health visitors with follow-up of at least six months.\nData collection and analysis\nTwo review authors extracted data independently. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically-validated rates if available. Where statistically and clinically appropriate, we pooled studies using a Mantel-Haenszel fixed-effect model and reported the outcome as a risk ratio (RR) with a 95% confidence interval (CI).\nMain results\nFifty-eight studies met the inclusion criteria, nine of which are new for this update. Pooling 44 studies (over 20,000 participants) comparing a nursing intervention to a control or to usual care, we found the intervention increased the likelihood of quitting (RR 1.29, 95% CI 1.21 to 1.38); however, statistical heterogeneity was moderate (I2 = 50%) and not explained by subgroup analysis. Because of this, we judged the quality of evidence to be moderate. Despite most studies being at unclear risk of bias in at least one domain, we did not downgrade the quality of evidence further, as restricting the main analysis to only those studies at low risk of bias did not significantly alter the effect estimate. Subgroup analyses found no evidence that high-intensity interventions, interventions with additional follow-up or interventions including aids that demonstrate the pathophysiological effect of smoking are more effective than lower intensity interventions, or interventions without additional follow-up or aids. There was no evidence that the effect of support differed by patient group or across healthcare settings.\nAuthors' conclusions\nThere is moderate quality evidence that behavioural support to motivate and sustain smoking cessation delivered by nurses can lead to a modest increase in the number of people who achieve prolonged abstinence. There is insufficient evidence to assess whether more intensive interventions, those incorporating additional follow-up, or those incorporating pathophysiological feedback are more effective than one-off support. There was no evidence that the effect of support differed by patient group or across healthcare settings.\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": "This review found moderate-quality evidence that advice and support from nurses could increase people's success in quitting smoking, whether in hospitals or in community settings. Eleven studies compared different nurse-delivered interventions and did not find that adding more components changed the effect."
}
] |
query-laysum
|
23902
|
[
{
"role": "user",
"content": "Abstract: Background\nAlzheimer's disease and other forms of dementia are becoming increasingly common with the aging of most populations. The majority of individuals with dementia will first present for care and assessment in primary care settings. There is a need for brief dementia screening instruments that can accurately detect dementia in primary care settings. The Mini-Cog is a brief, cognitive screening test that is frequently used to evaluate cognition in older adults in various settings.\nObjectives\nTo determine the accuracy of the Mini-Cog for detecting dementia in a primary care setting.\nSearch methods\nWe searched the Cochrane Dementia and Cognitive Improvement Register of Diagnostic Test Accuracy Studies, MEDLINE, Embase and four other databases, initially to September 2012. Since then, four updates to the search were performed using the same search methods, and the most recent was January 2017. We used citation tracking (using the databases' ‘related articles’ feature, where available) as an additional search method and contacted authors of eligible studies for unpublished data.\nSelection criteria\nWe only included studies that evaluated the Mini-Cog as an index test for the diagnosis of Alzheimer's disease dementia or related forms of dementia when compared to a reference standard using validated criteria for dementia. We only included studies that were conducted in primary care populations.\nData collection and analysis\nWe extracted and described information on the characteristics of the study participants and study setting. Using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) criteria we evaluated the quality of studies, and we assessed risk of bias and applicability of each study for each domain in QUADAS-2. Two review authors independently extracted information on the true positives, true negatives, false positives, and false negatives and entered the data into Review Manager 5 (RevMan 5). We then used RevMan 5 to determine the sensitivity, specificity, and 95% confidence intervals. We summarized the sensitivity and specificity of the Mini-Cog in the individual studies in forest plots and also plotted them in a receiver operating characteristic plot. We also created a 'Risk of bias' and applicability concerns graph to summarize information related to the quality of included studies.\nMain results\nThere were a total of four studies that met our inclusion criteria, including a total of 1517 total participants. The sensitivity of the Mini-Cog varied between 0.76 to 1.00 in studies while the specificity varied between 0.27 to 0.85. The included studies displayed significant heterogeneity in both methodologies and clinical populations, which did not allow for a meta-analysis to be completed. Only one study (Holsinger 2012) was found to be at low risk of bias on all methodological domains. The results of this study reported that the sensitivity of the Mini-Cog was 0.76 and the specificity was 0.73. We found the quality of all other included studies to be low due to a high risk of bias with methodological limitations primarily in their selection of participants.\nAuthors' conclusions\nThere is a limited number of studies evaluating the accuracy of the Mini-Cog for the diagnosis of dementia in primary care settings. Given the small number of studies, the wide range in estimates of the accuracy of the Mini-Cog, and methodological limitations identified in most of the studies, at the present time there is insufficient evidence to recommend that the Mini-Cog be used as a screening test for dementia in primary care. Further studies are required to determine the accuracy of Mini-Cog in primary care and whether this tool has sufficient diagnostic test accuracy to be useful as a screening test in this setting.\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results of the highest-quality study Holsinger 2012 found that the Mini-Cog had a sensitivity of 76%, indicating that the Mini-Cog failed to detect up to 24% of individuals who have dementia (e.g. false negatives). In this same study, the specificity of the Mini-Cog was 73% indicating that up to 27% of individuals may be incorrectly identified as having dementia on the Mini-Cog when these individuals do not actually have an underlying dementia (e.g. false positives). We conclude that at the present time there is not enough evidence to support the routine use of the Mini-Cog as a screening test for dementia in primary care and additional studies are required before concluding that the Mini-Cog is useful in this setting."
}
] |
query-laysum
|
23903
|
[
{
"role": "user",
"content": "Abstract: Background\nThalassaemia is a genetic disorder of the haemoglobin protein in red blood cells. It has been historically classified into thalassaemia minor, intermedia and major, depending on the genetic defect and severity of the disease. The clinical presentation of β-thalassaemia varies widely from a mild asymptomatic form in thalassaemia minor, to a severe disease in thalassaemia major where individuals are dependant on life-long blood transfusions. The hallmark of thalassaemia syndromes is the production of defective red blood cells that are removed by the spleen resulting in an enlarged hyperfunctioning spleen (splenomegaly). Removal of the spleen may thus prolong red blood cell survival by reducing the amount of red blood cells removed from circulation and may ultimately result in the reduced need for blood transfusions.\nObjectives\nTo assess the efficacy and safety of splenectomy in people with β-thalassaemia major or intermedia.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Review Group's Haemoglobinopathies Trials Register, compiled from searches of electronic databases and the handsearching of journals and conference abstract books. We also searched online trial registries and the reference lists of relevant articles and reviews (27 July 2018).\nDate of the most recent search of the Group's trials register: 02 August 2019.\nSelection criteria\nWe included randomised controlled and quasi-randomised controlled studies of people of any age with thalassaemia major or intermedia, evaluating splenectomy in comparison to conservative treatment (transfusion therapy and iron chelation) or other forms of splenectomy compared to each other (laparoscopic, open, radio-frequency).\nData collection and analysis\nTwo authors independently selected and extracted data from the single included study using a customised data extraction form and assessed the risk of bias. The quality of the evidence was assessed using GRADE.\nMain results\nOne study, including 28 participants was included in the review; the results were described, primarily, in a narrative manner. This study assessed the feasibility of splenectomy using a laparoscopic approach versus open surgery. Given the lack of detail regarding the study methods beyond randomisation, the overall risk of bias for this study was unclear. The study was carried out over a period of 3.5 years, with each participant followed up only until discharge (less than one week after the intervention); it did not assess the majority of the outcomes outlined in this review (including two of the three primary outcomes, frequency of transfusion and quality of life). A total of three serious post-operative adverse events (the review's third primary outcome) were reported in the laparoscopic splenectomy group (one case of atelectasis and two cases of bleeding), compared to two events of atelectasis in the open surgery group; however, there were no significant differences between the groups for either atelectasis, risk ratio (RR) 0.50 (95% confidence interval (CI) 0.05 to 4.90) or for bleeding, RR 5.00 (95% CI 0.26 to 95.61) (very low-quality evidence). In addition, the study also reported three serious cases of intra-operative bleeding in the laparoscopic group which mandated conversion to open surgery, although the difference between groups was not statistically significant, RR 7.00 (95% CI 0.39 to 124.14) (very low-quality evidence). These effect estimates are based on very small numbers and hence are unreliable and imprecise. From this small study, there appeared to be an advantage for the laparoscopic approach, in terms of post-operative hospital stay, although the group difference was not large (median difference of 1.5 days, P = 0.03).\nAuthors' conclusions\nThe review was unable to find good quality evidence, in the form of randomised controlled studies, regarding the efficacy of splenectomy for treating thalassaemia major or intermedia. The single included study provided little information about the efficacy of splenectomy, and compared open surgery and laparoscopic methods. Further studies need to evaluate the long-term effectiveness of splenectomy and the comparative advantages of surgical methods. Due to a lack of high quality evidence from randomised controlled studies, well-conducted observational studies may be used to answer this question.\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": "While we are satisfied that the participants had equal chances of undergoing either type of surgery, there is not enough information on other aspects of the study to make any overall judgement on its quality."
}
] |
query-laysum
|
23904
|
[
{
"role": "user",
"content": "Abstract: Background\nDifferent first-line drug classes for patients with hypertension are often assumed to have similar effectiveness with respect to reducing mortality and morbidity outcomes, and lowering blood pressure. First-line low-dose thiazide diuretics have been previously shown to have the best mortality and morbidity evidence when compared with placebo or no treatment. Head-to-head comparisons of thiazides with other blood pressure-lowering drug classes would demonstrate whether there are important differences.\nObjectives\nTo compare the effects of first-line diuretic drugs with other individual first-line classes of antihypertensive drugs on mortality, morbidity, and withdrawals due to adverse effects in patients with hypertension. Secondary objectives included assessments of the need for added drugs, drug switching, and blood pressure-lowering.\nSearch methods\nCochrane Hypertension's Information Specialist searched the Cochrane Hypertension Specialized Register, CENTRAL, MEDLINE, Embase, and trials registers to March 2021. We also checked references and contacted study authors to identify additional studies. A top-up search of the Specialized Register was carried out in June 2022.\nSelection criteria\nRandomized active comparator trials of at least one year's duration were included. Trials had a clearly defined intervention arm of a first-line diuretic (thiazide, thiazide-like, or loop diuretic) compared to another first-line drug class: beta-blockers, calcium channel blockers, alpha adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, direct renin inhibitors, or other antihypertensive drug classes. Studies had to include clearly defined mortality and morbidity outcomes (serious adverse events, total cardiovascular events, stroke, coronary heart disease (CHD), congestive heart failure, and withdrawals due to adverse effects).\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nWe included 20 trials with 26 comparator arms randomizing over 90,000 participants. The findings are relevant to first-line use of drug classes in older male and female hypertensive patients (aged 50 to 75) with multiple co-morbidities, including type 2 diabetes. First-line thiazide and thiazide-like diuretics were compared with beta-blockers (six trials), calcium channel blockers (eight trials), ACE inhibitors (five trials), and alpha-adrenergic blockers (three trials); other comparators included angiotensin II receptor blockers, aliskiren (a direct renin inhibitor), and clonidine (a centrally acting drug). Only three studies reported data for total serious adverse events: two studies compared diuretics with calcium channel blockers and one with a direct renin inhibitor.\nCompared to first-line beta-blockers, first-line thiazides probably result in little to no difference in total mortality (risk ratio (RR) 0.96, 95% confidence interval (CI) 0.84 to 1.10; 5 trials, 18,241 participants; moderate-certainty), probably reduce total cardiovascular events (5.4% versus 4.8%; RR 0.88, 95% CI 0.78 to 1.00; 4 trials, 18,135 participants; absolute risk reduction (ARR) 0.6%, moderate-certainty), may result in little to no difference in stroke (RR 0.85, 95% CI 0.66 to 1.09; 4 trials, 18,135 participants; low-certainty), CHD (RR 0.91, 95% CI 0.78 to 1.07; 4 trials, 18,135 participants; low-certainty), or heart failure (RR 0.69, 95% CI 0.40 to 1.19; 1 trial, 6569 participants; low-certainty), and probably reduce withdrawals due to adverse effects (10.1% versus 7.9%; RR 0.78, 95% CI 0.71 to 0.85; 5 trials, 18,501 participants; ARR 2.2%; moderate-certainty).\nCompared to first-line calcium channel blockers, first-line thiazides probably result in little to no difference in total mortality (RR 1.02, 95% CI 0.96 to 1.08; 7 trials, 35,417 participants; moderate-certainty), may result in little to no difference in serious adverse events (RR 1.09, 95% CI 0.97 to 1.24; 2 trials, 7204 participants; low-certainty), probably reduce total cardiovascular events (14.3% versus 13.3%; RR 0.93, 95% CI 0.89 to 0.98; 6 trials, 35,217 participants; ARR 1.0%; moderate-certainty), probably result in little to no difference in stroke (RR 1.06, 95% CI 0.95 to 1.18; 6 trials, 35,217 participants; moderate-certainty) or CHD (RR 1.00, 95% CI 0.93 to 1.08; 6 trials, 35,217 participants; moderate-certainty), probably reduce heart failure (4.4% versus 3.2%; RR 0.74, 95% CI 0.66 to 0.82; 6 trials, 35,217 participants; ARR 1.2%; moderate-certainty), and may reduce withdrawals due to adverse effects (7.6% versus 6.2%; RR 0.81, 95% CI 0.75 to 0.88; 7 trials, 33,908 participants; ARR 1.4%; low-certainty).\nCompared to first-line ACE inhibitors, first-line thiazides probably result in little to no difference in total mortality (RR 1.00, 95% CI 0.95 to 1.07; 3 trials, 30,961 participants; moderate-certainty), may result in little to no difference in total cardiovascular events (RR 0.97, 95% CI 0.92 to 1.02; 3 trials, 30,900 participants; low-certainty), probably reduce stroke slightly (4.7% versus 4.1%; RR 0.89, 95% CI 0.80 to 0.99; 3 trials, 30,900 participants; ARR 0.6%; moderate-certainty), probably result in little to no difference in CHD (RR 1.03, 95% CI 0.96 to 1.12; 3 trials, 30,900 participants; moderate-certainty) or heart failure (RR 0.94, 95% CI 0.84 to 1.04; 2 trials, 30,392 participants; moderate-certainty), and probably reduce withdrawals due to adverse effects (3.9% versus 2.9%; RR 0.73, 95% CI 0.64 to 0.84; 3 trials, 25,254 participants; ARR 1.0%; moderate-certainty).\nCompared to first-line alpha-blockers, first-line thiazides probably result in little to no difference in total mortality (RR 0.98, 95% CI 0.88 to 1.09; 1 trial, 24,316 participants; moderate-certainty), probably reduce total cardiovascular events (12.1% versus 9.0%; RR 0.74, 95% CI 0.69 to 0.80; 2 trials, 24,396 participants; ARR 3.1%; moderate-certainty) and stroke (2.7% versus 2.3%; RR 0.86, 95% CI 0.73 to 1.01; 2 trials, 24,396 participants; ARR 0.4%; moderate-certainty), may result in little to no difference in CHD (RR 0.98, 95% CI 0.86 to 1.11; 2 trials, 24,396 participants; low-certainty), probably reduce heart failure (5.4% versus 2.8%; RR 0.51, 95% CI 0.45 to 0.58; 1 trial, 24,316 participants; ARR 2.6%; moderate-certainty), and may reduce withdrawals due to adverse effects (1.3% versus 0.9%; RR 0.70, 95% CI 0.54 to 0.89; 3 trials, 24,772 participants; ARR 0.4%; low-certainty).\nFor the other drug classes, data were insufficient. No antihypertensive drug class demonstrated any clinically important advantages over first-line thiazides.\nAuthors' conclusions\nWhen used as first-line agents for the treatment of hypertension, thiazides and thiazide-like drugs likely do not change total mortality and likely decrease some morbidity outcomes such as cardiovascular events and withdrawals due to adverse effects, when compared to beta-blockers, calcium channel blockers, ACE inhibitors, and alpha-blockers.\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 whether the benefits and harms of diuretics given first for hypertension differed from other drug classes."
}
] |
query-laysum
|
23905
|
[
{
"role": "user",
"content": "Abstract: Background\nIntracranial venous thrombosis (ICVT) commonly presents with seizures in the acute period, and some people may develop recurrent seizures in the long term. The prophylactic use of antiepileptic drugs (AEDs) for the management of post-ICVT seizures is controversial, and there is currently no consensus on the optimal management of post-ICVT seizures. This is an updated version of the Cochrane review first published in theCochrane Database of Systematic Reviews 2006, Issue 3.\nObjectives\nTo assess the effects of AEDs for the primary and secondary prevention of seizures related to ICVT.\n(1) For the question of primary prevention, we aimed to examine whether AEDs reduce the likelihood of seizures in people who have had an ICVT but have not had a seizure.\n(2) For the question of secondary prevention, we aimed to examine whether AEDs reduce the likelihood of further seizures in people who have had an ICVT and at least one seizure.\nSearch methods\nFor the latest update, we searched the Cochrane Epilepsy Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO), and MEDLINE (Ovid 1946 onwards) to 20 April 2015, and we checked the reference lists of articles retrieved from the searches.\nSelection criteria\nWe planned to include all randomised and quasi-randomised controlled trials in which participants with a diagnosis of ICVT were assigned to a treatment group (that is, receiving at least one AED) or control group (receiving placebo or no drug).\nData collection and analysis\nBoth review authors independently screened and assessed the methodological quality of the studies. If studies had been included in the review, one review author would have extracted the data and another would have checked the extracted data.\nMain results\nNo relevant studies were found.\nAuthors' conclusions\nThere is no evidence to support or refute the use of antiepileptic drugs for the primary or secondary prevention of seizures related to intracranial venous thrombosis. Well-designed randomised controlled trials are urgently needed to inform practice. Since the last version of this review no new studies have been found.\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": "No study up to April 2015 met the inclusion criteria for review."
}
] |
query-laysum
|
23906
|
[
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease (SCD), one of the most common inherited disorders, is associated with vaso-occlusive pain episodes and haemolysis leading to recurrent morbidity, hospital admissions and work or school absenteeism. The crises are conventionally treated with opioids, non-opioids and other adjuvants with the risk of developing complications, addictions and drug-seeking behaviour. Different non-pharmacological treatments, such as transcutaneous electrical nerve stimulation (TENS) have been used for managing pain in other painful conditions. Hence, the efficacy of TENS for managing pain in SCD needs to be reviewed.\nObjectives\nTo assess the benefits and harms of TENS for managing pain in people with SCD who experience pain crises or chronic pain (or both).\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Register, comprising of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched online trial registries and the reference lists of relevant articles and reviews.\nDate of the last search: 26 Febraury 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs, where TENS was evaluated for managing pain in people with SCD.\nData collection and analysis\nTwo review authors independently assessed the eligibility of the trials identified by the literature searches according to the inclusion criteria. Two review authors then independently extracted data, assessed for risk of bias using the Cochrane standard tool and rated the quality of evidence using the GRADE guidelines.\nMain results\nOne double-blind cross-over RCT with 22 participants with SCD (aged 12 to 27 years) was eligible for inclusion. Following stratification into four pain crises severity grades, participants were then randomised to receive TENS or placebo (sham TENS). The trial was concluded after 60 treatment episodes (30 treatment episodes of each treatment group).\nThere is a lack of clarity regarding the trial design and the analysis of the cross-over data. If a participant was allocated to TENS treatment for an episode of pain and subsequently returned with a further episode of a similar degree of pain, they would then receive the sham TENS treatment (cross-over design). For those experiencing a pain episode of a different severity, it is not clear whether they were re-randomised or given the alternate treatment. Reporting and analysis was based on the total number pain events and not on the number of participants. It is unclear how many participants were crossed over from the TENS group to the sham TENS group and vice versa. The trial had a high risk of bias regarding random sequence generation and allocation concealment; an unclear risk regarding the blinding of participants and personnel; and a low risk regarding the blinding of the outcome assessors and selective outcome reporting.\nThe trial was small and of very low quality; furthermore, given the issue with trial design we were unable to quantitatively analyse the data. Therefore, we present only a narrative summary and caution is advised in interpreting the results. In relation to our pre-defined primary outcomes, the included trial did not report pain relief at two to four weeks post intervention. The trial authors reported that no difference was found in the changes in pain ratings (recorded at one hour and four hours post intervention) between the TENS and the placebo groups. In relation to our secondary outcomes, the analgesic usage during the trial also did not show any difference between groups. Given the quality of the evidence, we are uncertain whether TENS improves overall satisfaction as compared to sham TENS. The ability to cope with activities of daily living was not evaluated. Regarding adverse events, although one case of itching was reported in the TENS group, the site and nature of itching was not clearly stated; hence it cannot be clearly attributed to TENS. Also, two participants receiving 'sham' TENS reported a worsening of pain with the intervention.\nAuthors' conclusions\nSince we have only included one small and very low-quality trial, with a high risk of bias across several domains, we are unable to conclude whether TENS is harmful or beneficial for managing pain in people with SCD. There is a need for a well-designed, adequately-powered, RCT to evaluate the role of TENS in managing pain in people with SCD.\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 trial publication did not clearly report how the randomised list for allocating the participants to the two treatment groups was generated, therefore, we assessed this as having a high risk of bias. The reporting and analysis was based on only the total number pain events and not the number of people reporting pain episodes. It is unclear from this report how many participants were crossed over from TENS to 'sham' TENS treatment group. The first treatment may have an effect on the subsequent treatment and there is no clear data regarding the cross over process from one treatment group to the other. Hence we conclude that the trial has a high risk of bias and the results are hard to interpret."
}
] |
query-laysum
|
23907
|
[
{
"role": "user",
"content": "Abstract: Background\nThe common cold is a spontaneously remitting infection of the upper respiratory tract, characterised by a runny nose, nasal congestion, sneezing, cough, malaise, sore throat, and fever (usually < 37.8 ºC). Whilst the common cold is generally not harmful, it is a cause of economic burden due to school and work absenteeism. In the United States, economic loss due to the common cold is estimated at more than USD 40 billion per year, including an estimate of 70 million workdays missed by employees, 189 million school days missed by children, and 126 million workdays missed by parents caring for children with a cold. Additionally, data from Europe show that the total cost per episode may be up to EUR 1102. There is also a large expenditure due to inappropriate antimicrobial prescription. Vaccine development for the common cold has been difficult due to antigenic variability of the common cold viruses; even bacteria can act as infective agents. Uncertainty remains regarding the efficacy and safety of interventions for preventing the common cold in healthy people, thus we performed an update of this Cochrane Review, which was first published in 2011 and updated in 2013 and 2017.\nObjectives\nTo assess the clinical effectiveness and safety of vaccines for preventing the common cold in healthy people.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (April 2022), MEDLINE (1948 to April 2022), Embase (1974 to April 2022), CINAHL (1981 to April 2022), and LILACS (1982 to April 2022). We also searched three trials registers for ongoing studies, and four websites for additional trials (April 2022). We did not impose any language or date restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) of any virus vaccine compared with placebo to prevent the common cold in healthy people.\nData collection and analysis\nWe used Cochrane’s Screen4Me workflow to assess the initial search results. Four review authors independently performed title and abstract screening to identify potentially relevant studies. We retrieved the full-text articles for those studies deemed potentially relevant, and the review authors independently screened the full-text reports for inclusion in the review, recording reasons for exclusion of the excluded studies. Any disagreements were resolved by discussion or by consulting a third review author when needed. Two review authors independently collected data on a data extraction form, resolving any disagreements by consensus or by involving a third review author. We double-checked data transferred into Review Manager 5 software. Three review authors independently assessed risk of bias using RoB 1 tool as outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We carried out statistical analysis using Review Manager 5. We did not conduct a meta-analysis, and we did not assess publication bias. We used GRADEpro GDT software to assess the certainty of the evidence and to create a summary of findings table.\nMain results\nWe did not identify any new RCTs for inclusion in this update. This review includes one RCT conducted in 1965 with an overall high risk of bias. The RCT included 2307 healthy young men in a military facility, all of whom were included in the analyses, and compared the effect of three adenovirus vaccines (live, inactivated type 4, and inactivated type 4 and 7) against a placebo (injection of physiological saline or gelatin capsule). There were 13 (1.14%) events in 1139 participants in the vaccine group, and 14 (1.19%) events in 1168 participants in the placebo group. Overall, we do not know if there is a difference between the adenovirus vaccine and placebo in reducing the incidence of the common cold (risk ratio 0.95, 95% confidence interval 0.45 to 2.02; very low-certainty evidence). Furthermore, no difference in adverse events when comparing live vaccine preparation with placebo was reported. We downgraded the certainty of the evidence to very low due to unclear risk of bias, indirectness because the population of this study was only young men, and imprecision because confidence intervals were wide and the number of events was low. The included study did not assess vaccine-related or all-cause mortality.\nAuthors' conclusions\nThis Cochrane Review was based on one study with very low-certainty evidence, which showed that there may be no difference between the adenovirus vaccine and placebo in reducing the incidence of the common cold. We identified a need for well-designed, adequately powered RCTs to investigate vaccines for the common cold in healthy people. Future trials on interventions for preventing the common cold should assess a variety of virus vaccines for this condition, and should measure such outcomes as common cold incidence, vaccine safety, and mortality (all-cause and related to the vaccine).\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 did not identify any new trials for inclusion in this update. This review includes one previously identified randomised controlled trial (a type of study where participants are randomly assigned to one of two or more treatment groups) performed in 1965. This study involved 2307 young, healthy military men at a training facility in the United States Navy, and evaluated the effects of a live attenuated (weakened) adenovirus vaccine, an inactivated type 4, and an inactivated type 4 and 7 vaccines compared to a placebo (fake vaccine)."
}
] |
query-laysum
|
23908
|
[
{
"role": "user",
"content": "Abstract: Background\nIn acute asthma inhaled beta₂-agonists are often administered by nebuliser to relieve bronchospasm, but some have argued that metered-dose inhalers with a holding chamber (spacer) can be equally effective. Nebulisers require a power source and need regular maintenance, and are more expensive in the community setting.\nObjectives\nTo assess the effects of holding chambers (spacers) compared to nebulisers for the delivery of beta₂-agonists for acute asthma.\nSearch methods\nWe searched the Cochrane Airways Group Trial Register and reference lists of articles. We contacted the authors of studies to identify additional trials. Date of last search: February 2013.\nSelection criteria\nRandomised trials in adults and children (from two years of age) with asthma, where spacer beta₂-agonist delivery was compared with wet nebulisation.\nData collection and analysis\nTwo review authors independently applied study inclusion criteria (one review author for the first version of the review), extracted the data and assessed risks of bias. Missing data were obtained from the authors or estimated. Results are reported with 95% confidence intervals (CIs).\nMain results\nThis review includes a total of 1897 children and 729 adults in 39 trials. Thirty-three trials were conducted in the emergency room and equivalent community settings, and six trials were on inpatients with acute asthma (207 children and 28 adults). The method of delivery of beta₂-agonist did not show a significant difference in hospital admission rates. In adults, the risk ratio (RR) of admission for spacer versus nebuliser was 0.94 (95% CI 0.61 to 1.43). The risk ratio for children was 0.71 (95% CI 0.47 to 1.08, moderate quality evidence). In children, length of stay in the emergency department was significantly shorter when the spacer was used. The mean duration in the emergency department for children given nebulised treatment was 103 minutes, and for children given treatment via spacers 33 minutes less (95% CI -43 to -24 minutes, moderate quality evidence). Length of stay in the emergency department for adults was similar for the two delivery methods. Peak flow and forced expiratory volume were also similar for the two delivery methods. Pulse rate was lower for spacer in children, mean difference -5% baseline (95% CI -8% to -2%, moderate quality evidence), as was the risk of developing tremor (RR 0.64; 95% CI 0.44 to 0.95, moderate quality evidence).\nAuthors' conclusions\nNebuliser delivery produced outcomes that were not significantly better than metered-dose inhalers delivered by spacer in adults or children, in trials where treatments were repeated and titrated to the response of the participant. Spacers may have some advantages compared to nebulisers for children with acute asthma. The studies excluded people with life-threatening asthma; therefore, the results of this meta-analysis should not be extrapolated to this patient population.\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": "When someone is having an asthma attack is it as safe and effective to use a spacer instead of a nebuliser?"
}
] |
query-laysum
|
23909
|
[
{
"role": "user",
"content": "Abstract: Background\nHead position during care may affect cerebral haemodynamics and contribute to the development of germinal matrix-intraventricular haemorrhage (GM-IVH) in very preterm infants. Turning the head toward one side may occlude jugular venous drainage while increasing intracranial pressure and cerebral blood volume. It is suggested that cerebral venous pressure is reduced and hydrostatic brain drainage improved if the infant is cared for in the supine ‘head midline’ position.\nObjectives\nTo assess whether head midline position is more effective than other head positions for preventing (or preventing extension) of GM-IVH in very preterm infants (< 32 weeks’ gestation at birth).\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 9), MEDLINE via PubMed (1966 to 12 September 2019), Embase (1980 to 12 September 2019), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 12 September 2019). We searched clinical trials databases, conference proceedings, and reference lists of retrieved articles.\nSelection criteria\nRandomised controlled trials (RCTs) comparing caring for very preterm infants in a supine head midline position versus a prone or lateral decubitus position, or undertaking a strategy of regular position change, or having no prespecified position. We included trials enrolling infants with existing GM-IVH and planned to assess extension of haemorrhage in a subgroup of infants. We planned to analyse horizontal (flat) versus head elevated positions separately for all body positions.\nData collection and analysis\nWe used standard methods of Cochrane Neonatal. For each of the included trials, two review authors independently extracted data and assessed risk of bias. The primary outcomes were GM-IVH, severe IVH, and neonatal death. We evaluated treatment effects using a fixed-effect model with risk ratio (RR) for categorical data; and mean, standard deviation (SD), and mean difference (MD) for continuous data. We used the GRADE approach to assess the certainty of evidence.\nMain results\nThree RCTs, with a total of 290 infants (either < 30 weeks' gestational age or < 1000 g body weight), met the inclusion criteria. Two trials compared supine midline head position versus head rotated 90° with the cot flat. One trial compared supine midline head position versus head rotated 90° with the bed tilted at 30°. We found no trials that compared supine versus prone midline head position.\nMeta-analysis of three trials (290 infants) did not show an effect on rates of GM-IVH (RR 1.11, 95% confidence interval (CI) 0.78 to 1.56; I² = 0%) and severe IVH (RR 0.71, 95% CI 0.37 to 1.33; I² = 0%). Neonatal mortality (RR 0.49, 95% CI 0.25 to 0.93; I² = 0%; RD −0.09, 95% CI −0.16 to −0.01) and mortality until hospital discharge (typical RR 0.50, 95% CI 0.28 to 0.90; I² = 0%; RD −0.10, 95% CI −0.18 to −0.02) were lower in the supine midline head position. The certainty of the evidence was very low for all outcomes because of limitations in study design and imprecision of estimates. We identified one ongoing study.\nAuthors' conclusions\nWe found few trial data on the effects of head midline position on GM-IVH in very preterm infants. Although meta-analyses suggest that mortality might be reduced, the certainty of the evidence is very low and it is unclear whether any effect is due to cot tilting (a co-intervention in one trial). Further high-quality RCTs would be needed to resolve this uncertainty.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Though one of the studies reported lower mortality in the infants with head central position lying on the back and with bed tilting, results of this systematic review are consistent with beneficial or detrimental effects of a supine head midline position and do not provide a definitive answer to the review question."
}
] |
query-laysum
|
23911
|
[
{
"role": "user",
"content": "Abstract: Background\nNeuromuscular diseases (NMDs) are a heterogeneous group of diseases affecting the anterior horn cell of spinal cord, neuromuscular junction, peripheral nerves and muscles. NMDs cause physical disability usually due to progressive loss of strength in limb muscles, and some NMDs also cause respiratory muscle weakness. Respiratory muscle training (RMT) might be expected to improve respiratory muscle weakness; however, the effects of RMT are still uncertain. This systematic review will synthesize the available trial evidence on the effectiveness and safety of RMT in people with NMD, to inform clinical practice.\nObjectives\nTo assess the effects of respiratory muscle training (RMT) for neuromuscular disease (NMD) in adults and children, in comparison to sham training, no training, standard treatment, breathing exercises, or other intensities or types of RMT.\nSearch methods\nOn 19 November 2018, we searched the Cochrane Neuromuscular Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase. On 23 December 2018, we searched the US National Institutes for Health Clinical Trials Registry (ClinicalTrials.gov), the World Health Organization International Clinical Trials Registry Platform, and reference lists of the included studies.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-RCTs, including cross-over trials, of RMT in adults and children with a diagnosis of NMD of any degree of severity, who were living in the community, and who did not need mechanical ventilation. We compared trials of RMT (inspiratory muscle training (IMT) or expiratory muscle training (EMT), or both), with sham training, no training, standard treatment, different intensities of RMT, different types of RMT, or breathing exercises.\nData collection and analysis\nWe followed standard Cochrane methodological procedures.\nMain results\nWe included 11 studies involving 250 randomized participants with NMDs: three trials (N = 88) in people with amyotrophic lateral sclerosis (ALS; motor neuron disease), six trials (N = 112) in Duchenne muscular dystrophy (DMD), one trial (N = 23) in people with Becker muscular dystrophy (BMD) or limb-girdle muscular dystrophy, and one trial (N = 27) in people with myasthenia gravis.\nNine of the trials were at high risk of bias in at least one domain and many reported insufficient information for accurate assessment of the risk of bias. Populations, interventions, control interventions, and outcome measures were often different, which largely ruled out meta-analysis. All included studies assessed lung capacity, our primary outcome, but four did not provide data for analysis (1 in people with ALS and three cross-over studies in DMD). None provided long-term data (over a year) and only one trial, in ALS, provided information on adverse events. Unscheduled hospitalisations for chest infection or acute exacerbation of chronic respiratory failure were not reported and physical function and quality of life were reported in one (ALS) trial.\nAmyotrophic lateral sclerosis (ALS)\nThree trials compared RMT versus sham training in ALS. Short-term (8 weeks) effects of RMT on lung capacity in ALS showed no clear difference in the change of the per cent predicted forced vital capacity (FVC%) between EMT and sham EMT groups (mean difference (MD) 0.70, 95% confidence interval (CI) -8.48 to 9.88; N = 46; low-certainty evidence). The mean difference (MD) in FVC% after four months' treatment was 10.86% in favour of IMT (95% CI -4.25 to 25.97; 1 trial, N = 24; low-certainty evidence), which is larger than the minimal clinically important difference (MCID, as estimated in people with idiopathic pulmonary fibrosis). There was no clear difference between IMT and sham IMT groups, measured on the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALFRS; range of possible scores 0 = best to 40 = worst) (MD 0.85, 95% CI -2.16 to 3.85; 1 trial, N = 24; low-certainty evidence) or quality of life, measured on the EuroQol-5D (0 = worst to 100 = best) (MD 0.77, 95% CI -17.09 to 18.62; 1 trial, N = 24; low-certainty evidence) over the medium term (4 months). One trial report stated that the IMT protocol had no adverse effect (very low-certainty evidence).\nDuchenne muscular dystrophy (DMD)\nTwo DMD trials compared RMT versus sham training in young males with DMD. In one study, the mean post-intervention (6-week) total lung capacity (TLC) favoured RMT (MD 0.45 L, 95% CI -0.24 to 1.14; 1 trial, N = 16; low-certainty evidence). In the other trial there was no clear difference in post-intervention (18 days) FVC between RMT and sham RMT (MD 0.16 L, 95% CI -0.31 to 0.63; 1 trial, N = 20; low-certainty evidence). One RCT and three cross-over trials compared a form of RMT with no training in males with DMD; the cross-over trials did not provide suitable data. Post-intervention (6-month) values showed no clear difference between the RMT and no training groups in per cent predicted vital capacity (VC%) (MD 3.50, 95% CI -14.35 to 21.35; 1 trial, N = 30; low-certainty evidence).\nBecker or limb-girdle muscular dystrophy\nOne RCT (N = 21) compared 12 weeks of IMT with breathing exercises in people with Becker or limb-girdle muscular dystrophy. The evidence was of very low certainty and conclusions could not be drawn.\nMyasthenia gravis\nIn myasthenia gravis, there may be no clear difference between RMT and breathing exercises on measures of lung capacity, in the short term (TLC MD -0.20 L, 95% CI -1.07 to 0.67; 1 trial, N = 27; low-certainty evidence). Effects of RMT on quality of life are uncertain (1 trial; N = 27).\nSome trials reported effects of RMT on inspiratory and/or expiratory muscle strength; this evidence was also of low or very low certainty.\nAuthors' conclusions\nRMT may improve lung capacity and respiratory muscle strength in some NMDs. In ALS there may not be any clinically meaningful effect of RMT on physical functioning or quality of life and it is uncertain whether it causes adverse effects. Due to clinical heterogeneity between the trials and the small number of participants included in the analysis, together with the risk of bias, these results must be interpreted very cautiously.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The certainty of the evidence examined as part of this review was low or very low. Low-certainty evidence means that our confidence in the effect of respiratory muscle training is limited, and the true effect may be substantially different. When the evidence is of very low-certainty, the true effect is likely to be substantially different. Given the low or very low-certainty of the evidence presented in the studies, we believe that there is a need for more well-conducted studies in order to assess the efficacy of respiratory muscle training in people with NMD.\nThe evidence is current to November 2018."
}
] |
query-laysum
|
23912
|
[
{
"role": "user",
"content": "Abstract: Background\nPatients with longstanding ulcerative colitis and colonic Crohn's disease have an increased risk of colorectal cancer (CRC) compared with the general population. This review assessed the evidence that endoscopic surveillance may prolong life by allowing earlier detection of CRC or its pre-cursor lesion, dysplasia, in patients with inflammatory bowel disease (IBD).\nObjectives\nTo assess the effectiveness of cancer surveillance programs for diagnosis of IBD-associated colorectal cancer and in reducing the mortality rate from colorectal cancer in patients with IBD.\nSearch methods\nWe searched MEDLINE, EMBASE, CENTRAL and clinical clinicaltrials.gov from inception to 19 September 2016. We also searched conference abstracts and reference lists to identify additional studies.\nSelection criteria\nPotentially relevant articles were reviewed independently and unblinded by two authors to determine eligibility. Randomised controlled trials (RCTs) or observational studies (cohort or case control) assessing any form of endoscopic surveillance aimed at early detection of CRC were considered for inclusion. Studies had to have a no surveillance comparison group to be eligible for inclusion.\nData collection and analysis\nEligible studies were reviewed in duplicate and the results of the primary research trials were independently extracted by two authors. The primary outcome was detection of CRC. Secondary outcomes included death from CRC, time to cancer detection, time to death and adverse events. Deaths from CRC were derived from life tables, survival curves or where possible, by calculating life tables from the data provided. The presence of significant heterogeneity among studies was tested by the chi-square test. Because this is a relatively insensitive test, a P value of less than 0.1 was considered statistically significant. Provided statistical heterogeneity was not present, the fixed effects model was used for the pooling of data. The 2x2 tables were combined into a summary test statistic using the pooled odds ratio (OR) and 95% confidence intervals as described by Cochrane and Mantel and Haenszel. The methodological quality of the included studies was assessed using the Newcastle-Ottawa scale for non-randomised studies The overall quality of the evidence supporting the primary and selected secondary outcomes was assessed using the GRADE criteria.\nMain results\nNo RCTs were identified. Five observational studies (N = 7199) met the inclusion criteria. The studies scored well on the Newcastle-Ottawa scale, but due to the nature of observational studies, a high risk of bias was assigned to all the studies. Three studies were pooled to assess the rate of cancer detected in the surveillance group compared to the non-surveillance group. The studies found a significantly higher rate of cancer detection in the non surveillance group compared to the surveillance group. CRC was detected in 1.83% (53/2895) of patients in the surveillance group compared to 3.17% (135/4256) of patients in the non-surveillance group (OR 0.58, 95% CI 0.42 to 0.80; P = 0.0009). Four studies were pooled to assess the death rate associated with CRC in patients who underwent surveillance compared to patients who did not undergo surveillance. There was a significantly lower death rate associated with CRC in the surveillance group compared to the non-surveillance group. Eight per cent (15/176) of patients in the surveillance group died from CRC compared to 22% (79/354) of patients in the non-surveillance group (OR 0.36, 95% CI 0.19 to 0.69, P=0.002). Data were pooled from two studies to examine the rate of early stage versus late stage colorectal cancer (Duke stages A & B compared to Duke stages C & D) in patients who underwent surveillance compared to patients who do not undergo surveillance. A significantly higher rate of early stage CRC (Duke A & B) was detected in the surveillance group compared to the non-surveillance group. Sixteen per cent (17/110) of patients in the surveillance group had early stage CRC compared to 8% (9/117) of patients in the non-surveillance group (OR 5.40, 95% CI 1.51 to 19.30; P = 0.009). A higher rate of late stage CRC (Duke C & D) was observed in the non-surveillance group compared to the surveillance group. Nine per cent (10/110) of patients in the surveillance group had late stage CRC compared to 16% (19/117) of patients in the non-surveillance group (OR 0.46, 95% CI 0.08 to 2.51; P = 0.37). A GRADE analysis indicated that the quality of the data was very low for all of these outcomes. The included studies did not report on the other pre-specified outcomes including time to cancer detection, time to death and adverse events.\nAuthors' conclusions\nThe current data suggest that colonoscopic surveillance in IBD may reduce the development of both CRC and the rate of CRC-associated death through early detection, although the quality of the evidence is very low. The detection of earlier stage CRC in the surveillance group may explain some of the survival benefit observed. RCTs assessing the efficacy of endoscopic surveillance in people with IBD are unlikely to be undertaken due to ethical considerations.\n\nGiven the provided abstract, please respond to the following query: \"What did the researchers investigate?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The researchers reviewed published studies comparing people with IBD who had endoscopic surveillance to people who did not have endoscopic surveillance to see whether surveillance provided any benefit in terms of diagnosing colon cancer at an earlier stage or reducing the death rate due to colon cancer. The medical literature was searched and analysed up to 19 September 2016."
}
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query-laysum
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23913
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[
{
"role": "user",
"content": "Abstract: Background\nThe effectiveness of interventions to increase influenza vaccination uptake in people aged 60 years and older varies by country and participant characteristics. This review updates versions published in 2010 and 2014.\nObjectives\nTo assess access, provider, system, and societal interventions to increase the uptake of influenza vaccination in people aged 60 years and older in the community.\nSearch methods\nWe searched CENTRAL, which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE, Embase, CINAHL, and ERIC for this update, as well as WHO ICTRP and ClinicalTrials.gov for ongoing studies to 7 December 2017. We also searched reference lists of included studies.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster-RCTs of interventions to increase influenza vaccination in people aged 60 years or older in the community.\nData collection and analysis\nWe used standard methodological procedures as specified by Cochrane.\nMain results\nWe included 3 new RCTs for this update (total 61 RCTs; 1,055,337 participants). Trials involved people aged 60 years and older living in the community in high-income countries. Heterogeneity limited some meta-analyses. We assessed studies as at low risk of bias for randomisation (38%), allocation concealment (11%), blinding (44%), and selective reporting (100%). Half (51%) had missing data. We assessed the evidence as low-quality. We identified three levels of intervention intensity: low (e.g. postcards), medium (e.g. personalised phone calls), and high (e.g. home visits, facilitators).\nIncreasing community demand (12 strategies, 41 trials, 53 study arms, 767,460 participants)\nOne successful intervention that could be meta-analysed was client reminders or recalls by letter plus leaflet or postcard compared to reminder (odds ratio (OR) 1.11, 95% confidence interval (CI) 1.07 to 1.15; 3 studies; 64,200 participants). Successful interventions tested by single studies were patient outreach by retired teachers (OR 3.33, 95% CI 1.79 to 6.22); invitations by clinic receptionists (OR 2.72, 95% CI 1.55 to 4.76); nurses or pharmacists educating and nurses vaccinating patients (OR 152.95, 95% CI 9.39 to 2490.67); medical students counselling patients (OR 1.62, 95% CI 1.11 to 2.35); and multiple recall questionnaires (OR 1.13, 95% CI 1.03 to 1.24).\nSome interventions could not be meta-analysed due to significant heterogeneity: 17 studies tested simple reminders (the 95% CI was entirely above unity in 11 trials implying all 11 interventions increased vaccination rates); 16 tested personalised reminders (the 95% CI was entirely above unity in 12 trials implying all 12 interventions increased vaccination rates ); 2 investigated customised compared to form letters (the 95% CI was above unity in both trials implying both interventions increased vaccination rates); and 4 studies examined the impact of health risk appraisals (the 95% CI was above unity in all 4 trials implying all 4 interventions increased vaccination rates). One study of a lottery for free groceries was not effective.\nEnhancing vaccination access (6 strategies, 8 trials, 10 arms, 9353 participants)\nWe meta-analysed results from 2 studies of home visits (OR 1.30, 95% CI 1.05 to 1.61), and 2 studies that tested free vaccine compared to patient payment for vaccine (OR 2.36, 95% CI 1.98 to 2.82). We were unable to conduct meta-analyses of 2 studies of home visits by nurses plus a physician care plan (the 95% CI was entirely above unity in both trials implying both interventions increased vaccination rates) and 2 studies of free vaccine compared to no intervention (the 95% CI was entirely above unity in both trials implying both interventions increased vaccination rates). One study of group visits (OR 27.2, 95% CI 1.60 to 463.3) was effective, and 1 study of home visits compared to safety interventions was not.\nProvider- or system-based interventions (11 strategies, 15 trials, 17 arms, 278,524 participants)\nOne successful intervention that could be meta-analysed focused on payments to physicians (OR 2.22, 95% CI 1.77 to 2.77). Successful interventions tested by individual studies were: reminding physicians to vaccinate all patients (OR 2.47, 95% CI 1.53 to 3.99); posters in clinics presenting vaccination rates and encouraging competition between doctors (OR 2.03, 95% CI 1.86 to 2.22); and chart reviews and benchmarking to the rates achieved by the top 10% of physicians (OR 3.43, 95% CI 2.37 to 4.97).\nWe were unable to meta-analyse 4 studies that looked at physician reminders (the 95% CI was entirely above unity in 3 trials implying all 3 interventions increased vaccination rates) and 3 studies of facilitator encouragement of vaccination (the 95% CI was entirely above unity in 2 trials implying both interventions increased vaccination rates). Interventions that were not effective were: comparing letters on discharge from hospital to letters to general practitioners; posters plus postcards versus posters alone; educational reminders, academic detailing, and peer comparisons compared to mailed educational materials; educational outreach plus feedback to teams versus written feedback; and an intervention to increase staff vaccination rates.\nInterventions at the societal level\nNo studies reported on societal-level interventions.\nStudy funding sources\nStudies were funded by government health organisations (n = 33), foundations (n = 9), organisations that provided healthcare services in the studies (n = 3), and a pharmaceutical company offering free vaccines (n = 1). Fifteen studies did not report study funding sources.\nAuthors' conclusions\nWe identified interventions that demonstrated significant positive effects of low (postcards), medium (personalised phone calls), and high (home visits, facilitators) intensity that increase community demand for vaccination, enhance access, and improve provider/system response. The overall GRADE assessment of the evidence was moderate quality. Conclusions are unchanged from the 2014 review.\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": "Overall, we assessed the included studies as at moderate risk of bias. The overall GRADE assessment of the evidence was high to moderate quality."
}
] |
query-laysum
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23914
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[
{
"role": "user",
"content": "Abstract: Background\nThe prevalence of epilepsy among people with intellectual disabilities is much higher than in the general population. Seizures in this population are often complex and refractory to treatment and antiepileptic medication may have a profound effect upon behaviour (Kerr 1997).\nThis is an updated version of a Cochrane Review first published in Issue 3, 2007.\nObjectives\nTo assess the data available from randomised controlled trials (RCTs) of the efficacy of antiepileptic drug (AED) interventions in people with epilepsy and intellectual disabilities.\nSearch methods\nFor the latest update of this review, we searched the Cochrane Epilepsy Group Specialised Register (2 September 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO) (2 September 2014), MEDLINE (Ovid, 1946 to 3 September 2014) and PsycINFO (EBSCOhost, 1887 to 3 September 2014).\nSelection criteria\nRandomised and quasi-randomised controlled trials (RCTs) of pharmacological interventions for people with epilepsy and a learning disability.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We contacted study authors for additional information. We assessed epilepsy/seizure, behavioural and cognitive outcomes, as well as quality of life and adverse effects.\nMain results\nWe included 14 RCTs (1116 participants) in the present review. Data were heterogenous and a descriptive analysis is presented. In the majority of cases where antiepileptic drugs (AEDs) were trialled in this population, we found moderate reductions in seizure frequency in that there was a significantly higher rate of responders (reduction of 50% or more) in the treatment group compared with the placebo group, with some studies reporting a higher incidence of seizure freedom in the treatment group. In general, AEDs that are proven to be effective in the general epilepsy population are also effective for refractory epilepsy in people with intellectual disability. It is not possible to comment on the relative efficacy of medications, making clinical decisions difficult.\nIn trial settings patients continued on treatment in the majority of cases. Placebo groups often experienced fewer adverse events. Where adverse events were experienced they appeared similar to those in the general population. The methods by which adverse events were recorded and reported appeared to be inconsistent, resulting in very large variation between studies. This is problematic as clinically relevant interpretation of these findings is limited.\nThe quality of evidence provided in the present review is low to moderate. Additionally the majority of studies lacked or used non-reliable measures of behavioural exacerbation. However, where measured, little obvious impact on behaviour was seen in terms of behaviour disorder.\nAuthors' conclusions\nThis review broadly supports the use of AEDs to reduce seizure frequency in people with refractory epilepsy and intellectual disability. The evidence suggests that adverse events are similar to those in the general population and that behavioural adverse events leading to discontinuation are rare; however, other adverse effects are under-researched.\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": "Epilepsy is a common condition. Approximately 3% of the general population are diagnosed with epilepsy at some point in their life (Rugg-Gunn 2012). However, epilepsy is significantly more common in people with intellectual disabilities where estimates range from 14% to 44% (Bowley 2000). People with intellectual disability and epilepsy often do not respond as well to antiepileptic drugs (AEDs) as the general population and behavioural disturbances are frequent. We review the use of AEDs in this population."
}
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query-laysum
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23915
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[
{
"role": "user",
"content": "Abstract: Background\nAllergic bronchopulmonary aspergillosis (ABPA) is an allergic reaction to colonisation of the lungs with the fungus Aspergillus fumigatus, and affects around 10% of people with cystic fibrosis. ABPA is associated with an accelerated decline in lung function. High doses of corticosteroids are the main treatment for ABPA; although the long-term benefits are not clear, and their many side effects are well-documented. A group of compounds, the azoles, have activity against A fumigatus, and have been proposed as an alternative treatment for ABPA. Of this group, itraconazole is the most active. A separate antifungal compound, amphotericin B, has been used in aerosolised form to treat invasive infection with A fumigatus, and may have potential for the treatment of ABPA. Antifungal therapy for ABPA in cystic fibrosis needs to be evaluated. This is an update of a previously published review.\nObjectives\nThe review aimed to test the hypotheses that antifungal interventions for the treatment of ABPA in cystic fibrosis:\n1. improve clinical status compared to placebo or standard therapy (no placebo); and\n2. do not have unacceptable adverse effects.\nIf benefit was demonstrated, we planned to assess the optimal type, duration, and dose of antifungal therapy.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, which comprises references identified from comprehensive electronic database searches, handsearches of relevant journals, and abstract books of conference proceedings. Date of the most recent search of the Group's Trials Register was 28 September 2021.\nWe searched ongoing trials registries, most recently on 11 March 2022.\nEarlier, we also approached pharmaceutical companies regarding possible unpublished trials.\nSelection criteria\nPublished or unpublished randomised controlled trials, in which antifungal treatments were compared to either placebo or no treatment, or where different doses of the same treatment were used in the treatment of ABPA in people with cystic fibrosis.\nData collection and analysis\nThe searches identified six trials; none of which met the inclusion criteria for the review.\nMain results\nWe included no completed randomised controlled trials. There is currently one ongoing trial, which we may find eligible for a future update.\nAuthors' conclusions\nAt present, there are no randomised controlled trials that evaluate the use of antifungal therapies for the treatment of ABPA in people with cystic fibrosis, although one trial is currently ongoing.\nTrials with clear outcome measures are needed to properly evaluate the use of corticosteroids in people with ABPA and cystic fibrosis.\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 planned to review the evidence about the effect of treatments to fight fungal infections that cause allergic bronchopulmonary aspergillosis (ABPA) in people with cystic fibrosis."
}
] |
query-laysum
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23916
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[
{
"role": "user",
"content": "Abstract: Background\nAnkylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause and affects mainly the spine, but can also affect other joints. Disease progression may result in loss of mobility and function. Sulfasalazine is a disease-modifying antirheumatic drug used in the treatment of AS. However, its efficacy remains unclear. This is an update of a Cochrane review first published in 2005.\nObjectives\nTo evaluate the benefits and harms of sulfasalazine for the treatment of ankylosing spondylitis (AS).\nSearch methods\nWe searched for relevant randomized and quasi-randomized trials in any language, using the following sources: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 11); MEDLINE (2003 to 28 November 2013); EMBASE (2003 to 27 November 2013); CINAHL (2003 to 28 November 2013); Ovid MEDLINE data, World Health Organization International Clinical Trials Registry Platform (28 November 2013); and the reference sections of retrieved articles.\nSelection criteria\nWe evaluated randomized and quasi-randomized trials examining the benefits and harms of sulfasalazine on AS.\nData collection and analysis\nTwo review authors independently reviewed unblinded trial reports according to the selection criteria. Disagreements on the inclusion of the studies were resolved, when necessary, by recourse to a third review author. The same authors independently assessed the risk of bias of included trials and entered the data extracted from the included trials. We combined results using mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data.\nWe restructured outcome measures for this update based on recommendations from the editorial group. Major outcomes included: pain, Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis function index (BASFI), Bath ankylosing spondylitis metrology index (BASMI), radiographic progression, total number of withdrawals due to adverse events, and serious adverse events.\nMain results\nWe did not add any new studies to this review following the updated search. In the original review, we included 11 studies in the analysis, involving 895 participants in total. All included studies compared sulfasalazine with placebo. We judged most of the studies as low risk of bias or unclear risk of bias in five domains (random sequence generation, allocation concealment, blinding of outcome assessment, selective reporting, and other sources of bias). However, for incomplete outcome data, we only judged one trial at low risk of bias.\nNone of the included trials assessed BASDAI, BASFI, BASMI or radiographic progression. Different parameters were used to assess pain. The pooled MD for back pain measured on a 0 to 100 mm visual analogue scale was -2.96 (95% confidence interval (CI) -6.33 to 0.41; absolute risk difference 3%, 95% CI 1% to 6%; 6 trials). Compared to placebo, a significantly higher rate of withdrawals due to adverse effects (RR 1.50, 95% CI 1.04 to 2.15; absolute risk difference 4%, 95% CI 0.4% to 8.8%; 11 trials) was found in the sulfasalazine group. A serious adverse reaction was reported in one patient taking sulfasalazine (Peto odds ratio 7.50, 95% CI 0.15 to 378.16).\nAuthors' conclusions\nThere is not enough evidence to support any benefit of sulfasalazine in reducing pain, disease activity, radiographic progression, or improving physical function and spinal mobility in the treatment of AS. A statistically significant benefit in reducing the erythrocyte sedimentation rate and easing spinal stiffness was mentioned in the previous version. However, the effect size was very small and not clinically meaningful. More withdrawals because of side effects occurred with sulfasalazine. Further studies, with larger sample sizes, longer duration, and using validated outcome measures are needed to verify the uncertainty of sulfasalazine in AS.\n\nGiven the provided abstract, please respond to the following query: \"The review showed that in people with ankylosing spondylitis\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- compared with fake pills, sulfasalazine probably has little or no difference in pain, disease activity, physical function, spinal mobility, patient and physician global assessment;\n- damage to the spine as seen on x-ray or magnetic resonance image was not measured and therefore it is not known whether sulfasalazine slows damage;\n- people had side effects such as stomach upsets, skin reactions/rashes and mouth sores;\n- more people stopped taking sulfasalazine because of the side effects than when taking fake pills; and\n- there is not enough evidence to be certain of the benefits and harms of sulfasalazine for ankylosing spondylitis, and more research is needed."
}
] |
query-laysum
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23917
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[
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers, also known as bedsores, decubitus ulcers and pressure injuries, are localised areas of injury to the skin or the underlying tissue, or both. Dressings are widely used to treat pressure ulcers and there are many options to choose from including alginate dressings. A clear and current overview of current evidence is required to facilitate decision-making regarding dressing use for the treatment of pressure ulcers. This review is part of a suite of Cochrane reviews investigating the use of dressings in the treatment of pressure ulcers. Each review will focus on a particular dressing type.\nObjectives\nTo assess the effects of alginate dressings for treating pressure ulcers in any care setting.\nSearch methods\nFor this review, in April 2015 we searched the following databases the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. There were no restrictions based on language or date of publication.\nSelection criteria\nPublished or unpublished randomised controlled trials (RCTs) comparing the effects of alginate with alternative wound dressings or no dressing in the treatment of pressure ulcers (stage II or above).\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias assessment and data extraction.\nMain results\nWe included six studies (336 participants) in this review; all studies had two arms. The included studies compared alginate dressings with six other interventions that included: hydrocolloid dressings, silver containing alginate dressings, and radiant heat therapy. Each of the six comparisons included just one study and these had limited participant numbers and short follow-up times. All the evidence was of low or very low quality. Where data were available there was no evidence of a difference between alginate dressings and alternative treatments in terms of complete wound healing or adverse events.\nAuthors' conclusions\nThe relative effects of alginate dressings compared with alternative treatments are unclear. The existing trials are small, of short duration and at risk of bias. Decision makers may wish to consider aspects such as cost of dressings and the wound management properties offered by each dressing type, for example, exudate management.\n\nGiven the provided abstract, please respond to the following query: \"Why use alginate dressings to treat pressure ulcers?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Dressings are one treatment option for pressure ulcers. There are many types of dressings that can be used; these can vary considerably in cost. Alginate dressings are a type that is highly absorbant and so can absorb the fluid (exudate) that is produced by some ulcers."
}
] |
query-laysum
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23918
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[
{
"role": "user",
"content": "Abstract: Background\nThere is presently no certainty about the ideal feeding intervals for preterm infants. Shorter feeding intervals of, for example, two hours, have the theoretical advantage of allowing smaller volumes of milk. This may have the potential to reduce the incidence and severity of gastro-oesophageal reflux. Longer feeding intervals have the theoretical advantage of allowing more gastric emptying between two feeds. This potentially provides periods of rest (and thus less hyperaemia) for an immature digestive tract.\nObjectives\nTo determine the safety of shorter feeding intervals (two hours or shorter) versus longer feeding intervals (three hours or more) and to compare the effects in terms of days taken to regain birth weight and to achieve full feeding.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to run comprehensive searches in CENTRAL (2020, Issue 6) and Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions, and CINAHL on 25 June 2020. We searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-RCTs.\nSelection criteria\nWe included RCTs and quasi-RCTs comparing short (e.g. one or two hours) versus long (e.g. three or four hours) feeding intervals in preterm infants of any birth weight, all or most of whom were less than 32 weeks' gestation. Infants could be of any postnatal age at trial entry, but eligible infants should not have received feeds before study entry, with the exception of minimal enteral feeding. We included studies of nasogastric or orogastric bolus feeding, breast milk or formula, in which the feeding interval is the intervention.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We used the GRADE approach to assess the certainty of evidence. Our primary outcomes were days taken to achieve full enteral feeding and days to regain birth weight. Our other outcomes were duration of hospital stay, episodes of necrotising enterocolitis (NEC) and growth during hospital stay (weight, length and head circumference).\nMain results\nWe included four RCTs, involving 417 infants in the review. One study involving 350 infants is awaiting classification. All studies compared two-hourly versus three-hourly feeding interval. The risk of bias of the included studies was generally low, but all studies had high risk of performance bias due to lack of blinding of the intervention.\nThree studies were included in meta-analysis for the number of days taken to achieve full enteral feeding (351 participants). The mean days to achieve full feeds was between eight and 11 days. There was little or no difference in days taken to achieve full enteral feeding between two-hourly and three-hourly feeding, but this finding was of low certainty (mean difference (MD) ‒0.62, 95% confidence interval (CI) ‒1.60 to 0.36).\nThere was low-certainty evidence that the days taken to regain birth weight may be slightly longer in infants receiving two-hourly feeding than in those receiving three-hourly feeding (MD 1.15, 95% CI 0.11 to 2.20; 3 studies, 350 participants).\nWe are uncertain whether shorter feeding intervals have any effect on any of our secondary outcomes including the duration of hospital stay (MD ‒3.36, 95% CI ‒9.18 to 2.46; 2 studies, 207 participants; very low-certainty evidence) and the risk of NEC (typical risk ratio 1.07, 95% CI 0.54 to 2.11; 4 studies, 417 participants; low-certainty evidence).\nNo study reported growth during hospital stay.\nAuthors' conclusions\nThe low-certainty evidence we found in this review suggests that there may be no clinically important differences between two- and three-hourly feeding intervals. There is insufficient information about potential feeding complications and in particular NEC. No studies have looked at the effect of other feeding intervals and there is no long-term data on neurodevelopment or growth.\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": "When we combined the results of the studies, they suggested little or no difference between the two- and three-hourly feeding intervals. We are uncertain whether there is any difference between two- and three-hourly feeding in terms of days to achieve full enteral (tube) feeding because the results were imprecise and there were biases in the studies. Days taken to regain the birth weight, after the usual initial drop in weight during the first days after birth, may be slightly longer in infants receiving two-hourly feeds, but we are uncertain of the importance of this. We did not have enough data to determine whether there was any difference in any of the adverse outcomes that the studies reported. However, because only a small number of infants experienced NEC, we are uncertain whether there is any difference between the groups. There was no information on the effect of feeding interval on death, infant growth during hospital stay and neurodevelopmental outcome (brain development in childhood), and there was no information about other feeding intervals such as one-hourly or four-hourly feeds. There is one study awaiting classification as we need more information."
}
] |
query-laysum
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23919
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[
{
"role": "user",
"content": "Abstract: Background\nPeople with multiple sclerosis (MS) have complex symptoms and different types of needs. These demands include how to manage the burden of physical disability as well as how to organise daily life, restructure social roles in the family and at work, preserve personal identity and community roles, keep self-sufficiency in personal care, and how to be part of an integrated care network. Palliative care teams are trained to keep open full and competent lines of communication about symptoms and disease progression, advanced care planning, and end-of-life issues and wishes. Teams create a treatment plan for the total management of symptoms, supporting people and families on decision-making. Despite advances in research and the existence of many interventions to reduce disease activity or to slow the progression of MS, this condition remains a life-limiting disease with symptoms that impact negatively the lives of people with it and their families.\nObjectives\nTo assess the effects (benefits and harms) of palliative care interventions compared to usual care for people with any form of multiple sclerosis: relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS), primary-progressive MS (PPMS), and progressive-relapsing MS (PRMS) We also aimed to compare the effects of different palliative care interventions.\nSearch methods\nOn 31 October 2018, we conducted a literature search in the specialised register of the Cochrane MS and Rare Diseases of the Central Nervous System Review Group, which contains trials from CENTRAL, MEDLINE, Embase, CINAHL, LILACS, Clinical trials.gov and the World Health Organization International Clinical Trials Registry Platform. We also searched PsycINFO, PEDro and Opengrey. We also handsearched relevant journals and screened the reference lists of published reviews. We contacted researchers in palliative care and multiple sclerosis.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster randomised trials were eligible for inclusion, as well as the first phase of cross-over trials. We included studies that compared palliative care interventions versus usual care. We also included studies that compared palliative care interventions versus another type of palliative interventions.\nData collection and analysis\nWe used standard Cochrane methodological procedures. We summarised key results and certainty of evidence in a 'Summary of Finding' table that reported outcomes at six or more months of post-intervention.\nMain results\nThree studies (146 participants) met our selection criteria. Two studies compared multidisciplinary, fast-track palliative care versus multidisciplinary standard care while on a waiting-list control, and one study compared a multidisciplinary palliative approach versus multidisciplinary standard care at different time points (12, 16, and 24 weeks). Two were RCTs with parallel design (total 94 participants) and one was a cross-over design (52 participants). The three studies assessed palliative care as a home-based intervention. One of the three studies included participants with 'neurodegenerative diseases', with MS people being a subset of the randomised population. We assessed the risk of bias of included studies using Cochrane's 'Risk of Bias' tool.\nWe found no evidence of differences between intervention and control groups in long-time follow-up (> six months post-intervention) for the following outcomes: mean change in health-related quality of life (SEIQoL - higher scores mean better quality of life; MD 4.80, 95% CI -12.32 to 21.92; participants = 62; studies = 1; very low-certainty evidence), serious adverse events (RR 0.97, 95% CI 0.44 to 2.12; participants = 76; studies = 1, 22 events, low-certainty evidence) and hospital admission (RR 0.78, 95% CI 0.24 to 2.52; participants = 76; studies = 1, 10 events, low-certainty evidence).\nThe three included studies did not assess the following outcomes at long term follow-up (> six months post intervention): fatigue, anxiety, depression, disability, cognitive function, relapse-free survival, and sustained progression-free survival.\nWe did not find any trial that compared different types of palliative care with each other.\nAuthors' conclusions\nBased on the findings of the RCTs included in this review, we are uncertain whether palliative care interventions are beneficial for people with MS. There is low- or very low-certainty evidence regarding the difference between palliative care interventions versus usual care for long-term health-related quality of life, adverse events, and hospital admission in patients with MS. For intermediate-term follow-up, we are also uncertain about the effects of palliative care for the outcomes: health-related quality of life (measured by different assessments: SEIQoL or MSIS), disability, anxiety, and depression.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are uncertain about differences between palliative care versus usual care for the following outcomes assessed at long-term follow-up (> six months post-intervention): change in health-related quality of life, adverse events and hospital admission. The included studies did not assess fatigue, cognitive function, relapse-free survival or sustained progression-free survival."
}
] |
query-laysum
|
23920
|
[
{
"role": "user",
"content": "Abstract: Background\nPatellofemoral pain syndrome (PFPS) is a painful musculoskeletal condition, which is characterised by knee pain located in the anterior aspect (front) and retropatellar region (behind) of the knee joint. Various non-operative interventions are suggested for the treatment of this condition. Knee orthoses (knee braces, sleeves, straps or bandages) are worn over the knee and are thought to help reduce knee pain. They can be used in isolation or in addition to other treatments such as exercise or non-steroidal anti-inflammatory medications.\nObjectives\nTo assess the effects (benefits and harms) of knee orthoses (knee braces, sleeves, straps or bandages) for treating PFPS.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (11 May 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015 Issue 5), MEDLINE (1946 to 8 May 2015), EMBASE (1980 to 2015 Week 18), SPORTDiscus (1985 to 11 May 2015), AMED (1985 to 8 May 2015), CINAHL (1937 to 11 May 2015), PEDro (1929 to June 2015), trial registries and conference proceedings.\nSelection criteria\nRandomised and quasi-randomised controlled clinical trials evaluating knee orthoses for treating people with PFPS. Our primary outcomes were pain and function.\nData collection and analysis\nTwo review authors independently assessed studies for eligibility, assessed study risk of bias and extracted data. We calculated mean differences (MD) or, where pooling data from different scales, standardised mean differences (SMD) with 95% confidence intervals (CI) for continuous outcomes and risk ratios (RR) with 95% CIs for binary outcomes. We pooled data using the fixed-effect model.\nMain results\nWe included five trials (one of which was quasi-randomised) that reported results for 368 people who had PFPS. Participants were recruited from health clinics in three trials and were military recruits undergoing training in the other two trials. Although no trials recruited participants who were categorised as elite or professional athletes, military training does comprise intensive exercise regimens. All five trials were at high risk of bias, including performance bias reflecting the logistical problems in these trials of blinding of participants and care providers. As assessed using the GRADE approach, the available evidence for all reported outcomes is 'very low' quality. This means that we are very uncertain about the results.\nThe trials covered three different types of comparison: knee orthosis and exercises versus exercises alone; one type of orthosis versus another; and knee orthosis versus exercises. No trials assessed the mode of knee orthosis use, such as whether the orthosis was worn all day or only during physical activity. Two trials had two groups; two trials had three groups; and one trial had four groups.\nAll five trials compared a knee orthosis (knee sleeve, knee brace, or patellar strap) versus a 'no treatment' control group, with all participants receiving exercises, either through a military training programme or a home-based exercise programme. There is very low quality evidence of no clinically important differences between the two groups in short-term (2 to 12 weeks follow-up) knee pain based on the visual analogue scale (0 to 10 points; higher scores mean worse pain): MD -0.46 favouring knee orthoses, 95% CI -1.16 to 0.24; P = 0.19; 234 participants, 3 trials). A similar lack of clinically important difference was found for knee function (183 participants, 2 trials). None of the trials reported on quality of life measures, resource use or participant satisfaction. Although two trials reported on the impact on sporting or occupational participation, one trial (35 participants) did not provide data split by treatment group on the resumption of sport activity and the other reported only on abandonment of military training due to knee pain (both cases were allocated a knee orthosis). One trial (59 participants, 84 affected knees) recording only adverse events in the two knee orthoses (both were knee sleeves) groups, reported 16 knees (36% of 44 knees) had discomfort or skin abrasion.\nThree trials provided very low quality evidence on single comparisons of different types of knee orthoses: a knee brace versus a knee sleeve (63 participants), a patella strap with a knee sleeve (31 participants), and a knee sleeve with a patellar ring versus a knee sleeve only (44 knees). None of three trials found an important difference between the two types of knee orthosis in pain. One trial found no clinically important difference in function between a knee brace and a knee sleeve. None of the three trials reported on quality of life, resource use or participant satisfaction. One trial comparing a patella strap with a knee sleeve reported that both participants quitting military training due to knee pain were allocated a knee sleeve. One poorly reported trial found three times as many knees with adverse effects (discomfort or skin abrasion) in those given knee sleeves with a patella ring than those given knee sleeves only.\nOne trial compared a knee orthosis (knee brace) with exercise (66 participants). It found very low quality evidence of no clinically important difference between the two intervention groups in pain or knee function. The trial did not report on quality of life, impact on sporting or occupational participation, resource use, participant satisfaction or complications.\nAuthors' conclusions\nOverall, this review has found a lack of evidence to inform on the use of knee orthoses for treating PFPS. There is, however, very low quality evidence from clinically heterogeneous trials using different types of knee orthoses (knee brace, sleeve and strap) that using a knee orthosis did not reduce knee pain or improve knee function in the short term (under three months) in adults who were also undergoing an exercise programme for treating PFPS. This points to the need for good-quality clinically-relevant research to inform on the use of commonly-available knee orthoses for treating PFPS.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, we found a lack of evidence to inform on the use of knee orthoses for treating PFPS. Our review found very low quality evidence from trials testing different knee orthoses (knee brace, sleeve and strap) that using a knee orthosis may not reduce knee pain or improve knee function in the short term (under three months) in adults who were also undergoing an exercise programme for treating PFPS. These findings point to the need for good-quality clinically-relevant research to inform on the use of commonly-available knee orthoses for treating PFPS."
}
] |
query-laysum
|
23921
|
[
{
"role": "user",
"content": "Abstract: Background\nHeavy menstrual bleeding (HMB) is excessive menstrual blood loss that interferes with women's quality of life, regardless of the absolute amount of bleeding. It is a very common condition in women of reproductive age, affecting 2 to 5 of every 10 women. Diverse treatments, either medical (hormonal or non-hormonal) or surgical, are currently available for HMB, with different effectiveness, acceptability, costs and side effects. The best treatment will depend on the woman's age, her intention to become pregnant, the presence of other symptoms, and her personal views and preferences.\nObjectives\nTo identify, systematically assess and summarise all evidence from studies included in Cochrane Reviews on treatment for heavy menstrual bleeding (HMB), using reviews with comparable participants and outcomes; and to present a ranking of the first- and second-line treatments for HMB.\nMethods\nWe searched for published Cochrane Reviews of HMB interventions in the Cochrane Database of Systematic Reviews. The primary outcomes were menstrual bleeding and satisfaction. Secondary outcomes included quality of life, adverse events and the requirement of further treatment. Two review authors independently selected the systematic reviews, extracted data and assessed quality, resolving disagreements by discussion. We assessed review quality using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) 2 tool and evaluated the certainty of the evidence for each outcome using GRADE methods. We grouped the interventions into first- and second-line treatments, considering participant characteristics (desire for future pregnancy, failure of previous treatment, candidacy for surgery). First-line treatments included medical interventions, and second-line treatments included both the levonorgestrel-releasing intrauterine system (LNG-IUS) and surgical treatments; thus the LNG-IUS is included in both groups. We developed different networks for first- and second-line treatments. We performed network meta-analyses of all outcomes, except for quality of life, where we performed pairwise meta-analyses. We reported the mean rank, the network estimates for mean difference (MD) or odds ratio (OR), with 95% confidence intervals (CIs), and the certainty of evidence (moderate, low or very low certainty).\nWe also analysed different endometrial ablation and resection techniques separately from the main network: transcervical endometrial resection (TCRE) with or without rollerball, other resectoscopic endometrial ablation (REA), microwave non-resectoscopic endometrial ablation (NREA), hydrothermal ablation NREA, bipolar NREA, balloon NREA and other NREA.\nMain results\nWe included nine systematic reviews published in the Cochrane Library up to July 2021. We updated the reviews that were over two years old. In July 2020, we started the overview with no new reviews about the topic. The included medical interventions were: non-steroidal anti-inflammatory drugs (NSAIDs), antifibrinolytics (tranexamic acid), combined oral contraceptives (COC), combined vaginal ring (CVR), long-cycle and luteal oral progestogens, LNG-IUS, ethamsylate and danazol (included to provide indirect evidence), which were compared to placebo. Surgical interventions were: open (abdominal), minimally invasive (vaginal or laparoscopic) and unspecified (or surgeon's choice of route of) hysterectomy, REA, NREA, unspecified endometrial ablation (EA) and LNG-IUS. We grouped the interventions as follows.\nFirst-line treatments\nEvidence from 26 studies with 1770 participants suggests that LNG-IUS results in a large reduction of menstrual blood loss (MBL; mean rank 2.4, MD −105.71 mL/cycle, 95% CI −201.10 to −10.33; low certainty evidence); antifibrinolytics probably reduce MBL (mean rank 3.7, MD −80.32 mL/cycle, 95% CI −127.67 to −32.98; moderate certainty evidence); long-cycle progestogen reduces MBL (mean rank 4.1, MD −76.93 mL/cycle, 95% CI −153.82 to −0.05; low certainty evidence), and NSAIDs slightly reduce MBL (mean rank 6.4, MD −40.67 mL/cycle, −84.61 to 3.27; low certainty evidence; reference comparator mean rank 8.9). We are uncertain of the true effect of the remaining interventions and the sensitivity analysis for reduction of MBL, as the evidence was rated as very low certainty.\nWe are uncertain of the true effect of any intervention (very low certainty evidence) on the perception of improvement and satisfaction.\nSecond-line treatments\nBleeding reduction is related to the type of hysterectomy (total or supracervical/subtotal), not the route, so we combined all routes of hysterectomy for bleeding outcomes. We assessed the reduction of MBL without imputed data (11 trials, 1790 participants) and with imputed data (15 trials, 2241 participants). Evidence without imputed data suggests that hysterectomy (mean rank 1.2, OR 25.71, 95% CI 1.50 to 439.96; low certainty evidence) and REA (mean rank 2.8, OR 2.70, 95% CI 1.29 to 5.66; low certainty evidence) result in a large reduction of MBL, and NREA probably results in a large reduction of MBL (mean rank 2.0, OR 3.32, 95% CI 1.53 to 7.23; moderate certainty evidence). Evidence with imputed data suggests hysterectomy results in a large reduction of MBL (mean rank 1.0, OR 14.31, 95% CI 2.99 to 68.56; low certainty evidence), and NREA probably results in a large reduction of MBL (mean rank 2.2, OR 2.87, 95% CI 1.29 to 6.05; moderate certainty evidence). We are uncertain of the true effect for REA (very low certainty evidence). We are uncertain of the effect on amenorrhoea (very low certainty evidence).\nEvidence from 27 trials with 4284 participants suggests that minimally invasive hysterectomy results in a large increase in satisfaction (mean rank 1.3, OR 7.96, 95% CI 3.33 to 19.03; low certainty evidence), and NREA also increases satisfaction (mean rank 3.6, OR 1.59, 95% CI 1.09 to 2.33; low certainty evidence), but we are uncertain of the true effect of the remaining interventions (very low certainty evidence).\nAuthors' conclusions\nEvidence suggests LNG-IUS is the best first-line treatment for reducing menstrual blood loss (MBL); antifibrinolytics are probably the second best, and long-cycle progestogens are likely the third best. We cannot make conclusions about the effect of first-line treatments on perception of improvement and satisfaction, as evidence was rated as very low certainty. For second-line treatments, evidence suggests hysterectomy is the best treatment for reducing bleeding, followed by REA and NREA. We are uncertain of the effect on amenorrhoea, as evidence was rated as very low certainty. Minimally invasive hysterectomy may result in a large increase in satisfaction, and NREA also increases satisfaction, but we are uncertain of the true effect of the remaining second-line interventions, as evidence was rated as very low certainty.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found nine reviews with 104 studies, involving a total of 11,881 participants. Altogether, the data we analysed came from 85 trials and 9950 participants. The medical interventions included were: non-steroidal anti-inflammatory drugs (NSAIDs), antifibrinolytics (tranexamic acid), combined oral contraceptives (COC), combined vaginal ring (CVR), long-cycle and luteal oral progestogens, the LNG-IUS, ethamsylate and danazol (included only to provide indirect evidence). These were compared to placebo (sham treatment). The surgical interventions included were: open (abdominal), minimally invasive (vaginal or laparoscopic) and unspecified (or surgeon's choice of) route of hysterectomy, REA, NREA and unspecified endometrial ablation (EA)."
}
] |
query-laysum
|
23922
|
[
{
"role": "user",
"content": "Abstract: Background\nMultiple sclerosis (MS) is an autoimmune, T-cell-dependent, inflammatory, demyelinating disease of the central nervous system, with an unpredictable course. Current MS therapies focus on treating and preventing exacerbations, and avoiding the progression of disability. At present, there is no treatment that is capable of safely and effectively reaching these objectives. Clinical trials suggest that alemtuzumab, a humanized monoclonal antibody, could be a promising option for MS.\nObjectives\nTo evaluate the benefits and harms of alemtuzumab alone or associated with other treatments in people with any form of MS.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 21 June 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) in adults with any subtype of MS comparing alemtuzumab alone or associated with other medications versus placebo; another active drug; or alemtuzumab in another dose, regimen, or duration.\nData collection and analysis\nWe used standard Cochrane methods. Our co-primary outcomes were 1. relapse-free survival, 2. sustained disease progression, and 3. number of participants experiencing at least one adverse event. Our secondary outcomes were 4. participants free of clinical disability, 5. quality of life, 6. change in disability, 7. fatigue, 8. new or enlarging lesions on resonance imaging, and 9. dropouts. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included three RCTs (1713 participants) comparing intravenous alemtuzumab versus subcutaneous interferon beta-1a for relapsing–remitting MS. Participants were treatment-naive (two studies) or had experienced at least one relapse after interferon or glatiramer (one study). Alemtuzumab was given at doses of 12 mg/day or 24 mg/day for five days at months 0 and 12, or 24 mg/day for three days at months 12 and 24. Participants in the interferon beta-1a group received 44 μg three times weekly.\nAlemtuzumab 12 mg: 1. may improve relapse-free survival at 36 months (hazard ratio [HR] 0.31, 95% confidence interval [CI] 0.18 to 0.53; 1 study, 221 participants; low-certainty evidence); 2. may improve sustained disease progression-free survival at 36 months (HR 0.25, 95% CI 0.11 to 0.56; 1 study, 223 participants; low-certainty evidence); 3. may make little to no difference on the proportion of participants with at least one adverse event at 36 months (risk ratio [RR] 1.00, 95% CI 0.98 to 1.02; 1 study, 224 participants; low-certainty evidence), although the proportion of participants with at least one adverse event was high with both drugs; 4. may slightly reduce disability at 36 months (mean difference [MD] −0.70, 95% CI −1.04 to −0.36; 1 study, 223 participants; low-certainty evidence). The evidence is very uncertain regarding the risk of dropouts at 36 months (RR 0.81, 95% CI 0.57 to 1.14; 1 study, 224 participants; very low-certainty evidence).\nAlemtuzumab 24 mg: 1. may improve relapse-free survival at 36 months (HR 0.21, 95% CI 0.11 to 0.40; 1 study, 221 participants; low-certainty evidence); 2. may improve sustained disease progression-free survival at 36 months (HR 0.33, 95% CI 0.16 to 0.69; 1 study, 221 participants; low-certainty evidence); 3. may make little to no difference on the proportion of participants with at least one adverse event at 36 months (RR 0.99, 95% CI 0.97 to 1.02; 1 study, 215 participants; low-certainty evidence), although the proportion of participants with at least one adverse event was high with both drugs; 4. may slightly reduce disability at 36 months (MD −0.83, 95% CI −1.16 to −0.50; 1 study, 221 participants; low-certainty evidence); 5. may reduce the risk of dropouts at 36 months (RR 0.08, 95% CI 0.01 to 0.57; 1 study, 215 participants; low-certainty evidence).\nFor quality of life, fatigue, and participants free of clinical disease activity, the studies either did not consider these outcomes or they used different measuring tools to those planned in this review.\nAuthors' conclusions\nCompared with interferon beta-1a, alemtuzumab may improve relapse-free survival and sustained disease progression-free survival, and make little to no difference on the proportion of participants with at least one adverse event for people with relapsing–remitting MS at 36 months. The certainty of the evidence for these results was very low to low.\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 for studies that investigated alemtuzumab for people with any form of MS. We searched the literature up to October 2020. We analyzed and compared the results of the included studies and assessed how much confidence we had in the available evidence."
}
] |
query-laysum
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23923
|
[
{
"role": "user",
"content": "Abstract: Background\nCurrent and expected problems such as ageing, increased prevalence of chronic conditions and multi-morbidity, increased emphasis on healthy lifestyle and prevention, and substitution for care from hospitals by care provided in the community encourage countries worldwide to develop new models of primary care delivery. Owing to the fact that many tasks do not necessarily require the knowledge and skills of a doctor, interest in using nurses to expand the capacity of the primary care workforce is increasing. Substitution of nurses for doctors is one strategy used to improve access, efficiency, and quality of care. This is the first update of the Cochrane review published in 2005.\nObjectives\nOur aim was to investigate the impact of nurses working as substitutes for primary care doctors on:\n• patient outcomes;\n• processes of care; and\n• utilisation, including volume and cost.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), part of the Cochrane Library (www.cochranelibrary.com), as well as MEDLINE, Ovid, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and EbscoHost (searched 20.01.2015). We searched for grey literature in the Grey Literature Report and OpenGrey (21.02.2017), and we searched the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov trial registries (21.02.2017). We did a cited reference search for relevant studies (searched 27.01 2015) and checked reference lists of all included studies. We reran slightly revised strategies, limited to publication years between 2015 and 2017, for CENTRAL, MEDLINE, and CINAHL, in March 2017, and we have added one trial to ‘Studies awaiting classification’.\nSelection criteria\nRandomised trials evaluating the outcomes of nurses working as substitutes for doctors. The review is limited to primary healthcare services that provide first contact and ongoing care for patients with all types of health problems, excluding mental health problems. Studies which evaluated nurses supplementing the work of primary care doctors were excluded.\nData collection and analysis\nTwo review authors independently carried out data extraction and assessment of risk of bias of included studies. When feasible, we combined study results and determined an overall estimate of the effect. We evaluated other outcomes by completing a structured synthesis.\nMain results\nFor this review, we identified 18 randomised trials evaluating the impact of nurses working as substitutes for doctors. One study was conducted in a middle-income country, and all other studies in high-income countries. The nursing level was often unclear or varied between and even within studies. The studies looked at nurses involved in first contact care (including urgent care), ongoing care for physical complaints, and follow-up of patients with a particular chronic conditions such as diabetes. In many of the studies, nurses could get additional support or advice from a doctor. Nurse-doctor substitution for preventive services and health education in primary care has been less well studied.\nStudy findings suggest that care delivered by nurses, compared to care delivered by doctors, probably generates similar or better health outcomes for a broad range of patient conditions (low- or moderate-certainty evidence):\n• Nurse-led primary care may lead to slightly fewer deaths among certain groups of patients, compared to doctor-led care. However, the results vary and it is possible that nurse-led primary care makes little or no difference to the number of deaths (low-certainty evidence).\n• Blood pressure outcomes are probably slightly improved in nurse-led primary care. Other clinical or health status outcomes are probably similar (moderate-certainty evidence).\n• Patient satisfaction is probably slightly higher in nurse-led primary care (moderate-certainty evidence). Quality of life may be slightly higher (low-certainty evidence).\nWe are uncertain of the effects of nurse-led care on process of care because the certainty of this evidence was assessed as very low.\nThe effect of nurse-led care on utilisation of care is mixed and depends on the type of outcome. Consultations are probably longer in nurse-led primary care (moderate-certainty evidence), and numbers of attended return visits are slightly higher for nurses than for doctors (high-certainty evidence). We found little or no difference between nurses and doctors in the number of prescriptions and attendance at accident and emergency units (high-certainty evidence). There may be little or no difference in the number of tests and investigations, hospital referrals and hospital admissions between nurses and doctors (low-certainty evidence).\nWe are uncertain of the effects of nurse-led care on the costs of care because the certainty of this evidence was assessed as very low.\nAuthors' conclusions\nThis review shows that for some ongoing and urgent physical complaints and for chronic conditions, trained nurses, such as nurse practitioners, practice nurses, and registered nurses, probably provide equal or possibly even better quality of care compared to primary care doctors, and probably achieve equal or better health outcomes for patients. Nurses probably achieve higher levels of patient satisfaction, compared to primary care doctors. Furthermore, consultation length is probably longer when nurses deliver care and the frequency of attended return visits is probably slightly higher for nurses, compared to doctors. Other utilisation outcomes are probably the same. The effects of nurse-led care on process of care and the costs of care are uncertain, and we also cannot ascertain what level of nursing education leads to the best outcomes when nurses are substituted for doctors.\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": "In most countries, the population is growing older and more people have chronic disease. This means that the services that primary healthcare workers need to deliver are changing. At the same time, many countries lack doctors and other healthcare workers, or people struggle to pay for healthcare services. By using nurses instead of doctors, countries hope to deliver care of the same quality for less money.\nIn this review, we searched for studies that compared nurses to doctors for delivery of primary care services. We looked at whether this made any difference in patients’ health, satisfaction, and use of services. We also looked at whether this made any difference in how services were delivered and in how much they cost."
}
] |
query-laysum
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23924
|
[
{
"role": "user",
"content": "Abstract: Background\nLong-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and inhaled corticosteroids (ICSs) are inhaled medications used to manage chronic obstructive pulmonary disease (COPD). When two classes of medications are required, a LAMA plus an ICS (LABA+ICS) were previously recommended within a single inhaler as the first-line treatment for managing stable COPD in people in high-risk categories. However, updated international guidance recommends a LAMA plus a LABA (LAMA+LABA). This systematic review is an update of a Cochrane Review first published in 2017.\nObjectives\nTo compare the benefits and harms of LAMA+LABA versus LABA+ICS for treatment of people with stable COPD.\nSearch methods\nWe performed an electronic search of the Cochrane Airways Group Specialised Register, ClinicalTrials.gov, and the World Health Organization Clinical Trials Search Portal, followed by handsearches. Two review authors screened the selected articles. The most recent search was run on 10 September 2022.\nSelection criteria\nWe included parallel or cross-over randomised controlled trials of at least one month's duration, comparing LAMA+LABA and LABA+ICS for stable COPD. We included studies conducted in an outpatient setting and irrespective of blinding.\nData collection and analysis\nTwo review authors independently extracted data and evaluated risk of bias. We resolved any discrepancies through discussion. We analysed dichotomous data as odds ratios (ORs), and continuous data as mean differences (MDs), with 95% confidence intervals (CIs) using Review Manager 5. Primary outcomes were: participants with one or more exacerbations of COPD; serious adverse events; quality of life, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score change from baseline; and trough forced expiratory volume in one second (FEV1). We used the GRADE framework to rate our certainty of the evidence in each meta-analysis as high, moderate, low or very low.\nMain results\nThis review updates the first version of the review, published in 2017, and increases the number of included studies from 11 to 19 (22,354 participants). The median number of participants per study was 700. In each study, between 54% and 91% (median 70%) of participants were males. Study participants had an average age of 64 years and percentage predicted FEV1 of 51.5% (medians of study means). Included studies had a generally low risk of selection, performance, detection, attrition, and reporting biases. All but two studies were sponsored by pharmaceutical companies, which had varying levels of involvement in study design, conduct, and data analysis.\nPrimary outcomes\nThe odds of having an exacerbation were similar for LAMA+LABA compared with LABA+ICS (OR 0.91, 95% CI 0.78 to 1.06; I2 = 61%; 13 studies, 20,960 participants; moderate-certainty evidence). The odds of having a serious adverse event were also similar (OR 1.02, 95% CI 0.91 to 1.15; I2 = 20%; 18 studies, 23,183 participants; high-certainty evidence). Participants receiving LAMA+LABA had a similar improvement in quality of life, as measured by the SGRQ, to those receiving LABA+ICS (MD -0.57, 95% CI -1.36 to 0.21; I2 = 78%; 9 studies, 14,437 participants; moderate-certainty evidence) but showed a greater improvement in trough FEV1 (MD 0.07, 95% CI 0.05 to 0.08; I2 = 73%; 12 studies, 14,681 participants; moderate-certainty evidence).\nSecondary outcomes\nLAMA+LABA decreased the odds of pneumonia compared with LABA+ICS from 5% to 3% (OR 0.61, 95% CI 0.52 to 0.72; I2 = 0%; 14 studies, 21,829 participants; high-certainty evidence) but increased the odds of all-cause death from 1% to 1.4% (OR 1.35, 95% CI 1.05 to 1.75; I2 = 0%; 15 studies, 21,510 participants; moderate-certainty evidence). The odds of achieving a minimal clinically important difference of four or more points on the SGRQ were similar between LAMA+LABA and LABA+ICS (OR 1.06, 95% CI 0.90 to 1.25; I2 = 77%; 4 studies, 13,614 participants; moderate-certainty evidence).\nAuthors' conclusions\nCombination LAMA+LABA therapy probably holds similar benefits to LABA+ICS for exacerbations and quality of life, as measured by the St George's Respiratory Questionnaire, for people with moderate to severe COPD, but offers a larger improvement in FEV1 and a slightly lower risk of pneumonia. There is little to no difference between LAMA+LABA and LAMA+ICS in the odds of having a serious adverse event. Whilst all-cause death may be lower with LABA+ICS, there was a very small number of events in the analysis, translating to a low absolute risk. Findings are based on moderate- to high-certainty evidence from heterogeneous trials with an observation period of less than one year. This review should be updated again in a few years.\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 for trials that explored the benefits and harms of LAMA+LABA and LABA+ICS for the treatment of people with COPD. We summarised these results and rated our confidence in the evidence."
}
] |
query-laysum
|
23925
|
[
{
"role": "user",
"content": "Abstract: Background\nHyperopia in infancy requires accommodative effort to bring images into focus. Prolonged accommodative effort has been associated with an increased risk of strabismus. Strabismus may result in asthenopia and intermittent diplopia, and makes near work tasks difficult to complete. Spectacles to correct hyperopic refractive error is believed to prevent the development of strabismus.\nObjectives\nTo assess the effectiveness of prescription spectacles compared with no intervention for the prevention of strabismus in infants and children with hyperopia.\nSearch methods\nWe searched CENTRAL (2018, Issue 12; which contains the Cochrane Eyes and Vision Trials Register); Ovid MEDLINE; Embase.com; three other databases; and two trial registries. We used no date or language restrictions in the electronic search for trials. We last searched the electronic databases on 4 December 2018.\nSelection criteria\nWe included randomized controlled trials and quasi-randomized trials investigating spectacle intervention or no treatment for children with hyperopia. We required hyperopia to be at least greater than +2.00 diopters (D).\nData collection and analysis\nWe used standard Cochrane methodological procedures. The primary outcome was the proportion of children with manifest strabismus, as defined by study investigators. Other outcomes included the amblyopia, stereoacuity, and the effect of spectacle use of strabismus and visual acuity. We also collected information on change in refractive error as a measurement of the interference of emmetropization.\nMain results\nWe identified four randomized controlled trials (985 children enrolled who were aged six months to less than 36 months) in this review. Three trials were in the UK with follow-up periods ranging from one to 3.5 years and one in the US with three years' follow-up.\nInvestigators reported both incidence and final status regarding strabismus. Evidence of the incidence of strabismus, measured in 804 children over three to four years in four trials was uncertain although suggestive of a benefit with spectacle use (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.41 to 1.02). We have very low confidence in these results due to high risk of bias, inconsistency, and imprecision. When assessed as the proportion of children with strabismus at the end of three years' follow-up, we found a similar level of evidence for an effect of spectacles on strabismus as reported in one study (RR 1.00, 95% CI 0.31 to 3.25; 106 children). We have very low confidence in these results because of low sample size and risk of bias.\nOne trial reported on the risk for developing amblyopia and inadequate stereoacuity after three years in 106 children. There was unclear evidence for a decreased risk of developing amblyopia (RR 0.78, 95% CI 0.31 to 1.93), and limited evidence for a benefit of spectacles for prevention of inadequate stereoacuity (RR 0.38, 95% CI 0.16 to 0.88). We have very low confidence in these findings due to imprecision and risk of bias.\nThe risk of not developing emmetropization is unclear. One trial reported on the proportion of children not achieving emmetropization at three years' follow-up (RR 0.75, 95% CI 0.18 to 3.19). One trial suggested spectacles impede emmetropization, and one trial reported no difference. These two trials could not be combined because the methods for assessing emmetropization were different. With the high risk of bias and inconsistency, the certainty of evidence for a risk for impeding or benefiting emmetropization is very low.\nBased on a meta-analysis of four trials (770 children), the risk of having visual acuity worse than 20/30 measured up to three years of age or at the end of three years of follow-up was uncertain for children with spectacle correction compared with those without correction (RR 0.87, 95% CI 0.64 to 1.18; very low confidence due to risk of bias and imprecision).\nAuthors' conclusions\nThe effect of spectacle correction for prevention of strabismus is still unclear. In addition, the use of spectacle on the risk of visual acuity worse than 20/30, amblyopia, and inadequate emmetropization is also unclear. There may be a benefit on prevention of inadequate stereoacuity. However, these effects may have been chance findings or due to bias.\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": "Infants typically are born far-sighted, meaning they only have clear vision at distance. As children grow, their eyes also grow to where they can see clearly at both near and far distances. About 9% of children remain very far-sighted. Being far-sighted means that to focus on something up close the child must use a great deal of effort. This effort can cause symptoms, such as headaches, seeing double, and eyestrain, as well as cause difficulty doing things up close, such as reading. Children that remain far-sighted are more likely than children with normal vision to develop crossed eyes (strabismus), which may happen in 3.5% to 5.7% of children, or 10% to 20% of children with high levels of far-sightedness. Strabismus makes it difficult for the eyes to work together to focus. It is thought that about 50% of children with strabismus develop amblyopia, meaning a child cannot get clear vision even when using glasses. Depth perception, or how two things are related to each other in space, is often affected as well. Doctors often prescribe eyeglasses to prevent the development of strabismus and these other associated problems in far-sighted children, but it is unclear whether the glasses themselves may prevent the eyes from growing normally."
}
] |
query-laysum
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23927
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the 2009 Cochrane overview and network meta-analysis (NMA) of biologics for rheumatoid arthritis (RA).\nObjectives\nTo assess the benefits and harms of nine biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab) and small molecule tofacitinib, versus comparator (MTX, DMARD, placebo (PL), or a combination) in adults with rheumatoid arthritis who have failed to respond to methotrexate (MTX) or other disease-modifying anti-rheumatic drugs (DMARDs), i.e., MTX/DMARD incomplete responders (MTX/DMARD-IR).\nMethods\nWe searched for randomized controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (via The Cochrane Library Issue 6, June 2015), MEDLINE (via OVID 1946 to June 2015), and EMBASE (via OVID 1947 to June 2015). Data extraction, risk of bias and GRADE assessments were done in duplicate. We calculated both direct estimates using standard meta-analysis and used Bayesian mixed treatment comparisons approach for NMA estimates to calculate odds ratios (OR) and 95% credible intervals (CrI). We converted OR to risk ratios (RR) which are reported in the abstract for the ease of interpretation.\nMain results\nThis update included 73 new RCTs for a total of 90 RCTs; 79 RCTs with 32,874 participants provided usable data. Few trials were at high risk of bias for blinding of assessors/participants (13% to 21%), selective reporting (4%) or major baseline imbalance (8%); a large number had unclear risk of bias for random sequence generation (68%) or allocation concealment (74%).\nBased on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with a statistically significant and clinically meaningful improvement in ACR50 versus comparator (RR 2.71 (95% confidence interval (CI) 2.36 to 3.10); absolute benefit 24% more patients (95% CI 19% to 29%), number needed to treat for an additional beneficial outcome (NNTB) = 5 (4 to 6). NMA estimates for ACR50 in tumor necrosis factor (TNF) biologic+MTX/DMARD (RR 3.23 (95% credible interval (Crl) 2.75 to 3.79), non-TNF biologic+MTX/DMARD (RR 2.99; 95% Crl 2.36 to 3.74), and anakinra + MTX/DMARD (RR 2.37 (95% Crl 1.00 to 4.70) were similar to the direct estimates.\nBased on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with a clinically and statistically important improvement in function measured by the Health Assessment Questionnaire (0 to 3 scale, higher = worse function) with a mean difference (MD) based on direct evidence of -0.25 (95% CI -0.28 to -0.22); absolute benefit of -8.3% (95% CI -9.3% to -7.3%), NNTB = 3 (95% CI 2 to 4). NMA estimates for TNF biologic+MTX/DMARD (absolute benefit, -10.3% (95% Crl -14% to -6.7%) and non-TNF biologic+MTX/DMARD (absolute benefit, -7.3% (95% Crl -13.6% to -0.67%) were similar to respective direct estimates.\nBased on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with clinically and statistically significantly greater proportion of participants achieving remission in RA (defined by disease activity score DAS < 1.6 or DAS28 < 2.6) versus comparator (RR 2.81 (95% CI, 2.23 to 3.53); absolute benefit 18% more patients (95% CI 12% to 25%), NNTB = 6 (4 to 9)). NMA estimates for TNF biologic+MTX/DMARD (absolute improvement 17% (95% Crl 11% to 23%)) and non-TNF biologic+MTX/DMARD (absolute improvement 19% (95% Crl 12% to 28%) were similar to respective direct estimates.\nBased on direct evidence of moderate quality (downgraded for inconsistency), radiographic progression (scale 0 to 448) was statistically significantly reduced in those on biologics + MTX/DMARDs versus comparator, MD -2.61 (95% CI -4.08 to -1.14). The absolute reduction was small, -0.58% (95% CI -0.91% to -0.25%) and we are unsure of the clinical relevance of this reduction. NMA estimates of TNF biologic+MTX/DMARD (absolute reduction -0.67% (95% Crl -1.4% to -0.12%) and non-TNF biologic+MTX/DMARD (absolute reduction, -0.68% (95% Crl -2.36% to 0.92%)) were similar to respective direct estimates.\nBased on direct evidence of moderate quality (downgraded for imprecision), results for withdrawals due to adverse events were inconclusive, with wide confidence intervals encompassing the null effect and evidence of an important increase in withdrawals, RR 1.11 (95% CI 0.96 to 1.30). The NMA estimates of TNF biologic+MTX/DMARD (RR 1.24 (95% Crl 0.99 to 1.57)) and non-TNF biologic+MTX/DMARD (RR 1.20 (95% Crl 0.87 to 1.67)) were similarly inconclusive and downgraded to low for both imprecision and indirectness.\nBased on direct evidence of high quality, biologic+MTX/DMARD was associated with clinically significantly increased risk (statistically borderline significant) of serious adverse events on biologic+MTX/DMARD (Peto OR [can be interpreted as RR due to low event rate] 1.12 (95% CI 0.99 to 1.27); absolute risk 1% (0% to 2%), As well, the NMA estimate for TNF biologic+MTX/DMARD (Peto OR 1.20 (95% Crl 1.01 to 1.43)) showed moderate quality evidence of an increase in the risk of serious adverse events. The other two NMA estimates were downgraded to low quality due to imprecision and indirectness and had wide confidence intervals resulting in uncertainty around the estimates: non-TNF biologics + MTX/DMARD: 1.07 (95% Crl 0.89 to 1.29) and anakinra: RR 1.06 (95% Crl 0.65 to 1.75).\nBased on direct evidence of low quality (downgraded for serious imprecision), results were inconclusive for cancer (Peto OR 1.07 (95% CI 0.68 to 1.68) for all biologic+MTX/DMARD combinations. The NMA estimates of TNF biologic+MTX/DMARD (Peto OR 1.21 (95% Crl 0.63 to 2.38) and non-TNF biologic+MTX/DMARD (Peto OR 0.99 (95% Crl 0.58 to 1.78)) were similarly inconclusive and downgraded to low quality for both imprecision and indirectness.\nMain results text shows the results for tofacitinib and differences between medications.\nAuthors' conclusions\nBased primarily on RCTs of 6 months' to 12 months' duration, there is moderate quality evidence that the use of biologic+MTX/DMARD in people with rheumatoid arthritis who have failed to respond to MTX or other DMARDs results in clinically important improvement in function and higher ACR50 and remission rates, and increased risk of serious adverse events than the comparator (MTX/DMARD/PL; high quality evidence). Radiographic progression is slowed but its clinical relevance is uncertain. Results were inconclusive for whether biologics + MTX/DMARDs are associated with an increased risk of cancer or withdrawals due to adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Remission\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Eighteen more people out of 100 experienced no symptoms of their rheumatoid arthritis with biologics + MTX/DMARDs (18% absolute improvement).\nTwenty-eight patients out of 100 who were on biologic+ MTX experienced no symptoms compared to 10 people out of 100 who were on MTX/DMARD/placebo."
}
] |
query-laysum
|
23928
|
[
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis is a chronic disease characterized by joint pain, tenderness, and limitation of movement. At present, no cure is available. Thus only treatment of the person's symptoms and treatment to prevent further development of the disease are possible. Clinical trials indicate that aquatic exercise may have advantages for people with osteoarthritis. This is an update of a published Cochrane review.\nObjectives\nTo evaluate the effects of aquatic exercise for people with knee or hip osteoarthritis, or both, compared to no intervention.\nSearch methods\nWe searched the following databases up to 28 April 2015: the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library Issue 1, 2014), MEDLINE (from 1949), EMBASE (from 1980), CINAHL (from 1982), PEDro (Physiotherapy Evidence Database), and Web of Science (from 1945). There was no language restriction.\nSelection criteria\nRandomized controlled clinical trials of aquatic exercise compared to a control group (e.g. usual care, education, social attention, telephone call, waiting list for surgery) of participants with knee or hip osteoarthritis.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data and assessed risk of bias of the included trials. We analysed the pooled results using standardized mean difference (SMD) values.\nMain results\nNine new trials met the inclusion criteria and we excluded two earlier included trials. Thus the number of participants increased from 800 to 1190 and the number of included trials increased from six to 13. Most participants were female (75%), with an average age of 68 years and a body mass index (BMI) of 29.4. Osteoarthritis duration was 6.7 years, with a great variation of the included participants. The mean aquatic exercise duration was 12 weeks. We found 12 trials at low to unclear risk of bias for all domains except blinding of participants and personnel. They showed that aquatic exercise caused a small short term improvement compared to control in pain (SMD −0.31, 95% CI −0.47 to −0.15; 12 trials, 1076 participants) and disability (SMD −0.32, 95% CI −0.47 to −0.17; 12 trials, 1059 participants). Ten trials showed a small effect on quality of life (QoL) (SMD −0.25, 95% CI −0.49 to −0.01; 10 trials, 971 participants). These effects on pain and disability correspond to a five point lower (95% CI three to eight points lower) score on mean pain and mean disability compared to the control group (scale 0 to 100), and a seven point higher (95% CI 0 to 13 points higher) score on mean QoL compared with control group (scale 0 to 100). No included trials performed a radiographic evaluation. No serious adverse events were reported in the included trials with relation to aquatic exercise.\nAuthors' conclusions\nThere is moderate quality evidence that aquatic exercise may have small, short-term, and clinically relevant effects on patient-reported pain, disability, and QoL in people with knee and hip OA. The conclusions of this review update does not change those of the previous published version of this Cochrane review.\n\nGiven the provided abstract, please respond to the following query: \"Pain [lower score is better]\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People who completed an aquatic exercise programme rated their pain as five points lower (three to eight points lower) on a 0 to 100 scale at the end of aquatic exercise compared with people who did not receive aquatic exercise (5% absolute improvement)\nPeople who completed an exercise program rated their pain to be 41 points on a scale of 0 to 100\nPeople in the control group rated their pain to be 46 points on a scale of 0 to 100."
}
] |
query-laysum
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23929
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[
{
"role": "user",
"content": "Abstract: Background\nEnteral tube feeding is routinely used in many cystic fibrosis centres when oral dietary and supplement intake has failed to achieve an adequate nutritional status. The use of this method of feeding is assessed on an individual basis taking into consideration the patients age and clinical status. This is a final update of a previously published review.\nObjectives\nTo examine the evidence that in people with cystic fibrosis, supplemental enteral tube feeding improves nutritional status, respiratory function, and quality of life without significant adverse effects.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also contacted the companies that market enteral feeds and reviewed their databases.\nDate of the most recent search of the Group's Cystic Fibrosis Trials Register: 10 July 2019.\nDate of the most recent hand search of PubMed: 26 October 2018.\nSelection criteria\nAll randomised controlled trials comparing supplemental enteral tube feeding for one month or longer with no specific intervention in people with cystic fibrosis.\nData collection and analysis\nThe searches identified 44 trials; however, none were eligible for inclusion in this review.\nMain results\nThere are no trials included in this review.\nAuthors' conclusions\nSupplemental enteral tube feeding is widely used throughout the world to improve nutritional status in people with cystic fibrosis. The methods mostly used, nasogastric or gastrostomy feeding, are expensive and may have a negative effect on self-esteem and body image. Reported use of enteral tube feeding suggests that it results in nutritional and respiratory improvement; but, efficacy has not been fully assessed by randomised controlled trials. It is acknowledged, however, that performing a randomised controlled trial would be difficult due to the ethics of withholding an intervention in a group of people whose nutritional status necessitates it.\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": "Ideally, more research is needed to compare tube feeding with oral supplements and with normal diet. New trials should also look at when tube feeding should be started for the best results. These trials may be difficult to run as it may be wrong not to provide people with the extra calories they need, and when they need them, in this way."
}
] |
query-laysum
|
23930
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[
{
"role": "user",
"content": "Abstract: Background\nDental caries (tooth decay) is one of the commonest diseases which afflicts mankind, and has been estimated to affect up to 80% of people in high-income countries. Caries adversely affects and progressively destroys the tissues of the tooth, including the dental pulp (nerve), leaving teeth unsightly, weakened and with impaired function. The treatment of lesions of dental caries, which are progressing through dentine and have caused the formation of a cavity, involves the provision of dental restorations (fillings). This review updates the previous version published in 2009.\nObjectives\nTo assess the effects of adhesive bonding on the in-service performance and longevity of dental amalgam restorations.\nSearch methods\nWe searched the Cochrane Oral Health Group Trials Register (to 21 January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 12), MEDLINE via Ovid (1946 to 21 January 2016) and EMBASE via Ovid (1980 to 21 January 2016). We also searched the US National Institutes of Health Trials Registry (http://clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (www.who.int/ictrp/search/en) (both to 21 January 2016) for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials comparing adhesively bonded versus traditional non-bonded amalgam restorations in conventional preparations utilising deliberate retention, in adults with permanent molar and premolar teeth suitable for Class I and II amalgam restorations only.\nData collection and analysis\nTwo review authors independently screened papers, extracted trial details and assessed the risk of bias in the included study.\nMain results\nOne trial with 31 patients who received 113 restorations was included. At two years, 50 out of 53 restorations in the non-bonded group survived, and 55 of 60 bonded restorations survived with five unaccounted for at follow-up. Post-insertion sensitivity was not significantly different (P > 0.05) at baseline or two-year follow-up. No fractures of tooth tissue were reported and there was no significant difference between the groups or matched pairs of restorations in their marginal adaptation (P > 0.05).\nAuthors' conclusions\nThere is no evidence to either claim or refute a difference in survival between bonded and non-bonded amalgam restorations. This review only found one under-reported trial. This trial did not find any significant difference in the in-service performance of moderately sized adhesively bonded amalgam restorations, in terms of their survival rate and marginal integrity, in comparison to non-bonded amalgam restorations over a two-year period. In view of the lack of evidence on the additional benefit of adhesively bonding amalgam in comparison with non-bonded amalgam, it is important that clinicians are mindful of the additional costs that may be incurred.\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": "Tooth decay is a common problem affecting both children and adults. Cavities form in the teeth by the action of acid produced by bacteria present in dental plaque or biofilm.\nA number of techniques and a variety of materials can be used to restore or fill teeth affected by decay. One of the most commonly used and comparatively cheap filling materials is dental amalgam (a mixture of mercury and metal alloy particles). The review authors sought to evaluate the added benefit of using an adhesive to bond amalgam to tooth structure to see if bonded fillings would last longer and perform better."
}
] |
query-laysum
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23931
|
[
{
"role": "user",
"content": "Abstract: Background\nGallstones and alcohol account for more than 80% of acute pancreatitis. Cholecystectomy is the definitive treatment for gallstones. Laparoscopic cholecystectomy is the preferred route for performing cholecystectomy. The timing of laparoscopic cholecystectomy after an attack of acute biliary pancreatitis is controversial.\nObjectives\nTo compare the benefits and harms of early versus delayed laparoscopic cholecystectomy in people with acute biliary pancreatitis. For mild acute pancreatitis, we considered 'early' laparoscopic cholecystectomy to be laparoscopic cholecystectomy performed within three days of onset of symptoms. We considered all laparoscopic cholecystectomies performed beyond three days of onset of symptoms as 'delayed'. For severe acute pancreatitis, we considered 'early' laparoscopic cholecystectomy as laparoscopic cholecystectomy performed within the index admission. We considered all laparoscopic cholecystectomies performed in a later admission as 'delayed'.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, issue 12), MEDLINE, EMBASE, Science Citation Index Expanded, and trial registers until January 2013.\nSelection criteria\nWe included randomised controlled trials, irrespective of language or publication status, comparing early versus delayed laparoscopic cholecystectomy for people with acute biliary pancreatitis.\nData collection and analysis\nTwo authors independently assessed trials for inclusion and independently extracted data. We planned to analyse data with both the fixed-effect and the random-effects models using Review Manager 5 (RevMan 2011). We calculated the risk ratio (RR), or mean difference (MD) with 95% confidence intervals (CI) based on an intention-to-treat analysis.\nMain results\nWe identified one trial comparing early versus delayed laparoscopic cholecystectomy for people with mild acute pancreatitis. Fifty participants with mild acute gallstone pancreatitis were randomised either to early laparoscopic cholecystectomy (within 48 hours of admission irrespective of whether the abdominal symptoms were resolved or the laboratory values had returned to normal) (n = 25), or to delayed laparoscopic cholecystectomy (surgery after resolution of abdominal pain and after the laboratory values had returned to normal) (n = 25). This trial is at high risk of bias. There was no short-term mortality in either group. There was no significant difference between the groups in the proportion of participants who developed serious adverse events (RR 0.33; 95% CI 0.01 to 7.81). Health-related quality of life was not reported in this trial. There were no conversions to open cholecystectomy in either group. The total hospital stay was significantly shorter in the early laparoscopic cholecystectomy group than in the delayed laparoscopic cholecystectomy group (MD -2.30 days; 95% CI -4.40 to -0.20). This trial reported neither the number of work-days lost nor the costs. We did not identify any trials comparing early versus delayed laparoscopic cholecystectomy after severe acute pancreatitis.\nAuthors' conclusions\nThere is no evidence of increased risk of complications after early laparoscopic cholecystectomy. Early laparoscopic cholecystectomy may shorten the total hospital stay in people with mild acute pancreatitis. If appropriate facilities and expertise are available, early laparoscopic cholecystectomy appears preferable to delayed laparoscopic cholecystectomy in those with mild acute pancreatitis. There is currently no evidence to support or refute early laparoscopic cholecystectomy for people with severe acute pancreatitis. Further randomised controlled trials at low risk of bias are necessary in people with mild acute pancreatitis and severe acute pancreatitis.\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": "Based on the observations in the one trial included in this review, there appears to be no evidence of increased risk of complications after early laparoscopic cholecystectomy. Early laparoscopic cholecystectomy may shorten the total hospital stay in people with mild acute pancreatitis. If appropriate facilities and expertise are available, early laparoscopic cholecystectomy appears preferable to delayed laparoscopic cholecystectomy in people with mild acute pancreatitis. There is currently no evidence to support or refute early laparoscopic cholecystectomy for people with severe acute pancreatitis. Further well-designed randomised controlled trials are necessary in people with mild acute pancreatitis and severe acute pancreatitis."
}
] |
query-laysum
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23932
|
[
{
"role": "user",
"content": "Abstract: Background\nNausea and vomiting remain a problem for children undergoing treatment for malignancies despite new antiemetic therapies. Optimising antiemetic regimens could improve quality of life by reducing nausea, vomiting, and associated clinical problems. This is an update of the original systematic review.\nObjectives\nTo assess the effectiveness and adverse events of pharmacological interventions in controlling anticipatory, acute, and delayed nausea and vomiting in children and young people (aged less than 18 years) about to receive or receiving chemotherapy.\nSearch methods\nSearches included the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, PsycINFO, conference proceedings of the American Society of Clinical Oncology, International Society of Paediatric Oncology, Multinational Association of Supportive Care in Cancer, and ISI Science and Technology Proceedings Index from incept to December 16, 2014, and trial registries from their earliest records to December 2014. We examined references of systematic reviews and contacted trialists for information on further studies. We also screened the reference lists of included studies.\nSelection criteria\nTwo review authors independently screened abstracts in order to identify randomised controlled trials (RCTs) that compared a pharmacological antiemetic, cannabinoid, or benzodiazepine with placebo or any alternative active intervention in children and young people (less than 18 years) with a diagnosis of cancer who were to receive chemotherapy.\nData collection and analysis\nTwo review authors independently extracted outcome and quality data from each RCT. When appropriate, we undertook meta-analysis.\nMain results\nWe included 34 studies that examined a range of different antiemetics, used different doses and comparators, and reported a variety of outcomes. The quality and quantity of included studies limited the exploration of heterogeneity to narrative approaches only.\nThe majority of quantitative data related to the complete control of acute vomiting (27 studies). Adverse events were reported in 29 studies and nausea outcomes in 16 studies.\nTwo studies assessed the addition of dexamethasone to 5-HT3 antagonists for complete control of vomiting (pooled risk ratio (RR) 2.03; 95% confidence interval (CI) 1.35 to 3.04). Three studies compared granisetron 20 mcg/kg with 40 mcg/kg for complete control of vomiting (pooled RR 0.93; 95% CI 0.80 to 1.07). Three studies compared granisetron with ondansetron for complete control of acute nausea (pooled RR 1.05; 95% CI 0.94 to 1.17; 2 studies), acute vomiting (pooled RR 2.26; 95% CI 2.04 to 2.51; 3 studies), delayed nausea (pooled RR 1.13; 95% CI 0.93 to 1.38; 2 studies), and delayed vomiting (pooled RR 1.13; 95% CI 0.98 to 1.29; 2 studies). No other pooled analyses were possible.\nNarrative synthesis suggests that 5-HT3 antagonists are more effective than older antiemetic agents, even when these agents are combined with a steroid. Cannabinoids are probably effective but produce frequent side effects.\nAuthors' conclusions\nOur overall knowledge of the most effective antiemetics to prevent chemotherapy-induced nausea and vomiting in childhood is incomplete. Future research should be undertaken in consultation with children, young people, and families that have experienced chemotherapy and should make use of validated, age-appropriate measures. This review suggests that 5-HT3 antagonists are effective in patients who are to receive emetogenic chemotherapy, with granisetron or palonosetron possibly better than ondansetron. Adding dexamethasone improves control of vomiting, although the risk-benefit profile of adjunctive steroid remains uncertain.\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 only 34 properly randomised trials that had been undertaken in children, which examined 26 drug combinations. Trials tended to report vomiting rather than nausea, even though nausea is generally a more distressing experience. We could make no firm conclusions about which drugs are best, what dose of drug is most effective, or whether it is better to receive treatments orally (by mouth) or intravenously (injected). It seems that the 5-HT3 antagonists (the 'trons', for example ondansetron, granisetron, or tropisetron) are better than older agents, and that adding dexamethasone to these drugs makes them even more effective. Further research should consider what patients and families deem to be important, use established measures of nausea and vomiting, and attempt to use even newer techniques in the undertaking of reviews in order to maximise the information available."
}
] |
query-laysum
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23933
|
[
{
"role": "user",
"content": "Abstract: Background\nIdiopathic normal pressure hydrocephalus (iNPH) is a type of communicating hydrocephalus also known as non-obstructive hydrocephalus. This type of hydrocephalus is caused by impaired cerebrospinal fluid reabsorption without any obstruction in the ventricular system and is associated with normal cerebrospinal fluid pressure. It is characterised clinically by gait disturbance, cognitive dysfunction, and urinary incontinence (known as the Hakim-Adams triad). The exact cause of iNPH is unknown. It may be managed conservatively or treated surgically by inserting a ventriculoperitoneal (VP) or ventriculoatrial (VA) shunt. However, a substantial number of patients do not respond well to surgical treatment, complication rates are high and there is often a need for further surgery. Endoscopic third ventriculostomy (ETV) is an alternative surgical intervention. It has been suggested that ETV may lead to better outcomes, including fewer complications.\nObjectives\nTo determine the effectiveness of ETV for treatment of patients with iNPH compared to conservative therapy, or shunting of CSF using VP or VA shunts.\nTo assess the perioperative and postoperative complication rates in patients with iNPH after ETV compared to conservative therapy, VP or VA shunting.\nSearch methods\nWe searched for eligible studies using ALOIS: a comprehensive register of dementia studies, The Cochrane Central Register of Controlled Trials (CENTRAL) and several bibliographic databases such as MEDLINE (Ovid SP), EMBASE (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost) and LILACS (BIREME).\nWe also searched the Database of Abstracts of Reviews of Effects (DARE) to identify potentially relevant reviews. The search strategy was adapted for other databases, using the most appropriate controlled vocabulary for each. We did not apply any language or time restrictions. The searches were performed in August 2014.\nSelection criteria\nWe included randomised controlled trials (RCTs) of ETV treatment of iNPH. Patients had to have at least two symptoms of the Hakim-Adams triad. Exclusion criteria were obstructive causes of hydrocephalus, other significant intracranial pathology and other confirmed causes of dementia. The eligible comparators were conservative treatment or shunting using VP and VA shunts.\nData collection and analysis\nTwo review authors independently screened search results, selected eligible studies, assessed risk of bias and extracted data. We contacted trial authors for additional data.\nMain results\nOnly one study met the inclusion criteria: an RCT comparing effectiveness of ETV and non-programmable VP shunts in 42 patients with iNPH. The study was conducted in Brazil between 2009 and 2012. The overall study risk of bias was high. The primary outcome in the study was the proportion of patients with improved symptoms one year after surgery, determined as a change of at least two points on the Japanese NPH scale. Due to imprecision in the results, it was not possible to determine whether there was any difference between groups in the proportion of patients who improved 3 or 12 months after surgery (3 months: odds ration (OR) 1.12, 95% confidence interval (CI) 0.26 to 4.76, n = 42; 12 months: OR 2.5, 95% CI 0.62 to 10.11, n = 38). We were unable to estimate the effect of treatment on other efficacy outcomes (cognition, balance, function, gait and mobility) because they were inadequately reported. Of the 26 patients in the VP shunting group, 5 developed subdural hematoma postoperatively, while there were no complications among the 16 patients in the ETV group (OR 0.12, 95% CI 0.01 to 2.3, n = 42), but the estimate was too imprecise to determine whether this was likely to reflect a true difference in complication rates. This was also the case for rates of further surgical intervention (OR 1.4, 95% CI 0.31 to 6.24, n = 42). There were no deaths during the trial. We judged the quality of evidence for all outcomes to be very low because of a high risk of selection, attrition and reporting bias and serious imprecision in the results.\nAuthors' conclusions\nThe only randomised trial of ETV for iNPH compares it to an intervention which is not a standard practice (VP shunting using a non-programmable valve). The evidence from this study is inconclusive and of very low quality. Clinicians should be aware of the limitations of the evidence. There is a need for more robust research on this topic to be able to determine the effectiveness of ETV in patients with iNPH.\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": "We searched for trials which had been reported by August 2014. We were able to include only one RCT with 42 participants in the review. It compared ETV to insertion of a ventriculoperitoneal shunt, but unfortunately a type of shunt which is not often used in standard practice. We compared the numbers of patients whose symptoms improved with each treatment, but the result was too imprecise to allow us to draw a conclusion. In the shunting group, 19% of the patients had a surgical complication, while there were no complications in the ETV group. Due to the small number of participants, we could not be sure whether this was likely to reflect a true difference in complication rates."
}
] |
query-laysum
|
23934
|
[
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is a neurological disorder affecting both children and adults. Epileptic seizures are the result of excessive and abnormal cortical cell electrical activity in the brain. In response to criticism that epilepsy care for children has little impact on long-term outcomes, healthcare professionals and administrators have developed various service models and strategies to address perceived inadequacies.\nThis is an updated version of a Cochrane Review previously published in 2018.\nObjectives\nTo assess the effects of any specialised or dedicated intervention for epilepsy versus usual care in children and adolescents with epilepsy and their families.\nSearch methods\nWe searched the following databases on 14 January 2020: the Cochrane Register of Studies (CRS Web), MEDLINE (Ovid, 1946 to 13 January 2020), PsycINFO (1887 to 14 January 2020), CINAHL Plus (1937 to 14 January 2020), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. The Cochrane Register of Studies (CRS Web) includes the Cochrane Epilepsy Group Specialised Register and the Cochrane Central Register of Controlled Trials (CENTRAL). We also contacted experts in the field seeking information on unpublished and ongoing studies and checked the websites of epilepsy organisations and the reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials recruiting children and adolescents with epilepsy.\nData collection and analysis\nTwo review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: 1. Seizure frequency and severity; 2. Appropriateness and volume of medication prescribed (including evidence of drug toxicity); 3. Participants' reported knowledge of information and advice received from professionals; 4. Participants' reports of health and quality of life; 5. Objective measures of general health status; 6. Objective measures of social or psychological functioning (including the number of days spent on sick leave/absence from school or work, and employment status); and 7. Costs of care or treatment. The results of the data extraction and quality assessment for each study were presented in structured tables and as a narrative summary. All summary statistics were extracted for each outcome.\nMain results\nWe included nine studies of eight interventions in the review, reporting on seven distinct self-management programmes for educating or counselling children with epilepsy and their parents, and one new model of care. Based largely on self-reported outcomes, each programme showed some benefits for the well-being of children with epilepsy; however, all of the included studies had methodological flaws. No single programme was evaluated with different study samples, and in no instance was the same outcome measured and reported in the same way across studies, precluding any possible meta-analysis, even if the interventions were considered sufficiently similar to include in meta-analysis.\nWe chose the outcomes for which data might be important for decisions about the interventions as per guidance in the Cochrane Handbook for Systematic Reviews of Interventions. We found moderate certainty evidence that one of the educational interventions reduced seizure frequency. There was low certainty evidence that two other educational interventions reduced seizure severity, seizure control, and seizure cure rates. The evidence for all other outcomes (drug adherence, knowledge, self-efficacy and self-perception of epilepsy on quality of life) was mixed.\nAuthors' conclusions\nWhilst each of the programmes evaluated in this review showed some benefit to children with epilepsy, their impact was extremely variable. No programme showed benefits across the full range of outcomes, and all studies had methodological problems. There is currently insufficient evidence in favour of any single programme. Further evidence from randomised controlled trials using validated measures and considering clinical meaningfulness as well as statistical significance of results is required.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review compared seven education- or counselling-based self-management programmes for children and adolescents with epilepsy, plus one new way of delivering nursing care. Each strategy appeared to improve some of the outcomes studied, although no intervention improved all the outcomes that were measured. The studies also had problems with their methods, which made their results less reliable. Whilst none of the interventions caused any harm, their impact was limited. There is insufficient evidence to support any single strategy as the best one for children with epilepsy."
}
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query-laysum
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23935
|
[
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is an inherited life-limiting disorder. Over time persistent infection and inflammation within the lungs contribute to severe airway damage and loss of respiratory function. Chest physiotherapy, or airway clearance techniques (ACTs), are integral in removing airway secretions and initiated shortly after CF diagnosis. Conventional chest physiotherapy (CCPT) generally requires assistance, while alternative ACTs can be self-administered, facilitating independence and flexibility. This is an updated review.\nObjectives\nTo evaluate the effectiveness (in terms of respiratory function, respiratory exacerbations, exercise capacity) and acceptability (in terms of individual preference, adherence, quality of life) of CCPT for people with CF compared to alternative ACTs.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was 26 June 2022.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials (including cross-over design) lasting at least seven days and comparing CCPT with alternative ACTs in people with CF.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. pulmonary function tests and 2. number of respiratory exacerbations per year. Our secondary outcomes were 3. quality of life, 4. adherence to therapy, 5. cost–benefit analysis, 6. objective change in exercise capacity, 7. additional lung function tests, 8. ventilation scanning, 9. blood oxygen levels, 10. nutritional status, 11. mortality, 12. mucus transport rate and 13. mucus wet or dry weight.\nWe reported outcomes as short-term (seven to 20 days), medium-term (more than 20 days to up to one year) and long-term (over one year).\nMain results\nWe included 21 studies (778 participants) comprising seven short-term, eight medium-term and six long-term studies. Studies were conducted in the USA (10), Canada (five), Australia (two), the UK (two), Denmark (one) and Italy (one) with a median of 23 participants per study (range 13 to 166). Participant ages ranged from newborns to 45 years; most studies only recruited children and young people. Sixteen studies reported the sex of participants (375 males; 296 females).\nMost studies compared modifications of CCPT with a single comparator, but two studies compared three interventions and another compared four interventions. The interventions varied in the duration of treatments, times per day and periods of comparison making meta-analysis challenging. All evidence was very low certainty.\nNineteen studies reported the primary outcomes forced expiratory volume in one second (FEV1)and forced vital capacity (FVC), and found no difference in change from baseline in FEV1 % predicted or rate of decline between groups for either measure. Most studies suggested equivalence between CCPT and alternative ACTs, including positive expiratory pressure (PEP), extrapulmonary mechanical percussion, active cycle of breathing technique (ACBT), oscillating PEP devices (O-PEP), autogenic drainage (AD) and exercise. Where single studies suggested superiority of one ACT, these findings were not corroborated in similar studies; pooled data generally concluded that effects of CCPT were comparable to those of alternative ACTs.\nCCPT versus PEP\nWe are uncertain whether CCPT improves lung function or has an impact on the number of respiratory exacerbations per year compared with PEP (both very low-certainty evidence). There were no analysable data for our secondary outcomes, but many studies provided favourable narrative reports on the independence achieved with PEP mask therapy.\nCCPT versus extrapulmonary mechanical percussion\nWe are uncertain whether CCPT improves lung function compared with extrapulmonary mechanical percussions (very low-certainty evidence). The annual rate of decline in average forced expiratory flow between 25% and 75% of FVC (FEF25–75) was greater with high-frequency chest compression compared to CCPT in medium- to long-term studies, but there was no difference in any other outcome.\nCCPT versus ACBT\nWe are uncertain whether CCPT improves lung function compared to ACBT (very low-certainty evidence). Annual decline in FEF25–75 was worse in participants using the FET component of ACBT only (mean difference (MD) 6.00, 95% confidence interval (CI) 0.55 to 11.45; 1 study, 63 participants; very low-certainty evidence). One short-term study reported that directed coughing was as effective as CCPT for all lung function outcomes, but with no analysable data. One study found no difference in hospital admissions and days in hospital for exacerbations.\nCCPT versus O-PEP\nWe are uncertain whether CCPT improves lung function compared to O-PEP devices (Flutter device and intrapulmonary percussive ventilation); however, only one study provided analysable data (very low-certainty evidence). No study reported data for number of exacerbations. There was no difference in results for number of days in hospital for an exacerbation, number of hospital admissions and number of days of intravenous antibiotics; this was also true for other secondary outcomes.\nCCPT versus AD\nWe are uncertain whether CCPT improves lung function compared to AD (very low-certainty evidence). No studies reported the number of exacerbations per year; however, one study reported more hospital admissions for exacerbations in the CCPT group (MD 0.24, 95% CI 0.06 to 0.42; 33 participants). One study provided a narrative report of a preference for AD.\nCCPT versus exercise\nWe are uncertain whether CCPT improves lung function compared to exercise (very low-certainty evidence). Analysis of original data from one study demonstrated a higher FEV1 % predicted (MD 7.05, 95% CI 3.15 to 10.95; P = 0.0004), FVC (MD 7.83, 95% CI 2.48 to 13.18; P = 0.004) and FEF25–75 (MD 7.05, 95% CI 3.15 to 10.95; P = 0.0004) in the CCPT group; however, the study reported no difference between groups (likely because the original analysis accounted for baseline differences).\nAuthors' conclusions\nWe are uncertain whether CCPT has a more positive impact on respiratory function, respiratory exacerbations, individual preference, adherence, quality of life, exercise capacity and other outcomes when compared to alternative ACTs as the certainty of the evidence is very low.\nThere was no advantage in respiratory function of CCPT over alternative ACTs, but this may reflect insufficient evidence rather than real equivalence. Narrative reports indicated that participants prefer self-administered ACTs. This review is limited by a paucity of well-designed, adequately powered, long-term studies. This review cannot yet recommend any single ACT above others; physiotherapists and people with CF may wish to try different ACTs until they find an ACT that suits them best.\n\nGiven the provided abstract, please respond to the following query: \"What is cystic fibrosis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "CF is a life-limiting inherited disease affecting between 70,000 and 100,000 people worldwide. People with CF produce mucus in their lungs that can be thick, sticky and difficult to clear. This leads to repeated infections and lung damage. It is important to clear this mucus using medicines and various chest physiotherapy ACTs. CCPTs such as postural drainage, percussion and vibration, huffing and coughing have generally required assistance from someone else during treatments. Alternative ACTs such as active cycle of breathing techniques, forced expiration technique, autogenic drainage, positive expiratory pressure devices, oscillating positive expiratory pressure devices (e.g. Acapella, Aerobika, Flutter, RC-Cornet) or high-frequency chest compression and exercise are self-administered, which increases independence and flexibility."
}
] |
query-laysum
|
23936
|
[
{
"role": "user",
"content": "Abstract: Background\nProlonged treatment with benzodiazepines is common practice despite clinical recommendations of short-term use. Benzodiazepines are used by approximately 4% of the general population, with increased prevalence in psychiatric populations and the elderly. After long-term use it is often difficult to discontinue benzodiazepines due to psychological and physiological dependence. This review investigated if pharmacological interventions can facilitate benzodiazepine tapering.\nObjectives\nTo assess the benefits and harms of pharmacological interventions to facilitate discontinuation of chronic benzodiazepine use.\nSearch methods\nWe searched the following electronic databases up to October 2017: Cochrane Drugs and Alcohol Group's Specialised Register of Trials, CENTRAL, PubMed, Embase, CINAHL, and ISI Web of Science. We also searched ClinicalTrials.gov, the WHO ICTRP, and ISRCTN registry, and checked the reference lists of included studies for further references to relevant randomised controlled trials.\nSelection criteria\nWe included randomised controlled trials comparing pharmacological treatment versus placebo or no intervention or versus another pharmacological intervention in adults who had been treated with benzodiazepines for at least two months and/or fulfilled criteria for benzodiazepine dependence (any criteria).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 38 trials (involving 2543 participants), but we could only extract data from 35 trials with 2295 participants. Many different interventions were studied, and no single intervention was assessed in more than four trials. We extracted data on 18 different comparisons. The risk of bias was high in all trials but one. Trial Sequential Analysis showed imprecision for all comparisons.\nFor benzodiazepine discontinuation, we found a potential benefit of valproate at end of intervention (1 study, 27 participants; risk ratio (RR) 2.55, 95% confidence interval (CI) 1.08 to 6.03; very low-quality evidence) and of tricyclic antidepressants at longest follow-up (1 study, 47 participants; RR 2.20, 95% CI 1.27 to 3.82; low-quality evidence).\nWe found potentially positive effects on benzodiazepine withdrawal symptoms of pregabalin (1 study, 106 participants; mean difference (MD) -3.10 points, 95% CI -3.51 to -2.69; very low-quality evidence), captodiame (1 study, 81 participants; MD -1.00 points, 95% CI -1.13 to -0.87; very low-quality evidence), paroxetine (2 studies, 99 participants; MD -3.57 points, 95% CI -5.34 to -1.80; very low-quality evidence), tricyclic antidepressants (1 study, 38 participants; MD -19.78 points, 95% CI -20.25 to -19.31; very low-quality evidence), and flumazenil (3 studies, 58 participants; standardised mean difference -0.95, 95% CI -1.71 to -0.19; very low-quality evidence) at end of intervention. However, the positive effect of paroxetine on benzodiazepine withdrawal symptoms did not persist until longest follow-up (1 study, 54 participants; MD -0.13 points, 95% CI -4.03 to 3.77; very low-quality evidence).\nThe following pharmacological interventions reduced symptoms of anxiety at end of intervention: carbamazepine (1 study, 36 participants; MD -6.00 points, 95% CI -9.58 to -2.42; very low-quality evidence), pregabalin (1 study, 106 participants; MD -4.80 points, 95% CI -5.28 to -4.32; very low-quality evidence), captodiame (1 study, 81 participants; MD -5.70 points, 95% CI -6.05 to -5.35; very low-quality evidence), paroxetine (2 studies, 99 participants; MD -6.75 points, 95% CI -9.64 to -3.86; very low-quality evidence), and flumazenil (1 study, 18 participants; MD -1.30 points, 95% CI -2.28 to -0.32; very low-quality evidence).\nTwo pharmacological treatments seemed to reduce the proportion of participants that relapsed to benzodiazepine use: valproate (1 study, 27 participants; RR 0.31, 95% CI 0.11 to 0.90; very low-quality evidence) and cyamemazine (1 study, 124 participants; RR 0.33, 95% CI 0.14 to 0.78; very low-quality evidence). Alpidem decreased the proportion of participants with benzodiazepine discontinuation (1 study, 25 participants; RR 0.41, 95% CI 0.17 to 0.99; number needed to treat for an additional harmful outcome (NNTH) 2.3 participants; low-quality evidence) and increased the occurrence of withdrawal syndrome (1 study, 145 participants; RR 4.86, 95% CI 1.12 to 21.14; NNTH 5.9 participants; low-quality evidence). Likewise, magnesium aspartate decreased the proportion of participants discontinuing benzodiazepines (1 study, 144 participants; RR 0.80, 95% CI 0.66 to 0.96; NNTH 5.8; very low-quality evidence).\nGenerally, adverse events were insufficiently reported. Specifically, one of the flumazenil trials was discontinued due to severe panic reactions.\nAuthors' conclusions\nGiven the low or very low quality of the evidence for the reported outcomes, and the small number of trials identified with a limited number of participants for each comparison, it is not possible to draw firm conclusions regarding pharmacological interventions to facilitate benzodiazepine discontinuation in chronic benzodiazepine users. Due to poor reporting, adverse events could not be reliably assessed across trials. More randomised controlled trials are required with less risk of systematic errors ('bias') and of random errors ('play of chance') and better and full reporting of patient-centred and long-term clinical outcomes. Such trials ought to be conducted independently of industry involvement.\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 extracted data on 18 different comparisons in a total of 2295 participants. We are uncertain whether valproate and tricyclic antidepressants increase the chance of discontinuing benzodiazepines, and whether benzodiazepine withdrawal symptoms are reduced by pregabalin, captodiame, paroxetine, tricyclic antidepressants, and flumazenil, as we assessed the quality of the evidence as very low. We are uncertain as to whether symptoms of anxiety after withdrawal of benzodiazepines are reduced by carbamazepine, pregabalin, captodiame, paroxetine, and flumazenil, as we assessed the quality of the evidence as very low. The effects of the evaluated medications were too uncertain to inform clinical practice due to risk of bias (systematic errors with overestimation of benefits and underestimation of harms) and risk of chance occurrence (random errors giving any result). Tolerability and safety were poorly reported across the included studies, making it impossible to assess the balance between possible benefits and adverse effects. Consequently, no conclusions can be drawn about the effectiveness of the interventions."
}
] |
query-laysum
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23937
|
[
{
"role": "user",
"content": "Abstract: Background\nRed blood cell (RBC) transfusion is a common treatment for anaemia in many conditions. The safety and efficacy of transfusing RBC units that have been stored for different durations before a transfusion is a current concern. The duration of storage for a RBC unit can be up to 42 days. If evidence from randomised controlled trials (RCT) were to indicate that clinical outcomes are affected by storage duration, the implications for inventory management and clinical practice would be significant.\nObjectives\nTo assess the effects of using red blood cells (RBCs) stored for a shorter versus a longer duration, or versus RBCs stored for standard practice duration, in people requiring a RBC transfusion.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, PubMed (for epublications), LILACS, Transfusion Evidence Library, Web of Science CPCI-S and four international clinical trial registries on 20 November 2017.\nSelection criteria\nWe included RCTs that compared transfusion of RBCs of shorter versus longer storage duration, or versus standard practice storage duration.\nData collection and analysis\nWe used standard Cochrane methods.\nMain results\nWe included 22 trials (42,835 participants) in this review.\nThe GRADE quality of evidence ranged from very low to moderate for our primary outcome of in-hospital and short-term mortality reported at different time points.\nTransfusion of RBCs of shorter versus longer storage duration\nEleven trials (2249 participants) compared transfusion of RBCs of shorter versus longer storage duration. Two trials enrolled low birth weight neonates, two enrolled children with severe anaemia secondary to malaria or sickle cell disease, and eight enrolled adults across a range of clinical settings (intensive care, cardiac surgery, major elective surgery, hospitalised in-patients, haematology outpatients). We judged only two trials to be at low risk of bias across all domains; most trials had an unclear risk for multiple domains.\nTransfusion of RBCs of shorter versus longer storage duration probably leads to little or no difference in mortality at seven-day follow-up (risk ratio (RR) 1.42, 95% confidence interval (CI) 0.66 to 3.06; 1 trial, 3098 participants; moderate quality evidence) or 30-day follow-up (RR 0.85, 95%CI 0.50 to 1.45; 2 trials, 1121 participants; moderate quality evidence) in adults undergoing major elective cardiac or non-cardiac surgery.\nFor neonates, no studies reported on the primary outcome of in-hospital or short-term mortality. At 40 weeks gestational age, the effect of RBCs of shorter versus longer storage duration on the risk of death was uncertain, as the quality of evidence is very low (RR 0.90, 95% CI 0.41 to 1.85; 1 trial, 52 participants).\nThe effect of RBCs of shorter versus longer storage duration on the risk of death in children with severe anaemia was also uncertain within 24 hours of transfusion (RR 1.50, 95% CI 0.43 to 5.25; 2 trials, 364 participants; very low quality evidence), or at 30-day follow-up (RR 1.40, 95% CI 0.45 to 4.31; 1 trial, 290 participants; low quality evidence).\nOnly one trial, in children with severe anaemia (290 participants), reported adverse transfusion reactions. Only one child in each arm experienced an adverse reaction within 24 hours of transfusion.\nTransfusion of RBCs of shorter versus standard practice storage duration\nEleven trials (40,588 participants) compared transfusion of RBCs of shorter versus standard practice storage duration. Three trials enrolled critically ill term neonates; two of these enrolled very low birth weight neonates. There were no trials in children. Eight trials enrolled critically ill and non-critically ill adults, with most being hospitalised. We judged four trials to be at low risk of bias across all domains with the others having an unclear risk of bias across multiple domains.\nTransfusion of RBCs of shorter versus standard practice storage duration probably leads to little or no difference in adult in-hospital mortality (RR 1.05, 95% CI 0.97 to 1.14; 4 trials, 25,704 participants; moderate quality evidence), ICU mortality (RR 1.06, 95% CI 0.98 to 1.15; 3 trials, 13,066 participants; moderate quality evidence), or 30-day mortality (RR 1.04, 95% CI 0.96 to 1.13; 4 trials, 7510 participants;moderate quality evidence).\nTwo of the three trials that enrolled neonates reported that there were no adverse transfusion reactions. One trial reported an isolated case of cytomegalovirus infection in participants assigned to the standard practice storage duration group. Two trials in critically ill adults reported data on transfusion reactions: one observed no difference in acute transfusion reactions between arms (RR 0.67, 95% CI 0.19 to 2.36, 2413 participants), but the other observed more febrile nonhaemolytic reactions in the shorter storage duration arm (RR 1.48, 95% CI 1.13 to 1.95, 4919 participants).\nTrial sequential analysis showed that we may now have sufficient evidence to reject a 5% relative risk increase or decrease of death within 30 days when transfusing RBCs of shorter versus longer storage duration across all patient groups.\nAuthors' conclusions\nThe effect of storage duration on clinically important outcomes has now been investigated in large, high quality RCTs, predominantly in adults. There appears to be no evidence of an effect on mortality that is related to length of storage of transfused RBCs. However, the quality of evidence in neonates and children is low. The current practice in blood banks of using the oldest available RBCs can be continued safely. Additional RCTs are not required, but research using alternative study designs, should focus on particular subgroups (e.g. those requiring multiple RBC units) and on factors affecting RBC quality.\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 people needing a blood transfusion, is it better to give blood that has been stored for a shorter time compared to a longer time?"
}
] |
query-laysum
|
23938
|
[
{
"role": "user",
"content": "Abstract: Background\nIdentification of the causes of stillbirth is critical to the primary prevention of stillbirth and to the provision of optimal care in subsequent pregnancies. A wide variety of investigations are available, but there is currently no consensus on the optimal approach. Given their cost and potential to add further emotional burden to parents, there is a need to systematically assess the effect of these interventions on outcomes for parents, including psychosocial outcomes, economic costs, and on rates of diagnosis of the causes of stillbirth.\nObjectives\nTo assess the effect of different tests, protocols or guidelines for investigating and identifying the causes of stillbirth on outcomes for parents, including psychosocial outcomes, economic costs, and rates of diagnosis of the causes of stillbirth.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 May 2017).\nSelection criteria\nWe planned to include randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs. We planned to include studies published as abstract only, provided there was sufficient information to allow us to assess study eligibility. We planned to exclude cross-over trials.\nParticipants included parents (including mothers, fathers, and partners) who had experienced a stillbirth of 20 weeks' gestation or greater.\nThis review focused on interventions for investigating and identifying the causes of stillbirth. Such interventions are likely to be diverse, but could include:\n* review of maternal and family history, and current pregnancy and birth history;\n* clinical history of present illness;\n* maternal investigations (such as ultrasound, amniocentesis, antibody screening, etc.);\n* examination of the stillborn baby (including full autopsy, partial autopsy or noninvasive components, such as magnetic resonance imaging (MRI), computerised tomography (CT) scanning, and radiography);\n* umbilical cord examination;\n* placental examination including histopathology (microscopic examination of placental tissue); and\n* verbal autopsy (interviews with care providers and support people to ascertain causes, without examination of the baby).\nWe planned to include trials assessing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth, compared with the absence of a test, protocol or guideline, or usual care (further details are presented in the Background, see Description of the intervention).\nWe also planned to include trials comparing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth with another, for example, the use of a limited investigation protocol compared with a comprehensive investigation protocol.\nData collection and analysis\nTwo review authors assessed trial eligibility independently.\nMain results\nWe excluded five studies that were not RCTs. There were no eligible trials for inclusion in this review.\nAuthors' conclusions\nThere is currently a lack of RCT evidence regarding the effectiveness of interventions for investigating and identifying the causes of stillbirth. Seeking to determine the causes of stillbirth is an essential component of quality maternity care, but it remains unclear what impact these interventions have on the psychosocial outcomes of parents and families, the rates of diagnosis of the causes of stillbirth, and the care and management of subsequent pregnancies following stillbirth. Due to the absence of trials, this review is unable to inform clinical practice regarding the investigation of stillbirths, and the specific investigations that would determine the causes.\nFuture RCTs addressing this research question would be beneficial, but the settings in which the trials take place, and their design, need to be given careful consideration. Trials need to be conducted with the utmost care and consideration for the needs, concerns, and values of parents and families. Assessment of longer-term psychosocial variables, economic costs to health services, and effects on subsequent pregnancy care and outcomes should also be considered in any future trials.\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 no evidence available to guide how best to investigate the causes of stillbirth. Seeking to determine the causes of a baby's death is an essential component of quality maternity care in any setting. Future trials on this topic would be helpful, but such trials would need to be designed in a way that ensures all parents in the trial still receive the minimum standard of care in their local setting. Future trials would need to be conducted with the utmost care and consideration for the needs, concerns, and values of parents and families. Assessment of longer-term psychosocial variables, economic costs to health services, and effects on subsequent pregnancy care and outcomes should be considered in any future trials."
}
] |
query-laysum
|
23939
|
[
{
"role": "user",
"content": "Abstract: Background\nMany women experience perineal pain after childbirth, especially after having sustained perineal trauma. Perineal pain-management strategies are an important part of postnatal care. Non-steroidal anti-inflammatory drugs (NSAIDs) are a commonly-used type of medication in the management of postpartum pain, and their effectiveness and safety should be assessed. This is an update of a review first published in 2016.\nObjectives\nTo determine the effectiveness of a single dose of an oral NSAID for relief of acute perineal pain in the early postpartum period.\nSearch methods\nFor this update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (9 December 2019), OpenSIGLE and ProQuest Dissertations and Theses (28 February 2020), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) assessing a single dose of a NSAID versus a single dose of placebo, paracetamol or another NSAID for women with perineal pain in the early postpartum period. We excluded quasi-RCTs and cross-over trials. We included papers in abstract format only if they had sufficient information to determine that they met the review’s prespecified inclusion criteria.\nData collection and analysis\nTwo review authors (FW and VS) independently assessed all identified papers for inclusion and risks of bias, resolving any discrepancies through discussion. Two review authors independently conducted data extraction, including calculations of pain relief scores, and checked it for accuracy. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 35 studies examining 16 different NSAIDs and involving 5136 women (none were breastfeeding). Studies were published between 1967 and 2013. Risk of bias due to random sequence generation, allocation concealment and blinding of outcome assessors was generally unclearly to poorly reported, but participants and caregivers were blinded, and outcome data were generally complete. We downgraded the certainty of evidence due to risk of bias, suspected publication bias, and imprecision for small numbers of participants.\nNSAID versus placebo\nCompared to women who receive a placebo, more women who receive a single-dose NSAID may achieve adequate pain relief at four hours (risk ratio (RR) 1.91, 95% confidence interval (CI) 1.64 to 2.23; 10 studies, 1573 women; low-certainty evidence) and at six hours (RR 1.92, 95% CI 1.69 to 2.17; 17 studies, 2079 women; very low-certainty evidence), although we are less certain about the effects at six hours. At four hours after administration, women who receive a NSAID are probably less likely to needadditional analgesia compared to women who receive placebo (RR 0.39, 95% CI 0.26 to 0.58; 4 studies, 486 women; moderate-certainty evidence) and may be less likely to need additional analgesia at six hours after initial administration, although the evidence was less certain at six hours (RR 0.32, 95% CI 0.26 to 0.40; 10 studies, 1012 women; very low-certainty evidence).\nOne study reported that no adverse events were observed at four hours post-administration (90 women). There may be little or no difference in maternal adverse effects between NSAIDs and placebo at six hours post-administration (RR 1.38, 95% CI 0.71 to 2.70; 13 studies, 1388 women; low-certainty evidence). Fourteen maternal adverse effects were reported in the NSAID group (drowsiness (5), abdominal discomfort (2), weakness (1), dizziness (2), headache (2), moderate epigastralgia (1), not specified (1)) and eight in the placebo group (drowsiness (2), light-headedness (1), nausea (1), backache (1), dizziness (1), epigastric pain (1), not specified (1)), although not all studies assessed adverse effects. Neonatal adverse effects were not assessed in any of the studies.\nNSAID versus paracetamol\nNSAIDs may lead to more women achieving adequate pain relief at four hours, compared with paracetamol (RR 1.54, 95% CI 1.07 to 2.22; 3 studies, 342 women; low-certainty evidence). We are uncertain if there is any difference in adequate pain relief between NSAIDs and paracetamol at six hours post-administration (RR 1.82, 95% CI 0.61 to 5.47; 2 studies, 99 women; very low-certainty evidence) or in the need foradditional analgesia at four hours (RR 0.55, 95% CI 0.27 to 1.13; 1 study, 73 women; very low-certainty evidence). NSAIDs may reduce the risk of requiring additional analgesia at six hours compared with paracetamol (RR 0.28, 95% CI 0.12 to 0.67; 1 study, 59 women; low-certainty evidence).\nOne study reported that no maternal adverse effects were observed at four hours post-administration (210 women). Six hours post-administration, we are uncertain if there is any difference between groups in the number of maternal adverse effects (RR 0.74, 95% CI 0.27 to 2.08; 3 studies, 300 women; very low-certainty evidence), with one case of pruritis in the NSAID group and one case of sleepiness in the paracetamol group. Neonatal adverse effects were not assessed in any of the included studies.\nComparisons of different NSAIDs or doses did not demonstrate any differences in effectiveness for any primary outcome measures; however, few data were available on some NSAIDs.\nNone of the included studies reported on any of this review's secondary outcomes.\nAuthors' conclusions\nIn women who are not breastfeeding and who sustained perineal trauma, NSAIDs (compared to placebo or paracetamol) may provide greater pain relief for acute postpartum perineal pain and fewer women need additional analgesia, but uncertainty remains, as the evidence is rated as low- or very low-certainty. The risk of bias was unclear for many studies, adverse effects were often not assessed and breastfeeding women were not included. While this review provides some indication of the likely effect, there is uncertainty in our conclusions. The main reasons for downgrading were the inclusion of studies at high risk of bias and inconsistency in the findings of individual studies.\nFuture studies could examine NSAIDs' adverse effects, including neonatal effects and the compatibility of NSAIDs with breastfeeding, and could assess other secondary outcomes. Future research could consider women with and without perineal trauma, including perineal tears. High-quality studies could be conducted to further assess the efficacy of NSAIDs versus paracetamol and the efficacy of multimodal treatments.\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"
},
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"role": "assistant",
"content": "Following childbirth, many women experience pain in the perineum, an area between the anus and vagina. This Cochrane Review asked if this pain can be reduced by one dose of a non-steroidal anti-inflammatory drug (NSAID), such as aspirin or ibuprofen."
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query-laysum
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23940
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"role": "user",
"content": "Abstract: Background\nFluoxetine is a serotonin reuptake inhibitor indicated for major depression. It is also thought to affect weight control: this seems to happen through appetite changes resulting in decreased food intake and normalisation of unusual eating behaviours. However, the benefit-risk ratio of this off-label medication is unclear.\nObjectives\nTo assess the effects of fluoxetine for overweight or obese adults.\nSearch methods\nWe searched the Cochrane Library, MEDLINE, Embase, LILACS, the ICTRP Search Portal and ClinicalTrials.gov and World Health Organization (WHO) ICTRP Search Portal. The last date of the search was December 2018 for all databases, to which we applied no language restrictions .\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing the administration of fluoxetine versus placebo, other anti-obesity agents, non-pharmacological therapy or no treatment in overweight or obese adults without depression, mental illness or abnormal eating patterns.\nData collection and analysis\nTwo review authors independently screened abstracts and titles for relevance. Screening for inclusion, data extraction and risk of bias assessment was performed by one author and checked by the second. We assessed trials for the overall certainty of the evidence using the GRADE instrument. For additional information we contacted trial authors by email. We performed random-effects meta-analyses and calculated the risk ratio (RR) with 95% confidence intervals (95% CI) for dichotomous outcomes and the mean difference (MD) with 95% CI for continuous outcomes.\nMain results\nWe identified 1036 records, scrutinized 52 full-text articles and included 19 completed RCTs (one trial is awaiting assessment). A total of 2216 participants entered the trials, 1280 participants were randomly assigned to fluoxetine (60 mg/d, 40 mg/d, 20 mg/d and 10 mg/d) and 936 participants were randomly assigned to various comparison groups (placebo; the anti-obesity agents diethylpropion, fenproporex, mazindol, sibutramine, metformin, fenfluramine, dexfenfluramine, fluvoxamine, 5-hydroxy-tryptophan; no treatment; and omega-3 gel). Within the 19 RCTs there were 56 trial arms. Fifteen trials were parallel RCTs and four were cross-over RCTs. The participants in the included trials were followed up for periods between three weeks and one year. The certainty of the evidence was low or very low: the majority of trials had a high risk of bias in one or more of the risk of bias domains.\nFor our main comparison group — fluoxetine versus placebo — and across all fluoxetine dosages and durations of treatment, the MD was −2.7 kg (95% CI −4 to −1.4; P < 0.001; 10 trials, 956 participants; low-certainty evidence). The 95% prediction interval ranged between −7.1 kg and 1.7 kg. The MD in body mass index (BMI) reduction across all fluoxetine dosages compared with placebo was −1.1 kg/m² (95% CI −3.7 to 1.4; 3 trials, 97 participants; very low certainty evidence). Only nine placebo-controlled trials reported adverse events. A total of 399 out of 627 participants (63.6%) receiving fluoxetine compared with 352 out of 626 participants (56.2%) receiving placebo experienced an adverse event. Random-effects meta-analysis showed an increase in the risk of having at least one adverse event of any type in the fluoxetine groups compared with placebo (RR 1.18, 95% CI 0.99 to 1.42; P = 0.07; 9 trials, 1253 participants; low-certainty evidence). The 95% prediction interval ranged between 0.74 and 1.88. Following fluoxetine treatment the adverse events of dizziness, drowsiness, fatigue, insomnia and nausea were observed approximately twice as often compared to placebo. A total of 15 out of 197 participants (7.6%) receiving fluoxetine compared with 12 out of 196 participants (6.1%) receiving placebo experienced depression. The RR across all fluoxetine doses compared with placebo was 1.20 (95% CI 0.57 to 2.52; P = 0.62; 3 trials, 393 participants; very low certainty evidence). All-cause mortality, health-related quality of life and socioeconomic effects were not reported.\nThe comparisons of fluoxetine with other anti-obesity agents (3 trials, 234 participants), omega-3 gel (1 trial, 48 participants) and no treatment (1 trial, 60 participants) showed inconclusive results (very low certainty evidence).\nAuthors' conclusions\nLow-certainty evidence suggests that off-label fluoxetine may decrease weight compared with placebo. However, low-certainty evidence suggests an increase in the risk for dizziness, drowsiness, fatigue, insomnia and nausea following fluoxetine treatment.\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": "Fluoxetine is a medicine used for the treatment of depression, which reduces appetite as a side effect. Therefore, it is suspected that fluoxetine could be used as a treatment for overweight or obese people. In this group of people administration of fluoxetine means an off-label treatment which means it is not licensed for treating obesity."
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23941
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"role": "user",
"content": "Abstract: Background\nConvalescent plasma may reduce mortality in patients with viral respiratory diseases, and is being investigated as a potential therapy for coronavirus disease 2019 (COVID-19). A thorough understanding of the current body of evidence regarding benefits and risks of this intervention is required.\nObjectives\nTo assess the effectiveness and safety of convalescent plasma transfusion in the treatment of people with COVID-19; and to maintain the currency of the evidence using a living systematic review approach.\nSearch methods\nTo identify completed and ongoing studies, we searched the World Health Organization (WHO) COVID-19 Global literature on coronavirus disease Research Database, MEDLINE, Embase, Cochrane COVID-19 Study Register, and the Epistemonikos COVID-19 L*OVE Platform. We searched monthly until 03 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating convalescent plasma for COVID-19, irrespective of disease severity, age, gender or ethnicity.\nWe excluded studies that included populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)), as well as studies evaluating standard immunoglobulin.\nData collection and analysis\nWe followed standard Cochrane methodology.\nTo assess bias in included studies we used RoB 2. We used the GRADE approach to rate the certainty of evidence for the following outcomes: all-cause mortality at up to day 28, worsening and improvement of clinical status (for individuals with moderate to severe disease), hospital admission or death, COVID-19 symptoms resolution (for individuals with mild disease), quality of life, grade 3 or 4 adverse events, and serious adverse events.\nMain results\nIn this fourth review update version, we included 33 RCTs with 24,861 participants, of whom 11,432 received convalescent plasma. Of these, nine studies are single-centre studies and 24 are multi-centre studies. Fourteen studies took place in America, eight in Europe, three in South-East Asia, two in Africa, two in western Pacific and three in eastern Mediterranean regions and one in multiple regions. We identified a further 49 ongoing studies evaluating convalescent plasma, and 33 studies reporting as being completed.\nIndividuals with a confirmed diagnosis of COVID-19 and moderate to severe disease\n29 RCTs investigated the use of convalescent plasma for 22,728 participants with moderate to severe disease. 23 RCTs with 22,020 participants compared convalescent plasma to placebo or standard care alone, five compared to standard plasma and one compared to human immunoglobulin. We evaluate subgroups on detection of antibodies detection, symptom onset, country income groups and several co-morbidities in the full text.\nConvalescent plasma versus placebo or standard care alone\nConvalescent plasma does not reduce all-cause mortality at up to day 28 (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.92 to 1.03; 220 per 1000; 21 RCTs, 19,021 participants; high-certainty evidence). It has little to no impact on need for invasive mechanical ventilation, or death (RR 1.03, 95% CI 0.97 to 1.11; 296 per 1000; 6 RCTs, 14,477 participants; high-certainty evidence) and has no impact on whether participants are discharged from hospital (RR 1.00, 95% CI 0.97 to 1.02; 665 per 1000; 6 RCTs, 12,721 participants; high-certainty evidence). Convalescent plasma may have little to no impact on quality of life (MD 1.00, 95% CI −2.14 to 4.14; 1 RCT, 483 participants; low-certainty evidence). Convalescent plasma may have little to no impact on the risk of grades 3 and 4 adverse events (RR 1.17, 95% CI 0.96 to 1.42; 212 per 1000; 6 RCTs, 2392 participants; low-certainty evidence). It has probably little to no effect on the risk of serious adverse events (RR 1.14, 95% CI 0.91 to 1.44; 135 per 1000; 6 RCTs, 3901 participants; moderate-certainty evidence).\nConvalescent plasma versus standard plasma\nWe are uncertain whether convalescent plasma reduces or increases all-cause mortality at up to day 28 (RR 0.73, 95% CI 0.45 to 1.19; 129 per 1000; 4 RCTs, 484 participants; very low-certainty evidence). We are uncertain whether convalescent plasma reduces or increases the need for invasive mechanical ventilation, or death (RR 5.59, 95% CI 0.29 to 108.38; 311 per 1000; 1 study, 34 participants; very low-certainty evidence) and whether it reduces or increases the risk of serious adverse events (RR 0.80, 95% CI 0.55 to 1.15; 236 per 1000; 3 RCTs, 327 participants; very low-certainty evidence). We did not identify any study reporting other key outcomes.\nConvalescent plasma versus human immunoglobulin\nConvalescent plasma may have little to no effect on all-cause mortality at up to day 28 (RR 1.07, 95% CI 0.76 to 1.50; 464 per 1000; 1 study, 190 participants; low-certainty evidence). We did not identify any study reporting other key outcomes.\nIndividuals with a confirmed diagnosis of SARS-CoV-2 infection and mild disease\nWe identified two RCTs reporting on 536 participants, comparing convalescent plasma to placebo or standard care alone, and two RCTs reporting on 1597 participants with mild disease, comparing convalescent plasma to standard plasma.\nConvalescent plasma versus placebo or standard care alone\nWe are uncertain whether convalescent plasma reduces all-cause mortality at up to day 28 (odds ratio (OR) 0.36, 95% CI 0.09 to 1.46; 8 per 1000; 2 RCTs, 536 participants; very low-certainty evidence). It may have little to no effect on admission to hospital or death within 28 days (RR 1.05, 95% CI 0.60 to 1.84; 117 per 1000; 1 RCT, 376 participants; low-certainty evidence), on time to COVID-19 symptom resolution (hazard ratio (HR) 1.05, 95% CI 0.85 to 1.30; 483 per 1000; 1 RCT, 376 participants; low-certainty evidence), on the risk of grades 3 and 4 adverse events (RR 1.29, 95% CI 0.75 to 2.19; 144 per 1000; 1 RCT, 376 participants; low-certainty evidence) and the risk of serious adverse events (RR 1.14, 95% CI 0.66 to 1.94; 133 per 1000; 1 RCT, 376 participants; low-certainty evidence). We did not identify any study reporting other key outcomes.\nConvalescent plasma versus standard plasma\nWe are uncertain whether convalescent plasma reduces all-cause mortality at up to day 28 (OR 0.30, 95% CI 0.05 to 1.75; 2 per 1000; 2 RCTs, 1597 participants; very low-certainty evidence). It probably reduces admission to hospital or death within 28 days (RR 0.49, 95% CI 0.31 to 0.75; 36 per 1000; 2 RCTs, 1595 participants; moderate-certainty evidence). Convalescent plasma may have little to no effect on initial symptom resolution at up to day 28 (RR 1.12, 95% CI 0.98 to 1.27; 1 RCT, 416 participants; low-certainty evidence). We did not identify any study reporting other key outcomes.\nThis is a living systematic review. We search monthly for new evidence and update the review when we identify relevant new evidence.\nAuthors' conclusions\nFor the comparison of convalescent plasma versus placebo or standard care alone, our certainty in the evidence that convalescent plasma for individuals with moderate to severe disease does not reduce mortality and has little to no impact on clinical improvement or worsening is high. It probably has little to no effect on SAEs. For individuals with mild disease, we have very-low to low certainty evidence for most primary outcomes and moderate certainty for hospital admission or death. There are 49 ongoing studies, and 33 studies reported as complete in a trials registry. Publication of ongoing studies might resolve some of the uncertainties around convalescent plasma therapy for people with asymptomatic or mild disease.\n\nGiven the provided abstract, please respond to the following query: \"People with moderate to severe COVID-19\". 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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23942
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[
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"role": "user",
"content": "Abstract: Background\nFracture of the distal radius is a common clinical problem. A key method of surgical fixation is percutaneous pinning, involving the insertion of wires through the skin to stabilise the fracture. This is an update of a Cochrane Review published in 2007.\nObjectives\nTo assess the effects (benefits and harms) of percutaneous pinning versus cast immobilisation alone and of different methods and techniques of percutaneous pinning, modalities or duration of immobilisation after pinning, and methods or timing of pin or wire removal for treating fractures of the distal radius in adults. Our primary focus was on dorsally displaced fractures.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, trial registers, conference proceedings and reference lists of articles up to June 2019.\nSelection criteria\nRandomised or quasi-randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared percutaneous pinning with non-surgical treatment or different aspects of percutaneous pinning. Our main outcomes were patient-reported function at the short term (up to three months), medium term (three up to 12 months) and long term (greater than 12 months); overall numbers of participants with complications requiring secondary treatment and any complication; grip strength and health-related quality of life at 12 months.\nData collection and analysis\nAt least two review authors independently performed study screening and selection, 'Risk of bias' assessment and data extraction. We pooled data where appropriate and used GRADE for assessing the quality of evidence for each outcome.\nMain results\nWe included 21 randomised controlled trials (RCTs) and five quasi-RCTs, involving 1946 generally older and female adults with dorsally displaced and potentially or evidently unstable distal radial fractures. Trial populations varied but the majority of studies reported mean ages in the sixth decade or older. All trials were at high risk of bias, invariably performance bias - which for most trials reflected the impracticality of blinding care providers or participants to treatment allocation - and often detection bias and selective reporting bias. Allocation concealment was secure in one trial only. All trials reported outcomes incompletely. The studies tested one of 10 comparisons. In the following, we report on those of the main outcomes for which evidence was available. No subgroup analysis, such as by pinning methods, was viable.\nEleven heterogeneous trials involving 917 participants compared percutaneous pinning with plaster cast immobilisation after closed reduction of the fracture. The quality of the evidence was very low for all reported outcomes. Thus, we are uncertain if percutaneous pinning compared with plaster cast alone makes any difference to patient-reported function, measured using the DASH questionnaire, at six weeks or six months (incomplete data from one trial). Overall numbers of participants with complications were not reported. Redisplacement resulting in secondary treatment occurred on average in 12% (range 3.3% to 75%) of participants treated by cast alone (six trials) whereas pin tract infection requiring antibiotics and, often, early wire removal, occurred on average in 7.7% (range 0% to 15%) of pinning group participants (seven trials). We are uncertain whether pinning makes a difference to the incidence of complex regional pain syndrome, reported in four studies. Although two studies found finger stiffness after cast removal was less common after pinning (20% versus 36%), the treatment implications were not reported. Other reported complications were mainly surgery-related. Based on incomplete data or qualitative statements from only four studies, we are uncertain of the effects of pinning on grip strength at 12 months. We are uncertain if percutaneous pinning compared with plaster cast alone makes any difference to patient-reported quality of life at four months (one study).\nFive comparisons of different pinning methods were made by six trials in all. One of these trials, which reported results for 96 participants, compared Kapandji intrafocal pinning (2 or 3 wires) with early mobilisation versus trans-styloid fixation (2 wires) with six weeks cast immobilisation. We are uncertain whether Kapandji pinning slightly increases the risk of superficial radial nerve symptoms or complex regional pain syndrome, or whether it makes a difference in grip strength at 12 months (very low-quality evidence).\nTwo small trials using two distinct pinning techniques compared biodegradable pins versus metal pins in 70 participants. Although very low-quality evidence, the extra demands at surgery of insertion of biodegradable pins and excess of serious complications (e.g. severe osteolytic reactions) associated with biodegradable material are important findings.\nThree poorly-reported trials involving 168 participants compared burying of wire ends versus leaving them exposed. We are uncertain whether burying of wires reduces the incidence of superficial infection (very low-quality evidence). There is low-quality evidence that burying of wires may be associated with a higher risk of requiring more invasive treatment for wire removal.\nFour small trials compared different types or duration of postoperative immobilisation. Very low-quality evidence of small between-group differences in individual complications and grip strength at 17 weeks, means we are uncertain of the effects of positioning the wrist in dorsiflexion versus palmar flexion during cast immobilisation following pinning of redisplaced fractures (one trial; 60 participants). Three small heterogeneous trials compared cast immobilisation for one week (early mobilisation) versus four or six weeks after percutaneous pinning in 170 people. Although we note one trial using Kapandji pinning reported more complications in the early group, the very low-quality evidence means there is uncertainty of the effects of early mobilisation on overall and individual complications, or grip strength at 12 months.\nNo trials tested different methods for, or timing of, pin/wire removal.\nAuthors' conclusions\nOverall, there is insufficient RCT evidence to inform on the role of percutaneous pinning versus cast immobilisation alone or associated treatment decisions such as method of pinning, burying or not of wire ends, wrist position and duration of immobilisation after pinning. Although very low-quality evidence, the serious complications associated with biodegradable materials is noteworthy. We advise waiting on the results of a large ongoing study comparing pinning with plaster cast treatment as these could help inform future research.\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": "The review concluded that there is insufficient evidence to inform on the role of percutaneous pinning and associated treatment decisions. While further research is needed, we advise waiting on the results of a large ongoing study comparing pinning with plaster cast treatment."
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query-laysum
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23943
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[
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"role": "user",
"content": "Abstract: Background\nHepatitis C virus (HCV) is a single-stranded RNA (ribonucleic acid) virus that has the potential to cause inflammation of the liver. The traditional definition of acute HCV infection is the first six months following infection with the virus. Another commonly used definition of acute HCV infection is the absence of HCV antibody and subsequent seroconversion (presence of HCV antibody in a person who was previously negative for HCV antibody). Approximately 40% to 95% of people with acute HCV infection develop chronic HCV infection, that is, have persistent HCV RNA in their blood. In 2010, an estimated 160 million people worldwide (2% to 3% of the world's population) had chronic HCV infection. The optimal pharmacological treatment of acute HCV remains controversial. Chronic HCV infection can damage the liver.\nObjectives\nTo assess the comparative benefits and harms of different pharmacological interventions in the treatment of acute HCV infection through a network meta-analysis and to generate rankings of the available pharmacological treatments according to their safety and efficacy. However, it was not possible to assess whether the potential effect modifiers were similar across different comparisons. Therefore, we did not perform the network meta-analysis and instead we assessed the comparative benefits and harms of different interventions versus each other or versus no intervention using standard Cochrane methodology.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, World Health Organization International Clinical Trials Registry Platform, and randomised controlled trials registers to April 2016 to identify randomised clinical trials on pharmacological interventions for acute HCV infection.\nSelection criteria\nWe included only randomised clinical trials (irrespective of language, blinding, or publication status) in participants with acute HCV infection. We excluded trials which included previously liver transplanted participants and those with other coexisting viral diseases. We considered any of the various pharmacological interventions compared with placebo or each other.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We calculated the odds ratio (OR) and rate ratio with 95% confidence intervals (CI) using both fixed-effect and random-effects models based on the available-participant analysis with Review Manager 5. We assessed risk of bias according to Cochrane, controlled risk of random errors with Trial Sequential Analysis, and assessed the quality of the evidence using GRADE.\nMain results\nWe identified 10 randomised clinical trials with 488 randomised participants that met our inclusion criteria. All the trials were at high risk of bias in one or more domains. Overall, the evidence for all the outcomes was very low quality evidence. Nine trials (467 participants) provided information for one or more outcomes. Three trials (99 participants) compared interferon-alpha versus no intervention. Three trials (90 participants) compared interferon-beta versus no intervention. One trial (21 participants) compared pegylated interferon-alpha versus no intervention, but it did not provide any data for analysis. One trial (41 participants) compared MTH-68/B vaccine versus no intervention. Two trials (237 participants) compared pegylated interferon-alpha versus pegylated interferon-alpha plus ribavirin. None of the trials compared direct-acting antivirals versus placebo or other interventions. The mean or median follow-up period in the trials ranged from six to 36 months.\nThere was no short-term mortality (less than one year) in any group in any trial except for one trial where one participant died in the pegylated interferon-alpha plus ribavirin group (1/95: 1.1%). In the trials that reported follow-up beyond one year, there were no further deaths. The number of serious adverse events was higher with pegylated interferon-alpha plus ribavirin than with pegylated interferon-alpha (rate ratio 2.74, 95% CI 1.40 to 5.33; participants = 237; trials = 2; I2 = 0%). The proportion of people with any adverse events was higher with interferon-alpha and interferon-beta compared with no intervention (OR 203.00, 95% CI 9.01 to 4574.81; participants = 33; trials = 1 and OR 27.88, 95% CI 1.48 to 526.12; participants = 40; trials = 1). None of the trials reported health-related quality of life, liver transplantation, decompensated liver disease, cirrhosis, or hepatocellular carcinoma. The proportion of people with chronic HCV infection as indicated by the lack of sustained virological response was lower in the interferon-alpha group versus no intervention (OR 0.27, 95% CI 0.09 to 0.76; participants = 99; trials = 3; I2 = 0%). The differences between the groups were imprecise or not estimable (because neither group had any events) for all the remaining comparisons.\nFour of the 10 trials (40%) received financial or other assistance from pharmaceutical companies who would benefit from the findings of the research; the source of funding was not available in five trials (50%), and one trial (10%) was funded by a hospital.\nAuthors' conclusions\nVery low quality evidence suggests that interferon-alpha may decrease the incidence of chronic HCV infection as measured by sustained virological response. However, the clinical impact such as improvement in health-related quality of life, reduction in cirrhosis, decompensated liver disease, and liver transplantation has not been reported. It is also not clear whether this finding is applicable in the current clinical setting dominated by the use of pegylated interferons and direct-acting antivirals, although we found no evidence to support that pegylated interferons or ribavirin or both are effective in people with acute HCV infection. We could find no randomised trials comparing direct-acting antivirals with placebo or other interventions for acute HCV infection. There is significant uncertainty in the benefits and harms of the interventions, and high-quality randomised clinical trials are required.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "No deaths occurred less than one year after treatment in any group in any trial except for one trial where one participant died in the pegylated interferon-alpha plus ribavirin group (1/95: 1.1%). In the trials in which participants were followed up beyond one year, there were no further deaths. The number of serious complications was higher with pegylated interferon-alpha plus ribavirin than with pegylated interferon-alpha. The percentage of people with any complications was higher with interferon-alpha and interferon-beta than with no intervention. None of the trials reported health-related quality of life, liver transplantation, liver failure, severe liver damage, or liver cancer. The percentage of people in whom the virus remained in the blood six months after the end of treatment was lower in the interferon-alpha than in the no intervention groups. There was no evidence of differences between the groups for all the remaining comparisons. There is significant uncertainty about the size and direction of the results and high quality randomised clinical trials are required."
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query-laysum
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23944
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{
"role": "user",
"content": "Abstract: Background\nThe number of new cases of dementia is projected to rise significantly over the next decade. Thus, there is a pressing need for accurate tools to detect cognitive impairment in routine clinical practice. The Addenbrooke's Cognitive Examination III (ACE-III), and the mini-ACE are brief, bedside cognitive screens that have previously reported good sensitivity and specificity. The quality and quantity of this evidence has not, however, been robustly investigated.\nObjectives\nTo assess the diagnostic test accuracy of the ACE-III and mini-ACE for the detection of dementia, dementia sub-types, and mild cognitive impairment (MCI) at published thresholds in primary, secondary, and community care settings in patients presenting with, or at high risk of, cognitive decline.\nSearch methods\nWe performed the search for this review on 13 February 2019. We searched MEDLINE (OvidSP), Embase (OvidSP), BIOSIS Previews (ISI Web of Knowledge), Web of Science Core Collection (ISI Web of Knowledge), PsycINFO (OvidSP), and LILACS (BIREME). We applied no language or date restrictions to the electronic searches; and to maximise sensitivity we did not use methodological filters. The search yielded 5655 records, of which 2937 remained after we removed duplicates. We identified a further four articles through PubMed 'related articles'. We found no additional records through reference list citation searching, or grey literature.\nSelection criteria\nCross-sectional studies investigating the accuracy of the ACE-III or mini-ACE in patients presenting with, or at high risk of, cognitive decline were suitable for inclusion. We excluded case-control, delayed verification and longitudinal studies, and studies which investigated a secondary cause of dementia. We did not restrict studies by language; and we included those with pre-specified thresholds (88 and 82 for the ACE-III, and 21 or 25 for the mini-ACE).\nData collection and analysis\nWe extracted information on study and participant characteristics and used information on dementia and MCI prevalence, sensitivity, specificity, and sample size to generate 2×2 tables in Review Manager 5. We assessed methodological quality of included studies using the QUADAS-2 tool; and we assessed the quality of study reporting with the STARDdem tool.\nDue to significant heterogeneity in the included studies and an insufficient number of studies, we did not perform meta-analyses.\nMain results\nThis review identified seven studies (1711 participants in total) of cross-sectional design, four examining the accuracy of the ACE-III, and three of the mini-ACE. Overall, the majority of studies were at low or unclear risk of bias and applicability on quality assessment. Studies were at high risk of bias for the index test (n = 4) and reference standard (n = 2). Study reporting was variable across the included studies. No studies investigated dementia sub-types. The ACE-III had variable sensitivity across thresholds and patient populations (range for dementia at 82 and 88: 82% to 97%, n = 2; range for MCI at 88: 75% to 77%, n = 2), but with more variability in specificity (range for dementia: 4% to 77%, n = 2; range for MCI: 89% to 92%, n = 2). Similarly, sensitivity of the mini-ACE was variable (range for dementia at 21 and 25: 70% to 99%, n = 3; range for MCI at 21 and 25: 64% to 95%, n = 3) but with more variability specificity (range for dementia: 32% to 100%, n = 3; range for MCI: 46% to 79%, n = 3). We identified no studies in primary care populations: four studies were conducted in outpatient clinics, one study in an in-patient setting, and in two studies the settings were unclear.\nAuthors' conclusions\nThere is insufficient information in terms of both quality and quantity to recommend the use of either the ACE-III or mini-ACE for the screening of dementia or MCI in patients presenting with, or at high risk of, cognitive decline. No studies were conducted in a primary care setting so the accuracy of the ACE-III and mini-ACE in this setting are not known. Lower thresholds (82 for the ACE-III, and 21 for the mini-ACE) provide better specificity with acceptable sensitivity and may provide better clinical utility. The ACE-III and mini-ACE should only be used to support the diagnosis as an adjunct to a full clinical assessment. Further research is needed to determine the utility of the ACE-III and mini-ACE for the detection of dementia, dementia sub-types, and MCI. Specifically, the optimal thresholds for detection need to be determined in a variety of settings (primary care, secondary care (inpatient and outpatient), and community services), prevalences, and languages.\n\nGiven the provided abstract, please respond to the following query: \"Why is recognising dementia important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The number of people being diagnosed with dementia is expected to increase significantly over the next 10 years. There is therefore an increasing need for tools that can assess memory and learning to aid the diagnosis of dementia and MCI. The ACE-III and mini-ACE are currently used in clinical practice, but the evidence for their accuracy to identify dementia has not been fully established."
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query-laysum
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23945
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[
{
"role": "user",
"content": "Abstract: Background\nPreterm infants are often unable to co-ordinate sucking, swallowing and breathing for oral feeding because of their immaturity; in such cases, initial nutrition is provided by orogastric or nasogastric tube feeding. Feed intolerance is common and can delay attainment of full enteral feeds and sucking feeds, which prolongs the need for intravenous nutrition and hospital stay. Smell and taste play an important role in the activation of physiological pre-absorptive processes that contribute to food digestion and absorption. However, during tube feedings, milk bypasses the nasal and oral cavities, which limits exposure to the smell and taste of milk. Provision of the smell and taste of milk with tube feedings is non-invasive and inexpensive; and if it does accelerate the transition to enteral feeds, and then to sucking feeds, it would be of considerable potential benefit to infants, their families, and the healthcare system.\nObjectives\nTo assess whether exposure to the smell or taste (or both) of milk administered with tube feedings can accelerate progress to full sucking feeds without adverse effects in preterm infants.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 5), MEDLINE via PubMed (1966 to 1 June 2018), Embase (1980 to 1 June 2018), and CINAHL (1982 to 1 June 2018). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised and quasi-randomised trials.\nSelection criteria\nWe included randomised and quasi-randomised studies that compared the provision of the smell or taste of milk (or both) immediately before or at the time of tube feedings, with no provision of smell or taste.\nData collection and analysis\nTwo review authors independently abstracted data according to Cochrane Neonatal methodology; they also assessed risk of bias, and the quality of evidence at the outcome level using the GRADE approach. We performed meta-analyses using risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data, with their respective 95% confidence intervals (CIs).\nMain results\nThree trials involving a total of 161 preterm infants were included in this review, but only two trials (131 infants) contributed data for meta-analysis. There was no evidence of a clear effect of exposure to the smell and taste of milk with tube feedings on time taken to reach full sucking feeds (MD -2.57 days, 95% CI -5.15 to 0.02; I2 = 17%; 2 trials, 131 infants; very low-quality evidence). One trial reported no adverse effects. There was no evidence of a clear effect of exposure to the smell and taste of milk on the following outcomes: time taken to reach full enteral feeds (MD -1.57 days, 95% CI -6.25 to 3.11; 1 trial, 51 infants; very low-quality evidence), duration of parenteral nutrition (MD -2.20 days, 95% CI -9.49 to 5.09; 1 trial, 51 infants; very low-quality evidence), incidence of necrotising enterocolitis (RR 0.62, 95% CI 0.15 to 2.48; 1 trial, 51 infants; low-quality evidence), and late infection (RR 2.46, 95% CI 0.27 to 22.13; 1 trial, 51 infants; low-quality evidence). There was very low-quality evidence demonstrating that exposure to the smell and taste of milk decreased duration of hospitalisation by almost four days (MD -3.89 days, 95% CI -7.03 to -0.75; I2 = 51%; 2 trials, 131 infants). In two trials, an increased growth velocity was noted in infants exposed to the intervention, but we were unable to combine data to perform meta-analysis. No data were available to assess feed intolerance and rates of exclusive breastfeeding at discharge. Included trials were small and had methodological limitations including lack of randomisation (one trial), lack of blinding, and different inclusion criteria and administration of the interventions.\nAuthors' conclusions\nEvidence from two trials suggests that exposure to the smell and taste of milk with tube feedings has no clear effect on time taken to reach full sucking feeds, but it may decrease length of hospitalisation. However, these results are uncertain due to the very low quality of the evidence. There is also limited evidence about the impact on other important clinical outcomes and on safety. Future research should examine the effect of exposure to the smell and taste of milk with tube feedings on clinical outcomes during hospitalisation, such as attainment of full enteral and sucking feeds, safety, feed tolerance, incidence of infection, and infant growth. Additionally, future research should be sufficiently powered to evaluate the effect of the intervention in infants of different gestational ages, on each sex separately, and on the optimal frequency and duration of exposure.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that exposure to the smell and taste of milk with orogastric or nasogastric tube feedings had no clear effect on the time to reach full sucking feeds. One study reported no adverse effects. Exposure to the smell and taste of milk also had no clear effect on time to reach full tube feeding, feed tolerance, incidence of late infection and severe intestinal infection, duration of intravenous nutrition, and growth. Very low-quality evidence from two studies suggested that exposure to the smell and taste of milk decreased the length of hospital stay by almost four days compared to no exposure to the smell and taste of milk. However, the included studies were small and had several limitations in terms of how they were done."
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23946
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[
{
"role": "user",
"content": "Abstract: Background\nIntermittent claudication (IC) is a symptom of peripheral arterial disease (PAD) and is associated with high morbidity and mortality. Pentoxifylline, one of many drugs used to treat IC, acts by decreasing blood viscosity, improving erythrocyte flexibility, and promoting microcirculatory flow and tissue oxygen concentration. Many studies have evaluated the efficacy of pentoxifylline in treating people with PAD, but results of these studies are variable. This is the second update of a review first published in 2012.\nObjectives\nTo determine the efficacy of pentoxifylline in improving the walking capacity (i.e. pain-free walking distance and total (absolute, maximum) walking distance) of people with stable intermittent claudication, Fontaine stage II.\nSearch methods\nFor this update, the 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 28 January 2020. There were no language restrictions.\nSelection criteria\nWe included all double-blind, randomised controlled trials (RCTs) comparing pentoxifylline versus placebo or any other pharmacological intervention in people with IC Fontaine stage II.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, assessed the included studies, matched data and resolved disagreements by discussion. Review authors assessed the methodological quality of studies using the Cochrane 'Risk of bias' tool and collected results related to the outcomes of interest, pain-free walking distance (PFWD), total walking distance (TWD), ankle-brachial pressure index (ABI), quality of life (QoL) and side effects. Comparison of studies was based on duration and dose of pentoxifylline. We used GRADE criteria to assess the certainty of the evidence.\nMain results\nWe identified no new eligible studies for this update. This review includes 24 studies with 3377 participants. Seventeen studies compared pentoxifylline versus placebo. The seven remaining studies compared pentoxifylline with flunarizine (one study), aspirin (one study), Gingko biloba extract (one study), nylidrin hydrochloride (one study), prostaglandin E1 (two studies), and buflomedil and nifedipine (one study). Risk of bias for the individual studies was generally unclear because there was a lack of methodological reporting for many of the included studies, especially regarding randomisation and allocation methods. Most included studies did not provide adequate information to allow selective reporting to be judged and did not report blinding of assessors. Heterogeneity between included studies was considerable with regards to multiple variables, including duration of treatment, dose of pentoxifylline, baseline walking distance and participant characteristics; therefore, pooled analysis for comparisons which included more than one study, was not possible.\nPentoxifylline compared to placebo\nOf 17 studies comparing pentoxifylline with placebo, 11 reported PFWD and 14 reported TWD; the difference in percentage improvement in PFWD for pentoxifylline over placebo ranged from –33.8% to 73.9% and in TWD ranged from 1.2% to 155.9%. It was not possible to pool the data of the studies because data were insufficient and findings from individual trials were unclear. Most included studies suggested a possible improvement in PFWD and TWD for pentoxifylline over placebo (both low-certainty evidence).\nThe five studies which evaluated pre-exercise ABI comparing pentoxifylline and placebo found no evidence of a difference (moderate-certainty evidence). Two of the three studies that evaluated QoL between people who received pentoxifylline and placebo were larger studies that used validated QoL tools and generally found no evidence of a difference between groups. One small, short-term study, which did not specify which QoL tool was used, reported improved QoL in the pentoxifylline group (moderate-certainty evidence). Pentoxifylline generally was well tolerated; the most commonly reported side effects consisted of gastrointestinal symptoms such as nausea (low-certainty evidence).\nCertainty of the evidence from this review was low or moderate, with downgrading due to risk of bias concerns, inconsistencies between studies and the inability to evaluate imprecision because meta-analysis could not be undertaken.\nThe seven remaining studies compared pentoxifylline with either flunarizine, aspirin, Gingko biloba extract, nylidrin hydrochloride, prostaglandin E1, or buflomedil and nifedipine; data were too limited to allow any meaningful conclusions to be made.\nAuthors' conclusions\nThere is a lack of high-certainty evidence for the effects of pentoxifylline compared to placebo, or other treatments, for IC. There is low-certainty evidence that pentoxifylline may improve PFWD and TWD compared to placebo, but no evidence of a benefit to ABI or QoL (moderate-certainty evidence). Pentoxifylline was reported to be generally well tolerated (low-certainty evidence). Given the large degree of heterogeneity between the studies, the role of pentoxifylline for people with IC Fontaine class II remains uncertain.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are these results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are not confident in the results for whether pentoxifylline helps people to walk further, or about its side effects, because we found limitations in the ways that the studies were designed and reported. These results are likely to change when more evidence becomes available.\nWe are moderately confident that pentoxifylline treatment was similar to placebo in its effects on difference in ankle-brachial pressure index, and on people's well-being. These results might change when more evidence is available."
}
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query-laysum
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23947
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[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the Cochrane Review first published in 2010; it includes one additional study.\nPrimary generalised tonic-clonic seizures are a type of generalised seizure. Other types of seizures include: absence, myoclonic, and atonic seizures. Effective control of tonic-clonic seizures reduces the risk of injury and death, and improves quality of life. While most people achieve seizure control with one antiepileptic drug, around 30% do not, and require a combination of antiepileptic drugs.\nObjectives\nTo assess the effectiveness and tolerability of add-on lamotrigine for drug-resistant primary generalised tonic-clonic seizures.\nSearch methods\nFor the latest update, we searched these databases on 19 March 2019: Cochrane Register of Studies (CRS) Web, MEDLINE Ovid, and the WHO International Clinical Trials Registry Platform (ICTRP). The CRS includes records from the Cochrane Epilepsy Group Specialized Register, CENTRAL, Embase, and ClinicalTrials.gov. We imposed no language restrictions. We also contacted GlaxoSmithKline, manufacturers of lamotrigine.\nSelection criteria\nRandomised controlled parallel or cross-over trials of add-on lamotrigine for people of any age with drug-resistant primary generalised tonic-clonic seizures.\nData collection and analysis\nWe followed standard Cochrane methodology; two review authors independently assessed trials for inclusion, evaluated risk of bias, extracted relevant data, and GRADE-assessed evidence. We investigated these outcomes: (1) 50% or greater reduction in primary generalised tonic-clonic seizure frequency; (2) seizure freedom; (3) treatment withdrawal; (4) adverse effects; (5) cognitive effects; and (6) quality of life. We used an intention-to-treat (ITT) population for all analyses, and presented results as risk ratios (RRs) with 95% confidence intervals (CIs); for adverse effects, we used 99% CIs to compensate for multiple hypothesis testing.\nMain results\nWe included three studies (total 300 participants): two parallel-group studies and one cross-over study. We assessed varied risks of bias across studies; most limitations arose from the poor reporting of methodological details. We meta-analysed data extracted from the two parallel-group studies, and conducted a narrative synthesis for data from the cross-over study.\nBoth parallel-group studies (270 participants) reported all dichotomous outcomes. Participants taking lamotrigine were almost twice as likely to attain a 50% or greater reduction in primary generalised tonic-clonic seizure frequency than those taking a placebo (RR 1.88, 95% CI 1.43 to 2.45; low-certainty evidence). The results between groups were inconclusive for the likelihood of seizure freedom (RR 1.55, 95% CI 0.89 to 2.72; very low-certainty evidence); treatment withdrawal (RR 1.20, 95% CI 0.72 to 1.99; very low-certainty evidence); and individual adverse effects: ataxia (RR 3.05, 99% CI 0.05 to 199.36); dizziness (RR 0.91, 99% CI 0.29 to 2.86; very low-certainty evidence); fatigue (RR 1.02, 99% CI 0.13 to 8.14; very low-certainty evidence); nausea (RR 1.60, 99% CI 0.48 to 5.32; very low-certainty evidence); and somnolence (RR 3.73, 99% CI 0.36 to 38.90; low-certainty evidence).\nThe cross-over trial (26 participants) reported that 7/14 participants with generalised tonic-clonic seizures experienced a 50% or greater reduction in seizure frequency with add-on lamotrigine compared to placebo. The authors reported four treatment withdrawals, but did not specify during which treatment allocation they occurred. Rash (seven lamotrigine participants; zero placebo participants) and fatigue (five lamotrigine participants; zero placebo participants) were the most frequently reported adverse effects.\nNone of the included studies measured cognition. One parallel-group study (N = 153) evaluated quality of life. They reported inconclusive results for the overall quality of life score between groups (P = 0.74).\nAuthors' conclusions\nThis review provides insufficient information to inform clinical practice.\nLow-certainty evidence suggests that lamotrigine reduces the rate of generalised tonic-clonic seizures by 50% or more. Very low-certainty evidence found inconclusive results between groups for all other outcomes. Therefore, we are uncertain to very uncertain that the results reported are accurate, and suggest that the true effect could be grossly different.\nMore trials, recruiting larger populations, over longer periods, are necessary to determine lamotrigine's clinical use.\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": "Epilepsy is a common neurological (brain) condition that is characterised by repeated seizures. Most people can control their seizures with a single antiepileptic medicine, however, about 30% continue to have seizures. These people are said to have drug-resistant epilepsy. Lamotrigine is an antiepileptic medicine, which can be used as add-on treatment with other antiepileptic medication to try to manage drug-resistant epilepsy."
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query-laysum
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23948
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[
{
"role": "user",
"content": "Abstract: Background\nGestational diabetes mellitus (GDM) is associated with both short- and long-term complications for the mother and her baby. Exercise interventions may be useful in helping with glycaemic control and improve maternal and infant outcomes.\nThe original review on Exercise for diabetic pregnant women has been split into two new review titles reflecting the role of exercise for pregnant women with gestational diabetes and for pregnant women with pre-existing diabetes.\nExercise for pregnant women with gestational diabetes for improving maternal and fetal outcomes (this review)\nExercise for pregnant women with pre-existing diabetes for improving maternal and fetal outcomes\nObjectives\nTo evaluate the effects of exercise interventions for improving maternal and fetal outcomes in women with GDM.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (27 August 2016), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (18th August 2016), and reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing an exercise intervention with standard care or another intervention in pregnant women diagnosed with gestational diabetes. Quasi-randomised and cross-over studies, and studies including women with pre-existing type 1 or type 2 diabetes were not eligible for inclusion.\nData collection and analysis\nAll selection of studies, assessment of trial quality and data extraction was conducted independently by two review authors. Data were checked for accuracy.\nMain results\nWe included 11 randomised trials, involving 638 women. The overall risk of bias was judged to be unclear due to lack of methodological detail in the included studies.\nFor the mother, there was no clear evidence of a difference between women in the exercise group and those in the control group for the risk of pre-eclampsia as the measure of hypertensive disorders of pregnancy (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.01 to 7.09; two RCTs, 48 women; low-quality evidence), birth by caesarean section (RR 0.86, 95% CI 0.63 to 1.16; five RCTs, 316 women; I2 = 0%; moderate-quality evidence), the risk of induction of labour (RR 1.38, 95% CI 0.71 to 2.68; one RCT, 40 women; low-quality evidence) or maternal body mass index at follow-up (postnatal weight retention or return to pre-pregnancy weight) (mean difference (MD) 0.11 kg/m2, 95% CI -1.04 to 1.26; three RCTs, 254 women; I2 = 0%; high-quality evidence). Development of type 2 diabetes, perineal trauma/tearing and postnatal depression were not reported as outcomes in the included studies.\nFor the infant/child/adult, a single small (n = 19) trial reported no perinatal mortality (stillbirth and neonatal mortality) events in either the exercise intervention or control group (low-quality evidence). There was no clear evidence of a difference between groups for a mortality and morbidity composite (variously defined by trials, e.g. perinatal or infant death, shoulder dystocia, bone fracture or nerve palsy) (RR 0.56, 95% CI 0.12 to 2.61; two RCTs, 169 infants; I2 = 0%; moderate-quality evidence) or neonatal hypoglycaemia (RR 2.00, 95% CI 0.20 to 20.04; one RCT, 34 infants; low-quality evidence). None of the included trials pre-specified large-for-gestational age, adiposity (neonatal/infant, childhood or adulthood), diabetes (childhood or adulthood) or neurosensory disability (neonatal/infant) as trial outcomes.\nOther maternal outcomes of interest: exercise interventions were associated with both reduced fasting blood glucose concentrations (average standardised mean difference (SMD) -0.59, 95% CI -1.07 to -0.11; four RCTs, 363 women; I2 = 73%; T2 = 0.19) and a reduced postprandial blood glucose concentration compared with control interventions (average SMD -0.85, 95% CI -1.15 to -0.55; three RCTs, 344 women; I2 = 34%; T2 = 0.03).\nAuthors' conclusions\nShort- and long-term outcomes of interest for this review were poorly reported. Current evidence is confounded by the large variety of exercise interventions. There was insufficient high-quality evidence to be able to determine any differences between exercise and control groups for our outcomes of interest. For the woman, both fasting and postprandial blood glucose concentrations were reduced compared with the control groups. There are currently insufficient data for us to determine if there are also benefits for the infant. The quality of the evidence in this review ranged from high to low quality and the main reason for downgrading was for risk of bias and imprecision (wide CIs, low event rates and small sample size). Development of type 2 diabetes, perineal trauma/tearing, postnatal depression, large-for-gestational age, adiposity (neonate/infant, childhood or adulthood), diabetes (childhood or adulthood) or neurosensory disability (neonate/infant) were not reported as outcomes in the included studies.\nFurther research is required comparing different types of exercise interventions with control groups or with another exercise intervention that reports on both the short- and long-term outcomes (for both the mother and infant/child) as listed in this review.\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": "Exercise may help to control blood sugar levels and improve outcomes for the mother and her baby, possibly leading to long-term health benefits. Physical activity for this review is planned, structured and repetitive body movements undertaken to improve physical fitness."
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query-laysum
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23949
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[
{
"role": "user",
"content": "Abstract: Background\nErythropoiesis-stimulating agents (ESAs) are commonly used to treat chemotherapy-induced anemia (CIA). However, about half of patients do not benefit.\nObjectives\nTo evaluate the benefits and harms related to the use of iron as a supplement to ESA and iron alone compared with ESA alone in the management of CIA.\nSearch methods\nWe searched for relevant trials from the Cochrane Central Register of Controlled Trials (CENTRAL) (issue 1 January 2016), MEDLINE (1950 to February 2016), and www.clinicaltrials.gov without using any language limits.\nSelection criteria\nAll randomized controlled trials (RCTs) comparing 'iron plus ESA' or 'iron alone' versus 'ESA alone' in people with CIA were eligible for inclusion.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included eight RCTs (12 comparisons) comparing ESA plus iron versus ESA alone enrolling 2087 participants. We did not find any trial comparing iron alone versus ESAs alone in people with CIA. None of the included RCTs reported overall survival. There was a beneficial effect of iron supplementation to ESAs compared with ESAs alone on hematopoietic response (risk ratio (RR) 1.17, 95% confidence interval (CI) 1.09 to 1.26; P < 0.0001; 1712 participants; 11 comparisons; high-quality evidence). Assuming a baseline risk of 35% to 80% for hematopoietic response without iron supplementation, between seven and 16 patients should be treated to achieve hematopoietic response in one patient. In subgroup analyses, RCTs that used intravenous (IV) iron favored ESAs and iron (RR 1.20 (95% CI 1.10 to 1.31); P < 0.00001; 1321 participants; eight comparisons), whereas we found no evidence for a difference in hematopoietic response in RCTs using oral iron (RR 1.04 (95% CI 0.87 to 1.24); P = 0.68; 391 participants; three comparisons). There was no evidence for a difference between the subgroups of IV and oral iron (P = 0.16). There was no evidence for a difference between the subgroups of types of iron (P = 0.31) and types of ESAs (P = 0.16) for hematopoietic response.\nThe iron supplementation to ESAs might be beneficial as fewer participants treated with iron supplementation required red blood cell (RBC) transfusions compared to the number of participants treated with ESAs alone (RR 0.74 (95% CI 0.60 to 0.92); P = 0.007; 1719 participants; 11 comparisons; moderate-quality evidence). Assuming a baseline risk of 7% to 40% for RBC transfusion without iron supplementation, between 10 and 57 patients should be treated to avoid RBC transfusion in one patient.\nWe found no evidence for a difference in the median time to hematopoietic response with addition of iron to ESAs (hazard ratio (HR) 0.93 (95% CI 0.67 to 1.28); P = 0.65; 1042 participants; seven comparisons; low-quality evidence). In subgroup analyses, RCTs in which dextran (HR 0.95 (95% CI 0.36 to 2.52); P = 0.92; 340 participants; three comparisons), sucrose iron (HR 1.15 (95% CI 0.60 to 2.21); P = 0.67; 102 participants; one comparison) and sulfate iron (HR 1.24 (95% CI 0.99 to 1.56); P = 0.06; 55 participants; one comparison) were used showed no evidence for difference between iron supplementation versus ESAs alone compared with RCTs in which gluconate (HR 0.78 (95% CI 0.65 to 0.94); P = 0.01; 464 participants; two comparisons) was used for median time to hematopoietic response (P = 0.02). There was no evidence for a difference between the subgroups of route of iron administration (P = 0.13) and types of ESAs (P = 0.46) for median time to hematopoietic response.\nOur results indicated that there could be improvement in the hemoglobin (Hb) levels with addition of iron to ESAs (mean difference (MD) 0.48 (95% CI 0.10 to 0.86); P = 0.01; 827 participants; seven comparisons; low-quality evidence). In RCTs in which IV iron was used there was evidence for a difference (MD 0.84 (95% CI 0.21 to 1.46); P = 0.009; 436 participants; four comparisons) compared with oral iron (MD 0.07 (95% CI -0.19 to 0.34); P = 0.59; 391 participants; three comparisons) for mean change in Hb level (P = 0.03). RCTs in which dextran (MD 1.55 (95% CI 0.62 to 2.47); P = 0.001; 102 participants; two comparisons) was used showed evidence for a difference with iron supplementation versus ESAs alone compared with RCTs in which gluconate (MD 0.54 (95% CI -0.15 to 1.22); P = 0.12; 334 participants; two comparisons) and sulfate iron (MD 0.07 (95% CI -0.19 to 0.34); P = 0.59; 391 participants; three comparisons) were used for mean change in Hb level (P = 0.007). RCTs in which epoetin was used showed evidence for a difference with iron supplementation versus ESAs alone (MD 0.77 (95% CI 0.25 to 1.29); P = 0.004; 337 participants; five comparisons) compared with darbepoetin use (MD 0.10 (95% CI -0.13 to 0.33); P = 0.38; 490 participants; two comparisons) for mean change in Hb level (P = 0.02).\nWe found no evidence for a difference in quality of life with addition of iron to ESAs (standardized mean difference 0.01 (95% CI -0.10 to 0.12); P = 0.88; 1124 participants; three RCTs; high-quality evidence).\nWe found no evidence for a difference in risk of grade III-IV thromboembolic events (RR 0.95 (95% CI 0.54 to 1.65); P = 0.85; 783 participants; three RCTs; moderate-quality evidence). The incidence of treatment-related mortality (TRM) was 0% (997 participants; four comparisons; high-quality evidence).\nOther common adverse events included vomiting, asthenia, and leukopenia, and were similar in both arms.\nOverall the risk of bias across outcomes was high to low. Since the included RCTs had shorter follow-up duration (up to 20 weeks), the long-term effects of iron supplementation are unknown. Our main reasons for downgrading the quality of evidence were inconsistency across the included studies and imprecision of results.\nAuthors' conclusions\nOur systematic review shows that addition of iron to ESAs offers superior hematopoietic response, reduces the risk of RBC transfusions, and improves Hb levels, and appears to be well tolerated. None of the included RCTs reported overall survival. We found no evidence for a difference in quality of life with iron supplementation.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Is iron alone or iron as a supplement to erythropoiesis-stimulating agents (ESAs) superior to ESAs alone in the management of people diagnosed with chemotherapy-induced anemia (CIA)?"
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query-laysum
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23950
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[
{
"role": "user",
"content": "Abstract: Background\nPsoriatic arthritis is an inflammatory disease associated with joint damage, impaired function, pain, and reduced quality of life. Methotrexate is a disease-modifying anti-rheumatic drug (DMARD) commonly prescribed to alleviate symptoms, attenuate disease activity, and prevent progression of disease.\nObjectives\nTo assess the benefits and harms of methotrexate for psoriatic arthritis in adults.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, the WHO International Clinical Trials Registry Platform, and www.clinicaltrials.gov for relevant records. We searched all databases from inception to 29 January 2018. We handsearched included articles for additional records and contacted study authors for additional unpublished data. We applied no language restrictions.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and quasi-RCTs that compared methotrexate versus placebo, or versus another DMARD, for adults with psoriatic arthritis. We reported on the following major outcomes: disease response (measured by psoriatic arthritis response criteria (PsARC)), function (measured by the Health Assessment Questionnaire for Rheumatoid Arthritis (HAQ)), health-related quality of life, disease activity (measured by disease activity score (28 joints) with erythrocyte sedimentation rate (DAS28-ESR)), radiographic progression, serious adverse events, and withdrawals due to adverse events.\nData collection and analysis\nTwo review authors independently reviewed search results, assessed risk of bias, extracted trial data, and assessed the quality of evidence using the GRADE approach. We undertook meta-analysis only when this was meaningful.\nMain results\nWe included in this review eight RCTs conducted in an outpatient setting, in Italy, the United Kingdom, the United States of America, China, Russia, and Bangladesh. Five studies compared methotrexate versus placebo, and four studies compared methotrexate versus other DMARDs. The average age of participants varied across studies (26 to 52 years), as did the average duration of psoriatic arthritis (one to nine years). Doses of methotrexate varied from 7.5 mg to 25 mg orally per week, but most studies administered approximately 15 mg or less orally per week. Risk of bias was generally unclear or high across most domains for all studies. We considered only one study to have low risk of selection and detection bias. The main study informing results of the primary comparison (methotrexate vs placebo up to six months) was at low risk of bias for all domains except attrition bias and reporting bias.\nWe restricted reporting of results to the comparison of methotrexate versus placebo for up to six months. Low-quality evidence (downgraded due to bias and imprecision) from a single study (221 participants; methotrexate dose 15 mg orally or less per week) informed results for disease response, function, and disease activity. Disease response, measured by the proportion who responded to treatment according to PsARC (response indicates improvement), was 41/109 in the methotrexate group and 24/112 in the placebo group (risk ratio (RR) 1.76, 95% confidence interval (CI) 1.14 to 2.70). This equates to an absolute difference of 16% more responders with methotrexate (4% more to 28% more), and a number needed to treat for an additional beneficial outcome (NNTB) of 6 (95% CI 5 to 25). Mean function, measured by the HAQ (scale 0 to 3; 0 meaning no functional impairment; minimum clinically important difference 0.22), was 1.0 points with placebo and 0.3 points better (95% 0.51 better to 0.09 better) with methotrexate; absolute improvement was 10% (3% better to 17% better), and relative improvement 30% (9% better to 51% better). Mean disease activity as measured by the DAS28-ESR (scale of 0 to 10; lower score means lower disease activity; minimum clinically important difference unknown) was 3.8 points in the methotrexate group and 4.06 points in the placebo group; mean difference was -0.26 points (95% CI -0.65 to 0.13); absolute improvement was 3% (7% better to 1% worse), and relative improvement 6% (16% better to 3% worse).\nLow-quality evidence (downgraded due to risk of bias and imprecision) from three studies (n = 293) informed our results for serious adverse events and withdrawals due to adverse events. Due to low event rates, we are uncertain if methotrexate results show increased risk of serious adverse events or withdrawals due to adverse events compared to placebo. Results show 1/141 serious adverse events in the methotrexate group and 4/152 in the placebo group: RR 0.26 (95% CI 0.03 to 2.26); absolute difference was 2% fewer events with methotrexate (5% fewer to 1% more). In all, 9/141 withdrawals in the methotrexate group were due to adverse events and 7/152 in the placebo group: RR 1.32 (95% CI 0.51 to 3.42); absolute difference was 1% more withdrawals (4% fewer to 6% more).\nOne study measured health-related quality of life but did not report these results. No study measured radiographic progression.\nAuthors' conclusions\nLow-quality evidence suggests that low-dose (15 mg or less) oral methotrexate might be slightly more effective than placebo when taken for six months; however we are uncertain if it is more harmful. Effects of methotrexate on health-related quality of life, radiographic progression, enthesitis, dactylitis, and fatigue; its benefits beyond six months; and effects of higher-dose methotrexate have not been measured or reported in a randomised placebo-controlled trial.\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 six months of treatment, comparison with placebo (a fake drug) showed that methotrexate resulted in the following (note that one study measured but did not report quality of life, and no studies measured radiographic progression).\nProportion who responded to treatment as measured by the Psoriatic Arthritis Response Criteria\n16% more people, or 16 more people out of 100, improved with treatment (4% more to 28% more)\n37 out of 100 people taking methotrexate improved\n21 out of 100 people taking placebo improved\nFunction (lower scores mean better function)\nFunction was improved by 10% (ranging from 3% better to 17% better), or by 0.30 points (ranging from 0.09 better to 0.51 better) on a 0 to 3 scale (this is expected to be meaningful to patients)\nPeople taking methotrexate rated their function as 0.7 point\nPeople taking placebo rated their function as 1.0 point\nDisease activity (lower scores mean less active disease)\nDisease activity improved by 3% (7% better to 1% worse), or by 0.26 points (0.65 better to 0.13 worse) on a 0 to 10 scale\nPeople taking methotrexate had a disease activity score of 3.8 points\nPeople taking placebo had a disease activity score of 4.06 points\nSerious adverse events (more events mean more harm)\n2% fewer people, or two fewer people out of 100 (5% fewer to 1% more), reported a serious adverse event with methotrexate\nOne person out of 100 people taking methotrexate had a serious adverse event\nThree out of 100 people taking placebo had a serious adverse event\nWithdrawals due to adverse events (more events means more harm)\n1% more people, or one more person out of 100 (4% fewer to 6% more), withdrew from treatment with methotrexate\nSix out of 100 people taking methotrexate withdrew\nFive out of 100 people taking placebo withdrew"
}
] |
query-laysum
|
23951
|
[
{
"role": "user",
"content": "Abstract: Background\nTransurethral resection of the prostate (TURP) is a well-established surgical method for treatment of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO). This has traditionally been provided as monopolar TURP (MTURP), but morbidity associated with MTURP has led to the introduction of other surgical techniques. In bipolar TURP (BTURP), energy is confined between electrodes at the site of the resectoscope, allowing the use of physiological irrigation medium. There remains uncertainty regarding differences between these surgical methods in terms of patient outcomes.\nObjectives\nTo compare the effects of bipolar and monopolar TURP.\nSearch methods\nA comprehensive systematic electronic literature search was carried out up to 19 March 2019 via CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, PubMed, and WHO ICTRP. Handsearching of abstract proceedings of major urological conferences and of reference lists of included trials, systematic reviews, and health technology assessment reports was undertaken to identify other potentially eligible studies. No language restrictions were applied.\nSelection criteria\nRandomised controlled trials (RCTs) that compared monopolar and bipolar TURP in men (> 18 years) for management of LUTS secondary to BPO.\nData collection and analysis\nTwo independent review authors screened the literature, extracted data, and assessed eligible RCTs for risk of bias. Statistical analyses were undertaken according to the statistical guidelines presented in the Cochrane Handbook for Systematic Reviews of Interventions. The quality of evidence (QoE) was rated according to the GRADE approach.\nMain results\nA total of 59 RCTs with 8924 participants were included. The mean age of included participants ranged from 59.0 to 74.1 years. Mean prostate volume ranged from 39 mL to 82.6 mL.\nPrimary outcomes\nBTURP probably results in little to no difference in urological symptoms, as measured by the International Prostate Symptom Score (IPSS) at 12 months on a scale of 0 to 35, with higher scores reflecting worse symptoms (mean difference (MD) -0.24, 95% confidence interval (CI) -0.39 to -0.09; participants = 2531; RCTs = 16; I² = 0%; moderate certainty of evidence (CoE), downgraded for study limitations), compared to MTURP.\nBTURP probably results in little to no difference in bother, as measured by health-related quality of life (HRQoL) score at 12 months on a scale of 0 to 6, with higher scores reflecting greater bother (MD -0.12, 95% CI -0.25 to 0.02; participants = 2004; RCTs = 11; I² = 53%; moderate CoE, downgraded for study limitations), compared to MTURP.\nBTURP probably reduces transurethral resection (TUR) syndrome events slightly (risk ratio (RR) 0.17, 95% CI 0.09 to 0.30; participants = 6745; RCTs = 44; I² = 0%; moderate CoE, downgraded for study limitations), compared to MTURP. This corresponds to 20 fewer TUR syndrome events per 1000 participants (95% CI 22 fewer to 17 fewer).\nSecondary outcomes\nBTURP may carry a similar risk of urinary incontinence at 12 months (RR 0.20, 95% CI 0.01 to 4.06; participants = 751; RCTs = 4; I² = 0%; low CoE, downgraded for study limitations and imprecision), compared to MTURP. This corresponds to four fewer events of urinary incontinence per 1000 participants (95% CI five fewer to 16 more).\nBTURP probably slightly reduces blood transfusions (RR 0.42, 95% CI 0.30 to 0.59; participants = 5727; RCTs = 38; I² = 0%; moderate CoE, downgraded for study limitations), compared to MTURP. This corresponds to 28 fewer events of blood transfusion per 1000 participants (95% CI 34 fewer to 20 fewer).\nBTURP may result in similar rates of re-TURP (RR 1.02, 95% CI 0.44 to 2.40; participants = 652; RCTs = 6; I² = 0%; low CoE, downgraded for study limitations and imprecision). This corresponds to one more re-TURP per 1000 participants (95% CI 19 fewer to 48 more).\nErectile function as measured by the International Index of Erectile Function score (IIEF-5) at 12 months on a scale from 5 to 25, with higher scores reflecting better erectile function, appears to be similar (MD 0.88, 95% CI -0.56 to 2.32; RCTs = 3; I² = 68%; moderate CoE, downgraded for study limitations) for the two approaches.\nAuthors' conclusions\nBTURP and MTURP probably improve urological symptoms, both to a similar degree. BTURP probably reduces both TUR syndrome and postoperative blood transfusion slightly compared to MTURP. The impact of both procedures on erectile function is probably similar. The moderate certainty of evidence available for the primary outcomes of this review suggests that there is no need for further RCTs comparing BTURP and MTURP.\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": "Compared to MTURP, BTURP probably results in similar reduction in urinary symptoms and bother.\nIt probably slightly reduces both the risk of TUR syndrome and the need for blood transfusion.\nErectile function is probably similar after both procedures, as is the risk of urinary incontinence and the need for a repeat procedure."
}
] |
query-laysum
|
23952
|
[
{
"role": "user",
"content": "Abstract: Background\nMore than one in five patients who undergo treatment for breast cancer will develop breast cancer-related lymphedema (BCRL). BCRL can occur as a result of breast cancer surgery and/or radiation therapy. BCRL can negatively impact comfort, function, and quality of life (QoL). Manual lymphatic drainage (MLD), a type of hands-on therapy, is frequently used for BCRL and often as part of complex decongestive therapy (CDT). CDT is a fourfold conservative treatment which includes MLD, compression therapy (consisting of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises (LREs). Phase 1 of CDT is to reduce swelling; Phase 2 is to maintain the reduced swelling.\nObjectives\nTo assess the efficacy and safety of MLD in treating BCRL.\nSearch methods\nWe searched Medline, EMBASE, CENTRAL, WHO ICTRP (World Health Organization's International Clinical Trial Registry Platform), and Cochrane Breast Cancer Group's Specialised Register from root to 24 May 2013. No language restrictions were applied.\nSelection criteria\nWe included randomized controlled trials (RCTs) or quasi-RCTs of women with BCRL. The intervention was MLD. The primary outcomes were (1) volumetric changes, (2) adverse events. Secondary outcomes were (1) function, (2) subjective sensations, (3) QoL, (4) cost of care.\nData collection and analysis\nWe collected data on three volumetric outcomes. (1) LE (lymphedema) volume was defined as the amount of excess fluid left in the arm after treatment, calculated as volume in mL of affected arm post-treatment minus unaffected arm post-treatment. (2) Volume reduction was defined as the amount of fluid reduction in mL from before to after treatment calculated as the pretreatment LE volume of the affected arm minus the post-treatment LE volume of the affected arm. (3) Per cent reduction was defined as the proportion of fluid reduced relative to the baseline excess volume, calculated as volume reduction divided by baseline LE volume multiplied by 100. We entered trial data into Review Manger 5.2 (RevMan), pooled data using a fixed-effect model, and analyzed continuous data as mean differences (MDs) with 95% confidence intervals (CIs). We also explored subgroups to determine whether mild BCRL compared to moderate or severe BCRL, and BCRL less than a year compared to more than a year was associated with a better response to MLD.\nMain results\nSix trials were included. Based on similar designs, trials clustered in three categories.\n(1) MLD + standard physiotherapy versus standard physiotherapy (one trial) showed significant improvements in both groups from baseline but no significant between-groups differences for per cent reduction.\n(2) MLD + compression bandaging versus compression bandaging (two trials) showed significant per cent reductions of 30% to 38.6% for compression bandaging alone, and an additional 7.11% reduction for MLD (MD 7.11%, 95% CI 1.75% to 12.47%; two RCTs; 83 participants). Volume reduction was borderline significant (P = 0.06). LE volume was not significant. Subgroup analyses was significant showing that participants with mild-to-moderate BCRL were better responders to MLD than were moderate-to-severe participants.\n(3) MLD + compression therapy versus nonMLD treatment + compression therapy (three trials) were too varied to pool. One of the trials compared compression sleeve plus MLD to compression sleeve plus pneumatic pump. Volume reduction was statistically significant favoring MLD (MD 47.00 mL, 95% CI 15.25 mL to 78.75 mL; 1 RCT; 24 participants), per cent reduction was borderline significant (P=0.07), and LE volume was not significant. A second trial compared compression sleeve plus MLD to compression sleeve plus self-administered simple lymphatic drainage (SLD), and was significant for MLD for LE volume (MD -230.00 mL, 95% CI -450.84 mL to -9.16 mL; 1 RCT; 31 participants) but not for volume reduction or per cent reduction. A third trial of MLD + compression bandaging versus SLD + compression bandaging was not significant (P = 0.10) for per cent reduction, the only outcome measured (MD 11.80%, 95% CI -2.47% to 26.07%, 28 participants).\nMLD was well tolerated and safe in all trials.\nTwo trials measured function as range of motion with conflicting results. One trial reported significant within-groups gains for both groups, but no between-groups differences. The other trial reported there were no significant within-groups gains and did not report between-groups results. One trial measured strength and reported no significant changes in either group.\nTwo trials measured QoL, but results were not usable because one trial did not report any results, and the other trial did not report between-groups results.\nFour trials measured sensations such as pain and heaviness. Overall, the sensations were significantly reduced in both groups over baseline, but with no between-groups differences. No trials reported cost of care.\nTrials were small ranging from 24 to 45 participants. Most trials appeared to randomize participants adequately. However, in four trials the person measuring the swelling knew what treatment the participants were receiving, and this could have biased results.\nAuthors' conclusions\nMLD is safe and may offer additional benefit to compression bandaging for swelling reduction. Compared to individuals with moderate-to-severe BCRL, those with mild-to-moderate BCRL may be the ones who benefit from adding MLD to an intensive course of treatment with compression bandaging. This finding, however, needs to be confirmed by randomized data.\nIn trials where MLD and sleeve were compared with a nonMLD treatment and sleeve, volumetric outcomes were inconsistent within the same trial. Research is needed to identify the most clinically meaningful volumetric measurement, to incorporate newer technologies in LE assessment, and to assess other clinically relevant outcomes such as fibrotic tissue formation.\nFindings were contradictory for function (range of motion), and inconclusive for quality of life.\nFor symptoms such as pain and heaviness, 60% to 80% of participants reported feeling better regardless of which treatment they received.\nOne-year follow-up suggests that once swelling had been reduced, participants were likely to keep their swelling down if they continued to use a custom-made sleeve.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the Evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Trials were small ranging from 24 to 45 participants. Most trials appeared to randomize participants adequately. However, in four trials the person measuring the swelling knew what treatment the participants were receiving, and this could have biased results."
}
] |
query-laysum
|
23953
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a disease that causes progressive or relapsing and remitting weakness and numbness. It is probably caused by an autoimmune process. Immunosuppressive or immunomodulatory drugs would be expected to be beneficial. This review was first published in 2003 and has been updated most recently in 2016.\nObjectives\nTo assess the effects of immunomodulatory and immunosuppressive agents other than corticosteroids, immunoglobulin, and plasma exchange in CIDP.\nSearch methods\nOn 24 May 2016, we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 4) in the Cochrane Library, MEDLINE, Embase, CINAHL, and LILACS for completed trials, and clinical trial registers for ongoing trials. We contacted the authors of the trials identified and other disease experts seeking other published and unpublished trials.\nSelection criteria\nWe sought randomised and quasi-randomised trials of all immunosuppressive agents, such as azathioprine, cyclophosphamide, methotrexate, ciclosporin, mycophenolate mofetil, and rituximab, and all immunomodulatory agents, such as interferon (IFN) alfa and IFN beta, in participants fulfilling standard diagnostic criteria for CIDP. We included all comparisons of these agents with placebo, another treatment, or no treatment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We wanted to measure the change in disability after one year as our primary outcome. Our secondary outcomes were change in disability after four or more weeks (from randomisation); change in impairment after at least one year; change in maximum motor nerve conduction velocity and compound muscle action potential amplitude after one year; and for participants who were receiving corticosteroids or intravenous immunoglobulin (IVIg), the amount of this medication given during at least one year after randomisation. Participants with one or more serious adverse events during the first year was also a secondary outcome.\nMain results\nFour trials fulfilled the selection criteria: one of azathioprine (27 participants), two of IFN beta-1a (77 participants in total) and one of methotrexate (60 participants). The risk of bias was considered low in the trials of IFN beta-1a and methotrexate but high in the trial of azathioprine. None of the trials showed significant benefit in any of the outcomes selected by their authors. The results of the outcomes which approximated most closely to the primary outcome for this review were as follows.\nIn the azathioprine trial there was a median improvement in the Neuropathy Impairment Scale (scale range 0 to 280) after nine months of 29 points (range 49 points worse to 84 points better) in the azathioprine and prednisone treated participants compared with 30 points worse (range 20 points worse to 104 points better) in the prednisone alone group. There were no reports of adverse events.\nIn a cross-over trial of IFN beta-1a with 20 participants, the treatment periods were 12 weeks. The median improvement in the Guy's Neurological Disability Scale (range 1 to 10) was 0.5 grades (interquartile range (IQR) 1.8 grades better to zero grade change) in the IFN beta-1a treatment period and 0.5 grades (IQR 1.8 grades better to 1.0 grade worse) in the placebo treatment period. There were no serious adverse events in either treatment period.\nIn a parallel group trial of IFN beta-1a with 67 participants, none of the outcomes for this review was available. The trial design involved withdrawal from ongoing IVIg treatment. The primary outcome used by the trial authors was total IVIg dose administered from week 16 to week 32 in the placebo group compared with the IFN beta-1a groups. This was slightly but not significantly lower in the combined IFN beta-1a groups (1.20 g/kg) compared with the placebo group (1.34 g/kg, P = 0.75). There were four participants in the IFN beta-1a group and none in the placebo group with one or more serious adverse events, risk ratio (RR) 4.50 (95% confidence interval (CI) 0.25 to 80.05).\nThe methotrexate trial had a similar design involving withdrawal from ongoing corticosteroid or IVIg treatment. At the end of the trial (approximately 40 weeks) there was no significant difference in the change in the Overall Neuropathy Limitations Scale, a disability scale (scale range 0 to 12), the median change being 0 (IQR −1 to 0) in the methotrexate group and 0 (IQR −0.75 to 0) in the placebo group. These changes in disability might have been confounded by the reduction in corticosteroid or IVIg dose required by the protocol. There were three participants in the methotrexate group and one in the placebo with one or more serious adverse events, RR 3.56 (95% CI 0.39 to 32.23).\nAuthors' conclusions\nLow-quality evidence from randomised trials does not show significant benefit from azathioprine or interferon beta-1a and moderate-quality evidence from one randomised trial does not show significant benefit from a relatively low dose of methotrexate for the treatment of CIDP. None of the trials was large enough to rule out small or moderate benefit. The evidence from observational studies is insufficient to avoid the need for randomised controlled trials to discover whether these drugs are beneficial. Future trials should have improved designs, more sensitive outcome measures relevant to people with CIDP, and longer treatment durations.\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 for giving people with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) treatment that regulates the immune system other than corticosteroids, immunoglobulin and plasma exchange."
}
] |
query-laysum
|
23954
|
[
{
"role": "user",
"content": "Abstract: Background\nThere is a need to standardize monitoring in obstetric research of twin pregnancies. Identification of birth weight discordance (BWD), defined as a difference in the birth weights of twins, is a well-documented phenomenon in twin pregnancies. Ultrasound for the diagnosis of BWD informs complex decision making including whether to intervene medically (via laser photo coagulation) or deliver the twins to avoid fetal morbidities or even death. The question is, how accurate is this measurement?\nObjectives\nTo determine the diagnostic accuracy (sensitivity and specificity) of ultrasound estimated fetal weight discordance (EFWD) of 20% and 25% using different estimated biometric ultrasound measurements compared with the actual BWD as the reference standard in twin pregnancies.\nSearch methods\nThe search for this review was performed on 15 March 2019. We searched CENTRAL, MEDLINE (Ovid), Embase (Ovid), seven other databases, conference proceedings, reference lists and contacted experts. There were no language or date restrictions applied to the electronic searches, and no methodological filters to maximize sensitivity.\nSelection criteria\nWe selected cohort-type studies with delayed verification that evaluated the accuracy of biometric measurements at ultrasound scanning of twin pregnancies that had been proposed for the diagnosis of estimated BWD, compared to BWD measurements after birth as a reference standard. In addition, we only selected studies that considered twin pregnancies and applied a reference standard for EFWD for the target condition of BWD.\nData collection and analysis\nWe screened all titles generated by electronic database searches. Two review authors independently assessed the abstracts of all potentially relevant studies. We assessed the identified full papers for eligibility, and extracted data to create 2 × 2 tables. Two review authors independently performed quality assessment using the QUADAS-2 tool. We excluded studies that did not report data in sufficient detail to construct 2 × 2 tables, and where this information was not available from the primary investigators. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 39 eligible studies with a median study sample size of 140. In terms of risk of bias, there were many unclear statements regarding patient selection, index test and use of proper reference standard. Twenty-one studies (53%) were of methodological concern due to flow and timing. In terms of applicability, most studies were of low concern.\nUltrasound for diagnosis of BWD in twin pregnancies at 20% cut-off\nTwenty-two studies provided data for a BWD of 20% and the summary estimate of sensitivity was 0.51 (95% CI 0.42 to 0.60), and the summary estimate of specificity was 0.91 (95% CI 0.89 to 0.93) (8005 twin pregnancies; very low-certainty evidence).\nUltrasound for diagnosis of BWD in twin pregnancies at 25% cut-off\nEighteen studies provided data using a BWD discordance of 25%. The summary estimate of sensitivity was 0.46 (95% CI 0.26 to 0.66), and the summary estimate of specificity was 0.93 (95% CI 0.89 to 0.96) (6471 twin pregnancies; very low-certainty evidence).\nSubgroup analyses were possible for both BWD of 20% and 25%. The diagnostic accuracy did not differ substantially between estimation by abdominal circumference and femur length but femur length had a trend towards higher sensitivity and specificity. Subgroup analyses were not possible by sex of twins, chorionicity or gestational age due to insufficient data.\nAuthors' conclusions\nVery low-certainty evidence suggests that EFWD identified by ultrasound has low sensitivity but good specificity in detecting BWD in twin pregnancies. There is uncertain diagnostic value of EFWD; this review suggests there is insufficient evidence to support this index as the sole measure for clinical decision making to evaluate the prognosis of twins with growth discordance. The diagnostic accuracy of other measures including amniotic fluid index and umbilical artery Doppler resistive indices in combination with ultrasound for clinical intervention requires evaluation. Future well-designed studies could also evaluate the impact of chorionicity, sex and gestational age in the diagnostic accuracy of ultrasound for EFWD.\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": "Birth weight differences of more than 20% in twins is associated with poor outcomes for the mother and baby. Clinicians measure the estimated fetal weight differences by ultrasound before birth and compare it to differences in birth weight after the babies are born. In this review, we summarized data on whether the ultrasound measurements are accurate enough to predict birth weight differences in twins."
}
] |
query-laysum
|
23955
|
[
{
"role": "user",
"content": "Abstract: Background\nDonor site wounds of split-thickness skin grafts can be a major cause of morbidity. Choosing the appropriate dressing for these wounds is crucial to successful healing. Various types of dressing are available, including hydrogel dressings. A review of current evidence is required to guide clinical decision-making on the choice of dressing for the treatment of donor sites of split-thickness skin grafts.\nObjectives\nTo assess the effects of hydrogel dressings on donor site wounds following split-thickness skin grafts for wound healing.\nSearch methods\nIn July 2022 we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL EBSCO Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication, or study setting.\nSelection criteria\nRandomised controlled trials (RCTs) comparing hydrogel dressings with other types of dressing, topical treatments or no dressing, or with different types of hydrogel dressings in managing donor site wounds irrespective of language and publication status.\nData collection and analysis\nTwo review authors independently carried out data extraction, risk of bias assessment using the Cochrane risk of bias tool, RoB 1, and quality assessment according to GRADE methodology.\nMain results\nWe included two studies (162 participants) in this review. One study with three arms and 101 participants (15 months' duration) was conducted in a children's hospital, and compared hydrogel dressings in the form of Sorbact with Algisite, an alginate dressing and Cuticerin, a smooth acetate gauze impregnated with water-repellent ointment. Another study with two arms and 61 participants (19 months' duration) was conducted in three surgery departments and compared an octenidine-containing hydrogel dressing with an identical non-antimicrobial hydrogel dressing. We identified no studies that compared hydrogel dressings with another therapy such as a topical agent (a topical agent is a cream, an ointment or a solution that is applied directly to the wound), or no dressing, or a combination of hydrogel dressings and another therapy versus another therapy alone. Both studies were at high risk of attrition bias and the second study was also at unclear risk of selection bias.\nAmorphous hydrogel dressings versus other types of dressings\nAmorphous hydrogel dressings may increase time to wound healing when compared with alginate (mean difference (MD) 1.67 days, 95% confidence interval (CI) 0.56 to 2.78; 1 study, 69 participants; low-certainty evidence) or Cuticerin dressings (MD 1.67 days, 95% CI 0.55 to 2.79; 1 study, 68 participants; low-certainty evidence). The effect of amorphous hydrogel dressings compared with other types of dressings is uncertain for pain at the donor site and wound complications, including scarring and itching (very low-certainty evidence). No adverse events were reported in any of the groups. The study did not report health-related quality of life or wound infection.\nOctenidine-based hydrogel dressing versus octenidine-free hydrogel dressing\nThe effect of octenidine-based hydrogel dressings versus octenidine-free hydrogel dressings is uncertain for time to wound healing (MD 0.40, 95% CI 0.28 to 0.52; 1 study, 41 participants) and wound infection, as the certainty of the evidence is very low. The certainty of the evidence is also very low for adverse events, with two participants in the intervention group and one participant in the comparison group reporting adverse events (risk ratio (RR) 0.58, 95% CI 0.06 to 5.89; 1 study, 41 participants). The study did not report donor site pain, health-related quality of life, or wound complications.\nAuthors' conclusions\nThere is insufficient evidence to determine the effect of hydrogel dressings on donor site wounds of split thickness skin grafts compared with other types of dressings. There is a need for adequately powered and well-designed RCTs, with adequate sample sizes, types of populations and subgroups, types of interventions, and outcomes, that compare hydrogel dressings with other treatment options in the treatment of donor site wounds of split-thickness skin grafts.\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 for studies that compared hydrogel dressings with other treatments for healing donor site wounds after partial skin grafts. We analysed the results and rated our confidence in the combined evidence based on the size and quality of the included studies."
}
] |
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