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query-laysum | 4246 | [
{
"role": "user",
"content": "Abstract: Background\nThe incidence of hip fracture is increasing and it is more common with increasing age. Surgery is used for almost all hip fractures. Blood loss occurs as a consequence of both the fracture and the surgery and thus red blood cell transfusion is frequently used. However, red blood cell transfusion is not without risks. Therefore, it is important to identify the evidence for the effective and safe use of red blood cell transfusion in people with hip fracture.\nObjectives\nTo assess the effects (benefits and harms) of red blood cell transfusion in people undergoing surgery for hip fracture.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (31 October 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2014, Issue 10), MEDLINE (January 1946 to 20 November 2014), EMBASE (January 1974 to 20 November 2014), CINAHL (January 1982 to 20 November 2014), British Nursing Index Database (January 1992 to 20 November 2014), the Systematic Review Initiative's Transfusion Evidence Library, PubMed for e-publications, various other databases and ongoing trial registers.\nSelection criteria\nRandomised controlled trials comparing red blood cell transfusion versus no transfusion or an alternative to transfusion, different transfusion protocols or different transfusion thresholds in people undergoing surgery for hip fracture.\nData collection and analysis\nThree review authors independently assessed each study's risk of bias and extracted data using a study-specific form. We pooled data where there was homogeneity in the trial comparisons and the timing of outcome measurement. We used GRADE criteria to assess the quality (low, moderate or high) of the evidence for each outcome.\nMain results\nWe included six trials (2722 participants): all compared two thresholds for red blood cell transfusion: a 'liberal' strategy to maintain a haemoglobin concentration of usually 10 g/dL versus a more 'restrictive' strategy based on symptoms of anaemia or a lower haemoglobin concentration, usually 8 g/dL. The exact nature of the transfusion interventions, types of surgery and participants varied between trials. The mean age of participants ranged from 81 to 87 years and approximately 24% of participants were men. The largest trial enrolled 2016 participants, over 60% of whom had a history of cardiovascular disease. The percentage of participants receiving a red blood cell transfusion ranged from 74% to 100% in the liberal transfusion threshold group and from 11% to 45% in the restrictive transfusion threshold group. There were no results available for the smallest trial (18 participants). All studies were at some risk of bias, in particular performance bias relating to the absence of blinding of personnel. We judged the evidence for all outcomes, except myocardial infarction, was low quality reflecting risk of bias primarily from imbalances in protocol violations in the largest trial and imprecision, often because of insufficient events. Thus, further research is likely to have an important impact on these results.\nThere was no evidence of a difference between a liberal versus restricted threshold transfusion in mortality, at 30 days post hip fracture surgery (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.67 to 1.26; five trials; 2683 participants; low quality evidence) or at 60 days post surgery (RR 1.08, 95% CI 0.80 to 1.44; three trials; 2283 participants; low quality evidence). Assuming an illustrative baseline risk of 50 deaths per 1000 participants in the restricted threshold group at 30 days, these data equate to four fewer (95% CI 17 fewer to 14 more) deaths per 1000 in the liberal threshold group at 30 days.\nThere was no evidence of a difference between a liberal versus restricted threshold transfusion in functional recovery at 60 days, assessed in terms of the inability to walk 10 feet (3 m) without human assistance (RR 1.00, 95% CI 0.87 to 1.15; two trials; 2083 participants; low quality evidence).\nThere was low quality evidence of no difference between the transfusion thresholds in postoperative morbidity for the following complications: thromboembolism (RR 1.15 favouring a restrictive threshold, 95% CI 0.56 to 2.37; four trials; 2416 participants), stroke (RR 2.40 favouring a restrictive threshold, 95% CI 0.85 to 6.79; four trials; 2416 participants), wound infection (RR 1.61 favouring a restrictive threshold, 95% CI 0.77 to 3.35; three trials; 2332 participants), respiratory infection (pneumonia) (RR 1.35 favouring a restrictive threshold, 95% CI 0.95 to 1.92; four trials; 2416 participants) and new diagnosis of congestive heart failure (RR 0.77 favouring a liberal threshold, 95% CI 0.48 to 1.23; three trials; 2332 participants). There was very low quality evidence of a lower risk of myocardial infarction in the liberal compared with the restrictive transfusion threshold group (RR 0.59, 95% CI 0.36 to 0.96; three trials; 2217 participants). Assuming an illustrative baseline risk of myocardial infarction of 24 per 1000 participants in the restricted threshold group, this result was compatible with between one and 15 fewer myocardial infarctions in the liberal threshold group.\nAuthors' conclusions\nWe found low quality evidence of no difference in mortality, functional recovery or postoperative morbidity between 'liberal' versus 'restrictive' thresholds for red blood cell transfusion in people undergoing surgery for hip fracture. Although further research may change the estimates of effect, the currently available evidence does not support the use of liberal red blood cell transfusion thresholds based on a 10 g/dL haemoglobin trigger in preference to more restrictive transfusion thresholds based on lower haemoglobin levels or symptoms of anaemia in these people. Future research needs to address the effectiveness of red blood cell transfusions at different time points in the surgical pathway, whether pre-operative, peri-operative or postoperative. In particular, such research would need to consider people who are symptomatic or haemodynamically unstable who were excluded from most of these trials.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found no difference between the two transfusion threshold groups in the number of people who had died at 30 and 60 days after their operation. We found similar numbers of people in the two groups were unable to walk 10 feet (3 metres) or across a room without help at 60-day follow-up.\nWe were interested in the number of major complications following surgery (thromboembolism (blood clots), stroke, chest and wound infection, and cardiovascular events (heart attacks, heart failure or abnormal heart rhythms)). There was little difference between the two transfusion threshold groups in the number of people experiencing any of these major complications. Although we found the risk of a heart attack was lower in people treated with the liberal red blood cell transfusion threshold than in people treated with the restrictive red blood cell transfusion threshold, we are very unsure of this finding."
}
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query-laysum | 4247 | [
{
"role": "user",
"content": "Abstract: Background\nInvasive fungal infections (IFIs) are life-threatening opportunistic infections that occur in immunocompromised or critically ill people. Early detection and treatment of IFIs is essential to reduce morbidity and mortality in these populations. (1→3)-β-D-glucan (BDG) is a component of the fungal cell wall that can be detected in the serum of infected individuals. The serum BDG test is a way to quickly detect these infections and initiate treatment before they become life-threatening. Five different versions of the BDG test are commercially available: Fungitell, Glucatell, Wako, Fungitec-G, and Dynamiker Fungus.\nObjectives\nTo compare the diagnostic accuracy of commercially available tests for serum BDG to detect selected invasive fungal infections (IFIs) among immunocompromised or critically ill people.\nSearch methods\nWe searched MEDLINE (via Ovid) and Embase (via Ovid) up to 26 June 2019. We used SCOPUS to perform a forward and backward citation search of relevant articles. We placed no restriction on language or study design.\nSelection criteria\nWe included all references published on or after 1995, which is when the first commercial BDG assays became available. We considered published, peer-reviewed studies on the diagnostic test accuracy of BDG for diagnosis of fungal infections in immunocompromised people or people in intensive care that used the European Organization for Research and Treatment of Cancer (EORTC) criteria or equivalent as a reference standard. We considered all study designs (case-control, prospective consecutive cohort, and retrospective cohort studies). We excluded case studies and studies with fewer than ten participants. We also excluded animal and laboratory studies. We excluded meeting abstracts because they provided insufficient information.\nData collection and analysis\nWe followed the standard procedures outlined in the Cochrane Handbook for Diagnostic Test Accuracy Reviews. Two review authors independently screened studies, extracted data, and performed a quality assessment for each study. For each study, we created a 2 × 2 matrix and calculated sensitivity and specificity, as well as a 95% confidence interval (CI). We evaluated the quality of included studies using the Quality Assessment of Studies of Diagnostic Accuracy-Revised (QUADAS-2). We were unable to perform a meta-analysis due to considerable variation between studies, with the exception of Candida, so we have provided descriptive statistics such as receiver operating characteristics (ROCs) and forest plots by test brand to show variation in study results.\nMain results\nWe included in the review 49 studies with a total of 6244 participants. About half of these studies (24/49; 49%) were conducted with people who had cancer or hematologic malignancies. Most studies (36/49; 73%) focused on the Fungitell BDG test. This was followed by Glucatell (5 studies; 10%), Wako (3 studies; 6%), Fungitec-G (3 studies; 6%), and Dynamiker (2 studies; 4%). About three-quarters of studies (79%) utilized either a prospective or a retrospective consecutive study design; the remainder used a case-control design.\nBased on the manufacturer's recommended cut-off levels for the Fungitell test, sensitivity ranged from 27% to 100%, and specificity from 0% to 100%. For the Glucatell assay, sensitivity ranged from 50% to 92%, and specificity ranged from 41% to 94%. Limited studies have used the Dynamiker, Wako, and Fungitec-G assays, but individual sensitivities and specificities ranged from 50% to 88%, and from 60% to 100%, respectively. Results show considerable differences between studies, even by manufacturer, which prevented a formal meta-analysis. Most studies (32/49; 65%) had no reported high risk of bias in any of the QUADAS-2 domains. The QUADAS-2 domains that had higher risk of bias included participant selection and flow and timing.\nAuthors' conclusions\nWe noted considerable heterogeneity between studies, and these differences precluded a formal meta-analysis. Because of wide variation in the results, it is not possible to estimate the diagnostic accuracy of the BDG test in specific settings. Future studies estimating the accuracy of BDG tests should be linked to the way the test is used in clinical practice and should clearly describe the sampling protocol and the relationship of time of testing to time of diagnosis.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors searched for and reviewed studies published up to June 2019."
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query-laysum | 4248 | [
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers, which are localised injury to the skin or underlying tissue, or both, occur when people are unable to reposition themselves to relieve pressure on bony prominences. Pressure ulcers are often difficult to heal, painful and impact negatively on the individual's quality of life. The cost implications of pressure ulcer treatment are considerable, compounding the challenges in providing cost effective, efficient health service delivery. International guidelines suggest that to prevent and manage pressure ulcers successfully a team approach is required. Therefore, this review has been conducted to clarify the role of wound-care teams in the prevention and management of pressure ulcers.\nObjectives\nTo assess the impact of wound-care teams in preventing and treating pressure ulcers in people of any age, nursed in any healthcare setting.\nSearch methods\nIn April 2015 we searched: 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 with respect to language, date of publication or study setting.\nSelection criteria\nWe considered RCTs that evaluated the effect of any configuration of wound-care teams in the treatment or prevention of pressure ulcers.\nData collection and analysis\nTwo review authors independently assessed titles and, where available, abstracts of the studies identified by the search strategy for their eligibility. We obtained full versions of potentially relevant studies and two review authors independently screened these against the inclusion criteria.\nMain results\nWe identified no studies that met the inclusion criteria.\nAuthors' conclusions\nWe set out to evaluate the RCT evidence pertaining to the impact of wound-care teams on the prevention and management of pressure ulcers. However, no studies met the inclusion criteria. There is a lack of evidence concerning whether wound-care teams make a difference to the incidence or healing of pressure ulcers. Well-designed trials addressing important clinical, quality of life and economic outcomes are justified, based on the incidence of the problem and the high costs associated with pressure ulcer management.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies on 7 April 2015 and found no studies. Because we found no studies to include in this review, we cannot say whether wound-care teams improve the prevention or management of pressure ulcers. Therefore, the impact of wound-care teams on the prevention and management of pressure ulcers needs to be studied.\nThe evidence of this review is up-to-date as of 7 April 2015."
}
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query-laysum | 4249 | [
{
"role": "user",
"content": "Abstract: Background\nLow-back pain (LBP) is responsible for considerable personal suffering due to pain and reduced function, as well as the societal burden due to costs of health care and lost work productivity. For the vast majority of people with LBP, no specific anatomical cause can be reliably identified. For these people with non-specific LBP there are numerous treatment options, few of which have been shown to be effective in reducing pain and disability. The muscle energy technique (MET) is a treatment technique used predominantly by osteopaths, physiotherapists and chiropractors which involves alternating periods of resisted muscle contractions and assisted stretching. To date it is unclear whether MET is effective in reducing pain and improving function in people with LBP.\nObjectives\nTo examine the effectiveness of MET in the treatment of people with non-specific LBP compared with control interventions, with particular emphasis on subjective pain and disability outcomes.\nSearch methods\nCENTRAL, MEDLINE, EMBASE, five other databases and two trials registers were searched from inception to May and June 2014 together with reference checking and citation searching of relevant systematic reviews.\nSelection criteria\nRandomised controlled trials assessing the effect of MET on pain or disability in patients with non-specific LBP were included.\nData collection and analysis\nTwo authors independently assessed the risk of bias and extracted the data. Meta-analysis was performed where clinical homogeneity was sufficient. The quality of the evidence for each comparison was assessed with the GRADE approach.\nMain results\nThere were 12 randomised controlled trials with 14 comparisons included in the review, with a total sample of 500 participants across all comparisons. Included studies were typically very small (n = 20 to 72), all except one were assessed as being at high risk of bias, and all reported short-term outcomes. For the purposes of pooling, studies were divided into seven clinically homogenous comparisons according to the patient population (acute or chronic LBP) and the nature of the control intervention. Most of the comparisons (five out of seven) included only one study, one comparison had two studies, and one comparison included seven studies.\nThe meta-analyses provided low-quality evidence that MET provided no additional benefit when added to other therapies on the outcomes of chronic pain and disability in the short-term (weighted mean difference (WMD) for pain 0.00, 95% CI -2.97 to 2.98 on a 100-point scale; standardised mean difference (SMD) for disability -0.18, 95% CI -0.43 to 0.08, 7 studies, 232 participants). There was low-quality evidence that MET produced no clinically relevant differences in pain compared to sham MET (mean difference (MD) 14.20, 95% CI -10.14 to 38.54, 1 study, 20 participants). For the comparison of MET to other conservative therapies for acute non-specific LBP, there was very low-quality evidence of no clinically relevant difference for the outcomes of pain (MD -10.72, 95% CI -32.57 to 11.13, 2 studies, 88 participants) and functional status (MD 0.87, 95% CI -6.31 to 8.05, 1 study, 60 participants). For the comparison of MET to other conservative therapies for chronic non-specific LBP, there was low-quality evidence of no clinically relevant difference for the outcomes of pain (MD -9.70, 95% CI -20.20 to 0.80, 1 study, 30 participants) and functional status (MD -4.10, 95% CI -9.53 to 1.33, 1 study, 30 participants). There was low-quality evidence of no clinically relevant difference for the addition of MET to other interventions for acute non-specific LBP for the outcome of pain (MD -3, 95% CI -11.37 to 5.37, 1 study, 40 participants) and low-quality evidence of an effect in favour of MET for functional status (MD -17.6, 95% CI -27.05 to -8.15, 1 study, 40 participants). For chronic non-specific LBP, there was low-quality evidence of an effect in favour of MET for the addition of MET to other interventions for the outcomes of pain (MD -34.1, 95% CI -38.43 to -29.77, 1 study, 30 participants) and functional status (MD -22, 95% CI -27.41 to -16.59, 1 study, 30 participants). Lastly, there was low-quality evidence of no difference for the addition of MET to another manual intervention compared to the same intervention with other conservative therapies for the outcomes of pain (MD 5.20, 95% CI -3.03 to 13.43, 1 study, 20 participants) and functional status (MD 6.0, 95% CI -0.49 to 12.49, 1 study, 20 participants).\nNo study reported on our other primary outcome of general well-being. Seven studies reported that no adverse events were observed, whereas the other five studies did not report any information on adverse events.\nAuthors' conclusions\nThe quality of research related to testing the effectiveness of MET is poor. Studies are generally small and at high risk of bias due to methodological deficiencies. Studies conducted to date generally provide low-quality evidence that MET is not effective for patients with LBP. There is not sufficient evidence to reliably determine whether MET is likely to be effective in practice. Large, methodologically-sound studies are necessary to investigate this question.\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": "Low-back pain (LBP) is a common symptom from adolescence into old age. About 50% of the general population experiences back pain over the course of a year and up to 80% of people report LBP over the course of their lifetimes.\nThe vast majority of people have acute (short-term) back pain and recover within a few weeks, with or without treatment.\nLonger lasting LBP, subacute (for 6 to 12 weeks) and chronic (> 12 weeks) pain, generally has less favourable outcomes. A small proportion of people with acute LBP go on to have chronic disabling LBP, which can interfere with every aspect of normal living, cause significant pain and suffering, and create huge costs in terms of medical care, work disability, and workers’ compensation claims.\nThere are many therapies claimed to be useful for the treatment of LBP. Most of these treatments have not been well investigated or have been found to have modest effects in terms of pain relief and improving disability. For many people with LBP, however, even modestly effective treatments can help in coping with symptoms and returning to normal living. It is therefore useful to explore the effectiveness of treatments that may assist people with LBP, particularly those treatments such as MET which are non-invasive and are likely to be safe and inexpensive."
}
]
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query-laysum | 4250 | [
{
"role": "user",
"content": "Abstract: Background\nHeavy menstrual bleeding and pain are common reasons women discontinue intrauterine device (IUD) use. Copper IUD (Cu IUD) users tend to experience increased menstrual bleeding, whereas levonorgestrel IUD (LNG IUD) users tend to have irregular menstruation. Medical therapies used to reduce heavy menstrual bleeding or pain associated with Cu and LNG IUD use include non-steroidal anti-inflammatory drugs (NSAIDs), anti-fibrinolytics and paracetamol. We analysed treatment and prevention interventions separately because the expected outcomes for treatment and prevention interventions differ. We did not combine different drug classes in the analysis as they have different mechanisms of action. This is an update of a review originally on NSAIDs. The review scope has been widened to include all interventions for treatment or prevention of heavy menstrual bleeding or pain associated with IUD use.\nObjectives\nTo evaluate all randomized controlled trials (RCTs) that have assessed strategies for treatment and prevention of heavy menstrual bleeding or pain associated with IUD use, for example, pharmacotherapy and alternative therapies.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and CINAHL to January 2021.\nSelection criteria\nWe included RCTs in any language that tested strategies for treatment or prevention of heavy menstrual bleeding or pain associated with IUD (Cu IUD, LNG IUD or other IUD) use. The comparison could be no intervention, placebo or another active intervention.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, and extracted data. Primary outcomes were volume of menstrual blood loss, duration of menstruation and painful menstruation. We used a random-effects model in all meta-analyses. Review authors assessed the certainty of evidence using GRADE.\nMain results\nThis review includes 21 trials involving 3689 participants from middle- and high-income countries. Women were 18 to 45 years old and either already using an IUD or had just had one placed for contraception. The included trials examined NSAIDs and other interventions. Eleven were treatment trials, of these seven were on users of the Cu IUD, one on LNG IUD and three on an unknown type. Ten were prevention trials, six focused on Cu IUD users, and four on LNG IUD users. Sixteen trials had high risk of detection bias due to subjective assessment of pain and bleeding.\nTreatment of heavy menstrual bleeding\nCu IUD\nVitamin B1 resulted in fewer pads used per day (mean difference (MD) −7.00, 95% confidence interval (CI) −8.50 to −5.50) and fewer bleeding days (MD −2.00, 95% CI –2.38 to −1.62; 1 trial; 110 women; low-certainty evidence) compared to placebo. The evidence is very uncertain about the effect of naproxen on the volume of menstruation compared to placebo (odds ratio (OR) 0.09, 95% CI 0.00 to 1.78; 1 trial, 40 women; very low-certainty evidence).\nTreatment with mefenamic acid resulted in less volume of blood loss compared to tranexamic acid (MD −64.26, 95% CI −105.65 to −22.87; 1 trial, 94 women; low-certainty evidence). However, there was no difference in duration of bleeding with treatment of mefenamic acid or tranexamic acid (MD 0.08 days, 95% CI −0.27 to 0.42, 2 trials, 152 women; low-certainty evidence).\nLNG IUD\nThe use of ulipristal acetate in LNG IUD may not reduce the number of bleeding days in 90 days in comparison to placebo (MD −9.30 days, 95% CI −26.76 to 8.16; 1 trial, 24 women; low-certainty evidence).\nUnknown IUD type\nMefenamic acid may not reduce volume of bleeding compared to Vitex agnus measured by pictorial blood assessment chart (MD −2.40, 95% CI −13.77 to 8.97; 1 trial; 84 women; low-certainty evidence).\nTreatment of pain\nCu IUD\nTreatment with tranexamic acid and sodium diclofenac may result in little or no difference in the occurrence of pain (OR 1.00, 95% CI 0.06 to 17.25; 1 trial, 38 women; very low-certainty evidence).\nUnknown IUD type\nNaproxen may reduce pain (MD 4.10, 95% CI 0.91 to 7.29; 1 trial, 33 women; low-certainty evidence).\nPrevention of heavy menstrual bleeding\nCu IUD\nWe found very low-certainty evidence that tolfenamic acid may prevent heavy bleeding compared to placebo (OR 0.54, 95% CI 0.34 to 0.85; 1 trial, 310 women). There was no difference between ibuprofen and placebo in blood volume reduction (MD −14.11, 95% CI −36.04 to 7.82) and duration of bleeding (MD −0.2 days, 95% CI −1.40 to 1.0; 1 trial, 28 women, low-certainty evidence).\nAspirin may not prevent heavy bleeding in comparison to paracetamol (MD −0.30, 95% CI −26.16 to 25.56; 1 trial, 20 women; very low-certainty evidence).\nLNG IUD\nUlipristal acetate may increase the percentage of bleeding days compared to placebo (MD 9.50, 95% CI 1.48 to 17.52; 1 trial, 118 women; low-certainty evidence). There were insufficient data for analysis in a single trial comparing mifepristone and vitamin B.\nThere were insufficient data for analysis in the single trial comparing tranexamic acid and mefenamic acid and in another trial comparing naproxen with estradiol.\nPrevention of pain\nCu IUD\nThere was low-certainty evidence that tolfenamic acid may not be effective to prevent painful menstruation compared to placebo (OR 0.71, 95% CI 0.44 to 1.14; 1 trial, 310 women). Ibuprofen may not reduce menstrual cramps compared to placebo (OR 1.00, 95% CI 0.11 to 8.95; 1 trial, 20 women, low-certainty evidence).\nAuthors' conclusions\nFindings from this review should be interpreted with caution due to low- and very low-certainty evidence. Included trials were limited; the majority of the evidence was derived from single trials with few participants. Further research requires larger trials and improved trial reporting. The use of vitamin B1 and mefenamic acid to treat heavy menstruation and tolfenamic acid to prevent heavy menstruation associated with Cu IUD should be investigated. More trials are needed to generate evidence for the treatment and prevention of heavy and painful menstruation associated with LNG IUD.\n\nGiven the provided abstract, please respond to the following query: \"Unknown IUD type\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In one study with an unknown IUD type, we found that mefenamic acid may not reduce the volume of menstrual bleeding."
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query-laysum | 4251 | [
{
"role": "user",
"content": "Abstract: Background\nEarly accurate detection of all skin cancer types is essential to guide appropriate management and to improve morbidity and survival. Melanoma and cutaneous squamous cell carcinoma (cSCC) are high-risk skin cancers which have the potential to metastasise and ultimately lead to death, whereas basal cell carcinoma (BCC) is usually localised with potential to infiltrate and damage surrounding tissue. Anxiety around missing early curable cases needs to be balanced against inappropriate referral and unnecessary excision of benign lesions. Computer-assisted diagnosis (CAD) systems use artificial intelligence to analyse lesion data and arrive at a diagnosis of skin cancer. When used in unreferred settings ('primary care'), CAD may assist general practitioners (GPs) or other clinicians to more appropriately triage high-risk lesions to secondary care. Used alongside clinical and dermoscopic suspicion of malignancy, CAD may reduce unnecessary excisions without missing melanoma cases.\nObjectives\nTo determine the accuracy of CAD systems for diagnosing cutaneous invasive melanoma and atypical intraepidermal melanocytic variants, BCC or cSCC in adults, and to compare its accuracy with that of dermoscopy.\nSearch methods\nWe undertook a comprehensive search of the following databases from inception up to August 2016: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; Embase; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We studied reference lists and published systematic review articles.\nSelection criteria\nStudies of any design that evaluated CAD alone, or in comparison with dermoscopy, in adults with lesions suspicious for melanoma or BCC or cSCC, and compared with a reference standard of either histological confirmation or clinical follow-up.\nData collection and analysis\nTwo review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). We contacted authors of included studies where information related to the target condition or diagnostic threshold were missing. We estimated summary sensitivities and specificities separately by type of CAD system, using the bivariate hierarchical model. We compared CAD with dermoscopy using (a) all available CAD data (indirect comparisons), and (b) studies providing paired data for both tests (direct comparisons). We tested the contribution of human decision-making to the accuracy of CAD diagnoses in a sensitivity analysis by removing studies that gave CAD results to clinicians to guide diagnostic decision-making.\nMain results\nWe included 42 studies, 24 evaluating digital dermoscopy-based CAD systems (Derm–CAD) in 23 study cohorts with 9602 lesions (1220 melanomas, at least 83 BCCs, 9 cSCCs), providing 32 datasets for Derm–CAD and seven for dermoscopy. Eighteen studies evaluated spectroscopy-based CAD (Spectro–CAD) in 16 study cohorts with 6336 lesions (934 melanomas, 163 BCC, 49 cSCCs), providing 32 datasets for Spectro–CAD and six for dermoscopy. These consisted of 15 studies using multispectral imaging (MSI), two studies using electrical impedance spectroscopy (EIS) and one study using diffuse-reflectance spectroscopy. Studies were incompletely reported and at unclear to high risk of bias across all domains. Included studies inadequately address the review question, due to an abundance of low-quality studies, poor reporting, and recruitment of highly selected groups of participants.\nAcross all CAD systems, we found considerable variation in the hardware and software technologies used, the types of classification algorithm employed, methods used to train the algorithms, and which lesion morphological features were extracted and analysed across all CAD systems, and even between studies evaluating CAD systems. Meta–analysis found CAD systems had high sensitivity for correct identification of cutaneous invasive melanoma and atypical intraepidermal melanocytic variants in highly selected populations, but with low and very variable specificity, particularly for Spectro–CAD systems. Pooled data from 22 studies estimated the sensitivity of Derm–CAD for the detection of melanoma as 90.1% (95% confidence interval (CI) 84.0% to 94.0%) and specificity as 74.3% (95% CI 63.6% to 82.7%). Pooled data from eight studies estimated the sensitivity of multispectral imaging CAD (MSI–CAD) as 92.9% (95% CI 83.7% to 97.1%) and specificity as 43.6% (95% CI 24.8% to 64.5%). When applied to a hypothetical population of 1000 lesions at the mean observed melanoma prevalence of 20%, Derm–CAD would miss 20 melanomas and would lead to 206 false-positive results for melanoma. MSI–CAD would miss 14 melanomas and would lead to 451 false diagnoses for melanoma. Preliminary findings suggest CAD systems are at least as sensitive as assessment of dermoscopic images for the diagnosis of invasive melanoma and atypical intraepidermal melanocytic variants. We are unable to make summary statements about the use of CAD in unreferred populations, or its accuracy in detecting keratinocyte cancers, or its use in any setting as a diagnostic aid, because of the paucity of studies.\nAuthors' conclusions\nIn highly selected patient populations all CAD types demonstrate high sensitivity, and could prove useful as a back-up for specialist diagnosis to assist in minimising the risk of missing melanomas. However, the evidence base is currently too poor to understand whether CAD system outputs translate to different clinical decision–making in practice. Insufficient data are available on the use of CAD in community settings, or for the detection of keratinocyte cancers. The evidence base for individual systems is too limited to draw conclusions on which might be preferred for practice. Prospective comparative studies are required that evaluate the use of already evaluated CAD systems as diagnostic aids, by comparison to face–to–face dermoscopy, and in participant populations that are representative of those in which the test would be used in practice.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The review authors searched for and used studies published up to August 2016.\n*In these studies, biopsy, clinical follow up, or specialist clinician diagnosis were the reference standards (means of establishing the final diagnosis)."
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query-laysum | 4252 | [
{
"role": "user",
"content": "Abstract: Background\nBronchiectasis is a common but under-diagnosed chronic disorder characterised by permanent dilation of the airways arising from a cycle of recurrent infection and inflammation. Symptoms including chronic, persistent cough and productive phlegm are a significant burden for people with bronchiectasis, and the main aim of treatment is to reduce exacerbation frequency and improve quality of life. Prophylactic antibiotic therapy aims to break this infection cycle and is recommended by clinical guidelines for adults with three or more exacerbations a year, based on limited evidence. It is important to weigh the evidence for bacterial suppression against the prevention of antibiotic resistance and further evidence is required on the safety and efficacy of different regimens of intermittently administered antibiotic treatments for people with bronchiectasis.\nObjectives\nTo evaluate the safety and efficacy of intermittent prophylactic antibiotics in the treatment of adults and children with bronchiectasis.\nSearch methods\nWe identified trials from the Cochrane Airways Trials Register, which contains studies identified through multiple electronic searches and handsearches of other sources. We also searched trial registries and reference lists of primary studies. We conducted searches on 6 September 2021, with no restriction on language of publication.\nSelection criteria\nWe included randomised controlled trials (RCTs) of at least three months' duration comparing an intermittent regime of prophylactic antibiotics with placebo, usual care or an alternate intermittent regimen. Intermittent prophylactic administration was defined as repeated courses of antibiotics with on-treatment and off-treatment intervals of at least 14 days' duration. We included adults and children with a clinical diagnosis of bronchiectasis confirmed by high resolution computed tomography (HRCT), plain film chest radiograph, or bronchography and a documented history of recurrent chest infections. We excluded studies where participants received high dose antibiotics immediately prior to enrolment or those with a diagnosis of cystic fibrosis, allergic bronchopulmonary aspergillosis (ABPA), primary ciliary dyskinesia, hypogammaglobulinaemia, sarcoidosis, or a primary diagnosis of COPD. Our primary outcomes were exacerbation frequency and serious adverse events. We did not exclude studies on the basis of review outcomes.\nData collection and analysis\nWe analysed dichotomous data as odds ratios (ORs) or relative risk (RRs) and continuous data as mean differences (MDs) or standardised mean differences (SMDs). We used standard methodological procedures expected by Cochrane. We conducted GRADE assessments for the following primary outcomes: exacerbation frequency; serious adverse events and secondary outcomes: antibiotic resistance; hospital admissions; health-related quality of life.\nMain results\nWe included eight RCTs, with interventions ranging from 16 to 48 weeks, involving 2180 adults. All evaluated one of three types of antibiotics over two to six cycles of 28 days on/off treatment: aminoglycosides, ß-lactams or fluoroquinolones. Two studies also included 12 cycles of 14 days on/off treatment with fluoroquinolones. Participants had a mean age of 63.6 years, 65% were women and approximately 85% Caucasian. Baseline FEV1 ranged from 55.5% to 62.6% predicted. None of the studies included children. Generally, there was a low risk of bias in the included studies.\nAntibiotic versus placebo: cycle of 14 days on/off. Ciprofloxacin reduced the frequency of exacerbations compared to placebo (RR 0.75, 95% CI 0.61 to 0.93; I2 = 65%; 2 studies, 469 participants; moderate-certainty evidence), with eight people (95% CI 6 to 28) needed to treat for an additional beneficial outcome. The intervention increased the risk of antibiotic resistance more than twofold (OR 2.14, 95% CI 1.36 to 3.35; I2 = 0%; 2 studies, 624 participants; high-certainty evidence). Serious adverse events, lung function (FEV1), health-related quality of life, and adverse effects did not differ between groups.\nAntibiotic versus placebo: cycle of 28 days on/off. Antibiotics did not reduce overall exacerbation frequency (RR 0.92, 95% CI 0.82 to 1.02; I2 = 0%; 8 studies, 1695 participants; high-certainty evidence) but there were fewer severe exacerbations (OR 0.59, 95% CI 0.37 to 0.93; I2 = 54%; 3 studies, 624 participants), though this should be interpreted with caution due to low event rates. The risk of antibiotic resistance was more than twofold higher based on a pooled analysis (OR 2.20, 95% CI 1.42 to 3.42; I2 = 0%; 3 studies, 685 participants; high-certainty evidence) and consistent with unpooled data from four further studies. Serious adverse events, time to first exacerbation, duration of exacerbation, respiratory-related hospital admissions, lung function, health-related quality of life and adverse effects did not differ between study groups.\nAntibiotic versus usual care. We did not find any studies that compared intermittent antibiotic regimens with usual care.\nCycle of 14 days on/off versus cycle of 28 days on/off. Exacerbation frequency did not differ between the two treatment regimens (RR 1.02, 95% CI 0.84 to 1.24; I2 = 71%; 2 studies, 625 participants; moderate-certainty evidence) However, inconsistencies in the results from the two trials in this comparison indicate that the apparent aggregated similarities may not be reliable. There was no evidence of a difference in antibiotic resistance between groups (OR 1.00, 95% CI 0.68 to 1.48; I2 = 60%; 2 studies, 624 participants; moderate-certainty evidence). Serious adverse events, adverse effects, lung function and health-related quality of life did not differ between the two antibiotic regimens.\nAuthors' conclusions\nOverall, in adults who have frequent chest infections, long-term antibiotics given at 14-day on/off intervals slightly reduces the frequency of those infections and increases antibiotic resistance. Intermittent antibiotic regimens result in little to no difference in serious adverse events. The impact of intermittent antibiotic therapy on children with bronchiectasis is unknown due to an absence of evidence, and further research is needed to establish the potential risks and benefits.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In general, the included studies were of good quality. We had moderate to high confidence in the quality of the evidence for frequency of chest infections and occurrence of antibiotic resistance."
}
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query-laysum | 4253 | [
{
"role": "user",
"content": "Abstract: Background\nSurgical excision by removal of the head of the pancreas to decompress the obstructed ducts is one of the treatment options for people with symptomatic chronic pancreatitis. Surgical excision of the head of the pancreas can be performed by excision of the duodenum along with the head of the pancreas (pancreaticoduodenectomy (PD)) or without excision of the duodenum (duodenum-preserving pancreatic head resection (DPPHR)). There is currently no consensus on the method of pancreatic head resection in people with chronic pancreatitis.\nObjectives\nTo assess the benefits and harms of duodenum-preserving pancreatic head resection versus pancreaticoduodenectomy in people with chronic pancreatitis for whom pancreatic resection is considered the main treatment option.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, and trials registers to June 2015 to identify randomised trials. We also searched the references of included trials to identify further trials.\nSelection criteria\nWe considered only randomised controlled trials (RCT) performed in people with chronic pancreatitis undergoing pancreatic head resection, irrespective of language, blinding, or publication status, for inclusion in the review.\nData collection and analysis\nTwo review authors independently identified trials and extracted data. We calculated the risk ratio (RR), mean difference (MD), rate ratio (RaR), or hazard ratio (HR) with 95% confidence intervals (CI) based on an available-case analysis.\nMain results\nFive trials including 292 participants met the inclusion criteria for the review. After exclusion of 23 participants mainly due to pancreatic cancer or because participants did not receive the planned treatment, a total of 269 participants (with symptomatic chronic pancreatitis involving the head of pancreas and requiring surgery) were randomly assigned to receive DPPHR (135 participants) or PD (134 participants). The trials did not report the American Society of Anesthesiologists (ASA) status of the participants. All the trials were single-centre trials and included people with and without obstructive jaundice and people with and without duodenal stenosis but did not report data separately for those with and without jaundice or those with and without duodenal stenosis. The surgical procedures compared in the five trials included DPPHR (Beger or Frey procedures, or wide local excision of the head of the pancreas) and PD (pylorus-preserving pancreaticoduodenectomy or Whipple procedure). The participants were followed up for various periods of time ranging from one to 15 years. The trials were at unclear or high risk of bias. The overall quality of evidence was low or very low.\nThe differences in short-term mortality (up to 90 days after surgery) (RR 2.89, 95% CI 0.31 to 26.87; 369 participants; 5 studies; DPPHR: 2/135 (1.5%) versus PD: 0/134 (0%); very low quality evidence) or long-term mortality (maximal follow-up) (HR 0.65, 95% CI 0.31 to 1.34; 229 participants; 4 studies; very low quality evidence), medium-term (three months to five years) (only a narrative summary was possible; 229 participants; 4 studies; very low quality evidence), or long-term quality of life (more than five years) (MD 8.45, 95% CI -0.27 to 17.18; 101 participants; 2 studies; low quality evidence), proportion of people with adverse events (RR 0.55, 95% CI 0.22 to 1.35; 226 participants; 4 studies; DPPHR: 23/113 (adjusted proportion 20%) versus PD: 41/113 (36.3%); very low quality evidence), number of people with adverse events (RaR 0.95, 95% CI 0.43 to 2.12; 43 participants; 1 study; DPPHR: 12/22 (54.3 events per 100 participants) versus PD: 12/21 (57.1 events per 100 participants); very low quality evidence), proportion of people employed (maximal follow-up) (RR 1.54, 95% CI 1.00 to 2.37; 189 participants; 4 studies; DPPHR: 65/98 (adjusted proportion 69.4%) versus PD: 41/91 (45.1%); low quality evidence), incidence proportion of diabetes mellitus (maximum follow-up) (RR 0.78, 95% CI 0.50 to 1.22; 269 participants; 5 studies; DPPHR: 25/135 (adjusted proportion 18.6%) versus PD: 32/134 (23.9%); very low quality evidence), and prevalence proportion of pancreatic exocrine insufficiency (maximum follow-up) (RR 0.83, 95% CI 0.68 to 1.02; 189 participants; 4 studies; DPPHR: 62/98 (adjusted proportion 62.0%) versus PD: 68/91 (74.7%); very low quality evidence) were imprecise. The length of hospital stay appeared to be lower with DPPHR compared to PD and ranged between a reduction of one day and five days in the trials (208 participants; 4 studies; low quality evidence). None of the trials reported short-term quality of life (four weeks to three months), clinically significant pancreatic fistulas, serious adverse events, time to return to normal activity, time to return to work, and pain scores using a visual analogue scale.\nAuthors' conclusions\nLow quality evidence suggested that DPPHR may result in shorter hospital stay than PD. Based on low or very low quality evidence, there is currently no evidence of any difference in the mortality, adverse events, or quality of life between DPPHR and PD. However, the results were imprecise and further RCTs are required on this topic. Future RCTs comparing DPPHR with PD should report the severity as well as the incidence of postoperative complications and their impact on patient recovery. In such trials, participant and observer blinding should be performed and the analysis should be performed on an intention-to-treat basis to decrease the bias. In addition to the short-term benefits and harms such as mortality, surgery-related complications, quality of life, length of hospital stay, return to normal activity, and return to work, future trials should consider linkage of trial participants to health databases, social databases, and mortality registers to obtain the long-term benefits and harms of the different treatments.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The differences in short-term (up to 90 days after surgery) or long-term (maximal follow-up) mortality, medium-term (three months to five years) or long-term (more than five years) quality of life, percentage and number of people with side effects, percentage of people employed (maximal follow-up), percentage of people who developed diabetes (maximum follow-up), and percentage of people with pancreatic digestive enzyme deficiency (maximum follow-up) were imprecise. The length of hospital stay appeared to be lower with DPPHR compared to PD and ranged between a reduction of one and five days in the trials. None of the trials reported short-term quality of life (four weeks to three months), clinically significant pancreatic fistulas (abnormal drainage of pancreatic juice internally or externally), serious side effects, time to return to normal activity, time to return to work, and pain scores using a visual analogue scale (a measurement tool to compare subjective measures such as pain that cannot be directly measured; pain levels between 0 and 10 or 0 and 100)."
}
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query-laysum | 4254 | [
{
"role": "user",
"content": "Abstract: Background\nSmoking is a leading cause of cardiovascular disease (CVD), particularly coronary heart disease (CHD). However, quitting smoking may prevent secondary CVD events in people already diagnosed with CHD.\nObjectives\nTo examine the impact of smoking cessation on death from CVD and major adverse cardiovascular events (MACE), in people with incident CHD.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group's Specialised Register, CENTRAL, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and the trials registries clinicaltrials.gov and the International Clinical Trials Registry Platform. We ran all searches from database inception to 15 April 2021.\nSelection criteria\nWe included cohort studies, and both cluster- and individually randomised controlled trials of at least six months' duration. We treated all included studies as cohort studies and analysed them by smoking status at follow-up. Eligible studies had to recruit adults (> 18 years) with diagnosed CHD and who smoked tobacco at diagnosis, and assess whether they quit or continued smoking during the study. Studies had to measure at least one of our included outcomes with at least six months' follow-up. Our primary outcomes were death from CVD and MACE. Secondary outcomes included all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, new-onset angina and change in quality of life.\nData collection and analysis\nWe followed standard Cochrane methods for screening and data extraction.\nWe assessed the risk of bias for the primary outcomes using the ROBINS-I tool. We compared the incidence of death from CVD and of MACE (primary outcomes) between participants who quit smoking versus those who continued to smoke for each included study that reported these outcomes. We also assessed differences in all-cause mortality, incidence of non-fatal myocardial infarction, incidence of non-fatal stroke and new onset angina. We calculated hazard ratios (HRs) and 95% confidence intervals (95% CI). For our outcome, change in quality of life, we calculated the pooled standardised mean difference (SMD) and 95% CI for the difference in change in quality of life from baseline to follow-up between those who had quit smoking and those who had continued to smoke. For all meta-analyses we used a generic inverse variance random-effects model and quantified statistical heterogeneity using the I²statistic.\nWe assessed the certainty of evidence for our primary outcomes using the eight GRADE considerations relevant to non-randomised studies.\nMain results\nWe included 68 studies, consisting of 80,702 participants.\nFor both primary outcomes, smoking cessation was associated with a decreased risk compared with continuous smoking: CVD death (HR 0.61, 95% CI 0.49 to 0.75; I² = 62%; 18 studies, 17,982 participants; moderate-certainty evidence) and MACE (HR 0.57, 95% CI 0.45 to 0.71; I² = 84%; 15 studies, 20,290 participants; low-certainty evidence). These findings were robust to our planned sensitivity analyses. Through subgroup analysis, for example comparing adjusted versus non-adjusted estimates, we found no evidence of differences in the effect size. While there was substantial heterogeneity, this was primarily in magnitude rather than the direction of the effect estimates. Overall, we judged 11 (16%) studies to be at moderate risk of bias and 18 (26%) at serious risk, primarily due to possible confounding. There was also some evidence of funnel plot asymmetry for MACE outcomes. For these reasons, we rated our certainty in the estimates for CVD death as moderate and MACE as low.\nFor our secondary outcomes, smoking cessation was associated with a decreased risk in all-cause mortality (HR 0.60, 95% CI 0.55 to 0.66; I² = 58%; 48 studies, 59,354 participants), non-fatal myocardial infarction (HR 0.64, 95% CI 0.58 to 0.72; I² = 2%; 24 studies, 23,264 participants) and non-fatal stroke (HR 0.70, 95% CI 0.53 to 0.90; I² = 0%; 9 studies, 11,352 participants). As only one study reported new onset of angina, we did not conduct meta-analysis, but this study reported a lower risk in people who stopped smoking. Quitting smoking was not associated with a worsening of quality of life and suggested improvement in quality of life, with the lower bound of the CI also consistent with no difference (SMD 0.12, 95% CI 0.01 to 0.24; I² = 48%; 8 studies, 3182 participants).\nAuthors' conclusions\nThere is moderate-certainty evidence that smoking cessation is associated with a reduction of approximately one-third in the risk of recurrent cardiovascular disease in people who stop smoking at diagnosis. This association may be causal, based on the link between smoking cessation and restoration of endothelial and platelet function, where dysfunction of both can result in increased likelihood of CVD events.\nOur results provide evidence that there is a decreased risk of secondary CVD events in those who quit smoking compared with those who continue, and that there is a suggested improvement in quality of life as a result of quitting smoking. Additional studies that account for confounding, such as use of secondary CVD prevention medication, would strengthen the evidence in this area.\n\nGiven the provided abstract, please respond to the following query: \"What are the results of our review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Compared with people who continued to smoke, people who stopped smoking were a third less likely to die from heart disease or stroke (evidence from 17,982 people in 18 studies) and a third less likely to have another heart attack or stroke (evidence from 20,290 people in 15 studies). Our confidence in these results was moderate (death from heart disease or stroke) and low (death from heart disease or stroke, another heart attack or another stroke) respectively. Our confidence in the strength of our results was reduced because of issues with how some of the studies were designed and carried out. However, when we only examined studies of a higher standard, we continued to find that people who stopped smoking were less likely to die from heart disease or stroke. This suggests that while we may be uncertain about how big the reduction in the chance of dying is, people who stop smoking are likely to reduce their chances of dying from heart disease or stroke to some degree. We found similar results for a decreased likelihood of dying from any cause, having another heart attack that does not lead to death and having a stroke that does not lead to death.\nWe also found that people who stopped smoking had a suggested improvement in quality of life compared with those who continued smoking after being diagnosed with heart disease."
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query-laysum | 4255 | [
{
"role": "user",
"content": "Abstract: Background\nAsthma is a respiratory (airway) condition that affects an estimated 300 million people worldwide and is associated with significant morbidity and mortality. Omalizumab is a monoclonal antibody that binds and inhibits free serum immunoglobulin E (IgE). It is called an 'anti-IgE' drug. IgE is an immune mediator involved in clinical manifestations of asthma. A recent update of National Institute for Health and Care Excellence (NICE) guidance in 2013 recommends omalizumab for use as add-on therapy in adults and children over six years of age with inadequately controlled severe persistent allergic IgE-mediated asthma who require continuous or frequent treatment with oral corticosteroids.\nObjectives\nTo assess the effects of omalizumab versus placebo or conventional therapy for asthma in adults and children.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register of trials for potentially relevant studies. The most recent search was performed in June 2013. We also checked the reference lists of included trials and searched online trial registries and drug company websites.\nSelection criteria\nRandomised controlled trials examining anti-IgE administered in any manner for any duration. Trials with co-interventions were included, as long as they were the same in each arm.\nData collection and analysis\nTwo review authors independently assessed study quality and extracted and entered data. Three modes of administration were identified from the published literature: inhaled, intravenous and subcutaneous injection. The main focus of the updated review is subcutaneous administration, as this route is currently used in clinical practice. Subgroup analysis was performed by asthma severity. Data were extracted from published and unpublished sources.\nMain results\nIn all, 25 trials were included in the review, including 11 new studies since the last update, for a total of 19 that considered the efficacy of subcutaneous anti-IgE treatment as an adjunct to treatment with corticosteroids.\nFor participants with moderate or severe asthma who were receiving background inhaled corticosteroid steroid (ICS) therapy, a significant advantage favoured subcutaneous omalizumab with regard to experiencing an asthma exacerbation (odds ratio (OR) 0.55, 95% confidence interval (CI) 0.42 to 0.60; ten studies, 3261 participants). This represents an absolute reduction from 26% for participants suffering an exacerbation on placebo to 16% on omalizumab, over 16 to 60 weeks. A significant benefit was noted for subcutaneous omalizumab versus placebo with regard to reducing hospitalisations (OR 0.16, 95% CI 0.06 to 0.42; four studies, 1824 participants), representing an absolute reduction in risk from 3% with placebo to 0.5% with omalizumab over 28 to 60 weeks. No separate data on hospitalisations were available for the severe asthma subgroup, and all of these data were reported for participants with the diagnosis of moderate to severe asthma. Participants treated with subcutaneous omalizumab were also significantly more likely to be able to withdraw their ICS completely than those treated with placebo (OR 2.50, 95% CI 2.00 to 3.13), and a small but statistically significant reduction in daily inhaled steroid dose was reported for omalizumab-treated participants compared with those given placebo (weighted mean difference (WMD) -118 mcg beclomethasone dipropionate (BDP) equivalent per day, 95% CI -154 to -84). However, no significant difference between omalizumab and placebo treatment groups was seen in the number of participants who were able to withdraw from oral corticosteroid (OCS) therapy (OR 1.18, 95% CI 0.53 to 2.63).\nParticipants treated with subcutaneous omalizumab as an adjunct to treatment with corticosteroids required a small but significant reduction in rescue beta2-agonist medication compared with placebo (mean difference (MD) -0.39 puffs per day, 95% CI -0.55 to -0.24; nine studies, 3524 participants). This benefit was observed in both the moderate to severe (MD -0.58, 95% CI -0.84 to -0.31) and severe (MD -0.30, 95% CI -0.49 to -0.10) asthma subgroups on a background therapy of inhaled corticosteroids; however, no significant difference between subcutaneous omalizumab and placebo was noted for this outcome in participants with severe asthma who were receiving a background therapy of inhaled plus oral corticosteroids. Significantly fewer serious adverse events were reported in participants assigned to subcutaneous omalizumab than in those receiving placebo (OR 0.72, 95% CI 0.57 to 0.91; 15 studies, 5713 participants), but more injection site reactions were observed (from 5.6% with placebo to 9.1% with omalizumab).\nTo reflect current clinical practice, discussion of the results is limited to subcutaneous use, and trials involving intravenous and inhaled routes have been archived.\nAuthors' conclusions\nOmalizumab was effective in reducing asthma exacerbations and hospitalisations as an adjunctive therapy to inhaled steroids and during steroid tapering phases of clinical trials. Omalizumab was significantly more effective than placebo in increasing the numbers of participants who were able to reduce or withdraw their inhaled steroids. Omalizumab was generally well tolerated, although more injection site reactions were seen with omalizumab. Further assessment in paediatric populations is necessary, as is direct double-dummy comparison with ICS. Although subgroup analyses suggest that participants receiving prednisolone had better asthma control when they received omalizumab, it remains to be tested prospectively whether the addition of omalizumab has a prednisolone-sparing effect. It is also not clear whether there is a threshold level of baseline serum IgE for optimum efficacy of omalizumab. Given the high cost of the drug, identification of biomarkers predictive of response is of major importance for future research.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Twenty-five studies, involving 6382 people, were included in this review. These studies lasted between eight and 60 weeks. All of the people included in the studies had asthma, of different severity. Both men and women were included, and some of the studies included children and young people.\nAll studies compared omalizumab versus placebo. In keeping with current medical practice, most studies (21 of 25) used omalizumab given by injection under the skin. Some of the older studies used omalizumab injected into a vein or given by inhalation. The evidence presented here is current to June 2013. Most of the studies were sponsored by the pharmaceutical industry."
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"role": "user",
"content": "Abstract: Background\nPostoperative pancreatic fistula (POPF) is one of the most frequent and potentially life-threatening complications following pancreatic surgery. Fibrin sealants have been used in some centres to reduce POPF rate. However, the use of fibrin sealant during pancreatic surgery is controversial. This is an update of a Cochrane Review last published in 2020.\nObjectives\nTo evaluate the benefits and harms of fibrin sealant use for the prevention of POPF (grade B or C) in people undergoing pancreatic surgery compared to no fibrin sealant use.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, two other databases, and five trials registers on 09 March 2023, together with reference checking, citation searching, and contacting study authors to identify additional studies.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that compared fibrin sealant (fibrin glue or fibrin sealant patch) versus control (no fibrin sealant or placebo) in people undergoing pancreatic surgery.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 14 RCTs, randomising 1989 participants, comparing fibrin sealant use versus no fibrin sealant use for different locations: stump closure reinforcement (eight trials), pancreatic anastomosis reinforcement (five trials), or main pancreatic duct occlusion (two trials). Six RCTs were carried out in single centres; two in dual centres; and six in multiple centres. One RCT was conducted in Australia; one in Austria; two in France; three in Italy; one in Japan; two in the Netherlands; two in South Korea; and two in the USA. The mean age of the participants ranged from 50.0 years to 66.5 years. All RCTs were at high risk of bias.\nApplication of fibrin sealants to pancreatic stump closure reinforcement after distal pancreatectomy\nWe included eight RCTs involving 1119 participants: 559 were randomised to the fibrin sealant group and 560 to the control group after distal pancreatectomy. Fibrin sealant use may result in little to no difference in the rate of POPF (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.73 to 1.21; 5 studies, 1002 participants; low-certainty evidence) and overall postoperative morbidity (RR 1.20, 95% CI 0.98 to 1.48; 4 studies, 893 participants; low-certainty evidence). After fibrin sealant use, approximately 199 people (155 to 256 people) out of 1000 developed POPF compared with 212 people out of 1000 when no fibrin sealant was used. The evidence is very uncertain about the effect of fibrin sealant use on postoperative mortality (Peto odds ratio (OR) 0.39, 95% CI 0.12 to 1.29; 7 studies, 1051 participants; very low-certainty evidence) and total length of hospital stay (mean difference (MD) 0.99 days, 95% CI -1.83 to 3.82; 2 studies, 371 participants; very low-certainty evidence). Fibrin sealant use may reduce the reoperation rate slightly (RR 0.40, 95% CI 0.18 to 0.90; 3 studies, 623 participants; low-certainty evidence). Serious adverse events were reported in five studies (732 participants), and there were no serious adverse events related to fibrin sealant use (low-certainty evidence). The studies did not report quality of life or cost-effectiveness.\nApplication of fibrin sealants to pancreatic anastomosis reinforcement after pancreaticoduodenectomy\nWe included five RCTs involving 519 participants: 248 were randomised to the fibrin sealant group and 271 to the control group after pancreaticoduodenectomy. The evidence is very uncertain about the effect of fibrin sealant use on the rate of POPF (RR 1.34, 95% CI 0.72 to 2.48; 3 studies, 323 participants; very low-certainty evidence), postoperative mortality (Peto OR 0.24, 95% CI 0.05 to 1.06; 5 studies, 517 participants; very low-certainty evidence), reoperation rate (RR 0.74, 95% CI 0.33 to 1.66; 3 studies, 323 participants; very low-certainty evidence), and total hospital cost (MD -1489.00 US dollars, 95% CI -3256.08 to 278.08; 1 study, 124 participants; very low-certainty evidence). After fibrin sealant use, approximately 130 people (70 to 240 people) out of 1000 developed POPF compared with 97 people out of 1000 when no fibrin sealant was used. Fibrin sealant use may result in little to no difference both in overall postoperative morbidity (RR 1.02, 95% CI 0.87 to 1.19; 4 studies, 447 participants; low-certainty evidence) and in total length of hospital stay (MD -0.33 days, 95% CI -2.30 to 1.63; 4 studies, 447 participants; low-certainty evidence). Serious adverse events were reported in two studies (194 participants), and there were no serious adverse events related to fibrin sealant use (very low-certainty evidence). The studies did not report quality of life.\nApplication of fibrin sealants to pancreatic duct occlusion after pancreaticoduodenectomy\nWe included two RCTs involving 351 participants: 188 were randomised to the fibrin sealant group and 163 to the control group after pancreaticoduodenectomy. The evidence is very uncertain about the effect of fibrin sealant use on postoperative mortality (Peto OR 1.41, 95% CI 0.63 to 3.13; 2 studies, 351 participants; very low-certainty evidence), overall postoperative morbidity (RR 1.16, 95% CI 0.67 to 2.02; 2 studies, 351 participants; very low-certainty evidence), and reoperation rate (RR 0.85, 95% CI 0.52 to 1.41; 2 studies, 351 participants; very low-certainty evidence). Fibrin sealant use may result in little to no difference in the total length of hospital stay (median 16 to 17 days versus 17 days; 2 studies, 351 participants; low-certainty evidence). Serious adverse events were reported in one study (169 participants; low-certainty evidence): more participants developed diabetes mellitus when fibrin sealants were applied to pancreatic duct occlusion, both at three months' follow-up (33.7% fibrin sealant group versus 10.8% control group; 29 participants versus 9 participants) and 12 months' follow-up (33.7% fibrin sealant group versus 14.5% control group; 29 participants versus 12 participants). The studies did not report POPF, quality of life, or cost-effectiveness.\nAuthors' conclusions\nBased on the current available evidence, fibrin sealant use may result in little to no difference in the rate of POPF in people undergoing distal pancreatectomy. The evidence is very uncertain about the effect of fibrin sealant use on the rate of POPF in people undergoing pancreaticoduodenectomy. The effect of fibrin sealant use on postoperative mortality is uncertain in people undergoing either distal pancreatectomy or pancreaticoduodenectomy.\n\nGiven the provided abstract, please respond to the following query: \"What is a postoperative pancreatic fistula?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"content": "A postoperative pancreatic fistula is a potentially life-threatening complication that may follow major surgery for cancer or inflammation of the pancreas. The pancreas is a digestive gland situated at the back of the upper abdomen. A fistula occurs when the pancreatic stump or the reconnection between the pancreas and the nearby gut does not heal properly, creating a leak of pancreatic juice from the pancreas to the abdominal tissue. This delays recovery from surgery and often requires further treatment to ensure complete healing."
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query-laysum | 4257 | [
{
"role": "user",
"content": "Abstract: Background\nThe introduction and advancement of enteral feeds for preterm or low birth weight infants is often delayed because of concerns that early full enteral feeding will not be well tolerated or may increase the risk of necrotising enterocolitis. Early full enteral feeding, however, might increase nutrient intake and growth rates; accelerate intestinal physiological, metabolic, and microbiomic postnatal transition; and reduce the risk of complications associated with intravascular devices for fluid administration.\nObjectives\nTo determine how early full enteral feeding, compared with delayed or progressive introduction of enteral feeds, affects growth and adverse events such as necrotising enterocolitis, in preterm or low birth weight infants.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials; MEDLINE Ovid, Embase Ovid, Maternity & Infant Care Database Ovid, the Cumulative Index to Nursing and Allied Health Literature, and clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials to October 2020.\nSelection criteria\nRandomised controlled trials that compared early full enteral feeding with delayed or progressive introduction of enteral feeds in preterm or low birth weight infants.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal. Two review authors separately assessed trial eligibility, evaluated trial quality, extracted data, and synthesised effect estimates using risk ratios (RR), risk differences, and mean differences (MD) with 95% confidence intervals (CI). We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included six trials. All were undertaken in the 2010s in neonatal care facilities in India. In total, 526 infants participated. Most were very preterm infants of birth weight between 1000 g and 1500 g. Trials were of good methodological quality, but a potential source of bias was that parents, clinicians, and investigators were not masked. The trials compared early full feeding (60 mL/kg to 80 mL/kg on day one after birth) with minimal enteral feeding (typically 20 mL/kg on day one) supplemented with intravenous fluids. Feed volumes were advanced daily as tolerated by 20 mL/kg to 30 mL/kg body weight to a target steady-state volume of 150 mL/kg to 180 mL/kg/day. All participating infants were fed preferentially with maternal expressed breast milk, with two trials supplementing insufficient volumes with donor breast milk and four supplementing with preterm formula.\nFew data were available to assess growth parameters. One trial (64 participants) reported a slower rate of weight gain (median difference –3.0 g/kg/day), and another (180 participants) reported a faster rate of weight gain in the early full enteral feeding group (MD 1.2 g/kg/day). We did not meta-analyse these data (very low-certainty evidence). None of the trials reported rate of head circumference growth. One trial reported that the mean z-score for weight at hospital discharge was higher in the early full enteral feeding group (MD 0.24, 95% CI 0.06 to 0.42; low-certainty evidence). Meta-analyses showed no evidence of an effect on necrotising enterocolitis (RR 0.98, 95% CI 0.38 to 2.54; 6 trials, 522 participants; I² = 51%; very low-certainty evidence).\nAuthors' conclusions\nTrials provided insufficient data to determine with any certainty how early full enteral feeding, compared with delayed or progressive introduction of enteral feeds, affects growth in preterm or low birth weight infants. We are uncertain whether early full enteral feeding affects the risk of necrotising enterocolitis because of the risk of bias in the trials (due to lack of masking), inconsistency, and imprecision.\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": "'early full enteral feeding' means that preterm or low birth weight infants receive all their nutrition as milk feeds from shortly after birth, and do not receive any supplemental fluids or nutrition via intravenous drips. Assessing whether this approach is safe and beneficial is particularly relevant to feeding very preterm or very low birth weight infants (born before 32 weeks, or birth weigh less than 1500 g)."
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query-laysum | 4258 | [
{
"role": "user",
"content": "Abstract: Background\nThis review is an update of \"Single dose oral ketoprofen and dexketoprofen for acute postoperative pain in adults\" last updated in Issue 4, 2009. Ketoprofen is a non-selective nonsteroidal anti-inflammatory drug (NSAID) used to treat acute and chronic painful conditions. Dexketoprofen is the (S)-enantiomer, which is believed to confer analgesia. Theoretically dexketoprofen is expected to provide equivalent analgesia to ketoprofen at half the dose, with a consequent reduction in gastrointestinal adverse events. This review is one of a series on oral analgesics for acute postoperative pain. Individual reviews have been brought together in two overviews to provide information about the relative efficacy and harm of the different interventions.\nObjectives\nTo assess the efficacy and safety of single dose oral ketoprofen and oral dexketoprofen compared with placebo for acute postoperative pain, using methods that permit comparison with other analgesics evaluated in the same way, and criteria of efficacy recommended by an in-depth study at the individual patient level.\nSearch methods\nFor this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from 2009 to 28 March 2017. We also searched the reference lists of retrieved studies and reviews, and two online clinical trial registries.\nSelection criteria\nRandomised, double-blind, placebo-controlled trials of single dose orally administered ketoprofen or dexketoprofen in adults with moderate to severe acute postoperative pain.\nData collection and analysis\nTwo review authors independently considered studies for inclusion in the review, examined issues of study quality and potential bias, and extracted data. For dichotomous outcomes, we calculated risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNT) or harmful outcome (NNH) with 95% confidence intervals (CI) for ketoprofen and dexketoprofen, compared with placebo, where there were sufficient data. We collected information on the number of participants with at least 50% of the maximum possible pain relief over six hours, the median time to use of rescue medication, and the proportion of participants requiring rescue medication. We also collected information on adverse events and withdrawals. We assessed the quality of the evidence using GRADE, and created 'Summary of findings' tables.\nMain results\nThis updated review included 24 studies; six additional studies added 1001 participants involved in comparisons of ketoprofen or dexketoprofen and placebo, with a 12% increase in participants taking ketoprofen and a 65% increase for dexketoprofen. Most participants (70%) were women. Dental studies typically involved young participants (mean age 20 to 30 years); other types of surgery involved older participants (mean age 37 to 68 years). Overall, we judged the studies at high risk of bias only for small size, which can lead to an overestimation of benefit.\nKetoprofen doses ranged between 6.5 mg and 150 mg. The proportion of participants achieving at least 50% pain relief over six hours with the usual ketoprofen oral dose of 50 mg was 57%, compared to 23% with placebo, giving an NNT of 2.9 (95% CI 2.4 to 3.7) (RR 2.5, 95% CI 2.0 to 3.1; 594 participants; 8 studies; high quality evidence). Efficacy was significantly better in dental studies (NNT 1.8) than other surgery (NNT 4.2). The proportion of participants using rescue medication within six hours was lower with ketoprofen (32%) than with placebo (75%), giving a number needed to treat to prevent use of rescue medication (NNTp) of 2.3 (95% CI 1.8 to 3.1); 263 participants; 4 studies; high quality evidence). Median time to remedication estimates were poorly reported. Reports of any adverse event were similar with ketoprofen (18%) and placebo (11%) (RR 1.6, 95% CI 0.98 to 2.8; 342 participants; 5 studies; high quality evidence). No study reported any serious adverse events (very low quality evidence).\nDexketoprofen doses ranged between 5 mg and 100 mg. The proportion of participants achieving at least 50% pain relief over six hours with the usual dexketoprofen oral dose of 20 mg or 25 mg was 52%, compared to 27% with placebo, giving an NNT of 4.1 (95% CI 3.3 to 5.2) (RR 2.0, 95% CI 1.6 to 2.2; 1177 participants; 8 studies; high quality evidence). Efficacy was significantly better in dental studies (NNT 2.7) than other surgery (NNT 5.7). The proportion of participants using rescue medication within six hours was lower with dexketoprofen (47%) than placebo (69%), giving an NNTp of 4.7 (95% CI 3.3 to 8.0); 445 participants; 5 studies; high quality evidence). Median time to remedication estimates were poorly reported. Reports of any adverse event were similar with dexketoprofen (14%) and placebo (10%) (RR 1.4, 95% CI 0.89 to 2.2; 536 participants, 6 studies; high quality evidence). No study reported any serious adverse events (very low quality evidence).\nAuthors' conclusions\nKetoprofen at doses of 25 mg to 100 mg is an effective analgesic in moderate to severe acute postoperative pain with an NNT for at least 50% pain relief of 2.9 with a 50 mg dose. This is similar to that of commonly used NSAIDs such as ibuprofen (NNT 2.5 for 400 mg dose) and diclofenac (NNT 2.7 for 50 mg dose). Dexketoprofen is also effective with an NNT of 4.1 in the dose range 10 mg to 25 mg. Differential efficacy between dental surgery and other types of surgery seen for both drugs is unusual. Both drugs were well tolerated in single doses.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The quality of the evidence was judged to be high for most outcomes. This research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different is low."
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query-laysum | 4259 | [
{
"role": "user",
"content": "Abstract: Background\nPreterm infants are often growth-restricted at hospital discharge. Feeding nutrient-enriched formula rather than standard formula to infants after hospital discharge might facilitate 'catch-up' growth and might improve development.\nObjectives\nTo compare the effects of nutrient-enriched formula versus standard formula on growth and development of preterm infants after hospital discharge.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (2016, Issue 8) in the Cochrane Library, MEDLINE, Embase and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; to 8 September 2016), as well as conference proceedings and previous reviews.\nSelection criteria\nRandomised and quasi-randomised controlled trials that compared the effects of feeding nutrient-enriched formula (postdischarge formula or preterm formula) versus standard term formula to preterm infants after hospital discharge .\nData collection and analysis\nTwo review authors assessed trial eligibility and risk of bias and extracted data independently. We analysed treatment effects as described in the individual trials and reported risk ratios and risk differences for dichotomous data, and mean differences (MDs) for continuous data, with respective 95% confidence intervals (CIs). We used a fixed-effect model in meta-analyses and explored potential causes of heterogeneity by performing sensitivity analyses. We assessed quality of evidence at the outcome level using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nWe included 16 eligible trials with a total of 1251 infant participants. Trials were of variable methodological quality, with lack of allocation concealment and incomplete follow-up identified as major potential sources of bias. Trials (N = 11) that compared feeding infants with 'postdischarge formula' (energy density about 74 kcal/100 mL) versus standard term formula (about 67 kcal/100 mL) did not find consistent evidence of effects on growth parameters up to 12 to 18 months post term. GRADE assessments indicated that evidence was of moderate quality, and that inconsistency within pooled estimates was the main quality issue.\nTrials (N = 5) that compared feeding with 'preterm formula' (about 80 kcal/100 mL) versus term formula found evidence of higher rates of growth throughout infancy (weighted mean differences at 12 to 18 months post term: about 500 g in weight, 5 to 10 mm in length, 5 mm in head circumference). GRADE assessments indicated that evidence was of moderate quality, and that imprecision of estimates was the main quality issue.\nFew trials assessed neurodevelopmental outcomes, and these trials did not detect differences in developmental indices at 18 months post term. Data on growth or development through later childhood have not been provided.\nAuthors' conclusions\nRecommendations to prescribe 'postdischarge formula' for preterm infants after hospital discharge are not supported by available evidence. Limited evidence suggests that feeding 'preterm formula' (which is generally available only for in-hospital use) to preterm infants after hospital discharge may increase growth rates up to 18 months post term.\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": "Current recommendations to prescribe nutrient-enriched formula for preterm infants after hospital discharge are not supported by available evidence."
}
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query-laysum | 4260 | [
{
"role": "user",
"content": "Abstract: Background\nSexual problems are common among people with cardiovascular disease. Although clinical guidelines recommend sexual counselling for patients and their partners, there is little evidence on its effectiveness.\nObjectives\nTo evaluate the effectiveness of sexual counselling interventions (in comparison to usual care) on sexuality-related outcomes in patients with cardiovascular disease and their partners.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, and three other databases up to 2 March 2015 and two trials registers up to 3 February 2016.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs, including individual and cluster RCTs. We included studies that compared any intervention to counsel adult cardiac patients about sexual problems with usual care.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included three trials with 381 participants. We were unable to pool the data from the included studies due to the differences in interventions used; therefore we synthesised the trial findings narratively.\nTwo trials were conducted in the USA and one was undertaken in Israel. All trials included participants who were admitted to hospital with myocardial infarction (MI), and one trial also included participants who had undergone coronary artery bypass grafting. All trials followed up participants for a minimum of three months post-intervention; the longest follow-up timepoint was five months.\nOne trial (N = 92) tested an intensive (total five hours) psychotherapeutic sexual counselling intervention delivered by a sexual therapist. One trial (N = 115) used a 15-minute educational video plus written material on resuming sexual activity following a MI. One trial (N = 174) tested the addition of a component that focused on resumption of sexual activity following a MI within a hospital cardiac rehabilitation programme.\nThe quality of the evidence for all outcomes was very low.\nNone of the included studies reported any outcomes from partners.\nTwo trials reported sexual function. One trial compared intervention and control groups on 12 separate sexual function subscales and used a repeated measures analysis of variance (ANOVA) test. They reported statistically significant differences in favour of the intervention. One trial compared intervention and control groups using a repeated measures analysis of covariance (ANCOVA), and concluded: \"There were no significant differences between the two groups [for sexual function] at any of the time points\".\nTwo trials reported sexual satisfaction. In one trial, the authors compared sexual satisfaction between intervention and control and used a repeated measured ANOVA; they reported \"differences were reported in favour of the intervention\". One trial compared intervention and control with a repeated measures ANCOVA and reported: \"There were no significant differences between the two groups [for sexual satisfaction] at any of the timepoints\".\nAll three included trials reported the number of patients returning to sexual activity following MI. One trial found some evidence of an effect of sexual counselling on reported rate of return to sexual activity (yes/no) at four months after completion of the intervention (relative risk (RR) 1.71, 95% confidence interval (CI) 1.26 to 2.32; one trial, 92 participants, very low quality of evidence). Two trials found no evidence of an effect of sexual counselling on rate of return to sexual activity at 12 week (RR 1.01, 95% CI 0.94 to 1.09; one trial, 127 participants, very low quality of evidence) and three month follow-up (RR 0.98, 95% CI 0.88 to 1.10; one trial, 115 participants, very low quality of evidence).\nTwo trials reported psychological well-being. In one trial, no scores were reported, but the trial authors stated: \"No treatment effects were observed on state anxiety as measured in three points in time\". In the other trial no scores were reported but, based on results of a repeated measures ANCOVA to compare intervention and control groups, the trial authors stated: \"The experimental group had significantly greater anxiety at one month post MI\". They also reported: \"There were no significant differences between the two groups [for anxiety] at any other time points\".\nOne trial reporting relationship satisfaction and one trial reporting quality of life found no differences between intervention and control.\nNo trial reported on satisfaction in how sexual issues were addressed in cardiac rehabilitation services.\nAuthors' conclusions\nWe found no high quality evidence to support the effectiveness of sexual counselling for sexual problems in patients with cardiovascular disease. There is a clear need for robust, methodologically rigorous, adequately powered RCTs to test the effectiveness of sexual counselling interventions for people with cardiovascular disease and their partners.\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": "People with heart disease are more likely than people without heart disease to report sexual problems. Sexual counselling for people with heart disease is when a health professional supports a person to safely return to sexual activity after their heart event, by giving them information and helping them to deal with their concerns and anxieties."
}
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query-laysum | 4261 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane Review published in Issue 11, 2006 of the Cochrane Database of Systematic Reviews.\nEpilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment up to 70% of individuals with active epilepsy have the potential to become seizure-free, and to go into long-term remission shortly after starting drug therapy with a single antiepileptic drug (AED) in monotherapy.\nThe correct choice of first-line AED for individuals with newly diagnosed seizures is of great importance. It is important that the choice of AEDs for an individual is made using the highest quality evidence regarding the potential benefits and harms of the various treatments.\nCarbamazepine or lamotrigine are recommended as first-line treatments for new onset focal seizures and as a first- or second-line treatment for generalised tonic-clonic seizures. Performing a synthesis of the evidence from existing trials will increase the precision of the results for outcomes relating to efficacy and tolerability and may assist in informing a choice between the two drugs.\nObjectives\nTo review the time to treatment failure, remission and first seizure with lamotrigine compared to carbamazepine when used as monotherapy in people with focal onset seizures (simple or complex focal and secondarily generalised) or generalised onset tonic-clonic seizures (with or without other generalised seizure types).\nSearch methods\nWe conducted the first searches for this review in 1997. For the most recent 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), MEDLINE, Clinical Trials.gov and the WHO International Clinical Trials Registry Platform on 26 February 2018, without language restrictions\nSelection criteria\nRandomised controlled trials comparing monotherapy with either carbamazepine or lamotrigine in children or adults with focal onset seizures or generalised onset tonic-clonic seizures\nData collection and analysis\nThis was an individual participant data (IPD) review. Our primary outcome was time to treatment failure and our secondary outcomes were time to first seizure post randomisation, time to six-month, 12-month and 24-month remission, and incidence of adverse events. We used Cox proportional hazards regression models to obtain trial-specific estimates of hazard ratios (HRs) with 95% confidence intervals (CIs), using the generic inverse variance method to obtain the overall pooled HR and 95% CI.\nMain results\nWe included 14 trials in this review. Individual participant data were available for 2572 participants out of 3787 eligible individuals from nine out of 14 trials: 68% of the potential data. For remission outcomes, a HR of less than one indicated an advantage for carbamazepine; and for first seizure and treatment failure outcomes, a HR of less than one indicated an advantage for lamotrigine.\nThe main overall results were: time to treatment failure for any reason related to treatment (pooled HR adjusted for seizure type: 0.71, 95% CI 0.62 to 0.82, moderate-quality evidence), time to treatment failure due to adverse events (pooled HR adjusted for seizure type: 0.55 (95% CI 0.45 to 0.66, moderate-quality evidence), time to treatment failure due to lack of efficacy (pooled HR for all participants: 1.03 (95% CI 0.75 to 1.41), moderate-quality evidence) showing a significant advantage for lamotrigine compared to carbamazepine in terms of treatment failure for any reason related to treatment and treatment failure due to adverse events, but no different between drugs for treatment failure due to lack of efficacy.\nTime to first seizure (pooled HR adjusted for seizure type: 1.26, 95% CI 1.12 to 1.41, high-quality evidence) and time to six-month remission (pooled HR adjusted for seizure type: 0.86, 95% CI 0.76 to 0.97, high-quality evidence), showed a significant advantage for carbamazepine compared to lamotrigine for first seizure and six-month remission. We found no difference between the drugs for time to 12-month remission (pooled HR for all participants 0.91, 95% CI 0.77 to 1.07, high-quality evidence) or time to 24-month remission (HR for all participants 1.00, 95% CI 0.80 to 1.25, high-quality evidence), however only two trials followed up participants for more than one year so evidence is limited.\nThe results of this review are applicable mainly to individuals with focal onset seizures; 88% of included individuals experienced seizures of this type at baseline. Up to 50% of the limited number of individuals classified as experiencing generalised onset seizures at baseline may have had their seizure type misclassified, therefore we recommend caution when interpreting the results of this review for individuals with generalised onset seizures.\nThe most commonly reported adverse events for both of the drugs across all of the included trials were dizziness, fatigue, gastrointestinal disturbances, headache and skin problems. The rate of adverse events was similar across the two drugs.\nThe methodological quality of the included trials was generally good, however there is some evidence that the design choice of masked or open-label treatment may have influenced the treatment failure and withdrawal rates of the trials. Hence, we judged the quality of the evidence for the primary outcome of treatment failure to be moderate for individuals with focal onset seizures and low for individuals with generalised onset seizures. For efficacy outcomes (first seizure, remission), we judged the quality of evidence to be high for individuals with focal onset seizures and moderate for individuals with generalised onset seizures.\nAuthors' conclusions\nModerate quality evidence indicates that treatment failure for any reason related to treatment or due to adverse events occurs significantly earlier on carbamazepine than lamotrigine, but the results for time to first seizure suggested that carbamazepine may be superior in terms of seizure control. The choice between these first-line treatments must be made with careful consideration. We recommend that future trials should be designed to the highest quality possible with consideration of masking, choice of population, classification of seizure type, duration of follow-up, choice of outcomes and analysis, and presentation of results.\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": "For people with focal onset seizures, lamotrigine and carbamazepine are effective treatments and a choice between these two treatments must be made carefully. More information is needed for people with generalised onset seizures. We recommend that all future trials comparing these medications, or any other antiepileptic medications, should be designed using high-quality methods. Seizure types of people included in trials should also be classified very carefully to ensure that the results are also of high quality."
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query-laysum | 4262 | [
{
"role": "user",
"content": "Abstract: Background\nTyphoid fever and paratyphoid fever continue to be important causes of illness and death, particularly among children and adolescents in south-central and southeast Asia. Two typhoid vaccines are widely available, Ty21a (oral) and Vi polysaccharide (parenteral). Newer typhoid conjugate vaccines are at varying stages of development and use. The World Health Organization has recently recommended a Vi tetanus toxoid (Vi-TT) conjugate vaccine, Typbar-TCV, as the preferred vaccine for all ages.\nObjectives\nTo assess the effects of vaccines for preventing typhoid fever.\nSearch methods\nIn February 2018, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, and mRCT. We also searched the reference lists of all included trials.\nSelection criteria\nRandomized and quasi-randomized controlled trials (RCTs) comparing typhoid fever vaccines with other typhoid fever vaccines or with an inactive agent (placebo or vaccine for a different disease) in adults and children. Human challenge studies were not eligible.\nData collection and analysis\nTwo review authors independently applied inclusion criteria and extracted data, and assessed the certainty of the evidence using the GRADE approach. We computed vaccine efficacy per year of follow-up and cumulative three-year efficacy, stratifying for vaccine type and dose. The outcome addressed was typhoid fever, defined as isolation of Salmonella enterica serovar Typhi in blood. We calculated risk ratios (RRs) and efficacy (1 − RR as a percentage) with 95% confidence intervals (CIs).\nMain results\nIn total, 18 RCTs contributed to the quantitative analysis in this review: 13 evaluated efficacy (Ty21a: 5 trials; Vi polysaccharide: 6 trials; Vi-rEPA: 1 trial; Vi-TT: 1 trial), and 9 reported on adverse events. All trials but one took place in typhoid-endemic countries. There was no information on vaccination in adults aged over 55 years of age, pregnant women, or travellers. Only one trial included data on children under two years of age.\nTy21a vaccine (oral vaccine, three doses)\nA three-dose schedule of Ty21a vaccine probably prevents around half of typhoid cases during the first three years after vaccination (cumulative efficacy 2.5 to 3 years: 50%, 95% CI 35% to 61%, 4 trials, 235,239 participants, moderate-certainty evidence). These data include patients aged 3 to 44 years.\nCompared with placebo, this vaccine probably does not cause more vomiting, diarrhoea, nausea or abdominal pain (2 trials, 2066 participants; moderate-certainty evidence), headache, or rash (1 trial, 1190 participants; moderate-certainty evidence); however, fever (2 trials, 2066 participants; moderate-certainty evidence) is probably more common following vaccination.\nVi polysaccharide vaccine (injection, one dose)\nA single dose of Vi polysaccharide vaccine prevents around two-thirds of typhoid cases in the first year after vaccination (year 1: 69%, 95% CI 63% to 74%; 3 trials, 99,979 participants; high-certainty evidence). In year 2, trial results were more variable, with the vaccine probably preventing between 45% and 69% of typhoid cases (year 2: 59%, 95% CI 45% to 69%; 4 trials, 194,969 participants; moderate-certainty evidence). These data included participants aged 2 to 55 years of age.The three-year cumulative efficacy of the vaccine may be around 55% (95% CI 30% to 70%; 11,384 participants, 1 trial; low-certainty evidence). These data came from a single trial conducted in South Africa in the 1980s in participants aged 5 to 15 years.\nCompared with placebo, this vaccine probably did not increase the incidence of fever (3 trials, 132,261 participants; moderate-certainty evidence) or erythema (3 trials, 132,261 participants; low-certainty evidence); however, swelling (3 trials, 1767 participants; moderate-certainty evidence) and pain at the injection site (1 trial, 667 participants; moderate-certainty evidence) were more common in the vaccine group.\nVi-rEPA vaccine (two doses)\nAdministration of two doses of the Vi-rEPA vaccine probably prevents between 50% and 96% of typhoid cases during the first two years after vaccination (year 1: 94%, 95% CI 75% to 99%; year 2: 87%, 95% CI 56% to 96%, 1 trial, 12,008 participants; moderate-certainty evidence). These data came from a single trial with children two to five years of age conducted in Vietnam.\nCompared with placebo, both the first and the second dose of this vaccine increased the risk of fever (1 trial, 12,008 and 11,091 participants, low-certainty evidence) and the second dose increase the incidence of swelling at the injection site (one trial, 11,091 participants, moderate-certainty evidence).\nVi-TT vaccine (two doses)\nWe are uncertain of the efficacy of administration of two doses of Vi-TT (PedaTyph) in typhoid cases in children during the first year after vaccination (year 1: 94%, 95% CI −1% to 100%, 1 trial, 1625 participants; very low-certainty evidence). These data come from a single cluster-randomized trial in children aged six months to 12 years and conducted in India. For single dose Vi-TT (Typbar-TCV), we found no efficacy trials evaluating the vaccine with natural exposure.\nThere were no reported serious adverse effects in RCTs of any of the vaccines studied.\nAuthors' conclusions\nThe licensed Ty21a and Vi polysaccharide vaccines are efficacious in adults and children older than two years in endemic countries. The Vi-rEPA vaccine is just as efficacious, although data is only available for children. The new Vi-TT vaccine (PedaTyph) requires further evaluation to determine if it provides protection against typhoid fever. At the time of writing, there were only efficacy data from a human challenge setting in adults on the Vi-TT vaccine (Tybar), which clearly justify the ongoing field trials to evaluate vaccine efficacy.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found 18 relevant trials that evaluated four vaccines: 9 reported on vaccine effectiveness only, 4 reported on effectiveness and side effects, and 5 reported on side effects only (we could not analyse one additional trial on adverse events that met the inclusion criteria as it did not provide enough information). The two main vaccines currently licensed for use, Ty21a and Vi polysaccharide, were effective in reducing typhoid fever in adults and children over two years in endemic countries; adverse events such as nausea, vomiting, and fever were rare. Other vaccines, such as new, modified, conjugated Vi vaccines called Vi-rEPA and Vi-TT, are in development. These could be given to infants, which would be helpful as they are probably at higher risk for infection, although further evidence for these vaccines is still needed."
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query-laysum | 4263 | [
{
"role": "user",
"content": "Abstract: Background\nOrthostatic hypotension is an excessive fall in blood pressure (BP) while standing and is the result of a decrease in cardiac output or defective or inadequate vasoconstrictor mechanisms. Fludrocortisone is a mineralocorticoid that increases blood volume and blood pressure. Fludrocortisone is considered the first- or second-line pharmacological therapy for orthostatic hypotension alongside mechanical and positional measures such as increasing fluid and salt intake and venous compression methods. However, there has been no Cochrane Review of the benefits and harms of this drug for this condition.\nObjectives\nTo identify and evaluate the benefits and harms of fludrocortisone for orthostatic hypotension.\nSearch methods\nWe searched the following databases on 11 November 2019: Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL. We also searched trials registries.\nSelection criteria\nWe included all studies evaluating the benefits and harms of fludrocortisone compared to placebo, another drug for orthostatic hypotension, or studies without comparators, including randomized controlled trials (RCTs), quasi-RCTs and observational studies. We included studies in people with orthostatic hypotension due to a chronic peripheral neuropathy, a central autonomic neuropathy, or autonomic failure from other causes, but not medication-induced orthostatic hypotension or orthostatic hypotension from acute volume depletion or blood loss.\nData collection and analysis\nWe used Cochrane methodological procedures for most of the review. We developed and used a tool to prioritize observational studies that offered the best available evidence where there are gaps in the evidence from RCTs. We assessed the certainty of evidence for fludrocortisone versus placebo using GRADE.\nMain results\nWe included 13 studies of 513 participants, including three cross-over RCTs and 10 observational studies (three cohort studies, six case series and one case-control study). The included RCTs were small (total of 28 participants in RCTs), short term (two to three weeks), only examined fludrocortisone for orthostatic hypotension in people with two conditions (diabetes and Parkinson disease), and had variable risk of bias (two had unclear risk of bias and one had low risk of bias). Heterogeneity in participant populations, comparators and outcome assessment methods prevented meta-analyses of the RCTs.\nWe found very low-certainty evidence about the effects of fludrocortisone versus placebo on drop in BP in people with diabetes (-26 mmHg versus -39 mmHg systolic; -7 mmHg versus -11 mmHg diastolic; 1 cross-over study, 6 participants). For people with Parkinson disease, we found very-low certainty evidence about the effects of fludrocortisone on drop in BP compared to pyridostigmine (-14 mmHg versus -22.1 mmHg diastolic; P = 0.036; 1 cross-over study, 9 participants) and domperidone (no change after treatment in either group; 1 cross-over study, 13 participants).\nFor orthostatic symptoms, we found very low-certainty evidence for fludrocortisone versus placebo in people with diabetes (4 out of 5 analyzed participants had improvements in orthostatic symptoms, 1 cross-over study, 6 participants), for fludrocortisone versus pyridostigmine in people with Parkinson disease (orthostatic symptoms unchanged; 1 cross-over study, 9 participants) or fludrocortisone versus domperidone (improvement to 6 for both interventions on the Composite Autonomic Symptom Scale-Orthostatic Domain (COMPASS-OD); 1 cross-over study, 13 participants). Evidence on adverse events was also very low-certainty in both populations, but indicated side effects were minimal.\nObservational studies filled some gaps in evidence by examining the effects in larger groups of participants, with more diverse conditions, over longer periods of time. One cohort study (341 people studied retrospectively) found fludrocortisone may not be harmful in the long term for familial dysautonomia. However, it is unclear if this translates to long-term improvements in BP drop or a meaningful improvement in orthostatic symptoms.\nAuthors' conclusions\nThe evidence is very uncertain about the effects of fludrocortisone on blood pressure, orthostatic symptoms or adverse events in people with orthostatic hypotension and diabetes or Parkinson disease. There is a lack of information on long-term treatment and treatment of orthostatic hypotension in other disease states. There is a need for standardized reporting of outcomes and for standardization of measurements of blood pressure in orthostatic hypotension.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence is up to date to 11 November 2019."
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query-laysum | 4264 | [
{
"role": "user",
"content": "Abstract: Background\nInformed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented, for example, on the Internet or on DVD) are one such method. We updated a 2008 review of the effects of these interventions for informed consent for trial participation.\nObjectives\nTo assess the effects of audio-visual information interventions regarding informed consent compared with standard information or placebo audio-visual interventions regarding informed consent for potential clinical trial participants, in terms of their understanding, satisfaction, willingness to participate, and anxiety or other psychological distress.\nSearch methods\nWe searched: the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, issue 6, 2012; MEDLINE (OvidSP) (1946 to 13 June 2012); EMBASE (OvidSP) (1947 to 12 June 2012); PsycINFO (OvidSP) (1806 to June week 1 2012); CINAHL (EbscoHOST) (1981 to 27 June 2012); Current Contents (OvidSP) (1993 Week 27 to 2012 Week 26); and ERIC (Proquest) (searched 27 June 2012). We also searched reference lists of included studies and relevant review articles, and contacted study authors and experts. There were no language restrictions.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials comparing audio-visual information alone, or in conjunction with standard forms of information provision (such as written or verbal information), with standard forms of information provision or placebo audio-visual information, in the informed consent process for clinical trials. Trials involved individuals or their guardians asked to consider participating in a real or hypothetical clinical study. (In the earlier version of this review we only included studies evaluating informed consent interventions for real studies).\nData collection and analysis\nTwo authors independently assessed studies for inclusion and extracted data. We synthesised the findings using meta-analysis, where possible, and narrative synthesis of results. We assessed the risk of bias of individual studies and considered the impact of the quality of the overall evidence on the strength of the results.\nMain results\nWe included 16 studies involving data from 1884 participants. Nine studies included participants considering real clinical trials, and eight included participants considering hypothetical clinical trials, with one including both. All studies were conducted in high-income countries.\nThere is still much uncertainty about the effect of audio-visual informed consent interventions on a range of patient outcomes. However, when considered across comparisons, we found low to very low quality evidence that such interventions may slightly improve knowledge or understanding of the parent trial, but may make little or no difference to rate of participation or willingness to participate. Audio-visual presentation of informed consent may improve participant satisfaction with the consent information provided. However its effect on satisfaction with other aspects of the process is not clear. There is insufficient evidence to draw conclusions about anxiety arising from audio-visual informed consent. We found conflicting, very low quality evidence about whether audio-visual interventions took more or less time to administer. No study measured researcher satisfaction with the informed consent process, nor ease of use.\nThe evidence from real clinical trials was rated as low quality for most outcomes, and for hypothetical studies, very low. We note, however, that this was in large part due to poor study reporting, the hypothetical nature of some studies and low participant numbers, rather than inconsistent results between studies or confirmed poor trial quality. We do not believe that any studies were funded by organisations with a vested interest in the results.\nAuthors' conclusions\nThe value of audio-visual interventions as a tool for helping to enhance the informed consent process for people considering participating in clinical trials remains largely unclear, although trends are emerging with regard to improvements in knowledge and satisfaction. Many relevant outcomes have not been evaluated in randomised trials. Triallists should continue to explore innovative methods of providing information to potential trial participants during the informed consent process, mindful of the range of outcomes that the intervention should be designed to achieve, and balancing the resource implications of intervention development and delivery against the purported benefits of any intervention.\nMore trials, adhering to CONSORT standards, and conducted in settings and populations underserved in this review, i.e. low- and middle-income countries and people with low literacy, would strengthen the results of this review and broaden its applicability. Assessing process measures, such as time taken to administer the intervention and researcher satisfaction, would inform the implementation of audio-visual consent materials.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of evidence from real clinical trials was low, and from hypothetical clinical studies, very low. This is because of the small number of people in the studies, and some issues in the way they were conducted. If the next update of this review includes more studies of audio-visual informed consent presentation, it could change the results of this review."
}
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query-laysum | 4265 | [
{
"role": "user",
"content": "Abstract: Background\nFor patients with asymptomatic, incurable, metastatic colorectal cancer, palliative, systemic treatment can be started immediately, or can be delayed until disease-related symptoms occur. How the potential survival benefit of starting palliative, systemic treatment immediately after diagnosis weighs up against the potential side effects is currently under debate, and was investigated in this review.\nObjectives\nTo assess the effects of immediate versus delayed chemotherapy, with or without targeted therapy, on overall survival, toxicity, quality of life, progression-free survival, and compliance with chemotherapy for individuals with asymptomatic, metastatic, incurable colorectal cancer.\nSearch methods\nWe searched CENTRAL; 2018, Issue 8, MEDLINE Ovid, Embase Ovid, PsycINFO, the World Health Organization International Clinical Trials Registry Platform, and Clinicaltrials.gov, from inception to 23 August 2018. We did not apply limitations based on language or date of publication. We searched the reference lists of all included studies to identify trials that may not have been identified from the electronic searches.\nSelection criteria\nRandomised controlled trials evaluating immediate versus delayed chemotherapy in persons with asymptomatic, metastatic, incurable colorectal cancer.\nData collection and analysis\nWe applied standard methodological procedures, according to the recommendations of Cochrane and Cochrane Colorectal Cancer. Two review authors independently reviewed the studies identified by literature searches, selected relevant trials, extracted data, and assessed risk of bias of the included studies. We used the Cochrane tool to assess risk of bias, Review Manager 5 software for meta-analysis, GRADE methods to evaluate the quality of the evidence, and GRADEpro GDT software to develop a 'Summary of findings' table.\nMain results\nWe included three randomised controlled trials (351 participants) investigating immediate versus delayed chemotherapy in people diagnosed with asymptomatic, metastatic, incurable colorectal cancer. Giving immediate versus delayed chemotherapy may make little or no difference to overall survival (hazard ratio (HR) 1.17, 95% confidence interval (CI) 0.93 to 1.46; 3 studies, 351 persons; low-quality evidence). For toxicity, giving immediate versus delayed chemotherapy may make little or no difference to the risk of grade 3 or 4 nausea and vomiting (risk ratio (RR) 0.84, 95% CI 0.31 to 2.25; 2 studies, 140 persons; very low-quality evidence), stomatitis (RR 1.10, 95% CI 0.47 to 2.55; 2 studies, 140 persons; very low-quality evidence), or diarrhoea (RR 0.69, 95% CI 0.34 to 1.40; 2 studies, 140 persons, very low-quality evidence). We are uncertain whether delayed chemotherapy made a difference to quality of life (very low-quality evidence), progression-free survival (low-quality evidence), or compliance with chemotherapy (low-quality evidence), as we had insufficient data to pool for these outcomes.\nAuthors' conclusions\nBased on a limited number of trials, very sparse data, and uncertainty of the evidence, this review was unable to establish whether there was a difference in overall survival or other clinically relevant outcomes, between immediate or delayed chemotherapy in persons with metastatic, incurable, colorectal cancer. The results should be interpreted with caution.\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": "Based on very sparse data and uncertainty of the evidence, we were unable to establish whether there was a difference in overall survival and other important outcomes in people with metastatic, incurable, colorectal cancer, who received chemotherapy either straight away or waited until after symptoms had appeared."
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query-laysum | 4266 | [
{
"role": "user",
"content": "Abstract: Background\nDepressive illness is common in old age. Prevalence in the community of case level depression is around 15% and milder forms of depression are more common. It causes significant distress and disability. The number of people over the age of 60 years is expected to double by 2050 and so interventions for this often long-term and recurrent condition are increasingly important. The causes of late-life depression differ from depression in younger adults and so it is appropriate to study it separately.\nThis is an update of a Cochrane review first published in 2012.\nObjectives\nTo examine the efficacy of antidepressants and psychological therapies in preventing the relapse and recurrence of depression in older people.\nSearch methods\nWe performed a search of the Cochrane Common Mental Disorders Group's specialised register (the CCMDCTR) to 13 July 2015. The CCMDCTR includes relevant randomised controlled trials (RCTs) from the following bibliographic databases: The Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). We also conducted a cited reference search on 13 July 2015 of the Web of Science for citations of primary reports of included studies.\nSelection criteria\nBoth review authors independently selected studies. We included RCTs involving people aged 60 years and over successfully treated for an episode of depression and randomised to receive continuation and maintenance treatment with antidepressants, psychological therapies, or a combination.\nData collection and analysis\nTwo review authors independently extracted data. The primary outcome for benefit was recurrence rate of depression (reaching a cut-off on any depression rating scale) at 12 months and the primary outcome for harm was drop-outs at 12 months. Secondary outcomes included relapse/recurrence rates at other time points, global impression of change, social functioning, and deaths. We performed meta-analysis using risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with 95% confidence intervals (CI).\nMain results\nThis update identified no further trials. Seven studies from the previous review met the inclusion criteria (803 participants). Six compared antidepressant medication with placebo; two involved psychological therapies. There was marked heterogeneity between the studies.\nComparing antidepressants with placebo on the primary outcome for benefit, there was a statistically significant difference favouring antidepressants in reducing recurrence compared with placebo at 12 months with a GRADE rating of low for quality of evidence (three RCTs, n = 247, RR 0.67, 95% CI 0.54 to 0.82; number needed to treat for an additional beneficial outcome (NNTB) 5). Comparing antidepressants with placebo on the primary outcome for harms, there was no difference in drop-out rates at 12 months' follow-up, with a GRADE rating of low.\nThere was no significant difference between psychological treatment and antidepressant in recurrence rates at 12 months (one RCT, n = 53) or between combination treatment and antidepressant alone at 12 months.\nAuthors' conclusions\nThis updated Cochrane review supports the findings of the original 2012 review. The long-term benefits and harm of continuing antidepressant medication in the prevention of recurrence of depression in older people are not clear and no firm treatment recommendations can be made on the basis of this review. Continuing antidepressant medication for 12 months appears to be helpful with no increased harms; however, this was based on only three small studies, relatively few participants, use of a range of antidepressant classes, and clinically heterogeneous populations. Comparisons at other time points did not reach statistical significance.\nData on psychological therapies and combined treatments were too limited to draw any conclusions on benefits and harms.\nThe quality of the evidence used in reaching these conclusions was low and the review does not, therefore, offer clear guidance to clinicians and patients on best practice and matching interventions to particular patient characteristics.\nOf note, we identified no new studies that evaluated pharmacological or psychological interventions in the continuation and maintenance treatment of depression in older people. We are aware of studies conducted since the previous review that included both older people and adults under the age of 65 years, but these fall outside of the remit of this review. We believe that there remains a need for studies solely recruiting older people, particularly the 'older old' with comorbid medical problems. However, these studies are likely to be challenging to conduct and may not, so far, have been prioritised by funders.\n\nGiven the provided abstract, please respond to the following query: \"What should happen next?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review provides limited evidence that continuing antidepressant medication for one year can reduce the risk of depression recurring with no additional harm. However, it cannot be used to make firm recommendations due to the limited number and small size of studies involved. Limitations in the design and reporting of these studies may also make the results unrepresentative. Similarly, no firm conclusions can be drawn about psychological treatments or combinations of antidepressant and psychological treatments in preventing recurrence.\nFurther, larger, trials are required to clarify any benefits of antidepressant and psychological treatments. These trials should include more people aged over 75, and people with other problems typical of people treated in routine clinical services, such long-term physical illness and mild memory problems."
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query-laysum | 4267 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the review on \"Lidocaine for pain relief in burn injured patients\" first published in Issue 3, 2007, and first updated in 2012. Pain is a major issue for people with many different types of wounds, in particular those people with burn injuries. Prompt, aggressive use of opioid analgesics such as morphine has been suggested as critical to avert the cycle of pain and anxiety, but adverse effects are encountered. It has been proposed that newer agents such as lidocaine could be effective in reducing pain and alleviating the escalating opioid dosage requirements in people with burn injury.\nObjectives\nTo assess the safety and effectiveness of intravenous lidocaine as a means of pain relief versus no therapy, placebo, other drugs, or a combination of these therapies in people with burn injury.\nSearch methods\nFor this third update, we searched the Cochrane Central Register of Controlled Trials (Issue 11, 2013), and Ovid MEDLINE, MEDLINE in Process and Ovid EMBASE (up to December 2013).\nSelection criteria\nWe included randomised controlled trials (RCTs) and controlled clinical trials (CCTs), published and unpublished, which assessed the efficacy of intravenous lidocaine in varying doses as a single-agent therapy with no therapy, placebo, other analgesics (such as opioids), lidocaine plus another drug, or a combination of these therapies as a means of pain relief in people with burn injury.\nData collection and analysis\nTwo review authors independently abstracted data and assessed the risk of bias of the studies identified.\nMain results\nIn this 2014 update, we found no new studies. The one small randomised double-blind placebo-controlled cross-over trial found in 2012, which included only 45 participants and compared intravenous lidocaine against placebo as a means of pain relief in people with burns still remains central to this review. We assessed this study as being at a high risk of bias due to its small size (fewer than 50 participants per treatment arm). Subjective pain ratings, as measured by the verbal rating scale, increased during procedures for both treatment arms; however, the increase was less in the lidocaine treatment group. There were no significant clinical or statistical differences regarding the effects of lidocaine and placebo on opioid requests and consumption, anxiety or level of satisfaction during a wound care procedure, but the small included study provided insufficient data to draw any conclusions.\nAuthors' conclusions\nAs current clinical evidence is based on only one RCT as well as case series and reports, intravenous lidocaine must be considered a pharmacological agent under investigation in burns care, the effectiveness of which is yet to be determined with further well-designed and conducted clinical trials.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched scientific databases for studies assessing the pain-relieving effects of intravenous (given into the blood stream through a vein) lidocaine in adults with a burn injury. We included studies comparing lidocaine with no treatment, placebo (a pretend treatment), other analgesics (pain killers), or a combination of these. We wanted to look at (for example) severity of pain, time to requiring more medication, rescue analgesia (where extra pain relief is needed in addition to that planned) and side effects. The evidence is current to December 2013."
}
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query-laysum | 4268 | [
{
"role": "user",
"content": "Abstract: Background\nA variety of alpha-blockers are used for treating lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Silodosin is a novel, more selective alpha-blocker, which is specific to the lower urinary tract and may have fewer side effects than other alpha-blockers.\nObjectives\nTo assess the effects of silodosin for the treatment of LUTS in men with BPH.\nSearch methods\nWe performed a comprehensive search using multiple databases (Cochrane Library, MEDLINE, EMBASE, Scopus, Google Scholar, and Web of Science), trials registries, other sources of grey literature, and conference proceedings with no restrictions on the language of publication or publication status up until 13 June 2017.\nSelection criteria\nWe included all parallel, randomized controlled trials. We also included cross-over designs.\nData collection and analysis\nTwo review authors independently classified studies and abstracted data from the included studies. We performed statistical analyses using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the quality of evidence according to the GRADE approach.\nMain results\nWe included 19 unique studies with 4295 randomized participants across four comparisons for short-term follow-up. The mean age, prostate volume, and International Prostate Symptom Score were 66.5 years, 38.2 mL, and 19.1, respectively.\nSilodosin versus placebo\nBased on four studies with a total of 1968 randomized participants, silodosin may reduce urologic symptom scores in an appreciable number of men (mean difference (MD) -2.65, 95% confidence interval (CI) -3.23 to -2.08; low-quality evidence). Silodosin likely does not result in a clinically important reduction in quality of life (MD -0.42, 95% CI -0.71 to -0.13; moderate-quality evidence). It may not increase rates of treatment withdrawal for any reason (relative risk (RR) 1.08, 95% CI 0.70 to 1.66; low-quality evidence). We are uncertain about the effect of silodosin on cardiovascular adverse events (RR 1.28, 95% CI 0.67 to 2.45; very low-quality evidence). Silodosin likely increases sexual adverse events (RR 26.07, 95% CI 12.36 to 54.97; moderate-quality evidence); this would result in 180 more sexual adverse events per 1000 men (95% CI 82 more to 388 more).\nSilodosin versus tamsulosin\nBased on 13 studies with a total of 2129 randomized participants, silodosin may result in little to no difference in urologic symptom scores (MD -0.04, 95% CI -1.31 to 1.24; low-quality evidence) and quality of life (MD -0.15, 95% CI -0.53 to 0.22; low-quality evidence). We are uncertain about treatment withdrawals for any reason (RR 1.02, 95% CI 0.62 to 1.69; very low-quality evidence). Silodosin may result in little to no difference in cardiovascular adverse events (RR 0.77, 95% CI 0.53 to 1.12; low-quality evidence). Silodosin likely increases sexual adverse events (RR 6.05, 95% CI 3.55 to 10.31; moderate-quality evidence); this would result in 141 more sexual adverse events per 1000 men (95% CI 71 more to 261 more).\nSilodosin versus naftopidil\nBased on five studies with a total of 763 randomized participants, silodosin may result in little to no differences in urologic symptom scores (MD -0.85, 95% CI -2.57 to 0.87; low-quality evidence), quality of life (MD -0.17, 95% CI -0.60 to 0.27; low-quality evidence), treatment withdrawal for any reason (RR 1.25, 95% CI 0.81 to 1.93; low-quality evidence), and cardiovascular adverse events (RR 1.02, 95% CI 0.41 to 2.56; low-quality evidence). Silodosin likely increases sexual adverse events (RR 5.93, 95% CI 2.16 to 16.29; moderate-quality evidence); this would result in 74 more sexual adverse events per 1000 men (95% CI 17 more to 231 more).\nSilodosin versus alfuzosin\nBased on two studies with a total of 155 randomized participants, silodosin may or may not result in a clinically important increase in urologic symptom scores (MD 3.83, 95% CI 0.12 to 7.54; low-quality evidence). Silodosin likely results in little to no difference in quality of life (MD 0.14, 95% CI -0.46 to 0.74; moderate-quality evidence). We found no event of treatment withdrawal for any reason. Silodosin may not reduce cardiovascular adverse events (RR 0.67, 95% CI 0.36 to 1.24; low-quality evidence) but likely increases sexual adverse events (RR 37.21, 95% CI 5.32 to 260.07; moderate-quality evidence); this would result in 217 more sexual adverse events per 1000 men (95% CI 26 more to 1000 more).\nAuthors' conclusions\nSilodosin may reduce urologic symptom scores in an appreciable number of men compared to placebo. Quality of life and treatment withdrawals for any reason appears similar. Its efficacy appears similar to that of other alpha blockers (tamsulosin, naftopidil and alfuzosin) but the rate of sexual side effects is likely higher. Our certainty in the estimates of effect was lowered due to study limitations, inconsistency and imprecision.\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": "Prostate enlargement is common in men as they get older and may cause difficulties in urination such as a weak stream, having to get up at night and a feeling of not emptying the bladder completely. Silodosin is a newer medication that may help with these symptoms and may cause fewer unwanted drug effects. We did this review to compare silodosin to placebo (dummy drug) and other medications."
}
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query-laysum | 4269 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetes is the commonest cause of chronic kidney disease (CKD). Both conditions commonly co-exist. Glucometabolic changes and concurrent dialysis in diabetes and CKD make glucose-lowering challenging, increasing the risk of hypoglycaemia. Glucose-lowering agents have been mainly studied in people with near-normal kidney function. It is important to characterise existing knowledge of glucose-lowering agents in CKD to guide treatment.\nObjectives\nTo examine the efficacy and safety of insulin and other pharmacological interventions for lowering glucose levels in people with diabetes and CKD.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 12 February 2018 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials (RCTs) and quasi-RCTs looking at head-to-head comparisons of active regimens of glucose-lowering therapy or active regimen compared with placebo/standard care in people with diabetes and CKD (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2) were eligible.\nData collection and analysis\nFour authors independently assessed study eligibility, risk of bias, and quality of data and performed data extraction. Continuous outcomes were expressed as post-treatment mean differences (MD). Adverse events were expressed as post-treatment absolute risk differences (RD). Dichotomous clinical outcomes were presented as risk ratios (RR) with 95% confidence intervals (CI).\nMain results\nForty-four studies (128 records, 13,036 participants) were included. Nine studies compared sodium glucose co-transporter-2 (SGLT2) inhibitors to placebo; 13 studies compared dipeptidyl peptidase-4 (DPP-4) inhibitors to placebo; 2 studies compared glucagon-like peptide-1 (GLP-1) agonists to placebo; 8 studies compared glitazones to no glitazone treatment; 1 study compared glinide to no glinide treatment; and 4 studies compared different types, doses or modes of administration of insulin. In addition, 2 studies compared sitagliptin to glipizide; and 1 study compared each of sitagliptin to insulin, glitazars to pioglitazone, vildagliptin to sitagliptin, linagliptin to voglibose, and albiglutide to sitagliptin. Most studies had a high risk of bias due to funding and attrition bias, and an unclear risk of detection bias.\nCompared to placebo, SGLT2 inhibitors probably reduce HbA1c (7 studies, 1092 participants: MD -0.29%, -0.38 to -0.19 (-3.2 mmol/mol, -4.2 to -2.2); I2 = 0%), fasting blood glucose (FBG) (5 studies, 855 participants: MD -0.48 mmol/L, -0.78 to -0.19; I2 = 0%), systolic blood pressure (BP) (7 studies, 1198 participants: MD -4.68 mmHg, -6.69 to -2.68; I2 = 40%), diastolic BP (6 studies, 1142 participants: MD -1.72 mmHg, -2.77 to -0.66; I2 = 0%), heart failure (3 studies, 2519 participants: RR 0.59, 0.41 to 0.87; I2 = 0%), and hyperkalaemia (4 studies, 2788 participants: RR 0.58, 0.42 to 0.81; I2 = 0%); but probably increase genital infections (7 studies, 3086 participants: RR 2.50, 1.52 to 4.11; I2 = 0%), and creatinine (4 studies, 848 participants: MD 3.82 μmol/L, 1.45 to 6.19; I2 = 16%) (all effects of moderate certainty evidence). SGLT2 inhibitors may reduce weight (5 studies, 1029 participants: MD -1.41 kg, -1.8 to -1.02; I2 = 28%) and albuminuria (MD -8.14 mg/mmol creatinine, -14.51 to -1.77; I2 = 11%; low certainty evidence). SGLT2 inhibitors may have little or no effect on the risk of cardiovascular death, hypoglycaemia, acute kidney injury (AKI), and urinary tract infection (low certainty evidence). It is uncertain whether SGLT2 inhibitors have any effect on death, end-stage kidney disease (ESKD), hypovolaemia, fractures, diabetic ketoacidosis, or discontinuation due to adverse effects (very low certainty evidence).\nCompared to placebo, DPP-4 inhibitors may reduce HbA1c (7 studies, 867 participants: MD -0.62%, -0.85 to -0.39 (-6.8 mmol/mol, -9.3 to -4.3); I2 = 59%) but may have little or no effect on FBG (low certainty evidence). DPP-4 inhibitors probably have little or no effect on cardiovascular death (2 studies, 5897 participants: RR 0.93, 0.77 to 1.11; I2 = 0%) and weight (2 studies, 210 participants: MD 0.16 kg, -0.58 to 0.90; I2 = 29%; moderate certainty evidence). Compared to placebo, DPP-4 inhibitors may have little or no effect on heart failure, upper respiratory tract infections, and liver impairment (low certainty evidence). Compared to placebo, it is uncertain whether DPP-4 inhibitors have any effect on eGFR, hypoglycaemia, pancreatitis, pancreatic cancer, or discontinuation due to adverse effects (very low certainty evidence).\nCompared to placebo, GLP-1 agonists probably reduce HbA1c (7 studies, 867 participants: MD -0.53%, -1.01 to -0.06 (-5.8 mmol/mol, -11.0 to -0.7); I2 = 41%; moderate certainty evidence) and may reduce weight (low certainty evidence). GLP-1 agonists may have little or no effect on eGFR, hypoglycaemia, or discontinuation due to adverse effects (low certainty evidence). It is uncertain whether GLP-1 agonists reduce FBG, increase gastrointestinal symptoms, or affect the risk of pancreatitis (very low certainty evidence).\nCompared to placebo, it is uncertain whether glitazones have any effect on HbA1c, FBG, death, weight, and risk of hypoglycaemia (very low certainty evidence).\nCompared to glipizide, sitagliptin probably reduces hypoglycaemia (2 studies, 551 participants: RR 0.40, 0.23 to 0.69; I2 = 0%; moderate certainty evidence). Compared to glipizide, sitagliptin may have had little or no effect on HbA1c, FBG, weight, and eGFR (low certainty evidence). Compared to glipizide, it is uncertain if sitagliptin has any effect on death or discontinuation due to adverse effects (very low certainty).\nFor types, dosages or modes of administration of insulin and other head-to-head comparisons only individual studies were available so no conclusions could be made.\nAuthors' conclusions\nEvidence concerning the efficacy and safety of glucose-lowering agents in diabetes and CKD is limited. SGLT2 inhibitors and GLP-1 agonists are probably efficacious for glucose-lowering and DPP-4 inhibitors may be efficacious for glucose-lowering. Additionally, SGLT2 inhibitors probably reduce BP, heart failure, and hyperkalaemia but increase genital infections, and slightly increase creatinine. The safety profile for GLP-1 agonists is uncertain. No further conclusions could be made for the other classes of glucose-lowering agents including insulin. More high quality studies are required to help guide therapeutic choice for glucose-lowering in diabetes and CKD.\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 looked at studies comparing different medications with each other or to no medications in people with diabetes and CKD."
}
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query-laysum | 4270 | [
{
"role": "user",
"content": "Abstract: Background\nCardiovascular disease (CVD) is the leading cause of morbidity and mortality globally. Early intervention for those with high cardiovascular risk is crucial in improving patient outcomes. Traditional prevention strategies for CVD have focused on conventional risk factors, such as overweight, dyslipidaemia, diabetes, and hypertension, which may reflect the potential for cardiovascular insult. Natriuretic peptides (NPs), including B-type natriuretic peptide (BNP) and N-terminal pro B-type natriuretic peptide (NT-proBNP), are well-established biomarkers for the detection and diagnostic evaluation of heart failure. They are of interest for CVD prevention because they are secreted by the heart as a protective response to cardiovascular stress, strain, and damage. Therefore, measuring NP levels in patients without heart failure may be valuable for risk stratification, to identify those at highest risk of CVD who would benefit most from intensive risk reduction measures.\nObjectives\nTo assess the effects of natriuretic peptide (NP)-guided treatment for people with cardiovascular risk factors and without heart failure.\nSearch methods\nSearches of the following bibliographic databases were conducted up to 9 July 2019: CENTRAL, MEDLINE, Embase, and Web of Science. Three clinical trial registries were also searched in July 2019.\nSelection criteria\nWe included randomised controlled trials enrolling adults with one or more cardiovascular risk factors and without heart failure, which compared NP-based screening and subsequent NP-guided treatment versus standard care in all settings (i.e. community, hospital).\nData collection and analysis\nTwo review authors independently screened titles and abstracts and selected studies for inclusion, extracted data, and evaluated risk of bias. Risk ratios (RRs) were calculated for dichotomous data, and mean differences (MDs) with 95% confidence intervals (CIs) were calculated for continuous data. We contacted trial authors to obtain missing data and to verify crucial study characteristics. Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, two review authors independently assessed the quality of the evidence and GRADE profiler (GRADEPRO) was used to import data from Review Manager to create a 'Summary of findings' table.\nMain results\nWe included two randomised controlled trials (three reports) with 1674 participants, with mean age between 64.1 and 67.8 years. Follow-up ranged from 2 years to mean 4.3 years.\nFor primary outcome measures, effect estimates from a single study showed uncertainty for the effect of NP-guided treatment on cardiovascular mortality in patients with cardiovascular risk factors and without heart failure (RR 0.33, 95% CI 0.04 to 3.17; 1 study; 300 participants; low-quality evidence). Pooled analysis demonstrated that in comparison to standard care, NP-guided treatment probably reduces the risk of cardiovascular hospitalisation (RR 0.52, 95% CI 0.40 to 0.68; 2 studies; 1674 participants; moderate-quality evidence). This corresponds to a risk of 163 per 1000 in the control group and 85 (95% CI 65 to 111) per 1000 in the NP-guided treatment group.\nWhen secondary outcome measures were evaluated, evidence from a pooled analysis showed uncertainty for the effect of NP-guided treatment on all-cause mortality (RR 0.90, 95% CI 0.60 to 1.35; 2 studies; 1354 participants; low-quality evidence). Pooled analysis indicates that NP-guided treatment probably reduces the risk of all-cause hospitalisation (RR 0.83, 95% CI 0.75 to 0.92; 2 studies; 1354 participants; moderate-quality evidence). This corresponds to a risk of 601 per 1000 in the control group and 499 (95% CI 457 to 553) per 1000 in the NP-guided treatment group. The effect estimate from a single study indicates that NP-guided treatment reduced the risk of ventricular dysfunction (RR 0.61, 95% CI 0.41 to 0.91; 1374 participants; high-quality evidence). The risk in this study's control group was 87 per 1000, compared with 53 (95% CI 36 to 79) per 1000 with NP-guided treatment. Results from the same study show that NP-guided treatment does not affect change in NP level at the end of follow-up, relative to standard care (MD -4.06 pg/mL, 95% CI -15.07 to 6.95; 1 study; 1374 participants; moderate-quality evidence).\nAuthors' conclusions\nThis review shows that NP-guided treatment is likely to reduce ventricular dysfunction and cardiovascular and all-cause hospitalisation for patients who have cardiovascular risk factors and who do not have heart failure. Effects on mortality and natriuretic peptide levels are less certain. Neither of the included studies were powered to evaluate mortality. Available evidence shows uncertainty regarding the effects of NP-guided treatment on both cardiovascular mortality and all-cause mortality; very low event numbers resulted in a high degree of imprecision in these effect estimates. Evidence also shows that NP-guided treatment may not affect NP level at the end of follow-up.\nAs both trials included in our review were pragmatic studies, non-blinding of patients and practices may have biased results towards a finding of equivalence. Further studies with more adequately powered sample sizes and longer duration of follow-up are required to evaluate the effect of NP-guided treatment on mortality. As two trials are ongoing, one of which is a large multi-centre trial, it is hoped that future iterations of this review will benefit from larger sample sizes across a wider geographical area.\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": "Cardiovascular diseases (CVDs) are a group of conditions that affect the heart and blood vessels. They are the leading causes of avoidable death worldwide. Risk factors that increase a person's likelihood of developing CVD include diabetes, high blood pressure, high cholesterol, and obesity. Natriuretic peptides (NPs) are hormones produced by the heart that are measured in the blood. They help the body to eliminate fluids, relax the blood vessels, and funnel sodium into the urine. When the heart is damaged, the body releases more NPs to try to ease strain on the heart. By measuring a person's blood NP levels, we can identify those who have established damage to their heart and who are at higher risk of death and cardiovascular events such as heart attack and stroke. We can then use this information to reduce a person's cardiovascular risk by guiding decisions about their cardiovascular care (NP-guided treatment), such as what medication they should take, what investigations they need, and what adjustments they should make to their lifestyle."
}
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query-laysum | 4271 | [
{
"role": "user",
"content": "Abstract: Background\nTNF (tumor necrosis factor)-alpha inhibitors block a key protein in the inflammatory chain reaction responsible for joint inflammation, pain, and damage in ankylosing spondylitis.\nObjectives\nTo assess the benefit and harms of adalimumab, etanercept, golimumab, and infliximab (TNF-alpha inhibitors) in people with ankylosing spondylitis.\nSearch methods\nWe searched the following databases to January 26, 2009: MEDLINE (from 1966); EMBASE (from 1980); the Cochrane Central Register of Controlled Trials (CENTRAL; 2008, Issue 4); ACP Journal Club; CINAHL (from 1982); and ISI Web of Knowledge (from 1900). We ran updated searches in May 2012, October 2013, and in June 2014 for McMaster PLUS. We searched major regulatory agencies for safety warnings and clinicaltrials.gov for registered trials.\nSelection criteria\nRandomized controlled trials (RCTs) comparing adalimumab, etanercept, golimumab and infliximab to placebo, other drugs or usual care in patients with ankylosing spondylitis, reported in abstract or full-text.\nData collection and analysis\nTwo authors independently assessed search results, risk of bias, and extracted data. We conducted Bayesian mixed treatment comparison (MTC) meta-analyses using WinBUGS software. To investigate a class-effect of harms across biologics, we pooled harms data using Review Manager 5.\nMain results\nWe included twenty-one, short-term (24 weeks or less) RCTs with a total of 3308 participants; 18 contributed data to the MTC analysis: adalimumab (4 studies), etanercept (8 studies), golimumab (2 studies), infliximab (3 studies), and one head-to-head study (etanercept versus infliximab) which was unblinded and considered at a higher risk of bias. The risk of selection and detection bias was low or unclear for most of the studies. The risk of selective outcome reporting was low for most studies as they reported on outcomes recommended by the Assessment of SpondyloArthritis international Society. We found little heterogeneity and no significant inconsistency in the MTC analyses. The majority of the studies were funded by pharmaceutical companies. Most studies permitted concomitant therapy of stable doses of disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, or corticosteroids, but allowances varied across studies.\nCompared with placebo, there was high quality evidence that patients on an anti-TNF agent were three to four times more likely to achieve an ASAS40 response (assessing spinal pain, function, and inflammation, as measured by the mean of intensity and duration of morning stiffness, and patient global assessment) by six months (adalimumab: risk ratio (RR) 3.53, 95% credible interval (Crl) 2.49 to 4.91; etanercept: RR 3.31, 95% Crl 2.38 to 4.53; golimumab: RR 2.90, 95% Crl 1.90 to 4.23; infliximab: RR 4.07, 95% Crl 2.80 to 5.74, with a 25% to 40% absolute difference between treatment and placebo groups. The number needed to treat (NNT) to achieve an ASAS 40 response ranged from 3 to 5.\nThere was high quality evidence of improvement in physical function on a 0 to 10 scale (adalimumab: mean difference (MD) -1.6, 95% Crl -2.2 to -0.9; etanercept: MD -1.1, 95% CrI -1.6 to -0.6; golimumab: MD -1.5, 95% Crl -2.3 to -0.7; infliximab: MD -2.1, 95% Crl -2.7 to -1.4, with an 11% to 21% absolute difference between treatment and placebo groups. The NNT to achieve the minimally clinically important difference of 0.7 points ranged from 2 to 4.\nCompared with placebo, there was moderate quality evidence (downgraded for imprecision) that patients on an anti-TNF agent were more likely to achieve an ASAS partial remission by six months (adalimumab: RR 6.28, 95% Crl 3.13 to 12.78; etanercept: RR 4.24, 95% Crl 2.31 to 8.09; golimumab: RR 5.18, 95% Crl 1.90 to 14.79; infliximab: RR 15.41, 95% Crl 5.09 to 47.98 with a 10% to 44% absolute difference between treatment and placebo groups. The NNT to achieve an ASAS partial remission response ranged from 3 to 11.\nThere was low to moderate level evidence of a greater reduction in spinal inflammation as measured by magnetic resonance imaging though the absolute differences were small and the clinical relevance of the difference was unclear: adalimumab (1 trial; -6% (95% confidence interval (CI) -12% to 0.05%); 1 trial: 53.6% mean decrease from baseline versus 9.4% mean increase in the placebo group), golimumab (1 trial; -2.5%, (95% CI -5.6% to -0.7%)), and infliximab (1 trial; -3% (95% CI -4% to -2.4%)).\nRadiographic progression was measured in one trial (N = 60) of etanercept versus placebo and it found that radiologic changes were similar in both groups (detailed data not provided).\nThere were few events of withdrawals due to adverse events leading to imprecision around the estimates. When all the anti-TNF agents were combined against placebo, there was moderate quality evidence from 16 studies of an increased risk of withdrawals due to adverse events in the anti-TNF group (Peto odds ratio (OR) 2.44, 95% CI 1.26 to 4.72; total events: 38/1637 in biologic group; 7/986 in placebo) though the absolute increase in harm was small (1%; 95% CI 0% to 2%).\nDue to low event rates, evidence of the effect of individual TNF-inhibitors against placebo or for all four biologics pooled together versus placebo on serious adverse events is inconclusive (moderate quality; downgraded for imprecision). For all anti-TNF pooled versus placebo based on 16 studies: Peto OR 1.45, 95% CI 0.85 to 2.48; 51/1530 in biologic group; 18/878 in placebo; absolute difference: 1% (95% CI 0% to 2%).\nUsing indirect comparison methodology, and one head-to-head study of etanercept versus infliximab, wide confidence intervals meant that results were inconclusive for evidence of differences in the major outcomes between different anti-TNF agents. Regulatory agencies have published warnings about rare adverse events of serious infections, including tuberculosis, malignancies and lymphoma.\nAuthors' conclusions\nThere is moderate to high quality evidence that anti-TNF agents improve clinical symptoms in the treatment of ankylosing spondylitis. More participants withdrew due to adverse events when on an anti-TNF agent but we did not find evidence of an increase in serious adverse events, though event rates were low and trials had a short duration. The short-term toxicity profile appears acceptable. Based on indirect comparison methodology, we are uncertain whether there are differences between anti-TNF agents in terms of the key benefit or harm outcomes.\n\nGiven the provided abstract, please respond to the following query: \"ASAS40 (40% improvement in pain, function, and inflammation as measured by morning stiffness, and patient overall well-being)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Compared to 13 people out of 100 who experienced an improvement with a placebo, among people who took:\n- adalimumab: 46 people out of 100 experienced improvement (33% improvement);\n- etanercept: 43 people out of 100 experienced improvement (30% improvement);\n- golimumab: 38 people out of 100 experienced improvement (25% improvement); and\n- infliximab: 53 people out of 100 experienced improvement (40% improvement)."
}
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query-laysum | 4272 | [
{
"role": "user",
"content": "Abstract: Background\nAbout 10% of women of reproductive age suffer from endometriosis. Endometriosis is a costly chronic disease that causes pelvic pain and subfertility. Laparoscopy, the gold standard diagnostic test for endometriosis, is expensive and carries surgical risks. Currently, no non-invasive tests that can be used to accurately diagnose endometriosis are available in clinical practice. This is the first review of diagnostic test accuracy of imaging tests for endometriosis that uses Cochrane methods to provide an update on the rapidly expanding literature in this field.\nObjectives\n• To provide estimates of the diagnostic accuracy of imaging modalities for the diagnosis of pelvic endometriosis, ovarian endometriosis and deeply infiltrating endometriosis (DIE) versus surgical diagnosis as a reference standard.\n• To describe performance of imaging tests for mapping of deep endometriotic lesions in the pelvis at specific anatomical sites.\nImaging tests were evaluated as replacement tests for diagnostic surgery and as triage tests that would assist decision making regarding diagnostic surgery for endometriosis.\nSearch methods\nWe searched the following databases to 20 April 2015: MEDLINE, CENTRAL, EMBASE, CINAHL, PsycINFO, Web of Science, LILACS, OAIster, TRIP, ClinicalTrials.gov, MEDION, DARE, and PubMed. Searches were not restricted to a particular study design or language nor to specific publication dates. The search strategy incorporated words in the title, abstracts, text words across the record and medical subject headings (MeSH).\nSelection criteria\nWe considered published peer-reviewed cross-sectional studies and randomised controlled trials of any size that included prospectively recruited women of reproductive age suspected of having one or more of the following target conditions: endometrioma, pelvic endometriosis, DIE or endometriotic lesions at specific intrapelvic anatomical locations. We included studies that compared the diagnostic test accuracy of one or more imaging modalities versus findings of surgical visualisation of endometriotic lesions.\nData collection and analysis\nTwo review authors independently collected and performed a quality assessment of data from each study. For each imaging test, data were classified as positive or negative for surgical detection of endometriosis, and sensitivity and specificity estimates were calculated. If two or more tests were evaluated in the same cohort, each was considered as a separate data set. We used the bivariate model to obtain pooled estimates of sensitivity and specificity when sufficient data sets were available. Predetermined criteria for a clinically useful imaging test to replace diagnostic surgery included sensitivity ≥ 94% and specificity ≥ 79%. Criteria for triage tests were set at sensitivity ≥ 95% and specificity ≥ 50%, ruling out the diagnosis with a negative result (SnNout test - if sensitivity is high, a negative test rules out pathology) or at sensitivity ≥ 50% with specificity ≥ 95%, ruling in the diagnosis with a positive result (SpPin test - if specificity is high, a positive test rules in pathology).\nMain results\nWe included 49 studies involving 4807 women: 13 studies evaluated pelvic endometriosis, 10 endometriomas and 15 DIE, and 33 studies addressed endometriosis at specific anatomical sites. Most studies were of poor methodological quality. The most studied modalities were transvaginal ultrasound (TVUS) and magnetic resonance imaging (MRI), with outcome measures commonly demonstrating diversity in diagnostic estimates; however, sources of heterogeneity could not be reliably determined. No imaging test met the criteria for a replacement or triage test for detecting pelvic endometriosis, albeit TVUS approached the criteria for a SpPin triage test. For endometrioma, TVUS (eight studies, 765 participants; sensitivity 0.93 (95% confidence interval (CI) 0.87, 0.99), specificity 0.96 (95% CI 0.92, 0.99)) qualified as a SpPin triage test and approached the criteria for a replacement and SnNout triage test, whereas MRI (three studies, 179 participants; sensitivity 0.95 (95% CI 0.90, 1.00), specificity 0.91 (95% CI 0.86, 0.97)) met the criteria for a replacement and SnNout triage test and approached the criteria for a SpPin test. For DIE, TVUS (nine studies, 12 data sets, 934 participants; sensitivity 0.79 (95% CI 0.69, 0.89) and specificity 0.94 (95% CI 0.88, 1.00)) approached the criteria for a SpPin triage test, and MRI (six studies, seven data sets, 266 participants; sensitivity 0.94 (95% CI 0.90, 0.97), specificity 0.77 (95% CI 0.44, 1.00)) approached the criteria for a replacement and SnNout triage test. Other imaging tests assessed in small individual studies could not be statistically evaluated.\nTVUS met the criteria for a SpPin triage test in mapping DIE to uterosacral ligaments, rectovaginal septum, vaginal wall, pouch of Douglas (POD) and rectosigmoid. MRI met the criteria for a SpPin triage test for POD and vaginal and rectosigmoid endometriosis. Transrectal ultrasonography (TRUS) might qualify as a SpPin triage test for rectosigmoid involvement but could not be adequately assessed for other anatomical sites because heterogeneous data were scant. Multi-detector computerised tomography enema (MDCT-e) displayed the highest diagnostic performance for rectosigmoid and other bowel endometriosis and met the criteria for both SpPin and SnNout triage tests, but studies were too few to provide meaningful results.\nDiagnostic accuracies were higher for TVUS with bowel preparation (TVUS-BP) and rectal water contrast (RWC-TVS) and for 3.0TMRI than for conventional methods, although the paucity of studies precluded statistical evaluation.\nAuthors' conclusions\nNone of the evaluated imaging modalities were able to detect overall pelvic endometriosis with enough accuracy that they would be suggested to replace surgery. Specifically for endometrioma, TVUS qualified as a SpPin triage test. MRI displayed sufficient accuracy to suggest utility as a replacement test, but the data were too scant to permit meaningful conclusions. TVUS could be used clinically to identify additional anatomical sites of DIE compared with MRI, thus facilitating preoperative planning. Rectosigmoid endometriosis was the only site that could be accurately mapped by using TVUS, TRUS, MRI or MDCT-e. Studies evaluating recent advances in imaging modalities such as TVUS-BP, RWC-TVS, 3.0TMRI and MDCT-e were observed to have high diagnostic accuracies but were too few to allow prudent evaluation of their diagnostic role. In view of the low quality of most of the included studies, the findings of this review should be interpreted with caution. Future well-designed diagnostic studies undertaken to compare imaging tests for diagnostic test accuracy and costs are recommended.\n\nGiven the provided abstract, please respond to the following query: \"Future research\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Additional high-quality research is needed to accurately evaluate the diagnostic potential of non-invasive imaging tests for endometriosis."
}
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query-laysum | 4273 | [
{
"role": "user",
"content": "Abstract: Background\nHepatocellular carcinoma (HCC) is the fifth most common global cancer. When HCC is diagnosed early, interventions such as percutaneous ethanol injection (PEI), percutaneous acetic acid injection (PAI), or radiofrequency (thermal) ablation (RF(T)A) may have curative potential and represent less invasive alternatives to surgery.\nObjectives\nTo evaluate the beneficial and harmful effects of PEI or PAI in adults with early HCC defined according to the Milan criteria, that is, one cancer nodule up to 5 cm in diameter or up to three cancer nodules up to 3 cm in diameter compared with no intervention, sham intervention, each other, other percutaneous interventions, or surgery.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register (July 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 6), MEDLINE (1946 to July 2014), EMBASE (1976 to July 2014), and Science Citation Index Expanded (1900 to July 2014). We handsearched meeting abstracts of six oncological and hepatological societies and references of articles to July 2014. We contacted researchers in the field.\nSelection criteria\nWe considered randomised clinical trials comparing PEI or PAI versus no intervention, sham intervention, each other, other percutaneous interventions, or surgery for the treatment of early HCC regardless of blinding, publication status, or language. We excluded studies comparing RFA or combination of different interventions as such interventions have been or will be addressed in other Cochrane Hepato-Biliary Group systematic reviews.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, and extracted and analysed data. We calculated the hazard ratios (HR) for median overall survival and recurrence-free survival using the Cox regression model with Parmar's method. We reported type and number of adverse events descriptively. We assessed risk of bias by The Cochrane Collaboration domains to reduce systematic errors and risk of play of chance by trial sequential analysis to reduce random errors. We assessed the methodological quality with GRADE.\nMain results\nWe identified three randomised trials with 261 participants for inclusion. The risk of bias was low in one and high in two trials.\nTwo of the randomised trials compared PEI versus PAI; we included 185 participants in the analysis. The overall survival (HR 1.47; 95% confidence interval (CI) 0.68 to 3.19) and recurrence-free survival (HR 1.42; 95% CI 0.68 to 2.94) were not statistically significantly different between the intervention groups of the two trials. Trial sequential analysis for the comparison PEI versus PAI including two trials revealed that the number of participants that were included in the trials were insufficient in order to judge a relative risk reduction of 20%. Data on the duration of hospital stay were available from one trial for the comparison PEI versus PAI showing a significantly shorter hospital stay for the participants treated with PEI (mean 1.7 days; range 2 to 3 days) versus PAI (mean 2.2 days; range 2 to 5 days). Quality of life was not reported. There were only mild adverse events in participants treated with either PEI or PAI such as transient fever, flushing, and local pain.\nOne randomised trial compared PEI versus surgery; we included 76 participants in the analyses. There was no significant difference in the overall survival (HR 1.57; 95% CI 0.53 to 4.61) and recurrence-free survival (HR 1.35; 95% CI 0.69 to 2.63). No serious adverse events were reported in the PEI group while three postoperative deaths occurred in the surgery group.\nIn addition to the three randomised trials, we identified one quasi-randomised study comparing PEI versus PAI. Due to methodological flaws of the study, we extracted only the data on adverse events and presented them in a narrative way.\nWe found no randomised trials that compared PEI or PAI versus no intervention, best supportive care, sham intervention, or other percutaneous local ablative therapies excluding RFTA. We found also no randomised clinical trials that compared PAI versus other interventional treatments or surgery. We identified two ongoing randomised clinical trials. One of these two trials compares PEI versus surgery and the other PEI versus transarterial chemoembolization. To date, it is unclear whether the trials will be eligible for inclusion in this meta-analysis as the data are not yet available. This review will not be updated until new randomised clinical trials are published and can be used for analysis.\nAuthors' conclusions\nPEI versus PAI did not differ significantly regarding benefits and harms in people with early HCC, but the two included trials had only a limited number of participants and one trial was judged a high risk of bias. Thus, the current evidence precludes us from making any firm conclusions.\nThere was also insufficient evidence to determine whether PEI versus surgery (segmental liver resection) was more effective, because conclusions were based on a single randomised trial. While some data from this single trial suggested that PEI was safer, the high risk of bias and the lack of any confirmatory evidence make a reliable assessment impossible.\nWe found no trials assessing PEI or PAI versus no intervention, best supportive care, or sham intervention.\nThere is a need for more randomised clinical trials assessing interventions for people with early stage HCC. Such trials should be conducted with low risks of systematic errors and random errors.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors only identified three randomised trials with 261 participants. The risk of bias was low in one and high in two trials. We found two trials that compared PEI versus PAI and one trial that compared PEI versus surgery. We found no trials that compared PEI or PAI versus sham (pretend) intervention, best supportive care, cryotherapy, laser-induced thermotherapy, or high-frequency ultrasound. We found no randomised trials that compared PAI versus surgery.\nThe review authors found low-quality evidence suggesting that PEI yielded the same result as PAI regarding overall survival (the length of time that the person remains alive) and recurrence-free survival (time that the person remains free of cancer). We calculated the number of participants that would be required to judge a relative risk reduction (relative risk is a comparison of the risk of an event happening for one treatment group compared with another treatment group) for survival of 20%. We found that for the comparisons PEI versus PAI, the number of participants was too low to reach valid conclusions. In both groups, participants reported the occurrence of mild side effects such as transient fever, flushing, and local pain. Based on one randomised trial with high risk of bias, there was very low quality evidence that surgical resection does not seem to be superior to PEI in people with early liver cancer. Of note, no severe side effects occurred in people treated with PEI while there were three postoperative deaths in people treated surgically. Again, too few participants were randomised to claim or reject important differences.\nThere is a need for more randomised clinical trials assessing interventions for people with early-stage liver cancer. Such trials should be conducted with low risks of bias (systematic errors, that is overestimation of benefits and underestimation of harms) and of play of chance (random errors, that is errors due to too few participants and too few outcomes)."
}
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query-laysum | 4274 | [
{
"role": "user",
"content": "Abstract: Background\nIntermittent urethral self-dilatation is sometimes recommended to reduce the risk of recurrent urethral stricture. There is no consensus as to whether it is a clinically effective or cost-effective intervention in the management of this disease.\nObjectives\nThe purpose of this review is to evaluate the clinical effectiveness and cost-effectiveness of intermittent self-dilatation after urethral stricture surgery in males compared to no intervention. We also compared different programmes of, and devices for, intermittent self-dilatation. .\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Register (searched 7 May 2014), CENTRAL (2014, Issue 4), MEDLINE (1 January 1946 to Week 3April 2014), PREMEDLINE (covering 29 April 2014), EMBASE (1 January 1947 to Week 17 2014), CINAHL (31 December 1981 to 30 April 2014) OpenGrey (searched 6 May 2014), ClinicalTrials.gov (6 May 2014), WHO International Clinical Trials Registry Platform (6 May 2014), Current Controlled Trials (6 May 2014) and the reference lists of relevant articles.\nSelection criteria\nRandomised and quasi-randomised trials where one arm was a programme of intermittent self-dilatation for urethral stricture were identified. Studies were excluded if they were not randomised or quasi-randomised trials, or if they pertained to clean intermittent self-catheterisation for bladder emptying.\nData collection and analysis\nTwo authors screened the records for relevance and methodological quality. Data extraction was performed according to predetermined criteria using data extraction forms. Analyses were carried out in Cochrane Review Manager (RevMan 5). The primary outcomes were patient-reported symptoms and health-related quality of life, and risk of recurrence; secondary outcomes were adverse events, acceptability of the intervention to patients and cost-effectiveness. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nEleven trials were selected for inclusion in the review, including a total of 776 men. They were generally small; all were of poor quality and all were deemed to have high risk of bias.\nPerforming intermittent self-dilatationversus not performing intermittent self-dilatation\nThe data from six trials were heterogeneous, imprecise and had a high risk of bias, but indicated that recurrent urethral stricture was less likely in men who performed intermittent self-dilatation than men who did not perform intermittent self-dilatation (RR 0.70, 95% CI 0.48 to 1.00; very low quality evidence). Adverse events were generally poorly reported: two trials did not report adverse events and two trials reported adverse events only for the intervention group. Meta-analysis of the remaining two trials found no evidence of a difference between performing intermittent self-dilatation and not performing it (RR 0.60, 95% CI 0.11 to 3.26). No trials formally assessed acceptability, and no trials reported on patient-reported lower urinary tract symptoms, patient-reported health-related quality of life, or cost-effectiveness.\nOne programme of intermittent self-dilatationversus another\nWe identified two trials that compared different durations of intermittent self-dilatation, but data were not combined. One study could not draw robust conclusions owing to cross-over, protocol deviation, administrative error, post-hoc analysis and incomplete outcome reporting. The other study found no evidence of a difference between intermittent self-dilatation for six months versus for 12 months after optical urethrotomy (RR 0.67, 95% CI 0.12 to 3.64), although again the evidence is limited by the small sample size and risk of bias in the included study. Adverse events were reported narratively and were not stratified by group. No trials formally assessed acceptability, and no trials reported on patient-reported lower urinary tract symptoms, patient-reported health-related quality of life, or cost-effectiveness.\nOne device for performing intermittent self-dilatationversus another\nThree trials compared one device for performing intermittent self-dilatation with another. Results from one trial at a high risk of bias were too uncertain to determine the effects of a low friction hydrophilic catheter and a standard polyvinyl chloride catheter on the risk of recurrent urethral stricture (RR 0.32, 95% CI 0.07 to 1.40). Similarly one study did not find evidence of a difference between one percent triamcinolone gel for lubricating the intermittent self-dilatation catheter versus water-based gel on risk of recurrent urethral stricture (RR 0.68, 95% CI 0.35 to 1.32). Two trials reported adverse events, but one did not provide sufficient detail for analysis. The other small study reported fewer instances of prostatitis, urethral bleeding or bacteriuria with a low friction hydrophilic catheter compared with a standard polyvinyl chloride catheter (RR 0.13, 95% CI 0.02 to 0.98). ‘Happiness with the intervention’ was assessed using a non-validated scale in one study, but no trials formally assessed patient-reported health-related quality of life or acceptability. No trials reported on patient-reported lower urinary tract symptoms or cost-effectiveness.\nGRADE quality assessment\nThe evidence that intermittent self-dilatation reduces the risk of recurrent urethral stricture after surgical intervention was downgraded to 'very low' on the basis that the studies comprising the meta-analysis were deemed to have high risk of bias, and the data was imprecise and inconsistent.\nInsufficient evidence\nNo trials provided cost-effectiveness data or used a validated patient-reported outcome measure, and adverse events were not reported rigorously. Acceptability of the intervention to patients has not been assessed quantitatively or qualitatively.\nAuthors' conclusions\nPerforming intermittent self-dilatation may confer a reduced risk of recurrent urethral stricture after endoscopic treatment. We have very little confidence in the estimate of the effect owing to the very low quality of the evidence. Evidence for other comparisons and outcomes is limited. Further research is required to determine whether the apparent benefit is sufficient to make the intervention worthwhile, and in whom.\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 trials in this review were generally small and poorly designed or poorly explained. All of the trials were conducted in a way which meant they had a high chance of generating an answer that does not represent the truth."
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query-laysum | 4275 | [
{
"role": "user",
"content": "Abstract: Background\nMénière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. Aminoglycosides are sometimes administered directly into the middle ear to treat this condition. The aim of this treatment is to partially or completely destroy the balance function of the affected ear. The efficacy of this intervention in preventing vertigo attacks, and their associated symptoms, is currently unclear.\nObjectives\nTo evaluate the benefits and harms of intratympanic aminoglycosides versus placebo or no treatment in people with Ménière's disease.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with a diagnosis of Ménière's disease comparing intratympanic aminoglycosides with either placebo or no treatment. We excluded studies with follow-up of less than three months, or with a cross-over design (unless data from the first phase of the study could be identified).\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) change in hearing, 6) change in tinnitus and 7) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included five RCTs with a total of 137 participants. All studies compared the use of gentamicin to either placebo or no treatment. Due to the very small numbers of participants in these trials, and concerns over the conduct and reporting of some studies, we considered all the evidence in this review to be very low-certainty.\nImprovement in vertigo\nThis outcome was assessed by only two studies, and they used different time periods for reporting. Improvement in vertigo was reported by more participants who received gentamicin at both 6 to ≤ 12 months (16/16 participants who received gentamicin, compared to 0/16 participants with no intervention; risk ratio (RR) 33.00, 95% confidence interval (CI) 2.15 to 507; 1 study; 32 participants; very low-certainty evidence) and at > 12 months follow-up (12/12 participants receiving gentamicin, compared to 6/10 participants receiving placebo; RR 1.63, 95% CI 0.98 to 2.69; 1 study; 22 participants; very low-certainty evidence). However, we were unable to conduct any meta-analysis for this outcome, the certainty of the evidence was very low and we cannot draw any meaningful conclusions from the results.\nChange in vertigo\nAgain, two studies assessed this outcome, but used different methods of measuring vertigo and assessed the outcome at different time points. We were therefore unable to carry out any meta-analysis or draw any meaningful conclusions from the results. Global scores of vertigo were lower for those who received gentamicin at both 6 to ≤ 12 months (mean difference (MD) -1 point, 95% CI -1.68 to -0.32; 1 study; 26 participants; very low-certainty evidence; four-point scale; minimally clinically important difference presumed to be one point) and at > 12 months (MD -1.8 points, 95% CI -2.49 to -1.11; 1 study; 26 participants; very low-certainty evidence). Vertigo frequency was also lower at > 12 months for those who received gentamicin (0 attacks per year in participants receiving gentamicin compared to 11 attacks per year for those receiving placebo; 1 study; 22 participants; very low-certainty evidence).\nSerious adverse events\nNone of the included studies provided information on the total number of participants who experienced a serious adverse event. It is unclear whether this is because no adverse events occurred, or because they were not assessed or reported.\nAuthors' conclusions\nThe evidence for the use of intratympanic gentamicin in the treatment of Ménière's disease is very uncertain. This is primarily due to the fact that there are few published RCTs in this area, and all the studies we identified enrolled a very small number of participants. As the studies assessed different outcomes, using different methods, and reported at different time points, we were not able to pool the results to obtain more reliable estimates of the efficacy of this treatment. More people may report an improvement in vertigo following gentamicin treatment, and scores of vertigo symptoms may also improve. However, the limitations of the evidence mean that we cannot be sure of these effects. Although there is the potential for intratympanic gentamicin to cause harm (for example, hearing loss) we did not find any information about the risks of treatment in this review.\nConsensus on the appropriate outcomes to measure in studies of Ménière's disease is needed (i.e. a core outcome set) in order to guide future studies in this area and enable meta-analysis of the results. This must include appropriate consideration of the potential harms of treatment, as well as the benefits.\n\nGiven the provided abstract, please respond to the following query: \"How is Ménière's disease treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Oral medications (tablets) are often used as the first treatment for Ménière's disease. If these treatments do not control the symptoms, then a type of antibiotics known as aminoglycosides may be given directly into the ear. Typically this involves an antibiotic called gentamicin. This is most commonly given as an injection through the ear drum."
}
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query-laysum | 4276 | [
{
"role": "user",
"content": "Abstract: Background\nBlood pressure is a commonly measured risk factor for non-fatal and fatal cardiovascular adverse events such as heart attacks and strokes. Clinical trials have suggested that coenzyme Q10, a non-prescription nutritional supplement, can effectively lower blood pressure (BP). When this review was completed and published in October 2009, it concluded that \"due to the possible unreliability of the 3 included studies, it is uncertain whether or not coenzyme Q10 reduces blood pressure in the long-term management of primary hypertension.\"\nObjectives\nTo determine the blood pressure lowering effect of coenzyme Q10 in primary hypertension.\nSearch methods\nWe searched the Hypertension Group Specialised Register (1946 to November 2015), The Cochrane Central Register of Controlled Trials (The Cochrane Library 2015, Issue 10), MEDLINE (1946 to November 2015), MEDLINE In-Process (accessed 10 November 2015), EMBASE (1974 to November 2015), Web of Science (1899 to November 2015), CINAHL (1970 to November 2015), and ClinicalTrials.gov (accessed 10 November 2015). We also searched reference lists of articles for relevant clinical trials in any language.\nSelection criteria\nDouble blind, randomized, placebo-controlled parallel or cross-over trials evaluating the blood pressure (BP) lowering efficacy of coenzyme Q10 for a duration of at least three weeks, in patients with primary hypertension.\nData collection and analysis\nThe primary author determined trial inclusion, extracted the data and assessed the risk of bias. The second author independently verified trial inclusion and data extraction.\nMain results\nIn this update of the review, one new randomized, controlled cross-over trial with a total of 30 participants was added, and one trial included in the initial review was excluded. Only two of the three included trials were pooled in the meta-analysis, as one trial was judged to have an unacceptably high risk of bias. In the meta-analysis of two RCTs (50 participants), coenzyme Q10 did not significantly change systolic BP: -3.68 mm Hg (95% confidence interval (CI) -8.86 to 1.49), or diastolic BP: -2.03 mm Hg (95% CI -4.86 to 0.81] ), based on clinic data.\nAuthors' conclusions\nThis review provides moderate-quality evidence that coenzyme Q10 does not have a clinically significant effect on blood pressure. In one of three trials reporting adverse effects, coenzyme Q10 was well tolerated. Due to the small number of individuals and studies available for analysis, more well-conducted trials are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "High blood pressure is a common condition that can increase risk for certain diseases such as heart attacks, strokes, and kidney disease. Coenzyme Q10, a non-prescription nutritional supplement, has been suggested as a potential drug to lower blood pressure. When this review was completed and published in October 2009, it concluded that \"due to the possible unreliability of the three included studies, it is uncertain whether or not coenzyme Q10 reduces blood pressure in the long-term management of primary hypertension.\""
}
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query-laysum | 4277 | [
{
"role": "user",
"content": "Abstract: Background\nThe leading causes of mortality globally in children younger than five years of age (under-fives), and particularly in the regions of sub-Saharan Africa (SSA) and Southern Asia, in 2018 were infectious diseases, including pneumonia (15%), diarrhoea (8%), malaria (5%) and newborn sepsis (7%) (UNICEF 2019). Nutrition-related factors contributed to 45% of under-five deaths (UNICEF 2019).\nWorld Health Organization (WHO) and United Nations Children's Fund (UNICEF), in collaboration with other development partners, have developed an approach – now known as integrated community case management (iCCM) – to bring treatment services for children 'closer to home'. The iCCM approach provides integrated case management services for two or more illnesses – including diarrhoea, pneumonia, malaria, severe acute malnutrition or neonatal sepsis – among under-fives at community level (i.e. outside of healthcare facilities) by lay health workers where there is limited access to health facility-based case management services (WHO/UNICEF 2012).\nObjectives\nTo assess the effects of the integrated community case management (iCCM) strategy on coverage of appropriate treatment for childhood illness by an appropriate provider, quality of care, case load or severity of illness at health facilities, mortality, adverse events and coverage of careseeking for children younger than five years of age in low- and middle-income countries.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and CINAHL on 7 November 2019, Virtual Health Library on 8 November 2019, and Popline on 5 December 2018, three other databases on 22 March 2019 and two trial registers on 8 November 2019. We performed reference checking, and citation searching, and contacted study authors to identify additional studies.\nSelection criteria\nRandomized controlled trials (RCTs), cluster-RCTs, controlled before-after studies (CBAs), interrupted time series (ITS) studies and repeated measures studies comparing generic WHO/UNICEF iCCM (or local adaptation thereof) for at least two iCCM diseases with usual facility services (facility treatment services) with or without single disease community case management (CCM). We included studies reporting on coverage of appropriate treatment for childhood illness by an appropriate provider, quality of care, case load or severity of illness at health facilities, mortality, adverse events and coverage of careseeking for under-fives in low- and middle-income countries.\nData collection and analysis\nAt least two review authors independently screened abstracts, screened full texts and extracted data using a standardised data collection form adapted from the EPOC Good Practice Data Collection Form. We resolved any disagreements through discussion or, if required, we consulted a third review author not involved in the original screening. We contacted study authors for clarification or additional details when necessary. We reported risk ratios (RR) for dichotomous outcomes and hazard ratios (HR) for time to event outcomes, with 95% confidence intervals (CI), adjusted for clustering, where possible. We used estimates of effect from the primary analysis reported by the investigators, where possible. We analysed the effects of randomized trials and other study types separately. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included seven studies, of which three were cluster RCTs and four were CBAs. Six of the seven studies were in SSA and one study was in Southern Asia.\nThe iCCM components and inputs were fairly consistent across the seven studies with notable variation for the training and deployment component (e.g. on payment of iCCM providers) and the system component (e.g. on improving information systems).\nWhen compared to usual facility services, we are uncertain of the effect of iCCM on coverage of appropriate treatment from an appropriate provider for any iCCM illness (RR 0.96, 95% CI 0.77 to 1.19; 2 CBA studies, 5898 children; very low-certainty evidence). iCCM may have little to no effect on neonatal mortality (HR 1.01, 95% 0.73 to 1.28; 2 trials, 65,209 children; low-certainty evidence). We are uncertain of the effect of iCCM on infant mortality (HR 1.02, 95% CI 0.83 to 1.26; 2 trials, 60,480 children; very low-certainty evidence) and under-five mortality (HR 1.18, 95% CI 1.01 to 1.37; 1 trial, 4729 children; very low-certainty evidence). iCCM probably increases coverage of careseeking to an appropriate provider for any iCCM illness by 68% (RR 1.68, 95% CI 1.24 to 2.27; 2 trials, 9853 children; moderate-certainty evidence). None of the studies reported quality of care, severity of illness or adverse events for this comparison.\nWhen compared to usual facility services plus CCM for malaria, we are uncertain of the effect of iCCM on coverage of appropriate treatment from an appropriate provider for any iCCM illness (very low-certainty evidence) and iCCM may have little or no effect on careseeking to an appropriate provider for any iCCM illness (RR 1.06, 95% CI 0.97 to 1.17; 1 trial, 811 children; low-certainty evidence). None of the studies reported quality of care, case load or severity of illness at health facilities, mortality or adverse events for this comparison.\nAuthors' conclusions\niCCM probably increases coverage of careseeking to an appropriate provider for any iCCM illness. However, the evidence presented here underscores the importance of moving beyond training and deployment to valuing iCCM providers, strengthening health systems and engaging community systems.\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": "When iCCM is compared to usual facility services, it probably increases the number of parents who seek care from a healthcare worker. But we do not know if more children get the correct treatment, and it may have no effect on the number of children who die."
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query-laysum | 4278 | [
{
"role": "user",
"content": "Abstract: Background\nOver the decades, a variety of psychological interventions for borderline personality disorder (BPD) have been developed. This review updates and replaces an earlier review (Stoffers-Winterling 2012).\nObjectives\nTo assess the beneficial and harmful effects of psychological therapies for people with BPD.\nSearch methods\nIn March 2019, we searched CENTRAL, MEDLINE, Embase, 14 other databases and four trials registers. We contacted researchers working in the field to ask for additional data from published and unpublished trials, and handsearched relevant journals. We did not restrict the search by year of publication, language or type of publication.\nSelection criteria\nRandomised controlled trials comparing different psychotherapeutic interventions with treatment-as-usual (TAU; which included various kinds of psychotherapy), waiting list, no treatment or active treatments in samples of all ages, in any setting, with a formal diagnosis of BPD. The primary outcomes were BPD symptom severity, self-harm, suicide-related outcomes, and psychosocial functioning. There were 11 secondary outcomes, including individual BPD symptoms, as well as attrition and adverse effects.\nData collection and analysis\nAt least two review authors independently selected trials, extracted data, assessed risk of bias using Cochrane's 'Risk of bias' tool and assessed the certainty of the evidence using the GRADE approach. We performed data analysis using Review Manager 5 and quantified the statistical reliability of the data using Trial Sequential Analysis.\nMain results\nWe included 75 randomised controlled trials (4507 participants), predominantly involving females with mean ages ranging from 14.8 to 45.7 years. More than 16 different kinds of psychotherapy were included, mostly dialectical behaviour therapy (DBT) and mentalisation-based treatment (MBT). The comparator interventions included treatment-as-usual (TAU), waiting list, and other active treatments. Treatment duration ranged from one to 36 months.\nPsychotherapy versus TAU\nPsychotherapy reduced BPD symptom severity, compared to TAU; standardised mean difference (SMD) −0.52, 95% confidence interval (CI) −0.70 to −0.33; 22 trials, 1244 participants; moderate-quality evidence. This corresponds to a mean difference (MD) of −3.6 (95% CI −4.4 to −2.08) on the Zanarini Rating Scale for BPD (range 0 to 36), a clinically relevant reduction in BPD symptom severity (minimal clinical relevant difference (MIREDIF) on this scale is −3.0 points).\nPsychotherapy may be more effective at reducing self-harm compared to TAU (SMD −0.32, 95% CI −0.49 to −0.14; 13 trials, 616 participants; low-quality evidence), corresponding to a MD of −0.82 (95% CI −1.25 to 0.35) on the Deliberate Self-Harm Inventory Scale (range 0 to 34). The MIREDIF of −1.25 points was not reached.\nSuicide-related outcomes improved compared to TAU (SMD −0.34, 95% CI −0.57 to −0.11; 13 trials, 666 participants; low-quality evidence), corresponding to a MD of −0.11 (95% CI −0.19 to −0.034) on the Suicidal Attempt Self Injury Interview. The MIREDIF of −0.17 points was not reached.\nCompared to TAU, psychotherapy may result in an improvement in psychosocial functioning (SMD −0.45, 95% CI −0.68 to −0.22; 22 trials, 1314 participants; low-quality evidence), corresponding to a MD of −2.8 (95% CI −4.25 to −1.38), on the Global Assessment of Functioning Scale (range 0 to 100). The MIREDIF of −4.0 points was not reached.\nOur additional Trial Sequential Analysis on all primary outcomes reaching significance found that the required information size was reached in all cases.\nA subgroup analysis comparing the different types of psychotherapy compared to TAU showed no clear evidence of a difference for BPD severity and psychosocial functioning.\nPsychotherapy may reduce depressive symptoms compared to TAU but the evidence is very uncertain (SMD −0.39, 95% CI −0.61 to −0.17; 22 trials, 1568 participants; very low-quality evidence), corresponding to a MD of −2.45 points on the Hamilton Depression Scale (range 0 to 50). The MIREDIF of −3.0 points was not reached.\nBPD-specific psychotherapy did not reduce attrition compared with TAU. Adverse effects were unclear due to too few data.\nPsychotherapy versus waiting list or no treatment\nGreater improvements in BPD symptom severity (SMD −0.49, 95% CI −0.93 to −0.05; 3 trials, 161 participants), psychosocial functioning (SMD −0.56, 95% CI −1.01 to −0.11; 5 trials, 219 participants), and depression (SMD −1.28, 95% CI −2.21 to −0.34, 6 trials, 239 participants) were observed in participants receiving psychotherapy versus waiting list or no treatment (all low-quality evidence). No evidence of a difference was found for self-harm and suicide-related outcomes.\nIndividual treatment approaches\nDBT and MBT have the highest numbers of primary trials, with DBT as subject of one-third of all included trials, followed by MBT with seven RCTs.\nCompared to TAU, DBT was more effective at reducing BPD severity (SMD −0.60, 95% CI −1.05 to −0.14; 3 trials, 149 participants), self-harm (SMD −0.28, 95% CI −0.48 to −0.07; 7 trials, 376 participants) and improving psychosocial functioning (SMD −0.36, 95% CI −0.69 to −0.03; 6 trials, 225 participants). MBT appears to be more effective than TAU at reducing self-harm (RR 0.62, 95% CI 0.49 to 0.80; 3 trials, 252 participants), suicidality (RR 0.10, 95% CI 0.04, 0.30, 3 trials, 218 participants) and depression (SMD −0.58, 95% CI −1.22 to 0.05, 4 trials, 333 participants). All findings are based on low-quality evidence. For secondary outcomes see review text.\nAuthors' conclusions\nOur assessments showed beneficial effects on all primary outcomes in favour of BPD-tailored psychotherapy compared with TAU. However, only the outcome of BPD severity reached the MIREDIF-defined cut-off for a clinically meaningful improvement. Subgroup analyses found no evidence of a difference in effect estimates between the different types of therapies (compared to TAU) .\nThe pooled analysis of psychotherapy versus waiting list or no treatment found significant improvement on BPD severity, psychosocial functioning and depression at end of treatment, but these findings were based on low-quality evidence, and the true magnitude of these effects is uncertain. No clear evidence of difference was found for self-harm and suicide-related outcomes.\nHowever, compared to TAU, we observed effects in favour of DBT for BPD severity, self-harm and psychosocial functioning and, for MBT, on self-harm and suicidality at end of treatment, but these were all based on low-quality evidence. Therefore, we are unsure whether these effects would alter with the addition of more data.\n\nGiven the provided abstract, please respond to the following query: \"Objective\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review summarises what we currently know about the effect of psychotherapy in people with BPD."
}
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query-laysum | 4279 | [
{
"role": "user",
"content": "Abstract: Background\nMotor neuron disease (MND), which is also known as amyotrophic lateral sclerosis (ALS), causes a wide range of symptoms but the evidence base for the effectiveness of the symptomatic treatment therapies is limited.\nObjectives\nTo summarise the evidence from Cochrane Systematic Reviews of all symptomatic treatments for MND.\nMethods\nWe searched the Cochrane Database of Systematic Reviews (CDSR) on 15 November 2016 for systematic reviews of symptomatic treatments for MND. We assessed the methodological quality of the included reviews using the Assessment of Multiple Systematic Reviews (AMSTAR) tool and the GRADE approach. We followed standard Cochrane study (review) selection and data extraction procedures. We reported findings narratively and in tables.\nMain results\nWe included nine Cochrane Systematic Reviews of interventions to treat symptoms in people with MND. Three were empty reviews with no included randomised controlled trials (RCTs); however, all three reported on non-RCT evidence and the remaining six included mostly one or two studies. We deemed all of the included reviews of high methodological quality.\nDrug therapy for pain\nThere is no RCT evidence in a Cochrane Systematic Review exploring the efficacy of drug therapy for pain in MND.\nTreatment for cramps\nThere is evidence (13 RCTs, N = 4012) that for the treatment of cramps in MND, compared to placebo:\n– memantine and tetrahydrocannabinol (THC) are probably ineffective (moderate-quality evidence);\n– vitamin E may have little or no effect (low-quality evidence); and\n– the effects of L-threonine, gabapentin, xaliproden, riluzole, and baclofen are uncertain as the evidence is either very low quality or the trial specified the outcome but did not report numerical data.\nThe review reported adverse effects of riluzole, but it is not clear whether other interventions had adverse effects.\nTreatment for spasticity\nIt is uncertain whether an endurance-based exercise programme improved spasticity or quality of life, measured at three months after the programme, as the quality of evidence is very low (1 RCT, comparison \"usual activities\", N = 25). The review did not evaluate other approaches, such as use of baclofen as no RCTs were available.\nMechanical ventilation for supporting respiratory function\nNon-invasive ventilation (NIV) probably improves median survival and quality of life in people with respiratory insufficiency and normal to moderately impaired bulbar function compared to standard care, and improves quality of life but not survival for people with poor bulbar function (1 RCT, N = 41, moderate-quality evidence; a second RCT did not provide data). The review did not evaluate other approaches such as tracheostomy-assisted ('invasive') ventilation, or assess timing of NIV initiation.\nTreatment for sialorrhoea\nA single session of botulinum toxin type B injections to parotid and submandibular glands probably improves sialorrhoea and quality of life at up to 4 weeks compared to placebo injections, but not at 8 or 12 weeks after the injections (moderate-quality evidence from 1 placebo-controlled RCT, N = 20). The review authors found no trials of other approaches.\nEnteral tube feeding for supporting nutrition\nThere is no RCT evidence in a Cochrane Systematic Review to support benefit or harms of enteral tube feeding in supporting nutrition in MND.\nRepetitive transcranial magnetic stimulation\nIt is uncertain whether repetitive transcranial magnetic stimulation (rTMS) improves disability or limitation in activity in MND in comparison with sham rTMS (3 RCTs, very low quality evidence, N = 50).\nTherapeutic exercise\nThere is evidence that exercise may improve disability in MND at three months after the exercise programme, but not quality of life, in comparison with \"usual activities\" or \"usual care\" including stretching (2 RCTs, low-quality evidence, N = 43).\nMultidisciplinary care\nThere is no RCT evidence in a Cochrane Systematic Review to demonstrate any benefit or harm for multidisciplinary care in MND.\nNone of the reviews, other than the review of treatment for cramps, reported that adverse events occurred. However, the trials were too small for reliable adverse event reporting.\nAuthors' conclusions\nThis overview has highlighted the lack of robust evidence in Cochrane Systematic Reviews on interventions to manage symptoms resulting from MND. It is important to recognise that clinical trials may fail to demonstrate efficacy of an intervention for reasons other than a true lack of efficacy, for example because of insufficient statistical power, the wrong choice of dose, insensitive outcome measures or inappropriate participant eligibility. The trials were mostly too small to reliably assess adverse effects of the treatments. The nature of MND makes it difficult to research clinically accepted or recommended practice, regardless of the level of evidence supporting the practice. It would not be ethical, for example, to design a placebo-controlled trial for treatment of pain in MND or to withhold multidisciplinary care where such care is available. It is therefore highly unlikely that there will ever be classically designed placebo-controlled RCTs in these areas.\nWe need more research with appropriate study designs, robust methodology, and of sufficient duration to address the changing needs—of people with MND and their caregivers—associated with MND disease progression and mortality. There is a significant gap in studies assessing the effectiveness of interventions for symptoms relating to MND, such as pseudobulbar emotional lability and cognitive and behavioural difficulties. Future studies should use appropriate outcome measures that are reliable, have internal and external validity, and are sensitive to change in what is being measured (such as quality of life).\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": "Motor neuron disease (MND), which is also known as amyotrophic lateral sclerosis (ALS), is an uncommon, incurable disease that affects the nerves involved in movement. MND gets worse over time and affects muscles of the limbs, speech, swallowing and breathing. People with MND experience a wide range of symptoms, including a number of physical ability limitations, pain, spasticity, cramps, swallowing problems and difficulty breathing. It is important to recognise that clinical trials may fail to show that a treatment is effective for several reasons that are not related to the effects of the treatment itself, for example when there are too few people in a trial, or investigators choose an ineffective dose of a drug."
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query-laysum | 4280 | [
{
"role": "user",
"content": "Abstract: Background\nA blood transfusion is an acute intervention, used to address life- and health-threatening conditions on a short-term basis. Packed red blood cells are most often used for blood transfusion. Sometimes blood is transfused after prolonged storage but there is continuing debate as to whether transfusion of 'older' blood is as beneficial as transfusion of 'fresher' blood.\nObjectives\nTo assess the clinical benefits and harms of prolonged storage of packed red blood cells, in comparison with fresh, on recipients of blood transfusion.\nSearch methods\nWe ran the search on 1st May 2014. We searched the Cochrane Injuries Group Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), MEDLINE (OvidSP), Embase (OvidSP), CINAHL (EBSCO Host) and two other databases. We also searched clinical trials registers and screened reference lists of the retrieved publications and reviews. We updated this search in June 2015 but these results have not yet been incorporated.\nSelection criteria\nRandomised clinical trials including participants assessed as requiring red blood cell transfusion were eligible for inclusion. Prolonged storage was defined as red blood cells stored for ≥ 21 days in a blood bank. We did not apply limits regarding the duration of follow-up, or country where the study took place. We excluded trials where patients received a combination of short- and long-stored blood products, and also trials without a clear definition of prolonged storage.\nData collection and analysis\nWe independently performed study selection, risk of bias assessment and data extraction by at least two review authors. The major outcomes were death from any cause, transfusion-related acute lung injury, and adverse events. We estimated relative risk for dichotomous outcomes. We measured statistical heterogeneity using I2. We used a random-effects model to synthesise the findings.\nMain results\nWe identified three randomised clinical trials, involving a total of 120 participants, comparing packed red blood cells with ≥ 21 days storage ('prolonged' or 'older') versus packed red blood cells with < 21 days storage ('fresh'). We pooled data to assess the effect of prolonged storage on death from any cause. The confidence in the results from these trials was very low, due to the bias in their design and their limited sample sizes.\nThe estimated effect of packed red blood cells with ≥ 21 days storage versus packed red blood cells with < 21 days storage for the outcome death from any cause was imprecise (5/45 [11.11%] versus 2/46 [4.34%]; RR 2.36; 95% CI 0.65 to 8.52; I2: 0%, P = 0.26, very low quality of evidence). Trial sequential analysis, with only two trials, shows that we do not yet have convincing evidence that older packed red blood cells induce a 20% relative risk reduction of death from any cause compared with fresher packed red blood cells. No trial included other outcomes of interest specified in this review, namely transfusion-related acute lung injury, postoperative infections, and adverse events. The safety profile is unknown.\nAuthors' conclusions\nRecognising the limitations of the review, relating to the size and nature of the included trials, this Cochrane Review provides no evidence to support or reject the use of packed red blood cells for blood transfusion which have been stored for ≥ 21 days ('prolonged' or 'older') compared with those stored for < 21 days ('fresh'). These results are based on three small single centre trials with high risks of bias. There is insufficient evidence to determine the effects of fresh or older packed red blood cells for blood transfusion. Therefore, we urge readers to interpret the trial results with caution. The results from four large ongoing trials will help to inform future updates of this review.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The level of confidence in the results of this review is very low. The studies have limitations in the way they were designed and executed. Moreover, the limited number of people included in the studies led to imprecise results. We are aware of four large ongoing trials in this area which will help us to better understand the effects of storage on red blood cells in relation to outcomes for patients."
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query-laysum | 4281 | [
{
"role": "user",
"content": "Abstract: Background\nEarly accurate detection of all skin cancer types is important to guide appropriate management, to reduce morbidity and to improve survival. Basal cell carcinoma (BCC) is almost always a localised skin cancer with potential to infiltrate and damage surrounding tissue, whereas a minority of cutaneous squamous cell carcinomas (cSCCs) and invasive melanomas are higher-risk skin cancers with the potential to metastasise and cause death. Dermoscopy has become an important tool to assist specialist clinicians in the diagnosis of melanoma, and is increasingly used in primary-care settings. Dermoscopy is a precision-built handheld illuminated magnifier that allows more detailed examination of the skin down to the level of the superficial dermis. Establishing the value of dermoscopy over and above visual inspection for the diagnosis of BCC or cSCC in primary- and secondary-care settings is critical to understanding its potential contribution to appropriate skin cancer triage, including referral of higher-risk cancers to secondary care, the identification of low-risk skin cancers that might be treated in primary care and to provide reassurance to those with benign skin lesions who can be safely discharged.\nObjectives\nTo determine the diagnostic accuracy of visual inspection and dermoscopy, alone or in combination, for the detection of (a) BCC and (b) cSCC, in adults. We separated studies according to whether the diagnosis was recorded face-to-face (in person) or based on remote (image-based) assessment.\nSearch methods\nWe undertook a comprehensive search of the following databases from inception up to August 2016: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We studied reference lists and published systematic review articles.\nSelection criteria\nStudies of any design that evaluated visual inspection or dermoscopy or both in adults with lesions suspicious for skin cancer, compared with a reference standard of either histological confirmation or clinical follow-up.\nData collection and analysis\nTwo review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). We contacted authors of included studies where information related to the target condition or diagnostic thresholds were missing. We estimated accuracy using hierarchical summary ROC methods. We undertook analysis of studies allowing direct comparison between tests. To facilitate interpretation of results, we computed values of sensitivity at the point on the SROC curve with 80% fixed specificity and values of specificity with 80% fixed sensitivity. We investigated the impact of in-person test interpretation; use of a purposely-developed algorithm to assist diagnosis; and observer expertise.\nMain results\nWe included 24 publications reporting on 24 study cohorts, providing 27 visual inspection datasets (8805 lesions; 2579 malignancies) and 33 dermoscopy datasets (6855 lesions; 1444 malignancies). The risk of bias was mainly low for the index test (for dermoscopy evaluations) and reference standard domains, particularly for in-person evaluations, and high or unclear for participant selection, application of the index test for visual inspection and for participant flow and timing. We scored concerns about the applicability of study findings as of ‘high’ or 'unclear' concern for almost all studies across all domains assessed. Selective participant recruitment, lack of reproducibility of diagnostic thresholds and lack of detail on observer expertise were particularly problematic.\nThe detection of BCC was reported in 28 datasets; 15 on an in-person basis and 13 image-based. Analysis of studies by prior testing of participants and according to observer expertise was not possible due to lack of data. Studies were primarily conducted in participants referred for specialist assessment of lesions with available histological classification. We found no clear differences in accuracy between dermoscopy studies undertaken in person and those which evaluated images. The lack of effect observed may be due to other sources of heterogeneity, including variations in the types of skin lesion studied, in dermatoscopes used, or in the use of algorithms and varying thresholds for deciding on a positive test result.\nMeta-analysis found in-person evaluations of dermoscopy (7 evaluations; 4683 lesions and 363 BCCs) to be more accurate than visual inspection alone for the detection of BCC (8 evaluations; 7017 lesions and 1586 BCCs), with a relative diagnostic odds ratio (RDOR) of 8.2 (95% confidence interval (CI) 3.5 to 19.3; P < 0.001). This corresponds to predicted differences in sensitivity of 14% (93% versus 79%) at a fixed specificity of 80% and predicted differences in specificity of 22% (99% versus 77%) at a fixed sensitivity of 80%. We observed very similar results for the image-based evaluations.\nWhen applied to a hypothetical population of 1000 lesions, of which 170 are BCC (based on median BCC prevalence across studies), an increased sensitivity of 14% from dermoscopy would lead to 24 fewer BCCs missed, assuming 166 false positive results from both tests. A 22% increase in specificity from dermoscopy with sensitivity fixed at 80% would result in 183 fewer unnecessary excisions, assuming 34 BCCs missed for both tests. There was not enough evidence to assess the use of algorithms or structured checklists for either visual inspection or dermoscopy.\nInsufficient data were available to draw conclusions on the accuracy of either test for the detection of cSCCs.\nAuthors' conclusions\nDermoscopy may be a valuable tool for the diagnosis of BCC as an adjunct to visual inspection of a suspicious skin lesion following a thorough history-taking including assessment of risk factors for keratinocyte cancer. The evidence primarily comes from secondary-care (referred) populations and populations with pigmented lesions or mixed lesion types. There is no clear evidence supporting the use of currently-available formal algorithms to assist dermoscopy diagnosis.\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"
},
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"role": "assistant",
"content": "The review included 24 studies reporting information for people with lesions suspected of skin cancer.\nDiagnosis of BCC with the patient present\nWe found 11 relevant studies. Eight studies (including 7017 suspicious skin lesions) investigated the accuracy of visual inspection on its own and seven studies (with 4683 suspicious skin lesions) investigated the accuracy of dermoscopy added to visual inspection (four of which reported data for both visual inspection on its own and for dermoscopy added to visual inspection). The results suggest that dermoscopy is more accurate than visual inspection on its own, both for identifying BCC correctly and for excluding things that are not BCCs.\nThe results can be illustrated using a group of 1000 lesions, of which 170 (17%) are BCC. In order to see how much better dermoscopy is in identifying BCC correctly when compared to just looking at the skin, we have to assume that both lead to the same number of lesions being falsely diagnosed as BCC (we assumed that 166 of the 830 lesions without BCC would have an incorrect diagnosis of BCC). In this fixed situation, adding dermoscopy to visual inspection would correctly identify an extra 24 BCCs (158 compared with 134) that would have been missed by just looking at the skin alone. In other words, more BCC cancers would be correctly identified.\nIn order to see how much better dermoscopy is in deciding if a skin lesion is not a BCC when compared to just looking at the skin, we have to assume that both lead to the same number of BCCs being correctly diagnosed (in this case we assumed that 136 out of the 170 BCCs would be correctly diagnosed). In this situation, adding in dermoscopy to visual inspection would reduce the number of lesions being wrongly diagnosed as being BCC by 183 (a reduction from 191 in the visual inspection group to eight people in the dermoscopy group). In other words, more lesions that were not BCC would be correctly identified, and fewer people would end up being sent for surgery.\nImage-based diagnosis of BCC\nEleven studies concerning BCC diagnosis using either clinical photographs or magnified images from a dermatoscope were included. Four studies, (including 853 suspicious skin lesions) used visual inspection of photographs and nine studies (including 2271 suspicious lesions) used dermoscopic images (two studies reported data for diagnosis using both photographs and using dermoscopic images). Results were very similar to the in-person studies.\nValue of checklists and observer expertise\nThere was no evidence that use of a checklist to help visual inspection or dermoscopy interpretation improved diagnostic accuracy. There was not enough evidence to examine the effect of clinical expertise and training.\nDiagnosis of cSCC\nThere was not enough evidence to reliably comment on the accuracy of either test for the detection of cSCCs."
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query-laysum | 4282 | [
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"role": "user",
"content": "Abstract: Background\nNonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most frequently prescribed drugs for the treatment of sciatica. A previous Cochrane review on the efficacy of NSAIDs summarised findings for acute and chronic low back pain (LBP) and sciatica. This is an update of the original review (2008) focusing on people suffering from sciatica.\nObjectives\nTo determine the efficacy of NSAIDs in pain reduction, overall improvement, and reported side effects in people with sciatica.\nSearch methods\nWe performed electronic searches up to 24 June 2015 in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PubMed, and two trials registers. We searched reference lists of included studies and relevant reviews on the topics for additional trials.\nSelection criteria\nWe included randomised controlled trials (double-blind, single-blind, and open-label) that assessed the efficacy of NSAIDs in sciatica. We included all trials that compared NSAIDs to placebo, to other NSAIDs, or to other medication. Additional interventions were allowed if there was a clear contrast for the treatment with NSAIDs in the trial.\nData collection and analysis\nThree review authors independently assessed the risk of bias and extracted the data. Where feasible we calculated pooled results using Review Manager 5.3. We reported pain relief outcomes using mean difference (MD) with 95% confidence intervals (95% CI). We used risk ratios (RR) with 95% CI to report global improvement of treatment, adverse effects, and additional medication. We performed a meta-analysis if possible. We assessed level of evidence using the GRADE approach. We used standard methodological procedures recommended by The Cochrane Collaboration.\nMain results\nWe included 10 trials reported in 9 publications (N = 1651). Only one trial out of 10 was assessed at low risk of bias. Five trials used the currently recommended daily dose for the drug, and two trials used lower daily doses available over the counter. Three trials investigated NSAIDs no longer approved for human use. The follow-up duration was short in all studies but one.\nThree trials (n = 918) compared the effects of NSAIDs to those of placebo on pain reduction. The pooled mean difference showed comparable pain reduction (visual analogue scale, 0 to 100) in the NSAIDs and placebo groups (MD -4.56, 95% CI -11.11 to 1.99). Heterogeneity was high (I2 = 82%), and the quality of the evidence was very low. When we excluded one trial with a short follow-up of eight hours, the mean difference further decreased (MD -0.09, 95% CI -9.89 to 9.71). Three trials (n = 753) compared NSAIDs to placebo regarding global improvement. We found low-quality evidence that NSAIDs are more effective than placebo with a risk ratio of 1.14 (95% CI 1.03 to 1.27). One trial (n = 214) studied the effect of NSAIDs on disability, finding very low-quality evidence that NSAIDs are no more effective than placebo on disability. Four trials (n = 967) comparing NSAIDs to placebo reported adverse effects, with low-quality evidence that the risk for adverse effects is higher in the NSAID group than in the placebo group (RR 1.40, 95% CI 1.02 to 1.93). The adverse effects reported in this review are consistent with those previously reported in the literature.\nAuthors' conclusions\nThis updated systematic review including 10 trials evaluating the efficacy of NSAIDs versus placebo or other drugs in people with sciatica reports low- to very low-level evidence using the GRADE criteria. The efficacy of NSAIDs for pain reduction was not significant. NSAIDs showed a better global improvement compared to placebo. These findings must be interpreted with caution, as the level of evidence according to the GRADE classification was very low for the outcome pain reduction and low for global improvement due to small study samples, inconsistent results, imprecision, and a high risk of bias in the included trials. While the trials included in the analysis were not powered to detect potential rare side effects, we found an increased risk for side effects in the short-term NSAIDs use. As NSAIDs are frequently prescribed, the risk-benefit ratio of prescribing the drug needs to be considered.\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 regarding the effect of non-steroidal anti-inflammatory drugs (NSAIDs) among people with sciatica on pain reduction, overall improvement and side effects. NSAIDs were compared to placebo, other NSAIDs, or other drugs."
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query-laysum | 4283 | [
{
"role": "user",
"content": "Abstract: Background\nLumbar puncture is a common invasive procedure performed in newborns for diagnostic and therapeutic purposes. Approximately one in two lumbar punctures fail, resulting in both short- and long-term negative consequences for the clinical management of patients. The most common positions used to perform lumbar puncture are the lateral decubitus and sitting position, and each can impact the success rate and safety of the procedure. However, it is uncertain which position best improves patient outcomes.\nObjectives\nTo assess the benefits and harms of the lateral decubitus, sitting, and prone positions for lumbar puncture in newborn infants.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 24 January 2023.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-RCTs involving newborn infants of postmenstrual age up to 46 weeks and 0 days, undergoing lumbar puncture for any indication, comparing different positions (i.e. lateral decubitus, sitting, and prone position) during the procedure.\nData collection and analysis\nWe used standard Cochrane methods. We used the fixed-effect model with risk ratio (RR) and risk difference (RD) for dichotomous data and mean difference (MD) and standardized mean difference (SMD) for continuous data, with their 95% confidence intervals (CI). Our primary outcomes were successful lumbar puncture procedure at the first attempt; total number of lumbar puncture attempts; and episodes of bradycardia. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included five studies with 1476 participants.\nCompared to sitting position: lateral decubitus position may result in little to no difference in successful lumbar puncture procedure at the first attempt (RR 0.93, 95% CI 0.85 to 1.02; RD −0.04, 95% CI −0.09 to 0.01; I2 = 70% and 72% for RR and RD, respectively; 2 studies, 1249 infants, low-certainty evidence). None of the studies reported the total number of lumbar puncture attempts. Lateral decubitus position likely increases episodes of bradycardia (RR 1.72, 95% CI 1.08 to 2.76; RD 0.03, 95% CI 0.00 to 0.05; number needed to treat for an additional harmful outcome (NNTH) = 33; I2 = not applicable and 69% for RR and RD, respectively; 3 studies, 1279 infants, moderate-certainty evidence) and oxygen desaturation (RR 2.10, 95% CI 1.42 to 3.08; RD 0.06, 95% CI 0.03 to 0.09; NNTH = 17; I2 = not applicable and 96% for RR and RD, respectively; 2 studies, 1249 infants, moderate-certainty evidence). The evidence is very uncertain regarding the effect of lateral decubitus position on time to perform the lumbar puncture (MD 2.00, 95% CI −4.98 to 8.98; I2 = not applicable; 1 study, 20 infants, very low-certainty evidence). Lateral decubitus position may result in little to no difference in the number of episodes of apnea during the procedure (RR not estimable; RD 0.00, 95% CI −0.03 to 0.03; I2 = not applicable and 0% for RR and RD, respectively; 2 studies, 197 infants, low-certainty evidence). No studies reported apnea defined as number of infants with one or more episodes during the procedure.\nCompared to prone position: lateral decubitus position may reduce successful lumbar puncture procedure at first attempt (RR 0.75, 95% CI 0.63 to 0.90; RD −0.21, 95% CI −0.34 to −0.09; number needed to treat for an additional beneficial outcome = 5; I2 = not applicable; 1 study, 171 infants, low-certainty evidence). None of the studies reported the total number of lumbar puncture attempts or episodes of apnea. Pain intensity during and after the procedure was reported using a non-validated pain scale. None of the studies comparing lateral decubitus versus prone position reported the other critical outcomes of this review.\nAuthors' conclusions\nWhen compared to sitting position, lateral decubitus position may result in little to no difference in successful lumbar puncture procedure at first attempt. None of the included studies reported the total number of lumbar puncture attempts. Furthermore, infants in a lateral decubitus position likely experience more episodes of bradycardia and oxygen desaturation, and there may be little to no difference in episodes of apnea. The evidence is very uncertain regarding time to perform lumbar puncture. Pain intensity during and after the procedure was reported using a pain scale that was not included in our prespecified tools for pain assessment due to its high risk of bias. Most study participants were term newborns, thereby limiting the applicability of these results to preterm babies.\nWhen compared to prone position, lateral decubitus position may reduce successful lumbar puncture procedure at first attempt. Only one study reported on this comparison and did not evaluate adverse effects.\nFurther research exploring harms and benefits and the effect on patients' pain experience of different positions during lumbar puncture using validated pain scoring tool may increase the level of confidence in our conclusions.\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"
},
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"role": "assistant",
"content": "We wanted to find out whether in newborns different body positions may affect the chance of a successful spinal tap at the first attempt; the number of tries for a successful spinal tap; and the number of episodes of adverse events, such as slow heart rate, low oxygen levels in the blood, and apnea (episodes of not breathing). We also explored if there were any differences in the time taken to perform the spinal tap; pain and discomfort during a spinal tap; need for pain medication or sedation to perform a spinal tap; bleeding and bruising from spinal taps; and rate of infections related to spinal taps."
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"role": "user",
"content": "Abstract: Background\nBasilar skull fractures predispose patients to meningitis because of the possible direct contact of bacteria in the paranasal sinuses, nasopharynx or middle ear with the central nervous system (CNS). Cerebrospinal fluid (CSF) leakage has been associated with a greater risk of contracting meningitis. Antibiotics are often given prophylactically, although their role in preventing bacterial meningitis has not been established.\nObjectives\nTo evaluate the effectiveness of prophylactic antibiotics for preventing meningitis in patients with basilar skull fractures.\nSearch methods\nWe searched CENTRAL (2014, Issue 5), MEDLINE (1966 to June week 1, 2014), EMBASE (1974 to June 2014) and LILACS (1982 to June 2014). We also performed an electronic search of meeting proceedings from the American Association of Neurological Surgeons (1997 to September 2005) and handsearched the abstracts of meeting proceedings of the European Association of Neurosurgical Societies (1995, 1999 and 2003).\nSelection criteria\nRandomised controlled trials (RCTs) comparing any antibiotic versus placebo or no intervention. We also identified non-RCTs to perform a separate meta-analysis in order to compare results.\nData collection and analysis\nThree review authors independently screened and selected trials, assessed risk of bias and extracted data. We sought clarification with trial authors when needed. We pooled risk ratios (RRs) for dichotomous data with their 95% confidence intervals (CIs) using a random-effects model. We assessed the overall quality of evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.\nMain results\nIn this update we did not identify any new trials for inclusion. We included five RCTs with 208 participants in the review and meta-analysis. We also identified 17 non-RCTs comparing different types of antibiotic prophylaxis with placebo or no intervention in patients with basilar skull fractures. Most trials presented insufficient methodological detail. All studies included meningitis in their primary outcome. When we evaluated the five included RCTs, there were no significant differences between antibiotic prophylaxis groups and control groups in terms of reduction of the frequency of meningitis, all-cause mortality, meningitis-related mortality and need for surgical correction in patients with CSF leakage. There were no reported adverse effects of antibiotic administration, although one of the five RCTs reported an induced change in the posterior nasopharyngeal flora towards potentially more pathogenic organisms resistant to the antibiotic regimen used in prophylaxis. We performed a subgroup analysis to evaluate the primary outcome in patients with and without CSF leakage. We also completed a meta-analysis of all the identified controlled non-RCTs (enrolling a total of 2168 patients), which produced results consistent with the randomised data from the included studies.\nUsing the GRADE approach, we assessed the quality of trials as moderate.\nAuthors' conclusions\nCurrently available evidence from RCTs does not support prophylactic antibiotic use in patients with basilar skull fractures, whether there is evidence of CSF leakage or not. Until more research is available, the effectiveness of antibiotics in patients with basilar skull fractures cannot be determined because studies published to date are flawed by biases. Large, appropriately designed RCTs are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Basilar skull fracture (7% to 15.8% of all skull fractures) places the central nervous system in contact with bacteria from the nose and throat and may be associated with cerebrospinal fluid leakage (occurring in 2% to 20.8% of patients). Blood or watery discharge from the nose or ears, bruising behind the ear or around the eyes, hearing loss, inability to perceive odours or facial asymmetry may lead physicians to the diagnosis of basilar skull fracture. Patients with a basilar skull fracture may develop meningitis and some doctors give antibiotics in an attempt to reduce this risk."
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query-laysum | 4285 | [
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"role": "user",
"content": "Abstract: Background\nCartilage defects of the knee are often debilitating and predispose to osteoarthritis. Microfracture, drilling, mosaicplasty, and allograft transplantation are four surgical treatment options that are increasingly performed worldwide. We set out to examine the relative effects of these different methods.\nObjectives\nTo assess the relative effects (benefits and harms) of different surgical interventions (microfracture, drilling, mosaicplasty, and allograft transplantation) for treating isolated cartilage defects of the knee in adults.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL, EMBASE, MEDLINE, SPORTDiscus, LILACS, trial registers and conference proceedings up to February 2016.\nSelection criteria\nAny randomised or quasi-randomised trials that evaluated surgical interventions (microfracture, drilling, mosaicplasty, and allograft transplantation) for treating isolated cartilage defects of the knee in adults.\nData collection and analysis\nAt least two review authors independently selected studies, assessed risk of bias and extracted data. Intervention effects were assessed using risk ratios (RR) for dichotomous data and mean differences (MD) for continuous data, with 95% confidence intervals (CI). Data were pooled using the fixed-effect model, where possible.\nMain results\nWe included three randomised controlled trials comparing mosaicplasty versus microfracture for isolated cartilage defects in adults. Two trials were single-centre trials and one involved three centres. These small trials reported results for a total of 133 participants, of whom 79 (59%) were male. Mean participant age in the three trials ranged from 24.4 years to 32.3 years. All studies included grade 3 or 4 cartilage lesions (International Cartilage Repair Society (ICRS) classification). The defect area ranged from 1.0 cm² to 6.0 cm²; the mean area in all three trials was 2.8 cm². No trials of allograft transplantation or drilling were identified.\nAll trials were judged as being at high or unclear risk of performance and reporting bias. We judged that the quality of evidence was very low for all outcomes. For individual outcomes, we downgraded the quality of evidence by one or two levels for risk of bias, one level for indirectness where there were data from a single-centre trial only, one or two levels for imprecision where there were wide confidence intervals and an insufficient number of events, and one level for inconsistency reflecting heterogeneity. This means that we are very uncertain about the estimates for all outcomes.\nThere is very low quality evidence from one single-centre trial (57 participants), which included athletes only, that mosaicplasty resulted in higher patient-reported function scores (probably the IKDC 2000 subjective knee evaluation score) compared with microfracture (range 0 to 100; higher score = better function) at one year follow-up (MD 10.29 favouring mosaicplasty, 95% CI 7.87 to 12.71). Very low quality evidence from the same trial showed that this effect persisted in the long term at 10 years follow-up. However, there is very low quality evidence from the two other trials (72 participants) of little difference in patient-reported function, assessed via the Lysholm score (range 0 to 100; higher score = better function), between the two groups at long-term follow-up (MD -1.10 favouring microfracture, 95% CI -4.54 to 2.33). One trial (25 participants) provided very low quality evidence of no significant difference between the two groups in quality of life or pain at long-term follow-up. Pooled results for treatment failure - primarily symptom recurrence - reported at long-term follow-up (means ranging from 6.3 to 1.4 years) in the three trials (129 participants) favoured mosaicplasty (10/64 versus 20/65; RR 0.47, 95% CI 0.24 to 0.90). Based on an illustrative risk of 379 treatment failures per 1000 patients treated with microfracture, there is very low quality evidence that 201 fewer patients (95% CI 38 to 288 fewer) would have treatment failure after mosaicplasty. All three trials reported activity scores but due to clear statistical and clinical heterogeneity, we did not pool the long term Tegner score results. There was very low quality evidence from one study (57 participants) of higher Tegner scores - indicating greater activity - at intermediate-term and long-term follow-up in the mosaicplasty group; however, the between-group difference may not be clinically important. The other two trials provided very low quality evidence of no significant difference between the two groups in activity scores.\nAuthors' conclusions\nWe found no evidence from randomised controlled trials on allograft transplantation or drilling. The very low quality evidence from RCTs comparing mosaicplasty with microfracture is insufficient to draw conclusions on the relative effects of these two interventions for treating isolated cartilage defects of the knee in adults. Of note is that treatment failure, with recurrence of symptoms, occurred with both procedures. Further research is needed to define the best surgical option for treating isolated cartilage defects. We suggest the greatest need is for multi-centre RCTs comparing reconstructive procedures (mosaicplasty versus allograft transplantation) for large osteochondral lesions and reparative procedures (microfracture versus drilling) for small chondral lesions.\n\nGiven the provided abstract, please respond to the following query: \"Which of these surgical techniques works better in practice?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This review examines the evidence from randomised controlled trials that compared two or more of these surgical methods in clinical practice.\nWe searched a number of medical databases up to February 2016 and found three studies that compared mosaicplasty versus microfracture. These studies reported results for a total of 133 participants, the majority of whom were young adults and male. No trials of allograft transplantation or drilling were identified.\nOne study conducted at a single centre found better patient-reported function after mosaicplasty at 1, 2, 3, and 10 years follow-up. However, the other studies did not find a difference in function (two studies), pain (one study) or activities of daily living (one study) between mosaicplasty and microfracture in the long term (6 to 10 years follow-up). Treatment failure, with recurrence of symptoms, occurred with both procedures. Data pooled from the three trials showed half as many people had treatment failure in the mosaicplasty group. However, more evidence is required to test whether this is a true finding. The evidence regarding activity levels in the long term was inconclusive.\nWe considered that all the evidence for these outcomes was very low quality. This means that we are unsure of these results, which are likely to change when more evidence becomes available."
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"role": "user",
"content": "Abstract: Background\nSkeletal muscle spasticity is a major physical complication resulting from traumatic brain injury (TBI), which can lead to muscle contracture, joint stiffness, reduced range of movement, broken skin and pain. Treatments for spasticity include a range of pharmacological and non-pharmacological interventions, often used in combination. Management of spasticity following TBI varies from other clinical populations because of the added complexity of behavioural and cognitive issues associated with TBI.\nObjectives\nTo assess the effects of interventions for managing skeletal muscle spasticity in people with TBI.\nSearch methods\nIn June 2017, we searched key databases including the Cochrane Injuries Group Specialised Register, CENTRAL, MEDLINE (Ovid), Embase (Ovid) and others, in addition to clinical trials registries and the reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and cross-over RCTs evaluating any intervention for the management of spasticity in TBI. Only studies where at least 50% of participants had a TBI (or for whom separate data for participants with TBI were available) were included. The primary outcomes were spasticity and adverse effects. Secondary outcome measures were classified according to the World Health Organization International Classification of Functioning, Disability and Health including body functions (sensory, pain, neuromusculoskeletal and movement-related functions) and activities and participation (general tasks and demands; mobility; self-care; domestic life; major life areas; community, social and civic life).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Data were synthesised narratively; meta-analysis was precluded due to the paucity and heterogeneity of data.\nMain results\nWe included nine studies in this review which involved 134 participants with TBI. Only five studies reported between-group differences, yielding outcome data for 105 participants with TBI. These five studies assessed the effects of a range of pharmacological (baclofen, botulinum toxin A) and non-pharmacological (casting, physiotherapy, splints, tilt table standing and electrical stimulation) interventions, often in combination. The studies which tested the effect of baclofen and tizanidine did not report their results adequately. Where outcome data were available, spasticity and adverse events were reported, in addition to some secondary outcome measures.\nOf the five studies with results, three were funded by governments, charities or health services and two were funded by a pharmaceutical or medical technology company. The four studies without useable results were funded by pharmaceutical or medical technology companies.\nIt was difficult to draw conclusions about the effectiveness of these interventions due to poor reporting, small study size and the fact that participants with TBI were usually only a proportion of the overall total. Meta-analysis was not feasible due to the paucity of data and heterogeneity of interventions and comparator groups. Some studies concluded that the intervention they tested had beneficial effects on spasticity, and others found no difference between certain treatments. The most common adverse event was minor skin damage in people who received casting. We believe it would be misleading to provide any further description of study results given the quality of the evidence was very low for all outcomes.\nAuthors' conclusions\nThe very low quality and limited amount of evidence about the management of spasticity in people with TBI means that we are uncertain about the effectiveness or harms of these interventions. Well-designed and adequately powered studies using functional outcome measures to test the interventions used in clinical practice are needed.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We reviewed the evidence about the effect of treatments (drug and non-drug) for spasticity following a brain injury caused by a blow to the head (traumatic brain injury (TBI))."
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query-laysum | 4287 | [
{
"role": "user",
"content": "Abstract: Background\nChildren with acute pneumonia may be vitamin D deficient. Clinical trials have found that prophylactic vitamin D supplementation decreases children's risk of developing pneumonia. Data on the therapeutic effects of vitamin D in acute childhood pneumonia are limited. This is an update of a Cochrane Review first published in 2018.\nObjectives\nTo evaluate the efficacy and safety of vitamin D supplementation as an adjunct to antibiotics for the treatment of acute childhood pneumonia.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two trial registries on 28 December 2021. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared vitamin D supplementation with placebo in children (aged one month to five years) hospitalised with acute community-acquired pneumonia, as defined by the World Health Organization (WHO) acute respiratory infection guidelines. For this update, we reappraised eligible trials according to research integrity criteria, excluding RCTs published from April 2018 that were not prospectively registered in a trials registry according to WHO or Clinical Trials Registry – India (CTRI) guidelines (it was not mandatory to register clinical trials in India before April 2018).\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and extracted data. For dichotomous data, we extracted the number of participants experiencing the outcome and the total number of participants in each treatment group. For continuous data, we used the arithmetic mean and standard deviation (SD) for each treatment group together with number of participants in each group. We used standard methodological procedures expected by Cochrane.\nMain results\nIn this update, we included three new trials involving 468 children, bringing the total number of trials to seven, with 1601 children (631 with pneumonia and 970 with severe or very severe pneumonia). We categorised three previously included studies and three new studies as 'awaiting classification' based on the research integrity screen.\nFive trials used a single bolus dose of vitamin D (300,000 IU in one trial and 100,000 IU in four trials) at the onset of illness or within 24 hours of hospital admission; one used a daily dose of oral vitamin D (1000 IU for children aged up to one year and 2000 IU for children aged over one year) for five days; and one used variable doses (on day 1, 20,000 IU in children younger than six months, 50,000 IU in children aged six to 12 months, and 100,000 IU in children aged 13 to 59 months; followed by 10,000 IU/day for four days or until discharge). Three trials performed microbiological diagnosis of pneumonia, radiological diagnosis of pneumonia, or both.\nVitamin D probably has little or no effect on the time to resolution of acute illness (mean difference (MD) −1.28 hours, 95% confidence interval (CI) −5.47 to 2.91; 5 trials, 1188 children; moderate-certainty evidence). We do not know if vitamin D has an effect on the duration of hospitalisation (MD 4.96 hours, 95% CI −8.28 to 18.21; 5 trials, 1023 children; very low-certainty evidence). We do not know if vitamin D has an effect on mortality rate (risk ratio (RR) 0.69, 95% CI 0.44 to 1.07; 3 trials, 584 children; low-certainty evidence). The trials reported no major adverse events.\nAccording to GRADE criteria, the evidence was of very low-to-moderate certainty for all outcomes, owing to serious trial limitations, inconsistency, indirectness, and imprecision.\nThree trials received funding: one from the New Zealand Aid Corporation, one from an institutional grant, and one from multigovernment organisations (Bangladesh, Sweden, and UK). The remaining four trials were unfunded.\nAuthors' conclusions\nBased on the available evidence, we are uncertain whether vitamin D supplementation has important effects on outcomes of acute pneumonia when used as an adjunct to antibiotics. The trials reported no major adverse events. Uncertainty in the evidence is due to imprecision, risk of bias, inconsistency, and indirectness.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to 28 December 2021."
}
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query-laysum | 4288 | [
{
"role": "user",
"content": "Abstract: Background\n'Fast-track surgery' or 'enhanced recovery protocol' or 'fast-track rehabilitation', incorporating one or more elements of preoperative education, pain relief, early mobilisation, enteral nutrition and growth factors, may improve health-related quality of life and reduce length of hospital stay and costs. The role of enhanced recovery protocols in major upper gastrointestinal, liver and pancreatic surgery is unclear.\nObjectives\nTo assess the benefits and harms of enhanced recovery protocols compared with standard care (or usual practice) in major upper gastrointestinal, liver and pancreatic surgery.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; Cochrane Library; 2015, Issue 3), MEDLINE, EMBASE and Science Citation Index Expanded until March 2015 to identify randomised trials. We also searched the references of included trials to identify further trials.\nSelection criteria\nWe considered only randomised controlled trials (RCTs) performed in people undergoing major upper gastrointestinal, liver and pancreatic surgery, irrespective of language, blinding or publication status for inclusion in the review.\nData collection and analysis\nTwo review authors independently identified trials and independently extracted data. We calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CIs) using both fixed-effect and random-effects models using Review Manager 5, based on available case analysis.\nMain results\nTen studies met the inclusion criteria for the review, and nine studies provided information on one or more outcomes for the review. A total of 1014 participants were randomly assigned to the enhanced recovery protocol (499 participants) or standard care (515 participants) in the nine RCTs. Most of the trials included low anaesthetic risk participants with high performance status undergoing different upper gastrointestinal, liver and pancreatic surgeries. Eight trials incorporated more than one element of the enhanced recovery protocol. All of the trials were at high risk of bias. The overall quality of evidence was low or very low.\nNone of the trials reported long-term mortality, medium-term health-related quality of life(three months to one year), time to return to normal activity, or time to return to work. The difference between the enhanced recovery protocol and standard care were imprecise for short-term mortality (enhanced recovery protocol: 4/425 (adjusted proportion = 0.6%); standard care: 1/443 (0.2%); seven trials; 868 participants; RR 2.79; 95% CI 0.44 to 17.73; very low quality evidence), proportion of people with serious adverse events (enhanced recovery protocol: 4/157 (adjusted proportion = 0.6%); standard care: 0/184 (0.0%); two trials; 341 participants; RR 5.57; 95% CI 0.68 to 45.89; very low quality evidence), number of serious adverse events (enhanced recovery protocol: 34/421 (8 per 100 participants); standard care: 46/438 (11 per 100 participants); seven trials; 859 participants; rate ratio 0.72; 95% CI 0.45 to 1.13; very low quality evidence), health-related quality of life (four trials; 373 participants; SMD 0.29; 95% CI -0.04 to 0.62; very low quality evidence) and hospital readmissions (enhanced recovery protocol: 14/355 (adjusted proportion = 3.3%); standard care: 9/378 (2.4%); seven trials; 733 participants; RR 1.4; 95% CI 0.69 to 2.87; very low quality evidence). The enhanced recovery protocol group had a lower proportion of people with mild adverse events (enhanced recovery protocol: 31/254 (adjusted proportion = 10.9%); standard care: 51/271 (18.8%); four trials; 525 participants; RR 0.58; 95% CI 0.39 to 0.85; low quality evidence), fewer number of mild adverse events (enhanced recovery protocol: 69/499 (13 per 100 participants); standard care: 128/515 (25 per 100 participants); nine trials; 1014 participants; rate ratio 0.52; 95% CI 0.39 to 0.70; low quality evidence), shorter length of hospital stay (nine trials; 1014 participants; MD -2.19 days; 95% CI -2.53 to -1.85; low quality evidence) and lower costs (four trials; 282 participants; MD USD -6300; 95% CI -8400 to -4200; low quality evidence) than standard care group.\nAuthors' conclusions\nBased on low quality evidence, enhanced recovery protocols may reduce length of hospital stay and costs (primarily because of reduction in hospital stay) in people undergoing major upper gastrointestinal, liver and pancreatic surgeries. However, the validity of the results is uncertain because of the risk of bias in the trials and the way the outcomes were measured. Future RCTs should be conducted with low risk of bias, and measure clinically important outcomes for including the three months to one year period.\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 enhanced recovery protocols beneficial or harmful when compared to standard surgery in people undergoing major surgeries of food pipe (oesophagus), stomach, liver and pancreas?"
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query-laysum | 4289 | [
{
"role": "user",
"content": "Abstract: Background\nSmoking bans or restrictions can assist in eliminating nonsmokers' exposure to the dangers of secondhand smoke and can reduce tobacco consumption amongst smokers themselves. Evidence exists identifying the impact of tobacco control regulations and interventions implemented in general workplaces and at an individual level. However, it is important that we also review the evidence for smoking bans at a meso- or organisational level, to identify their impact on reducing the burden of exposure to tobacco smoke. Our review assesses evidence for meso- or organisational-level tobacco control bans or policies in a number of specialist settings, including public healthcare facilities, higher education and correctional facilities.\nObjectives\nTo assess the extent to which institutional smoking bans may reduce passive smoke exposure and active smoking, and affect other health-related outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE, EMBASE, and the reference lists of identified studies. We contacted authors to identify completed or ongoing studies eligible for inclusion in this review. We also checked websites of state agencies and organisations, such as trial registries. Date of latest searches was 22nd June 2015.\nSelection criteria\nWe considered studies that reported the effects of tobacco bans or policies, whether complete or partial, on reducing secondhand smoke exposure, tobacco consumption, smoking prevalence and other health outcomes, in public healthcare, higher educational and correctional facilities, from 2005 onwards.\nThe minimum standard for inclusion was having a settings-level policy or ban implemented in the study, and a minimum of six months follow-up for measures of smoking behaviour. We included quasi-experimental studies (i.e. controlled before-and-after studies), interrupted time series as defined by the Cochrane Effective Practice and Organization of Care Group, and uncontrolled pre- and post-ban data.\nData collection and analysis\nTwo or more review authors independently assessed studies for inclusion in the review. Due to variation in the measurement of outcomes we did not conduct a meta-analysis for all of the studies included in this review, but carried out a Mantel-Haenszel fixed-effect meta-analysis, pooling 11 of the included studies. We evaluated all studies using a qualitative narrative synthesis.\nMain results\nWe included 17 observational studies in this review. We found no randomized controlled trials. Twelve studies are based in hospitals, three in prisons and two in universities. Three studies used a controlled before-and-after design, with another site used for comparison. The remaining 14 studies used an uncontrolled before-and-after study design. Five studies reported evidence from two participant groups, including staff and either patients or prisoners (depending on specialist setting), with the 12 remaining studies investigating only one participant group.\nThe four studies (two in prisons, two in hospitals) providing health outcomes data reported an effect of reduced secondhand smoke exposure and reduced mortality associated with smoking-related illnesses. No studies included in the review measured cotinine levels to validate secondhand smoke exposure. Eleven studies reporting active smoking rates with 12,485 participants available for pooling, but with substantial evidence of statistical heterogeneity (I² = 72%). Heterogeneity was lower in subgroups defined by setting, and provided evidence for an effect of tobacco bans on reducing active smoking rates. An analysis exploring heterogeneity within hospital settings showed evidence of an effect on reducing active smoking rates in both staff (risk ratio (RR) 0.71, 95% confidence interval ( CI) 0.64 to 0.78) and patients (RR 0.86, 95% CI 0.76 to 0.98), but heterogeneity remained in the staff subgroup (I² = 76%). In prisons, despite evidence of reduced mortality associated with smoking-related illnesses in two studies, there was no evidence of effect on active smoking rates (1 study, RR 0.99, 95% CI 0.84 to 1.16).\nWe judged the quality of the evidence to be low, using the GRADE approach, as the included studies are all observational.\nAuthors' conclusions\nWe found evidence of an effect of settings-based smoking policies on reducing smoking rates in hospitals and universities. In prisons, reduced mortality rates and reduced exposure to secondhand smoke were reported. However, we rated the evidence base as low quality. We therefore need more robust studies assessing the evidence for smoking bans and policies in these important specialist settings.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that measured whether introducing a smoking policy or ban, in hospitals, universities or prisons, reduced secondhand smoke exposure and helped people to quit smoking. The study could be in any language. It had to report information on health and smoking before the policy or ban started and for at least six months afterwards. We have included 17 studies in this review. Twelve studies provide evidence from hospitals, three from prisons and two from universities. The evidence is up-to-date to June 2015."
}
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query-laysum | 4290 | [
{
"role": "user",
"content": "Abstract: Background\nChronic rhinosinusitis frequently occurs in people with cystic fibrosis. Several medical interventions are available for treating chronic rhinosinusitis in people with cystic fibrosis; for example, different concentrations of nasal saline irrigations, topical or oral corticosteroids, antibiotics - including nebulized antibiotics - dornase alfa and modulators of the cystic fibrosis transmembrane conductance regulator (CFTR) (such as lumacaftor, ivacaftor or tezacaftor). However, the efficacy of these interventions is unclear.\nThis is an update of a previously published review.\nObjectives\nThe objective of this review is to compare the effects of different medical interventions in people diagnosed with cystic fibrosis and chronic rhinosinusitis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and hand searching of journals and conference abstract books. Date of last search of trials register: 09 September 2021.\nWe also searched ongoing trials databases, other medical databases and the reference lists of relevant articles and reviews. Date of latest additional searches: 22 November 2021.\nSelection criteria\nRandomized and quasi-randomized trials of different medical interventions compared to each other or to no intervention or to placebo.\nData collection and analysis\nTwo review authors independently assessed trials identified for potential inclusion in the review. We planned to conduct data collection and analysis in accordance with Cochrane methods and to independently rate the quality of the evidence for each outcome using the GRADE guidelines.\nMain results\nWe identified no trials that met the pre-defined inclusion criteria. The most recent searches identified 44 new references, none of which were eligible for inclusion in the current version of this review; 12 studies are listed as excluded and one as ongoing.\nAuthors' conclusions\nWe identified no eligible trials assessing the medical interventions in people with cystic fibrosis and chronic rhinosinusitis. High-quality trials are needed which should assess the efficacy of different treatment options detailed above for managing chronic rhinosinusitis, preventing pulmonary exacerbations and improving quality of life in people with cystic fibrosis.\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": "Chronic rhinosinusitis is long-term infection and inflammation of the nasal cavity and air-filled spaces around the eyes and nose. Cystic fibrosis is a genetic condition that makes secretions in the body thick, and hence stagnant. When this occurs in and around the nose, it causes chronic rhinosinusitis. Better care of people with cystic fibrosis has led to them living longer, increasing the chance of developing chronic rhinosinusitis. Early and effective interventions with antibiotics, steroids, drugs that thin the mucus (e.g. dornase alfa) and drugs to improve how the cell membrane channel functions (CFTR modulators) can help to improve quality of life and prevent the development of lower airway disease. Currently, there are no guidelines based on trials to know how best to treat chronic rhinosinusitis in people with cystic fibrosis."
}
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query-laysum | 4291 | [
{
"role": "user",
"content": "Abstract: Background\nEndometriosis is a common gynaecological condition affecting 6 to 11% of reproductive-age women and may cause dyspareunia, dysmenorrhoea, and infertility. One treatment strategy is medical therapy with gonadotrophin-releasing hormone analogues (GnRHas) to reduce pain due to endometriosis. One of the adverse effects of GnRHas is a decreased bone mineral density. In addition to assessing the effect on pain, quality of life, most troublesome symptom and patients' satisfaction, the current review also evaluated the effect on bone mineral density and risk of adverse effects in women with endometriosis who use GnRHas versus other treatment options.\nObjectives\nTo assess the effectiveness and safety of GnRH analogues (GnRHas) in the treatment of painful symptoms associated with endometriosis and to determine the effects of GnRHas on bone mineral density of women with endometriosis.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO and the trial registries in May 2022 together with reference checking and contact with study authors and experts in the field to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) which compared GnRHas with other hormonal treatment options, including analgesics, danazol, intra-uterine progestogens, oral or injectable progestogens, gestrinone and also GnRHas compared with no treatment or placebo. Trials comparing GnRHas versus GnRHas in conjunction with add-back therapy (hormonal or non-hormonal) or calcium-regulation agents were also included in this review.\nData collection and analysis\nWe used standard methodology as recommended by Cochrane. Primary outcomes are relief of overall pain and the objective measurement of bone mineral density. Secondary outcomes include adverse effects, quality of life, improvement in the most troublesome symptoms and patient satisfaction.\nDue to high risk of bias associated with some of the studies, primary analyses of all review outcomes were restricted to studies at low risk of selection bias. Sensitivity analysis including all studies was then performed.\nMain results\nSeventy-two studies involving 7355 patients were included. The evidence was very low to low quality: the main limitations of all studies were serious risk of bias due to poor reporting of study methods, and serious imprecision.\nTrials comparing GnRHas versus no treatment\nWe did not identify any studies.\nTrials comparing GnRHas versus placebo\nThere may be a decrease in overall pain, reported as pelvic pain scores (RR 2.14; 95% CI 1.41 to 3.24, 1 RCT, n = 87, low-certainty evidence), dysmenorrhoea scores (RR 2.25; 95% CI 1.59 to 3.16, 1 RCT, n = 85, low-certainty evidence), dyspareunia scores (RR 2.21; 95% CI 1.39 to 3.54, 1 RCT, n = 59, low-certainty evidence), and pelvic tenderness scores (RR 2.28; 95% CI 1.48 to 3.50, 1 RCT, n = 85, low-certainty evidence) after three months of treatment. We are uncertain of the effect for pelvic induration, based on the results found after three months of treatment (RR 1.07; 95% CI 0.64 to 1.79, 1 RCT, n = 81, low-certainty evidence). Besides, treatment with GnRHas may be associated with a greater incidence of hot flushes at three months of treatment (RR 3.08; 95% CI 1.89 to 5.01, 1 RCT, n = 100, low-certainty evidence).\nTrials comparing GnRHas versus danazol\nFor overall pain, for women treated with either GnRHas or danazol, a subdivision was made between pelvic tenderness, partly resolved and completely resolved. We are uncertain about the effect on relief of overall pain, when a subdivision was made for overall pain (MD -0.30; 95% CI -1.66 to 1.06, 1 RCT, n = 41, very low-certainty evidence), pelvic pain (MD 0.20; 95% CI -0.26 to 0.66, 1 RCT, n = 41, very low-certainty evidence), dysmenorrhoea (MD 0.10; 95% CI -0.49 to 0.69, 1 RCT, n = 41, very low-certainty evidence), dyspareunia (MD -0.20; 95% CI -0.77 to 0.37, 1 RCT, n = 41, very low-certainty evidence), pelvic induration (MD -0.10; 95% CI -0.59 to 0.39, 1 RCT, n = 41, very low-certainty evidence), and pelvic tenderness (MD -0.20; 95% CI -0.78 to 0.38, 1 RCT, n = 41, very low-certainty evidence) after three months of treatment. For pelvic pain (MD 0.50; 95% CI 0.10 to 0.90, 1 RCT, n = 41, very low-certainty evidence) and pelvic induration (MD 0.70; 95% CI 0.21 to 1.19, 1 RCT, n = 41, very low-certainty evidence), the complaints may decrease slightly after treatment with GnRHas, compared to danazol, for six months of treatment.\nTrials comparing GnRHas versus analgesics\nWe did not identify any studies.\nTrials comparing GnRHas versus intra-uterine progestogens\nWe did not identify any low risk of bias studies.\nTrials comparing GnRHas versus GnRHas in conjunction with calcium-regulating agents\nThere may be a slight decrease in bone mineral density (BMD) after 12 months treatment with GnRHas, compared to GnRHas in conjunction with calcium-regulating agents for anterior-posterior spine (MD -7.00; 95% CI -7.53 to -6.47, 1 RCT, n = 41, very low-certainty evidence) and lateral spine (MD -12.40; 95% CI -13.31 to -11.49, 1 RCT, n = 41, very low-certainty evidence).\nAuthors' conclusions\nFor relief of overall pain, there may be a slight decrease in favour of treatment with GnRHas compared to placebo or oral or injectable progestogens. We are uncertain about the effect when comparing GnRHas with danazol, intra-uterine progestogens or gestrinone. For BMD, there may be a slight decrease when women are treated with GnRHas, compared to gestrinone. There was a bigger decrease of BMD in favour of GnRHas, compared to GnRHas in conjunction with calcium-regulating agents. However, there may be a slight increase in adverse effects when women are treated with GnRHas, compared to placebo or gestrinone.\nDue to a very low to low certainty of the evidence, a wide range of outcome measures and a wide range of outcome measurement instruments, the results should be interpreted with caution.\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": "In the current review, we looked at women with endometriosis, who were treated with GnRHas, and compared this treatment with other forms of hormonal treatment.\nWe wanted to find out if GnRHas were better than any other hormonal treatment to improve pain and to see their effect on bone mineral density.\nAdditionally, we wanted to find out if GnRHas were associated with an improved quality of life and also unveil any unwanted effects."
}
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query-laysum | 4292 | [
{
"role": "user",
"content": "Abstract: Background\nYoga is an ancient body-mind practice which originated in India and is popular in the Western world as a form of relaxation and exercise. It has been of interest for people with schizophrenia to determine the efficacy of yoga delivered as a package of care versus non-standard care.\nObjectives\nTo examine the effects of yoga as part of a package of care versus non-standard care for schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register (latest 15 May 2018) which is based on regular searches of MEDLINE, PubMed, Embase, CINAHL, BIOSS, AMED, PsychINFO, and registries of clinical trials. We searched the references of all included studies. There are no language, date, document type, or publication status limitations for inclusion of records in the register.\nSelection criteria\nAll randomised controlled trials (RCTs) including people with schizophrenia comparing yoga as part of a package of care with non-standard care.\nData collection and analysis\nThere were no data to analyse as no studies met the inclusion criteria.\nMain results\nThe searches identified 30 studies that could be relevant to this review. After careful inspection, 29 were excluded and one is ongoing. No data were available for analyses.\nAuthors' conclusions\nIn view of the lack of evidence from RCTs, it is currently not possible for us to comment on the use of yoga as part of a package of care versus non-standard care.\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": "Currenlty, there is no high-quality evidence to support or discourage the use of yoga as part of a package of care versus non-standard care. Schizophrenia is often a long-term illness and studies which compare yoga packages to other types of therapies are necessary."
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query-laysum | 4293 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original review, published in Issue 1, 2011, of The Cochrane Library. Acute lower abdominal pain is common, and making a diagnosis is particularly challenging in premenopausal women, as ovulation and menstruation symptoms overlap with symptoms of appendicitis, early pregnancy complications and pelvic infection. A management strategy involving early laparoscopy could potentially provide a more accurate diagnosis, earlier treatment and reduced risk of complications.\nObjectives\nTo evaluate the effectiveness and harms of laparoscopy for the management of acute lower abdominal pain in women of childbearing age.\nSearch methods\nThe Menstrual Disorders and Subfertility Group (MDSG) Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, PsycINFO, LILACS and CINAHL were searched (October 2013). The International Clinical Trials Registry Platform (ICTRP) was also searched. No new studies were included in this updated version.\nSelection criteria\nRandomised controlled trials (RCTs) that included women of childbearing age who presented with acute lower abdominal pain, non-specific lower abdominal pain or suspected appendicitis were included. Trials were included if they evaluated laparoscopy with open appendicectomy, or laparoscopy with a wait and see strategy. Study selection was carried out by two review authors independently.\nData collection and analysis\nData from studies that met the inclusion criteria were independently extracted by two review authors and the risk of bias assessed. We used standard methodological procedures as expected by The Cochrane Collaboration. A summary of findings table was prepared using GRADE criteria.\nMain results\nA total of 12 studies including 1020 participants were incorporated into the review. These studies had low to moderate risk of bias, mainly because allocation concealment or methods of sequence generation were not adequately reported. In addition, it was not clear whether follow-up was similar for the treatment groups. The index test was incorporated as a reference standard in the laparoscopy group, and differential verification or partial verification bias may have occurred in most RCTs. Overall the quality of the evidence was low to moderate for most outcomes, as per the GRADE approach.\nLaparoscopy was compared with open appendicectomy in eight RCTs. Laparoscopy was associated with an increased rate of specific diagnoses (seven RCTs, 561 participants; odds ratio (OR) 4.10, 95% confidence interval (CI) 2.50 to 6.71; I2 = 18%), but no evidence was found of reduced rates for any adverse events (eight RCTs, 623 participants; OR 0.46, 95% CI 0.19 to 1.10; I2 = 0%). A meta-analysis of seven studies found a significant difference favouring the laparoscopic procedure in the rate of removal of normal appendix (seven RCTs, 475 participants; OR 0.13, 95% CI 0.07 to 0.24; I2 = 0%).\nLaparoscopic diagnosis versus a 'wait and see' strategy was investigated in four RCTs. A significant difference favoured laparoscopy in terms of rate of specific diagnoses (four RCTs, 395 participants; OR 6.07, 95% CI 1.85 to 29.88; I2 = 79%), but no evidence suggested a difference in rates of adverse events (OR 0.87, 95% CI 0.45 to 1.67; I2 = 0%).\nAuthors' conclusions\nWe found that laparoscopy in women with acute lower abdominal pain, non-specific lower abdominal pain or suspected appendicitis led to a higher rate of specific diagnoses being made and a lower rate of removal of normal appendices compared with open appendicectomy only. Hospital stays were shorter. No evidence showed an increase in adverse events when any of these strategies were used.\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": "Twelve studies were identified with 1020 women from 11 countries. Eight studies compared laparoscopy versus open appendicectomy, and four compared laparoscopy using a wait and see approach. The evidence is current to October 2013."
}
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query-laysum | 4294 | [
{
"role": "user",
"content": "Abstract: Background\nPopliteal artery aneurysm (PAA) is a focal dilatation and weakening of the popliteal artery. If left untreated, the aneurysm may thrombose, rupture or the clot within the aneurysm may embolise causing severe morbidity. PAA may be treated surgically by performing a bypass from the arterial segment proximal to the aneurysm to the arterial segment below the aneurysm, which excludes the aneurysm from the circulation. It may also be treated by a stent graft that is inserted percutaneously or through a small cut in the groin. The success of the procedure is gauged by the ability of the graft to stay patent over an extended duration. While surgical treatment is usually preferred in an emergency, the evidence on first line treatment in a non-emergency setting is unclear. This is an update of a review first published in 2014.\nObjectives\nTo assess the effectiveness of an endovascular stent graft versus conventional open surgery for the treatment of asymptomatic popliteal artery aneurysms (PAA) on primary and assisted patency rates, hospital stay, length of the procedure and local complications.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 29 January 2019.\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing endovascular stent grafting versus conventional open surgical repair in patients undergoing unilateral or bilateral prophylactic repair of asymptomatic PAAs.\nData collection and analysis\nWe collected data on primary and assisted primary patency rates (primary endpoints) as well as operating time, the length of hospital stay, limb salvage and local wound complications (secondary endpoints). We presented results as risk ratio or mean difference with 95% confidence intervals and assessed the certainty of the evidence using GRADE.\nMain results\nNo new studies were identified for this update. A single RCT with a total of 30 PAAs met the inclusion criteria. There was a low risk of selection bias and detection bias. However, the risks of performance bias, attrition bias and reporting bias were unclear from the study. Despite being an RCT, the certainty of the evidence was downgraded to moderate due to the small sample size, resulting in wide confidence intervals (CIs); only 30 PAAs were randomised over a period of five years (15 PAAs each in the groups receiving endovascular stent graft and undergoing conventional open surgery). The primary patency rate at one year was 93.3% in the endovascular group and 100% in the surgery group (RR 0.94, 95% CI 0.78 to 1.12; moderate-certainty evidence). The assisted patency rate at one year was similar in both groups (RR 1.00, 95% CI 0.88 to 1.13; moderate-certainty evidence). There was no clear evidence of a difference between the two groups in the primary or assisted patency rates at four years (13 grafts were patent from 15 PAA treatments in each group; RR 1.00, 95% CI 0.76 to 1.32; moderate-certainty evidence); the effects were imprecise and compatible with the benefit of either endovascular stent graft or surgery or no difference. Mean hospital stay was shorter in the endovascular group (4.3 days for the endovascular group versus 7.7 days for the surgical group; mean difference (MD) -3.40 days, 95% CI -4.42 to -2.38; P < 0.001; moderate-certainty evidence). Mean operating time was also reduced in the endovascular group (75.4 minutes in the endovascular group versus 195.3 minutes in the surgical group; MD -119.90 minutes, 95% CI -137.71 to -102.09; P < 0.001; moderate-certainty evidence). Limb salvage was 100% in both groups. Data on local wound complications were not published in the trial report.\nAuthors' conclusions\nEvidence to determine the effectiveness of endovascular stent graft versus conventional open surgery for the treatment of asymptomatic PAAs is limited to data from one small study. At one year there is moderate-certainty evidence that primary patency may be improved in the surgery group but assisted primary patency rates were similar between groups. At four years there was no clear benefit from either endovascular stent graft or surgery to primary or assisted primary patency (moderate-certainty evidence). As both operating time and hospital stay were reduced in the endovascular group (moderate-certainty evidence), it may represent a viable alternative to open repair of PAA. A large multicenter RCT may provide more information in the future. However, difficulties in recruiting enough patients are likely, unless it is an international collaboration including a number of high volume vascular centres.\n\nGiven the provided abstract, please respond to the following query: \"Reliability of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The major limitation of this study was that there were only 15 PAAs in each group so our certainty in the evidence is downgraded from high to moderate. Due to the limitations of the current evidence, we are unable to determine the effects of an endovascular stent graft versus conventional open surgery for the treatment of asymptomatic PAAs. A larger multicenter clinical trial is required so we can be more confident in the findings. We cannot say if there was a clear overall benefit on patency to either group (moderate-certainty evidence). As both operating time and hospital stay were reduced in the endovascular group (moderate certainty evidence), it may represent a viable alternative to open repair of PAA."
}
]
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query-laysum | 4295 | [
{
"role": "user",
"content": "Abstract: Background\nThis is the second substantive update of this review. It was originally published in 1998 and was previously updated in 2009. Elevated blood pressure (known as 'hypertension') increases with age - most rapidly over age 60. Systolic hypertension is more strongly associated with cardiovascular disease than is diastolic hypertension, and it occurs more commonly in older people. It is important to know the benefits and harms of antihypertensive treatment for hypertension in this age group, as well as separately for people 60 to 79 years old and people 80 years or older.\nObjectives\nPrimary objective\n• To quantify the effects of antihypertensive drug treatment as compared with placebo or no treatment on all-cause mortality in people 60 years and older with mild to moderate systolic or diastolic hypertension\nSecondary objectives\n• To quantify the effects of antihypertensive drug treatment as compared with placebo or no treatment on cardiovascular-specific morbidity and mortality in people 60 years and older with mild to moderate systolic or diastolic hypertension\n• To quantify the rate of withdrawal due to adverse effects of antihypertensive drug treatment as compared with placebo or no treatment in people 60 years and older with mild to moderate systolic or diastolic hypertension\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to 24 November 2017: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We contacted authors of relevant papers regarding further published and unpublished work.\nSelection criteria\nRandomised controlled trials of at least one year's duration comparing antihypertensive drug therapy versus placebo or no treatment and providing morbidity and mortality data for adult patients (≥ 60 years old) with hypertension defined as blood pressure greater than 140/90 mmHg.\nData collection and analysis\nOutcomes assessed were all-cause mortality; cardiovascular morbidity and mortality; cerebrovascular morbidity and mortality; coronary heart disease morbidity and mortality; and withdrawal due to adverse effects. We modified the definition of cardiovascular mortality and morbidity to exclude transient ischaemic attacks when possible.\nMain results\nThis update includes one additional trial (MRC-TMH 1985). Sixteen trials (N = 26,795) in healthy ambulatory adults 60 years or older (mean age 73.4 years) from western industrialised countries with moderate to severe systolic and/or diastolic hypertension (average 182/95 mmHg) met the inclusion criteria. Most of these trials evaluated first-line thiazide diuretic therapy for a mean treatment duration of 3.8 years.\nAntihypertensive drug treatment reduced all-cause mortality (high-certainty evidence; 11% with control vs 10.0% with treatment; risk ratio (RR) 0.91, 95% confidence interval (CI) 0.85 to 0.97; cardiovascular morbidity and mortality (moderate-certainty evidence; 13.6% with control vs 9.8% with treatment; RR 0.72, 95% CI 0.68 to 0.77; cerebrovascular mortality and morbidity (moderate-certainty evidence; 5.2% with control vs 3.4% with treatment; RR 0.66, 95% CI 0.59 to 0.74; and coronary heart disease mortality and morbidity (moderate-certainty evidence; 4.8% with control vs 3.7% with treatment; RR 0.78, 95% CI 0.69 to 0.88. Withdrawals due to adverse effects were increased with treatment (low-certainty evidence; 5.4% with control vs 15.7% with treatment; RR 2.91, 95% CI 2.56 to 3.30. In the three trials restricted to persons with isolated systolic hypertension, reported benefits were similar.\nThis comprehensive systematic review provides additional evidence that the reduction in mortality observed was due mostly to reduction in the 60- to 79-year-old patient subgroup (high-certainty evidence; RR 0.86, 95% CI 0.79 to 0.95). Although cardiovascular mortality and morbidity was significantly reduced in both subgroups 60 to 79 years old (moderate-certainty evidence; RR 0.71, 95% CI 0.65 to 0.77) and 80 years or older (moderate-certainty evidence; RR 0.75, 95% CI 0.65 to 0.87), the magnitude of absolute risk reduction was probably higher among 60- to 79-year-old patients (3.8% vs 2.9%). The reduction in cardiovascular mortality and morbidity was primarily due to a reduction in cerebrovascular mortality and morbidity.\nAuthors' conclusions\nTreating healthy adults 60 years or older with moderate to severe systolic and/or diastolic hypertension with antihypertensive drug therapy reduced all-cause mortality, cardiovascular mortality and morbidity, cerebrovascular mortality and morbidity, and coronary heart disease mortality and morbidity. Most evidence of benefit pertains to a primary prevention population using a thiazide as first-line treatment.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This is the second update of this review, first published in 1998 and first updated in 2009. We wanted to study the benefits and harms of using blood pressure-lowering drugs in adults 60 years or older with raised blood pressure."
}
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query-laysum | 4296 | [
{
"role": "user",
"content": "Abstract: Background\nThoracic outlet syndrome (TOS) is one of the most controversial diagnoses in clinical medicine. Despite many reports of operative and non-operative interventions, rigorous scientific investigation of this syndrome leading to evidence-based management is lacking. This is the first update of a review first published in 2010.\nObjectives\nTo evaluate the beneficial and adverse effects of the available operative and non-operative interventions for the treatment of TOS a minimum of six months after the intervention.\nSearch methods\nOn 23 June 2014 we searched the Cochrane Neuromuscular Disease Group Trials Specialized Register, CENTRAL, The Database of Abstracts of Reviews of Effects (DARE), MEDLINE, EMBASE, CINAHL Plus and AMED. We also searched reference lists of the identified trials.\nSelection criteria\nWe selected randomized or quasi-randomized studies involving participants with the diagnosis of TOS of any type (neurogenic, vascular, and 'disputed'), without limitations as to language of publication.\nWe accepted studies that examined any intervention aimed at treating TOS.\nThe primary outcome measure was change in pain rating, measured on a validated visual analog or similar scale at least six months after the intervention.\nThe secondary outcomes were change in muscle strength, disability, experiences of paresthesias (numbness and tingling sensations), and adverse effects of the interventions.\nData collection and analysis\nThree authors independently selected the trials to be included and extracted data. Authors rated included studies for risk of bias, according to the methods recommended in the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nThis review was complicated by a lack of generally accepted criteria for the diagnosis of TOS and had to rely exclusively on the diagnosis of TOS by the investigators in the reviewed studies. We identified one study comparing natural progression with an active intervention. We found three randomized controlled trials (RCTs), but only two of them had a follow-up of six months or more, which was the minimum required follow-up for inclusion in the review. The first trial that met our requirements involved 55 participants with the 'disputed type' of TOS and compared transaxillary first rib resection (TFRR) with supraclavicular neuroplasty of the brachial plexus (SNBP). The trial had a high risk of bias. TFRR decreased pain more than SNBP. There were no adverse effects in either group. The second trial that met these requirements analyzed 37 people with TOS of any type, comparing treatment with a botulinum toxin (BTX) injection into the scalene muscles with a saline placebo injection. This trial had a low risk of bias. There was no significant effect of treatment with the BTX injection over placebo in terms of pain relief or improvements in disability, but it did significantly improve paresthesias at six months' follow-up. There were no adverse events of the BTX treatment above saline injection.\nAuthors' conclusions\nThis review was complicated by a lack of generally accepted diagnostic criteria for the diagnosis of TOS. There was very low quality evidence that transaxillary first rib resection decreased pain more than supraclavicular neuroplasty, but no randomized evidence that either is better than no treatment. There is moderate evidence to suggest that treatment with BTX injections yielded no great improvements over placebo injections of saline. There is no evidence from RCTs for the use of other currently used treatments. There is a need for an agreed definition for the diagnosis of TOS, especially the disputed form, agreed outcome measures, and high quality randomized trials that compare the outcome of interventions with no treatment and with each other.\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": "From our systematic search we identified two trials. One trial compared surgery to remove the first rib (transaxillary first rib resection) with surgery in which the surgeon freed the nerves from surrounding tissues (neuroplasty) without removing a rib, in 55 people with the disputed type of TOS. The participants had not responded to non-surgical treatments. Average follow-up was 37 months. A second trial analyzed 19 people who underwent double-blinded provision of a single injection of BTX (muscle relaxant) into the scalene muscles of the neck, and 18 people in the placebo group who received no active injection, with follow-up at six weeks, three months and, critically for the purpose of this review, six months."
}
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query-laysum | 4297 | [
{
"role": "user",
"content": "Abstract: Background\nChildren with motor impairments often have the motor speech disorder dysarthria, a condition which effects the tone, strength and co-ordination of any or all of the muscles used for speech. Resulting speech difficulties can range from mild, with slightly slurred articulation and breathy voice, to profound, with an inability to produce any recognisable words. Children with dysarthria are often prescribed communication aids to supplement their natural forms of communication. However, there is variation in practice regarding the provision of therapy focusing on voice and speech production. Descriptive studies have suggested that therapy may improve speech, but its effectiveness has not been evaluated.\nObjectives\nTo assess whether any speech and language therapy intervention aimed at improving the speech of children with dysarthria is more effective in increasing children's speech intelligibility or communicative participation than no intervention at all , and to compare the efficacy of individual types of speech language therapy in improving the speech intelligibility or communicative participation of children with dysarthria.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015 , Issue 7 ), MEDLINE, EMBASE, CINAHL , LLBA, ERIC, PsychInfo, Web of Science, Scopus, UK National Research Register and Dissertation Abstracts up to July 2015, handsearched relevant journals published between 1980 and July 2015, and searched proceedings of relevant conferences between 1996 to 2015. We placed no restrictions on the language or setting of the studies. A previous version of this review considered studies published up to April 2009. In this update we searched for studies published from April 2009 to July 2015.\nSelection criteria\nWe considered randomised controlled trials and studies using quasi-experimental designs in which children were allocated to groups using non-random methods.\nData collection and analysis\nOne author (LP) conducted searches of all databases, journals and conference reports. All searches included a reliability check in which a second review author independently checked a random sample comprising 15% of all identified reports. We planned that two review authors would independently assess the quality and extract data from eligible studies.\nMain results\nNo randomised controlled trials or group studies were identified.\nAuthors' conclusions\nThis review found no evidence from randomised trials of the effectiveness of speech and language therapy interventions to improve the speech of children with early acquired dysarthria. Rigorous, fully powered randomised controlled trials are needed to investigate if the positive changes in children's speech observed in phase I and phase II studies are generalisable to the population of children with early acquired dysarthria served by speech and language therapy services. Research should examine change in children's speech production and intelligibility. It must also investigate children's participation in social and educational activities, and their quality of life, as well as the cost and acceptability of interventions.\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": "Dysarthria is a speech disorder linked to difficulties controlling the muscles needed for speaking. Children with dysarthria often have shallow, irregular breathing which creates difficulties in generating sufficient breath to support speech. They have low pitched, breathy or harsh voices, nasalised speech and very poor pronunciation. Together, these difficulties make the children's speech difficult to understand. Dysarthria is caused by neurological impairment and can arise early in children's lives, from neurological damage sustained before, during or after birth, such as in cerebral palsy, or in early childhood through traumatic brain injury or neurological disease. Communication difficulties have a profound impact on children’s development. They reduce the quality of life of children with cerebral palsy and place children at risk of social exclusion, educational failure and later unemployment. Speech and language therapy aims to help children to control the movements for breathing and speech and so become more intelligible."
}
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query-laysum | 4298 | [
{
"role": "user",
"content": "Abstract: Background\nEvery year, an estimated one million children and young adolescents become ill with tuberculosis, and around 226,000 of those children die. Xpert MTB/RIF Ultra (Xpert Ultra) is a molecular World Health Organization (WHO)-recommended rapid diagnostic test that simultaneously detects Mycobacterium tuberculosis complex and rifampicin resistance. We previously published a Cochrane Review 'Xpert MTB/RIF and Xpert MTB/RIF Ultra assays for tuberculosis disease and rifampicin resistance in children'. The current review updates evidence on the diagnostic accuracy of Xpert Ultra in children presumed to have tuberculosis disease. Parts of this review update informed the 2022 WHO updated guidance on management of tuberculosis in children and adolescents.\nObjectives\nTo assess the diagnostic accuracy of Xpert Ultra for detecting: pulmonary tuberculosis, tuberculous meningitis, lymph node tuberculosis, and rifampicin resistance, in children with presumed tuberculosis.\nSecondary objectives\nTo investigate potential sources of heterogeneity in accuracy estimates. For detection of tuberculosis, we considered age, comorbidity (HIV, severe pneumonia, and severe malnutrition), and specimen type as potential sources.\nTo summarize the frequency of Xpert Ultra trace results.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, three other databases, and three trial registers without language restrictions to 9 March 2021.\nSelection criteria\nCross-sectional and cohort studies and randomized trials that evaluated Xpert Ultra in HIV-positive and HIV-negative children under 15 years of age. We included ongoing studies that helped us address the review objectives. We included studies evaluating sputum, gastric, stool, or nasopharyngeal specimens (pulmonary tuberculosis), cerebrospinal fluid (tuberculous meningitis), and fine needle aspirate or surgical biopsy tissue (lymph node tuberculosis). For detecting tuberculosis, reference standards were microbiological (culture) or composite reference standard; for stool, we also included Xpert Ultra performed on a routine respiratory specimen. For detecting rifampicin resistance, reference standards were drug susceptibility testing or MTBDRplus.\nData collection and analysis\nTwo review authors independently extracted data and, using QUADAS-2, assessed methodological quality judging risk of bias separately for each target condition and reference standard. For each target condition, we used the bivariate model to estimate summary sensitivity and specificity with 95% confidence intervals (CIs). We stratified all analyses by type of reference standard. We summarized the frequency of Xpert Ultra trace results; trace represents detection of a very low quantity of Mycobacterium tuberculosis DNA. We assessed certainty of evidence using GRADE.\nMain results\nWe identified 14 studies (11 new studies since the previous review). For detection of pulmonary tuberculosis, 335 data sets (25,937 participants) were available for analysis. We did not identify any studies that evaluated Xpert Ultra accuracy for tuberculous meningitis or lymph node tuberculosis. Three studies evaluated Xpert Ultra for detection of rifampicin resistance. Ten studies (71%) took place in countries with a high tuberculosis burden based on WHO classification. Overall, risk of bias was low.\nDetection of pulmonary tuberculosis\nSputum, 5 studies\nXpert Ultra summary sensitivity verified by culture was 75.3% (95% CI 64.3 to 83.8; 127 participants; high-certainty evidence), and specificity was 97.1% (95% CI 94.7 to 98.5; 1054 participants; high-certainty evidence).\nGastric aspirate, 7 studies\nXpert Ultra summary sensitivity verified by culture was 70.4% (95% CI 53.9 to 82.9; 120 participants; moderate-certainty evidence), and specificity was 94.1% (95% CI 84.8 to 97.8; 870 participants; moderate-certainty evidence).\nStool, 6 studies\nXpert Ultra summary sensitivity verified by culture was 56.1% (95% CI 39.1 to 71.7; 200 participants; moderate-certainty evidence), and specificity was 98.0% (95% CI 93.3 to 99.4; 1232 participants; high certainty-evidence).\nNasopharyngeal aspirate, 4 studies\nXpert Ultra summary sensitivity verified by culture was 43.7% (95% CI 26.7 to 62.2; 46 participants; very low-certainty evidence), and specificity was 97.5% (95% CI 93.6 to 99.0; 489 participants; high-certainty evidence).\nXpert Ultra sensitivity was lower against a composite than a culture reference standard for all specimen types other than nasopharyngeal aspirate, while specificity was similar against both reference standards.\nInterpretation of results\nIn theory, for a population of 1000 children:\n• where 100 have pulmonary tuberculosis in sputum (by culture):\n- 101 would be Xpert Ultra-positive, and of these, 26 (26%) would not have pulmonary tuberculosis (false positive); and\n- 899 would be Xpert Ultra-negative, and of these, 25 (3%) would have tuberculosis (false negative).\n• where 100 have pulmonary tuberculosis in gastric aspirate (by culture):\n- 123 would be Xpert Ultra-positive, and of these, 53 (43%) would not have pulmonary tuberculosis (false positive); and\n- 877 would be Xpert Ultra-negative, and of these, 30 (3%) would have tuberculosis (false negative).\n• where 100 have pulmonary tuberculosis in stool (by culture):\n- 74 would be Xpert Ultra-positive, and of these, 18 (24%) would not have pulmonary tuberculosis (false positive); and\n- 926 would be Xpert Ultra-negative, and of these, 44 (5%) would have tuberculosis (false negative).\n• where 100 have pulmonary tuberculosis in nasopharyngeal aspirate (by culture):\n- 66 would be Xpert Ultra-positive, and of these, 22 (33%) would not have pulmonary tuberculosis (false positive); and\n- 934 would be Xpert Ultra-negative, and of these, 56 (6%) would have tuberculosis (false negative).\nDetection of rifampicin resistance\nXpert Ultra sensitivity was 100% (3 studies, 3 participants; very low-certainty evidence), and specificity range was 97% to 100% (3 studies, 128 participants; low-certainty evidence).\nTrace results\nXpert Ultra trace results, regarded as positive in children by WHO standards, were common. Xpert Ultra specificity remained high in children, despite the frequency of trace results.\nAuthors' conclusions\nWe found Xpert Ultra sensitivity to vary by specimen type, with sputum having the highest sensitivity, followed by gastric aspirate and stool. Nasopharyngeal aspirate had the lowest sensitivity. Xpert Ultra specificity was high against both microbiological and composite reference standards. However, the evidence base is still limited, and findings may be imprecise and vary by study setting. Although we found Xpert Ultra accurate for detection of rifampicin resistance, results were based on a very small number of studies that included only three children with rifampicin resistance. Therefore, findings should be interpreted with caution. Our findings provide support for the use of Xpert Ultra as an initial rapid molecular diagnostic in children being evaluated for tuberculosis.\n\nGiven the provided abstract, please respond to the following query: \"How confident are we in the results of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "For pulmonary tuberculosis, we are fairly confident because we included studies from different countries and used two different benchmarks, though neither is perfect. However, the evidence base is still limited and there were few studies with few children for one of the specimen types (nasopharyngeal aspirate).\nFor rifampicin resistance, we identified few studies with very few children with rifampicin resistance, so we are less confident."
}
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query-laysum | 4299 | [
{
"role": "user",
"content": "Abstract: Background\nDepression is an important morbidity associated with stroke that impacts on recovery, yet is often undetected or inadequately treated.\nObjectives\nTo evaluate the benefits and harms of pharmacological intervention, non-invasive brain stimulation, psychological therapy, or combinations of these to treat depression after stroke.\nSearch methods\nThis is a living systematic review. We search for new evidence every two months and update the review when we identify relevant new evidence. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review.\nWe searched the Specialised Registers of Cochrane Stroke, and Cochrane Depression Anxiety and Neurosis, CENTRAL, MEDLINE, Embase, five other databases, two clinical trials registers, reference lists and conference proceedings (February 2022). We contacted study authors.\nSelection criteria\nRandomised controlled trials (RCTs) comparing: 1) pharmacological interventions with placebo; 2) non-invasive brain stimulation with sham stimulation or usual care; 3) psychological therapy with usual care or attention control; 4) pharmacological intervention and psychological therapy with pharmacological intervention and usual care or attention control; 5) pharmacological intervention and non-invasive brain stimulation with pharmacological intervention and sham stimulation or usual care; 6) non-invasive brain stimulation and psychological therapy versus sham brain stimulation or usual care and psychological therapy; 7) pharmacological intervention and psychological therapy with placebo and psychological therapy; 8) pharmacological intervention and non-invasive brain stimulation with placebo and non-invasive brain stimulation; and 9) non-invasive brain stimulation and psychological therapy versus non-invasive brain stimulation and usual care or attention control, with the intention of treating depression after stroke.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, and extracted data from included studies. We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I² statistic and certainty of the evidence according to GRADE.\nMain results\nWe included 65 trials (72 comparisons) with 5831 participants. Data were available for: 1) 20 comparisons; 2) nine comparisons; 3) 25 comparisons; 4) three comparisons; 5) 14 comparisons; and 6) one comparison. We found no trials for comparisons 7 to 9.\nComparison 1: Pharmacological interventions\nVery low-certainty evidence from eight trials suggests pharmacological interventions decreased the number of people meeting the study criteria for depression (RR 0.70, 95% CI 0.55 to 0.88; P = 0.002; 8 RCTs; 1025 participants) at end of treatment and very low-certainty evidence from six trials suggests that pharmacological interventions decreased the number of people with inadequate response to treatment (RR 0.47, 95% CI 0.32 to 0.70; P = 0.0002; 6 RCTs; 511 participants) compared to placebo. More adverse events related to the central nervous system (CNS) (RR 1.55, 95% CI 1.12 to 2.15; P = 0.008; 5 RCTs; 488 participants; very low-certainty evidence) and gastrointestinal system (RR 1.62, 95% CI 1.19 to 2.19; P = 0.002; 4 RCTs; 473 participants; very low-certainty evidence) were noted in the pharmacological intervention than in the placebo group.\nComparison 2: Non-invasive brain stimulation\nVery low-certainty evidence from two trials show that non-invasive brain stimulation had little to no effect on the number of people meeting the study criteria for depression (RR 0.67, 95% CI 0.39 to 1.14; P = 0.14; 2 RCTs; 130 participants) and the number of people with inadequate response to treatment (RR 0.84, 95% CI 0.52, 1.37; P = 0.49; 2 RCTs; 130 participants) compared to sham stimulation. Non-invasive brain stimulation resulted in no deaths.\nComparison 3: Psychological therapy\nVery low-certainty evidence from six trials suggests that psychological therapy decreased the number of people meeting the study criteria for depression at end of treatment (RR 0.77, 95% CI 0.62 to 0.95; P = 0.01; 521 participants) compared to usual care/attention control. No trials of psychological therapy reported on the outcome inadequate response to treatment. No differences in the number of deaths or adverse events were found in the psychological therapy group compared to the usual care/attention control group.\nComparison 4: Pharmacological interventions with psychological therapy\nNo trials of this combination reported on the primary outcomes. Combination therapy resulted in no deaths.\nComparison 5: Pharmacological interventions with non-invasive brain stimulation\nNon-invasive brain stimulation with pharmacological intervention reduced the number of people meeting study criteria for depression at end of treatment (RR 0.77, 95% CI 0.64 to 0.91; P = 0.002; 3 RCTs; 392 participants; low-certainty evidence) but not the number of people with inadequate response to treatment (RR 0.95, 95% CI 0.69 to 1.30; P = 0.75; 3 RCTs; 392 participants; very low-certainty evidence) compared to pharmacological therapy alone. Very low-certainty evidence from five trials suggest no difference in deaths between this combination therapy (RR 1.06, 95% CI 0.27 to 4.16; P = 0.93; 487 participants) compared to pharmacological therapy intervention and sham stimulation or usual care.\nComparison 6: Non-invasive brain stimulation with psychological therapy\nNo trials of this combination reported on the primary outcomes.\nAuthors' conclusions\nVery low-certainty evidence suggests that pharmacological, psychological and combination therapies can reduce the prevalence of depression while non-invasive brain stimulation had little to no effect on the prevalence of depression. Pharmacological intervention was associated with adverse events related to the CNS and the gastrointestinal tract. More research is required before recommendations can be made about the routine use of such treatments.\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": "Depression is common after stroke yet often is not detected or is inadequately treated."
}
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query-laysum | 4300 | [
{
"role": "user",
"content": "Abstract: Background\nThe workplace has potential as a setting through which large groups of people can be reached to encourage smoking cessation.\nObjectives\n1. To categorize workplace interventions for smoking cessation tested in controlled studies and to determine the extent to which they help workers to stop smoking.\n2. To collect and evaluate data on costs and cost effectiveness associated with workplace interventions.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialized Register (July 2013), MEDLINE (1966 - July 2013), EMBASE (1985 - June 2013), and PsycINFO (to June 2013), amongst others. We searched abstracts from international conferences on tobacco and the bibliographies of identified studies and reviews for additional references.\nSelection criteria\nWe selected interventions conducted in the workplace to promote smoking cessation. We included only randomized and quasi-randomized controlled trials allocating individuals, workplaces, or companies to intervention or control conditions.\nData collection and analysis\nOne author extracted information relating to the characteristics and content of all kinds of interventions, participants, outcomes and methods of the studies, and a second author checked them. For this update we have conducted meta-analyses of the main interventions, using the generic inverse variance method to generate odds ratios and 95% confidence intervals.\nMain results\nWe include 57 studies (61 comparisons) in this updated review. We found 31 studies of workplace interventions aimed at individual workers, covering group therapy, individual counselling, self-help materials, nicotine replacement therapy, and social support, and 30 studies testing interventions applied to the workplace as a whole, i.e. environmental cues, incentives, and comprehensive programmes. The trials were generally of moderate to high quality, with results that were consistent with those found in other settings. Group therapy programmes (odds ratio (OR) for cessation 1.71, 95% confidence interval (CI) 1.05 to 2.80; eight trials, 1309 participants), individual counselling (OR 1.96, 95% CI 1.51 to 2.54; eight trials, 3516 participants), pharmacotherapies (OR 1.98, 95% CI 1.26 to 3.11; five trials, 1092 participants), and multiple intervention programmes aimed mainly or solely at smoking cessation (OR 1.55, 95% CI 1.13 to 2.13; six trials, 5018 participants) all increased cessation rates in comparison to no treatment or minimal intervention controls. Self-help materials were less effective (OR 1.16, 95% CI 0.74 to 1.82; six trials, 1906 participants), and two relapse prevention programmes (484 participants) did not help to sustain long-term abstinence. Incentives did not appear to improve the odds of quitting, apart from one study which found a sustained positive benefit. There was a lack of evidence that comprehensive programmes targeting multiple risk factors reduced the prevalence of smoking.\nAuthors' conclusions\n1. We found strong evidence that some interventions directed towards individual smokers increase the likelihood of quitting smoking. These include individual and group counselling, pharmacological treatment to overcome nicotine addiction, and multiple interventions targeting smoking cessation as the primary or only outcome. All these interventions show similar effects whether offered in the workplace or elsewhere. Self-help interventions and social support are less effective. Although people taking up these interventions are more likely to stop, the absolute numbers who quit are low.\n2. We failed to detect an effect of comprehensive programmes targeting multiple risk factors in reducing the prevalence of smoking, although this finding was not based on meta-analysed data.\n\n3. There was limited evidence that participation in programmes can be increased by competitions and incentives organized by the employer, although one trial demonstrated a sustained effect of financial rewards for attending a smoking cessation course and for long-term quitting. Further research is needed to establish which components of this trial contributed to the improvement in success rates.\n4. Further research would be valuable in low-income and developing countries, where high rates of smoking prevail and smoke-free legislation is not widely accepted or enforced.\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 studies in July 2013, and identified ten new trials that fitted our criteria, making a total for this update of 61 comparisons across 57 included studies. We grouped them into two broad categories: those aimed at helping individual smokers, and those that targeted the workplace environment as a whole. The first group includes such methods as individual or group counselling, self help, nicotine replacement therapy (NRT) and other medications, help from workmates or other staff, and helping quitters to stay smoke-free. The second group includes environmental cues (posters, reminders), financial or material incentives, and comprehensive smoking cessation or health promotion programmes. The review found that programmes based on group behaviour therapy (eight trials; 1309 participants), on individual counselling (eight trials; 3516 participants), on medications (five trials; 1092 participants), and on several interventions combined (six trials; 5018 participants) helped people to stop smoking. The chances of stopping smoking using these methods are about the same in the workplace as they are in other settings. This review found that the following do not help people to stop smoking when delivered in the workplace: self-help methods, support from friends, family and workmates, relapse prevention programmes, environmental cues, or comprehensive programmes aimed at changing several high-risk behaviours. Results were mixed for incentives, with one high-quality trial finding a clear benefit for incentives while the remaining five did not."
}
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query-laysum | 4301 | [
{
"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: \"deaths from any cause\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "deaths from any causeat up to 28 days after treatment, about 225 in 1000 people died, compared to 220 in 1000 people who had been given convalescent plasma (21 studies, 19,021 people)."
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query-laysum | 4302 | [
{
"role": "user",
"content": "Abstract: Background\nBenign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH.\nObjectives\nTo assess the effects of Serenoa repens in the treatment of men with LUTS consistent with BPH.\nSearch methods\nWe performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to 16 September 2022, with no restrictions on language or publication status.\nSelection criteria\nWe included randomized controlled trials of participants with BPH who were treated with Serenoa repens or placebo/no treatment.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion at each stage and undertook data extraction and risk of bias assessment and GRADE assessment of the certainty of the evidence. We considered review outcomes measured up to 12 months after randomization as short term, and beyond 12 months as long term. Our main outcomes included urologic symptom scores, quality of life, and adverse events.\nMain results\nFor this update, we narrowed the review question to only comparisons with placebo. We included 27 studies (of which 9 were new) involving a total of 4656 participants, 19 studies comparing Serenoa repens with placebo, and 8 studies comparing Serenoa repens in combination with other phytotherapeutic agents versus placebo. Most studies included men aged > 50 (mean age range 52 to 68) with moderate urologic symptoms (International Prostate Symptom Score [IPSS] range 8 to 19). Ten studies were funded by the pharmaceutical industry; two studies were funded by government agencies; and the remaining studies did not specify funding sources.\nSerenoa repens versus placebo or no intervention\nResults for this comparison are based on predefined sensitivity analyses limited to studies at low risk of bias. Serenoa repens results in little to no difference in urologic symptoms at short-term follow-up (3 to 6 months; IPSS score range 0 to 35, higher scores indicate worse symptoms; mean difference (MD) −0.90, 95% confidence interval (CI) −1.74 to −0.07; I2 = 68%; 9 studies, 1681 participants; high-certainty evidence). Serenoa repens results in little to no difference in the quality of life at short-term follow-up (3 to 6 months; IPSS quality of life domain range 0 to 6, higher scores indicate worse quality of life; MD −0.20, 95% CI −0.40 to −0.00; I2 = 39%; 5 studies, 1001 participants; high-certainty evidence). Serenoa repens probably results in little to no difference in adverse events (1 to 17 months; risk ratio (RR) 1.01, 95% CI 0.77 to 1.31; I2 = 18%; 12 studies, 2399 participants; moderate-certainty evidence). Based on 164 cases per 1000 men in the placebo group, this corresponds to 2 more (38 fewer to 51 more) per 1000 men in the Serenoa repens group.\nSerenoa repens results in little to no difference in urologic symptoms at long-term follow-up (12 to 17 months, IPSS score, MD 0.07, 95% CI −0.75 to 0.88; I2 = 34%; 3 studies, 898 participants; high-certainty evidence). Serenoa repens results in little to no difference in quality of life at long-term follow-up (12 to 17 months, IPSS quality of life, MD −0.11, 95% CI −0.41 to 0.19; I2 = 65%; 3 studies, 882 participants; high-certainty evidence). There were no data on long-term adverse events for this comparison.\nSerenoa repens in combination with other phytotherapy versus placebo or no intervention\nDifferent phytotherapeutic agents that include Serenoa repens may result in little to no difference in urologic symptoms compared to placebo at short-term follow-up (12 to 24 weeks, IPSS score, MD −2.41, 95% CI −4.54 to −0.29; I2 = 67%; 4 studies, 460 participants; low-certainty evidence). We are very uncertain about the effects of these agents on quality of life (very low-certainty evidence). These agents may result in little to no difference in the occurrence of adverse events; however, the CIs included substantial benefits and harms (12 to 48 weeks, RR 0.91, 95% CI 0.58 to 1.41; I2 = 0%; 4 studies, 481 participants; low-certainty evidence). Based on 132 cases per 1000 men in the placebo group, this corresponds to 12 fewer (55 fewer to 54 more) per 1000 men in the combined phytotherapeutic agents with Serenoa repens group.\nAuthors' conclusions\nSerenoa repens alone provides little to no benefits for men with lower urinary tract symptoms due to benign prostatic enlargement. There is more uncertainty about the role of Serenoa repens in combination with other phytotherapeutic agents.\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": "Based on the most trustworthy studies, Serenoa repens alone results in little to no difference in urinary tract symptoms or quality of life compared to placebo at three to six months. This treatment is also likely not associated with adverse events. Results were similar at 12 to 17 months.\nSerenoa repens in combination with other herbal products may result in little to no difference in urinary tract symptoms, but there is more uncertainty about effects on quality of life and adverse events.\nThe findings of this review are current to 16 September 2022."
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query-laysum | 4303 | [
{
"role": "user",
"content": "Abstract: Background\nTraumatic brain injury (TBI) is a major public health problem and a fundamental cause of morbidity and mortality worldwide. The burden of TBI disproportionately affects low- and middle-income countries. Intracranial hypertension is the most frequent cause of death and disability in brain-injured people. Special interventions in the intensive care unit are required to minimise factors contributing to secondary brain injury after trauma. Therapeutic positioning of the head (different degrees of head-of-bed elevation (HBE)) has been proposed as a low cost and simple way of preventing secondary brain injury in these people. The aim of this review is to evaluate the evidence related to the clinical effects of different backrest positions of the head on important clinical outcomes or, if unavailable, relevant surrogate outcomes.\nObjectives\nTo assess the clinical and physiological effects of HBE during intensive care management in people with severe TBI.\nSearch methods\nWe searched the following electronic databases from their inception up to March 2017: Cochrane Injuries' Specialised Register, CENTRAL, MEDLINE, Embase, three other databases and two clinical trials registers. The Cochrane Injuries' Information Specialist ran the searches.\nSelection criteria\nWe selected all randomised controlled trials (RCTs) involving people with TBI who underwent different HBE or backrest positions. Studies may have had a parallel or cross-over design. We included adults and children over two years of age with severe TBI (Glasgow Coma Scale (GCS) less than 9). We excluded studies performed in children of less than two years of age because of their unfused skulls. We included any therapeutic HBE including supine (flat) or different degrees of head elevation with or without knee gatch or reverse Trendelenburg applied during the acute management of the TBI.\nData collection and analysis\nTwo review authors independently checked all titles and abstracts, excluding references that clearly didn't meet all selection criteria, and extracted data from selected studies on to a data extraction form specifically designed for this review. There were no cases of multiple reporting. Each review author independently evaluated risk of bias through assessing sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other sources of bias.\nMain results\nWe included three small studies with a cross-over design, involving a total of 20 participants (11 adults and 9 children), in this review. Our primary outcome was mortality, and there was one death by the time of follow-up 28 days after hospital admission. The trials did not measure the clinical secondary outcomes of quality of life, GCS, and disability. The included studies provided information only for the secondary outcomes intracranial pressure (ICP), cerebral perfusion pressure (CPP), and adverse effects.\nWe were unable to pool the results as the data were either presented in different formats or no numerical data were provided. We included narrative interpretations of the available data.\nThe overall risk of bias of the studies was unclear due to poor reporting of the methods. There was marked inconsistency across studies for the outcome of ICP and small sample sizes or wide confidence intervals for all outcomes. We therefore rated the quality of the evidence as very low for all outcomes and have not included the results of individual studies here. We do not have enough evidence to draw conclusions about the effect of HBE during intensive care management of people with TBI.\nAuthors' conclusions\nThe lack of consistency among studies, scarcity of data and the absence of evidence to show a correlation between physiological measurements such as ICP, CCP and clinical outcomes, mean that we are uncertain about the effects of HBE during intensive care management in people with severe TBI.\nWell-designed and larger trials that measure long-term clinical outcomes are needed to understand how and when different backrest positions can affect the management of severe TBI.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In March 2017 the review authors searched for randomised studies."
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query-laysum | 4304 | [
{
"role": "user",
"content": "Abstract: Background\nCoronary heart disease (CHD) is the single most common cause of death globally. However, with falling CHD mortality rates, an increasing number of people live with CHD and may need support to manage their symptoms and improve prognosis. Cardiac rehabilitation is a complex multifaceted intervention which aims to improve the health outcomes of people with CHD. Cardiac rehabilitation consists of three core modalities: education, exercise training and psychological support. This is an update of a Cochrane systematic review previously published in 2011, which aims to investigate the specific impact of the educational component of cardiac rehabilitation.\nObjectives\n1. To assess the effects of patient education delivered as part of cardiac rehabilitation, compared with usual care on mortality, morbidity, health-related quality of life (HRQoL) and healthcare costs in patients with CHD.\n2. To explore the potential study level predictors of the effects of patient education in patients with CHD (e.g. individual versus group intervention, timing with respect to index cardiac event).\nSearch methods\nWe updated searches from the previous Cochrane review, by searching the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library, Issue 6, 2016), MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid) and CINAHL (EBSCO) in June 2016. Three trials registries, previous systematic reviews and reference lists of included studies were also searched. No language restrictions were applied.\nSelection criteria\n1. Randomised controlled trials (RCTs) where the primary interventional intent was education delivered as part of cardiac rehabilitation.\n2. Studies with a minimum of six-months follow-up and published in 1990 or later.\n3. Adults with a diagnosis of CHD.\nData collection and analysis\nTwo review authors independently screened all identified references for inclusion based on the above inclusion criteria. One author extracted study characteristics from the included trials and assessed their risk of bias; a second review author checked data. Two independent reviewers extracted outcome data onto a standardised collection form. For dichotomous variables, risk ratios and 95% confidence intervals (CI) were derived for each outcome. Heterogeneity amongst included studies was explored qualitatively and quantitatively. Where appropriate and possible, results from included studies were combined for each outcome to give an overall estimate of treatment effect. Given the degree of clinical heterogeneity seen in participant selection, interventions and comparators across studies, we decided it was appropriate to pool studies using random-effects modelling. We planned to undertake subgroup analysis and stratified meta-analysis, sensitivity analysis and meta-regression to examine potential treatment effect modifiers. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to evaluate the quality of the evidence and the GRADE profiler (GRADEpro GDT) to create summary of findings tables.\nMain results\nThis updated review included a total of 22 trials which randomised 76,864 people with CHD to an education intervention or a 'no education' comparator. Nine new trials (8215 people) were included for this update. We judged most included studies as low risk of bias across most domains. Educational 'dose' ranged from one 40 minute face-to-face session plus a 15 minute follow-up call, to a four-week residential stay with 11 months of follow-up sessions. Control groups received usual medical care, typically consisting of referral to an outpatient cardiologist, primary care physician, or both.\nWe found no difference in effect of education-based interventions on total mortality (13 studies, 10,075 participants; 189/5187 (3.6%) versus 222/4888 (4.6%); random effects risk ratio (RR) 0.80, 95% CI 0.60 to 1.05; moderate quality evidence). Individual causes of mortality were reported rarely, and we were unable to report separate results for cardiovascular mortality or non-cardiovascular mortality. There was no evidence of a difference in effect of education-based interventions on fatal and/or non fatal myocardial infarction (MI) (2 studies, 209 participants; 7/107 (6.5%) versus 12/102 (11.8%); random effects RR 0.63, 95% CI 0.26 to 1.48; very low quality of evidence). However, there was some evidence of a reduction with education in fatal and/or non-fatal cardiovascular events (2 studies, 310 studies; 21/152 (13.8%) versus 61/158 (38.6%); random effects RR 0.36, 95% CI 0.23 to 0.56; low quality evidence). There was no evidence of a difference in effect of education on the rate of total revascularisations (3 studies, 456 participants; 5/228 (2.2%) versus 8/228 (3.5%); random effects RR 0.58, 95% CI 0.19 to 1.71; very low quality evidence) or hospitalisations (5 studies, 14,849 participants; 656/10048 (6.5%) versus 381/4801 (7.9%); random effects RR 0.93, 95% CI 0.71 to 1.21; very low quality evidence). There was no evidence of a difference between groups for all cause withdrawal (17 studies, 10,972 participants; 525/5632 (9.3%) versus 493/5340 (9.2%); random effects RR 1.04, 95% CI 0.88 to 1.22; low quality evidence). Although some health-related quality of life (HRQoL) domain scores were higher with education, there was no consistent evidence of superiority across all domains.\nAuthors' conclusions\nWe found no reduction in total mortality, in people who received education delivered as part of cardiac rehabilitation, compared to people in control groups (moderate quality evidence). There were no improvements in fatal or non fatal MI, total revascularisations or hospitalisations, with education. There was some evidence of a reduction in fatal and/or non-fatal cardiovascular events with education, but this was based on only two studies. There was also some evidence to suggest that education-based interventions may improve HRQoL. Our findings are supportive of current national and international clinical guidelines that cardiac rehabilitation for people with CHD should be comprehensive and include educational interventions together with exercise and psychological therapy. Further definitive research into education interventions for people with CHD is needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Coronary heart disease (CHD) is the single most common cause of death globally. However, more people now live with heart disease and may need support to manage symptoms and reduce risk of future problems such as heart attacks. Education is a common element of cardiac rehabilitation, which aims to improve the health and outcomes of people with heart disease. This is an update of a review last published in 2011."
}
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query-laysum | 4305 | [
{
"role": "user",
"content": "Abstract: Background\nPeople living in 'humanitarian settings' in low- and middle-income countries (LMICs) are exposed to a constellation of physical and psychological stressors that make them vulnerable to developing mental disorders. A range of psychological and social interventions have been implemented with the aim to prevent the onset of mental disorders and/or lower psychological distress in populations at risk, and it is not known whether interventions are effective.\nObjectives\nTo compare the efficacy and acceptability of psychological and social interventions versus control conditions (wait list, treatment as usual, attention placebo, psychological placebo, or no treatment) aimed at preventing the onset of non-psychotic mental disorders in people living in LMICs affected by humanitarian crises.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMD-CTR), the Cochrane Drugs and Alcohol Review Group (CDAG) Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), Embase (OVID), PsycINFO (OVID), and ProQuest PILOTS database with results incorporated from searches to February 2020. We also searched the World Health Organization's (WHO) International Clinical Trials Registry Platform and ClinicalTrials.gov to identify unpublished or ongoing studies. We checked the reference lists of relevant studies and reviews.\nSelection criteria\nAll randomised controlled trials (RCTs) comparing psychological and social interventions versus control conditions to prevent the onset of mental disorders in adults and children living in LMICs affected by humanitarian crises. We excluded studies that enrolled participants based on a positive diagnosis of mental disorder (or based on a proxy of scoring above a cut-off score on a screening measure).\nData collection and analysis\nWe calculated standardised mean differences for continuous outcomes and risk ratios for dichotomous data, using a random-effects model. We analysed data at endpoint (zero to four weeks after therapy) and at medium term (one to four months after intervention). No data were available at long term (six months or longer). We used GRADE to assess the quality of evidence.\nMain results\nIn the present review we included seven RCTs with a total of 2398 participants, coming from both children/adolescents (five RCTs), and adults (two RCTs). Together, the seven RCTs compared six different psychosocial interventions against a control comparator (waiting list in all studies). All the interventions were delivered by paraprofessionals and, with the exception of one study, delivered at a group level.\nNone of the included studies provided data on the efficacy of interventions to prevent the onset of mental disorders (incidence). For the primary outcome of acceptability, there may be no evidence of a difference between psychological and social interventions and control at endpoint for children and adolescents (RR 0.93, 95% CI 0.78 to 1.10; 5 studies, 1372 participants; low-quality evidence) or adults (RR 0.96, 95% CI 0.61 to 1.50; 2 studies, 767 participants; very low quality evidence). No information on adverse events related to the interventions was available.\nFor children's and adolescents' secondary outcomes of prevention interventions, there may be no evidence of a difference between psychological and social intervention groups and control groups for reducing PTSD symptoms (standardised mean difference (SMD) −0.16, 95% CI −0.50 to 0.18; 3 studies, 590 participants; very low quality evidence), depressive symptoms (SMD −0.01, 95% CI −0.29 to 0.31; 4 RCTs, 746 participants; very low quality evidence) and anxiety symptoms (SMD 0.11, 95% CI −0.09 to 0.31; 3 studies, 632 participants; very low quality evidence) at study endpoint.\nIn adults' secondary outcomes of prevention interventions, psychological counselling may be effective for reducing depressive symptoms (MD −7.50, 95% CI −9.19 to −5.81; 1 study, 258 participants; very low quality evidence) and anxiety symptoms (MD −6.10, 95% CI −7.57 to −4.63; 1 study, 258 participants; very low quality evidence) at endpoint. No data were available for PTSD symptoms in the adult population.\nOwing to the small number of RCTs included in the present review, it was not possible to carry out neither sensitivity nor subgroup analyses.\nAuthors' conclusions\nOf the seven prevention studies included in this review, none assessed whether prevention interventions reduced the incidence of mental disorders and there may be no evidence for any differences in acceptability. Additionally, for both child and adolescent populations and adult populations, a very small number of RCTs with low quality evidence on the review's secondary outcomes (changes in symptomatology at endpoint) did not suggest any beneficial effect for the studied prevention interventions.\nConfidence in the findings is hampered by the scarcity of prevention studies eligible for inclusion in the review, by risk of bias in the studies, and by substantial levels of heterogeneity. Moreover, it is possible that random error had a role in distorting results, and that a more thorough picture of the efficacy of prevention interventions will be provided by future studies. For this reason, prevention studies are urgently needed to assess the impact of interventions on the incidence of mental disorders in children and adults, with extended periods of follow-up.\n\nGiven the provided abstract, please respond to the following query: \"What are psychological and social interventions?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Psychological interventions of a preventive nature usually offer people support and practical help to develop ways of coping, a sense of hope, and focus on building resilience. Social interventions of a preventive nature usually aim to strengthen social support systems and help people to feel more connected."
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query-laysum | 4306 | [
{
"role": "user",
"content": "Abstract: Background\nRecurrence of atrial tachyarrhythmias (ATa) following catheter ablation for atrial fibrillation (AF) is a common problem. Antiarrhythmic drugs have been used shortly after ablation in an attempt to maintain sinus rhythm, particularly Class I and III agents. However, it still needs to be established if the use of Class I or III antiarrhythmic medications, or both, reduce the risk of recurrence of ATa.\nObjectives\nTo assess the effects of oral Class I and III antiarrhythmic drugs versus control (standard medical therapy without Class I or III antiarrhythmics, or placebo) for maintaining sinus rhythm in people undergoing catheter ablation for AF.\nSearch methods\nWe systematically searched CENTRAL, MEDLINE, Embase, Web of Science Core Collection, and two clinical trial registers without restrictions on language or date to 5 August 2022.\nSelection criteria\nWe sought published, unpublished, and ongoing parallel-design, randomised controlled trials (RCTs) involving adult participants undergoing ablation for AF, with subsequent comparison of Class I and/or III antiarrhythmic use versus control (standard medical therapy or non-Class I and/or III antiarrhythmic use).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and performed meta-analyses with risk ratios (RR) and Peto odds ratios (Peto OR). Our primary outcomes were recurrence of atrial tachyarrhythmias; adverse events: thromboembolic events; adverse events: myocardial infarction; adverse events: new diagnosis of heart failure; and adverse events: requirement for one or more hospitalisations for atrial tachyarrhythmia. Our secondary outcomes were: all-cause mortality; and requirement for one or more repeat ablations. Where possible, we performed comparison analysis by Class I and/or III antiarrhythmic and divided follow-up periods for our primary outcome. We performed comprehensive assessments of risk of bias and certainty of evidence applying the GRADE methodology.\nMain results\nWe included nine RCTs involving a total of 3269 participants. Participants were on average 59.3 years old; 71.0% were male; and 72.9% and 27.4% had paroxysmal and persistent AF, respectively. Class I and/or III antiarrhythmics may reduce recurrence of ATa at 0 to 3 months postablation (risk ratio (RR) 0.74, 95% confidence interval (CI) 0.59 to 0.94, 8 trials, 3046 participants, low-certainty evidence) and likely reduce recurrence at > 3 to 6 months, our a priori primary time point (RR 0.85, 95% CI 0.78 to 0.93, 5 trials, 2591 participants, moderate-certainty evidence). Beyond six months the evidence is very uncertain, and the benefit of antiarrhythmics may not persist (RR 1.14, 95% CI 0.84 to 1.55, 4 trials, 2244 participants, very low-certainty evidence). The evidence suggests that Class I and/or III antiarrhythmics may not increase the risk of thromboembolic events, myocardial infarction, all-cause mortality, or requirement for repeat ablation, at 0 to 3, > 3 to 6, and > 6 months (where data were available; low- to very low-certainty evidence). The use of Class I and/or III antiarrhythmics postablation likely reduces hospitalisations for ATa by approximately 57% at 0 to 3 months (RR 0.43, 95% CI 0.28 to 0.64, moderate-certainty evidence). No data were available beyond three months. No data were available on new diagnoses of heart failure.\nFewer data were available for Class I and III antiarrhythmics individually. Based on only one and two trials (n = 125 to 309), Class I antiarrhythmics may have little effect on recurrence of ATa at 0 to 3, > 3 to 6, and > 6 months (RR 0.88, 95% CI 0.64 to 1.20, 2 trials, 309 participants; RR 0.54, 95% CI 0.25 to 1.19, 1 trial, 125 participants; RR 0.87, 95% CI 0.57 to 1.32, 1 trial, 125 participants; low-certainty evidence throughout); requirement for hospitalisation for ATa at 0 to 3 months (low-certainty evidence); or requirement for repeat ablation at 0 to 3 months (low-certainty evidence). No data were available for thromboembolic events, myocardial infarction, new diagnosis of heart failure, or all-cause mortality at any time points, or hospitalisation or repeat ablation beyond three months.\nClass III antiarrhythmics may have little effect on recurrence of ATa at up to 3 months and at > 3 to 6 months (RR 0.76, 95% CI 0.50 to 1.16, 4 trials, 599 participants, low-certainty evidence; RR 0.82, 95% CI 0.62 to 1.09, 2 trials, 318 participants, low-certainty evidence), and beyond 6 months one trial reported a possible increase in recurrence of ATa (RR 1.95, 95% CI 1.29 to 2.94, 1 trial, 112 participants, low-certainty evidence). Class III antiarrhythmics likely reduce hospitalisations for ATa at 0 to 3 months (RR 0.40, 95% CI 0.26 to 0.63, moderate-certainty evidence), and may have little effect on all-cause mortality (low- to very low-certainty evidence). The effect of Class III antiarrhythmics on thromboembolic events and requirement for repeat ablation was uncertain (very low-certainty evidence for both outcomes). No data were available for myocardial infarction or new diagnosis of heart failure at any time point, outcomes other than recurrence beyond 6 months, or for hospitalisation and repeat ablation > 3 to 6 months.\nWe assessed the majority of included trials as at low or unclear risk of bias. One trial reported an error in the randomisation process, raising the potential risk of selection bias; most of the included trials were non-blinded; and two trials were at high risk of attrition bias.\nAuthors' conclusions\nWe found evidence to suggest that the use of Class I and/or III antiarrhythmics up to 3 months after ablation is associated with a reduced recurrence of ATa 0 to 6 months after ablation, which may not persist beyond 6 months, and an immediate reduction in hospitalisation for ATa 0 to 3 months after ablation. The evidence suggests there is no difference in rates of all-cause mortality, thromboembolic events, or myocardial infarction between Class I and/or III antiarrhythmics versus control.\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 conducted the search on 5 August 2022, and identified 4682 citations (papers), out of which nine were eligible randomised controlled trials (a type of study where people are randomly assigned to one of two or more treatment groups). The studies included a total of 3269 participants from six countries, who were assigned to either Class I or III antiarrhythmics (or both) or placebo (sugar pill)/standard treatment. People taking part in the studies were on average 59 years old, and 71% were male. Most people had paroxysmal atrial fibrillation (meaning they were not in atrial fibrillation all the time and alternated with normal rhythms)."
}
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query-laysum | 4307 | [
{
"role": "user",
"content": "Abstract: Background\nAlcoholic hepatitis is a form of alcoholic liver disease characterised by steatosis, necroinflammation, fibrosis, and complications to the liver. Typically, alcoholic hepatitis presents in people between 40 and 50 years of age. Alcoholic hepatitis can be resolved if people abstain from drinking, but the risk of death will depend on the severity of the liver damage and abstinence from alcohol. Glucocorticosteroids have been studied extensively in randomised clinical trials to assess their benefits and harms. However, the results have been contradictory.\nObjectives\nTo assess the benefits and harms of glucocorticosteroids in people with alcoholic hepatitis.\nSearch methods\nWe identified trials through electronic searches in Cochrane Hepato-Biliary's (CHB) Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS, and Science Citation Index Expanded. We looked for ongoing or unpublished trials in clinical trials registers and pharmaceutical company sources. We also scanned reference lists of the studies retrieved. The last search was 18 January 2019.\nSelection criteria\nRandomised clinical trials assessing glucocorticosteroids versus placebo or no intervention in people with alcoholic hepatitis, irrespective of year, language of publication, or format. We considered trials with adults diagnosed with alcoholic hepatitis, which could have been established through clinical or biochemical diagnostic criteria or both. We defined alcoholic hepatitis as mild (Maddrey's score less than 32) and severe (Maddrey's score 32 or more). We allowed cointerventions in the trial groups, provided they were similar.\nData collection and analysis\nWe followed Cochrane methodology, performing the meta-analyses using Review Manager 5. We presented the results of dichotomous outcomes as risk ratios (RR) and of continuous outcomes as mean difference (MD), with 95% confidence intervals (CI). We used both the fixed-effect and the random-effects models for meta-analyses. Whenever there were significant discrepancies in the results, we reported the more conservative point estimate of the two. We considered a P value of 0.01 or less, two-tailed, as statistically significant if the required information size was reached for our three primary outcomes (all-cause mortality, health-related quality of life, and serious adverse events during treatment) and our post hoc decision to include analyses of mortality at more time points. We presented heterogeneity using the I² statistic. If trialists used intention-to-treat analysis to deal with missing data, we used these data in our primary analysis; otherwise, we used the available data. We assessed the bias risk of the trials using bias risk domains and the certainty of the evidence using GRADE.\nMain results\nSixteen trials fulfilled our inclusion criteria. All trials but one were at overall high risk of bias. Fifteen trials (one of which was an abstract) provided data for analysis (927 participants received glucocorticosteroids and 934 participants received placebo or no intervention). Glucocorticosteroids were administered orally or parenterally for a median 28 days (range 3 days to 12 weeks). The participants were between 25 and 70 years old, had different stages of alcoholic liver disease, and 65% were men. Follow-up, when reported, was up to the moment of discharge from the hospital, until they died (median of 63 days), or for at least one year. There was no evidence of effect of glucocorticosteroids on all-cause mortality up to three months following randomisation (random-effects RR 0.90, 95% CI 0.70 to 1.15; participants = 1861; trials = 15; very low-certainty evidence) or on health-related quality of life up to three months, measured with the European Quality of Life – 5 Dimensions – 3 Levels scale (MD –0.04 points, 95% CI –0.11 to 0.03; participants = 377; trial = 1; low-certainty evidence). There was no evidence of effect on the occurrence of serious adverse events during treatment (random-effects RR 1.05, 95% CI 0.85 to 1.29; participants = 1861; trials = 15; very low-certainty evidence), liver-related mortality up to three months following randomisation (random-effects RR 0.89, 95% CI 0.69 to 1.14; participants = 1861; trials = 15; very low-certainty evidence), number of participants with any complications up to three months following randomisation (random-effects RR 1.04, 95% CI 0.86 to 1.27; participants = 1861; very low-certainty evidence), and number of participants of non-serious adverse events up to three months' follow-up after end of treatment (random-effects RR 1.99, 95% CI 0.72 to 5.48; participants = 160; trials = 4; very low-certainty evidence). Based on the information that we collected from the published trial reports, only one of the trials seems not to be industry-funded, and the remaining 15 trials did not report clearly whether they were partly or completely funded by the industry.\nAuthors' conclusions\nWe are very uncertain about the effect estimate of no difference between glucocorticosteroids and placebo or no intervention on all-cause mortality and serious adverse events during treatment because the certainty of evidence was very low, and low for health-related quality of life. Due to inadequate reporting, we cannot exclude increases in adverse events. As the CIs were wide, we cannot rule out significant benefits or harms of glucocorticosteroids. Therefore, we need placebo-controlled randomised clinical trials, designed according to the SPIRIT guidelines and reported according to the CONSORT guidelines. Future trials ought to report depersonalised individual participant data, so that proper individual participant data meta-analyses of the effects of glucocorticosteroids in subgroups can be conducted.\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": "Sixteen randomised clinical trials compared glucocorticosteroids with placebo or no intervention in people with alcoholic hepatitis. Fifteen trials provided data for analysis (927 participants received glucocorticosteroids and 934 participants received placebo or no intervention). Glucocorticosteroids were administered orally or as an injection for a median of 28 days (range 3 days to 12 weeks). The trial participants were between 25 and 70 years old, 65% were men, and had different stages of alcoholic liver disease. Trial participants were followed up to the moment of discharge from the hospital, or until they died (a median of 63 days), or for at least one year. Not all trials reported the follow-up of participants. The trials were conducted in France, India, the UK, and the USA. Two trials administered pentoxifylline (a medicine used for diseases of the blood vessels) to both glucocorticosteroids and placebo intervention groups."
}
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query-laysum | 4308 | [
{
"role": "user",
"content": "Abstract: Background\nRapid antimicrobial susceptibility tests are expected to reduce the time to clinically important results of a blood culture. This might enable clinicians to better target therapy to a person's needs, and thereby, improve health outcomes (mortality, length of hospital stay), and reduce unnecessary prescribing of broad-spectrum antibiotics; thereby reducing antimicrobial resistance rates.\nObjectives\nTo assess the effects of rapid susceptibility testing versus standard susceptibility testing for bloodstream infections (BSIs).\nSearch methods\nTo identify studies with selected outcomes, we searched the Cochrane Infectious Diseases Group Specialised Register, CENTRAL, MEDLINE, LILACS, and two trials registries, between 1987 and October 2020. We used 'bloodstream infection' and 'antimicrobial susceptibility tests' as search terms. We had no language or publication status limitations.\nSelection criteria\nRandomized controlled trials (RCTs) comparing rapid antimicrobial susceptibility testing (with a time-to-result of ≤ 8 hours) versus conventional antimicrobial susceptibility testing in people with a BSI caused by any bacteria, as identified by a positive blood culture.\nData collection and analysis\nTwo review authors independently screened references, full-text reports of potentially relevant studies, extracted data from the studies, and assessed risk of bias. Any disagreement was discussed and resolved with a third review author. For mortality, a dichotomous outcome, we extracted the number of events in each arm, and presented a risk ratio (RR) with 95% confidence interval (CI) to compare rapid susceptibility testing to conventional methods. We used Review Manager 5.4 to meta-analyse the data. For other outcomes, which are time-to-event outcomes (time-to-discharge from hospital, time-to-first appropriate antibiotic change), we conducted qualitative narrative synthesis, due to heterogeneity of outcome measures.\nMain results\nWe included six trials, with 1638 participants. For rapid antimicrobial susceptibility testing compared to conventional methods, there was little or no difference in mortality between groups (RR 1.10, 95% CI 0.82 to 1.46; 6 RCTs, 1638 participants; low-certainty evidence). In subgroup analysis, for rapid genotypic or molecular antimicrobial susceptibility testing compared to conventional methods, there was little or no difference in mortality between groups (RR 1.02, 95% CI 0.69 to 1.49; 4 RCTs, 1074 participants; low-certainty evidence). For phenotypic rapid susceptibility testing compared to conventional methods, there was little or no difference in mortality between groups (RR 1.37, 95% CI 0.80 to 2.35; 2 RCTs, 564 participants; low-certainty evidence).\nIn qualitative analysis, rapid susceptibility testing may make little or no difference in time-to-discharge (4 RCTs, 1165 participants; low-certainty evidence). In qualitative analysis, rapid genotypic susceptibility testing compared to conventional testing may make little or no difference in time-to-appropriate antibiotic (3 RCTs, 929 participants; low-certainty evidence). In subgroup analysis, rapid phenotypic susceptibility testing compared to conventional testing may improve time-to-appropriate antibiotic (RR -17.29, CI -45.05 to 10.47; 2 RCTs, 564 participants; low-certainty evidence).\nAuthors' conclusions\nThe theoretical benefits of rapid susceptibility testing have not been demonstrated to directly improve mortality, time-to-discharge, or time-to-appropriate antibiotic in these randomized studies. Future large prospective studies should be designed to focus on the most clinically meaningful outcomes, and aim to optimize blood culture pathways.\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": "Rapid susceptibility tests to identify an appropriate antibiotic quickly for people with blood sepsis may make little to no difference to:\n· how many people die within 30 days of diagnosis of blood sepsis;\n· how long people stay in hospital;\n· whether given a suitable antibiotic.\nLarger studies will help determine if using rapid susceptibility tests improves these outcomes."
}
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query-laysum | 4309 | [
{
"role": "user",
"content": "Abstract: Background\nVenous leg ulcers are common, chronic wounds caused by venous diseases, with a high recurrence rate and heavy disease burden. Compression therapy (bandages or stockings) is the first choice treatment for venous leg ulcers. However, when ulcers remain unhealed, medication can also be used with or without compression therapy. Sulodexide, a highly purified glycosaminoglycan (a naturally occurring molecule) has antithrombotic and profibrinolytic properties (it reduces the formation of blood clots) as well as anti-inflammatory effects. Sulodexide has been studied as a potential treatment for venous leg ulcers.\nObjectives\nTo assess the efficacy and safety of sulodexide for treating venous leg ulcers.\nSearch methods\nIn July 2015 we searched: The Cochrane Wounds 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; EBSCO CINAHL; Chinese Biomedical Literature Database (CBM); China National Knowledge Infrastructure Database (CNKI); Wan Fang and VIP. We also searched clinical trials registries to identify ongoing studies, as well as references listed in relevant publications. There were no restrictions based on date of publication, language or study setting.\nSelection criteria\nRandomised controlled trials (RCTs) involving people with a diagnosis of venous leg ulcers which compared sulodexide with placebo or any other drug therapy (such as pentoxifylline, flavonoids, aspirin), with or without compression therapy.\nData collection and analysis\nWe used standard Cochrane methodological procedures. The authors independently selected studies, extracted data and assessed risk of bias. We pooled data to present the risk ratio (RR) with 95% confidence interval (CI), or presented a narrative summary. We assessed overall evidence quality according to the GRADE approach.\nMain results\nWe included four RCTs with a total of 463 participants (aged 42 years to 93 years); one report was only available as a published abstract.\nMeta-analysis of three RCTs suggests an increase in the proportion of ulcers completely healed with sulodexide as an adjuvant to local treatment (including wound care and compression therapy) compared with local treatment alone (rate of complete healing with sulodexide 49.4% compared with 29.8% with local treatment alone; RR 1.66; 95% CI 1.30 to 2.12). This evidence for sulodexide increasing the rate of complete healing is low quality due to risk of bias. It is unclear whether sulodexide is associated with any increase in adverse events (4.4% with sulodexide versus 3.1% with no sulodexide; RR 1.44; 95% CI 0.48 to 4.34). The evidence for adverse events is very low quality, downgraded twice for risk of bias and once for imprecision.\nAuthors' conclusions\nSulodexide may increase the healing of venous ulcers, when used alongside local wound care, however the evidence is only low quality and the conclusion is likely to be affected by new research. It is not clear whether sulodexide is associated with adverse effects. The standard dosage, route and frequency of sulodexide reported in the trials was unclear. Further rigorous, adequately powered RCTs examining the effects of sulodexide on healing, ulcer recurrence, quality of life and costs are necessary.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review includes four studies involving 463 people with venous leg ulcers aged between 42 and 93 years old. The studies compared sulodexide used in combination with local treatment (including wound care and compression therapy) with local treatment alone. The duration of the four studies ranged from one month to three months."
}
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query-laysum | 4310 | [
{
"role": "user",
"content": "Abstract: Background\nDeep venous thrombosis (DVT) occurs in approximately one in 1000 adults every year, and has an annual mortality of 14.6%. In particular, iliofemoral DVT can lead to recurrent thrombosis and post-thrombotic syndrome (PTS), a painful condition which can lead to chronic venous insufficiency, oedema, and ulceration. It causes significant disability, impaired quality of life, and economic burden. Early thrombus removal techniques have been advocated in patients with an iliofemoral DVT in order to improve vein patency, prevent valvular dysfunction, and reduce future complications, such as post-thrombotic syndrome and venous ulceration. One such technique is pharmacomechanical thrombectomy, a combination of catheter-based thrombectomy and catheter-directed thrombolysis.\nObjectives\nTo assess the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Specialised Register (last searched December 2015) and the Cochrane Register of Studies (last searched December 2015). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles retrieved by electronic searches for additional citations.\nSelection criteria\nRandomised controlled trials in which patients with an iliofemoral deep vein thrombosis were allocated to receive pharmacomechanical thrombectomy versus anticoagulation, mechanical thrombectomy, thrombolysis (systemic or catheter directed thrombolysis), or other endovascular techniques for the treatment of iliofemoral DVT.\nData collection and analysis\nAt least two review authors independently assessed studies identified for potential inclusion.\nMain results\nWe found no randomised controlled trials that met the eligibility criteria for this review. We identified one ongoing study.\nAuthors' conclusions\nThere were no randomised controlled trials that assessed the effects of pharmacomechanical thrombectomy versus anticoagulation (alone or with compression stockings), mechanical thrombectomy, thrombolysis, or other endovascular techniques in the management of people with acute DVT of the iliofemoral vein that met the eligibility criteria for this review. Further high quality randomised controlled trials are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Deep vein thrombosis (DVT) is a condition in which a blood clot forms in the deep vein of the leg or pelvis. It affects approximately 1 in 1000 people. If it is not treated, the clot can travel in the blood, and block the arteries in the lungs. This life-threatening condition is called a pulmonary embolism and occurs in approximately 3 to 4 in 10,000 people. Another side-effect of DVT is post-thrombotic syndrome (PTS), a condition in which the patient suffers pain, swelling, and changes in the skin of the leg, which can lead to an ulcer. This causes significant disability and diminished qualify of life, and is costly to the healthcare system.\nOne way to prevent another blood clot or PTS is to remove the clot. There are a number of ways to do this. A catheter can be inserted into the vein and the clot removed directly (mechanical thrombectomy), the clot can be broken down through the use of drugs infused into a vein in the foot or directly at the site of the clot using a catheter and X-ray control (pharmacomechanical thrombolysis), or a combination of the two procedures. This review aimed to measure how safe and effective pharmacomechanical thrombectomy is, compared to other techniques."
}
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query-laysum | 4311 | [
{
"role": "user",
"content": "Abstract: Background\nInfantile colic is typically defined as full-force crying for at least three hours per day, on at least three days per week, for at least three weeks. Colic appears to be more frequent in the first six weeks of life (prevalence range of 17% to 25%), depending on the specific location reported and definitions used, and usually resolves by three months. The aetiopathogenesis of infantile colic is unclear but most likely multifactorial. A number of psychological, behavioural and biological components (food hypersensitivity, allergy or both; gut microflora and dysmotility) are thought to contribute to it. The role of diet as a component in infantile colic remains controversial.\nObjectives\nTo assess the effects of dietary modifications for reducing colic in infants less than four months of age.\nSearch methods\nIn July 2018 we searched CENTRAL, MEDLINE, Embase, 17 other databases and 2 trials registers. We also searched Google, checked references and contacted study authors.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of dietary modifications, alone or in combination, for colicky infants younger than four months of age versus another intervention or placebo. We used specific definitions for colic, age of onset and the methods for performing the intervention. We defined 'modified diet' as any diet altered to include or exclude certain components.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Our primary outcome was duration of crying, and secondary outcomes were response to intervention, frequency of crying episodes, parental/family quality of life, infant sleep duration, parental satisfaction and adverse effects.\nMain results\nWe included 15 RCTs involving 1121 infants aged 2 to 16 weeks. All studies were small and at high risk of bias across multiple design factors (e.g. selection, attrition). The studies covered a wide range of dietary interventions, and there was no scope for meta-analysis. Using GRADE, we assessed the quality of the evidence as very low.\nNo study reported on parental or family quality of life, infant sleep duration per 24 h, or parental satisfaction.\nLow-allergen maternal diet versus a diet containing potential allergens: one study (90 infants) found that 35/47 (74%) of infants responded (reduction in cry/fuss duration of 25%) to a low-allergen maternal diet, compared with 16/43 (37%) of infants with a maternal diet containing potential allergens (37% difference; 95% confidence interval (CI) 18 to 56; P < 0.001).\nLow-allergen diet or soy milk formula versus standard diet or cow's milk formula and dicyclomine hydrochloride: one study (120 infants) found that 10/15 (66.6%) breastfed babies responded to dicyclomine hydrochloride and a normal diet, compared with 10/16 (62.5%) on a low-allergen diet, while 24/45 (53.3%) standard formula-fed babies taking dicyclomine hydrochloride improved compared with 29/44 (65.9%) on soy milk formula. Response was defined as a reduction of crying to less than one hour per day after 48 hours of treatment, with remission persisting for one month.\nHydrolysed formula versus standard formula: one study (43 infants) reported that the number of infants who responded to the intervention (cried for less than 3 hours per day on at least 3 days a week) was 8/23 in the whey hydrolysate group versus 5/20 in the standard formula group (χ2 using yate's correction = 0.20, P = 0.65).\nThe same study (43 infants) reported a greater reduction in crying time postintervention with hydrolysed formula (104 min/d, 95% CI 55 to 155) than with standard formula (3 min/d, 95% CI −63 to 67); difference = 101 min/d, 95% CI 25 to 179; P = 0.02).\nThe author confirmed there were no adverse effects.\nHydrolysed formula or dairy- and soy-free maternal diet versus standard diet/formula and parental education or counselling: one study (21 infants) found that crying time decreased to 2.03 h/d (SD 1.03) in the hydrolysed or dairy- and soy-free maternal diet group compared with 1.08 h/d (SD 0.7) in the parent education or counselling group, nine days postintervention.\nPartially hydrolysed, lower lactose, whey-based formulae containing oligosaccharide versus standard formula with simethicone: one study (267 infants) found both groups experienced decreased colic episodes after seven days (partially hydrolysed formula: from 5.99 episodes (SD 1.84) to 2.47 episodes (SD 1.94); standard formula: from 5.41 episodes (SD 1.88) to 3.72 episodes (SD 1.98)); 95% CI 95% −0.7 to −1.8; P < 0.001). This difference was significant after two weeks (partially hydrolysed: 1.76 episodes (SD 1.60); standard formula: 3.32 episodes (SD 2.06); P < 0.001). The study author confirmed there were no adverse effects.\nLactase enzyme supplementation versus placebo: three studies (138 infants) assessed this comparison, but they are cross-over trials that did not report data from before washout. There were no adverse effects in any of the studies.\nExtract of Foeniculum vulgare, Matricariae recutita, and Melissa officinalis versus placebo: one study (93 infants) found that average daily crying time was lower for infants given the extract (76.9 min/d (SD 23.5), than infants given placebo (169.9 min/d (SD 23.1) at the end of the one-week study (95% CI −102.89 to −83.11; P < 0.01). There were no adverse effects.\nSoy protein-based formula versus standard cows' milk protein-based formula: one study (19 infants) reported a mean crying time of 12.7 h/week (SD 16.4) in the soy formula group versus 17.3 h/week (SD 6.9) in the standard cows' milk group, and that 5/10 (50%) responded in the soy formula group versus 0/9 (0%) in the standard cows' milk group.\nSoy protein formula with polysaccharide versus standard soy protein formula: one cross-over study (27 infants) assessed this comparison but did not provide disaggregated data for the pre-wash-out data.\nAuthors' conclusions\nCurrently, evidence of the effectiveness of dietary modifications for the treatment of infantile colic is sparse and at significant risk of bias. The few available studies had small sample sizes, and most had serious limitations. There were insufficient studies, making the use of meta-analysis unfeasable. Benefits reported for hydrolysed formulas were inconsistent.\nBased on available evidence, we are unable to recommend any intervention. Future studies of single interventions, using clinically significant outcome measures, and appropriate design and power are needed.\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": "Most studies reported data on a combination of outcomes: duration of crying, number of responders in each group after treatment (i.e. those who experienced a decrease in daily crying), or frequency of crying episodes. We present these findings below. No study reported on parental or family quality of life, infant sleep or parental satisfaction. Six studies reported that there were no side effects as a result of the dietary changes."
}
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query-laysum | 4312 | [
{
"role": "user",
"content": "Abstract: Background\nSchizophrenia is a severe mental disorder with a prevalence of about 1% among the general population. It is listed among the top 10 causes of disability-adjusted life years (DALYs) worldwide. Antipsychotics are the mainstay treatment. Piperacetazine has been reported to be as clinically effective as chlorpromazine, a well established 'benchmark' antipsychotic, for people with schizophrenia. However, the side effect profiles of these antipsychotics differ and it is important that an evidence base is available comparing the benefits, and potential harms of these two antipsychotics.\nObjectives\nTo assess the clinical and side effects of chlorpromazine for people with schizophrenia and schizophrenia-like psychoses in comparison with piperacetazine.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Trials Register (6 June 2015 and 8 October 2018) which is based on regular searches of CINAHL, CENTRAL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO and registries of clinical trials. There are no language, date, document type, or publication status limitations for inclusion of records in the register.\nSelection criteria\nWe included randomised controlled trials (RCTs) focusing on chlorpromazine versus piperacetazine for people with schizophrenia, reporting useable data.\nData collection and analysis\nWe extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE.\nMain results\nWe found 12 records referring to six trials. We included five trials, all from the 1970s, randomising 343 participants. We excluded one trial. The overall methodology and data reporting by the trials was poor. Only short-term data were available.\nResults from the included trials found that, in terms of global state improvement, when rated by a psychiatrist, there was no clear difference between chlorpromazine and piperacetazine (RR 0.90, 95% CI 0.80 to 1.02; participants = 208; studies = 2; very low-quality evidence). One trial reported change scores on the mental state scale Brief Psychiatric Rating Scale (BPRS); no clear difference was observed (MD -0.40, 95% CI -1.41 to 0.61; participants = 182; studies = 1; very low-quality evidence). Chlorpromazine appears no worse or better than piperacetazine regarding adverse effects. In both treatment groups, around 60% of participants experienced some sort of adverse effect (RR 1.00, 95% CI 0.75 to 1.33; participants = 74; studies = 3; very low-quality evidence), with approximately 40% of these participants experiencing some parkinsonism-type movement disorder (RR 0.95, CI 0.61 to 1.49; participants = 106; studies = 3; very low-quality evidence). No clear difference in numbers of participants leaving the study early for any reason was observed (RR 0.50, 95% CI 0.10 to 2.56; participants = 256; studies = 4; very low-quality evidence). No trial reported data for change in negative symptoms or economic costs.\nAuthors' conclusions\nThe results of this review show chlorpromazine and piperacetazine may have similar clinical efficacy, but data are based on very small numbers of participants and the evidence is very low quality. We can not make firm conclusions based on such data. Currently, should clinicians and people with schizophrenia need to choose between chlorpromazine and piperacetazine they should be aware there is no good quality evidence to base decisions. More high quality research is needed.\n\nGiven the provided abstract, please respond to the following query: \"Searching for evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A search for randomised controlled trials that could be relevant to this review was carried out on 6 June 2015, and another search was carried out 8 October 2018. This was achieved by searching the Specialised Register of Cochrane Schizophrenia. The 2015 search found six possible trials and we carefully checked these to see if we could include them in the review. The 2018 search found no new trials."
}
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query-laysum | 4313 | [
{
"role": "user",
"content": "Abstract: Background\nPlatinum-based therapy, including cisplatin, carboplatin, oxaliplatin or a combination of these, is used to treat a variety of paediatric malignancies. One of the most significant adverse effects is the occurrence of hearing loss or ototoxicity. In an effort to prevent this ototoxicity, different otoprotective medical interventions have been studied. This review is the third update of a previously published Cochrane Review.\nObjectives\nTo assess the efficacy of medical interventions to prevent hearing loss and to determine possible effects of these interventions on antitumour efficacy, toxicities other than hearing loss and quality of life in children with cancer treated with platinum-based therapy as compared to placebo, no additional treatment or another protective medical intervention.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE (PubMed) and Embase (Ovid) to 8 January 2019. We handsearched reference lists of relevant articles and assessed the conference proceedings of the International Society for Paediatric Oncology (2006 up to and including 2018), the American Society of Pediatric Hematology/Oncology (2007 up to and including 2018) and the International Conference on Long-Term Complications of Treatment of Children and Adolescents for Cancer (2010 up to and including 2015). We scanned ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP; apps.who.int/trialsearch) for ongoing trials (on 2 January 2019).\nSelection criteria\nRandomized controlled trials (RCTs) or controlled clinical trials (CCTs) evaluating platinum-based therapy with an otoprotective medical intervention versus platinum-based therapy with placebo, no additional treatment or another protective medical intervention in children with cancer.\nData collection and analysis\nTwo review authors independently performed the study selection, data extraction, risk of bias assessment and GRADE assessment of included studies, including adverse effects. We performed analyses according to the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nWe identified two RCTs and one CCT (total number of participants 149) evaluating the use of amifostine versus no additional treatment in the original version of the review; the updates identified no additional studies. Two studies included children with osteosarcoma, and the other study included children with hepatoblastoma. Children received cisplatin only or a combination of cisplatin and carboplatin, either intra-arterially or intravenously. Pooling of results of the included studies was not possible. From individual studies the effect of amifostine on symptomatic ototoxicity only (i.e. National Cancer Institute Common Toxicity Criteria version 2 (NCICTCv2) or modified Brock grade 2 or higher) and combined asymptomatic and symptomatic ototoxicity (i.e. NCICTCv2 or modified Brock grade 1 or higher) were uncertain (low-certainty evidence). Only one study including children with osteosarcoma treated with intra-arterial cisplatin provided information on tumour response, defined as the number of participants with a good or partial remission. The available-data analysis (data were missing for one participant), best-case scenario analysis and worst-case scenario analysis showed a difference in favour of amifostine, although the certainty of evidence for this effect was low. There was no information on survival for any of the included studies. Only one study, including children with osteosarcoma treated with intra-arterial cisplatin, provided data on the number of participants with adverse effects other than ototoxicity grade 3 or higher (on NCICTCv2 scale). There was low-certainty evidence that grade 3 or 4 vomiting was higher with amifostine (risk ratio (RR) 9.04, 95% confidence interval (CI) 1.99 to 41.12). The effects on cardiotoxicity and renal toxicity grade 3 or 4 were uncertain (low-certainty evidence). None of the studies evaluated quality of life.\nIn the recent update, we also identified one RCT including 109 children with localized hepatoblastoma evaluating the use of sodium thiosulfate versus no additional treatment. Children received intravenous cisplatin only (one child also received carboplatin). There was moderate-certainty evidence that both symptomatic ototoxicity only (i.e. Brock criteria grade 2 or higher) and combined asymptomatic and symptomatic ototoxicity (i.e. Brock criteria grade 1 or higher) was lower with sodium thiosulfate (combined asymptomatic and symptomatic ototoxicity: RR 0.52, 95% CI 0.33 to 0.81; symptomatic ototoxicity only: RR 0.39, 95% CI 0.19 to 0.83). The effect of sodium thiosulfate on tumour response (defined as number of participants with a complete or partial response at the end of treatment), overall survival (calculated from time of randomization to death or last follow-up), event-free survival (calculated from time of randomization until disease progression, disease relapse, second primary cancer, death, or last follow-up, whichever came first) and adverse effects other than hearing loss and tinnitus grade 3 or higher (according to National Cancer Institute Common Toxicity Criteria Adverse Effects version 3 (NCICTCAEv3) criteria) was uncertain (low-certainty evidence for all these outcomes). Quality of life was not assessed.\nWe found no eligible studies for possible otoprotective medical interventions other than amifostine and sodium thiosulfate and for other types of malignancies.\nAuthors' conclusions\nAt the moment there is no evidence from individual studies in children with osteosarcoma or hepatoblastoma treated with different platinum analogues and dosage schedules that underscores the use of amifostine as an otoprotective intervention as compared to no additional treatment. Since pooling of results was not possible and the evidence was of low certainty, no definitive conclusions can be made. Since we found only one RCT evaluating the use of sodium thiosulfate in children with localized hepatoblastoma treated with cisplatin, no definitive conclusions on benefits and harms can be drawn. It should be noted that 'no evidence of effect', as identified in this review, is not the same as 'evidence of no effect'. We identified no eligible studies for other possible otoprotective medical interventions and other types of malignancies, so no conclusions can be made about their efficacy in preventing ototoxicity in children treated with platinum-based therapy. More high-quality research is needed.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to January 2019.\nWe found two randomized studies (clinical studies where people are randomly put into one of two or more treatment groups) and one controlled study (clinical studies where people are put into one of two or more treatment groups but this is not done in a random way) (149 participants), all comparing amifostine with no additional treatment. Two studies included children with osteosarcoma (a type of bone cancer), the other study included children with hepatoblastoma (a type of liver cancer). Combining the results of the included studies was not possible. It is not clear how long participants were monitored.\nWe also found one randomized study (109 children with localized hepatoblastoma) comparing sodium thiosulfate with no additional treatment. Half of the participants were monitored for more than four years."
}
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query-laysum | 4314 | [
{
"role": "user",
"content": "Abstract: Background\nOvulation induction with follicle stimulating hormone (FSH) is a second-line treatment in women with polycystic ovary syndrome (PCOS) who do not ovulate or conceive on clomiphene citrate.\nObjectives\nTo compare the effectiveness and safety of gonadotrophins as a second-line treatment for ovulation induction in women with clomiphene citrate-resistant polycystic ovary syndrome (PCOS), and women who do not ovulate or conceive after clomiphene citrate.\nSearch methods\nIn January 2018, we searched the Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, the World Health Organisation clinical trials register, Clinicaltrials.gov, LILACs, and PubMed databases, and Google Scholar. We checked references of in all obtained studies. We had no language restrictions.\nSelection criteria\nAll randomised controlled trials reporting data on clinical outcomes in women with PCOS who did not ovulate or conceive on clomiphene citrate, and undergoing ovulation induction with urinary-derived gonadotrophins, including urofollitropin (uFSH) in purified FSH (FSH-P) or highly purified FSH (FSH-HP) form, human menopausal gonadotropin (HMG) and highly purified human menopausal gonadotrophin (HP-HMG), or recombinant FSH (rFSH), or continuing clomiphene citrate. We included trials reporting on ovulation induction followed by intercourse or intrauterine insemination. We excluded studies that described co-treatment with clomiphene citrate, metformin, luteinizing hormone, or letrozole.\nData collection and analysis\nThree review authors (NW, EK, and MvW) independently selected studies for inclusion, assessed risk of bias, and extracted study data. Primary outcomes were live birth rate per woman and multiple pregnancy per woman. Secondary outcomes were clinical pregnancy, miscarriage, incidence of ovarian hyperstimulation syndrome (OHSS) per woman, total gonadotrophin dose, and total duration of stimulation per woman. We combined data using a fixed-effect model to calculate the risk ratio (RR). We summarised the overall quality of evidence for the main outcomes using GRADE criteria.\nMain results\nThe review included 15 trials with 2387 women. Ten trials compared rFSH with urinary-derived gonadotrophins (three compared rFSH with human menopausal gonadotrophin, and seven compared rFSH with FSH-HP), four trials compared FSH-P with HMG. We found no trials that compared FSH-HP with FSH-P. One trial compared FSH with continued clomiphene citrate.\nRecombinant FSH (rFSH) versus urinary-derived gonadotrophins\nThere may be little or no difference in the birth rate between rFSH and urinary-derived gonadotrophins (RR 1.21, 95% confidence interval (CI) 0.83 to 1.78; five trials, N = 505; I² = 9%; low-quality evidence). This suggests that for the observed average live birth per woman who used urinary-derived FSH of 16%, the chance of live birth with rFSH is between 13% and 28%. There may also be little or no difference between groups in incidence of multiple pregnancy (RR 0.86, 95% CI 0.46 to 1.61; eight trials, N = 1368; I² = 0%; low-quality evidence), clinical pregnancy rate (RR 1.05, 95% CI 0.88 to 1.27; eight trials, N = 1330; I² = 0; low-quality evidence), or miscarriage rate (RR 1.20, 95% CI 0.71 to 2.04; seven trials, N = 970; I² = 0; low-quality evidence). We are uncertain whether rFSH reduces the incidence of OHSS (RR 1.48, 95% CI 0.82 to 2.65, ten trials, n=1565, I² = 0%, very low-quality evidence).\nHuman menopausal gonadotrophin (HMG) or HP-HMG versus uFSH\nWhen compared to uFSH, we are uncertain whether HMG or HP-HMG improves live birth rate (RR 1.28, 95% CI 0.65 to 2.52; three trials, N = 138; I² = 0%; very low quality evidence), or reduces multiple pregnancy rate (RR 2.13, 95% CI 0.51 to 8.91; four trials, N = 161; I² = 0%; very low quality evidence). We are also uncertain whether HMG or HP-HMG improves clinical pregnancy rate (RR 1.31, 95% CI 0.66 to 2.59; three trials, N = 102; I² = 0; very low quality evidence), reduces miscarriage rate (RR 0.33, 95% CI 0.06 to 1.97; two trials, N = 98; I² = 0%; very low quality evidence), or reduces the incidence of OHSS (RR 7.07, 95% CI 0.42 to 117.81; two trials, N = 53; very low quality evidence) when compared to uFSH.\nGonadotrophins versus continued clomiphene citrate\nGonadotrophins resulted in more live births than continued clomiphene citrate (RR 1.24, 95% CI 1.05 to 1.46; one trial, N = 661; I² = 0%; moderate-quality evidence). This suggests that for a woman with a live birth rate of 41% with continued clomiphene citrate, the live birth rate with FSH was between 43% and 60%. There is probably little or no difference in the incidence of multiple pregnancy between treatments (RR 0.89, 95% CI 0.33 to 2.44; one trial, N = 661; I² = 0%; moderate-quality evidence). Gonadotrophins resulted in more clinical pregnancies than continued clomiphene citrate (RR 1.31, 95% CI 1.13 to 1.52; one trial, N = 661; I² = 0%; moderate-quality evidence), and more miscarriages (RR 2.23, 95% CI 1.11 to 4.47; one trial, N = 661; I² = 0%; moderate-quality evidence). None of the women developed OHSS.\nAuthors' conclusions\nThere may be little or no difference in live birth, incidence of multiple pregnancy, clinical pregnancy rate, or miscarriage rate between urinary-derived gonadotrophins and recombinant follicle stimulating hormone in women with polycystic ovary syndrome. For human menopausal gonadotropin or highly purified human menopausal gonadotrophin versus urinary follicle stimulating hormone we are uncertain whether one or the other improves or lowers live birth, incidence of multiple pregnancy, clinical pregnancy rate, or miscarriage rate. We are uncertain whether any of the interventions reduce the incidence of ovarian hyperstimulation syndrome. We suggest weighing costs and convenience in the decision to use one or the other gonadotrophin. In women with clomiphene citrate failure, gonadotrophins resulted in more live births than continued clomiphene citrate without increasing multiple pregnancies.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence was low to very low for outcomes from rFSH versus urinary gonadotrophins, and human menopausal gonadotrophin versus FSH-P. The quality of the evidence was moderate for outcomes from gonadotrophins versus continued clomiphene citrate.\nTen of the fifteen studies included in this review reported a commercial sponsor."
}
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query-laysum | 4315 | [
{
"role": "user",
"content": "Abstract: Background\nLong chain polyunsaturated fatty acids (LCPUFA), especially docosahexaenoic acid (DHA), are the most abundant fatty acids in the brain and are necessary for growth and maturation of an infant's brain and retina. LCPUFAs are named “essential” because they cannot be synthesised efficiently by the human body and come from maternal diet. It remains controversial whether LCPUFA supplementation to breastfeeding mothers is beneficial for the development of their infants.\nObjectives\nTo assess the effectiveness and safety of supplementation with LCPUFA in breastfeeding mothers in the cognitive and physical development of their infants as well as safety for the mother and infant.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (6 August 2014), CENTRAL (Cochrane Library 2014, Issue 8), PubMed (1966 to August 2014), EMBASE (1974 to August 2014), LILACS (1982 to August 2014), Google Scholar (August 2014) and reference lists of published narrative and systematic reviews.\nSelection criteria\nRandomised controlled trials or cluster-randomised controlled trials evaluating the effects of LCPUFA supplementation on breastfeeding mothers (including the pregnancy period) and their infants.\nData collection and analysis\nTwo review authors independently assessed eligibility and trial quality, performed data extraction and evaluated data accuracy.\nMain results\nWe included eight randomised controlled trials involving 1567 women. All the studies were performed in high-income countries. The longest follow-up was seven years.\nWe report the results from the longest follow-up time point from included studies. Overall, there was moderate quality evidence as assessed using the GRADE approach from these studies for the following outcomes measured beyond 24 months age of children: language development and child weight. There was low-quality evidence for the outcomes: Intelligence or solving problems ability, psychomotor development, child attention, and child visual acuity.\nWe found no significant difference in children's neurodevelopment at long-term follow-up beyond 24 months: language development (standardised mean difference (SMD) -0.27, 95% confidence interval (CI) -0.56 to 0.02; two trials, 187 participants); intelligence or problem-solving ability (three trials, 238 participants; SMD 0.00, 95% CI -0.36 to 0.36); psychomotor development (SMD -0.11, 95% CI -0.48 to 0.26; one trial, 113 participants); motor development (SMD -0.23, 95% CI -0.60 to 0.14; one trial, 115 participants), or in general movements (risk ratio, RR, 1.12, 95% CI 0.58 to 2.14; one trial, 77 participants; at 12 weeks of life). However, child attention scores were better at five years of age in the group of children whose mothers had received supplementation with fatty acids (mean difference (MD) 4.70, 95% CI 1.30 to 8.10; one study, 110 participants)). In working memory and inhibitory control, we found no significant difference (MD -0.02 95% CI -0.07 to 0.03 one trial, 63 participants); the neurological optimality score did not present any difference (P value: 0.55).\nFor child visual acuity, there was no significant difference (SMD 0.33, 95% CI -0.04 to 0.71; one trial, 111 participants).\nFor growth, there were no significant differences in length (MD -0.39 cm, 95% CI -1.37 to 0.60; four trials, 441 participants), weight (MD 0.13 kg, 95% CI -0.49 to 0.74; four trials, 441 participants), and head circumference (MD 0.15 cm, 95% CI -0.27 to 0.58; three trials, 298 participants). Child fat mass and fat mass distribution did not differ between the intervention and control group (MD 2.10, 95% CI -0.48 to 4.68; one trial, 115 participants, MD -0.50, 95% CI -1.69 to 0.69; one trial, 165 participants, respectively).\nOne study (117 infants) reported a significant difference in infant allergy at short-term follow-up (risk ratio (RR) 0.13, 95% CI 0.02 to 0.95), but not at medium-term follow-up (RR 0.52, 95% CI 0.17 to 1.59).\nWe found no significant difference in two trials evaluating postpartum depression. Data were not possible to be pooled due to differences in the describing of the outcome. One study (89 women) did not find any significant difference between the LCPUFA supplementation and the control group at four weeks postpartum (MD 1.00, 95%CI -1.72 to 3.72).\nNo adverse effects were reported.\nAuthors' conclusions\nBased on the available evidence, LCPUFA supplementation did not appear to improve children's neurodevelopment, visual acuity or growth. In child attention at five years of age, weak evidence was found (one study) favouring the supplementation. Currently, there is inconclusive evidence to support or refute the practice of giving LCPUFA supplementation to breastfeeding mothers in order to improve neurodevelopment or visual acuity.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review of trials showed that supplementing a mother’s diet with LCPUFA during the pregnancy and the first four months after birth did not improve the child’s growth or neurodevelopment in terms of problem-solving ability or intelligence, psychomotor, motor, or language development. In child attention at five years of age, weak evidence was found (one study) favouring the supplementation. The age of the children at the last neurodevelopment assessment was seven years. The children’s visual acuity was not different at five years of age compared with children of the control group of mothers who received supplements of soybean or corn oils."
}
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query-laysum | 4316 | [
{
"role": "user",
"content": "Abstract: Background\nCholelithiasis refers to the presence of gallstones, which are concretions that form in the biliary tract, usually in the gallbladder. Cholelithiasis is one of the most common surgical problems worldwide and is particularly prevalent in most Western countries.\nBiliary colic is the term used for gallbladder pain experienced by a person with gallstones and without overt infection around the gallbladder. It is the most common manifestation of cholelithiasis, observed in over one-third of people with gallstones over the course of 10 or more years. Non-steroid anti-inflammatory drugs (NSAIDs) have been widely used to relieve biliary colic pain, but their role needs further elucidation. They may decrease the frequency of short-term complications, such as mild form of acute cholecystitis, jaundice, cholangitis, and acute pancreatitis, but they may also increase the occurrence of more severe and possibly life-threatening adverse events such as gastrointestinal bleeding, renal function impairment, cardiovascular events, or milder events such as abdominal pain, drowsiness, headache, dizziness, or cutaneous manifestations.\nObjectives\nTo assess the benefits and harms of NSAIDs in people with biliary colic.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Controlled Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE (Ovid SP), Embase (Ovid SP), Science Citation Index Expanded (Web of Science), and ClinicalTrials.gov until July 2016. We applied no language limitation.\nSelection criteria\nRandomised clinical trials recruiting participants presenting with biliary colic and comparing NSAIDs versus no intervention, placebo, or other drugs.\nData collection and analysis\nTwo review authors (MF and AC) independently identified trials for inclusion. We used risk ratios (RR) to express intervention effect estimates, and we analysed the data with both fixed-effect and random-effects model meta-analyses, depending on the amount of heterogeneity. We controlled random errors with Trial Sequential Analysis. We assessed the methodological quality of the evidence using GRADE criteria.\nMain results\nTwelve randomised clinical trials (RCTs) met our predefined review protocol criteria for analysis. We found only one trial to be at low risk of bias, considering the remaining trials to be at high risk of bias. The risk of selection bias in nine studies was unclear due to poor reporting, leading to uncertainty in the pooled effect estimates. Five trials compared NSAIDs versus placebo, four trials compared NSAID versus opioids, and four trials compared NSAID versus spasmolytic drugs (one of the 12 trials was a three-arm study comparing NSAIDs versus both opioids and spasmolytic drugs). There were 828 randomised participants (minimum 30 and maximum 324 per trial), of whom 416 received NSAIDs and 412 received placebo, spasmolytic drugs, or opioids. Twenty-four per cent of the participants were males. The age of the participants in the trials ranged from 18 to 86 years. All people were admitted to emergency departments for acute biliary pain. There was no mortality. When compared with placebo, NSAIDs obtained a significantly lower proportion of participants without complete pain relief (RR 0.27, 95% confidence interval (CI) 0.19 to 0.40; I2 = 0%; 5 trials; moderate-quality evidence), which was confirmed by Trial Sequential Analysis, but not regarding participants with complications (RR 0.66, 95% CI 0.38 to 1.15; I2 = 26%; 3 trials; very low-quality evidence). NSAIDs showed more pain control than spasmolytic drugs (RR 0.51, 95% CI 0.37 to 0.71; I2 = 0%; 4 trials; low-quality evidence), which was not confirmed by Trial Sequential Analysis, and a significantly lower proportion of participants with complications (RR 0.27, 95% CI 0.12 to 0.57; I2 = 0%; 2 trials; low-quality evidence), which was also not confirmed by Trial Sequential Analysis. We found no difference in the proportions of participants without complete pain relief when comparing NSAIDs versus opioids (RR 0.98, 95% CI 0.47 to 2.07; I2 = 52%), suggesting moderate heterogeneity among trials (4 trials; very low-quality evidence). Only one trial comparing NSAIDs versus opioids reported results on complications, finding no significant difference between treatments. None of the included trials reported severe adverse events. Seven out of the 12 trials assessed non-severe adverse events: in two out of the seven trials, adverse events were not observed, and minor events were reported in the remaining five trials.\nIn addition, we found one ongoing RCT assessing the analgesic efficacy of intravenous ibuprofen in biliary colic.\nAuthors' conclusions\nNSAIDs have been assessed in relatively few trials including a limited number of participants for biliary colic, considering its common occurrence. We found only one trial to be at low risk of bias. There was no mortality. None of the included trials reported quality of life. The generalisability of the review is low as most of the RCTs included neither elderly people nor participants with comorbidities, who are more prone to complications as compared to others with biliary colic.\nThe beneficial effect of NSAIDs compared with placebo on pain relief was confirmed when we applied Trial Sequential Analysis.\nThe quality of evidence according to GRADE criteria was moderate for the comparison of NSAIDs versus placebo regarding the outcome lack of pain relief and low or very low for the other outcomes and comparisons.\nWe found only one trial at low risk of bias, following the predefined 'Risk of bias' domains. We found the risk of selection bias to be unclear in nine studies due to poor reporting, leading to uncertainty in the pooled effect estimates.\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": "Non-steroid anti-inflammatory drugs (NSAIDs) such as diclofenac, ketorolac, tenoxicam, flurbiprofen, etc. are commonly used to relieve biliary colic pain."
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query-laysum | 4317 | [
{
"role": "user",
"content": "Abstract: Background\nInfantile nystagmus syndrome (INS) is a type of eye movement disorder that can negatively impact vision. Currently, INS cannot be cured, but its effects can potentially be treated pharmacologically, optically, or surgically. This review focuses on the surgical interventions for INS.\nDespite the range of surgical interventions available, and currently applied in practice for the management of INS, there is no clear consensus, and no accepted clinical guidelines regarding the relative efficacy and safety of the various treatment options. A better understanding of these surgical options, along with their associated side effects, will assist clinicians in evidence-based decision-making in relation to the management of INS.\nObjectives\nTo assess the efficacy and safety of surgical interventions for INS.\nSearch methods\nWe searched CENTRAL, MEDLINE Ovid, Embase Ovid, ISRCTN registry, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) to 3 July 2020, with no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) studying the efficacy and safety of surgical options for treating INS.\nData collection and analysis\nOur prespecified outcome measures were the change from baseline in: binocular best-corrected distance visual acuity; head posture; amplitude, frequency, intensity, and foveation period durations of the nystagmus waveform; visual recognition times; quality of life and self-reported outcome measures; incidence of adverse effects with a probable causal link to treatment; and permanent adverse effects after surgery.\nTwo review authors independently screened titles and abstracts and full-text articles, extracted data from eligible RCTs, and judged the risk of bias using the Cochrane tool. We reached consensus on any disagreements by discussion. We summarised the overall certainty of the evidence using the GRADE approach.\nMain results\nWe only identified one eligible RCT (N = 10 participants), undertaken in India. This trial randomised participants to receive either a large retro-equatorial recession of the horizontal rectus muscle of 9 mm on the medial rectus and 12 mm on the lateral rectus, or a simple tenotomy and resuturing of the four horizontal rectus muscles. We did not identify any RCTs comparing a surgical intervention for INS relative to no treatment.\nIn the single eligible RCT, both eyes of each participant received the same intervention. The participants’ age and gender were not reported, nor was information on whether participants were idiopathic or had sensory disorders. The study only included participants with null in primary position and did not explicitly exclude those with congenital periodic alternating nystagmus. The study did not report funding source(s) or author declaration of interests. The evaluation period was six months.\nWe judged this study at low risk for sequence generation and other sources of bias, but at high risk of bias for performance and detection bias. The risk of bias was unclear for selection bias, attrition bias, and reporting bias.\nThere is very uncertain evidence about the effect of the interventions on visual acuity and change in amplitude, frequency, and intensity of the nystagmus waveform. We were unable to calculate relative effects due to lack of data. None of the participants in either intervention group reported adverse effects at six-month follow-up (very low-certainty evidence). There was no quantitative data reported for quality of life, although the study reported an improvement in quality of life after surgery in both intervention groups (very low-certainty evidence).\nChange in head posture, foveation period durations of the nystagmus waveform, visual recognition times, and permanent adverse effects after surgery were not reported in the included study.\nWe judged the certainty of the evidence, for both the primary and secondary efficacy outcomes, to be very low. Due to a lack of comprehensive reporting of adverse events, there was also very low-certainty of the safety profile of the evaluated surgical interventions in this population. As such, we are very uncertain about the relative efficacy and safety of these interventions for the surgical management of INS.\nAuthors' conclusions\nThis systematic review identified minimal high-quality evidence relating to the efficacy and safety of surgical interventions for INS. The limited availability of evidence must be considered by clinicians when treating INS, particularly given these procedures are irreversible and often performed on children. More high-quality RCTs are needed to better understand the efficacy and safety profile of surgical interventions for INS. This will assist clinicians, people with INS, and their parents or caregivers to make evidence-based treatment decisions.\n\nGiven the provided abstract, please respond to the following query: \"How-up-to date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence in this Cochrane Review is current to July 2020."
}
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query-laysum | 4318 | [
{
"role": "user",
"content": "Abstract: Background\nCardiovascular diseases (CVD) are a major cause of disability and the leading cause of death worldwide. To reduce mortality and morbidity, prevention strategies such as following an optimal diet are crucial. In recent years, low-gluten and gluten-free diets have gained strong popularity in the general population. However, study results on the benefits of a gluten-reduced or gluten-free diet are conflicting, and it is unclear whether a gluten-reduced diet has an effect on the primary prevention of CVD.\nObjectives\nTo determine the effects of a gluten-reduced or gluten-free diet for the primary prevention of CVD in the general population.\nSearch methods\nWe systematically searched CENTRAL, MEDLINE, Embase, CINAHL and Web of Science up to June 2021 without language restrictions or restrictions regarding publication status. Additionally, we searched ClinicalTrials.gov for ongoing or unpublished trials and checked reference lists of included studies as well as relevant systematic reviews for additional studies.\nSelection criteria\nWe planned to include randomised controlled trials (RCTs) and non-randomised studies of interventions (NRSIs), such as prospective cohort studies, comparing a low-gluten or gluten-free diet or providing advice to decrease gluten consumption with no intervention, diet as usual, or a reference gluten-intake category. The population of interest comprised adults from the general population, including those at increased risk for CVD (primary prevention). We excluded cluster-RCTs, case-control studies, studies focusing on participants with a previous myocardial infarction and/or stroke, participants who have undergone a revascularisation procedure as well as participants with angina or angiographically-defined coronary heart disease, with a confirmed diagnosis of coeliac disease or with type 1 diabetes.\nData collection and analysis\nTwo review authors independently assessed eligibility of studies in a two-step procedure following Cochrane methods. Risk of bias (RoB) was assessed using the Cochrane risk of bias tool (RoB2) and the 'Risk Of Bias In Non-randomised Studies — of Interventions' (ROBINS-I) tool, and the certainty of evidence was rated using the GRADE approach.\nMain results\nOne RCT and three NRSIs (with an observational design reporting data on four cohorts: Health Professionals Follow-up Study (HPFS), Nurses' Health Study (NHS-I), NHS-II, UK Biobank) met the inclusion criteria. The RCT was conducted in Italy (60 participants, mean age 41 ± 12.1 years), two NRSIs (three cohorts, HPFS, NHS-I, NHS II) were conducted across the USA (269,282 health professionals aged 24 to 75 years) and one NRSI (Biobank cohort) was conducted across the UK (159,265 participants aged 49 to 62 years). Two NRSIs reported that the lowest gluten intake ranged between 0.0 g/day and 3.4 g/day and the highest gluten intake between 6.2 g/day and 38.4 g/day. The NRSI reporting data from the UK Biobank referred to a median gluten intake of 8.5 g/day with an interquartile range from 5.1 g/day to 12.4 g/day without providing low- and high-intake categories.\nCardiovascular mortality\nFrom a total of 269,282 participants, 3364 (1.3%) died due to cardiovascular events during 26 years of follow-up. Low-certainty evidence may show no association between gluten intake and cardiovascular mortality (adjusted hazard ratio (HR) for low- versus high-gluten intake 1.00, 95% confidence interval (CI) 0.95 to 1.06; 2 NRSIs (3 cohorts)).\nAll-cause mortality\nFrom a total of 159,265 participants, 6259 (3.9%) died during 11.1 years of follow-up. Very low-certainty evidence suggested that it is unclear whether gluten intake is associated with all-cause mortality (adjusted HR for low vs high gluten intake 1.00, 95% CI 0.99 to 1.01; 1 NRSI (1 cohort)).\nMyocardial infarction\nFrom a total of 110,017 participants, 4243 (3.9%) participants developed non-fatal myocardial infarction within 26 years. Low-certainty evidence suggested that gluten intake may not be associated with the development of non-fatal myocardial infarction (adjusted HR for low versus high gluten intake 0.99, 95% CI 0.89 to 1.10; 1 NRSI (2 cohorts)). Lowering gluten intake by 5 g/day also showed no association on the primary prevention of non-fatal and fatal myocardial infarction (composite endpoint) in linear dose-response meta-analyses (adjusted HR 1.02, 95% CI 0.98 to 1.06; 1 NRSI (2 cohorts)).\nCoronary risk factors\nType 2 diabetes\nFrom a total of 202,114 participants, 15,947 (8.0%) developed type 2 diabetes after a follow-up between 22 and 28 years. There was low-certainty evidence that a lower compared with a higher gluten intake may be associated with a slightly increased risk to develop type 2 diabetes (adjusted HR 1.14, 95% CI 1.07 to 1.22; 1 NRSI (3 cohorts)). Furthermore, lowering gluten intake by 5 g/day may be associated with a slightly increased risk to develop type 2 diabetes in linear dose-response meta-analyses (adjusted HR 1.12, 95% CI 1.08 to 1.16; 1 NRSI (3 cohorts)).\nBlood pressure, low-density lipoprotein level, body mass index (BMI)\nAfter six months of follow-up, very low-certainty evidence suggested that it is unclear whether gluten intake affects systolic blood pressure (mean difference (MD) -6.9, 95% CI -17.1 to 3.3 mmHg). There was also no difference between the interventions for diastolic blood pressure (MD -0.8, 95% CI -5.9 to 4.3 mmHg), low-density lipoprotein levels (MD -0.1, 95% CI -0.5 to 0.3 mmol/L) and BMI (MD -0.1, 95% CI -3.3 to 3.1 kg/m²).\nNo study reported data on adverse events or on other outcomes. Funding sources did not appear to have distorted the results in any of the studies.\nAuthors' conclusions\nVery low-certainty evidence suggested that it is unclear whether gluten intake is associated with all-cause mortality. Our findings also indicate that low-certainty evidence may show little or no association between gluten intake and cardiovascular mortality and non-fatal myocardial infarction. Low-certainty evidence suggested that a lower compared with a higher gluten intake may be associated with a slightly increased risk to develop type 2 diabetes — a major cardiovascular risk factor. For other cardiovascular risk factors it is unclear whether there is a difference between a gluten-free and normal diet. Given the limited findings from this review predominantly based on observational studies, no recommendations for practice can be made.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence is current to June 2021. We identified one randomised controlled trial (RCT) and three non-randomised studies of interventions (NRSIs) with an observational design. The RCT was conducted in Italy and included 60 healthy adults with a follow-up of six months. The NRSIs included more than 450,000 participants (either health professionals from the USA or adults (volunteers) from the general population from the UK) and reported a maximum follow-up of more than 25 years. In the NRSIs, the lowest median gluten intake was 2.6 g/day and the highest was 9.4 g/day (thereby, 1 g/day of gluten intake is equivalent to half a slice of white bread). The RCT compared a gluten-free with a usual diet."
}
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query-laysum | 4319 | [
{
"role": "user",
"content": "Abstract: Background\nExercise programmes are a relatively inexpensive, low-risk option compared with other, more invasive therapies for treatment of leg pain on walking (intermittent claudication (IC)). This is the fourth update of a review first published in 1998.\nObjectives\nOur goal was to determine whether an exercise programme was effective in alleviating symptoms and increasing walking treadmill distances and walking times in people with intermittent claudication. Secondary objectives were to determine whether exercise was effective in preventing deterioration of underlying disease, reducing cardiovascular events, and improving quality of life.\nSearch methods\nFor this update, the Cochrane Vascular Information Specialist searched the Specialised Register (last searched 15 November 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 10) via the Cochrane Register of Studies Online, along with trials registries.\nSelection criteria\nRandomised controlled trials of an exercise regimen versus control or versus medical therapy for people with IC due to peripheral arterial disease (PAD). We included any exercise programme or regimen used for treatment of IC, such as walking, skipping, and running. Inclusion of trials was not affected by duration, frequency, or intensity of the exercise programme. Outcome measures collected included treadmill walking distance (time to onset of pain or pain-free walking distance and maximum walking time or maximum walking distance), ankle brachial index (ABI), quality of life, morbidity, or amputation; if none of these was reported, we did not include the trial in this review.\nData collection and analysis\nFor this update (2017), RAL and AH selected trials and extracted data independently. We assessed study quality by using the Cochrane 'Risk of bias' tool. We analysed continuous data by determining mean differences (MDs) and 95% confidence intervals (CIs), and dichotomous data by determining risk ratios (RRs) and 95% CIs. We pooled data using a fixed-effect model unless we identified significant heterogeneity, in which case we used a random-effects model. We used the GRADE approach to assess the overall quality of evidence supporting the outcomes assessed in this review.\nMain results\nWe included two new studies in this update and identified additional publications for previously included studies, bringing the total number of studies meeting the inclusion criteria to 32, and involving a total of 1835 participants with stable leg pain. The follow-up period ranged from two weeks to two years. Types of exercise varied from strength training to polestriding and upper or lower limb exercises; supervised sessions were generally held at least twice a week. Most trials used a treadmill walking test for one of the primary outcome measures. The methodological quality of included trials was moderate, mainly owing to absence of relevant information. Most trials were small and included 20 to 49 participants. Twenty-seven trials compared exercise versus usual care or placebo, and the five remaining trials compared exercise versus medication (pentoxifylline, iloprost, antiplatelet agents, and vitamin E) or pneumatic calf compression; we generally excluded people with various medical conditions or other pre-existing limitations to their exercise capacity.\nMeta-analysis from nine studies with 391 participants showed overall improvement in pain-free walking distance in the exercise group compared with the no exercise group (MD 82.11 m, 95% CI 71.73 to 92.48, P < 0.00001, high-quality evidence). Data also showed benefit from exercise in improved maximum walking distance (MD 120.36 m, 95% CI 50.79 to 189.92, P < 0.0007, high-quality evidence), as revealed by pooling data from 10 studies with 500 participants. Improvements were seen for up to two years.\nExercise did not improve the ABI (MD 0.04, 95% CI 0.00 to 0.08, 13 trials, 570 participants, moderate-quality evidence). Limited data were available for the outcomes of mortality and amputation; trials provided no evidence of an effect of exercise, when compared with placebo or usual care, on mortality (RR 0.92, 95% CI 0.39 to 2.17, 5 trials, 540 participants, moderate-quality evidence) or amputation (RR 0.20, 95% CI 0.01 to 4.15, 1 trial, 177 participants, low-quality evidence).\nResearchers measured quality of life using Short Form (SF)-36 at three and six months. At three months, the domains 'physical function', 'vitality', and 'role physical' improved with exercise; however this was a limited finding, as it was reported by only two trials. At six months, meta-analysis showed improvement in 'physical summary score' (MD 2.15, 95% CI 1.26 to 3.04, P = 0.02, 5 trials, 429 participants, moderate-quality evidence) and in 'mental summary score' (MD 3.76, 95% CI 2.70 to 4.82, P < 0.01, 4 trials, 343 participants, moderate-quality evidence) secondary to exercise. Two trials reported the remaining domains of the SF-36. Data showed improvements secondary to exercise in 'physical function' and 'general health'. The other domains - 'role physical', 'bodily pain', 'vitality', 'social', 'role emotional', and 'mental health' - did not show improvement at six months.\nEvidence was generally limited in trials comparing exercise versus antiplatelet therapy, pentoxifylline, iloprost, vitamin E, and pneumatic foot and calf compression owing to small numbers of trials and participants.\nReview authors used GRADE to assess the evidence presented in this review and determined that quality was moderate to high. Although results showed significant heterogeneity between trials, populations and outcomes were comparable overall, with findings relevant to the claudicant population. Results were pooled for large sample sizes - over 300 participants for most outcomes - using reproducible methods.\nAuthors' conclusions\nHigh-quality evidence shows that exercise programmes provided important benefit compared with placebo or usual care in improving both pain-free and maximum walking distance in people with leg pain from IC who were considered to be fit for exercise intervention. Exercise did not improve ABI, and we found no evidence of an effect of exercise on amputation or mortality. Exercise may improve quality of life when compared with placebo or usual care. As time has progressed, the trials undertaken have begun to include exercise versus exercise or other modalities; therefore we can include fewer of the new trials in this update.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The present review shows that exercise programmes appear to improve walking distance for people considered fit for exercise regimens. This benefit appears to be sustained over two years. Evidence presented in this review was of moderate to high quality. Although differences between trials were evident, populations and outcomes were comparable overall, and findings were relevant to people with intermittent claudication. Combined results were derived from large sample sizes - over 300 participants for most outcomes - using reproducible methods."
}
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query-laysum | 4320 | [
{
"role": "user",
"content": "Abstract: Background\nAsthma is a respiratory (airway) condition that affects an estimated 300 million people worldwide and is associated with significant morbidity and mortality. Omalizumab is a monoclonal antibody that binds and inhibits free serum immunoglobulin E (IgE). It is called an 'anti-IgE' drug. IgE is an immune mediator involved in clinical manifestations of asthma. A recent update of National Institute for Health and Care Excellence (NICE) guidance in 2013 recommends omalizumab for use as add-on therapy in adults and children over six years of age with inadequately controlled severe persistent allergic IgE-mediated asthma who require continuous or frequent treatment with oral corticosteroids.\nObjectives\nTo assess the effects of omalizumab versus placebo or conventional therapy for asthma in adults and children.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register of trials for potentially relevant studies. The most recent search was performed in June 2013. We also checked the reference lists of included trials and searched online trial registries and drug company websites.\nSelection criteria\nRandomised controlled trials examining anti-IgE administered in any manner for any duration. Trials with co-interventions were included, as long as they were the same in each arm.\nData collection and analysis\nTwo review authors independently assessed study quality and extracted and entered data. Three modes of administration were identified from the published literature: inhaled, intravenous and subcutaneous injection. The main focus of the updated review is subcutaneous administration, as this route is currently used in clinical practice. Subgroup analysis was performed by asthma severity. Data were extracted from published and unpublished sources.\nMain results\nIn all, 25 trials were included in the review, including 11 new studies since the last update, for a total of 19 that considered the efficacy of subcutaneous anti-IgE treatment as an adjunct to treatment with corticosteroids.\nFor participants with moderate or severe asthma who were receiving background inhaled corticosteroid steroid (ICS) therapy, a significant advantage favoured subcutaneous omalizumab with regard to experiencing an asthma exacerbation (odds ratio (OR) 0.55, 95% confidence interval (CI) 0.42 to 0.60; ten studies, 3261 participants). This represents an absolute reduction from 26% for participants suffering an exacerbation on placebo to 16% on omalizumab, over 16 to 60 weeks. A significant benefit was noted for subcutaneous omalizumab versus placebo with regard to reducing hospitalisations (OR 0.16, 95% CI 0.06 to 0.42; four studies, 1824 participants), representing an absolute reduction in risk from 3% with placebo to 0.5% with omalizumab over 28 to 60 weeks. No separate data on hospitalisations were available for the severe asthma subgroup, and all of these data were reported for participants with the diagnosis of moderate to severe asthma. Participants treated with subcutaneous omalizumab were also significantly more likely to be able to withdraw their ICS completely than those treated with placebo (OR 2.50, 95% CI 2.00 to 3.13), and a small but statistically significant reduction in daily inhaled steroid dose was reported for omalizumab-treated participants compared with those given placebo (weighted mean difference (WMD) -118 mcg beclomethasone dipropionate (BDP) equivalent per day, 95% CI -154 to -84). However, no significant difference between omalizumab and placebo treatment groups was seen in the number of participants who were able to withdraw from oral corticosteroid (OCS) therapy (OR 1.18, 95% CI 0.53 to 2.63).\nParticipants treated with subcutaneous omalizumab as an adjunct to treatment with corticosteroids required a small but significant reduction in rescue beta2-agonist medication compared with placebo (mean difference (MD) -0.39 puffs per day, 95% CI -0.55 to -0.24; nine studies, 3524 participants). This benefit was observed in both the moderate to severe (MD -0.58, 95% CI -0.84 to -0.31) and severe (MD -0.30, 95% CI -0.49 to -0.10) asthma subgroups on a background therapy of inhaled corticosteroids; however, no significant difference between subcutaneous omalizumab and placebo was noted for this outcome in participants with severe asthma who were receiving a background therapy of inhaled plus oral corticosteroids. Significantly fewer serious adverse events were reported in participants assigned to subcutaneous omalizumab than in those receiving placebo (OR 0.72, 95% CI 0.57 to 0.91; 15 studies, 5713 participants), but more injection site reactions were observed (from 5.6% with placebo to 9.1% with omalizumab).\nTo reflect current clinical practice, discussion of the results is limited to subcutaneous use, and trials involving intravenous and inhaled routes have been archived.\nAuthors' conclusions\nOmalizumab was effective in reducing asthma exacerbations and hospitalisations as an adjunctive therapy to inhaled steroids and during steroid tapering phases of clinical trials. Omalizumab was significantly more effective than placebo in increasing the numbers of participants who were able to reduce or withdraw their inhaled steroids. Omalizumab was generally well tolerated, although more injection site reactions were seen with omalizumab. Further assessment in paediatric populations is necessary, as is direct double-dummy comparison with ICS. Although subgroup analyses suggest that participants receiving prednisolone had better asthma control when they received omalizumab, it remains to be tested prospectively whether the addition of omalizumab has a prednisolone-sparing effect. It is also not clear whether there is a threshold level of baseline serum IgE for optimum efficacy of omalizumab. Given the high cost of the drug, identification of biomarkers predictive of response is of major importance for future research.\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": "Asthma is a respiratory condition that affects millions of people worldwide. It is thought that allergy may be an important part of the disease for many people with asthma. Omalizumab is a drug that targets a protein, called IgE, and removes it from free circulation in the body. IgE is centrally involved in allergy. Omalizumab is an expensive drug that is usually given by injection under the skin every two to four weeks. It is licenced for use in asthma sufferers who are not being adequately treated with standard therapy and who require frequent courses or continuous use of oral steroid tablets. We looked for evidence on whether administration of omalizumab is better or worse than giving placebo."
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query-laysum | 4321 | [
{
"role": "user",
"content": "Abstract: Background\nSecond language (L2) learners are a heterogeneous group. Their L2 skills are highly varied due to internal factors (e.g. cognitive development) and external factors (e.g. cultural and linguistic contexts). As a group, their L2 vocabulary skills appear to be lower than their monolingual peers. This pattern tends to persist over time and may have negative consequences for social interaction and inclusion, learning, and academic achievement.\nObjectives\nTo examine the immediate and long-term effects of second language (L2) vocabulary interventions targeting L2 learners up to six years of age on vocabulary and social-emotional well-being.\nTo examine the associations between L2 vocabulary interventions and the general characteristics of L2 learners (e.g. age, L2 exposure, and L1 skills).\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was December 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing the effects of vocabulary interventions for L2 learners up to six years of age with standard care.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our primary outcomes were 1. receptive and 2. expressive L2 vocabulary (both proximal and distal), and 3. mean length of utterance (MLU; which is a measure of potential adverse effects). Our secondary outcomes were 4. L2 narrative skills, 5. L1 receptive vocabulary (both proximal and distal), 6. L1 expressive vocabulary (both proximal and distal), 7. L1 listening comprehension, 8. L2 grammatical knowledge, 9. L2 reading comprehension (long-term), and 10. socio-emotional well-being (measured with Strengths and Difficulties Questionnaire).\nMain results\nWe found 12 studies involving 1943 participants. Two studies were conducted in Norway, seven in the USA, and single studies conducted in Canada, China, and the Netherlands.\nTen studies were conducted in preschool settings, with a preschool teacher being the most common delivery agent for the intervention. The interventions were mainly organised as small-group sessions, with three or four children per group. The mean dosage per week was 80 minutes and ranged from 24 to 120 minutes.\nThe studies commonly applied shared book reading (reading aloud with the children), with target words embedded in the books.\nStandard care differed based on the setting and local conditions in each country or (pre)school. In some studies, the comparison groups received vocabulary instruction in preschool groups.\nCompared to standard care, the effect of L2 vocabulary interventions varied across outcome measures. For vocabulary measures including words that were taught in the intervention (proximal outcome measures), the intervention effects were large for both receptive L2 vocabulary (i.e. understanding of words; standardised mean difference (SMD) 0.97, 95% confidence interval (CI) 0.64 to 1.30; 4 studies, 1973 participants; very low-certainty evidence) and expressive L2 vocabulary (i.e. expressing or producing words; SMD 0.86, 95% CI 0.56 to 1.17; 6 studies, 1121 participants; very low-certainty evidence). However, due to some concerns in the overall risk of bias assessment, substantial heterogeneity, and wide CIs, we have limited confidence in these results.\nFor language measures that did not include taught vocabulary (distal outcome measures), the intervention effects were small for receptive vocabulary (SMD 0.29, 95% CI 0.02 to 0.55; 6 studies, 1074 participants; low-certainty evidence) and probably made little to no difference to expressive vocabulary (SMD 0.10, 95% CI −0.02 to 0.23; 7 studies, 960 participants; moderate-certainty evidence). There was little to no intervention effect on L2 listening comprehension (SMD 0.19, 95% CI −0.31 to 0.68; 2 studies, 294 participants; very low-certainty evidence), but the evidence was uncertain, and the interventions probably increased L2 narrative skills slightly (SMD 0.37, 95% CI 0.14 to 0.59; 2 studies, 487 participants; moderate-certainty evidence). Only one study reported data on MLU, and we were unable to examine the effect of intervention on this outcome. The level of certainty of the evidence was downgraded mainly due to inconsistency and imprecision.\nWe were unable to draw conclusions about socio-emotional well-being, or conduct the planned subgroup analyses to examine the second objective, due to lack of data.\nAuthors' conclusions\nFindings from this review suggest that, compared to standard care, vocabulary interventions may benefit children's L2 vocabulary learning but have little to no effect on their listening comprehension, though the evidence is uncertain. Vocabulary interventions probably improve the children's storytelling skills slightly.\nDue to the limited number of studies that met our inclusion criteria and the very low- to moderate-certainty evidence as a result of inconsistency and imprecision, implications for practice should be considered with caution.\nThis review highlights the need for more high-quality trials (e.g. RCTs) of vocabulary interventions for L2 learners, particularly studies of learners outside the USA.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "– Studies included in this review suggest that vocabulary interventions for L2 learners may benefit children's L2 vocabulary learning but have little to no effect on their listening comprehension skills, though the evidence is very uncertain. Vocabulary interventions probably improve their storytelling skills.\n– There is a need for more high-quality research that follows L2 learners over a longer time to investigate longer-term effects. This should include learners outside the USA."
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query-laysum | 4322 | [
{
"role": "user",
"content": "Abstract: Background\nSurgical resection for early-stage non-small cell lung cancer (NSCLC) offers the best chance of cure, but it is associated with a risk of postoperative pulmonary complications. It is unclear if preoperative exercise training, and the potential resultant improvement in exercise capacity, may improve postoperative outcomes. This review updates our initial 2017 systematic review.\nObjectives\n1. To evaluate the benefits and harm of preoperative exercise training on postoperative outcomes, such as the risk of developing a postoperative pulmonary complication and the postoperative duration of intercostal catheter, in adults scheduled to undergo lung resection for NSCLC.\n2. To determine the effect on length of hospital stay (and costs associated with postoperative hospital stay), fatigue, dyspnoea, exercise capacity, lung function and postoperative mortality.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was from 28 November 2016 to 23 November 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which study participants who were scheduled to undergo lung resection for NSCLC were allocated to receive either preoperative exercise training or no exercise training.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. risk of developing a postoperative pulmonary complication; 2. postoperative duration of intercostal catheter and 3. safety. Our secondary outcomes were 1. postoperative length of hospital stay; 2. postintervention fatigue; 3. postintervention dyspnoea; 4. postintervention and postoperative exercise capacity; 5. postintervention lung function and 6. postoperative mortality. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nAlong with the five RCTs included in the original version, we identified an additional five RCTs, resulting in 10 RCTs involving 636 participants. Preoperative exercise training results in a large reduction in the risk of developing a postoperative pulmonary complication compared to no preoperative exercise training (risk ratio (RR) 0.45, 95% CI 0.33 to 0.61; I2 = 0%; 9 studies, 573 participants; high-certainty evidence). The evidence is very uncertain about its effect on postoperative intercostal catheter duration (MD −2.07 days, 95% CI −4.64 to 0.49; I2 = 77%, 3 studies, 111 participants; very low-certainty evidence). Preoperative exercise training is likely safe as studies reported no adverse events. Preoperative exercise training likely results in a reduction in postoperative length of hospital stay (MD −2.24 days, 95% CI −3.64 to −0.85; I2 = 85%; 9 studies, 573 participants; moderate-certainty evidence). Preoperative exercise training likely increases postintervention exercise capacity measured by peak oxygen consumption (MD 3.36 mL/kg/minute, 95% CI 2.70 to 4.02; I2 = 0%; 2 studies, 191 participants; moderate-certainty evidence); but the evidence is very uncertain about its effect on postintervention exercise capacity measured by the 6-minute walk distance (MD 29.55 m, 95% CI 12.05 to 47.04; I2 = 90%; 6 studies, 474 participants; very low-certainty evidence). Preoperative exercise training may result in little to no effect on postintervention lung function (forced expiratory volume in one second: MD 5.87% predicted, 95% CI 4.46 to 7.28; I2 = 0%; 4 studies, 197 participants; low-certainty evidence).\nAuthors' conclusions\nPreoperative exercise training results in a large reduction in the risk of developing a postoperative pulmonary complication compared to no preoperative exercise training for people with NSCLC. It may also reduce postoperative length of hospital stay, and improve exercise capacity and lung function in people undergoing lung resection for NSCLC. The findings of this review should be interpreted with caution due to risk of bias. Research investigating the cost-effectiveness and long-term outcomes associated with preoperative exercise training in NSCLC is warranted.\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": "Lung surgery for non-small cell lung cancer offers people a chance of cure; however, lung surgery is associated with a risk of complications. Exercise training before surgery, through its improvement in fitness, may reduce the risk of lung complications and improve other outcomes, such as number of days people need a chest drain (a plastic tube inserted into the chest to drain off fluid or air that might be collecting after the operation), and length of hospital stay. In the 2017 version of this review, we found that exercise training was associated with a reduced risk of developing lung complications after surgery, shorter time people needed a chest drain, shorter hospital stay, and improved fitness and lung function before surgery. However, the quality of evidence was low."
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query-laysum | 4323 | [
{
"role": "user",
"content": "Abstract: Background\nCrohn’s disease (CD) is a chronic inflammatory disorder that can involve any part of the gastrointestinal tract. 5-Aminosalicylates (5-ASAs) are locally acting, anti-inflammatory compounds that reduce inflammation of the colonic mucosa with release profiles that vary among various commercially available formulations. This updated Cochrane review summarizes current evidence on the use of 5-ASA formulations for maintenance of surgically-induced remission in CD.\nObjectives\nTo assess the efficacy and safety of 5-ASA agents for the maintenance of surgically-induced remission in CD.\nSearch methods\nWe searched MEDLINE, Embase, CENTRAL, the Cochrane IBD Group Specialized Register from inception to 16 July 2018. We also searched references, conference abstracts, and trials registers.\nSelection criteria\nRandomised controlled trials (RCTs) that included participants with CD in remission following surgery and compared 5-ASAs to no treatment, placebo or any other active intervention with duration of at least three months were considered for inclusion.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. The primary outcome was clinical relapse. Secondary outcomes included endoscopic recurrence, radiologic and surgical relapse, adverse events, serious adverse events and withdrawal due to adverse events.\nMain results\nFourteen RCTs (1867 participants) were included in the review. Participants (15 to 70 years) were recruited from gastroenterology hospitals and medical clinics in Europe and North America and followed up between 3 and 72 months. The risk of bias was assessed as 'low' in one study, 'unclear' in seven and as 'high' in six.\nAt 12 months, 36% (20/55) of participants in the 5-ASA group experienced clinical relapse compared to 51% (28/55) in the no treatment control group (RR 0.71, 95% CI 0.46 to 1.10; low certainty evidence). Moderate certainty evidence suggests that 5-ASAs are more effective for preventing clinical relapse than placebo. During a follow-up period of 12 to 72 months, 36% (131/361) of 5-ASA participants relapsed compared to 43% (160/369) of placebo participants (RR 0.83, 95% CI 0.72 to 0.96; I² = 0%; moderate certainty evidence). At 12 months, 17% (17/101) of the 4 g/day mesalamine group relapsed compared to 26% (27/105) of the 2.4 g/day group (RR 0.65, 95% CI 0.38 to 1.13; moderate certainty evidence). There was no evidence of a difference in clinical relapse rates when 5-ASA compounds were compared to purine antimetabolites. At 24 months, 61% (103/170) of mesalamine participants relapsed compared to 67% (119/177) of azathioprine participants (RR 0.90, 95% CI 0.76 to 1.07; I² = 28%; low certainty evidence). During 24 months, 50% (9/18) of 5-ASA participants had clinical relapse compared to 13% (2/16) of adalimumab participants (RR 4.0, 95% CI 1.01 to 15.84; low certainty evidence). The effects of sulphasalazine compared to placebo on clinical relapse rate is uncertain. After 18 to 36 months, 66% (95/143) of participants treated with sulphasalazine relapsed compared to 71% (110/155) in the placebo group (RR 0.88, 95% CI 0.56 to 1.38; I² = 38%; low certainty evidence).\nThe effect of 5-ASA drugs on safety was uncertain. During 24 months follow-up, 4% (2/55) of 5-ASA participants experienced adverse events compared to none (0/55) in the no treatment control group (RR 5.00, 95% CI 0.25 to 101.81; very low certainty evidence). An equal proportion of 5-ASA participants (10%; 23/241) and placebo (9%; 20/225) groups experienced an adverse event during a follow-up of 3 to 72 months (RR 1.07, 95% CI 0.60 to 1.91; I² = 0%; low certainty evidence). Adverse event rates were similar in the 5-ASA and purine analogues groups. However, serious adverse events and withdrawals due to adverse events were more common in participants who received purine analogues than 5-ASA. At 52 weeks to 24 months, 52% (107/207) of 5-ASA participants had an adverse event compared to 47% (102/218) of purine analogue participants (RR 1.11, 95% CI 0.97 to 1.27, I² = 0%; low certainty evidence). Four per cent (6/152) of 5-ASA participants had a serious adverse event compared to 17% (27/159) of purine analogue participants (RR 0.30, 95% CI 0.11 to 0.80; very low certainty evidence). Eight per cent (17/207) of 5-ASA participants withdrew due to an adverse event compared to 19% (42/218) of purine analogue participants (RR 0.48, 95% CI 0.28 to 0.83; low certainty evidence). Adverse event rates were similar in high and low dose mesalamine participants. After 12 months, 2% (2/101) of 4 g/day mesalamine participants had an adverse event compared to 2% (2/105) of 2.4 g/day participants (RR 1.04, 95% CI 0.15 to 7.24; low certainty evidence). The proportion of participants who experienced adverse events over a 24 month follow-up in the mesalamine group was 78% (14/18) compared to 69% (11/16) of adalimumab participants (RR 1.13, 95% CI 0.75 to 1.71; very low certainty evidence). None (0/32) of the sulphasalazine participants had an adverse event at 18 months follow-up compared to 3% (1/34) of the placebo group (RR 0.35, 95% CI 0.01 to 8.38; very low certainty evidence). Commonly reported adverse events in the included studies were diarrhoea, nausea, increased liver function tests, pancreatitis, and abdominal pain.\nAuthors' conclusions\n5-ASA preparations are superior to placebo for the maintenance of surgically-induced clinical remission in patients with CD (moderate certainty). The number needed to treat to prevent one relapse was 13 patients. The evidence for endoscopic remission is uncertain. The sulphasalazine class of 5-ASA agents failed to demonstrate superiority against placebo, 5-ASAs failed to demonstrate superiority compared to no treatment (very low and low certainty). The efficacy of two different doses of the same 5-ASA and the efficacy of 5-ASA compared to purine antimetabolites (azathioprine or 6-mercaptopurine) in maintaining surgically-induced remission of CD remains unclear. However, purine analogues lead to more serious adverse events and discontinuation due to adverse events. There is a low certainty that 5-ASA is inferior for maintaining surgically-induced remission of CD compared to biologics (anti TNF-ɑ). 5-ASA formulations appear to be safe with no difference in the occurrence of adverse events or withdrawal when compared with placebo, no treatment or biologics.\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": "5-ASA drugs are superior to placebo for maintaining surgically-induced remission of Crohn's disease (moderate certainty evidence). Sulphasalazine failed to demonstrate superiority against placebo (very low certainty evidence), and similarly 5-ASAs failed to demonstrate superiority to no treatment (low certainty evidence). The effectiveness of two different doses of the same 5-ASA and the effectiveness of 5-ASA compared to purine antimetabolites (azathioprine or 6-mercaptopurine) for maintaining surgically-induced remission of Crohn's disease remains unclear. However, purine analogues lead to more serious side effects and discontinuation due to side effects than 5-ASA. There is a low certainty that 5-ASA is inferior to adalimumab for maintaining surgically-induced remission of CD. There was no evidence of a difference in the occurrence of side effects or withdrawal due to side effects with 5-ASA formulations when compared with placebo, no treatment or biologics."
}
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query-laysum | 4324 | [
{
"role": "user",
"content": "Abstract: Background\nAcceptable, effective and feasible support strategies (interventions) for parents experiencing complex post-traumatic stress disorder (CPTSD) symptoms or with a history of childhood maltreatment may offer an opportunity to support parental recovery, reduce the risk of intergenerational transmission of trauma and improve life-course trajectories for children and future generations. However, evidence relating to the effect of interventions has not been synthesised to provide a comprehensive review of available support strategies. This evidence synthesis is critical to inform further research, practice and policy approaches in this emerging area.\nObjectives\nTo assess the effects of interventions provided to support parents who were experiencing CPTSD symptoms or who had experienced childhood maltreatment (or both), on parenting capacity and parental psychological or socio-emotional wellbeing.\nSearch methods\nIn October 2021 we searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers, together with checking references and contacting experts to identify additional studies.\nSelection criteria\nAll variants of randomised controlled trials (RCTs) comparing any intervention delivered in the perinatal period designed to support parents experiencing CPTSD symptoms or with a history of childhood maltreatment (or both), to any active or inactive control. Primary outcomes were parental psychological or socio-emotional wellbeing and parenting capacity between pregnancy and up to two years postpartum.\nData collection and analysis\nTwo review authors independently assessed the eligibility of trials for inclusion, extracted data using a pre-designed data extraction form, and assessed risk of bias and certainty of evidence. We contacted study authors for additional information as required. We analysed continuous data using mean difference (MD) for outcomes using a single measure, and standardised mean difference (SMD) for outcomes using multiple measures, and risk ratios (RR) for dichotomous data. All data are presented with 95% confidence intervals (CIs). We undertook meta-analyses using random-effects models.\nMain results\nWe included evidence from 1925 participants in 15 RCTs that investigated the effect of 17 interventions. All included studies were published after 2005. Interventions included seven parenting interventions, eight psychological interventions and two service system approaches. The studies were funded by major research councils, government departments and philanthropic/charitable organisations. All evidence was of low or very low certainty.\nParenting interventions\nEvidence was very uncertain from a study (33 participants) assessing the effects of a parenting intervention compared to attention control on trauma-related symptoms, and psychological wellbeing symptoms (postpartum depression), in mothers who had experienced childhood maltreatment and were experiencing current parenting risk factors. Evidence suggested that parenting interventions may improve parent-child relationships slightly compared to usual service provision (SMD 0.45, 95% CI -0.06 to 0.96; I2 = 60%; 2 studies, 153 participants; low-certainty evidence). There may be little or no difference between parenting interventions and usual perinatal service in parenting skills including nurturance, supportive presence and reciprocity (SMD 0.25, 95% CI -0.07 to 0.58; I2 = 0%; 4 studies, 149 participants; low-certainty evidence). No studies assessed the effects of parenting interventions on parents' substance use, relationship quality or self-harm.\nPsychological interventions\nPsychological interventions may result in little or no difference in trauma-related symptoms compared to usual care (SMD -0.05, 95% CI -0.40 to 0.31; I2 = 39%; 4 studies, 247 participants; low-certainty evidence). Psychological interventions may make little or no difference compared to usual care to depression symptom severity (8 studies, 507 participants, low-certainty evidence, SMD -0.34, 95% CI -0.66 to -0.03; I2 = 63%). An interpersonally focused cognitive behavioural analysis system of psychotherapy may slightly increase the number of pregnant women who quit smoking compared to usual smoking cessation therapy and prenatal care (189 participants, low-certainty evidence). A psychological intervention may slightly improve parents' relationship quality compared to usual care (1 study, 67 participants, low-certainty evidence). Benefits for parent-child relationships were very uncertain (26 participants, very low-certainty evidence), while there may be a slight improvement in parenting skills compared to usual care (66 participants, low-certainty evidence). No studies assessed the effects of psychological interventions on parents' self-harm.\nService system approaches\nOne service system approach assessed the effect of a financial empowerment education programme, with and without trauma-informed peer support, compared to usual care for parents with low incomes. The interventions increased depression slightly (52 participants, low-certainty evidence). No studies assessed the effects of service system interventions on parents' trauma-related symptoms, substance use, relationship quality, self-harm, parent-child relationships or parenting skills.\nAuthors' conclusions\nThere is currently a lack of high-quality evidence regarding the effectiveness of interventions to improve parenting capacity or parental psychological or socio-emotional wellbeing in parents experiencing CPTSD symptoms or who have experienced childhood maltreatment (or both). This lack of methodological rigour and high risk of bias made it difficult to interpret the findings of this review. Overall, results suggest that parenting interventions may slightly improve parent-child relationships but have a small, unimportant effect on parenting skills. Psychological interventions may help some women stop smoking in pregnancy, and may have small benefits on parents' relationships and parenting skills. A financial empowerment programme may slightly worsen depression symptoms. While potential beneficial effects were small, the importance of a positive effect in a small number of parents must be considered when making treatment and care decisions. There is a need for further high-quality research into effective strategies for this population.\n\nGiven the provided abstract, please respond to the following query: \"Interventions for parents with complex PTSD (post-traumatic stress disorder) or who experienced childhood maltreatment\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Childhood maltreatment can lead to complex post-traumatic stress disorder (CPTSD) in adulthood and problems with relationships. People who experienced childhood maltreatment are also more likely to experience other life adversities and health inequity. These problems can affect parenting and lead to ‘intergenerational cycles’ of trauma.\nTypes of support for parents who experience childhood maltreatment include psychological therapies, parenting interventions, mind-body and biomedical approaches, pharmacological therapies and service system approaches."
}
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query-laysum | 4325 | [
{
"role": "user",
"content": "Abstract: Background\nXpert MTB/RIF Ultra (Xpert Ultra) and Xpert MTB/RIF are World Health Organization (WHO)-recommended rapid nucleic acid amplification tests (NAATs) widely used for simultaneous detection of Mycobacterium tuberculosis complex and rifampicin resistance in sputum. To extend our previous review on extrapulmonary tuberculosis (Kohli 2018), we performed this update to inform updated WHO policy (WHO Consolidated Guidelines (Module 3) 2020).\nObjectives\nTo estimate diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for extrapulmonary tuberculosis and rifampicin resistance in adults with presumptive extrapulmonary tuberculosis.\nSearch methods\nCochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, Science Citation Index, Web of Science, Latin American Caribbean Health Sciences Literature, Scopus, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform, the International Standard Randomized Controlled Trial Number Registry, and ProQuest, 2 August 2019 and 28 January 2020 (Xpert Ultra studies), without language restriction.\nSelection criteria\nCross-sectional and cohort studies using non-respiratory specimens. Forms of extrapulmonary tuberculosis: tuberculous meningitis and pleural, lymph node, bone or joint, genitourinary, peritoneal, pericardial, disseminated tuberculosis. Reference standards were culture and a study-defined composite reference standard (tuberculosis detection); phenotypic drug susceptibility testing and line probe assays (rifampicin resistance detection).\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias and applicability using QUADAS-2. For tuberculosis detection, we performed separate analyses by specimen type and reference standard using the bivariate model to estimate pooled sensitivity and specificity with 95% credible intervals (CrIs). We applied a latent class meta-analysis model to three forms of extrapulmonary tuberculosis. We assessed certainty of evidence using GRADE.\nMain results\n69 studies: 67 evaluated Xpert MTB/RIF and 11 evaluated Xpert Ultra, of which nine evaluated both tests. Most studies were conducted in China, India, South Africa, and Uganda. Overall, risk of bias was low for patient selection, index test, and flow and timing domains, and low (49%) or unclear (43%) for the reference standard domain. Applicability for the patient selection domain was unclear for most studies because we were unsure of the clinical settings.\nCerebrospinal fluid\nXpert Ultra (6 studies)\nXpert Ultra pooled sensitivity and specificity (95% CrI) against culture were 89.4% (79.1 to 95.6) (89 participants; low-certainty evidence) and 91.2% (83.2 to 95.7) (386 participants; moderate-certainty evidence). Of 1000 people where 100 have tuberculous meningitis, 168 would be Xpert Ultra-positive: of these, 79 (47%) would not have tuberculosis (false-positives) and 832 would be Xpert Ultra-negative: of these, 11 (1%) would have tuberculosis (false-negatives).\nXpert MTB/RIF (30 studies)\nXpert MTB/RIF pooled sensitivity and specificity against culture were 71.1% (62.8 to 79.1) (571 participants; moderate-certainty evidence) and 96.9% (95.4 to 98.0) (2824 participants; high-certainty evidence). Of 1000 people where 100 have tuberculous meningitis, 99 would be Xpert MTB/RIF-positive: of these, 28 (28%) would not have tuberculosis; and 901 would be Xpert MTB/RIF-negative: of these, 29 (3%) would have tuberculosis.\nPleural fluid\nXpert Ultra (4 studies)\nXpert Ultra pooled sensitivity and specificity against culture were 75.0% (58.0 to 86.4) (158 participants; very low-certainty evidence) and 87.0% (63.1 to 97.9) (240 participants; very low-certainty evidence). Of 1000 people where 100 have pleural tuberculosis, 192 would be Xpert Ultra-positive: of these, 117 (61%) would not have tuberculosis; and 808 would be Xpert Ultra-negative: of these, 25 (3%) would have tuberculosis.\nXpert MTB/RIF (25 studies)\nXpert MTB/RIF pooled sensitivity and specificity against culture were 49.5% (39.8 to 59.9) (644 participants; low-certainty evidence) and 98.9% (97.6 to 99.7) (2421 participants; high-certainty evidence). Of 1000 people where 100 have pleural tuberculosis, 60 would be Xpert MTB/RIF-positive: of these, 10 (17%) would not have tuberculosis; and 940 would be Xpert MTB/RIF-negative: of these, 50 (5%) would have tuberculosis.\nLymph node aspirate\nXpert Ultra (1 study)\nXpert Ultra sensitivity and specificity (95% confidence interval) against composite reference standard were 70% (51 to 85) (30 participants; very low-certainty evidence) and 100% (92 to 100) (43 participants; low-certainty evidence). Of 1000 people where 100 have lymph node tuberculosis, 70 would be Xpert Ultra-positive and 0 (0%) would not have tuberculosis; 930 would be Xpert Ultra-negative and 30 (3%) would have tuberculosis.\nXpert MTB/RIF (4 studies)\nXpert MTB/RIF pooled sensitivity and specificity against composite reference standard were 81.6% (61.9 to 93.3) (377 participants; low-certainty evidence) and 96.4% (91.3 to 98.6) (302 participants; low-certainty evidence). Of 1000 people where 100 have lymph node tuberculosis, 118 would be Xpert MTB/RIF-positive and 37 (31%) would not have tuberculosis; 882 would be Xpert MTB/RIF-negative and 19 (2%) would have tuberculosis.\nIn lymph node aspirate, Xpert MTB/RIF pooled specificity against culture was 86.2% (78.0 to 92.3), lower than that against a composite reference standard. Using the latent class model, Xpert MTB/RIF pooled specificity was 99.5% (99.1 to 99.7), similar to that observed with a composite reference standard.\nRifampicin resistance\nXpert Ultra (4 studies)\nXpert Ultra pooled sensitivity and specificity were 100.0% (95.1 to 100.0), (24 participants; low-certainty evidence) and 100.0% (99.0 to 100.0) (105 participants; moderate-certainty evidence). Of 1000 people where 100 have rifampicin resistance, 100 would be Xpert Ultra-positive (resistant): of these, zero (0%) would not have rifampicin resistance; and 900 would be Xpert Ultra-negative (susceptible): of these, zero (0%) would have rifampicin resistance.\nXpert MTB/RIF (19 studies)\nXpert MTB/RIF pooled sensitivity and specificity were 96.5% (91.9 to 98.8) (148 participants; high-certainty evidence) and 99.1% (98.0 to 99.7) (822 participants; high-certainty evidence). Of 1000 people where 100 have rifampicin resistance, 105 would be Xpert MTB/RIF-positive (resistant): of these, 8 (8%) would not have rifampicin resistance; and 895 would be Xpert MTB/RIF-negative (susceptible): of these, 3 (0.3%) would have rifampicin resistance.\nAuthors' conclusions\nXpert Ultra and Xpert MTB/RIF may be helpful in diagnosing extrapulmonary tuberculosis. Sensitivity varies across different extrapulmonary specimens: while for most specimens specificity is high, the tests rarely yield a positive result for people without tuberculosis. For tuberculous meningitis, Xpert Ultra had higher sensitivity and lower specificity than Xpert MTB/RIF against culture. Xpert Ultra and Xpert MTB/RIF had similar sensitivity and specificity for rifampicin resistance. Future research should acknowledge the concern associated with culture as a reference standard in paucibacillary specimens and consider ways to address this limitation.\n\nGiven the provided abstract, please respond to the following query: \"rifampicin resistance\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "-Xpert Ultra (4 studies):\n· 100% sensitivity: 100 people would test positive (all have rifampicin resistance)\n· 100% specificity: 900 people would test negative (none have rifampicin resistance)\n- MTB/RIF test (19 studies):\n· 97% sensitivity: 105 people would test positive, including eight without rifampicin resistance\n· 99% specificity: 895 people would test negative, including three with rifampicin resistance"
}
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query-laysum | 4326 | [
{
"role": "user",
"content": "Abstract: Background\nFolate is a B-vitamin required for DNA synthesis, methylation, and cellular division. Wheat and maize (corn) flour are staple crops consumed widely throughout the world and have been fortified with folic acid in over 80 countries to prevent neural tube defects. Folic acid fortification may be an effective strategy to improve folate status and other health outcomes in the overall population.\nObjectives\nTo evaluate the health benefits and safety of folic acid fortification of wheat and maize flour (i.e. alone or in combination with other micronutrients) on folate status and health outcomes in the overall population, compared to wheat or maize flour without folic acid (or no intervention).\nSearch methods\nWe searched the following databases in March and May 2018: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE In Process, Embase, CINAHL, Web of Science (SSCI, SCI), BIOSIS, Popline, Bibliomap, TRoPHI, ASSIA, IBECS, SCIELO, Global Index Medicus-AFRO and EMRO, LILACS, PAHO, WHOLIS, WPRO, IMSEAR, IndMED, and Native Health Research Database. We searched the International Clinical Trials Registry Platform and ClinicalTrials.gov for ongoing or planned studies in June 2018, and contacted authors for further information.\nSelection criteria\nWe included randomised controlled trials (RCTs), with randomisation at the individual or cluster level. We also included non-RCTs and prospective observational studies with a control group; these studies were not included in meta-analyses, although their characteristics and findings were described. Interventions included wheat or maize flour fortified with folic acid (i.e. alone or in combination with other micronutrients), compared to unfortified flour (or no intervention). Participants were individuals over two years of age (including pregnant and lactating women), from any country.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data, and assessed risk of bias.\nMain results\nWe included 10 studies: four provided data for quantitative analyses (437 participants); five studies were randomised trials (1182 participants); three studies were non-RCTs (1181 participants, 8037 live births); two studies were interrupted time series (ITS) studies (1 study population of 2,242,438, 1 study unreported). Six studies were conducted in upper-middle-income countries (China, Mexico, South Africa), one study was conducted in a lower-middle-income country (Bangladesh), and three studies were conducted in a high-income country (Canada). Seven studies examined wheat flour fortified with folic acid alone or with other micronutrients. Three studies included maize flour fortified with folic acid alone or with other micronutrients. The duration of interventions ranged from two weeks to 36 months, and the ITS studies included postfortification periods of up to seven years. Most studies had unclear risk of bias for randomisation, blinding, and reporting, and low/unclear risk of bias for attrition and contamination.\nNeural tube defects: none of the included RCTs reported neural tube defects as an outcome. In one non-RCT, wheat flour fortified with folic acid and other micronutrients was associated with significantly lower occurrence of total neural tube defects, spina bifida, and encephalocoele, but not anencephaly, compared to unfortified flour (total neural tube defects risk ratio (RR) 0.32, 95% confidence interval (CI) 0.21 to 0.48; 1 study, 8037 births; low-certainty evidence).\nFolate status: pregnant women who received folic acid-fortified maize porridge had significantly higher erythrocyte folate concentrations (mean difference (MD) 238.90 nmol/L, 95% CI 149.40 to 328.40); 1 study, 38 participants; very low-certainty evidence) and higher plasma folate (MD 14.98 nmol/L, 95% CI 9.63 to 20.33; 1 study, 38 participants; very low-certainty evidence), compared to no intervention. Women of reproductive age consuming maize flour fortified with folic acid and other micronutrients did not have higher erythrocyte folate (MD -61.80 nmol/L, 95% CI -152.98 to 29.38; 1 study, 35 participants; very low-certainty evidence) or plasma folate (MD 0.00 nmol/L, 95% CI -0.00 to 0.00; 1 study, 35 participants; very low-certainty evidence) concentrations, compared to women consuming unfortified maize flour. Adults consuming folic acid-fortified wheat flour bread rolls had higher erythrocyte folate (MD 0.66 nmol/L, 95% CI 0.13 to 1.19; 1 study, 30 participants; very low-certainty evidence) and plasma folate (MD 27.00 nmol/L, 95% CI 15.63 to 38.37; 1 study, 30 participants; very low-certainty evidence), versus unfortified flour. In two non-RCTs, serum folate concentrations were significantly higher among women who consumed flour fortified with folic acid and other micronutrients compared to women who consumed unfortified flour (MD 2.92 nmol/L, 95% CI 1.99 to 3.85; 2 studies, 657 participants; very low-certainty evidence).\nHaemoglobin or anaemia: in a cluster-randomised trial among children, there were no significant effects of fortified wheat flour flatbread on haemoglobin concentrations (MD 0.00 nmol/L, 95% CI -2.08 to 2.08; 1 study, 334 participants; low-certainty evidence) or anaemia (RR 1.07, 95% CI 0.74 to 1.55; 1 study, 334 participants; low-certainty evidence), compared to unfortified wheat flour flatbread.\nAuthors' conclusions\nFortification of wheat flour with folic acid may reduce the risk of neural tube defects; however, this outcome was only reported in one non-RCT. Fortification of wheat or maize flour with folic acid (i.e. alone or with other micronutrients) may increase erythrocyte and serum/plasma folate concentrations. Evidence is limited for the effects of folic acid-fortified wheat or maize flour on haemoglobin levels or anaemia. The effects of folic acid fortification of wheat or maize flour on other primary outcomes assessed in this review is not known. No studies reported on the occurrence of adverse effects. Limitations of this review were the small number of studies and participants, limitations in study design, and low-certainty of evidence due to how included studies were designed and reported.\n\nGiven the provided abstract, please respond to the following query: \"Key results and certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Fortification of wheat flour with folic acid may reduce the likelihood of neural tube defects (i.e. total neural tube defects and two specific types of neural tube defects, spina bifida and encephalocoele (a type of neural tube defect that affects the brain and the membranes that cover it through an opening in the skull). Fortification of wheat or maize flour with folic acid (i.e. alone or with other vitamins and minerals) may increase folate status. There was limited evidence of the effects of folic acid-fortified wheat flour on haemoglobin levels or anaemia. The effects of folic acid fortification of wheat or maize flour on other main outcomes assessed in this review is not known. No studies reported on the occurrence of adverse effects. Limitations of this review were the small number of studies and participants, and the low-certainty of evidence due to how included studies were designed and reported."
}
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query-laysum | 4327 | [
{
"role": "user",
"content": "Abstract: Background\nReceiving a diagnosis of cancer and the subsequent related treatments can have a significant impact on an individual's physical and psychosocial well-being. To ensure that cancer care addresses all aspects of well-being, systematic screening for distress and supportive care needs is recommended. Appropriate screening could help support the integration of psychosocial approaches in daily routines in order to achieve holistic cancer care and ensure that the specific care needs of people with cancer are met and that the organisation of such care is optimised.\nObjectives\nTo examine the effectiveness and safety of screening of psychosocial well-being and care needs of people with cancer. To explore the intervention characteristics that contribute to the effectiveness of these screening interventions.\nSearch methods\nWe searched five electronic databases in January 2018: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, and CINAHL. We also searched five trial registers and screened the contents of relevant journals, citations, and references to find published and unpublished trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) and non-randomised controlled trials (NRCTs) that studied the effect of screening interventions addressing the psychosocial well-being and care needs of people with cancer compared to usual care. These screening interventions could involve self-reporting of people with a patient-reported outcome measures (PROMs) or a semi-structured interview with a screening interventionist, and comprise a solitary screening intervention or screening with guided actions. We excluded studies that evaluated screening integrated as an element in more complex interventions (e.g. therapy, coaching, full care pathways, or care programmes).\nData collection and analysis\nTwo review authors independently extracted the data and assessed methodological quality for each included study using the Cochrane tool for RCTs and the Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tool for NRCTs. Due to the high level of heterogeneity in the included studies, only three were included in meta-analysis. Results of the remaining 23 studies were analysed narratively.\nMain results\nWe included 26 studies (18 RCTs and 8 NRCTs) with sample sizes of 41 to 1012 participants, involving a total of 7654 adults with cancer. Two studies included only men or women; all other studies included both sexes. For most studies people with breast, lung, head and neck, colorectal, prostate cancer, or several of these diagnoses were included; some studies included people with a broader range of cancer diagnosis. Ten studies focused on a solitary screening intervention, while the remaining 16 studies evaluated a screening intervention combined with guided actions. A broad range of intervention instruments was used, and were described by study authors as a screening of health-related quality of life (HRQoL), distress screening, needs assessment, or assessment of biopsychosocial symptoms or overall well-being. In 13 studies, the screening was a self-reported questionnaire, while in the remaining 13 studies an interventionist conducted the screening by interview or paper-pencil assessment. The interventional screenings in the studies were applied 1 to 12 times, without follow-up or from 4 weeks to 18 months after the first interventional screening. We assessed risk of bias as high for eight RCTs, low for five RCTs, and unclear for the five remaining RCTs. There were further concerns about the NRCTs (1 = critical risk study; 6 = serious risk studies; 1 = risk unclear).\nDue to considerable heterogeneity in several intervention and study characteristics, we have reported the results narratively for the majority of the evidence.\nIn the narrative synthesis of all included studies, we found very low-certainty evidence for the effect of screening on HRQoL (20 studies). Of these studies, eight found beneficial effects of screening for several subdomains of HRQoL, and 10 found no effects of screening. One study found adverse effects, and the last study did not report quantitative results. We found very low-certainty evidence for the effect of screening on distress (16 studies). Of these studies, two found beneficial effects of screening, and 14 found no effects of screening. We judged the overall certainty of the evidence for the effect of screening on HRQoL to be very low. We found very low-certainty evidence for the effect of screening on care needs (seven studies). Of these studies, three found beneficial effects of screening for several subdomains of care needs, and two found no effects of screening. One study found adverse effects, and the last study did not report quantitative results. We judged the overall level of evidence for the effect of screening on HRQoL to be very low. None of the studies specifically evaluated or reported adverse effects of screening. However, three studies reported unfavourable effects of screening, including lower QoL, more unmet needs, and lower satisfaction.\nThree studies could be included in a meta-analysis. The meta-analysis revealed no beneficial effect of the screening intervention on people with cancer HRQoL (mean difference (MD) 1.65, 95% confidence interval (CI) −4.83 to 8.12, 2 RCTs, 6 months follow-up); distress (MD 0.0, 95% CI −0.36 to 0.36, 1 RCT, 3 months follow-up); or care needs (MD 2.32, 95% CI −7.49 to 12.14, 2 RCTs, 3 months follow-up). However, these studies all evaluated one specific screening intervention (CONNECT) in people with colorectal cancer.\nIn the studies where some effects could be identified, no recurring relationships were found between intervention characteristics and the effectiveness of screening interventions.\nAuthors' conclusions\nWe found low-certainty evidence that does not support the effectiveness of screening of psychosocial well-being and care needs in people with cancer. Studies were heterogeneous in population, intervention, and outcome assessment.\nThe results of this review suggest a need for more uniformity in outcomes and reporting; for the use of intervention description guidelines; for further improvement of methodological certainty in studies and for combining subjective patient-reported outcomes with objective outcomes.\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": "People with cancer may experience physical, psychological, and social problems due to the disease and its treatment. It is therefore important to take into account all of these aspects during the diagnosis and treatment of people with cancer. Nowadays, screening for psychosocial well-being and care needs is often recommended. This means that patients are systematically queried about their well-being and needs related to several psychosocial aspects (e.g. cognitive functioning, emotions, relationships and communication with loved ones, sexuality, social participation, employment). This is applied with self-report questionnaires, or interviews in which the content of these questionnaires or checklists is used as interview guide. The current review had two objectives: to examine the effects and possible harms of screening of psychosocial well-being and care needs of people with cancer, and to examine which characteristics of screening are more or less effective."
}
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query-laysum | 4328 | [
{
"role": "user",
"content": "Abstract: Background\nNon-invasive positive pressure ventilation (NPPV) has been used to treat respiratory distress due to acute cardiogenic pulmonary oedema (ACPE). We performed a systematic review and meta-analysis update on NPPV for adults presenting with ACPE.\nObjectives\nTo evaluate the safety and effectiveness of NPPV compared to standard medical care (SMC) for adults with ACPE. The primary outcome was hospital mortality. Important secondary outcomes were endotracheal intubation, treatment intolerance, hospital and intensive care unit length of stay, rates of acute myocardial infarction, and adverse event rates.\nSearch methods\nWe searched CENTRAL (CRS Web, 20 September 2018), MEDLINE (Ovid, 1946 to 19 September 2018), Embase (Ovid, 1974 to 19 September 2018), CINAHL Plus (EBSCO, 1937 to 19 September 2018), LILACS, WHO ICTRP, and clinicaltrials.gov. We also reviewed reference lists of included studies. We applied no language restrictions.\nSelection criteria\nWe included blinded or unblinded randomised controlled trials in adults with ACPE. Participants had to be randomised to NPPV (continuous positive airway pressure (CPAP) or bilevel NPPV) plus standard medical care (SMC) compared with SMC alone.\nData collection and analysis\nTwo review authors independently screened and selected articles for inclusion. We extracted data with a standardised data collection form. We evaluated the risks of bias of each study using the Cochrane 'Risk of bias' tool. We assessed evidence quality for each outcome using the GRADE recommendations.\nMain results\nWe included 24 studies (2664 participants) of adult participants (older than 18 years of age) with respiratory distress due to ACPE, not requiring immediate mechanical ventilation. People with ACPE presented either to an Emergency Department or were inpatients. ACPE treatment was provided in an intensive care or Emergency Department setting. There was a median follow-up of 13 days for hospital mortality, one day for endotracheal intubation, and three days for acute myocardial infarction. Compared with SMC, NPPV may reduce hospital mortality (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.51 to 0.82; participants = 2484; studies = 21; I2 = 6%; low quality of evidence) with a number needed to treat for an additional beneficial outcome (NNTB) of 17 (NNTB 12 to 32). NPPV probably reduces endotracheal intubation rates (RR 0.49, 95% CI 0.38 to 0.62; participants = 2449; studies = 20; I2 = 0%; moderate quality of evidence) with a NNTB of 13 (NNTB 11 to 18). There is probably little or no difference in acute myocardial infarction (AMI) incidence with NPPV compared to SMC for ACPE (RR 1.03, 95% CI 0.91 to 1.16; participants = 1313; studies = 5; I2 = 0%; moderate quality of evidence). We are uncertain as to whether NPPV increases hospital length of stay (mean difference (MD) −0.31 days, 95% CI −1.23 to 0.61; participants = 1714; studies = 11; I2 = 55%; very low quality of evidence). Adverse events were generally similar between NPPV and SMC groups, but evidence was of low quality.\nAuthors' conclusions\nOur review provides support for continued clinical application of NPPV for ACPE, to improve outcomes such as hospital mortality and intubation rates. NPPV is a safe intervention with similar adverse event rates to SMC alone. Additional research is needed to determine if specific subgroups of people with ACPE have greater benefit of NPPV compared to SMC. Future research should explore the benefit of NPPV for ACPE patients with hypercapnia.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We sought to address if non-invasive ventilation in adults with acute cardiogenic pulmonary oedema reduces rates of deaths, the need for a breathing tube, and heart attacks."
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query-laysum | 4329 | [
{
"role": "user",
"content": "Abstract: Background\nThe post-COVID-19 condition (PCC) consists of a wide array of symptoms including fatigue and impaired daily living. People seek a wide variety of approaches to help them recover.\nA new belief, arising from a few laboratory studies, is that 'microclots' cause the symptoms of PCC. This belief has been extended outside these studies, suggesting that to recover people need plasmapheresis (an expensive process where blood is filtered outside the body). We appraised the laboratory studies, and it was clear that the term 'microclots' is incorrect to describe the phenomenon being described. The particles are amyloid and include fibrin(ogen); amyloid is not a part of a thrombus which is a mix of fibrin mesh and platelets. Initial acute COVID-19 infection is associated with clotting abnormalities; this review concerns amyloid fibrin(ogen) particles in PCC only.\nWe have reported here our appraisal of laboratory studies investigating the presence of amyloid fibrin(ogen) particles in PCC, and of evidence that plasmapheresis may be an effective therapy to remove amyloid fibrin(ogen) particles for treating PCC.\nObjectives\nLaboratory studies review\nTo summarize and appraise the research reports on amyloid fibrin(ogen) particles related to PCC.\nRandomized controlled trials review\nTo assess the evidence of the safety and efficacy of plasmapheresis to remove amyloid fibrin(ogen) particles in individuals with PCC from randomized controlled trials.\nSearch methods\nLaboratory studies review\nWe searched for all relevant laboratory studies up to 27 October 2022 using a comprehensive search strategy which included the search terms ‘COVID’, ‘amyloid’, ‘fibrin’, ‘fibrinogen’.\nRandomized controlled trials review\nWe searched the following databases on 21 October 2022: Cochrane COVID-19 Study Register; MEDLINE (Ovid); Embase (Ovid); and BIOSIS Previews (Web of Science). We also searched the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov for trials in progress.\nSelection criteria\nLaboratory studies review\nLaboratory studies that investigate the presence of amyloid fibrin(ogen) particles in plasma samples from patients with PCC were eligible. This included studies with or without controls.\nRandomized controlled trials review\nStudies were eligible if they were of randomized controlled design and investigated the effectiveness or safety of plasmapheresis for removing amyloid fibrin(ogen) particles for treating PCC.\nData collection and analysis\nTwo review authors applied study inclusion criteria to identify eligible studies and extracted data.\nLaboratory studies review\nWe assessed the risk of bias of included studies using pre-developed methods for laboratory studies. We planned to perform synthesis without meta-analysis (SWiM) as described in our protocol.\nRandomized controlled trials review\nWe planned that if we identified any eligible studies, we would assess risk of bias and report results with 95% confidence intervals. The primary outcome was recovery, measured using the Post-COVID-19 Functional Status Scale (absence of symptoms related to the illness, ability to do usual daily activities, and a return to a previous state of health and mind).\nMain results\nLaboratory studies review\nWe identified five laboratory studies. Amyloid fibrin(ogen) particles were identified in participants across all studies, including those with PCC, healthy individuals, and those with diabetes. The results of three studies were based on visual images of amyloid fibrin(ogen) particles, which did not quantify the amount or size of the particles identified. Formal risk of bias assessment showed concerns in how the studies were conducted and reported. This means the results were insufficient to support the belief that amyloid fibrin(ogen) particles are associated with PCC, or to determine whether there is a difference in the amount or size of amyloid fibrin(ogen) particles in the plasma of people with PCC compared to healthy controls.\nRandomized controlled trials review\nWe identified no trials meeting our inclusion criteria.\nAuthors' conclusions\nIn the absence of reliable research showing that amyloid fibrin(ogen) particles contribute to the pathophysiology of PCC, there is no rationale for plasmapheresis to remove amyloid fibrin(ogen) particles in PCC. Plasmapheresis for this indication should not be used outside the context of a well-conducted randomized controlled trial.\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": "Laboratory studies review\nWe identified five studies that assessed whether amyloid fibrin(ogen) particles were present in the blood of patients with post-COVID-19 condition. The studies identified these particles in healthy controls, those with type 2 diabetes, and those with PCC, meaning they are not unique to PCC. We also identified problems with how these studies were conducted and how the findings were presented, for example it is unclear whether these particles were found in all participants with PCC, or only some.\nRandomized controlled trials review\nWe found no studies where patients with post-COVID-19 condition had undergone plasmapheresis with the intention of removing amyloid fibrin(ogen) particles. We also did not find any ongoing trials that are investigating this."
}
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query-laysum | 4330 | [
{
"role": "user",
"content": "Abstract: Background\nLong-term physical conditions affect 10% to 12% of children and adolescents worldwide. These individuals are at greater risk of developing psychological problems, particularly anxiety and depression, sometimes directly related to their illness or medical care (e.g. health-related anxiety). There is limited evidence regarding the effectiveness of psychological therapies for treating anxiety and depression in this population. Therapies designed for children and adolescents without medical issues may or may not be appropriate for use with those who have long-term physical conditions.\nObjectives\nThis review was undertaken to assess the effectiveness and acceptability of psychological therapies in comparison with controls (treatment-as-usual, waiting list, attention placebo, psychological placebo, or non-psychological treatment) for treating anxiety and depression in children and adolescents with long-term physical conditions.\nSearch methods\nWe searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 27 September 2018. An earlier search of these databases was conducted via the Cochrane Common Mental Disorders Controlled Trial Register (CCMD-CTR) (all years to May 2016). In addition, we searched the Web of Science (Core Collection) (12 October 2018) and conducted a cited reference search for reports of all included trials. We handsearched relevant conference proceedings, reference lists of included articles, and grey literature.\nSelection criteria\nRandomised controlled trials (RCTs), cluster-randomised trials and cross-over trials of psychological therapies for treating anxiety or depression in children with long-term physical conditions were included.\nData collection and analysis\nAbstracts and complete articles were independently reviewed by two authors. Discrepancies were addressed by a third author. Odds ratio (OR) was used for comparing dichotomous data and standardised mean differences (SMD) for comparing continuous data. Meta-analysis was undertaken when treatments, participants, and the underlying clinical question were similar. Otherwise, narrative analysis of data was undertaken.\nMain results\nTwenty-eight RCTs and one cross-over trial with 1349 participants were included in the review. Most participants were recruited from community settings and hospital clinics in high-income countries. For the primary outcome of treatment efficacy, short-term depression (versus any control), there was low-quality evidence from 16 trials involving 1121 participants suggesting that psychological therapies may be more effective than control therapies (SMD -0.31, 95% CI -0.59 to -0.03; I2 = 79%). For the primary outcome of treatment efficacy, short-term anxiety (versus any control), there was inadequate evidence of moderate-quality from 13 studies involving 578 participants to determine whether psychological therapies were more effective than control conditions (SMD -0.26, CI -0.59 to 0.07, I2 = 72%). Planned sensitivity analyses could not be undertaken for risk of bias due to the small number of trials that rated high for each domain. Additional sensitivity analysis demonstrated that psychological interventions specifically designed to reduce anxiety or depression were more effective than psychological therapies designed to improve other symptoms or general coping. There was some suggestion from subgroup analyses that they type of intervention (Chi² = 14.75, df = 5 (P = 0.01), I² = 66.1%), the severity of depression (Chi² = 23.29, df = 4 (P = 0.0001), I² = 82.8%) and the type of long-term physical condition (Chi² = 10.55, df = 4 (P = 0.03), I² = 62.1%) may have an impact on the overall treatment effect.There was qualitative (reported), but not quantitative evidence confirming the acceptability of selected psychological therapies for anxiety and depression. There was low-quality evidence that psychological therapies were more effective than control conditions in improving quality of life (SMD 1.13, CI 0.44 to 1.82, I2 = 89%) and symptoms of long-term physical conditions (SMD -0.34, CI -0.6 to -0.06, I2 = 70%), but only in the short term. There was inadequate low-quality evidence to determine whether psychological therapies were more effective than control conditions at improving functioning in either the short term or long term. No trials of therapies for addressing health-related anxiety were identified and only two trials reported adverse effects; these were unrelated to psychological therapies. Overall, the evidence was of low to moderate quality, results were heterogeneous, and only one trial had an available protocol.\nAuthors' conclusions\nA limited number of trials of variable quality have been undertaken to assess whether psychological therapies are effective for treating anxiety and depression in children and adolescents with long-term physical conditions. According to the available evidence, therapies specifically designed to treat anxiety or depression (especially those based on principles of cognitive behaviour therapy (CBT)) may be more likely to work in children and adolescents who have mild to moderate levels of symptoms of these disorders, at least in the short term. There is a dearth of therapies specifically designed to treat health-related anxiety in this age group.\n\nGiven the provided abstract, please respond to the following query: \"Why is this review important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "More than one in ten children and adolescents have long-term physical conditions such as asthma, diabetes, and cancer. They are more likely to develop psychological problems like anxiety or depression. Treating these problems early can prevent difficulties with family life, school, and future mental health problems. It is currently unclear whether psychological therapies (talking therapies) designed for children and adolescents without medical issues are appropriate for use with this population."
}
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query-laysum | 4331 | [
{
"role": "user",
"content": "Abstract: Background\nPeripheral arterial disease (PAD) affects between 4% and 12% of people aged 55 to 70 years, and 20% of people over 70 years. A common complaint is intermittent claudication (exercise-induced lower limb pain relieved by rest). These patients have a three- to six-fold increase in cardiovascular mortality. Cilostazol is a drug licensed for the use of improving claudication distance and, if shown to reduce cardiovascular risk, could offer additional clinical benefits. This is an update of the review first published in 2007.\nObjectives\nTo determine the effect of cilostazol on initial and absolute claudication distances, mortality and vascular events in patients with stable intermittent claudication.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries, on 9 November 2020.\nSelection criteria\nWe considered double-blind, randomised controlled trials (RCTs) of cilostazol versus placebo, or versus other drugs used to improve claudication distance in patients with stable intermittent claudication.\nData collection and analysis\nTwo authors independently assessed trials for selection and independently extracted data. Disagreements were resolved by discussion. We assessed the risk of bias with the Cochrane risk of bias tool. Certainty of the evidence was evaluated using GRADE. For dichotomous outcomes, we used odds ratios (ORs) with corresponding 95% confidence intervals (CIs) and for continuous outcomes we used mean differences (MDs) and 95% CIs. We pooled data using a fixed-effect model, or a random-effects model when heterogeneity was identified. Primary outcomes were initial claudication distance (ICD) and quality of life (QoL). Secondary outcomes were absolute claudication distance (ACD), revascularisation, amputation, adverse events and cardiovascular events.\nMain results\nWe included 16 double-blind, RCTs (3972 participants) comparing cilostazol with placebo, of which five studies also compared cilostazol with pentoxifylline. Treatment duration ranged from six to 26 weeks. All participants had intermittent claudication secondary to PAD. Cilostazol dose ranged from 100 mg to 300 mg; pentoxifylline dose ranged from 800 mg to 1200 mg. The certainty of the evidence was downgraded by one level for all studies because publication bias was strongly suspected. Other reasons for downgrading were imprecision, inconsistency and selective reporting.\nCilostazol versus placebo\nParticipants taking cilostazol had a higher ICD compared with those taking placebo (MD 26.49 metres; 95% CI 18.93 to 34.05; 1722 participants; six studies; low-certainty evidence). We reported QoL measures descriptively due to insufficient statistical detail within the studies to combine the results; there was a possible indication in improvement of QoL in the cilostazol treatment groups (low-certainty evidence). Participants taking cilostazol had a higher ACD compared with those taking placebo (39.57 metres; 95% CI 21.80 to 57.33; 2360 participants; eight studies; very-low certainty evidence). The most commonly reported adverse events were headache, diarrhoea, abnormal stools, dizziness, pain and palpitations. Participants taking cilostazol had an increased odds of experiencing headache compared to participants taking placebo (OR 2.83; 95% CI 2.26 to 3.55; 2584 participants; eight studies; moderate-certainty evidence).Very few studies reported on other outcomes so conclusions on revascularisation, amputation, or cardiovascular events could not be made.\nCilostazol versus pentoxifylline\nThere was no difference detected between cilostazol and pentoxifylline for improving walking distance, both in terms of ICD (MD 20.0 metres, 95% CI -2.57 to 42.57; 417 participants; one study; low-certainty evidence); and ACD (MD 13.4 metres, 95% CI -43.50 to 70.36; 866 participants; two studies; very low-certainty evidence). One study reported on QoL; the study authors reported no difference in QoL between the treatment groups (very low-certainty evidence). No study reported on revascularisation, amputation or cardiovascular events. Cilostazol participants had an increased odds of experiencing headache compared with participants taking pentoxifylline at 24 weeks (OR 2.20, 95% CI 1.16 to 4.17; 982 participants; two studies; low-certainty evidence).\nAuthors' conclusions\nCilostazol has been shown to improve walking distance in people with intermittent claudication. However, participants taking cilostazol had higher odds of experiencing headache. There is insufficient evidence about the effectiveness of cilostazol for serious events such as amputation, revascularisation, and cardiovascular events. Despite the importance of QoL to patients, meta-analysis could not be undertaken because of differences in measures used and reporting. Very limited data indicated no difference between cilostazol and pentoxifylline for improving walking distance and data were too limited for any conclusions on other outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics and key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 16 double-blind, randomised controlled trials, with 3972 adults (search up to 9 November 2020). Participants taking cilostazol for three to six months could walk approximately 26 metres further before calf pain and 40 metres further in total compared to participants taking placebo. However, participants taking cilostazol had nearly three times the odds of experiencing headache related to study medication. There is currently not enough information about the effectiveness of cilostazol for serious events such as amputation, revascularisation and cardiovascular events. Despite its importance, only four studies reported quality of life, using different tools and ways of reporting. Very limited data indicated no difference between cilostazol and pentoxifylline for improving walking distance, and there was not enough information comparing cilostazol with pentoxifylline, for any other outcomes."
}
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query-laysum | 4332 | [
{
"role": "user",
"content": "Abstract: Background\nLong-acting reversible contraception (LARC), including intrauterine devices (IUDs) and contraceptive implants, are highly effective, reversible methods of contraception. Providing LARC methods during the postpartum period is important to support contraceptive choice, and to prevent unintended pregnancy and short interpregnancy intervals. Delaying offering contraception to postpartum people until the first comprehensive postpartum visit, traditionally at around six weeks postpartum, may put some postpartum people at risk of unintended pregnancy, either due to loss to follow-up or because of initiation of sexual intercourse prior to receiving contraception. Therefore, immediate provision of highly effective contraception, prior to discharge from hospital, has the potential to improve contraceptive use and prevent unintended pregnancies and short interpregnancy intervals.\nObjectives\nTo compare the initiation rate, utilization rates (at six months and 12 months after delivery), effectiveness, and adverse effects of immediate versus delayed postpartum insertion of implants and IUDs for contraception.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and POPLINE for eligible studies up to December 2020. We examined review articles and contacted investigators. We checked registers of ongoing clinical trials, citation lists of included studies, key textbooks, grey literature, and previous systematic reviews for potentially relevant studies.\nSelection criteria\nWe sought randomized controlled trials (RCTs) that compared immediate postpartum versus delayed insertion of contraceptive implant and IUDs for contraception.\nData collection and analysis\nTwo review authors (JS, SK) independently screened titles and abstracts of the search results, and assessed the full-text articles of potentially relevant studies for inclusion. They extracted data from the included studies, assessed risk of bias, compared results, and resolved disagreements by consulting a third review author (PL, SA or PP). We contacted investigators for additional data, where possible. We computed the Mantel-Haenszel or inverse variance risk ratio (RR) with 95% confidence interval (CI) for binary outcomes and the mean difference (MD) with 95% CI for continuous variables.\nMain results\nIn this updated review, 16 studies met the inclusion criteria; five were studies of contraceptive implants (715 participants) and 11 were studies of IUDs (1894 participants). We identified 12 ongoing studies. We applied GRADE judgements to our results; the overall certainty of the evidence for each outcome ranged from moderate to very low, with the main limitations being risk of bias, inconsistency, and imprecision.\nContraceptive implants\nImmediate insertion probably improves the initiation rate for contraceptive implants compared with delayed insertion (RR 1.48, 95% CI 1.11 to 1.98; 5 studies, 715 participants; I2 = 95%; moderate-certainty evidence).\nWe are uncertain if there was a difference between the two groups for the utilization rate of contraceptive implants at six months after delivery (RR 1.16, 95% CI 0.90 to 1.50; 3 studies, 330 participants; I2 = 89%; very low-certainty evidence) or at 12 months after insertion (RR 0.98, 95% CI 0.93 to 1.04; 2 studies, 164 participants; I2 = 0%; very low-certainty evidence).\nPeople who received an immediate postpartum contraceptive implant insertion may have had a higher mean number of days of prolonged vaginal bleeding within six weeks postpartum (mean difference (MD) 2.98 days, 95% CI -2.71 to 8.66; 2 studies, 420 participants; I2 = 91%; low-certainty evidence) and a higher rate of other adverse effects in the first six weeks after birth (RR 2.06, 95% CI 1.38 to 3.06; 1 study, 215 participants; low-certainty evidence) than those who received a delayed postpartum insertion. We are uncertain if there was a difference between the two groups for prolonged bleeding at six months after delivery (RR 1.19, 95% CI 0.29 to 4.94; 2 studies, 252 participants; I2 = 0%; very low-certainty evidence).\nThere may be little or no difference between the two groups for rates of unintended pregnancy at six months (RR 0.20, 95% CI 0.01 to 4.08; one study, 205 participants; low-certainty evidence). We are uncertain whether there was a difference in rates of unintended pregnancy at 12 months postpartum (RR 1.82, 95% CI 0.38 to 8.71; 1 study, 64 participants; very low-certainty evidence). There may be little or no difference between the two groups for any breastfeeding rates at six months (RR 0.97, 95% CI 0.92 to 1.01; 2 studies, 225 participants; I2 = 48%; low-certainty evidence).\nIUDs\nImmediate insertion of IUDs probably improves the initiation rate compared with delayed insertion, regardless of type of IUD (RR 1.27, 95% CI 1.07 to 1.51; 10 studies, 1894 participants; I2 = 98%; moderate-certainty evidence). However, people who received an immediate postpartum IUD insertion may have had a higher expulsion rate at six months after delivery (RR 4.55, 95% CI 2.52 to 8.19; 8 studies, 1206 participants; I2 = 31%; low-certainty evidence) than those who received a delayed postpartum insertion.\nWe are uncertain if there was a difference between the two groups in the utilization of IUDs at six months after insertion (RR 1.02, 95% CI 0.65 to 1.62; 6 studies, 971 participants; I2 = 96%; very low-certainty evidence) or at 12 months after insertion (RR 0.86, 95% CI 0.5 to 1.47; 3 studies, 796 participants; I2 = 92%; very low-certainty evidence).\nImmediate IUDs insertion may reduce unintended pregnancy at 12 months (RR 0.26, 95% CI 0.17 to 0.41; 1 study, 1000 participants; low-certainty evidence). We are uncertain whether there was difference in any breastfeeding rates at six months in people receiving progestin-releasing IUDs (RR 0.90, 95% CI 0.63 to 1.30; 5 studies, 435 participants; I2 = 54%; very low-certainty evidence).\nAuthors' conclusions\nEvidence from this updated review indicates that immediate postpartum insertion improves the initiation rate of both contraceptive implants and IUDs by the first postpartum visit compared to delayed insertion. However, it is not clear whether that there are differences in utilization rates at six and 12 months postpartum. We are uncertain whether there is any difference in the unintended pregnancy rate at 12 months. Provision of progestin-releasing implants and IUDs immediately postpartum may have little or no negative impact on breastfeeding. However, the expulsion rate of IUDs and prolonged vaginal bleeding associated with immediate implants appears to be higher.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up to date to December 2020."
}
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query-laysum | 4333 | [
{
"role": "user",
"content": "Abstract: Background\nPortal hypertension commonly accompanies advanced liver disease and often gives rise to life-threatening complications, including bleeding (haemorrhage) from oesophageal and gastrointestinal varices. Variceal bleeding commonly occurs in children and adolescents with chronic liver disease or portal vein thrombosis. Prevention is, therefore, important. Randomised clinical trials have shown that non-selective beta-blockers and endoscopic variceal band ligation decrease the incidence of variceal bleeding in adults. In children and adolescents, band ligation, beta-blockers, and sclerotherapy have been proposed as primary prophylaxis alternatives for oesophageal variceal bleeding. However, it is unknown whether these interventions are of benefit or harm when used for primary prophylaxis in children and adolescents.\nObjectives\nTo assess the benefits and harms of band ligation compared with sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, PubMed, Embase, and two other databases (April 2020). We scrutinised the reference lists of the retrieved publications, and we also handsearched abstract books of the two main paediatric gastroenterology and hepatology conferences from January 2008 to December 2019. We also searched clinicaltrials.gov, the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO) for ongoing clinical trials. We imposed no language or document type restrictions on our search.\nSelection criteria\nWe aimed to include randomised clinical trials irrespective of blinding, language, or publication status, to assess the benefits and harms of band ligation versus sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis. If the search for randomised clinical trials retrieved quasi-randomised and other observational studies, then we read them through to extract information on harm.\nData collection and analysis\nWe used standard Cochrane methodology to perform this systematic review. We used GRADE to assess the certainty of evidence for each outcome. Our primary outcomes were all-cause mortality, serious adverse events and liver-related morbidity, and quality of life. Our secondary outcomes were oesophageal variceal bleeding and adverse events not considered serious. We used the intention-to-treat principle. We analysed data using Review Manager 5.\nMain results\nOne conference abstract, describing a feasibility multi-centre randomised clinical trial, fulfilled our review inclusion criteria. We judged the trial at overall high risk of bias. This trial was conducted in three hospital centres in the United Kingdom. The aim of the trial was to determine the feasibility and safety of further larger randomised clinical trials of prophylactic band ligation versus no active treatment in children with portal hypertension and large oesophageal varices. Twelve children received prophylactic band ligation and 10 children received no active treatment. There was no information on the age of the children included, or about the diagnosis of any child included. All children were followed up for at least six months. Mortality was 8% (1/12) in the band ligation group versus 0% (0/10) in the no active intervention group (risk ratio (RR) 2.54, 95% confidence interval (CI) 0.11 to 56.25; very low certainty of evidence). The abstract did not report when the death occurred, but we assume it happened between the six-month follow-up and one year. No child (0%) in the band ligation group developed adverse events (RR 0.28, 95% CI 0.01 to 6.25; very low certainty of evidence) but one child out of 10 (10%) in the no active intervention group developed idiopathic thrombocytopaenic purpura. One child out of 12 (8%) in the band ligation group underwent liver transplantation versus none in the no active intervention group (0%) (RR 2.54, 95% CI 0.11 to 56.25; very low certainty of evidence). The trial reported no other serious adverse events or liver-related morbidity. Quality of life was not reported. Oesophageal variceal bleeding occurred in 8% (1/12) of the children in the band ligation group versus 30% (3/10) of the children in the no active intervention group (RR 0.28, 95% CI 0.03 to 2.27; very low certainty of evidence). No adverse events considered non-serious were reported. Two children were lost to follow-up by one-year. Ten children in total completed the trial at two-year follow-up. There was no information on funding.\nWe found two observational studies on endoscopic variceal ligation when searching for randomised trials. One found no harm, and the other reported Enterobactercloacae septicaemia in one child and mild, transient, upper oesophageal sphincter stenosis in another. We did not assess these studies for risk of bias.\nWe did not find any ongoing randomised clinical trials of interest to our review.\nAuthors' conclusions\nThe evidence, obtained from only one feasibility randomised clinical trial at high risk of bias, is very scanty. It is very uncertain about whether prophylactic band ligation versus sham or no (active) intervention may affect mortality, serious adverse events and liver-related morbidity, or oesophageal variceal bleeding in children and adolescents with portal hypertension and large oesophageal varices. We have no data on quality of life. No adverse events considered non-serious were reported. The results presented in the trial need to be interpreted with caution. In addition, the highly limited data cover only part of our research question; namely, children with portal hypertension and large oesophageal varices. Data on children with portal vein thrombosis are lacking.\nLarger randomised clinical trials assessing the benefits and harms of band ligation compared with sham treatment for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis are needed. The trials should include important clinical outcomes such as death, quality of life, failure to control bleeding, and adverse events.\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 insufficient and poor reporting of results from one small, randomised study, and the lack of other randomised studies, mean that we cannot draw trustworthy conclusions. We do not know how well elastic rings work to prevent bleeding from enlarged veins in the oesophagus in children and young people, or about any unwanted effects they might cause.\nUntil good-quality randomised studies take place and measure the numbers of deaths, quality of life, failure to control bleeding, and unwanted effects, we will not know if elastic rings are a good treatment to prevent bleeding in children and young people with long-lasting liver disease or portal vein thrombosis."
}
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query-laysum | 4334 | [
{
"role": "user",
"content": "Abstract: Background\nChildhood and adolescent mental health problems are a serious and growing concern worldwide. Research suggests that psychotherapy can have a significant and positive impact on children and adolescents with mental health problems, such as anxiety disorders, depression and conduct disorders. Client feedback tools serve as a method of monitoring clients' progress and providing feedback from clients to therapists during the therapeutic process. These tools may help to enhance clinicians' decision-making by allowing them to adapt their treatment plans as the therapy progresses, resulting in a reduction of treatment failures. Research has shown that client feedback tools have a positive effect on adults' psychotherapy. This review addresses whether feedback tools in child and adolescent therapy could help therapists to better treat their young clients.\nObjectives\nTo assess the effects of client feedback in psychological therapy on child and adolescent mental health outcomes.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR, Studies and References), the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (1946-), Embase (1974-) and PsycINFO (1967-) to 3 April 2018. We did not apply any restriction on date, language or publication status to the search.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared client feedback to no client feedback in psychological therapies for children and adolescents.\nData collection and analysis\nTwo review authors independently assessed references for inclusion eligibility and extracted outcome, risk of bias and study characteristics data into customised forms. We contacted study authors to obtain missing data. We analysed dichotomous data using risk ratios (RRs) and calculated their 95% confidence intervals (CIs). For continuous data, we calculated mean differences (MDs), or standardised mean differences (SMDs) if different scales were used to measure the same outcome. We used a random-effects model for all analyses.\nMain results\nWe included six published RCTs, conducted in the USA (5 RCTs) and Israel (1 RCT), with 1097 children and adolescents (11 to 18 years old), in the review.\nWe are very uncertain about the effect of client feedback on improvement of symptoms, as reported by youth in the short term because we considered evidence to be of very low-certainty due to high risk of bias and very serious inconsistency in the effect estimates from the different studies. Similarly, we are very uncertain about the effect of client feedback on treatment acceptability, due to high risk of bias, imprecision in the results, and indirectness of measuring the outcome (RR 1.08, 95% CI 0.73 to 1.61; 2 studies, 237 participants; very low-certainty).\nOverall, most studies reported and carried out randomisation and allocation concealment adequately. None of the studies were blinded or attempted to blind participants and personnel and were at high risk of performance bias, and only one study had blind outcome assessors. All of the studies were at high or unclear risk of attrition bias mainly due to poor, non-transparent reporting of participants' flow through the studies.\nAuthors' conclusions\nDue to the paucity of high-quality data and considerable inconsistency in results from different studies, there is currently insufficient evidence to reach any firm conclusions regarding the role of client feedback in psychological therapies for children and adolescents with mental health problems, and further research on this important topic is needed.\nFuture studies should avoid risks of performance, detection and attrition biases, as seen in the studies included in this review. Studies from countries other than the USA are needed, as well as studies including children younger than 10 years.\n\nGiven the provided abstract, please respond to the following query: \"Who will be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Psychotherapists working with children and adolescents, policy makers, children and adolescents with mental health problems, and their caregivers and relatives."
}
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query-laysum | 4335 | [
{
"role": "user",
"content": "Abstract: Background\nTuberculous pericarditis can impair the heart's function and cause death; long term, it can cause the membrane to fibrose and constrict causing heart failure. In addition to antituberculous chemotherapy, treatments include corticosteroids, drainage, and surgery.\nObjectives\nTo assess the effects of treatments for tuberculous pericarditis.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register (27 March 2017); the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library (2017, Issue 2); MEDLINE (1966 to 27 March 2017); Embase (1974 to 27 March 2017); and LILACS (1982 to 27 March 2017). In addition we searched the metaRegister of Controlled Trials (mRCT) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal using 'tuberculosis' and 'pericard*' as search terms on 27 March 2017. We searched ClinicalTrials.gov and contacted researchers in the field of tuberculous pericarditis. This is a new version of the original 2002 review.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-RCTs.\nData collection and analysis\nTwo review authors independently screened search outputs, evaluated study eligibility, assessed risk of bias, and extracted data; and we resolved any discrepancies by discussion and consensus. One trial assessed the effects of both corticosteroid and Mycobacterium indicus pranii treatment in a two-by-two factorial design; we excluded data from the group that received both interventions. We conducted fixed-effect meta-analysis and assessed the certainty of the evidence using the GRADE approach.\nMain results\nSeven trials met the inclusion criteria; all were from sub-Saharan Africa and included 1959 participants, with 1051/1959 (54%) HIV-positive. All trials evaluated corticosteroids and one each evaluated colchicine, M. indicus pranii immunotherapy, and open surgical drainage. Four trials (1841 participants) were at low risk of bias, and three trials (118 participants) were at high risk of bias.\nIn people who are not infected with HIV, corticosteroids may reduce deaths from all causes (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.59 to 1.09; 660 participants, 4 trials, low certainty evidence) and the need for repeat pericardiocentesis (RR 0.85, 95% CI 0.70 to 1.04; 492 participants, 2 trials, low certainty evidence). Corticosteroids probably reduce deaths from pericarditis (RR 0.39, 95% CI 0.19 to 0.80; 660 participants, 4 trials, moderate certainty evidence). However, we do not know whether or not corticosteroids have an effect on constriction or cancer among HIV-negative people (very low certainty evidence).\nIn people living with HIV, only 19.9% (203/1959) were on antiretroviral drugs. Corticosteroids may reduce constriction (RR 0.55, 0.26 to 1.16; 575 participants, 3 trials, low certainty evidence). It is uncertain whether corticosteroids have an effect on all-cause death or cancer (very low certainty evidence); and may have little or no effect on repeat pericardiocentesis (RR 1.02, 0.89 to 1.18; 517 participants, 2 trials, low certainty evidence).\nFor colchicine among people living with HIV, we found one small trial (33 participants) which had insufficient data to make any conclusions about any effects on death or constrictive pericarditis.\nIrrespective of HIV status, due to very low certainty evidence from one trial, it is uncertain whether adding M. indicus pranii immunotherapy to antituberculous drugs has an effect on any outcome.\nOpen surgical drainage for effusion may reduce repeat pericardiocentesis In HIV-negative people (RR 0.23, 95% CI 0.07 to 0.76; 122 participants, 1 trial, low certainty evidence) but may make little or no difference to other outcomes. We did not find an eligible trial that assessed the effects of open surgical drainage in people living with HIV.\nThe review authors found no eligible trials that examined the length of antituberculous treatment needed nor the effects of other adjunctive treatments for tuberculous pericarditis.\nAuthors' conclusions\nFor HIV-negative patients, corticosteroids may reduce death. For HIV-positive patients not on antiretroviral drugs, corticosteroids may reduce constriction. For HIV-positive patients with good antiretroviral drug viral suppression, clinicians may consider the results from HIV-negative patients more relevant.\nFurther research may help evaluate percutaneous drainage of the pericardium under local anaesthesia, the timing of pericardiectomy in tuberculous constrictive pericarditis, and new antibiotic regimens.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Tuberculosis infection of the pericardium surrounding the heart is uncommon but life-threatening."
}
]
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query-laysum | 4336 | [
{
"role": "user",
"content": "Abstract: Background\nThe female perineum becomes suffused and stretched during pregnancy, and further strain during vaginal childbirth contributes to approximately 85% of women experiencing some degree of trauma to the perineal region. Multiple factors play a role in the type and severity of trauma experienced, including parity, delivery method, and local practices. There is ongoing debate about best midwifery practice to reduce perineal trauma. Once perineal trauma has occurred, treatment also varies greatly, depending on its degree and severity, local practice and customs, and personal preference. In order to optimise wound-healing outcomes, it is important that wounds are assessed and managed in an appropriate and timely manner. A perineal wound may cause significant physical and/or psychological impact in the short or long term, however little evidence is available on this subject.\nAntenatal education serves to prepare women and their partners for pregnancy, delivery and the postpartum period. The delivery of this education varies widely in type, content, and nature. This review examined antenatal education which is specifically tailored towards perineal care and wound healing in the postnatal period via formal channels. Appropriate patient education positively impacts on wound-healing rates and compliance with wound care. Risk factors that contribute to the breakdown of wounds and poor healing rates may be addressed antenatally in order to optimise postnatal wound healing. It is important to assess whether or not antenatal wound-care education positively affects perineal healing, in order to empower women to incorporate best practice, evidence-based treatment with this important aspect of self-care in the immediate postnatal period.\nObjectives\nTo evaluate the effects of antenatal education on perineal wound healing in postnatal women who have birthed in a hospital setting, and who have experienced a break in the skin of the perineum as a result of a tear or episiotomy, or both.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2017), ClinicalTrials.gov (8th September 2017), the WHO International Clinical Trials Registry Platform (ICTRP) (8th September 2017) and reference lists of retrieved studies.\nSelection criteria\nWe considered randomised controlled trials (RCTs) which referred to all formal methods of antenatal education and addressed care of a potential perineal wound as a result of a tear or episiotomy, which was experienced by pregnant women who planned to give birth within a hospital setting.\nTrials using a cluster-RCT and a quasi-randomised design would have been eligible for inclusion in this review but none were identified. Cross-over trials were not eligible for inclusion in this review. Studies published in abstract form would have been eligible for inclusion in this review, but none were identified.\nWe planned to consider all formal methods of antenatal education which addressed care of a perineal wound. We also planned to consider all contact points where there was an opportunity for formal education, including midwifery appointments, antenatal education classes, obstetrician appointments, general practitioner appointments and physiotherapist appointments.\nData collection and analysis\nTwo review authors independently assessed titles and abstracts of the studies identified by the search strategy for their eligibility.\nMain results\nNo studies met the inclusion criteria for this review. We excluded one study and one other study is ongoing.\nAuthors' conclusions\nWe set out to evaluate the RCT evidence pertaining to the impact of antenatal education on perineal wound healing in postnatal women who have birthed in a hospital setting, and who experienced a break in the skin of the perineum as a result of a tear or episiotomy, or both. However, no studies met the inclusion criteria. There is a lack of evidence concerning whether or not antenatal education relating to perineal wound healing in this cohort of women will change the outcome for these women in relation to wound healing, infection rate, re-attendance or re-admission to hospital, pain, health-related quality of life, maternal bonding, and negative emotional experiences. Further study is warranted in this area given the significant physical, psychological and economic impact of perineal wounds, and the large proportion of childbearing women who have experienced a postnatal wound. The benefits of any future research in this field would be maximised by incorporating women in a range of socio-economic groups, and with a range of healthcare options. This research could take both a qualitative and a quantitative approach and examine the outcomes identified in this review in order to assess fully the potential benefits of a tailored antenatal package, and to make recommendations for future practice. There is currently no evidence to inform practice in this regard.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We cannot say whether or not antenatal education has an effect on perineal wound healing after childbirth among women who have birthed in a hospital setting. We do not know from randomised controlled trials what the benefits and harms of this education might be. More research is this area is needed to determine the impact of education delivered before childbirth on perineal wound healing in women who have birthed in a hospital setting. Trials may also examine the outcome on related issues including infection rate, re-attendance or re-admission to hospital, pain, health-related quality of life, maternal bonding, and negative emotional experiences relating to a perineal wound. A large proportion of childbearing women experience a perineal wound in childbirth, and these wounds are known to have a significant physical, psychological and economic impact. Future research could examine the potential benefits of a tailor-made education package to be delivered to this cohort of women, as there is currently no evidence to support this."
}
]
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query-laysum | 4337 | [
{
"role": "user",
"content": "Abstract: Background\nMany people with schizophrenia do not reach a satisfactory clinical response with a standard dose of an initially prescribed antipsychotic drug. In such cases, clinicians face the dilemma of increasing the antipsychotic dose in order to enhance antipsychotic efficacy.\nObjectives\nTo examine the efficacy of increasing antipsychotic dose compared to keeping the same dose in the treatment of people with schizophrenia who have not responded (as defined in the individual studies) to an initial antipsychotic drug trial. We also examine the adverse effects associated with such a procedure.\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register (10 June 2014, 6 October 2015, and 30 March 2017). We examined references of all included studies for further trials.\nSelection criteria\nAll relevant randomised controlled trials (RCTs), reporting useable data, comparing increasing the antipsychotic dose rather than maintaining the original dose for people with schizophrenia who do not respond to their initial antipsychotic treatment.\nData collection and analysis\nAt least two review authors independently extracted data . We analysed dichotomous data using relative risks (RR) and the 95% confidence intervals (CI). We analysed continuous data using mean differences (MD) and their 95% CI. We assessed risk of bias for included studies and used GRADE to create a 'Summary of findings' table.\nMain results\nTen relevant RCTs with 675 participants are included in this review. All trials were double blind except one single blind. All studies had a run-in phase to confirm they did not respond to their initial antipsychotic treatment. The trials were published between 1980 and 2016. In most studies the methods of randomisation, allocation and blinding were poorly reported. In addition sample sizes were often small, limiting the overall quality of the evidence. Overall, no clear difference was found between groups in terms of the number of participants who showed clinically relevant response (RR 1.09, 95% CI 0.86 to 1.40, 9 RCTs, N = 533, low-quality evidence), or left the study early due to adverse effects (RR 1.63, 95% CI 0.52 to 5.07, very low quality evidence), or due to any reason (RR 1.30, 95% CI 0.89 to 1.90, 5 RCTs, N = 353, low-quality evidence). Similarly, no clear difference was found in general mental state as measured by PANSS total score change (MD −1.44, 95% CI −6.85 to 3.97, 3 RCTs, N = 258, very low quality evidence). At least one adverse effect was equivocal between groups (RR 0.91, 95% CI 0.55 to 1.50, 2 RCTs, N = 191, very low quality evidence). Data were not reported for time in hospital or quality-of-life outcomes. Finally, subgroup and sensitivity analyses did not show any effect on the primary outcome but these analyses were clearly underpowered.\nAuthors' conclusions\nCurrent data do not show any clear differences between increasing or maintaining the antipsychotic dose for people with schizophrenia who do not respond to their initial antipsychotic treatment. Adverse effect reporting was limited and poor. There is an urgent need for further trials in order to determine the optional treatment strategy in such cases.\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": "Many people with the serious mental illness schizophrenia do not respond fully (i.e. symptoms such as delusions and hallucinations still remain) with a standard dose of an initially prescribed antipsychotic drug. In such cases, clinicians can consider increasing the antipsychotic dose beyond regular thresholds or switching to a different antipsychotic drug in order to enhance antipsychotic efficacy. The evidence surrounding the optimal treatment strategy is scarce."
}
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query-laysum | 4338 | [
{
"role": "user",
"content": "Abstract: Background\nAn estimated 60% of pharmacological randomised trials use placebo control interventions to blind (i.e. mask) participants. However, standard placebos do not control for perceptible non-therapeutic effects (i.e. side effects) of the experimental drug, which may unblind participants. Trials rarely use active placebo controls, which contain pharmacological compounds designed to mimic the non-therapeutic experimental drug effects in order to reduce the risk of unblinding. A relevant improvement in the estimated effects of active placebo compared with standard placebo would imply that trials with standard placebo may overestimate experimental drug effects.\nObjectives\nWe aimed to estimate the difference in drug effects when an experimental drug is compared with an active placebo versus a standard placebo control intervention, and to explore causes for heterogeneity. In the context of a randomised trial, this difference in drug effects can be estimated by directly comparing the effect difference between the active placebo and standard placebo intervention.\nSearch methods\nWe searched PubMed, CENTRAL, Embase, two other databases, and two trial registries up to October 2020. We also searched reference lists and citations and contacted trial authors.\nSelection criteria\nWe included randomised trials that compared an active placebo versus a standard placebo intervention. We considered trials both with and without a matching experimental drug arm.\nData collection and analysis\nWe extracted data, assessed risk of bias, scored active placebos for adequacy and risk of unintended therapeutic effect, and categorised active placebos as unpleasant, neutral, or pleasant. We requested individual participant data from the authors of four cross-over trials published after 1990 and one unpublished trial registered after 1990. Our primary inverse-variance, random-effects meta-analysis used standardised mean differences (SMDs) of active versus standard placebo for participant-reported outcomes at earliest post-treatment assessment. A negative SMD favoured the active placebo. We stratified analyses by trial type (clinical or preclinical) and supplemented with sensitivity and subgroup analyses and meta-regression. In secondary analyses, we investigated observer-reported outcomes, harms, attrition, and co-intervention outcomes.\nMain results\nWe included 21 trials (1462 participants). We obtained individual participant data from four trials. Our primary analysis of participant-reported outcomes at earliest post-treatment assessment resulted in a pooled SMD of −0.08 (95% confidence interval (CI) −0.20 to 0.04; I2 = 31%; 14 trials), with no clear difference between clinical and preclinical trials. Individual participant data contributed 43% of the weight of this analysis. Two of seven sensitivity analyses found more pronounced and statistically significant differences; for example, in the five trials with low overall risk of bias, the pooled SMD was −0.24 (95% CI −0.34 to −0.13). The pooled SMD of observer-reported outcomes was similar to the primary analysis. The pooled odds ratio (OR) for harms was 3.08 (95% CI 1.56 to 6.07), and for attrition, 1.22 (95% CI 0.74 to 2.03). Co-intervention data were limited. Meta-regression found no statistically significant association with adequacy of the active placebo or risk of unintended therapeutic effect.\nAuthors' conclusions\nWe did not find a statistically significant difference between active and standard placebo control interventions in our primary analysis, but the result was imprecise and the CI compatible with a difference ranging from important to irrelevant. Furthermore, the result was not robust, because two sensitivity analyses produced a more pronounced and statistically significant difference. We suggest that trialists and users of information from trials carefully consider the type of placebo control intervention in trials with high risk of unblinding, such as those with pronounced non-therapeutic effects and participant-reported outcomes.\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 treatment effects in randomised trials differ when using active placebos compared to standard placebos."
}
]
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query-laysum | 4339 | [
{
"role": "user",
"content": "Abstract: Background\nThe presence of oesophageal varices is associated with the risk of upper gastrointestinal bleeding. Endoscopic variceal ligation is used to prevent this occurrence but the ligation procedure may be associated with complications.\nObjectives\nTo assess the beneficial and harmful effects of band ligation versus no intervention for primary prevention of upper gastrointestinal bleeding in adults with cirrhosis and oesophageal varices.\nSearch methods\nWe combined searches in the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, and Science Citation Index with manual searches. The last search update was 9 February 2019.\nSelection criteria\nWe included randomised clinical trials comparing band ligation verus no intervention regardless of publication status, blinding, or language in the analyses of benefits and harms, and observational studies in the assessment of harms. Included participants had cirrhosis and oesophageal varices with no previous history of variceal bleeding.\nData collection and analysis\nThree review authors extracted data independently. The primary outcome measures were all-cause mortality, upper gastrointestinal bleeding, and serious adverse events. We undertook meta-analyses and presented results using risk ratios (RRs) with 95% confidence intervals (CIs) and I2 values as a marker of heterogeneity. In addition, we calculated the number needed to treat to benefit (NNTTB) for the primary outcomes . We assessed bias control using the Cochrane Hepato-Biliary domains; determined the certainty of the evidence using GRADE; and conducted sensitivity analyses including Trial Sequential Analysis.\nMain results\nSix randomised clinical trials involving 637 participants fulfilled our inclusion criteria. One of the trials included an additional small number of participants (< 10% of the total) with non-cirrhotic portal hypertension/portal vein block. We classified one trial as at low risk of bias for the outcome, mortality and high risk of bias for the remaining outcomes; the five remaining trials were at high risk of bias for all outcomes. We downgraded the evidence to moderate certainty due to the bias risk. We gathered data on all primary outcomes from all trials. Seventy-one of 320 participants allocated to band ligation compared to 129 of 317 participants allocated to no intervention died (RR 0.55, 95% CI 0.43 to 0.70; I2 = 0%; NNTTB = 6 persons). In addition, band ligation was associated with reduced risks of upper gastrointestinal bleeding (RR 0.44, 95% CI 0.28 to 0.72; 6 trials, 637 participants; I2 = 61%; NNTTB = 5 persons), serious adverse events (RR 0.55, 95% CI 0.43 to 0.70; 6 trials, 637 participants; I2 = 44%; NNTTB = 4 persons), and variceal bleeding (RR 0.43, 95% CI 0.27 to 0.69; 6 trials, 637 participants; I² = 56%; NNTTB = 5 persons). The non-serious adverse events reported in association with band ligation included oesophageal ulceration, dysphagia, odynophagia, retrosternal and throat pain, heartburn, and fever, and in the one trial involving participants with either small or large varices, the incidence of non-serious side effects in the banding group was much higher in those with small varices, namely ulcers: small versus large varices 30.5% versus 8.7%; heartburn 39.2% versus 17.4%. No trials reported on health-related quality of life.\nTwo trials did not receive support from pharmaceutical companies; the remaining four trials did not provide information on this issue.\nAuthors' conclusions\nThis review found moderate-certainty evidence that, in patients with cirrhosis, band ligation of oesophageal varices reduces mortality, upper gastrointestinal bleeding, variceal bleeding, and serious adverse events compared to no intervention. It is unlikely that further trials of band ligation versus no intervention would be considered ethical.\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": "Our analyses showed a beneficial effect of band ligation on the rates of death, bleeding, and serious adverse events compared to no treatment."
}
]
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query-laysum | 4340 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with severe mental illness are twice as likely to develop type 2 diabetes as those without severe mental illness. Treatment guidelines for type 2 diabetes recommend that structured education should be integrated into routine care and should be offered to all. However, for people with severe mental illness, physical health may be a low priority, and motivation to change may be limited. These additional challenges mean that the findings reported in previous systematic reviews of diabetes self management interventions may not be generalised to those with severe mental illness, and that tailored approaches to effective diabetes education may be required for this population.\nObjectives\nTo assess the effects of diabetes self management interventions specifically tailored for people with type 2 diabetes and severe mental illness.\nSearch methods\nWe searched the Cochrane Library, MEDLINE, EMBASE, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the International Clinical Trials Registry Platform (ICTRP) Search Portal, ClinicalTrials.gov and grey literature. The date of the last search of all databases was 07 March 2016.\nSelection criteria\nRandomised controlled trials of diabetes self management interventions for people with type 2 diabetes and severe mental illness.\nData collection and analysis\nTwo review authors independently screened abstracts and full-text articles, extracted data and conducted the risk of bias assessment. We used a taxonomy of behaviour change techniques and the framework for behaviour change theory to describe the theoretical basis of the interventions and active ingredients. We used the GRADE method (Grades of Recommendation, Assessment, Development and Evaluation Working Group) to assess trials for overall quality of evidence.\nMain results\nWe included one randomised controlled trial involving 64 participants with schizophrenia or schizoaffective disorder. The average age of participants was 54 years; participants had been living with type 2 diabetes for on average nine years, and with their psychiatric diagnosis since they were on average 28 years of age. Investigators evaluated the 24-week Diabetes Awareness and Rehabilitation Training (DART) programme in comparison with usual care plus information (UCI). Follow-up after trial completion was six months. Risk of bias was mostly unclear but was high for selective reporting. Trial authors did not report on diabetes-related complications, all-cause mortality, adverse events, health-related quality of life nor socioeconomic effects. Twelve months of data on self care behaviours as measured by total energy expenditure showed a mean of 2148 kcal for DART and 1496 kcal for UCI (52 participants; very low-quality evidence), indicating no substantial improvement. The intervention did not have a substantial effect on glycosylated haemoglobin A1c (HbA1c) at 6 or 12 months of follow-up (12-month HbA1c data 7.9% for DART vs 6.9% for UCI; 52 participants; very low-quality evidence). Researchers noted small improvements in body mass index immediately after the intervention was provided and at six months, along with improved weight post intervention. Diabetes knowledge and self efficacy improved immediately following receipt of the intervention, and knowledge also at six months. The intervention did not improve blood pressure.\nAuthors' conclusions\nEvidence is insufficient to show whether type 2 diabetes self management interventions for people with severe mental illness are effective in improving outcomes. Researchers must conduct additional trials to establish efficacy, and to identify the active ingredients in these interventions and the people most likely to benefit from them.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We rated the overall quality of the evidence as very low, mainly because of the small numbers of included studies and participants, and because reported study results showed inconsistency."
}
]
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query-laysum | 4341 | [
{
"role": "user",
"content": "Abstract: Background\nAnxiety in relation to surgery is a well-known problem. Melatonin offers an alternative treatment to benzodiazepines for ameliorating this condition in the preoperative and postoperative periods.\nObjectives\nTo assess the effects of melatonin on preoperative and postoperative anxiety compared to placebo or benzodiazepines.\nSearch methods\nWe searched the following databases on 10 July 2020: CENTRAL, MEDLINE, Embase, CINAHL, and Web of Science. For ongoing trials and protocols, we searched clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform.\nSelection criteria\nWe included randomized, placebo-controlled or standard treatment-controlled (or both) studies that evaluated the effects of preoperatively administered melatonin on preoperative or postoperative anxiety. We included adult patients of both sexes (15 to 90 years of age) undergoing any kind of surgical procedure for which it was necessary to use general, regional, or topical anaesthesia.\nData collection and analysis\nOne review author conducted data extraction in duplicate. Data extracted included information about study design, country of origin, number of participants and demographic details, type of surgery, type of anaesthesia, intervention and dosing regimens, preoperative anxiety outcome measures, and postoperative anxiety outcome measures.\nMain results\nWe included 27 randomized controlled trials (RCTs), involving 2319 participants, that assessed melatonin for treating preoperative anxiety, postoperative anxiety, or both.\nTwenty-four studies compared melatonin with placebo. Eleven studies compared melatonin to a benzodiazepine (seven studies with midazolam, three studies with alprazolam, and one study with oxazepam). Other comparators in a small number of studies were gabapentin, clonidine, and pregabalin.\nNo studies were judged to be at low risk of bias for all domains. Most studies were judged to be at unclear risk of bias overall. Eight studies were judged to be at high risk of bias in one or more domain, and thus, to be at high risk of bias overall.\nMelatonin versus placebo\nMelatonin probably results in a reduction in preoperative anxiety measured by a visual analogue scale (VAS, 0 to 100 mm) compared to placebo (mean difference (MD) -11.69, 95% confidence interval (CI) -13.80 to -9.59; 18 studies, 1264 participants; moderate-certainty evidence), based on a meta-analysis of 18 studies.\nMelatonin may reduce immediate postoperative anxiety measured on a 0 to 100 mm VAS compared to placebo (MD -5.04, 95% CI -9.52 to -0.55; 7 studies, 524 participants; low-certainty evidence), and may reduce delayed postoperative anxiety measured six hours after surgery using the State-Trait Anxiety Inventory (STAI) (MD -5.31, 95% CI -8.78 to -1.84; 2 studies; 73 participants; low-certainty evidence).\nMelatonin versus benzodiazepines (midazolam and alprazolam)\nMelatonin probably results in little or no difference in preoperative anxiety measured on a 0 to 100 mm VAS (MD 0.78, 95% CI -2.02 to 3.58; 7 studies, 409 participants; moderate-certainty evidence) and there may be little or no difference in immediate postoperative anxiety (MD -2.12, 95% CI -4.61 to 0.36; 3 studies, 176 participants; low-certainty evidence).\nAdverse events\nFourteen studies did not report on adverse events. Six studies specifically reported that no side effects were observed, and the remaining seven studies reported cases of nausea, sleepiness, dizziness, and headache; however, no serious adverse events were reported. Eleven studies measured psychomotor and cognitive function, or both, and in general, these studies found that benzodiazepines impaired psychomotor and cognitive function more than placebo and melatonin. Fourteen studies evaluated sedation and generally found that benzodiazepine caused the highest degree of sedation, but melatonin also showed sedative properties compared to placebo. Several studies did not report on adverse events; therefore, it is not possible to conclude with certainty, from the data on adverse effects collected in this review, that melatonin is better tolerated than benzodiazepines.\nAuthors' conclusions\nWhen compared with placebo, melatonin given as premedication (as tablets or sublingually) probably reduces preoperative anxiety in adults (measured 50 to 120 minutes after administration), which is potentially clinically relevant. The effect of melatonin on postoperative anxiety compared to placebo (measured in the recovery room and six hours after surgery) was also evident but was much smaller, and the clinical relevance of this finding is uncertain. There was little or no difference in anxiety when melatonin was compared with benzodiazepines. Thus, melatonin may have a similar effect to benzodiazepines in reducing preoperative and postoperative anxiety in adults.\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": "Giving melatonin before surgery may effectively reduce anxiety before surgery, but any reduction in anxiety after surgery with melatonin is less clear when compared with placebo."
}
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query-laysum | 4342 | [
{
"role": "user",
"content": "Abstract: Background\nSevere acute pancreatitis is associated with high rates of mortality and life-threatening complications. Continuous veno-venous hemofiltration (CVVH) has been used in some centers to reduce mortality and avoid local or systemic complications; however, its efficacy and safety are uncertain.\nObjectives\nTo assess the benefits and harms of CVVH in patients suffering from severe acute pancreatitis; to compare the effects of different CVVH techniques; and to evaluate the optimal time for delivery of CVVH.\nSearch methods\nWe searched the Cochrane Library (2019, Issue 8), MEDLINE (1946 to 13 September 2019), Embase (1974 to 13 September 2019), and Science Citation Index Expanded (1982 to 13 September 2019).\nSelection criteria\nWe included all randomized controlled trials (RCTs) that compared CVVH versus no CVVH in participants with severe acute pancreatitis. We also included RCTs that compared different types of CVVH and different schedules for CVVH in participants with severe acute pancreatitis.\nData collection and analysis\nTwo review authors independently identified the trials for inclusion, collected the data, and assessed the risk of bias. We performed the meta-analyses using Review Manager 5. We calculated the risk ratio (RR) for dichotomous outcomes, and the mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). We used GRADE to assess the certainty of the evidence for all outcomes.\nMain results\nWe included three RCTs, involving a total of 219 adults with severe acute pancreatitis with various etiologies, including alcoholic abuse, biliary disease, high-fat diet, hyperlipidemia, etc. All of the participants had single or multiple organ failure. All of the RCTs were single-center studies conducted in China. The mean age of participants was 47.4 years. The mean proportion of females was 42.0%. All RCTs were at high risk of bias.\nCVVH versus no CVVH\nWe included two RCTs in which 189 participants with severe acute pancreatitis were randomized to undergo CVVH (97 participants) or no CVVH (92 participants). The evidence is very uncertain about the effect of CVVH on in-hospital mortality (RR 0.62, 95% CI 0.27 to 1.40; 2 studies, 189 participants; very low-certainty evidence) compared with no CVVH. The evidence suggests that CVVH may reduce length of stay in the intensive care unit (ICU) (MD -8.80 days, 95% CI -10.24 to -7.36 days; 1 study, 125 participants; very low-certainty evidence), length of hospital stay (MD -26.40 days, 95% CI -30.17 to -22.63 days; 1 study, 125 participants; very low-certainty evidence), and total hospital cost (MD -2800.00 dollars, 95% CI -3881.74 to -1718.26 dollars; 1 study, 125 participants; very low-certainty evidence) compared with no CVVH but the evidence is very uncertain. Adverse events and quality of life were not reported in the studies.\nOne type ofCVVH versus a different type of CVVH\nWe included one RCT in which 30 participants with severe acute pancreatitis were randomized to undergo high-volume CVVH (15 participants) or standard CVVH (15 participants). High-volume CVVH may result in little to no difference in in-hospital mortality compared with standard CVVH (RR 0.60, 95% CI 0.17 to 2.07; 1 study, 30 participants; low-certainty evidence). The evidence is very uncertain about the effect of high-volume CVVH on adverse events compared with standard CVVH (RR 1.00, 95% CI 0.16 to 6.20; 1 study, 30 participants; very low-certainty evidence). Length of ICU stay, length of hospital stay, total hospital cost, and quality of life were not reported in the study.\nAuthors' conclusions\nThe certainty of the current evidence is very low or low. For both comparisons addressed in this review, data are sparse. The evidence is very uncertain about the effect of CVVH on mortality in patients with severe acute pancreatitis. Very low-certainty evidence suggests CVVH may reduce length of ICU stay, length of hospital stay, and total hospital cost but the evidence is very uncertain. The evidence is also very uncertain whether high-volume CVVH is superior, equivalent or inferior to standard CVVH in patients with severe acute pancreatitis.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to September 2019."
}
]
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query-laysum | 4343 | [
{
"role": "user",
"content": "Abstract: Background\nRupture of the anterior cruciate ligament (ACL) is a common injury, mainly affecting young, physically active individuals. The injury is characterised by joint instability, leading to decreased activity, which can lead to poor knee-related quality of life. It is also associated with increased risk of secondary osteoarthritis of the knee. It is unclear whether stabilising the knee surgically via ACL reconstruction produces a better overall outcome than non-surgical (conservative) treatment.\nObjectives\nTo assess the effects of surgical versus conservative interventions for treating ACL injuries.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (18 January 2016), the Cochrane Central Register of Controlled Trials (2016, Issue 1), MEDLINE (1946 to January Week 1 2016), MEDLINE In-Process & Other Non-Indexed Citations (18 January 2016), EMBASE (1974 to 15 January 2016), trial registers (February 2016) and reference lists.\nSelection criteria\nWe included randomised controlled trials that compared the use of surgical and conservative interventions in participants with an ACL rupture. We included any trial that evaluated surgery for ACL reconstruction using any method of reconstruction, type of reconstruction technique, graft fixation or type of graft.\nData collection and analysis\nThree review authors independently screened all titles and abstracts for potentially eligible studies, for which we then obtained full-text reports. Two authors then independently confirmed eligibility, extracted data and assessed the risk of bias using the Cochrane 'Risk of bias' tool. We used the GRADE approach to assess the overall quality of the evidence.\nMain results\nWe identified one study in which 141 young, active adults with acute ACL injury were randomised to either ACL reconstruction followed by structured rehabilitation (results reported for 62 participants) or conservative treatment comprising structured rehabilitation alone (results reported for 59 participants). Built into the study design was a formal option for subsequent (delayed) ACL reconstruction in the conservative treatment group, if the participant requested surgery and met pre-specified criteria.\nThis study was deemed at low risk of selection and reporting biases, at high risk of performance and detection biases because of the lack of blinding and at unclear risk of attrition bias because of an imbalance in the post-randomisation exclusions. According to GRADE methodology, the overall quality of the evidence was low across different outcomes.\nThis study identified no difference in subjective knee score (measured using the average score on four of the five sub-scales of the KOOS score (range from 0 (extreme symptoms) to 100 (no symptoms)) between ACL reconstruction and conservative treatment at two years (difference in KOOS-4 change from baseline scores: MD -0.20, 95% confidence interval (CI) -6.78 to 6.38; N = 121 participants; low-quality evidence), or at five years (difference in KOOS-4 final scores: MD -2.0, 95% CI -8.27 to 4.27; N = 120 participants; low-quality evidence). The total number of participants incurring one or more complications in each group was not reported; serious events reported in the surgery group were predominantly surgery-related, while those in conservative treatment group were predominantly knee instability. There were also incomplete data for total participants with treatment failure, including subsequent surgery. In the surgical group at two years, there was low-quality evidence of far fewer ACL-related treatment failures, when defined as either graft rupture or subsequent ACL reconstruction. This result is dominated by the uptake by 39% (23/59) of the participants in the conservative treatment group of ACL reconstruction for knee instability at two years and by 51% (30/59) of the participants at five years. There was low-quality evidence of little difference between the two groups in participants who had undergone meniscal surgery at anytime up to five years. There was low-quality evidence of no clinically important between-group differences in SF-36 physical component scores at two years. There was low-quality evidence of a higher return to the same or greater level of sport activity at two years in the ACL reconstruction group, but the wide 95% CI also included the potential for a higher return in the conservative treatment group. Based on an illustrative return to sport activities of 382 per 1000 conservatively treated patients, this amounts to an extra 84 returns per 1000 ACL-reconstruction patients (95% CI 84 fewer to 348 more). There was very low-quality evidence of a higher incidence of radiographically-detected osteoarthritis in the surgery group (19/58 (35%) versus 10/55 (18%)).\nAuthors' conclusions\nFor adults with acute ACL injuries, we found low-quality evidence that there was no difference between surgical management (ACL reconstruction followed by structured rehabilitation) and conservative treatment (structured rehabilitation only) in patient-reported outcomes of knee function at two and five years after injury. However, these findings need to be viewed in the context that many participants with an ACL rupture remained symptomatic following rehabilitation and later opted for ACL reconstruction surgery. Further research, including the two identified ongoing trials, will help to address the limitations in the current evidence, which is from one small trial in a young, active, adult population.\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": "Rupture of the anterior cruciate ligament (ACL) in the knee is a common injury in young, active individuals. It often results in an unstable knee that increases the risk of further knee damage, such as to the knee meniscii. Anterior cruciate ligament injuries in athletic individuals are often treated surgically. Surgery usually entails ACL reconstruction, that involves removing the torn ligament and replacing it with a tendon graft, often taken from another part of the patient's knee. Conservative (non-surgical) interventions are also used as treatment for this injury. This usually takes the form of a progressive rehabilitation programme that includes exercises aimed at improving strength and balance. We aimed to assess the effects of surgical versus conservative interventions for treating ACL injuries."
}
]
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query-laysum | 4344 | [
{
"role": "user",
"content": "Abstract: Background\nChildren who are securely attached to at least one parent are able to be comforted by that parent when they are distressed and explore the world confidently by using that parent as a 'secure base'. Research suggests that a secure attachment enables children to function better across all aspects of their development. Promoting secure attachment, therefore, is a goal of many early interventions. Attachment is mediated through parental sensitivity to signals of distress from the child. One means of improving parental sensitivity is through video feedback, which involves showing a parent brief moments of their interaction with their child, to strengthen their sensitivity and responsiveness to their child's signals.\nObjectives\nTo assess the effects of video feedback on parental sensitivity and attachment security in children aged under five years who are at risk for poor attachment outcomes.\nSearch methods\nIn November 2018 we searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, nine other databases and two trials registers. We also handsearched the reference lists of included studies, relevant systematic reviews, and several relevant websites\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs that assessed the effects of video feedback versus no treatment, inactive alternative intervention, or treatment as usual for parental sensitivity, parental reflective functioning, attachment security and adverse effects in children aged from birth to four years 11 months.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nThis review includes 22 studies from seven countries in Europe and two countries in North America, with a total of 1889 randomised parent-child dyads or family units. Interventions targeted parents of children aged under five years, experiencing a wide range of difficulties (such as deafness or prematurity), or facing challenges that put them at risk of attachment issues (for example, parental depression). Nearly all studies reported some form of external funding, from a charitable organisation (n = 7) or public body, or both (n = 18).\nWe considered most studies as being at low or unclear risk of bias across the majority of domains, with the exception of blinding of participants and personnel, where we assessed all studies as being at high risk of performance bias. For outcomes where self-report measures were used, such as parental stress and anxiety, we rated all studies at high risk of bias for blinding of outcome assessors.\nParental sensitivity. A meta-analysis of 20 studies (1757 parent-child dyads) reported evidence of that video feedback improved parental sensitivity compared with a control or no intervention from postintervention to six months' follow-up (standardised mean difference (SMD) 0.34, 95% confidence interval (CI) 0.20 to 0.49, moderate-certainty evidence). The size of the observed impact compares favourably to other, similar interventions.\nParental reflective functioning. No studies reported this outcome.\nAttachment security. A meta-analysis of two studies (166 parent-child dyads) indicated that video feedback increased the odds of being securely attached, measured using the Strange Situation Procedure, at postintervention (odds ratio 3.04, 95% CI 1.39 to 6.67, very low-certainty evidence). A second meta-analysis of two studies (131 parent-child dyads) that assessed attachment security using a different measure (Attachment Q-sort) found no effect of video feedback compared with the comparator groups (SMD 0.02, 95% CI −0.33 to 0.38, very low-certainty evidence).\nAdverse events. Eight studies (537 parent-child dyads) contributed data at postintervention or short-term follow-up to a meta-analysis of parental stress, and two studies (311 parent-child dyads) contributed short-term follow-up data to a meta-analysis of parental anxiety. There was no difference between intervention and comparator groups for either outcome. For parental stress the SMD between video feedback and control was −0.09 (95% CI −0.26 to 0.09, low-certainty evidence), while for parental anxiety the SMD was −0.28 (95% CI −0.87 to 0.31, very low-certainty evidence).\nChild behaviour. A meta-analysis of two studies (119 parent-child dyads) at long-term follow-up found no evidence of the effectiveness of video feedback on child behaviour (SMD 0.04, 95% CI −0.33 to 0.42, very low-certainty evidence).\nA moderator analysis found no evidence of an effect for the three prespecified variables (intervention type, number of feedback sessions and participating carer) when jointly tested. However, parent gender (both parents versus only mothers or only fathers) potentially has a statistically significant negative moderation effect, though only at α (alpha) = 0.1\nAuthors' conclusions\nThere is moderate-certainty evidence that video feedback may improve sensitivity in parents of children who are at risk for poor attachment outcomes due to a range of difficulties. There is currently only little, very low-certainty evidence regarding the impact of video feedback on attachment security, compared with control: results differed based on the type of measure used, and follow-up was limited in duration. There is no evidence that video feedback has an impact on parental stress or anxiety (low- and very low-certainty evidence, respectively). Further evidence is needed regarding the longer-term impact of video feedback on attachment and more distal outcomes such as children's behaviour (very low-certainty evidence). Further research is needed on the impact of video-feedback on paternal sensitivity and parental reflective functioning, as no study measured these outcomes. This review is limited by the fact that the majority of included parents were mothers.\n\nGiven the provided abstract, please respond to the following query: \"Study certainty\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We rated the overall certainty of the evidence (the extent to which we believe that the results are correct or adequate) as moderate for parental sensitivity, and low or very low for the other outcomes. This means that we are reasonably certain that video feedback improves parental sensitivity in the short term, but we are not very certain of its impact on our other findings."
}
]
|
query-laysum | 4345 | [
{
"role": "user",
"content": "Abstract: Background\nWork disability such as sickness absence is common in people with depression.\nObjectives\nTo evaluate the effectiveness of interventions aimed at reducing work disability in employees with depressive disorders.\nSearch methods\nWe searched CENTRAL (The Cochrane Library), MEDLINE, Embase, CINAHL, and PsycINFO until April 4th 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) and cluster-RCTs of work-directed and clinical interventions for depressed people that included sickness absence days or being off work as an outcome. We also analysed the effects on depression and work functioning.\nData collection and analysis\nTwo review authors independently extracted the data and rated the certainty of the evidence using GRADE. We used standardised mean differences (SMDs) or risk ratios (RR) with 95% confidence intervals (CI) to pool study results in studies we judged to be sufficiently similar.\nMain results\nIn this update, we added 23 new studies. In total, we included 45 studies with 88 study arms, involving 12,109 participants with either a major depressive disorder or a high level of depressive symptoms.\nRisk of bias\nThe most common types of bias risk were detection bias (27 studies) and attrition bias (22 studies), both for the outcome of sickness absence.\nWork-directed interventions\nWork-directed interventionscombined with clinical interventions\nA combination of a work-directed intervention and a clinical intervention probably reduces sickness absence days within the first year of follow-up (SMD -0.25, 95% CI -0.38 to -0.12; 9 studies; moderate-certainty evidence). This translates back to 0.5 fewer (95% CI -0.7 to -0.2) sick leave days in the past two weeks or 25 fewer days during one year (95% CI -37.5 to -11.8). The intervention does not lead to fewer persons being off work beyond one year follow-up (RR 1.08, 95% CI 0.64 to 1.83; 2 studies, high-certainty evidence). The intervention may reduce depressive symptoms (SMD -0.25, 95% CI -0.49 to -0.01; 8 studies, low-certainty evidence) and probably has a small effect on work functioning (SMD -0.19, 95% CI -0.42 to 0.06; 5 studies, moderate-certainty evidence) within the first year of follow-up.\nStand alone work-directed interventions\nA specific work-directed intervention alone may increase the number of sickness absence days compared with work-directed care as usual (SMD 0.39, 95% CI 0.04 to 0.74; 2 studies, low-certainty evidence) but probably does not lead to more people being off work within the first year of follow-up (RR 0.93, 95% CI 0.77 to 1.11; 1 study, moderate-certainty evidence) or beyond (RR 1.00, 95% CI 0.82 to 1.22; 2 studies, moderate-certainty evidence). There is probably no effect on depressive symptoms (SMD -0.10, 95% -0.30 CI to 0.10; 4 studies, moderate-certainty evidence) within the first year of follow-up and there may be no effect on depressive symptoms beyond that time (SMD 0.18, 95% CI -0.13 to 0.49; 1 study, low-certainty evidence). The intervention may also not lead to better work functioning (SMD -0.32, 95% CI -0.90 to 0.26; 1 study, low-certainty evidence) within the first year of follow-up.\nPsychological interventions\nA psychological intervention, either face-to-face, or an E-mental health intervention, with or without professional guidance, may reduce the number of sickness absence days, compared with care as usual (SMD -0.15, 95% CI -0.28 to -0.03; 9 studies, low-certainty evidence). It may also reduce depressive symptoms (SMD -0.30, 95% CI -0.45 to -0.15, 8 studies, low-certainty evidence). We are uncertain whether these psychological interventions improve work ability (SMD -0.15 95% CI -0.46 to 0.57; 1 study; very low-certainty evidence).\nPsychological interventioncombined with antidepressant medication\nTwo studies compared the effect of a psychological intervention combined with antidepressants to antidepressants alone. One study combined psychodynamic therapy with tricyclic antidepressant (TCA) medication and another combined telephone-administered cognitive behavioural therapy (CBT) with a selective serotonin reuptake inhibitor (SSRI). We are uncertain if this intervention reduces the number of sickness absence days (SMD -0.38, 95% CI -0.99 to 0.24; 2 studies, very low-certainty evidence) but found that there may be no effect on depressive symptoms (SMD -0.19, 95% CI -0.50 to 0.12; 2 studies, low-certainty evidence).\nAntidepressant medication only\nThree studies compared the effectiveness of SSRI to selective norepinephrine reuptake inhibitor (SNRI) medication on reducing sickness absence and yielded highly inconsistent results.\nImproved care\nOverall, interventions to improve care did not lead to fewer sickness absence days, compared to care as usual (SMD -0.05, 95% CI -0.16 to 0.06; 7 studies, moderate-certainty evidence). However, in studies with a low risk of bias, the intervention probably leads to fewer sickness absence days in the first year of follow-up (SMD -0.20, 95% CI -0.35 to -0.05; 2 studies; moderate-certainty evidence). Improved care probably leads to fewer depressive symptoms (SMD -0.21, 95% CI -0.35 to -0.07; 7 studies, moderate-certainty evidence) but may possibly lead to a decrease in work-functioning (SMD 0.5, 95% CI 0.34 to 0.66; 1 study; moderate-certainty evidence).\nExercise\nSupervised strength exercise may reduce sickness absence, compared to relaxation (SMD -1.11; 95% CI -1.68 to -0.54; one study, low-certainty evidence). However, aerobic exercise probably is not more effective than relaxation or stretching (SMD -0.06; 95% CI -0.36 to 0.24; 2 studies, moderate-certainty evidence). Both studies found no differences between the two conditions in depressive symptoms.\nAuthors' conclusions\nA combination of a work-directed intervention and a clinical intervention probably reduces the number of sickness absence days, but at the end of one year or longer follow-up, this does not lead to more people in the intervention group being at work. The intervention may also reduce depressive symptoms and probably increases work functioning more than care as usual. Specific work-directed interventions may not be more effective than usual work-directed care alone. Psychological interventions may reduce the number of sickness absence days, compared with care as usual. Interventions to improve clinical care probably lead to lower sickness absence and lower levels of depression, compared with care as usual. There was no evidence of a difference in effect on sickness absence of one antidepressant medication compared to another. Further research is needed to assess which combination of work-directed and clinical interventions works best.\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": "Combining workplace changes with a clinical programme probably helps people with depression to return to work more quickly and to take fewer days off sick. We need more evidence to assess which combination of workplace changes and clinical programmes works best.\nImproved healthcare probably also helps people with depression to take fewer days off sick."
}
]
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