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query-laysum | 3539 | [
{
"role": "user",
"content": "Abstract: Background\nThe success of epidural anaesthesia depends on correct identification of the epidural space. For several decades, the decision of whether to use air or physiological saline during the loss of resistance technique for identification of the epidural space has been governed by the personal experience of the anaesthesiologist. Epidural block remains one of the main regional anaesthesia techniques. It is used for surgical anaesthesia, obstetrical analgesia, postoperative analgesia and treatment of chronic pain and as a complement to general anaesthesia. The sensation felt by the anaesthesiologist from the syringe plunger with loss of resistance is different when air is compared with saline (fluid). Frequently fluid allows a rapid change from resistance to non-resistance and increased movement of the plunger. However, the ideal technique for identification of the epidural space remains unclear.\nObjectives\n• To evaluate the efficacy and safety of both air and saline in the loss of resistance technique for identification of the epidural space.\n• To evaluate complications related to the air or saline injected.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 9), MEDLINE, EMBASE and the Latin American and Caribbean Health Science Information Database (LILACS) (from inception to September 2013). We applied no language restrictions. The date of the most recent search was 7 September 2013.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-randomized controlled trials (quasi-RCTs) on air and saline in the loss of resistance technique for identification of the epidural space.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data.\nMain results\nWe included in the review seven studies with a total of 852 participants. The methodological quality of the included studies was generally ranked as showing low risk of bias in most domains, with the exception of one study, which did not mask participants. We were able to include data from 838 participants in the meta-analysis. We found no statistically significant differences between participants receiving air and those given saline in any of the outcomes evaluated: inability to locate the epidural space (three trials, 619 participants) (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.33 to 2.31, low-quality evidence); accidental intravascular catheter placement (two trials, 223 participants) (RR 0.90, 95% CI 0.33 to 2.45, low-quality evidence); accidental subarachnoid catheter placement (four trials, 682 participants) (RR 2.95, 95% CI 0.12 to 71.90, low-quality evidence); combined spinal epidural failure (two trials, 400 participants) (RR 0.98, 95% CI 0.44 to 2.18, low-quality evidence); unblocked segments (five studies, 423 participants) (RR 1.66, 95% CI 0.72 to 3.85); and pain measured by VAS (two studies, 395 participants) (mean difference (MD) -0.09, 95% CI -0.37 to 0.18). With regard to adverse effects, we found no statistically significant differences between participants receiving air and those given saline in the occurrence of paraesthesias (three trials, 572 participants) (RR 0.89, 95% CI 0.69 to 1.15); difficulty in advancing the catheter (two trials, 227 participants) (RR 0.91, 95% CI 0.32 to 2.56); catheter replacement (two trials, 501 participants) (RR 0.69, 95% CI 0.26 to 1.83); and postdural puncture headache (one trial, 110 participants) (RR 0.83, 95% CI 0.12 to 5.71).\nAuthors' conclusions\nLow-quality evidence shows that results do not differ between air and saline in terms of the loss of resistance technique for identification of the epidural space and reduction of complications. Applicability might be compromised, as most of the results described in this review were obtained from parturient patients. This review underlines the need to conduct well-designed trials in this field.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion and future research\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Low-quality evidence shows that results do not differ between air and saline in using loss of resistance technique for identification of the epidural space and in reducing complications."
}
]
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query-laysum | 3540 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetes and vascular disease are the leading causes of lower limb amputation. Currently, 463 million adults are living with diabetes, and 202 million with peripheral vascular disease, worldwide. When a lower limb amputation is considered, preservation of the knee in a below-knee amputation allows for superior functional recovery when compared with amputation at a higher level. When a below-knee amputation is not feasible, the most common alternative performed is an above-knee amputation. Another possible option, which is less commonly performed, is a through-knee amputation which may offer some potential functional benefits over an above-knee amputation.\nObjectives\nTo assess the effects of through-knee amputation compared to above-knee amputation on clinical and rehabilitation outcomes and complication rates for all patients undergoing vascular and non-vascular major lower limb amputation.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases; the World Health Organization International Clinical Trials Registry Platform; and the ClinicalTrials.gov trials register to 17 February 2021.\nWe undertook reference checking, citation searching, and contact with study authors to identify additional studies.\nSelection criteria\nPublished and unpublished randomised controlled trials (RCTs) comparing through-knee amputation and above-knee amputation were eligible for inclusion in this study. Primary outcomes were uncomplicated primary wound healing and prosthetic limb fitting. Secondary outcomes included time taken to achieve independent mobility with a prosthesis, health-related quality of life, walking speed, pain, and 30-day survival.\nData collection and analysis\nTwo review authors independently reviewed all records identified by the search. Data collection and extraction were planned in line with recommendations outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to assess the certainty of evidence using the GRADE approach.\nMain results\nWe did not identify RCTs that met the inclusion criteria for this review.\nAuthors' conclusions\nNo RCTs have been conducted to determine comparative clinical or rehabilitation outcomes of through-knee amputation and above-knee amputation, or complication rates. It is unknown whether either of these approaches offers improved outcomes for patients. RCTs are needed to guide practice and to ensure the best outcomes for this patient group.\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": "Each year, thousands of people worldwide need to have their lower leg surgically removed (lower limb amputation) due to problems such as blockages in blood vessels (vascular disease), diabetes, and injury. When an amputation is planned, a surgeon needs to decide how high up the leg to go, and therefore how much leg to leave behind. This decision is based on a balance between leaving as much of the leg as possible to improve a person’s ability to walk with an artificial leg (prosthesis) and removing anything that will not survive or go on to heal. If possible, a surgeon will prefer to preserve the knee, as having a working knee of one's own ensures a person’s best chance of walking. In some cases, this is not possible, and currently almost all people in this situation will have an amputation in the middle of the thigh (above the knee). However, another option is an amputation that can be performed through the knee joint itself. This carries potential advantages, as all of the muscles controlling movements of the thighbone are undamaged. A longer remaining leg would be expected to act as a lever to reduce the effort of swinging a prosthetic limb during walking and to aid sitting balance and transfer from bed to chair. By avoiding cutting the muscles, it is possible to minimise the physical trauma of surgery, allowing a procedure with reduced blood loss and less procedure time. In addition, the end of the thighbone and in some cases the knee cap remain. These bones can support the body’s weight at the end of the remaining limb through the same mechanism as kneeling down. On the other hand, some surgeons think that problems with healing may be more common with this approach. It is unclear whether amputation through the knee may therefore be a better operation, allowing improved recovery, greater likelihood of being able to walk with an artificial leg, and better quality of life, or whether it is associated with worse outcomes due to wound healing failure and the need for further surgery. The aim of this review was to look at the best available evidence to see how these operations compare.\nThis review searched for studies that looked at whether through-the-knee or above-the-knee amputation resulted in better wound healing after amputation, improved patient survival, and reduced pain (clinical outcomes), as well as better rates of prosthesis use, walking speed, and quality of life (rehabilitation outcomes)."
}
]
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query-laysum | 3541 | [
{
"role": "user",
"content": "Abstract: Background\nThis review supersedes the original Cochrane review first published in 2008 (Huertas-Ceballos 2008).\nBetween 4% and 25% of school-aged children complain of recurrent abdominal pain (RAP) severe enough to interfere with their daily activities. No organic cause for this pain can be found on physical examination or investigation for the majority of such children. Although many children are managed by reassurance and simple measures, a large range of psychosocial interventions involving cognitive and behavioural components have been recommended.\nObjectives\nTo determine the effectiveness of psychosocial interventions for reducing pain in school-aged children with RAP.\nSearch methods\nIn June 2016 we searched CENTRAL, MEDLINE, Embase, eight other databases, and two trials registers. We also searched the references of identified studies and relevant reviews.\nSelection criteria\nRandomised controlled trials comparing psychosocial therapies with usual care, active control, or wait-list control for children and adolescents (aged 5 to 18 years) with RAP or an abdominal pain-related functional gastrointestinal disorder defined by the Rome III criteria were eligible for inclusion.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Five review authors independently selected studies, assessed them for risk of bias, and extracted relevant data. We also assessed the quality of the evidence using the GRADE approach.\nMain results\nThis review includes 18 randomised controlled trials (14 new to this version), reported in 26 papers, involving 928 children and adolescents with RAP between the ages of 6 and 18 years. The interventions were classified into four types of psychosocial therapy: cognitive behavioural therapy (CBT), hypnotherapy (including guided imagery), yoga, and written self-disclosure. The studies were carried out in the USA, Australia, Canada, the Netherlands, Germany, and Brazil. The majority of the studies were small and short term; only two studies included more than 100 participants, and only five studies had follow-up assessments beyond six months. Small sample sizes and the degree of assessed risk of performance and detection bias in many studies led to the overall quality of the evidence being rated as low to very low for all outcomes.\nFor CBT compared to control, we found evidence of treatment success postintervention (odds ratio (OR) 5.67, 95% confidence interval (CI) 1.18 to 27.32; Z = 2.16; P = 0.03; 4 studies; 175 children; very low-quality evidence), but no evidence of treatment success at medium-term follow-up (OR 3.08, 95% CI 0.93 to 10.16; Z = 1.85; P = 0.06; 3 studies; 139 children; low-quality evidence) or long-term follow-up (OR 1.29, 95% CI 0.50 to 3.33; Z = 0.53; P = 0.60; 2 studies; 120 children; low-quality evidence). We found no evidence of effects of intervention on pain intensity scores measured postintervention (standardised mean difference (SMD) -0.33, 95% CI -0.74 to 0.08; 7 studies; 405 children; low-quality evidence), or at medium-term follow-up (SMD -0.32, 95% CI -0.85 to 0.20; 4 studies; 301 children; low-quality evidence).\nFor hypnotherapy (including studies of guided imagery) compared to control, we found evidence of greater treatment success postintervention (OR 6.78, 95% CI 2.41 to 19.07; Z = 3.63; P = 0.0003; 4 studies; 146 children; low-quality evidence) as well as reductions in pain intensity (SMD -1.01, 95% CI -1.41 to -0.61; Z = 4.97; P < 0.00001; 4 studies; 146 children; low-quality evidence) and pain frequency (SMD -1.28, 95% CI -1.84 to -0.72; Z = 4.48; P < 0.00001; 4 studies; 146 children; low-quality evidence). The only study of long-term effect reported continued benefit of hypnotherapy compared to usual care after five years, with 68% reporting treatment success compared to 20% of controls (P = 0.005).\nFor yoga therapy compared to control, we found no evidence of effectiveness on pain intensity reduction postintervention (SMD -0.31, 95% CI -0.67 to 0.05; Z = 1.69; P = 0.09; 3 studies; 122 children; low-quality evidence).\nThe single study of written self-disclosure therapy reported no benefit for pain.\nThere was no evidence of effect from the pooled analyses for any type of intervention on the secondary outcomes of school performance, social or psychological functioning, and quality of daily life.\nThere were no adverse effects for any of the interventions reported.\nAuthors' conclusions\nThe data from trials to date provide some evidence for beneficial effects of CBT and hypnotherapy in reducing pain in the short term in children and adolescents presenting with RAP. There was no evidence for the effectiveness of yoga therapy or written self-disclosure therapy. There were insufficient data to explore effects of treatment by RAP subtype.\nHigher-quality, longer-duration trials are needed to fully investigate the effectiveness of psychosocial interventions. Identifying the active components of the interventions and establishing whether benefits are sustained in the long term are areas of priority. Future research studies would benefit from employing active control groups to help minimise potential bias from wait-list control designs and to help account for therapist and intervention time.\n\nGiven the provided abstract, please respond to the following query: \"Methods and study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "As of June 2016, we identified 18 randomised controlled trials (a type of scientific experiment in which people are randomly assigned to one of two or more treatments), which included 928 children and adolescents between the ages of 6 and 18 years. These studies compared a range of psychosocial therapy to usual care or some form of non-therapy control (such as education or breathing exercises). We identified four different kinds of psychosocial therapy: cognitive behavioural therapy, hypnotherapy, yoga, and written self-disclosure (a therapy that involves writing down thoughts and feelings about something distressing). The duration of the included studies ranged from five days to three months. The studies were conducted in the USA, Australia, Canada, the Netherlands, Germany, and Brazil."
}
]
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query-laysum | 3542 | [
{
"role": "user",
"content": "Abstract: Background\nChelation therapy is promoted and practiced around the world as a form of alternative medicine in the treatment of atherosclerotic cardiovascular disease. It has been suggested as a safe, relatively inexpensive, non-surgical method of restoring blood flow in atherosclerotic vessels. However, there is currently limited high-quality, adequately-powered research informing evidence-based medicine on the topic, specifically regarding clinical outcomes. Due to this limited evidence, the benefit of chelation therapy remains controversial at present. This is an update of a review first published in 2002.\nObjectives\nTo assess the effects of ethylene diamine tetra-acetic acid (EDTA) chelation therapy versus placebo or no treatment on clinical outcomes among people with atherosclerotic cardiovascular disease.\nSearch methods\nFor this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 6 August 2019. We searched the bibliographies of the studies retrieved by the literature searches for further trials.\nSelection criteria\nWe included studies if they were randomised controlled trials of EDTA chelation therapy versus placebo or no treatment in participants with atherosclerotic cardiovascular disease. The main outcome measures we considered include all-cause or cause-specific mortality, non-fatal cardiovascular events, direct or indirect measurement of disease severity, and subjective measures of improvement or adverse events.\nData collection and analysis\nTwo review authors independently extracted data and assessed trial quality using standard Cochrane procedures. A third author considered any unresolved issues, and we discussed any discrepancies until a consensus was reached. We contacted study authors for additional information.\nMain results\nWe included five studies with a total of 1993 randomised participants. Three studies enrolled participants with peripheral vascular disease and two studies included participants with coronary artery disease, one of which specifically recruited people who had had a myocardial infarction. The number of participants in each study varied widely (from 10 to 1708 participants), but all studies compared EDTA chelation to a placebo. Risk of bias for the included studies was generally moderate to low, but one study had high risk of bias because the study investigators broke their randomisation code halfway through the study and rolled the placebo participants over to active treatment. Certainty of the evidence, as assessed by GRADE, was generally low to very low, which was mostly due to a paucity of data in each outcome's meta-analysis. This limited our ability to draw any strong conclusions. We also had concerns about one study's risk of bias regarding blinding and outcome assessment that may have biased the results.\nTwo studies with coronary artery disease participants reported no evidence of a difference in all-cause mortality between chelation therapy and placebo (risk ratio (RR) 0.97, 95% CI 0.73 to 1.28; 1792 participants; low-certainty). One study with coronary artery disease participants reported no evidence of a difference in coronary heart disease deaths between chelation therapy and placebo (RR 1.02, 95% CI 0.70 to 1.48; 1708 participants; very low-certainty). Two studies with coronary artery disease participants reported no evidence of a difference in myocardial infarction (RR 0.81, 95% CI 0.57 to 1.14; 1792 participants; moderate-certainty), angina (RR 0.95, 95% CI 0.55 to 1.67; 1792 participants; very low-certainty), and coronary revascularisation (RR 0.46, 95% CI 0.07 to 3.25; 1792 participants). Two studies (one with coronary artery disease participants and one with peripheral vascular disease participants) reported no evidence of a difference in stroke (RR 0.88, 95% CI 0.40 to 1.92; 1867 participants; low-certainty). Ankle-brachial pressure index (ABPI; also known as ankle brachial index) was measured in three studies, all including participants with peripheral vascular disease; two studies found no evidence of a difference in the treatment groups after three months after treatment (mean difference (MD) 0.02, 95% CI -0.03 to 0.06; 181 participants; low-certainty). A third study reported an improvement in ABPI in the EDTA chelation group, but this study was at high risk of bias. Meta-analysis of maximum and pain-free walking distances three months after treatment included participants with peripheral vascular disease and showed no evidence of a difference between the treatment groups (MD -31.46, 95% CI -87.63 to 24.71; 165 participants; 2 studies; low-certainty). Quality of life outcomes were reported by two studies that included participants with coronary artery disease, but we were unable to pool the data due to different methods of reporting and varied criteria. However, there did not appear to be any major differences between the treatment groups. None of the included studies reported on vascular deaths. Overall, there was no evidence of major or minor adverse events associated with EDTA chelation treatment.\nAuthors' conclusions\nThere is currently insufficient evidence to determine the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes of people with atherosclerotic cardiovascular disease. More high-quality, randomised controlled trials are needed that assess the effects of chelation therapy on longevity and quality of life among people with atherosclerotic cardiovascular disease.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review included evidence from five studies with a total of 1993 participants (current until August 2019). Three studies enrolled participants with peripheral vascular disease, and two of the studies included participants with coronary artery disease, one of which specifically recruited people who had had a heart attack. All five studies compared chelation therapy with no treatment or placebo. Only two of the studies (both of which included participants with coronary artery disease) reported death from any cause, and these reported no difference in overall deaths between those that received chelation therapy and those who did not. Ony one study (in people with coronary artery disease) reported cardiovascular death, and this study found no difference between in risk between those who had chelation therapy and those who did not. Two studies of people with coronary artery disease reported rates of heart attack and angina, and found no difference in the risk of these between participants who had chelation treatment and those who did not. Similarly, two studies (one in people with coronary artery disease and one in people with peripheral vascular disease) reported the chance of having a stroke, and found no clear difference in the chance of this between people who did or did not received chelation treatment. Two studies in people with peripheral vascular disease used an indirect measure of blood flow known as the ankle-brachial pressure index (ABPI), or ankle brachial index. These studies did not show any differences in this measure between people who received chelation therapy for three or six months and those who did not get the treatment. There was also no clear differences in the distance participants could walk.\nWe could not combine specific measures of quality of life in a single analysis. Looking at the two studies in people with coronary artery disease that reported this outcome, there was no difference in the quality of life reported by people who received chelation therapy and those who did not get the treatment. Two studies reported information about adverse events, but we could not combine this in a single analysis because they reported them in different ways and the events were different. However, the people who had chelation therapy did not appear to have any increase in either minor or major adverse events, compared with people who did not have the therapy."
}
]
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query-laysum | 3543 | [
{
"role": "user",
"content": "Abstract: Background\nThalassaemia is a quantitative abnormality of haemoglobin caused by mutations in genes controlling production of alpha or beta globins. Abnormally unpaired globin chains cause membrane damage and cell death within organ systems and destruction of erythroid precursors in the bone marrow, leading to haemolytic anaemia. The life-long management of the general health effects of thalassaemia is highly challenging, and failure to deal with dental and orthodontic complications exacerbates the public health, financial and personal burden of the condition. There is a lack of evidence-based guidelines to help care seekers and providers manage such dental and orthodontic complications. This review aimed to evaluate the available evidence on methods for treating dental and orthodontic complications in people with thalassaemia to inform future recommendations. This is an update of a Cochrane Review first published in 2019.\nObjectives\nTo assess different methods for treating dental and orthodontic complications in people with thalassaemia.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register in September 2022, and we searched nine online databases and trials registries in January 2022. We searched the reference lists of relevant articles and reviews and contacted haematologists, experts in fields of dentistry, organisations, pharmaceutical companies and researchers working in this field.\nSelection criteria\nWe searched for published or unpublished randomised controlled trials (RCTs) that evaluated treatment of dental and orthodontic complications in individuals diagnosed with thalassaemia, irrespective of phenotype, severity, age, sex and ethnic origin.\nData collection and analysis\nTwo review authors independently screened the 37,242 titles retrieved by the search. After deduplication, we identified two potentially relevant RCTs. On assessing their eligibility against our inclusion and exclusion criteria, we excluded one and included the other.\nMain results\nWe included one parallel-design RCT conducted in Saudi Arabia and involving 29 participants (19 males, 10 females) with thalassaemia. It aimed to assess the effectiveness of photodynamic therapy as an adjuvant to conventional full-mouth ultrasonic scaling for the treatment of gingivitis. The average age of participants was around 23 years.\nThere is very low-certainty evidence from this trial that full-mouth ultrasonic scaling plus photodynamic therapy compared to full-mouth ultrasonic scaling alone may improve gingival index score and bleeding on probing after 12 weeks in people with thalassaemia.\nWe found no studies that assessed other interventions for the various dental or orthodontic complications of thalassaemia.\nAuthors' conclusions\nAlthough the included study showed greater reduction in gingivitis in the group treated with full-mouth ultrasonic scaling plus photodynamic therapy, the evidence is of very low certainty. The study had unclear risk of bias, a short follow-up period and no data on safety or adverse effects. We cannot make definitive recommendations for clinical practice based on the limited evidence of a single trial. Future studies will very likely affect the conclusions of this review.\nThis review highlights the need for high-quality RCTs that investigate the effectiveness of various treatment modalities for dental and orthodontic complications in people with thalassaemia. It is crucial that future trials assess adverse effects of interventions.\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": "Full-mouth cleaning plus light stimulation may reduce some aspects of gum inflammation more than full-mouth cleaning alone. The study did not report any of our other outcomes of interest listed above."
}
]
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query-laysum | 3544 | [
{
"role": "user",
"content": "Abstract: Background\nKidney transplantation is the therapy of choice for many patients with end-stage kidney disease (ESKD) with an improvement in survival rates and satisfactory short term graft survival. However, there has been little improvement in long-term survival. The place of target of rapamycin inhibitors (TOR-I) (sirolimus, everolimus), which have different modes of action from other commonly used immunosuppressive agents, in kidney transplantation remains uncertain. This is an update of a review first published in 2006.\nObjectives\nTo evaluate the short and long-term benefits and harms of TOR-I (sirolimus and everolimus) when used in primary immunosuppressive regimens for kidney transplant recipients.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 20 September 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register were 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 in which drug regimens, containing TOR-I commenced within seven days of transplant, were compared to alternative drug regimens, were included without age restriction, dosage or language of report.\nData collection and analysis\nThree authors independently assessed study eligibility, risk of bias, and extracted data. Results were reported as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) with 95% CI for continuous outcomes. Statistical analyses were performed using the random-effects model. The certainty of the evidence was assessed using GRADE\nMain results\nSeventy studies (17,462 randomised participants) were included; eight studies included two comparisons to provide 78 comparisons. Outcomes were reported at six months to three years post transplant.\nRisk of bias was judged to be low for sequence generation in 25 studies, for allocation concealment in 23 studies, performance bias in four studies, detection bias in 65 studies, attrition bias in 45 studies, selective reporting bias in 48 studies, and for other potential bias in three studies. Risk of bias was judged to be at high risk of bias for sequence generation in two studies, allocation concealment in two studies, performance bias in 61 studies, detection bias in one study, attrition bias in four studies, for selective reporting bias in 11 studies and for other potential risk of bias in 46 studies.\nCompared with CNI and antimetabolite, TOR-I with antimetabolite probably makes little or no difference to death (RR 1.31, 95% CI 0.87 to 1.98; 19 studies) or malignancies (RR 0.86, 95% CI 0.50 to 1.48; 10 studies); probably increases graft loss censored for death (RR 1.32, 95% CI 0.96 to 1.81; 15 studies), biopsy-proven acute rejection (RR 1.60, 95% CI 1.25 to 2.04; 15 studies), need to change treatment (RR 2.42, 95% CI 1.88 to 3.11; 14 studies) and wound complications (RR 2.56, 95% CI 1.94 to 3.36; 12 studies) (moderate certainty evidence); but reduces CMV infection (RR 0.43, 95% CI 0.29 to 0.63; 13 studies) (high certainty evidence).\nCompared with antimetabolites and CNI, TOR-I with CNI probably makes little or no difference to death (RR 1.06, 95% CI 0.84 to 1.33; 31 studies), graft loss censored for death (RR 1.09, 95% CI 0.82 to 1.45; 26 studies), biopsy-proven acute rejection (RR 0.95, 95% CI 0.81 to 1.12; 24 studies); and malignancies (RR 0.83, 95% CI 0.64 to 1.07; 17 studies); probably increases the need to change treatment (RR 1.56, 95% CI 1.28 to 1.90; 25 studies), and wound complications (RR 1.56, 95% CI 1.28 to 1.91; 17 studies); but probably reduces CMV infection (RR 0.44, 95% CI 0.34 to 0.58; 25 studies) (moderate certainty evidence).\nLower dose TOR-I and standard dose CNI compared with higher dose TOR-I and reduced dose CNI probably makes little or no difference to death (RR 1.07, 95% CI 0.64 to 1.78; 9 studies), graft loss censored for death (RR 1.09, 95% CI 0.54 to 2.20; 8 studies), biopsy-proven acute rejection (RR 0.87, 95% CI 0.67 to 1.13; 8 studies), and CMV infection (RR 1.42, 95% CI 0.78 to 2.60; 5 studies) (moderate certainty evidence); and may make little or no difference to wound complications (RR 0.95, 95% CI 0.53 to 1.71; 3 studies), malignancies (RR 1.04, 95% CI 0.36 to 3.04; 7 studies), and the need to change treatments (RR 1.18, 95% CI 0.58 to 2.42; 5 studies) (low certainty evidence).\nLower dose of TOR-I compared with higher doses probably makes little or no difference to death (RR 0.84, 95% CI 0.67 to 1.06; 13 studies), graft loss censored for death (RR 0.92, 95% CI 0.71 to 1.19; 12 studies), biopsy-proven acute rejection (RR 1.26, 95% CI 1.10 to 1.43; 11 studies), CMV infection (RR 0.87, 95% CI 0.63 to 1.21; 9 studies), wound complications (RR 0.92, 95% CI 0.66 to 1.29; 7 studies), and malignancy (RR 0.84, 95% CI 0.54 to 1.32; 10 studies) (moderate certainty evidence); and may make little or no difference to the need to change treatments (RR 0.91, 95% CI 0.78 to 1.05; 10 studies) (low certainty evidence).\nIt is uncertain whether sirolimus and everolimus differ in their effects on kidney function and lipid levels because the certainty of the evidence is very low based on a single small study with only three months of follow-up.\nAuthors' conclusions\nIn studies with follow-up to three years, TOR-I with an antimetabolite increases the risk of graft loss and acute rejection compared with CNI and an antimetabolite. TOR-I with CNI potentially offers an alternative to an antimetabolite with CNI as rates of graft loss and acute rejection are similar between interventions and TOR-I regimens are associated with a reduced risk of CMV infections. Wound complications and the need to change immunosuppressive medications are higher with TOR-I regimens. While further new studies are not required, longer-term follow-up data from participants in existing methodologically robust RCTs are needed to determine how useful immunosuppressive regimens, which include TOR-I, are in maintaining kidney transplant function and survival beyond three years.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed 70 studies, with 17,462 randomised participants, which compared TOR-1 (everolimus or sirolimus) with other agents for initial immunosuppressive therapy for kidney transplant recipients."
}
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query-laysum | 3545 | [
{
"role": "user",
"content": "Abstract: Background\nSymptomatic patent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. In these infants, prophylactic use of indomethacin, a non-selective cyclooxygenase inhibitor, has demonstrated short-term clinical benefits. The effect of indomethacin in preterm infants with a symptomatic PDA remains unexplored.\nObjectives\nTo determine the effectiveness and safety of indomethacin (given by any route) compared to placebo or no treatment in reducing mortality and morbidity in preterm infants with a symptomatic PDA.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 7), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and Cumulative Index to Nursing and Allied Health Literature (CINAHL), on 31 July 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs.\nSelection criteria\nWe included RCTs and quasi-RCTs that compared indomethacin (any dose, any route) versus placebo or no treatment in preterm infants.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal, with separate evaluation of trial quality and data extraction by at least two review authors. We used the GRADE approach to assess the certainty of evidence for the following outcomes: failure of PDA closure within one week of administration of the first dose of indomethacin; bronchopulmonary dysplasia (BPD) at 28 days' postnatal age and at 36 weeks' postmenstrual age; proportion of infants requiring surgical ligation or transcatheter occlusion; all-cause neonatal mortality; necrotizing enterocolitis (NEC) (≥ Bell stage 2); and mucocutaneous or gastrointestinal bleeding.\nMain results\nWe included 14 RCTs (880 preterm infants). Four out of the 14 included studies were judged to have high risk of bias in one or more domains. Indomethacin administration was associated with a large reduction in failure of PDA closure within one week of administration of the first dose (risk ratio (RR) 0.30, 95% confidence interval (CI) 0.23 to 0.38; risk difference (RD) -0.52, 95% CI -0.58 to -0.45; 10 studies, 654 infants; high-certainty evidence). There may be little to no difference in the incidence of BPD (BPD defined as supplemental oxygen need at 28 days' postnatal age: RR 1.45, 95% CI 0.60 to 3.51; 1 study, 55 infants; low-certainty evidence; BPD defined as supplemental oxygen need at 36 weeks' postmenstrual age: RR 0.80, 95% CI 0.41 to 1.55; 1 study, 92 infants; low-certainty evidence) and probably little to no difference in mortality (RR 0.78, 95% CI 0.46 to 1.33; 8 studies, 314 infants; moderate-certainty evidence) with use of indomethacin for symptomatic PDA. No differences were demonstrated in the need for surgical PDA ligation (RR 0.66, 95% CI 0.33 to 1.29; 7 studies, 275 infants; moderate-certainty evidence), in NEC (RR 1.27, 95% CI 0.36 to 4.55; 2 studies, 147 infants; low-certainty evidence), or in mucocutaneous or gastrointestinal bleeding (RR 0.33, 95% CI 0.01 to 7.58; 2 studies, 119 infants; low-certainty evidence) with use of indomethacin compared to placebo or no treatment. Certainty of evidence for BPD, surgical PDA ligation, NEC, and mucocutaneous or gastrointestinal bleeding was downgraded for very serious or serious imprecision.\nAuthors' conclusions\nHigh-certainty evidence shows that indomethacin is effective in closing a symptomatic PDA compared to placebo or no treatment in preterm infants. Evidence is insufficient regarding effects of indomethacin on other clinically relevant outcomes and medication-related adverse effects.\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": "PDA is a common complication among preterm and low birth weight infants. PDA is an open vascular channel between the lungs and the heart, which usually closes shortly after birth. In preterm infants, the PDA remains open and may contribute to life-threatening complications. We wanted to see if a medicine commonly used to close PDA, indomethacin, was better or worse than no treatment or placebo for preterm infants who were experiencing symptoms from their PDA."
}
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query-laysum | 3546 | [
{
"role": "user",
"content": "Abstract: Background\nNitrous oxide has been used for over 160 years for the induction and maintenance of general anaesthesia. It has been used as a sole agent but is most often employed as part of a technique using other anaesthetic gases, intravenous agents, or both. Its low tissue solubility (and therefore rapid kinetics), low cost, and low rate of cardiorespiratory complications have made nitrous oxide by far the most commonly used general anaesthetic. The accumulating evidence regarding adverse effects of nitrous oxide administration has led many anaesthetists to question its continued routine use in a variety of operating room settings. Adverse events may result from both the biological actions of nitrous oxide and the fact that to deliver an effective dose, nitrous oxide, which is a relatively weak anaesthetic agent, needs to be given in high concentrations that restrict oxygen delivery (for example, a common mixture is 30% oxygen with 70% nitrous oxide). As well as the risk of low blood oxygen levels, concerns have also been raised regarding the risk of compromising the immune system, impaired cognition, postoperative cardiovascular complications, bowel obstruction from distention, and possible respiratory compromise.\nObjectives\nTo determine if nitrous oxide-based anaesthesia results in similar outcomes to nitrous oxide-free anaesthesia in adults undergoing surgery.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014 Issue 10); MEDLINE (1966 to 17 October 2014); EMBASE (1974 to 17 October 2014); and ISI Web of Science (1974 to 17 October 2014). We also searched the reference lists of relevant articles, conference proceedings, and ongoing trials up to 17 October 2014 on specific websites (http://clinicaltrials.gov/, http://controlled-trials.com/, and http://www.centerwatch.com).\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing general anaesthesia where nitrous oxide was part of the anaesthetic technique used for the induction or maintenance of general anaesthesia (or both) with any general anaesthesia using a volatile anaesthetic or propofol-based maintenance of anaesthesia but no nitrous oxide for adults undergoing surgery. Our primary outcome was inhospital case fatality rate. Secondary outcomes were complications and length of stay.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted the outcome data. We used meta-analysis for data synthesis. Heterogeneity was examined with the Chi² test and by calculating the I² statistic. We used a fixed-effect model if the measure of inconsistency was low for all comparisons (I² statistic < 50%); otherwise we used a random-effects model for measures with high inconsistency. We undertook subgroup analyses to explore inconsistency and sensitivity analyses to evaluate whether the results were robust. We assessed the quality of evidence of the main outcomes using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system.\nMain results\nWe included 35 trials (13,872 adult participants). Seven included studies were at low risk of bias. We identified eight studies as awaiting classification since we could not obtain the full texts, and had insufficient information to include or exclude them. We included data from 24 trials for quantitative synthesis. The results of meta-analyses showed that nitrous oxide-based techniques increased the incidence of pulmonary atelectasis (odds ratio (OR) 1.57, 95% confidence interval (CI) 1.18 to 2.10, P = 0.002), but had no effects on the inhospital case fatality rate, the incidence of pneumonia, myocardial infarction, stroke, severe nausea and vomiting, venous thromboembolism, wound infection, or the length of hospital stay. The sensitivity analyses suggested that the results of the meta-analyses were all robust except for the outcomes of pneumonia, and severe nausea and vomiting. Two trials reported length of intensive care unit (ICU) stay but the data were skewed so were not pooled. Both trials reported that nitrous oxide-based techniques had no effects on the length of ICU stay. We rated the quality of evidence for two outcomes (pulmonary atelectasis, myocardial infarction) as high, four outcomes (inhospital case fatality rate, stroke, venous thromboembolism, length of hospital stay) as moderate, and three (pneumonia, severe nausea and vomiting, wound infection rate) as low.\nAuthors' conclusions\nGiven the evidence from this Cochrane review, the avoidance of nitrous oxide may be reasonable in participants with pre-existing poor pulmonary function or at high risk of postoperative nausea and vomiting. Since there are eight studies awaiting classification, selection bias may exist in our systematic review.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We examined the evidence available up to 17 October 2014. We included 35 trials involving 13,872 adult participants, all of whom were randomized to either receive nitrous oxide or no nitrous oxide. The trials covered a variety of situations during general anaesthesia."
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query-laysum | 3547 | [
{
"role": "user",
"content": "Abstract: Background\nSurgical site infections (SSI) can delay wound healing, impair cosmetic outcome and increase healthcare costs. Topical antibiotics are sometimes used to reduce microbial contaminant exposure following surgical procedures, with the aim of reducing SSIs.\nObjectives\nThe primary objective of this review was to determine whether the application of topical antibiotics to surgical wounds that are healing by primary intention reduces the incidence of SSI and whether it increases the incidence of adverse outcomes (allergic contact dermatitis, infections with patterns of antibiotic resistance and anaphylaxis).\nSearch methods\nIn May 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 and EBSCO CINAHL. We also searched clinical trial registries for ongoing studies, and bibliographies of relevant publications to identify further eligible trials. There was no restriction of language, date of study or setting. The search was repeated in May 2016 to ensure currency of included studies.\nSelection criteria\nAll randomized controlled trials (RCTs) and quasi-randomised trials that assessed the effects of topical antibiotics (any formulation, including impregnated dressings) in people with surgical wounds healing by primary intention were eligible for inclusion.\nData collection and analysis\nTwo review authors independently selected studies and independently extracted data. Two authors then assessed the studies for risk of bias. Risk ratios were calculated for dichotomous variables, and when a sufficient number of comparable trials were available, trials were pooled in a meta-analysis.\nMain results\nA total of 10 RCTs and four quasi-randomised trials with 6466 participants met the inclusion criteria. Six studies involved minor procedures conducted in an outpatient or emergency department setting; eight studies involved major surgery conducted in theatre. Nine different topical antibiotics were included. We included two three-arm trials, two four-arm trials and 10 two-arm trials. The control groups comprised; an alternative topical antibiotic (two studies), topical antiseptic (six studies) and no topical antibiotic (10 studies), which comprised inert ointment (five studies) no treatment (four studies) and one study with one arm of each.\nThe risk of bias of the 14 studies varied. Seven studies were at high risk of bias, five at unclear risk of bias and two at low risk of bias. Most risk of bias concerned risk of selection bias.\nTwelve of the studies (6259 participants) reported infection rates, although we could not extract the data for this outcome from one study. Four studies (3334 participants) measured allergic contact dermatitis as an outcome. Four studies measured positive wound swabs for patterns of antimicrobial resistance, for which there were no outcomes reported. No episodes of anaphylaxis were reported.\nTopical antibiotic versus no topical antibiotic\nWe pooled the results of eight trials (5427 participants) for the outcome of SSI. Topical antibiotics probably reduce the risk of SSI in people with surgical wounds healing by primary intention compared with no topical antibiotic (RR 0.61, 95% CI 0.42 to 0.87; moderate-quality evidence downgraded once for risk of bias). This equates to 20 fewer SSIs per 1000 patients treated with topical antibiotics (95% CI 7 to 29) and a number needed to treat for one additional beneficial outcome (NNTB) (i.e. prevention of one SSI) of 50.\nWe pooled the results of three trials (3012 participants) for the outcome of allergic contact dermatitis, however this comparison was underpowered, and it is unclear whether topical antibiotics affect the risk of allergic contact dermatitis (RR 3.94, 95% CI 0.46 to 34.00; very low-quality evidence, downgraded twice for risk of bias, once for imprecision).\nTopical antibiotic versus antiseptic\nWe pooled the results of five trials (1299 participants) for the outcome of SSI. Topical antibiotics probably reduce the risk of SSI in people with surgical wounds healing by primary intention compared with using topical antiseptics (RR 0.49, 95% CI 0.30 to 0.80; moderate-quality evidence downgraded once for risk of bias). This equates to 43 fewer SSIs per 1000 patients treated with topical antibiotics instead of antiseptics (95% CI 17 to 59) and an NNTB of 24.\nWe pooled the results of two trials (541 participants) for the outcome of allergic contact dermatitis; there was no clear difference in the risk of dermatitis between topical antibiotics and antiseptics, however this comparison was underpowered and a difference cannot be ruled out (RR 0.97, 95% CI 0.52 to 1.82; very low-quality evidence, downgraded twice for risk of bias and once for imprecision).\nTopical antibiotic versus topical antibiotic\nOne study (99 participants) compared mupirocin ointment with a combination ointment of neomycin/polymyxin B/bacitracin zinc for the outcome of SSI. There was no clear difference in the risk of SSI, however this comparison was underpowered (very low-quality evidence downgraded twice for risk of bias, once for imprecision).\nA four-arm trial involved two antibiotic arms (neomycin sulfate/bacitracin zinc/polymyxin B sulphate combination ointment versus bacitracin zinc, 219 participants). There was no clear difference in risk of SSI between the combination ointment and the bacitracin zinc ointment. The quality of evidence for this outcome was low, downgraded once for risk of bias, and once for imprecision.\nAuthors' conclusions\nTopical antibiotics applied to surgical wounds healing by primary intention probably reduce the risk of SSI relative to no antibiotic, and relative to topical antiseptics (moderate quality evidence). We are unable to draw conclusions regarding the effects of topical antibiotics on adverse outcomes such as allergic contact dermatitis due to lack of statistical power (small sample sizes). We are also unable to draw conclusions regarding the impact of increasing topical antibiotic use on antibiotic resistance. The relative effects of different topical antibiotics are unclear.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about how effective topical antibiotics are in preventing surgical site infection if applied directly to wounds after surgery. We focused on the effect of topical antibiotics on the type of surgical wound where the edges are held closely together so that the wound heals more easily (known as healing by primary intention). The edges of these wounds can be held together with stitches, staples, clips or glue."
}
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query-laysum | 3548 | [
{
"role": "user",
"content": "Abstract: Background\nAn effective way of preventing sudden cardiac death is the use of an implantable cardioverter defibrillator (ICD). In spite of the potential mortality benefits of receiving an ICD device, psychological problems experienced by patients after receiving an ICD may negatively impact their health-related quality of life, and lead to increased readmission to hospital and healthcare needs, loss of productivity and employment earnings, and increased morbidity and mortality. Evidence from other heart conditions suggests that cardiac rehabilitation should consist of both exercise training and psychoeducational interventions; such rehabilitation may benefit patients with an ICD. Prior systematic reviews of cardiac rehabilitation have excluded participants with an ICD. A systematic review was therefore conducted to assess the evidence for the use of exercise-based intervention programmes following implantation of an ICD.\nObjectives\nTo assess the benefits and harms of exercise-based cardiac rehabilitation programmes (exercise-based interventions alone or in combination with psychoeducational components) compared with control (group of no intervention, treatment as usual or another rehabilitation programme with no physical exercise element) in adults with an ICD.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and four other databases on 30 August 2018 and three trials registers on 14 November 2017. We also undertook reference checking, citation searching and contacted study authors for missing data.\nSelection criteria\nWe included randomised controlled trials (RCTs) if they investigated exercise-based cardiac rehabilitation interventions compared with no intervention, treatment as usual or another rehabilitation programme. The trial participants were adults (aged 18 years or older), who had been treated with an ICD regardless of type or indication.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias. The primary outcomes were all-cause mortality, serious adverse events and health-related quality of life. The secondary outcomes were exercise capacity, antitachycardia pacing, shock, non-serious adverse events, employment or loss of employment and costs and cost-effectiveness. Risk of systematic errors (bias) was assessed by evaluation of predefined bias risk domains. Clinical and statistical heterogeneity were assessed. Meta-analyses were undertaken using both fixed-effect and random-effects models. We used the GRADE approach to assess the quality of evidence.\nMain results\nWe identified eight trials published from 2004 to 2017 randomising a total of 1730 participants, with mean intervention duration of 12 weeks. All eight trials were judged to be at overall high risk of bias and effect estimates are reported at the end of the intervention with a follow-up range of eight to 24 weeks.\nSeven trials reported all-cause mortality, but deaths only occurred in one trial with no evidence of a difference between exercise-based cardiac rehabilitation and control (risk ratio (RR) 1.96, 95% confidence interval (CI) 0.18 to 21.26; participants = 196; trials = 1; quality of evidence: low). There was also no evidence of a difference in serious adverse events between exercise-based cardiac rehabilitation and control (RR 1.05, 95% CI 0.77 to 1.44; participants = 356; trials = 2; quality of evidence: low). Due to the variation in reporting of health-related quality of life outcomes, it was not possible to pool data. However, the five trials reporting health-related quality of life at the end of the intervention, each showed little or no evidence of a difference between exercise-based cardiac rehabilitation and control.\nFor secondary outcomes, there was evidence of a higher pooled exercise capacity (peak VO2) at the end of the intervention (mean difference (MD) 0.91 mL/kg/min, 95% CI 0.60 to 1.21; participants = 1485; trials = 7; quality of evidence: very low) favouring exercise-based cardiac rehabilitation, albeit there was evidence of substantial statistical heterogeneity (I2 = 78%). There was no evidence of a difference in the risk of requiring antitachycardia pacing (RR 1.26, 95% CI 0.84 to 1.90; participants = 356; trials = 2; quality of evidence: moderate), appropriate shock (RR 0.56, 95% CI 0.20 to 1.58; participants = 428; studies = 3; quality of evidence: low) or inappropriate shock (RR 0.60, 95% CI 0.10 to 3.51; participants = 160; studies = 1; quality of evidence: moderate).\nAuthors' conclusions\nDue to a lack of evidence, we were unable to definitively assess the impact of exercise-based cardiac rehabilitation on all-cause mortality, serious adverse events and health-related quality of life in adults with an ICD. However, our findings do provide very low-quality evidence that patients following exercise-based cardiac rehabilitation experience a higher exercise capacity compared with the no exercise control. Further high-quality randomised trials are needed in order to assess the impact of exercise-based cardiac rehabilitation in this population on all-cause mortality, serious adverse events, health-related quality of life, antitachycardia pacing and shock.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The review showed no evidence of an impact on the risk of death, harmful side effects or having antitachycardia pacing or shock therapy when comparing the exercise intervention to the control. There was also little or no evidence of a difference on health-related quality of life. However, there was an improvement in exercise capacity in favour of the exercise group."
}
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query-laysum | 3549 | [
{
"role": "user",
"content": "Abstract: Background\nDelirium is a common clinical syndrome defined as alterations in attention with an additional disturbance in cognition or perception, which develop over a short period of time and tend to fluctuate during the course of the episode. Delirium is commonly treated in hospitals or community settings and is often associated with multiple adverse outcomes such as increased cost, morbidity, and even mortality. The first-line intervention involves a multicomponent non-pharmacological approach that includes ensuring effective communication and reorientation in addition to providing reassurance or a suitable care environment. There are currently no drugs approved specifically for the treatment of delirium. Clinically, however, various medications are employed to provide symptomatic relief, such as antipsychotic medications and cholinesterase inhibitors, among others.\nObjectives\nTo evaluate the effectiveness and safety of cholinesterase inhibitors for treating people with established delirium in a non-intensive care unit (ICU) setting.\nSearch methods\nWe searched ALOIS, which is the Cochrane Dementia and Cognitive Improvement Group's Specialised Register, on 26 October 2017. We also cross-checked the reference lists of included studies to identify any potentially eligible trials.\nSelection criteria\nWe included randomised controlled trials, published or unpublished, reported in English or Chinese, which compared cholinesterase inhibitors to placebo or other drugs intended to treat people with established delirium in a non-ICU setting.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. The primary outcomes were duration of delirium, severity of delirium, and adverse events. The secondary outcomes were use of rescue medications, persistent cognitive impairment, length of hospitalisation, institutionalisation, mortality, cost of intervention, leaving the study early, and quality of life. For dichotomous outcomes, we calculated the risk ratio (RR) with 95% confidence intervals (CIs); for continuous outcomes we calculated the mean difference (MD) with 95% CIs. We assessed the quality of evidence using GRADE to generate a 'Summary of findings' table.\nMain results\nWe included one study involving 15 participants from the UK. The included participants were diagnosed with delirium based on the Confusion Assessment Method (CAM) criteria. Eight males and seven females were included, with a mean age of 82.5 years. Seven of the 15 participants had comorbid dementia at baseline. The risk of bias was low in all domains.\nThe study compared rivastigmine with placebo. We did not find any clear differences between the two groups in terms of duration of delirium (MD -3.6, 95% CI -15.6 to 8.4), adverse events (nausea, RR 0.30, 95% CI 0.01 to 6.29), use of rescue medications (RR 0.13, 95% CI 0.01 to 2.1), mortality (RR 0.10, 95% CI 0.01 to 1.56), and leaving the study early (RR 0.88, 95% CI 0.07 to 11.54). Evidence was not available regarding the severity of delirium, persistent cognitive impairment, length of hospitalisation, cost of intervention, or other predefined secondary outcomes.\nThe quality of evidence is low due to the very small sample size.\nAuthors' conclusions\nThere is insufficient evidence to support or refute the use of cholinesterase inhibitors for the treatment of delirium in non-ICU settings. No clear benefits or harms associated with cholinesterase inhibitors were observed when compared with placebo due to the lack of data. More trials are required.\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": "During a period of illness, people can develop symptoms of confusion and altered consciousness, which is known as delirium. Compared to patients with no delirium, patients with delirium spend a longer time in hospital and are less likely to survive their illness. Treatment of delirium should focus on good care of the underlying illness and strategies such as reorientation of the patient. However, medication-based treatments are still often used. Medications used for treating the symptoms of dementia (cholinesterase inhibitors) may have a role in treating delirium."
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query-laysum | 3550 | [
{
"role": "user",
"content": "Abstract: Background\nMenorrhagia or heavy menstrual bleeding (HMB) is an excessive blood loss that impairs a woman's quality of life, either physical, emotional, social or material. It is benign and not associated with pregnancy or any other gynaecological or systemic disease. Medical treatments used to reduce excessive menstrual blood loss (MBL) include prostaglandin synthetase inhibitors, antifibrinolytics, oral contraceptive pills, and other hormones. The combined oral contraceptive pill (COCP) is claimed to have a variety of beneficial effects, inducing a regular shedding of a thinner endometrium and inhibiting ovulation, thus having the effect of both treating HMB and providing contraception. More recently, a contraceptive vaginal ring (CVR) has been trialled to investigate whether this treatment can provide similar benefits to COCP while lessening hormonal systemic exposure. This review is an update of a review which originally focused on COCP alone. The scope of the review has been widened to consider other types of delivery of combined hormonal contraceptives for reduction of MBL.\nObjectives\nTo determine the efficacy of combined hormonal contraceptives (pills, vaginal ring or patch) compared with other medical therapies, placebo, or no therapy in the treatment of HMB. A secondary objective was to compare the COCP with the CVR.\nSearch methods\nWe searched the Gynecology and Fertility Group trials register, MEDLINE, Embase, CENTRAL, CINAHL and PsycINFO (search dates: Oct 1996, May 2002, June 2004, April 2006, June 2009, July 2017 and September 2018) for all randomised controlled trials (RCTs) of COCP and CVR for the treatment of HMB. We also searched trial registers and the reference lists of retrieved studies for additional trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) of the use of COCP or CVR compared with no treatment, placebo, or other medical therapies for women with HMB and regular menstrual cycles.\nData collection and analysis\nAll assessments of trial quality and data extraction were performed unblinded by at least two review authors. Our primary review outcomes were treatment success, menstrual bleeding (assessed objectively, semi-objectively or subjectively), and participant satisfaction with treatment. Secondary outcomes were adverse events, quality of life, and haemoglobin level.\nMain results\nWe identified eight RCTs involving 805 participants. Two trials comparing COCP with placebo were considered to be moderate quality and the remaining studies were low to very low quality, mainly because of serious risk of bias from lack of blinding and concerns over precision.\nCOCP versus placebo\nCOCP, with a step-down oestrogen and step-up progestogen regimen, improved response to treatment (return to menstrual 'normality') (OR 22.12, 95% CI 4.40 to 111.12; 2 trials; 363 participants; I2 = 50%; moderate-quality evidence), and lowered MBL (OR 5.15, 95% CI 3.16 to 8.40; 2 trials; 339 participants; I2 = 0%; moderate-quality evidence) when compared to placebo. The results suggested that, if the chance of 'successful' treatment was 3% in women taking placebo, then COCP increased this chance from 12% to 77% in women with unacceptable HMB. Minor adverse events, in particular breast pain, were more common with COCP. No study in this comparison reported semi-objectively assessed MBL or participant satisfaction with treatment.\nCOCP versus other medical treatments\nNon-steroidal anti-inflammatory drugs (NSAIDs)\nThere was insufficient evidence to determine whether the COCP reduced MBL when compared to NSAIDs (mefenamic acid and naproxen). No study in this comparison reported semi-objectively assessed MBL, subjectively assessed MBL, participant satisfaction with treatment or adverse events.\nLevonorgestrel-releasing intrauterine system (LNG IUS)\nThe LNG IUS was more effective than COCP in reducing MBL (OR 0.21, 95% CI 0.09 to 0.48; 2 trials; 151 participants; I2 = 0%; low-quality evidence) but it was not clear whether satisfaction with treatment or adverse effects varied according to which treatment was used. No study in this comparison reported semi-objectively assessed MBL or subjectively assessed MBL.\nContraceptive vaginal ring (CVR) versus other medical treatments\nCOCP\nCOCP was compared with CVR in two trials. There were discrepancies between some of the findings and there was no evidence of a benefit for one treatment compared to the other for response to treatment, MBL or participant satisfaction with treatment. There was a greater likelihood of nausea with COCP. No study in this comparison reported objectively assessed MBL or subjectively assessed MBL.\nProgestogens\nCVR was compared to long course progestogens in one trial. It is possible that CVR increased the odds of satisfaction; but we are uncertain whether CVR improved MBL. The evidence was based on small numbers of participants and was very low quality, so definitive conclusions could not be reached. No study in this comparison reported objectively assessed MBL, subjectively assessed MBL, or adverse events.\nAuthors' conclusions\nModerate-quality evidence suggests that the combined oral contraceptive pill over six months reduces HMB in women with unacceptable HMB from 12% to 77% (compared to 3% in women taking placebo). When compared with other medical options for HMB, COCP was less effective than the LNG IUS. Limited evidence suggested that COCP and CVR had similar effects. There was insufficient evidence to determine comparative efficacy of combined hormonal contraceptives with NSAIDs, or long course progestogens.\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 that compared the oral contraceptive pill with placebo was moderate, but the evidence for the other comparisons was either low or very low in quality. The LNG IUS is more effective than the COCP at reducing menstrual bleeding but evidence was insufficient for the other treatment comparisons. This means that, although it is likely that combined hormonal contraceptives can reduce HMB, we cannot be absolutely certain how they compare with other medical treatments for reducing HMB (although LNG IUS appears to be more effective)."
}
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query-laysum | 3551 | [
{
"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: \"Funding\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "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."
}
]
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query-laysum | 3552 | [
{
"role": "user",
"content": "Abstract: Background\nCorticosteroids are widely used in the treatment of idiopathic facial paralysis (Bell's palsy), but the effectiveness of additional treatment with an antiviral agent is uncertain. This review was first published in 2001 and most recently updated in 2015. Since a significant benefit of corticosteroids for the early management of Bell's palsy has been demonstrated, the main focus of this update, as in the previous version, was to determine the effect of adding antivirals to corticosteroid treatment. We undertook this update to integrate additional evidence and to better assess the robustness of findings, taking risk of bias fully into account.\nObjectives\nTo assess the effects of antiviral treatments alone or in combination with any other therapy for Bell's palsy.\nSearch methods\nWe searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS in July 2019. We reviewed the bibliographies of the identified trials and contacted trial authors to identify additional published or unpublished data. We searched clinical trials registries for ongoing studies.\nSelection criteria\nWe considered randomised controlled trials (RCTs) or quasi-RCTs of antivirals with and without corticosteroids versus control therapies for the treatment of Bell's palsy. We excluded trials that followed-up participants for less than three months.\nData collection and analysis\nWe independently assessed trials for relevance, eligibility, and risk of bias, using standard Cochrane procedures. We performed sensitivity analyses excluding trials at high or unclear risk of bias in at least five domains, and reported these data as the primary analyses.\nMain results\nFourteen trials, including 2488 participants, met the inclusion criteria. Most were small, and most were at high or unclear risk of bias in multiple domains. We included four new studies at this update.\nIncomplete recovery\nA combination of antivirals and corticosteroids may have little or no effect on rates of incomplete recovery in people with Bell's palsy compared to corticosteroids alone (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.38 to 1.74; 3 trials, N = 766; random-effects; low-certainty evidence). We excluded 10 trials that were at high or unclear risk of bias in several domains from this analysis and limited all analyses to studies at lower risk of bias. Recovery rates were better in participants receiving corticosteroids alone than antivirals alone (RR 2.69, 95% CI 0.73 to 10.01; 2 trials, N = 667; random-effects), but the result was imprecise and allowed for the possibility of no effect. The rate of incomplete recovery was lower with antivirals plus corticosteroids than with placebo or no treatment (RR 0.56, 95% CI 0.42 to 0.76; 2 trials, N = 658; random-effects). Antivirals alone had no clear effect on incomplete recovery rates compared with placebo, but the result was imprecise (RR 1.10, 95% CI 0.87 to 1.40; 2 trials, N = 658; fixed-effect). For people with severe Bell's palsy (House-Brackmann score of 5 and 6, or equivalent on other scales), we found that the combination of antivirals and corticosteroids had no clear effect on incomplete recovery at month six compared to corticosteroids alone, although the result was again imprecise (RR 0.82, 95% CI 0.57 to 1.17; 2 trials, N = 98; random-effects).\nMotor synkinesis or crocodile tears\nAntivirals plus corticosteroids reduced the proportion of participants who experienced these long-term sequelae from Bell's palsy compared to placebo plus corticosteroids (RR 0.56, 95% CI 0.36 to 0.87; 2 trials, N = 469; fixed-effect; moderate-certainty evidence). Antivirals plus corticosteroids reduced long-term sequelae compared to placebo but there was no clear difference in this outcome with antivirals alone compared to placebo.\nAdverse events\nAdverse event data were available in four studies providing data on 1592 participants. None of the four comparisons showed clear differences in adverse events between treatment and comparison arms (very low-certainty evidence); for the comparison of antivirals plus corticosteroids and corticosteroids alone in studies at lower risk of bias, the RR was 1.17 (95% CI 0.81 to 1.69; 2 trials, N = 656; fixed-effect; very low-certainty evidence).\nAuthors' conclusions\nThe combination of antivirals and corticosteroids may have little or no effect on rates of incomplete recovery in comparison to corticosteroids alone in Bell's palsy of various degrees of severity, or in people with severe Bell's palsy, but the results were very imprecise. Corticosteroids alone were probably more effective than antivirals alone and antivirals plus corticosteroids were more effective than placebo or no treatment. There was no clear benefit from antivirals alone over placebo.\nThe combination of antivirals and corticosteroids probably reduced the late sequelae of Bell's palsy compared with corticosteroids alone. Studies also showed fewer episodes of long-term sequelae in corticosteroid-treated participants than antiviral-treated participants.\nWe found no clear difference in adverse events from the use of antivirals compared with either placebo or corticosteroids, but the evidence is too uncertain for us to draw conclusions.\nAn adequately powered RCT in people with Bell’s palsy that compares different antiviral agents may be indicated.\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": "The review showed that there may be no clear difference in rates of incomplete recovery from Bell's palsy after treatment with the combination of antivirals and corticosteroids, compared to corticosteroids alone. This finding was of low certainty and was based on data from three trials involving 766 people with Bell's palsy of various degrees of severity. We excluded data from 10 trials with multiple potential sources of bias. However, we can be moderately confident that the combined therapy reduced the number of people left with long-term effects of Bell's palsy (excessive tearing of the eyes or an abnormal facial movement) compared to corticosteroid treatment alone.\nData from two studies (98 participants) showed that in people with severe Bell's palsy (complete or almost complete facial paralysis), combined antivirals and corticosteroids had no clear effect on recovery compared with corticosteroid treatment alone.\nCorticosteroids alone were more effective than antivirals alone on rates of incomplete recovery (667 participants, 2 trials); antivirals and corticosteroids combined were more effective than placebo or no treatment (658 participants, 2 trials); and there was no clear benefit from antivirals alone over placebo (658 participants, 2 trials).\nAlthough, based on data from two trials (656 participants), we found no clear difference in the occurrence of side effects between people receiving both antivirals and corticosteroids, compared to those receiving corticosteroids alone, this evidence is too uncertain for us to draw conclusions.\nLarge studies in people with Bell's palsy comparing additional antiviral agents may be indicated in the future."
}
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query-laysum | 3553 | [
{
"role": "user",
"content": "Abstract: Background\nAntibiotic resistance is a major public health problem. Infections caused by multidrug-resistant bacteria are associated with prolonged hospital stay and death compared with infections caused by susceptible bacteria. Appropriate antibiotic use in hospitals should ensure effective treatment of patients with infection and reduce unnecessary prescriptions. We updated this systematic review to evaluate the impact of interventions to improve antibiotic prescribing to hospital inpatients.\nObjectives\nTo estimate the effectiveness and safety of interventions to improve antibiotic prescribing to hospital inpatients and to investigate the effect of two intervention functions: restriction and enablement.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE, and Embase. We searched for additional studies using the bibliographies of included articles and personal files. The last search from which records were evaluated and any studies identified incorporated into the review was January 2015.\nSelection criteria\nWe included randomised controlled trials (RCTs) and non-randomised studies (NRS). We included three non-randomised study designs to measure behavioural and clinical outcomes and analyse variation in the effects: non- randomised trials (NRT), controlled before-after (CBA) studies and interrupted time series (ITS) studies. For this update we also included three additional NRS designs (case control, cohort, and qualitative studies) to identify unintended consequences. Interventions included any professional or structural interventions as defined by the Cochrane Effective Practice and Organisation of Care Group. We defined restriction as 'using rules to reduce the opportunity to engage in the target behaviour (or increase the target behaviour by reducing the opportunity to engage in competing behaviours)'. We defined enablement as 'increasing means/reducing barriers to increase capability or opportunity'. The main comparison was between intervention and no intervention.\nData collection and analysis\nTwo review authors extracted data and assessed study risk of bias. We performed meta-analysis and meta-regression of RCTs and meta-regression of ITS studies. We classified behaviour change functions for all interventions in the review, including those studies in the previously published versions. We analysed dichotomous data with a risk difference (RD). We assessed certainty of evidence with GRADE criteria.\nMain results\nThis review includes 221 studies (58 RCTs, and 163 NRS). Most studies were from North America (96) or Europe (87). The remaining studies were from Asia (19), South America (8), Australia (8), and the East Asia (3). Although 62% of RCTs were at a high risk of bias, the results for the main review outcomes were similar when we restricted the analysis to studies at low risk of bias.\nMore hospital inpatients were treated according to antibiotic prescribing policy with the intervention compared with no intervention based on 29 RCTs of predominantly enablement interventions (RD 15%, 95% confidence interval (CI) 14% to 16%; 23,394 participants; high-certainty evidence). This represents an increase from 43% to 58% .There were high levels of heterogeneity of effect size but the direction consistently favoured intervention.\nThe duration of antibiotic treatment decreased by 1.95 days (95% CI 2.22 to 1.67; 14 RCTs; 3318 participants; high-certainty evidence) from 11.0 days. Information from non-randomised studies showed interventions to be associated with improvement in prescribing according to antibiotic policy in routine clinical practice, with 70% of interventions being hospital-wide compared with 31% for RCTs. The risk of death was similar between intervention and control groups (11% in both arms), indicating that antibiotic use can likely be reduced without adversely affecting mortality (RD 0%, 95% CI -1% to 0%; 28 RCTs; 15,827 participants; moderate-certainty evidence). Antibiotic stewardship interventions probably reduce length of stay by 1.12 days (95% CI 0.7 to 1.54 days; 15 RCTs; 3834 participants; moderate-certainty evidence). One RCT and six NRS raised concerns that restrictive interventions may lead to delay in treatment and negative professional culture because of breakdown in communication and trust between infection specialists and clinical teams (low-certainty evidence).\nBoth enablement and restriction were independently associated with increased compliance with antibiotic policies, and enablement enhanced the effect of restrictive interventions (high-certainty evidence). Enabling interventions that included feedback were probably more effective than those that did not (moderate-certainty evidence).\nThere was very low-certainty evidence about the effect of the interventions on reducing Clostridium difficile infections (median -48.6%, interquartile range -80.7% to -19.2%; 7 studies). This was also the case for resistant gram-negative bacteria (median -12.9%, interquartile range -35.3% to 25.2%; 11 studies) and resistant gram-positive bacteria (median -19.3%, interquartile range -50.1% to +23.1%; 9 studies). There was too much variance in microbial outcomes to reliably assess the effect of change in antibiotic use.\nHeterogeneity of intervention effect on prescribing outcomes\nWe analysed effect modifiers in 29 RCTs and 91 ITS studies. Enablement and restriction were independently associated with a larger effect size (high-certainty evidence). Feedback was included in 4 (17%) of 23 RCTs and 20 (47%) of 43 ITS studies of enabling interventions and was associated with greater intervention effect. Enablement was included in 13 (45%) of 29 ITS studies with restrictive interventions and enhanced intervention effect.\nAuthors' conclusions\nWe found high-certainty evidence that interventions are effective in increasing compliance with antibiotic policy and reducing duration of antibiotic treatment. Lower use of antibiotics probably does not increase mortality and likely reduces length of stay. Additional trials comparing antibiotic stewardship with no intervention are unlikely to change our conclusions. Enablement consistently increased the effect of interventions, including those with a restrictive component. Although feedback further increased intervention effect, it was used in only a minority of enabling interventions. Interventions were successful in safely reducing unnecessary antibiotic use in hospitals, despite the fact that the majority did not use the most effective behaviour change techniques. Consequently, effective dissemination of our findings could have considerable health service and policy impact. Future research should instead focus on targeting treatment and assessing other measures of patient safety, assess different stewardship interventions, and explore the barriers and facilitators to implementation. More research is required on unintended consequences of restrictive interventions.\n\nGiven the provided abstract, please respond to the following query: \"Review aim\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane review was to learn of ways to improve how physicians working in hospital settings prescribe antibiotics. We collected and analysed all relevant studies to answer this question and found 221 studies."
}
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query-laysum | 3554 | [
{
"role": "user",
"content": "Abstract: Background\nBronchopulmonary dysplasia (BPD) remains an important cause of mortality and morbidity in preterm infants and inflammation plays a significant role in its pathogenesis. The use of inhaled corticosteroids may modulate the inflammatory process without concomitant high systemic steroid concentrations and less risk of adverse effects. This is an update of a review published in 2012 (Shah 2012). We recently updated the related review on \"Inhaled versus systemic corticosteroids for treating bronchopulmonary dysplasia in ventilated very low birth weight preterm neonates\".\nObjectives\nTo determine the effect of inhaled versus systemic corticosteroids started within the first 7 days of life on preventing death or BPD in ventilated very low birth weight infants.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2017, Issue 1), MEDLINE via PubMed (1966 to 23 February 2017), Embase (1980 to 23 February 2017), and CINAHL (1982 to 23 February 2017). We searched clinical trials registers, conference proceedings and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials.\nSelection criteria\nRandomised or quasi-randomised controlled trials comparing inhaled versus systemic corticosteroid therapy (irrespective of dose and duration) starting in the first seven days of life in very low birth weight preterm infants receiving assisted ventilation.\nData collection and analysis\nClinical outcomes data were extracted and analysed using Review Manager. When appropriate, meta-analysis was performed using typical relative risk (RR), typical risk difference (RD) and weighted mean difference (WMD). Meta-analyses were performed using typical relative risk, typical risk difference (RD), and weighted mean difference with their 95% confidence intervals (CI). If RD was statistically significant, the number needed to benefit or the number needed to harm was calculated. We assessed the quality of evidence was evaluated using GRADE principles.\nMain results\nWe included two trials that involved 294 infants. No new studies were included for the 2017 update. The incidence of death or BPD at 36 weeks' postmenstrual age was not statistically significantly different between infants who received inhaled or systemic steroids (RR 1.09, 95% CI 0.88 to 1.35; RD 0.05, 95% CI -0.07 to 0.16; 1 trial, N = 278). The incidence of BPD at 36 weeks' postmenstrual age among survivors was not statistically significant between groups (RR 1.34, 95% CI 0.94 to 1.90; RD 0.11, 95% CI -0.02 to 0.24; 1 trial, N = 206). There was no statistically significant difference in the outcomes of BPD at 28 days, death at 28 days or 36 weeks' postmenstrual age and the combined outcome of death or BPD by 28 days between groups (2 trials, N = 294). The duration of mechanical ventilation was significantly longer in the inhaled steroid group compared with the systemic steroid group (typical MD 4 days, 95% CI 0.2 to 8; 2 trials, N = 294; I² = 0%) as was the duration of supplemental oxygen (typical MD 11 days, 95% CI 2 to 20; 2 trials, N = 294; I² = 33%).\nThe incidence of hyperglycaemia was significantly lower with inhaled steroids (RR 0.52, 95% CI 0.39 to 0.71; RD -0.25, 95% CI -0.37 to -0.14; 1 trial, N = 278; NNTB 4, 95% CI 3 to 7 to avoid 1 infant experiencing hyperglycaemia). The rate of patent ductus arteriosus increased in the group receiving inhaled steroids (RR 1.64, 95% CI 1.23 to 2.17; RD 0.21, 95% CI 0.10 to 0.33; 1 trial, N = 278; NNTH 5, 95% CI 3 to 10). In a subset of surviving infants in the United Kingdom and Ireland there were no significant differences in developmental outcomes at 7 years of age. However, there was a reduced risk of having ever been diagnosed as asthmatic by 7 years of age in the inhaled steroid group compared with the systemic steroid group (N = 48) (RR 0.42, 95% CI 0.19 to 0.94; RD -0.31, 95% CI -0.58 to -0.05; NNTB 3, 95% CI 2 to 20).\nAccording to GRADE the quality of the evidence was moderate to low. Evidence was downgraded on the basis of design (risk of bias), consistency (heterogeneity) and precision of the estimates.\nBoth studies received grant support and the industry provided aero chambers and metered dose inhalers of budesonide and placebo for the larger study. No conflict of interest was identified.\nAuthors' conclusions\nWe found no evidence that early inhaled steroids confer important advantages over systemic steroids in the management of ventilator-dependent preterm infants. Based on this review inhaled steroids cannot be recommended over systemic steroids as a part of standard practice for ventilated preterm infants. Because they might have fewer adverse effects than systemic steroids, further randomised controlled trials of inhaled steroids are needed that address risk/benefit ratio of different delivery techniques, dosing schedules and long-term effects, with particular attention to neurodevelopmental outcome.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "According to GRADE the quality of the evidence was moderate to low."
}
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query-laysum | 3555 | [
{
"role": "user",
"content": "Abstract: Background\nEczema is a common skin condition. Although topical corticosteroids have been a first-line treatment for eczema for decades, there are uncertainties over their optimal use.\nObjectives\nTo establish the effectiveness and safety of different ways of using topical corticosteroids for treating eczema.\nSearch methods\nWe searched databases to January 2021 (Cochrane Skin Specialised Register; CENTRAL; MEDLINE; Embase; GREAT) and five clinical trials registers. We checked bibliographies from included trials to identify further trials.\nSelection criteria\nRandomised controlled trials in adults and children with eczema that compared at least two strategies of topical corticosteroid use. We excluded placebo comparisons, other than for trials that evaluated proactive versus reactive treatment.\nData collection and analysis\nWe used standard Cochrane methods, with GRADE certainty of evidence for key findings. Primary outcomes were changes in clinician-reported signs and relevant local adverse events. Secondary outcomes were patient-reported symptoms and relevant systemic adverse events. For local adverse events, we prioritised abnormal skin thinning as a key area of concern for healthcare professionals and patients.\nMain results\nWe included 104 trials (8443 participants). Most trials were conducted in high-income countries (81/104), most likely in outpatient or other hospital settings. We judged only one trial to be low risk of bias across all domains. Fifty-five trials had high risk of bias in at least one domain, mostly due to lack of blinding or missing outcome data.\nStronger-potency versus weaker-potency topical corticosteroids\nSixty-three trials compared different potencies of topical corticosteroids: 12 moderate versus mild, 22 potent versus mild, 25 potent versus moderate, and 6 very potent versus potent. Trials were usually in children with moderate or severe eczema, where specified, lasting one to five weeks. The most reported outcome was Investigator Global Assessment (IGA) of clinician-reported signs of eczema.\nWe pooled four trials that compared moderate- versus mild-potency topical corticosteroids (420 participants). Moderate-potency topical corticosteroids probably result in more participants achieving treatment success, defined as cleared or marked improvement on IGA (52% versus 34%; odds ratio (OR) 2.07, 95% confidence interval (CI) 1.41 to 3.04; moderate-certainty evidence). We pooled nine trials that compared potent versus mild-potency topical corticosteroids (392 participants). Potent topical corticosteroids probably result in a large increase in number achieving treatment success (70% versus 39%; OR 3.71, 95% CI 2.04 to 6.72; moderate-certainty evidence). We pooled 15 trials that compared potent versus moderate-potency topical corticosteroids (1053 participants). There was insufficient evidence of a benefit of potent topical corticosteroids compared to moderate topical corticosteroids (OR 1.33, 95% CI 0.93 to 1.89; moderate-certainty evidence). We pooled three trials that compared very potent versus potent topical corticosteroids (216 participants). The evidence is uncertain with a wide confidence interval (OR 0.53, 95% CI 0.13 to 2.09; low-certainty evidence).\nTwice daily or more versus once daily application\nWe pooled 15 of 25 trials in this comparison (1821 participants, all reported IGA). The trials usually assessed adults and children with moderate or severe eczema, where specified, using potent topical corticosteroids, lasting two to six weeks.\nApplying potent topical corticosteroids only once a day probably does not decrease the number achieving treatment success compared to twice daily application (OR 0.97, 95% CI 0.68 to 1.38; 15 trials, 1821 participants; moderate-certainty evidence).\nLocal adverse events\nWithin the trials that tested 'treating eczema flare-up' strategies, we identified only 26 cases of abnormal skin thinning from 2266 participants (1% across 22 trials). Most cases were from the use of higher-potency topical corticosteroids (16 with very potent, 6 with potent, 2 with moderate and 2 with mild). We assessed this evidence as low certainty, except for very potent versus potent topical corticosteroids, which was very low-certainty evidence.\nLonger versus shorter-term duration of application for induction of remission\nNo trials were identified.\nTwice weekly application (weekend, or ‘proactive therapy') to prevent relapse (flare-ups) versus no topical corticosteroids/reactive application\nNine trials assessed this comparison, generally lasting 16 to 20 weeks. We pooled seven trials that compared weekend (proactive) topical corticosteroids therapy versus no topical corticosteroids (1179 participants, children and adults with a range of eczema severities, though mainly moderate or severe).\nWeekend (proactive) therapy probably results in a large decrease in likelihood of a relapse from 58% to 25% (risk ratio (RR) 0.43, 95% CI 0.32 to 0.57; 7 trials, 1149 participants; moderate-certainty evidence).\nLocal adverse events\nWe did not identify any cases of abnormal skin thinning in seven trials that assessed skin thinning (1050 participants) at the end of treatment. We assessed this evidence as low certainty.\nOther comparisons\nOther comparisons included newer versus older preparations of topical corticosteroids (15 trials), cream versus ointment (7 trials), topical corticosteroids with wet wrap versus no wet wrap (6 trials), number of days per week applied (4 trials), different concentrations of the same topical corticosteroids (2 trials), time of day applied (2 trials), topical corticosteroids alternating with topical calcineurin inhibitors versus topical corticosteroids alone (1 trial), application to wet versus dry skin (1 trial) and application before versus after emollient (1 trial). No trials compared branded versus generic topical corticosteroids and time between application of emollient and topical corticosteroids.\nAuthors' conclusions\nPotent and moderate topical corticosteroids are probably more effective than mild topical corticosteroids, primarily in moderate or severe eczema; however, there is uncertain evidence to support any advantage of very potent over potent topical corticosteroids. Effectiveness is similar between once daily and twice daily (or more) frequent use of potent topical corticosteroids to treat eczema flare-ups, and topical corticosteroids weekend (proactive) therapy is probably better than no topical corticosteroids/reactive use to prevent eczema relapse (flare-ups). Adverse events were not well reported and came largely from low- or very low-certainty, short-term trials. In trials that reported abnormal skin thinning, frequency was low overall and increased with increasing potency. We found no trials on the optimum duration of treatment of a flare, branded versus generic topical corticosteroids, and time to leave between application of topical corticosteroids and emollient. There is a need for longer-term trials, in people with mild eczema.\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": "- Generally, stronger topical corticosteroids (steroid cream applied to the skin) are probably more effective than weaker preparations. Strong steroid cream applied once daily is probably as good as twice daily, and using steroid cream for two consecutive days weekly probably prevents eczema flare-ups.\n- About a third of studies looked for skin thinning, but cases were very low. This made it difficult to judge differences between strategies, although there were more cases with stronger steroid cream.\n- We need better-quality research on unwanted effects, over longer timeframes, but intermittent use of steroid cream probably causes fewer unwanted effects."
}
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query-laysum | 3556 | [
{
"role": "user",
"content": "Abstract: Background\nCoronary heart disease (CHD) is the most common cause of death globally, although mortality rates are falling. Psychological symptoms are prevalent for people with CHD, and many psychological treatments are offered following cardiac events or procedures with the aim of improving health and outcomes. This is an update of a Cochrane systematic review previously published in 2011.\nObjectives\nTo assess the effectiveness of psychological interventions (alone or with cardiac rehabilitation) compared with usual care (including cardiac rehabilitation where available) for people with CHD on total mortality and cardiac mortality; cardiac morbidity; and participant-reported psychological outcomes of levels of depression, anxiety, and stress; and to explore potential study-level predictors of the effectiveness of psychological interventions in this population.\nSearch methods\nWe updated the previous Cochrane Review searches by searching the following databases on 27 April 2016: CENTRAL in the Cochrane Library, MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid), and CINAHL (EBSCO).\nSelection criteria\nWe included randomised controlled trials (RCTs) of psychological interventions compared to usual care, administered by trained staff, and delivered to adults with a specific diagnosis of CHD. We selected only studies estimating the independent effect of the psychological component, and with a minimum follow-up of six months. The study population comprised of adults after: a myocardial infarction (MI), a revascularisation procedure (coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI)), and adults with angina or angiographically defined coronary artery disease (CAD). RCTs had to report at least one of the following outcomes: mortality (total- or cardiac-related); cardiac morbidity (MI, revascularisation procedures); or participant-reported levels of depression, anxiety, or stress.\nData collection and analysis\nTwo review authors independently screened titles and abstracts of all references for eligibility. A lead review author extracted study data, which a second review author checked. We contacted study authors to obtain missing information.\nMain results\nThis review included 35 studies which randomised 10,703 people with CHD (14 trials and 2577 participants added to this update). The population included mainly men (median 77.0%) and people post-MI (mean 65.7%) or after undergoing a revascularisation procedure (mean 27.4%). The mean age of participants within trials ranged from 53 to 67 years. Overall trial reporting was poor, with around a half omitting descriptions of randomisation sequence generation, allocation concealment procedures, or the blinding of outcome assessments. The length of follow-up ranged from six months to 10.7 years (median 12 months). Most studies (23/35) evaluated multifactorial interventions, which included therapies with multiple therapeutic components. Ten studies examined psychological interventions targeted at people with a confirmed psychopathology at baseline and two trials recruited people with a psychopathology or another selecting criterion (or both). Of the remaining 23 trials, nine studies recruited unselected participants from cardiac populations reporting some level of psychopathology (3.8% to 53% with depressive symptoms, 32% to 53% with anxiety), 10 studies did not report these characteristics, and only three studies excluded people with psychopathology.\nModerate quality evidence showed no risk reduction for total mortality (risk ratio (RR) 0.90, 95% confidence interval (CI) 0.77 to 1.05; participants = 7776; studies = 23) or revascularisation procedures (RR 0.94, 95% CI 0.81 to 1.11) with psychological therapies compared to usual care. Low quality evidence found no risk reduction for non-fatal MI (RR 0.82, 95% CI 0.64 to 1.05), although there was a 21% reduction in cardiac mortality (RR 0.79, 95% CI 0.63 to 0.98). There was also low or very low quality evidence that psychological interventions improved participant-reported levels of depressive symptoms (standardised mean difference (SMD) -0.27, 95% CI -0.39 to -0.15; GRADE = low), anxiety (SMD -0.24, 95% CI -0.38 to -0.09; GRADE = low), and stress (SMD -0.56, 95% CI -0.88 to -0.24; GRADE = very low).\nThere was substantial statistical heterogeneity for all psychological outcomes but not clinical outcomes, and there was evidence of small-study bias for one clinical outcome (cardiac mortality: Egger test P = 0.04) and one psychological outcome (anxiety: Egger test P = 0.012). Meta-regression exploring a limited number of intervention characteristics found no significant predictors of intervention effects for total mortality and cardiac mortality. For depression, psychological interventions combined with adjunct pharmacology (where deemed appropriate) for an underlying psychological disorder appeared to be more effective than interventions that did not (β = -0.51, P = 0.003). For anxiety, interventions recruiting participants with an underlying psychological disorder appeared more effective than those delivered to unselected populations (β = -0.28, P = 0.03).\nAuthors' conclusions\nThis updated Cochrane Review found that for people with CHD, there was no evidence that psychological treatments had an effect on total mortality, the risk of revascularisation procedures, or on the rate of non-fatal MI, although the rate of cardiac mortality was reduced and psychological symptoms (depression, anxiety, or stress) were alleviated; however, the GRADE assessments suggest considerable uncertainty surrounding these effects. Considerable uncertainty also remains regarding the people who would benefit most from treatment (i.e. people with or without psychological disorders at baseline) and the specific components of successful interventions. Future large-scale trials testing the effectiveness of psychological therapies are required due to the uncertainty within the evidence. Future trials would benefit from testing the impact of specific (rather than multifactorial) psychological interventions for participants with CHD, and testing the targeting of interventions on different populations (i.e. people with CHD, with or without psychopathologies).\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is considerable uncertainty regarding the effects observed, as the quality of the evidence was either low (for cardiac mortality, non-fatal heart attack, depression, anxiety) or very low (for stress) for most measures, except deaths (any cause) or cardiac surgery, both of which had moderate quality of evidence."
}
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query-laysum | 3557 | [
{
"role": "user",
"content": "Abstract: Background\nThere is growing interest in paying for performance (P4P) as a means to align the incentives of healthcare providers with public health goals. Rigorous evidence on the effectiveness of these strategies in improving health care and health in low- and middle-income countries (LMICs) is lacking; this is an update of the 2012 review on this topic.\nObjectives\nTo assess the effects of paying for performance on the provision of health care and health outcomes in low- and middle-income countries.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and 10 other databases between April and June 2018. We also searched two trial registries, websites, online resources of international agencies, organizations and universities, and contacted experts in the field. Studies identified from rerunning searches in 2020 are under 'Studies awaiting classification.'\nSelection criteria\nWe included randomized or non-randomized trials, controlled before-after studies, or interrupted time series studies conducted in LMICs (as defined by the World Bank in 2018). P4P refers to the transfer of money or material goods conditional on taking a measurable action or achieving a predetermined performance target. To be included, a study had to report at least one of the following outcomes: patient health outcomes, changes in targeted measures of provider performance (such as the delivery of healthcare services), unintended effects, or changes in resource use.\nData collection and analysis\nWe extracted data as per original review protocol and narratively synthesised findings. We used standard methodological procedures expected by Cochrane. Given diversity and variability in intervention types, patient populations, analyses and outcome reporting, we deemed meta-analysis inappropriate. We noted the range of effects associated with P4P against each outcome of interest. Based on intervention descriptions provided in documents, we classified design schemes and explored variation in effect by scheme design.\nMain results\nWe included 59 studies: controlled before-after studies (19), non-randomized (16) or cluster randomized trials (14); and interrupted time-series studies (9). One study included both an interrupted time series and a controlled before-after study.\nStudies focused on a wide range of P4P interventions, including target payments and payment for outputs as modified by quality (or quality and equity assessments). Only one study assessed results-based aid. Many schemes were funded by national governments (23 studies) with the World Bank funding most externally funded schemes (11 studies). Targeted services varied; however, most interventions focused on reproductive, maternal and child health indicators. Participants were predominantly located in public or in a mix of public, non-governmental and faith-based facilities (54 studies). P4P was assessed predominantly at health facility level, though districts and other levels were also involved.\nMost studies assessed the effects of P4P against a status quo control (49 studies); however, some studies assessed effects against comparator interventions (predominantly enhanced financing intended to match P4P funds (17 studies)). Four studies reported intervention effects against both comparator and status quo.\nControlled before-after studies were at higher risk of bias than other study designs. However, some randomised trials were also downgraded due to risk of bias. The interrupted time-series studies provided insufficient information on other concurrent changes in the study context.\nP4P compared to a status quo control\nFor health services that are specifically targeted, P4P may slightly improve health outcomes (low certainty evidence), but few studies assessed this. P4P may also improve service quality overall (low certainty evidence); and probably increases the availability of health workers, medicines and well-functioning infrastructure and equipment (moderate certainty evidence). P4P may have mixed effects on the delivery and use of services (low certainty evidence) and may have few or no distorting unintended effects on outcomes that were not targeted (low-certainty evidence), but few studies assessed these. For secondary outcomes, P4P may make little or no difference to provider absenteeism, motivation or satisfaction (low certainty evidence); but may improve patient satisfaction and acceptability (low certainty evidence); and may positively affect facility managerial autonomy (low certainty evidence). P4P probably makes little to no difference to management quality or facility governance (low certainty evidence). Impacts on equity were mixed (low certainty evidence).\nFor health services that are untargeted, P4P probably improves some health outcomes (moderate certainty evidence); may improve the delivery, use and quality of some health services but may make little or no difference to others (low certainty evidence); and may have few or no distorting unintended effects (low certainty evidence). The effects of P4P on the availability of medicines and other resources are uncertain (very low certainty evidence).\nP4P compared to other strategies\nFor health outcomes and services that are specifically targeted, P4P may make little or no difference to health outcomes (low certainty evidence), but few studies assessed this. P4P may improve service quality (low certainty evidence); and may have mixed effects on the delivery and use of health services and on the availability of equipment and medicines (low certainty evidence).\nFor health outcomes and services that are untargeted, P4P may make little or no difference to health outcomes and to the delivery and use of health services (low certainty evidence). The effects of P4P on service quality, resource availability and unintended effects are uncertain (very low certainty evidence).\nFindings of subgroup analyses\nResults-based aid, and schemes using payment per output adjusted for service quality, appeared to yield the greatest positive effects on outcomes. However, only one study evaluated results-based aid, so the effects may be spurious. Overall, schemes adjusting both for quality of service and rewarding equitable delivery of services appeared to perform best in relation to service utilization outcomes.\nAuthors' conclusions\nThe evidence base on the impacts of P4P schemes has grown considerably, with study quality gradually increasing. P4P schemes may have mixed effects on outcomes of interest, and there is high heterogeneity in the types of schemes implemented and evaluations conducted. P4P is not a uniform intervention, but rather a range of approaches. Its effects depend on the interaction of several variables, including the design of the intervention (e.g., who receives payments ), the amount of additional funding, ancillary components (such as technical support) and contextual factors (including organizational context).\n\nGiven the provided abstract, please respond to the following query: \"The effects of paying for performance compared to business as usual\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "For health services that are specifically targeted, pay for performance:\n- may improve some health outcomes, may improve service quality and probably increase the availability of health workers, medicines and well-functioning infrastructure and equipment; but\n- may have both positive and negative effects on the delivery and use of health services.\nFor health services that are untargeted, pay for performance:\n- probably improves some health outcomes;\n- may improve the delivery, use and quality of some health services but may make little or no difference to others; and\n- may have few or no unintended effects.\nWe don’t know what the effects of pay for performance are on the availability of medicines and other resources because the evidence was of very low certainty"
}
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query-laysum | 3558 | [
{
"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: \"Bottom line\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review found that most people with moderate or severe pain after an operation get good pain relief from taking ketoprofen 50 mg or dexketoprofen 25 mg."
}
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query-laysum | 3559 | [
{
"role": "user",
"content": "Abstract: Background\nPanic disorder is common in the general population. It is often associated with other psychiatric disorders, such as drug dependence, major depression, bipolar disorder, social phobia, specific phobia and generalised anxiety disorder. Azapirones are a class of drugs used as anxiolytics. They are associated with less drowsiness, psychomotor impairment, alcohol potentiation and potential for addiction or abuse than benzodiazepines. However, azapirones are not widely used in the treatment of panic disorder and evidence for their efficacy is unclear. It is important to find out if azapirones are effective and acceptable in the treatment of panic disorder.\nObjectives\nTo assess the effects of azapirones on panic disorder in adults, specifically:\n1. to determine the efficacy of azapirones in alleviating symptoms of panic disorder, with or without agoraphobia, in comparison with placebo;\n2. to review the acceptability of azapirones in panic disorder, with or without agoraphobia, in comparison with placebo; and\n3. to investigate adverse effects of azapirones in panic disorder with or without agoraphobia, including general prevalence of adverse effects, compared with placebo.\nSearch methods\nWe searched the Cochrane Depression Anxiety and Neurosis Group Trials Specialised Register (CCDANCTR, search date: 10th January 2014), which includes relevant randomised controlled trials from The Cochrane Library (all years), MEDLINE (1950-), EMBASE (1974-), and PsycINFO (1967-).\nSelection criteria\nRandomised controlled trials that compared azapirones with placebo for panic disorder in adults.\nData collection and analysis\nThree review authors independently identified studies, assessed trial quality and extracted data. We contacted study authors for additional information.\nMain results\nThree studies involving 170 participants compared the azapirone buspirone with placebo. No study provided enough usable information on our primary efficacy outcome (response). For our primary acceptability outcome, moderate-quality evidence indicated that azapirones had lower acceptability than placebo: risk ratio (RR) for dropouts for any reason 2.13 (95% confidence interval (CI) 1.11 to 4.07; 3 studies, 170 participants. Evidence for secondary efficacy outcomes were of low quality. Results on efficacy between azapirone and placebo in terms of agoraphobia (standardised mean difference (SMD) -0.01, 95% CI -0.56 to 0.53; 1 study, 52 participants), general anxiety (mean difference (MD) -2.20, 95% CI -5.45 to 1.06; 2 studies, 115 participants) and depression (MD -1.80, 95% CI -5.60 to 2.00; 1 study, 52 participants) were uncertain. None of the studies provided information for the assessment of allocation concealment or sequence generation. Conflicts of interest were not explicitly expressed. The risk of attrition bias was rated high for all three studies. Information on adverse effects other than dropouts for any reason was insufficient to include in the analyses.\nAuthors' conclusions\nThe efficacy of azapirones is uncertain due to the lack of meta-analysable data for the primary outcome and low-quality evidence for secondary efficacy outcomes. A small amount of moderate-quality evidence suggested that the acceptability of azapirones for panic disorder was lower than for placebo. However, only trials of one azapirone (namely buspirone) were included in this review; this, combined with the small sample size, limits our conclusions. If further research is to be conducted, studies with larger sample sizes, with different azapirones and with less risk of bias are necessary to draw firm conclusions regarding azapirones for panic disorder.\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": "Panic disorder is common in the general population and is often associated with various psychiatric disorders. Azapirones are a class of drugs occasionally used in the treatment of panic disorder, although none has been approved by a regulatory agency for this purpose. They are associated with less drowsiness, psychomotor impairment, alcohol potentiation and potential for addiction or abuse. However, azapirones are not widely used for panic disorder. Evidence for their efficacy in treating panic disorder is unclear. It is important to find out if azapirones are effective and acceptable in the treatment of panic disorder."
}
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query-laysum | 3560 | [
{
"role": "user",
"content": "Abstract: Background\nVarious rehabilitation treatments may be offered following carpal tunnel syndrome (CTS) surgery. The effectiveness of these interventions remains unclear. This is the first update of a review first published in 2013.\nObjectives\nTo review the effectiveness and safety of rehabilitation interventions following CTS surgery compared with no treatment, placebo, or another intervention.\nSearch methods\nOn 29 September 2015, we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL Plus, AMED, LILACS, and PsycINFO. We also searched PEDro (3 December 2015) and clinical trials registers (3 December 2015).\nSelection criteria\nRandomised or quasi-randomised clinical trials that compared any postoperative rehabilitation intervention with either no intervention, placebo, or another postoperative rehabilitation intervention in individuals who had undergone CTS surgery.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data, assessed risk of bias, and assessed the quality of the body of evidence for primary outcomes using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach according to standard Cochrane methodology.\nMain results\nIn this review we included 22 trials with a total of 1521 participants. Two of the trials were newly identified at this update. We studied different rehabilitation treatments including immobilisation using a wrist orthosis, dressings, exercise, controlled cold therapy, ice therapy, multi-modal hand rehabilitation, laser therapy, electrical modalities, scar desensitisation, and arnica. Three trials compared a rehabilitation treatment to a placebo, four compared rehabilitation to a no treatment control, three compared rehabilitation to standard care, and 15 compared various rehabilitation treatments to one another.\nOverall, the included studies were very low in quality. Thirteen trials explicitly reported random sequence generation; of these, five adequately concealed the allocation sequence. Four trials achieved blinding of both participants and outcome assessors. Five were at high risk of bias from incompleteness of outcome data at one or more time intervals, and eight had high risk of selective reporting bias.\nThese trials were heterogeneous in terms of treatments provided, duration of interventions, the nature and timing of outcomes measured, and setting. Therefore, we were not able to pool results across trials.\nFour trials reported our primary outcome, change in self reported functional ability at three months or more. Of these, three trials provided sufficient outcome data for inclusion in this review. One small high-quality trial studied a desensitisation programme compared with standard treatment and revealed no statistically significant functional benefit based on the Boston Carpal Tunnel Questionnaire (BCTQ) (mean difference (MD) -0.03, 95% confidence interval (CI) -0.39 to 0.33). One low-quality trial assessed participants six months post surgery using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and found no significant difference between a no formal therapy group and a group given a two-week course of multi-modal therapy commenced at five to seven days post surgery (MD 1.00, 95% CI -4.44 to 6.44). One very low-quality quasi-randomised trial found no statistically significant difference in function on the BCTQ at three months post surgery with early immobilisation (plaster wrist orthosis worn until suture removal) compared with a splint and late mobilisation (MD 0.39, 95% CI -0.45 to 1.23).\nDifferences between treatments for secondary outcome measures (change in self reported functional ability measured at less than three months; change in CTS symptoms; change in CTS-related impairment measures; presence of iatrogenic symptoms from surgery; return to work or occupation; and change in neurophysiological parameters) were generally small and not statistically significant. Few studies reported adverse events.\nAuthors' conclusions\nThere is limited and, in general, low quality evidence for the benefit of the reviewed interventions. People who have undergone CTS surgery should be informed about the limited evidence of effectiveness of postoperative rehabilitation interventions. Until researchers provide results of more high-quality trials that assess the effectiveness and safety of various rehabilitation treatments, the decision to provide rehabilitation following CTS surgery should be based on the clinician's expertise, the patient's preferences and the context of the rehabilitation environment. It is important for researchers to identify patients who respond to a particular treatment and those who do not, and to undertake high-quality studies that evaluate the severity of iatrogenic symptoms from surgery, measure function and return-to-work rates, and control for confounding variables.\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": "On 29 September 2015, we searched for all relevant clinical trials in which a rehabilitation treatment was compared with another rehabilitation treatment, no treatment or placebo (sham treatment). We found 22 trials with a total of 1521 participants that assessed the benefits and harms of different rehabilitation treatments following CTS surgery. Two of the trials were newly identified at this update."
}
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query-laysum | 3561 | [
{
"role": "user",
"content": "Abstract: Background\nAlopecia areata is an autoimmune disease leading to nonscarring hair loss on the scalp or body. There are different treatments including immunosuppressants, hair growth stimulants, and contact immunotherapy.\nObjectives\nTo assess the benefits and harms of the treatments for alopecia areata (AA), alopecia totalis (AT), and alopecia universalis (AU) in children and adults.\nSearch methods\nThe Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and WHO ICTRP were searched up to July 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated classical immunosuppressants, biologics, small molecule inhibitors, contact immunotherapy, hair growth stimulants, and other therapies in paediatric and adult populations with AA.\nData collection and analysis\nWe used the standard procedures expected by Cochrane including assessment of risks of bias using RoB2 and the certainty of the evidence using GRADE. The primary outcomes were short-term hair regrowth ≥ 75% (between 12 and 26 weeks of follow-up), and incidence of serious adverse events. The secondary outcomes were long-term hair regrowth ≥ 75% (greater than 26 weeks of follow-up) and health-related quality of life. We could not perform a network meta-analysis as very few trials compared the same treatments. We presented direct comparisons and made a narrative description of the findings.\nMain results\nWe included 63 studies that tested 47 different treatments in 4817 randomised participants. All trials used a parallel-group design except one that used a cross-over design. The mean sample size was 78 participants. All trials recruited outpatients from dermatology clinics. Participants were between 2 and 74 years old. The trials included patients with AA (n = 25), AT (n = 1), AU (n = 1), mixed cases (n = 31), and unclear types of alopecia (n = 4).\nThirty-three out of 63 studies (52.3%) reported the proportion of participants achieving short-term hair regrowth ≥ 75% (between 12 and 26 weeks). Forty-seven studies (74.6%) reported serious adverse events and only one study (1.5%) reported health-related quality of life. Five studies (7.9%) reported the proportion of participants with long-term hair regrowth ≥ 75% (greater than 26 weeks).\nAmongst the variety of interventions found, we prioritised some groups of interventions for their relevance to clinical practice: systemic therapies (classical immunosuppressants, biologics, and small molecule inhibitors), and local therapies (intralesional corticosteroids, topical small molecule inhibitors, contact immunotherapy, hair growth stimulants and cryotherapy).\nConsidering only the prioritised interventions, 14 studies from 12 comparisons reported short-term hair regrowth ≥ 75% and 22 studies from 10 comparisons reported serious adverse events (18 reported zero events and 4 reported at least one). One study (1 comparison) reported quality of life, and two studies (1 comparison) reported long-term hair regrowth ≥ 75%.\nFor the main outcome of short-term hair regrowth ≥ 75%, the evidence is very uncertain about the effect of oral prednisolone or cyclosporine versus placebo (RR 4.68, 95% CI 0.57 to 38.27; 79 participants; 2 studies; very low-certainty evidence), intralesional betamethasone or triamcinolone versus placebo (RR 13.84, 95% CI 0.87 to 219.76; 231 participants; 1 study; very low-certainty evidence), oral ruxolitinib versus oral tofacitinib (RR 1.08, 95% CI 0.77 to 1.52; 80 participants; 1 study; very low-certainty evidence), diphencyprone or squaric acid dibutil ester versus placebo (RR 1.16, 95% CI 0.79 to 1.71; 99 participants; 1 study; very-low-certainty evidence), diphencyprone or squaric acid dibutyl ester versus topical minoxidil (RR 1.16, 95% CI 0.79 to 1.71; 99 participants; 1 study; very low-certainty evidence), diphencyprone plus topical minoxidil versus diphencyprone (RR 0.67, 95% CI 0.13 to 3.44; 30 participants; 1 study; very low-certainty evidence), topical minoxidil 1% and 2% versus placebo (RR 2.31, 95% CI 1.34 to 3.96; 202 participants; 2 studies; very low-certainty evidence) and cryotherapy versus fractional CO2 laser (RR 0.31, 95% CI 0.11 to 0.86; 80 participants; 1 study; very low-certainty evidence). The evidence suggests oral betamethasone may increase short-term hair regrowth ≥ 75% compared to prednisolone or azathioprine (RR 1.67, 95% CI 0.96 to 2.88; 80 participants; 2 studies; low-certainty evidence). There may be little to no difference between subcutaneous dupilumab and placebo in short-term hair regrowth ≥ 75% (RR 3.59, 95% CI 0.19 to 66.22; 60 participants; 1 study; low-certainty evidence) as well as between topical ruxolitinib and placebo (RR 5.00, 95% CI 0.25 to 100.89; 78 participants; 1 study; low-certainty evidence). However, baricitinib results in an increase in short-term hair regrowth ≥ 75% when compared to placebo (RR 7.54, 95% CI 3.90 to 14.58; 1200 participants; 2 studies; high-certainty evidence).\nFor the incidence of serious adverse events, the evidence is very uncertain about the effect of topical ruxolitinib versus placebo (RR 0.33, 95% CI 0.01 to 7.94; 78 participants; 1 study; very low-certainty evidence). Baricitinib and apremilast may result in little to no difference in the incidence of serious adverse events versus placebo (RR 1.47, 95% CI 0.60 to 3.60; 1224 participants; 3 studies; low-certainty evidence). The same result is observed for subcutaneous dupilumab compared to placebo (RR 1.54, 95% CI 0.07 to 36.11; 60 participants; 1 study; low-certainty evidence).\nFor health-related quality of life, the evidence is very uncertain about the effect of oral cyclosporine compared to placebo (MD 0.01, 95% CI -0.04 to 0.07; very low-certainty evidence).\nBaricitinib results in an increase in long-term hair regrowth ≥ 75% compared to placebo (RR 8.49, 95% CI 4.70 to 15.34; 1200 participants; 2 studies; high-certainty evidence).\nRegarding the risk of bias, the most relevant issues were the lack of details about randomisation and allocation concealment, the limited efforts to keep patients and assessors unaware of the assigned intervention, and losses to follow-up.\nAuthors' conclusions\nWe found that treatment with baricitinib results in an increase in short- and long-term hair regrowth compared to placebo. Although we found inconclusive results for the risk of serious adverse effects with baricitinib, the reported small incidence of serious adverse events in the baricitinib arm should be balanced with the expected benefits. We also found that the impact of other treatments on hair regrowth is very uncertain. Evidence for health-related quality of life is still scant.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that tested therapies to treat alopecia areata (AA), alopecia totalis (AT) and alopecia universalis (AU). The therapies we searched for included medicines administered orally or subcutaneously with systemic effects (that affect the body as a whole) such as immunosuppressants, and local treatments (that affect the skin surface) such as hair growth stimulants or cryotherapy. These treatments were compared with a placebo (a 'dummy' treatment that does not contain any drug) or with another medicine. We assessed the effect of the treatments on significant hair regrowth (equal or greater than 75% and measured from 12 to 26 weeks after starting the treatment or beyond 26 weeks), on well-being (quality of life), and if they are likely to cause serious adverse events (unwanted or harmful effects).\nWe also summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and number of participants."
}
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query-laysum | 3562 | [
{
"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: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- Surgical glue may make little to no difference to postoperative pancreatic fistula in people undergoing removal of the pancreatic tail.\n- We do not know if surgical glue has an effect on postoperative pancreatic fistula in people undergoing removal of the pancreatic head.\n- We also do not know if surgical glue has an effect on death rate in people undergoing either of these pancreatic surgeries."
}
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query-laysum | 3563 | [
{
"role": "user",
"content": "Abstract: Background\nNewborn admission temperature is a strong predictor of outcomes across all gestations. Hypothermia immediately after birth remains a worldwide issue and, if prolonged, is associated with harm. Keeping preterm infants warm is difficult even when recommended routine thermal care guidelines are followed in the delivery room.\nObjectives\nTo assess the efficacy and safety of interventions designed for prevention of hypothermia in preterm and/or low birth weight infants applied within 10 minutes after birth in the delivery room, compared with routine thermal care or any other single/combination of intervention(s) also designed for prevention of hypothermia in preterm and/or low birth weight infants applied within 10 minutes after birth in the delivery room.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 5), MEDLINE via PubMed (1966 to 30 June 2016), Embase (1980 to 30 June 2016), and CINAHL (1982 to 30 June 2016). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nTrials using randomised or quasi-randomised allocations to test interventions designed to prevent hypothermia (apart from 'routine' thermal care) applied within 10 minutes after birth in the delivery room for infants at < 37 weeks' gestation and/or birth weight ≤ 2500 grams.\nData collection and analysis\nWe used Cochrane Neonatal methods when performing data collection and analysis.\nMain results\nTwenty-five studies across 15 comparison groups met the inclusion criteria, categorised as: barriers to heat loss (18 studies); external heat sources (three studies); and combinations of interventions (four studies).\nBarriers to heat loss\nPlastic wrap or bag versus routine care\n\nPlastic wraps improved core body temperature on admission to the neonatal intensive care unit (NICU) or up to two hours after birth (mean difference (MD) 0.58°C, 95% confidence interval (CI) 0.50 to 0.66; 13 studies; 1633 infants), and fewer infants had hypothermia on admission to the NICU or up to two hours after birth (typical risk ratio (RR) 0.67, 95% CI 0.62 to 0.72; typical risk reduction (RD) -0.25, 95% CI -0.29 to -0.20; number needed to treat for an additional beneficial outcome (NNTB) 4, 95% CI 4 to 5; 10 studies; 1417 infants). Risk of hyperthermia on admission to the NICU or up to two hours after birth was increased in infants in the wrapped group (typical RR 3.91, 95% CI 2.05 to 7.44; typical RD 0.04, 95% CI 0.02 to 0.06; number needed to treat for an additional harmful outcome (NNTH) 25, 95% CI 17 to 50; 12 studies; 1523 infants), but overall, fewer infants receiving plastic wrap were outside the normothermic range (typical RR 0.75, 95% CI 0.69 to 0.81; typical RD -0.20, 95% CI -0.26 to -0.15; NNTH 5, 95% CI 4 to 7; five studies; 1048 infants).\nEvidence was insufficient to suggest that plastic wraps or bags significantly reduce risk of death during hospital stay or other major morbidities, with the exception of reducing risk of pulmonary haemorrhage.\nEvidence of practices regarding permutations on this general approach is still emerging and has been based on the findings of only one or two small studies.\nExternal heat sources\nEvidence is emerging on the efficacy of external heat sources, including skin-to-skin care (SSC) versus routine care (one study; 31 infants) and thermal mattress versus routine care (two studies; 126 infants).\nSSC was shown to be effective in reducing risk of hypothermia when compared with conventional incubator care for infants with birth weight ≥ 1200 and ≤ 2199 grams (RR 0.09, 95% CI 0.01 to 0.64; RD -0.56, 95% CI -0.84 to -0.27; NNTB 2, 95% CI 1 to 4). Thermal (transwarmer) mattress significantly kept infants ≤ 1500 grams warmer (MD 0.65°C, 95% CI 0.36 to 0.94) and reduced the incidence of hypothermia on admission to the NICU, with no significant difference in hyperthermia risk.\nCombinations of interventions\nTwo studies (77 infants) compared thermal mattresses versus plastic wraps or bags for infants at ≤ 28 weeks' gestation. Investigators reported no significant differences in core body temperature nor in the incidence of hypothermia, hyperthermia, or core body temperature outside the normothermic range on admission to the NICU.\nTwo additional studies (119 infants) compared plastic bags and thermal mattresses versus plastic bags alone for infants at < 31 weeks' gestation. Meta-analysis of these two studies showed improvement in core body temperature on admission to the NICU or up to two hours after birth, but an increase in hyperthermia. Data show no significant difference in the risk of having a core body temperature outside the normothermic range on admission to the NICU nor in the risk of other reported morbidities.\nAuthors' conclusions\nEvidence of moderate quality shows that use of plastic wraps or bags compared with routine care led to higher temperatures on admission to NICUs with less hypothermia, particularly for extremely preterm infants. Thermal mattresses and SSC also reduced hypothermia risk when compared with routine care, but findings are based on two or fewer small studies. Caution must be taken to avoid iatrogenic hyperthermia, particularly when multiple interventions are used simultaneously. Limited evidence suggests benefit and no evidence of harm for most short-term morbidity outcomes known to be associated with hypothermia, including major brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotising enterocolitis, and nosocomial infection. Many observational studies have shown increased mortality among preterm hypothermic infants compared with those who maintain normothermia, yet evidence is insufficient to suggest that these interventions reduce risk of in-hospital mortality across all comparison groups. Hypothermia may be a marker for illness and poorer outcomes by association rather than by causality. Limitations of this review include small numbers of identified studies; small sample sizes; and variations in methods and definitions used for hypothermia, hyperthermia, normothermia, routine care, and morbidity, along with lack of power to detect effects on morbidity and mortality across most comparison groups. Future studies should: be adequately powered to detect rarer outcomes; apply standardised morbidity definitions; focus on longer-term outcomes, particularly neurodevelopmental outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review identified 25 studies involving 2433 babies; researchers used additional preventive actions in the first 10 minutes of life to prevent problems with hypothermia. Use of plastic coverings, heated mattresses, and skin-to-skin contact kept infants warmer (and within normal body temperature ranges) than routine preventive action. However, care must be taken, particularly when these methods are combined, to avoid the unintended effect of making babies too warm, which may be harmful. Limitations consist of small numbers of babies and studies included in some comparison groups; variations in methods and definitions used for normal body temperature and routine care; and differences in materials used.\nAlthough this review confirmed that some of these measures are effective in preventing hypothermia, results across all studies show no reduction in deaths and only limited improvement in short-term complications or illnesses normally associated with being too cold. Findings suggest that perhaps hypothermia is a marker for poorer outcomes, particularly in the most immature and smallest babies, rather than a direct cause. Review authors recommend that future studies should be large enough to detect changes for rarer illnesses, should define these illnesses in the same way so they can be combined across studies, and should focus on longer-term consequences."
}
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query-laysum | 3564 | [
{
"role": "user",
"content": "Abstract: Background\nThe coronavirus disease 2019 (COVID-19) pandemic has impacted healthcare systems worldwide. Multiple reports on thromboembolic complications related to COVID-19 have been published, and researchers have described that people with COVID-19 are at high risk for developing venous thromboembolism (VTE). Anticoagulants have been used as pharmacological interventions to prevent arterial and venous thrombosis, and their use in the outpatient setting could potentially reduce the prevalence of vascular thrombosis and associated mortality in people with COVID-19. However, even lower doses used for a prophylactic purpose may result in adverse events such as bleeding. It is important to consider the evidence for anticoagulant use in non-hospitalised people with COVID-19.\nObjectives\nTo evaluate the benefits and harms of prophylactic anticoagulants versus active comparators, placebo or no intervention, or non-pharmacological interventions in non-hospitalised people with COVID-19.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 18 April 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing prophylactic anticoagulants with placebo or no treatment, another active comparator, or non-pharmacological interventions in non-hospitalised people with COVID-19. We included studies that compared anticoagulants with a different dose of the same anticoagulant. We excluded studies with a duration of under two weeks.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Our primary outcomes were all-cause mortality, VTE (deep vein thrombosis (DVT) or pulmonary embolism (PE)), and major bleeding. Our secondary outcomes were DVT, PE, need for hospitalisation, minor bleeding, adverse events, and quality of life. We used GRADE to assess the certainty of the evidence.\nMain results\nWe included five RCTs with up to 90 days of follow-up (short term). Data were available for meta-analysis from 1777 participants.\nAnticoagulant compared to placebo or no treatment\nFive studies compared anticoagulants with placebo or no treatment and provided data for three of our outcomes of interest (all-cause mortality, major bleeding, and adverse events). The evidence suggests that prophylactic anticoagulants may lead to little or no difference in all-cause mortality (risk ratio (RR) 0.36, 95% confidence interval (CI) 0.04 to 3.61; 5 studies; 1777 participants; low-certainty evidence) and probably reduce VTE from 3% in the placebo group to 1% in the anticoagulant group (RR 0.36, 95% CI 0.16 to 0.85; 4 studies; 1259 participants; number needed to treat for an additional beneficial outcome (NNTB) = 50; moderate-certainty evidence). There may be little to no difference in major bleeding (RR 0.36, 95% CI 0.01 to 8.78; 5 studies; 1777 participants; low-certainty evidence). Anticoagulants probably result in little or no difference in DVT (RR 1.02, 95% CI 0.30 to 3.46; 3 studies; 1009 participants; moderate-certainty evidence), but probably reduce the risk of PE from 2.7% in the placebo group to 0.7% in the anticoagulant group (RR 0.25, 95% CI 0.08 to 0.79; 3 studies; 1009 participants; NNTB 50; moderate-certainty evidence). Anticoagulants probably lead to little or no difference in reducing hospitalisation (RR 1.01, 95% CI 0.59 to 1.75; 4 studies; 1459 participants; moderate-certainty evidence) and may lead to little or no difference in adverse events (minor bleeding, RR 2.46, 95% CI 0.90 to 6.72; 5 studies, 1777 participants; low-certainty evidence).\nAnticoagulant compared to a different dose of the same anticoagulant\nOne study compared anticoagulant (higher-dose apixaban) with a different (standard) dose of the same anticoagulant and reported five relevant outcomes. No cases of all-cause mortality, VTE, or major bleeding occurred in either group during the 45-day follow-up (moderate-certainty evidence). Higher-dose apixaban compared to standard-dose apixaban may lead to little or no difference in reducing the need for hospitalisation (RR 1.89, 95% CI 0.17 to 20.58; 1 study; 278 participants; low-certainty evidence) or in the number of adverse events (minor bleeding, RR 0.47, 95% CI 0.09 to 2.54; 1 study; 278 participants; low-certainty evidence).\nAnticoagulant compared to antiplatelet agent\nOne study compared anticoagulant (apixaban) with antiplatelet agent (aspirin) and reported five relevant outcomes. No cases of all-cause mortality or major bleeding occurred during the 45-day follow-up (moderate-certainty evidence). Apixaban may lead to little or no difference in VTE (RR 0.36, 95% CI 0.01 to 8.65; 1 study; 279 participants; low-certainty evidence), need for hospitalisation (RR 3.20, 95% CI 0.13 to 77.85; 1 study; 279 participants; low-certainty evidence), or adverse events (minor bleeding, RR 2.13, 95% CI 0.40 to 11.46; 1 study; 279 participants; low-certainty evidence).\nNo included studies reported on quality of life or investigated anticoagulants compared to a different anticoagulant, or anticoagulants compared to non-pharmacological interventions.\nAuthors' conclusions\nWe found low- to moderate-certainty evidence from five RCTs that prophylactic anticoagulants result in little or no difference in major bleeding, DVT, need for hospitalisation, or adverse events when compared with placebo or no treatment in non-hospitalised people with COVID-19. Low-certainty evidence indicates that prophylactic anticoagulants may result in little or no difference in all-cause mortality when compared with placebo or no treatment, but moderate-certainty evidence indicates that prophylactic anticoagulants probably reduce the incidence of VTE and PE.\nLow-certainty evidence suggests that comparing different doses of the same prophylactic anticoagulant may result in little or no difference in need for hospitalisation or adverse events. Prophylactic anticoagulants may result in little or no difference in risk of VTE, hospitalisation, or adverse events when compared with antiplatelet agents (low-certainty evidence). Given that there were only short-term data from one study, these results should be interpreted with caution.\nAdditional trials of sufficient duration are needed to clearly determine any effect on clinical outcomes.\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 used in the outpatient setting, anticoagulants (blood thinners) probably reduce venous thromboembolism (VTE) and pulmonary embolism (PE) when compared with placebo or no treatment in people with COVID-19. However, these drugs seem to have little or no effect in reducing death, major bleeding, need for hospitalisation, or adverse events."
}
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query-laysum | 3565 | [
{
"role": "user",
"content": "Abstract: Background\nThe ideal quantity of dietary protein for formula-fed low birth weight infants is still a matter of debate. Protein intake must be sufficient to achieve normal growth without leading to negative effects such as acidosis, uremia, and elevated levels of circulating amino acids.\nObjectives\nTo determine whether higher (≥ 3.0 g/kg/d) versus lower (< 3.0 g/kg/d) protein intake during the initial hospital stay of formula-fed preterm infants or low birth weight infants (< 2.5 kilograms) results in improved growth and neurodevelopmental outcomes without evidence of short- or long-term morbidity.\nSpecific objectives were to examine the following comparisons of interventions and to conduct subgroup analyses if possible.\n1. Low protein intake if the amount was less than 3.0 g/kg/d.\n2. High protein intake if the amount was equal to or greater than 3.0 g/kg/d but less than 4.0 g/kg/d.\n3. Very high protein intake if the amount was equal to or greater than 4.0 g/kg/d.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 8), in the Cochrane Library (August 2, 2019); OVID MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily, and Ovid MEDLINE(R) (to August 2, 2019); MEDLINE via PubMed (to August 2, 2019) for the previous year; and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (to August 2, 2019). We also searched clinical trials databases and the reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-randomized trials.\nSelection criteria\nWe included RCTs contrasting levels of formula protein intake as low (< 3.0 g/kg/d), high (≥ 3.0 g/kg/d but < 4.0 g/kg/d), or very high (≥ 4.0 g/kg/d) in formula-fed hospitalized neonates weighing less than 2.5 kilograms. We excluded studies if infants received partial parenteral nutrition during the study period, or if infants were fed formula as a supplement to human milk.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and the GRADE approach to assess the certainty of evidence.\nMain results\nWe identified six eligible trials that enrolled 218 infants through searches updated to August 2, 2019. Five studies compared low (< 3 g/kg/d) versus high (3.0 to 4.0 g/kg/d) protein intake using formulas that kept other nutrients constant. The trials were small (n = 139), and almost all had methodological limitations; the most frequent uncertainty was about attrition. Low-certainty evidence suggests improved weight gain (mean difference [MD] 2.36 g/kg/d, 95% confidence interval [CI] 1.31 to 3.40) and higher nitrogen accretion in infants receiving formula with higher protein content (3.0 to 4.0 g/kg/d) versus lower protein content (< 3 g/kg/d), while other nutrients were kept constant. No significant differences were seen in rates of necrotizing enterocolitis, sepsis, or diarrhea. We are uncertain whether high versus low protein intake affects head growth (MD 0.37 cm/week, 95% CI 0.16 to 0.58; n = 18) and length gain (MD 0.16 cm/week, 95% CI -0.02 to 0.34; n = 48), but sample sizes were small for these comparisons.\nOne study compared high (3.0 to 4.0 g/kg/d) versus very high (≥ 4 g/kg/d) protein intake (average intakes were 3.6 and 4.1 g/kg/d) during and after an initial hospital stay (n = 77). Moderate-certainty evidence shows no significant differences in weight gain or length gain to discharge, term, and 12 weeks corrected age from very high protein intake (4.1 versus 3.6 g/kg/d). Three of the 24 infants receiving very high protein intake developed uremia.\nAuthors' conclusions\nHigher protein intake (≥ 3.0 g/kg/d but < 4.0 g/kg/d) from formula accelerates weight gain. However, limited information is available regarding the impact of higher formula protein intake on long-term outcomes such as neurodevelopment. Research is needed to investigate the safety and effectiveness of protein intake ≥ 4.0 g/kg/d.\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": "Higher protein intake (3 to 4 versus less than 3 grams of protein per kilogram) resulted in slightly greater weight gain, of around 2 grams per kilogram per day. We are uncertain whether this difference in protein intake affects head and length growth because not many infants were studied. Existing research does support specific recommendations regarding formula with protein content that provides more than 4 g/kg/d. No harmful effects were observed."
}
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query-laysum | 3566 | [
{
"role": "user",
"content": "Abstract: Background\nApproximately 60% to 80% of people with Parkinson's disease (PD) experience cognitive impairment that impacts on their quality of life. Cognitive decline is a core feature of the disease and can often present before the onset of motor symptoms. Cognitive training may be a useful non-pharmacological intervention that could help to maintain or improve cognition and quality of life for people with PD dementia (PDD) or PD-related mild cognitive impairment (PD-MCI).\nObjectives\nTo determine whether cognitive training (targeting single or multiple domains) improves cognition in people with PDD and PD-MCI or other clearly defined forms of cognitive impairment in people with PD.\nSearch methods\nWe searched the Cochrane Dementia and Cognitive Improvement Group Trials Register (8 August 2019), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and PsycINFO. We searched reference lists and trial registers, searched relevant reviews in the area and conference proceedings. We also contacted experts for clarifications on data and ongoing trials.\nSelection criteria\nWe included randomised controlled trials where the participants had PDD or PD-MCI, and where the intervention was intended to train general or specific areas of cognitive function, targeting either a single domain or multiple domains of cognition, and was compared to a control condition. Multicomponent interventions that also included motor or other elements were considered eligible.\nData collection and analysis\nTwo review authors independently screened titles, abstracts, and full-text articles for inclusion in the review. Two review authors also independently undertook extraction of data and assessment of methodological quality. We used GRADE methods to assess the overall quality of the evidence.\nMain results\nSeven studies with a total of 225 participants met the inclusion criteria for this review. All seven studies compared the effects of a cognitive training intervention to a control intervention at the end of treatment periods lasting four to eight weeks. Six studies included people with PD living in the community. These six studies recruited people with single-domain (executive) or multiple-domain mild cognitive impairment in PD. Four of these studies identified participants with MCI using established diagnostic criteria, and two included both people with PD-MCI and people with PD who were not cognitively impaired. One study recruited people with a diagnosis of PD dementia who were living in long-term care settings. The cognitive training intervention in three studies targeted a single cognitive domain, whilst in four studies multiple domains of cognitive function were targeted. The comparison groups either received no intervention or took part in recreational activities (sports, music, arts), speech or language exercises, computerised motor therapy, or motor rehabilitation combined with recreational activity.\nWe found no clear evidence that cognitive training improved global cognition. Although cognitive training was associated with higher scores on global cognition at the end of treatment, the result was imprecise and not statistically significant (6 trials, 178 participants, standardised mean difference (SMD) 0.28, 95% confidence interval (CI) −0.03 to 0.59; low-certainty evidence). There was no evidence of a difference at the end of treatment between cognitive training and control interventions on executive function (5 trials, 112 participants; SMD 0.10, 95% CI −0.28 to 0.48; low-certainty evidence) or visual processing (3 trials, 64 participants; SMD 0.30, 95% CI −0.21 to 0.81; low-certainty evidence). The evidence favoured the cognitive training group on attention (5 trials, 160 participants; SMD 0.36, 95% CI 0.03 to 0.68; low-certainty evidence) and verbal memory (5 trials, 160 participants; SMD 0.37, 95% CI 0.04 to 0.69; low-certainty evidence), but these effects were less certain in sensitivity analyses that excluded a study in which only a minority of the sample were cognitively impaired. There was no evidence of differences between treatment and control groups in activities of daily living (3 trials, 67 participants; SMD 0.03, 95% CI −0.47 to 0.53; low-certainty evidence) or quality of life (5 trials, 147 participants; SMD −0.01, 95% CI −0.35 to 0.33; low-certainty evidence). There was very little information on adverse events. We considered the certainty of the evidence for all outcomes to be low due to risk of bias in the included studies and imprecision of the results.\nWe identified six ongoing trials recruiting participants with PD-MCI, but no ongoing trials of cognitive training for people with PDD.\nAuthors' conclusions\nThis review found no evidence that people with PD-MCI or PDD who receive cognitive training for four to eight weeks experience any important cognitive improvements at the end of training. However, this conclusion was based on a small number of studies with few participants, limitations of study design and execution, and imprecise results. There is a need for more robust, adequately powered studies of cognitive training before conclusions can be drawn about the effectiveness of cognitive training for people with PDD and PD-MCI. Studies should use formal criteria to diagnose cognitive impairments, and there is a particular need for more studies testing the efficacy of cognitive training in people with PDD.\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": "Approximately 60% to 80% of people with Parkinson's disease (PD) develop some degree of cognitive impairment, meaning that they may have difficulties with thinking and reasoning, memory, language, or perception. If these difficulties are severe enough to affect the person's ability to carry out daily activities, then the person is said to have Parkinson's disease dementia (PDD). If someone has cognitive problems but their daily activities are not significantly affected, then he or she is said to have mild cognitive impairment in Parkinson's disease (PD-MCI). Cognitive training involves practising cognitive skills such as memory, attention, and language through specific tasks. It may be able to help people with PDD or PD-MCI maintain better cognitive skills."
}
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query-laysum | 3567 | [
{
"role": "user",
"content": "Abstract: Background\nMost women living in low- and middle-income countries (LMICs) present with advanced-stage breast cancer. Limitations of poor serviceable health systems, restricted access to treatment facilities, and lack of breast cancer screening programmes all likely contribute to the late presentation of women with breast cancer living in these countries. Women are diagnosed with advanced disease and frequently do not complete their care due to a number of factors, including financial reasons as health expenditure is largely out of pocket resulting in financial toxicity; health system failures, such as missing services or health worker lack of awareness on common signs and symptoms of cancer; and sociocultural barriers, such as stigma and use of alternative therapies. Clinical breast examination (CBE) is an inexpensive early detection technique for breast cancer in women with palpable breast masses. Training health workers from LMICs to conduct CBE has the potential to improve the quality of the technique and the ability of health workers to detect breast cancers early.\nObjectives\nTo assess whether training in CBE affects the ability of health workers in LMICs to detect early breast cancer.\nSearch methods\nWe searched the Cochrane Breast Cancer Specialised Registry, CENTRAL, MEDLINE, Embase, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal, and ClinicalTrials.gov up to 17 July 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) (including individual and cluster-RCTs), quasi-experimental studies and controlled before-and-after studies if they fulfilled the eligibility criteria.\nData collection and analysis\nTwo review authors independently screened studies for inclusion, and extracted data, assessed risk of bias, and assessed the certainty of the evidence using the GRADE approach. We performed statistical analysis using Review Manager software and presented the main findings of the review in a summary of findings table.\nMain results\nWe included four RCTs that screened a total population of 947,190 women for breast cancer, out of which 593 breast cancers were diagnosed. All included studies were cluster-RCTs; two were conducted in India, one in the Philippines, and one in Rwanda. Health workers trained to perform CBE in the included studies were primary health workers, nurses, midwives, and community health workers. Three of the four included studies reported on the primary outcome (breast cancer stage at the time of presentation). Amongst secondary outcomes, included studies reported CBE coverage, follow-up, accuracy of health worker-performed CBE, and breast cancer mortality. None of the included studies reported knowledge attitude practice (KAP) outcomes and cost-effectiveness.\nThree studies reported diagnosis of breast cancer at early stage (at stage 0+I+II), suggesting that training health workers in CBE may increase the number of women detected with breast cancer at an early stage compared to the non-training group (45% detected versus 31% detected; risk ratio (RR) 1.44, 95% confidence interval (CI) 1.01 to 2.06; three studies; 593 participants; I2 = 0%; low-certainty evidence).\nThree studies reported diagnosis at late stage (III+IV) suggesting that training health workers in CBE may slightly reduce the number of women detected with breast cancer at late stage compared to the non-training group (13% detected versus 42%, RR 0.58, 95% CI 0.36 to 0.94; three studies; 593 participants; I2 = 52%; low-certainty evidence).\nRegarding secondary outcomes, two studies reported breast cancer mortality, implying that the evidence is uncertain for the impact on breast cancer mortality (RR 0.88, 95% CI 0.24 to 3.26; two studies; 355 participants; I2 = 68%; very low-certainty evidence). Due to the study heterogeneity, we could not conduct meta-analysis for accuracy of health worker-performed CBE, CBE coverage, and completion of follow-up, and therefore reported narratively using the 'Synthesis without meta-analysis' (SWiM) guideline. Sensitivity of health worker-performed CBE was reported to be 53.2% and 51.7%; while specificity was reported to be 100% and 94.3% respectively in two included studies (very low-certainty evidence). One trial reported CBE coverage with a mean adherence of 67.07% for the first four screening rounds (low-certainty evidence). One trial reported follow-up suggesting that compliance rates for diagnostic confirmation following a positive CBE were 68.29%, 71.20%, 78.84% and 79.98% during the respective first four rounds of screening in the intervention group compared to 90.88%, 82.96%, 79.56% and 80.39% during the respective four rounds of screening in the control group.\nAuthors' conclusions\nOur review findings suggest some benefit of training health workers from LMICs in CBE on early detection of breast cancer. However, the evidence regarding mortality, accuracy of health worker-performed CBE, and completion of follow up is uncertain and requires further evaluation.\n\nGiven the provided abstract, please respond to the following query: \"We found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "four studies that answered our research question. The CBE training was provided to health workers, nurses, midwives, and community health workers working in LMICs. A total population of 947,190 women were screened for breast cancer. Of the total population screened, 593 breast cancers were diagnosed, with more cancers diagnosed at an early stage by trained health workers than by health workers who were not trained. The results from these studies suggest that training health workers in CBE may increase breast cancer diagnosis at an early stage, but the existing evidence is of low quality. More research is needed to assess its impact on other outcomes, including how accurately CBE is performed, knowledge about CBE, uptake of CBE, and if CBE has any impact on deaths due to breast cancer."
}
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query-laysum | 3568 | [
{
"role": "user",
"content": "Abstract: Background\nPediatric acute respiratory infections (ARIs) represent a significant burden on pediatric Emergency Departments (EDs) and families. Most of these illnesses are due to viruses. However, investigations (radiography, blood, and urine testing) to rule out bacterial infections and antibiotics are often ordered because of diagnostic uncertainties. This results in prolonged ED visits and unnecessary antibiotic use. The risk of concurrent bacterial infection has been reported to be negligible in children over three months of age with a confirmed viral infection. Rapid viral testing in the ED may alleviate the need for precautionary testing and antibiotic use.\nObjectives\nTo determine if the use of a rapid viral detection test for children with an acute respiratory infection (ARI) in Emergency Departments (EDs) changes patient management and resource use in the ED, compared to not using a rapid viral detection test. We hypothesized that rapid viral testing reduces antibiotic use in the ED as well as reduces the rate of ancillary testing and length of ED visits.\nSearch methods\nWe searched CENTRAL (2014, Issue 6), MEDLINE (1950 to July week 1, 2014), MEDLINE In-Process & Other Non-Indexed Citations (15 July 2014), EMBASE.com (1988 to July 2014), HealthStar (1966 to 2009), BIOSIS Previews (1969 to July 2014), CAB Abstracts (1973 to July 2014), CBCA Reference (1970 to 2007) and ProQuest Dissertations and Theses (1861 to 2009).\nSelection criteria\nRandomized controlled trials (RCTs) of rapid viral testing for children with ARIs in the ED.\nData collection and analysis\nTwo review authors used the inclusion criteria to select trials, evaluate their quality, and extract data. We obtained missing data from trial authors. We expressed differences in rate of investigations and antibiotic use as risk ratios (RRs), and expressed difference in ED length of visits as mean differences (MDs), with 95% confidence intervals (CIs).\nMain results\nNo new trials were identified in this 2014 update. We included four trials (three RCTs and one quazi-RCT), with 759 children in the rapid viral testing group and 829 in the control group. Three out of the four studies were comparable in terms of young age of participants, with one study increasing the age of inclusion up to five years of age. All studies included either fever or respiratory symptoms as inclusion criteria (two required both, one required fever or respiratory symptoms, and one required only fever). All studies were comparable in terms of exclusion criteria, intervention, and outcome data. In terms of risk of bias, one study failed to utilize a random sequence generator, one study did not comment on completeness of outcome data, and only one of four studies included allocation concealment as part of the study design. None of the studies definitively blinded participants.\nRapid viral testing resulted in a trend toward decreased antibiotic use in the ED, but this was not statistically significant. We found lower rates of chest radiography (RR 0.77, 95% CI 0.65 to 0.91) in the rapid viral testing group, but no effect on length of ED visits, or blood or urine testing in the ED. No study made mention of any adverse effects related to viral testing.\nAuthors' conclusions\nThere is insufficient evidence to support routine rapid viral testing to reduce antibiotic use in pediatric EDs. Rapid viral testing may or may not reduce rates of antibiotic use, and other investigations (urine and blood testing); these studies do not provide enough power to resolve this question. However, rapid viral testing does reduce the rate of chest X-rays in the ED. An adequately powered trial with antibiotic use as an outcome is 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"
},
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"role": "assistant",
"content": "Based on these four studies, involving 759 study participants, we found that in previously healthy children coming to the ED with fever and respiratory symptoms, a rapid viral test showed a trend towards fewer antibiotic prescriptions, but this finding was not statistically significant. However, we found that rapid viral testing reduces the use of chest X-rays. There are also blood and urine investigations that can be undertaken. The true impact of this intervention on the frequency of blood and urine testing, as well as the length of the ED visit, requires trials with larger numbers of children. None of the included studies reported harm or adverse events related to the intervention tested."
}
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query-laysum | 3569 | [
{
"role": "user",
"content": "Abstract: Background\nSince December 2019, the world has struggled with the COVID-19 pandemic. Even after the introduction of various vaccines, this disease still takes a considerable toll. In order to improve the optimal allocation of resources and communication of prognosis, healthcare providers and patients need an accurate understanding of factors (such as obesity) that are associated with a higher risk of adverse outcomes from the COVID-19 infection.\nObjectives\nTo evaluate obesity as an independent prognostic factor for COVID-19 severity and mortality among adult patients in whom infection with the COVID-19 virus is confirmed.\nSearch methods\nMEDLINE, Embase, two COVID-19 reference collections, and four Chinese biomedical databases were searched up to April 2021.\nSelection criteria\nWe included case-control, case-series, prospective and retrospective cohort studies, and secondary analyses of randomised controlled trials if they evaluated associations between obesity and COVID-19 adverse outcomes including mortality, mechanical ventilation, intensive care unit (ICU) admission, hospitalisation, severe COVID, and COVID pneumonia. Given our interest in ascertaining the independent association between obesity and these outcomes, we selected studies that adjusted for at least one factor other than obesity. Studies were evaluated for inclusion by two independent reviewers working in duplicate.\nData collection and analysis\nUsing standardised data extraction forms, we extracted relevant information from the included studies. When appropriate, we pooled the estimates of association across studies with the use of random-effects meta-analyses. The Quality in Prognostic Studies (QUIPS) tool provided the platform for assessing the risk of bias across each included study. In our main comparison, we conducted meta-analyses for each obesity class separately. We also meta-analysed unclassified obesity and obesity as a continuous variable (5 kg/m2 increase in BMI (body mass index)). We used the GRADE framework to rate our certainty in the importance of the association observed between obesity and each outcome. As obesity is closely associated with other comorbidities, we decided to prespecify the minimum adjustment set of variables including age, sex, diabetes, hypertension, and cardiovascular disease for subgroup analysis.\nMain results\nWe identified 171 studies, 149 of which were included in meta-analyses. As compared to 'normal' BMI (18.5 to 24.9 kg/m2) or patients without obesity, those with obesity classes I (BMI 30 to 35 kg/m2), and II (BMI 35 to 40 kg/m2) were not at increased odds for mortality (Class I: odds ratio [OR] 1.04, 95% confidence interval [CI] 0.94 to 1.16, high certainty (15 studies, 335,209 participants); Class II: OR 1.16, 95% CI 0.99 to 1.36, high certainty (11 studies, 317,925 participants)). However, those with class III obesity (BMI 40 kg/m2 and above) may be at increased odds for mortality (Class III: OR 1.67, 95% CI 1.39 to 2.00, low certainty, (19 studies, 354,967 participants)) compared to normal BMI or patients without obesity. For mechanical ventilation, we observed increasing odds with higher classes of obesity in comparison to normal BMI or patients without obesity (class I: OR 1.38, 95% CI 1.20 to 1.59, 10 studies, 187,895 participants, moderate certainty; class II: OR 1.67, 95% CI 1.42 to 1.96, 6 studies, 171,149 participants, high certainty; class III: OR 2.17, 95% CI 1.59 to 2.97, 12 studies, 174,520 participants, high certainty). However, we did not observe a dose-response relationship across increasing obesity classifications for ICU admission and hospitalisation.\nAuthors' conclusions\nOur findings suggest that obesity is an important independent prognostic factor in the setting of COVID-19. Consideration of obesity may inform the optimal management and allocation of limited resources in the care of COVID-19 patients.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified 171 eligible studies, with 149 studies (12,045,976 participants) providing quantitative data for at least one of our meta-analyses. In terms of the outcomes, 111 studies reported on mortality, 48 on requiring a breathing tube, 47 on ICU admission, 34 on hospitalisation, 32 on severe COVID-19, six on pneumonia, five on length of hospitalisation, two on length of ICU admission, and one on the duration of the requirement of a breathing tube."
}
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query-laysum | 3570 | [
{
"role": "user",
"content": "Abstract: Background\nAsthma is one of the most common long-term conditions worldwide, which places considerable pressure on patients, communities and health systems. The major international clinical guidelines now recommend the inclusion of self management programmes in the routine management of patients with asthma. These programmes have been associated with improved outcomes in patients with asthma. However, the implementation of self management programmes in clinical practice, and their uptake by patients, is still poor. Recent developments in mobile technology, such as smartphone and tablet computer apps, could help develop a platform for the delivery of self management interventions that are highly customisable, low-cost and easily accessible.\nObjectives\nTo assess the effectiveness, cost-effectiveness and feasibility of using smartphone and tablet apps to facilitate the self management of individuals with asthma.\nSearch methods\nWe searched the Cochrane Airways Group Register (CAGR), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, Global Health Library, Compendex/Inspec/Referex, IEEEXplore, ACM Digital Library, CiteSeerx and CAB abstracts via Web of Knowledge. We also searched registers of current and ongoing trials and the grey literature. We checked the reference lists of all primary studies and review articles for additional references. We searched for studies published from 2000 onwards. The latest search was run in June 2013.\nSelection criteria\nWe included parallel randomised controlled trials (RCTs) that compared self management interventions for patients with clinician-diagnosed asthma delivered via smartphone apps to self management interventions delivered via traditional methods (e.g. paper-based asthma diaries).\nData collection and analysis\nWe used standard methods expected by the Cochrane Collaboration. Our primary outcomes were symptom scores; frequency of healthcare visits due to asthma exacerbations or complications and health-related quality of life.\nMain results\nWe included two RCTs with a total of 408 participants. We found no cluster RCTs, controlled before and after studies or interrupted time series studies that met the inclusion criteria for this systematic review. Both RCTs evaluated the effect of a mobile phone-based asthma self management intervention on asthma control by comparing it to traditional, paper-based asthma self management. One study allowed participants to keep daily entries of their asthma symptoms, asthma medication usage, peak flow readings and peak flow variability on their mobile phone, from which their level of asthma control was calculated remotely and displayed together with the corresponding asthma self management recommendations. In the other study, participants recorded the same readings twice daily, and they received immediate self management feedback in the form of a three-colour traffic light display on their phones. Participants falling into the amber zone of their action plan twice, or into the red zone once, received a phone call from an asthma nurse who enquired about the reasons for their uncontrolled asthma.\nWe did not conduct a meta-analysis of the data extracted due to the considerable degree of heterogeneity between these studies. Instead we adopted a narrative synthesis approach. Overall, the results were inconclusive and we judged the evidence to have a GRADE rating of low quality because further evidence is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. In addition, there was not enough information in one of the included studies to assess the risk of bias for the majority of the domains. Although the other included study was methodologically rigorous, it was not possible to blind participants or personnel in the study. Moreover, there are concerns in both studies in relation to attrition bias and other sources of bias.\nOne study showed that the use of a smartphone app for the delivery of an asthma self management programme had no statistically significant effect on asthma symptom scores (mean difference (MD) 0.01, 95% confidence interval (CI) -0.23 to 0.25), asthma-related quality of life (MD of mean scores 0.02, 95% CI -0.35 to 0.39), unscheduled visits to the emergency department (OR 7.20, 95% CI 0.37 to 140.76) or frequency of hospital admissions (odds ratio (OR) 3.07, 95% CI 0.32 to 29.83). The other included study found that the use of a smartphone app resulted in higher asthma-related quality of life scores at six-month follow-up (MD 5.50, 95% CI 1.48 to 9.52 for the physical component score of the SF-12 questionnaire; MD 6.00, 95% CI 2.51 to 9.49 for the mental component score of the SF-12 questionnaire), improved lung function (PEFR) at four (MD 27.80, 95% CI 4.51 to 51.09), five (MD 31.40, 95% CI 8.51 to 54.29) and six months (MD 39.20, 95% CI 16.58 to 61.82), and reduced visits to the emergency department due to asthma-related complications (OR 0.20, 95% CI 0.04 to 0.99). Both studies failed to find any statistical differences in terms of adherence to the intervention and occurrence of other asthma-related complications.\nAuthors' conclusions\nThe current evidence base is not sufficient to advise clinical practitioners, policy-makers and the general public with regards to the use of smartphone and tablet computer apps for the delivery of asthma self management programmes. In order to understand the efficacy of apps as standalone interventions, future research should attempt to minimise the differential clinical management of patients between control and intervention groups. Those studies evaluating apps as part of complex, multicomponent interventions, should attempt to tease out the relative contribution of each intervention component. Consideration of the theoretical constructs used to inform the development of the intervention would help to achieve this goal. Finally, researchers should also take into account: the role of ancillary components in moderating the observed effects, the seasonal nature of asthma and long-term adherence to self management practices.\n\nGiven the provided abstract, please respond to the following query: \"Description of the studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included two studies with a total of 408 participants. Both studies evaluated the effect of a mobile phone-based asthma self management intervention on asthma control by comparing it to traditional, paper-based asthma self management. One study allowed participants to keep daily entries of their asthma symptoms, asthma medication usage, peak flow readings and peak flow variability on their mobile phone, from which their level of asthma control was calculated remotely and displayed together with the corresponding asthma self management recommendations. In the other study, participants recorded the same readings twice daily, and they received immediate self management feedback in the form of a three-colour traffic light display on their phones. Participants falling into the amber zone of their action plan twice, or into the red zone once, received a phone call from an asthma nurse who enquired about the reasons for their uncontrolled asthma."
}
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query-laysum | 3571 | [
{
"role": "user",
"content": "Abstract: Background\nPeyronie's disease is a condition that results in the development of penile plaques that can lead to penile curvature, pain, and erectile dysfunction, making sexual activity difficult. A number of non-surgical interventions exist to improve this condition, which include topical and injection agents as well as mechanical methods; however, their effectiveness remains uncertain. We performed this review to determine the effects of these non-surgical treatments.\nObjectives\nTo assess the effects of non-surgical therapies compared to placebo or no treatment in individuals with Peyronie's disease.\nSearch methods\nWe performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Google Scholar, and Web of Science), trials registries, other sources of grey literature, and conference proceedings, up to 23 September 2022. We applied no restrictions on publication language or status.\nSelection criteria\nWe included trials in which men with Peyronie's disease were randomized to undergo non-surgical therapies versus placebo or no treatment for penile curvature and sexual function.\nData collection and analysis\nTwo of four review authors, working in pairs, independently classified studies and abstracted data from the included studies. Primary outcomes were: patient-reported ability to have intercourse, quality of life, and treatment-related adverse effects. Secondary outcomes were: degree of penile curvature, discontinuation from treatment (for any reason), subjective patient-reported change in penile curvature, and improvement in penile pain. We performed statistical analyses using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach.\nMain results\nOur search identified 1288 relevant references of which we included 18 records corresponding to 14 unique randomized controlled trials (RCTs) with 1810 men. These informed 10 distinct comparisons with relevant outcome data that were mostly extracted from single trials. In this abstract, we focus only on the most clinically relevant comparisons for the three primary outcomes and also include the outcome of degree penile curvature.\nInjectional collagenase (short-term): We found no short-term evidence on injectional collagenase for patients' self-reported ability to have intercourse and treatment-related adverse effects compared to placebo injection. Injectional collagenase may result in little to no difference in quality of life (scale 0 to 20 with lower scores indicating better quality of life; mean difference (MD) 1.8 lower, 95% confidence interval (CI) -3.58 to -0.02; 1 study, 134 participants; low CoE) and there may be little to no effect on the degree of penile curvature (MD 10.90 degrees less, 95% CI -16.24 to -5.56; 1 study, 136 participants; low CoE).\nInjectional collagenase (long-term): We also found no long-term evidence on injectional collagenase for patients' self-reported ability to have intercourse compared to placebo injection. It likely results in little to no effect on quality of life (MD 1.00 lower, 95% CI -1.60 to -0.40; 1 study, 612 participants; moderate CoE). Treatment-related adverse effects are likely increased (risk ratio (RR) 2.32, 95% CI 1.98 to 2.72; 1 study, 832 participants; moderate CoE). Injectional collagenase likely results in little to no change in the degree of penile curvature (MD 6.90 degrees less, 95% CI -9.64 to -4.14; 1 study, 612 participants; moderate CoE).\nInjectional verapamil (short-term): We are very uncertain how injectional verapamil may affect patients' self-reported ability to have intercourse compared to placebo injection short-term (RR 7.00, 95% CI 0.43 to 114.70; 1 study, 14 participants; very low CoE). We found no evidence for the outcome of quality of life. We are very uncertain how injectional verapamil may affect treatment-related adverse effects (RR not estimable; 1 study, 14 participants; very low CoE). Similarly, we are very uncertain how injectional verapamil may affect degree of penile curvature (MD -1.86, 95% CI -10.39 to 6.67; 1 study, 14 participants; very low CoE). We found no long-term data for any outcome.\nExtracorporeal shock wave treatment (ESWT) (short-term): We are very uncertain how ESWT affects patients' self-reported ability to have intercourse short-term (RR 1.60, 95% CI 0.71 to 3.60; 1 study, 26 participants; very low CoE). ESWT may result in little to no difference in quality of life (MD 3.10, 95% CI 1.57 to 4.64; 2 studies, 130 participants; low CoE). We are very uncertain if ESWT has an effect on treatment-related adverse effects (RR 2.73, 95% CI 0.74 to 10.14; 3 studies, 166 participants; very low CoE). ESWT may result in little to no difference in the degree of penile curvature compared to placebo (RR -2.84, 95% -7.35 to 1.67; 3 studies, 166 participants; low CoE). We found no long-term data for any outcome.\nPenile traction therapy (short-term): We found no evidence for whether penile traction compared to no treatment affects patients' self-reported ability to have intercourse. We are very uncertain how traction therapy may affect quality of life (MD 1.50 lower, 95% CI -3.42 to 0.42; 1 study, 90 participants; very low CoE). We are also very uncertain how traction therapy may affect treatment-related adverse effects (RR not estimable; 1 study, 90 participants; very low CoE) and how it affects the degree of curvature (MD 7.40 degrees less, 95% CI -11.18 to -3.62; 1 study, 89 participants; very low CoE). We found no long-term data for any outcome.\nAuthors' conclusions\nThere is little evidence supporting the effectiveness of most non-surgical treatments for Peyronie’s disease. Existing trials are mostly of poor methodological quality and/or fail to address patient-centered outcomes. Injectional collagenase appears to have some effectiveness; however, many individuals may not experience the improvement as clinically relevant, and this comes with the risk of increased adverse events. There is a critical need for better non-surgical treatment options for men with Peyronie’s disease.\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 findings of our review are up-to-date to 23 September 2022."
}
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query-laysum | 3572 | [
{
"role": "user",
"content": "Abstract: Background\nStroke is the third leading cause of disability worldwide. Physical activity is important for secondary stroke prevention and for promoting functional recovery. However, people with stroke are more inactive than healthy age-matched controls. Therefore, interventions to increase activity after stroke are vital to reduce stroke-related disability.\nObjectives\nTo summarise the available evidence regarding the effectiveness of commercially available, wearable activity monitors and smartphone applications for increasing physical activity levels in people with stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, SPORTDiscus, and the following clinical trial registers: WHO International Clinical Trials Registry Platform, Clinical Trials, EU Clinical Trial Register, ISRCTN Registry, Australian and New Zealand Clinical Trial Registry, and Stroke Trials Registry to 3 March 2018. We also searched reference lists, Web of Science forward tracking, and Google Scholar, and contacted trial authors to obtain further data if required. We did not restrict the search on language or publication status.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and randomised cross-over trials that included use of activity monitors versus no intervention, another type of intervention, or other activity monitor. Participants were aged 18 years or older with a diagnosis of stroke, in hospital or living in the community. Primary outcome measures were steps per day and time in moderate-to-vigorous intensity activity. Secondary outcomes were sedentary time, time spent in light intensity physical activity, walking duration, fatigue, mood, quality of life, community participation and adverse events. We excluded upper limb monitors that only measured upper limb activity.\nData collection and analysis\nWe followed standard Cochrane methodology to analyse and interpret the data. At least two authors independently screened titles and abstracts for inclusion. We resolved disagreements by consulting a third review author. We extracted the following data from included studies into a standardised template: type of study, participant population, study setting, intervention and co-interventions, time-frame, and outcomes. We graded levels of bias as high, low, or unclear, and assessed the quality of evidence for each outcome using the GRADE approach.\nMain results\nWe retrieved 28,098 references, from which we identified 29 potential articles. Four RCTs (in 11 reports) met the inclusion criteria.The sample sizes ranged from 27 to 135 (total 245 participants). Time poststroke varied from less than one week (n = 1), to one to three months (n = 2), or a median of 51 months (n = 1). Stroke severity ranged from a median of one to six on the National Institutes of Health Stroke Scale (NIHSS). Three studies were conducted in inpatient rehabilitation, and one was in a university laboratory. All studies compared use of activity monitor plus another intervention (e.g. a walking retraining programme or an inpatient rehabilitation programme) versus the other intervention alone. Three studies reported on the primary outcome of daily step counts.\nThere was no clear effect for the use of activity monitors in conjunction with other interventions on step count in a community setting (mean difference (MD) -1930 steps, 95% confidence interval (CI) -4410 to 550; 1 RCT, 27 participants; very low-quality evidence), or in an inpatient rehabilitation setting (MD 1400 steps, 95% CI -40 to 2840; 2 RCTs, 83 participants; very low-quality evidence). No studies reported the primary outcome moderate-to-vigorous physical activity, but one did report time spent in moderate and vigorous intensity activity separately: this study reported that an activity monitor in addition to usual inpatient rehabilitation increased the time spent on moderate intensity physical activity by 4.4 minutes per day (95% CI 0.28 to 8.52; 1 RCT, 48 participants; low-quality evidence) compared with usual rehabilitation alone, but there was no clear effect for the use of an activity monitor plus usual rehabilitation for increasing time spent in vigorous intensity physical activity compared to usual rehabilitation (MD 2.6 minutes per day, 95% CI -0.8 to 6; 1 RCT, 48 participants; low-quality evidence). The overall risk of bias was low, apart from high-risk for blinding of participants and study personnel. None of the included studies reported any information relating to adverse effects.\nAuthors' conclusions\nOnly four small RCTs with 274 participants (three in inpatient rehabilitation and one in the community) have examined the efficacy of activity monitors for increasing physical activity after stroke. Although these studies showed activity monitors could be incorporated into practice, there is currently not enough evidence to support the use of activity monitors to increase physical activity after stroke.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the available evidence regarding the effectiveness of commercially available, wearable devices (for example pedometers, Fitbit, and Garmin watches) and smartphone applications (for example Runkeeper, Fitbit application) for increasing physical activity levels for people with stroke."
}
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query-laysum | 3573 | [
{
"role": "user",
"content": "Abstract: Background\nAnthracycline combined with cytarabine has been the standard for induction therapy of newly diagnosed acute myeloid leukaemia (AML) for several decades. Due to theoretical advantages, idarubicin (IDA) might be the most effective and tolerable anthracycline. However, there is no evidence that would definitively prove the superiority of IDA over other anthracyclines.\nObjectives\nTo assess the efficacy and safety of IDA versus other anthracyclines in induction therapy of newly diagnosed AML.\nSearch methods\nWe identified relevant randomised controlled trials (RCTs) by searching the Cochrane Central Register of Controlled Trials (The Cochrane Library 2014, Issue 8), MEDLINE (from 1946 to 3 August 2014), EMBASE (from 1974 to 3 August 2014), Chinese BioMedical Literature Database (1978 to 3 August 2014), relevant conference proceedings and databases of ongoing trials.\nSelection criteria\nRCTs that compared IDA with other anthracyclines in induction therapy of newly diagnosed AML.\nData collection and analysis\nTwo review authors independently extracted data and assessed the quality of studies according to methodological standards of the Cochrane Collaboration. We estimated hazard ratios (HRs) for time-to-event data outcomes using the inverse variance method, and risk ratios (RRs) for dichotomous data outcomes using the Mantel-Haenszel method. We adopted a fixed-effect model and repeated the main meta-analysis by a random-effects model in a sensitivity analysis.\nMain results\nWe identified 2017 references. Ultimately, 27 RCTs (including 22 two-armed RCTs and five three-armed RCTs) involving 9549 patients were eligible. The consolidation treatments adopted in the studies were comparable and had no impact on the results. Overall, the risk of bias of the studies was unclear to high.\nEighteen RCTs (N = 6755) assessed IDA versus daunorubicin (DNR). The main meta-analyses showed that IDA compared with DNR prolonged overall survival (OS) (12 studies, 5976 patients; HR 0.90, 95% confidence interval (CI) 0.84 to 0.96, P = 0.0008; high quality of evidence) and disease-free survival (DFS) (eight studies, 3070 patients; HR 0.88, 95% CI 0.81 to 0.96, P = 0.004; moderate quality of evidence), increased complete remission (CR) rate (18 studies, 6692 patients; RR 1.04, 95% CI 1.01 to 1.07, P = 0.009; moderate quality of evidence), and reduced relapse rate (four studies, 1091 patients; RR 0.88, 95% CI 0.80 to 0.98, P = 0.02; moderate quality of evidence), although increased the risks of death on induction therapy (14 studies, 6349 patients; RR 1.18, 95% CI 1.01 to 1.36, P = 0.03; moderate quality of evidence) and grade 3/4 mucositis (five studies, 2000 patients; RR 1.22, 95% CI 1.04 to 1.44, P = 0.02; moderate quality of evidence). There was no evidence for difference in the risks of grade 3/4 cardiac toxicity (six studies, 2795 patients; RR 0.98, 95% CI 0.70 to 1.37, P = 0.91; moderate quality of evidence) and other grade 3/4 adverse events (AEs). None of the studies reported on quality of life (QoL).\nEight RCTs (N = 2419) evaluated IDA versus mitoxantrone (MIT). The main meta-analyses showed that there was no evidence for difference between arms in OS (six studies, 2171 patients; HR 0.98, 95% CI 0.89 to 1.08, P = 0.69; high quality of evidence), DFS (four studies, 249 patients; HR 0.88, 95% CI 0.70 to 1.10, P = 0.26; low quality of evidence), CR rate (eight studies, 2411 patients; RR 0.97, 95% CI 0.92 to 1.03, P = 0.32;moderate quality of evidence), the risks of death on induction therapy (five studies, 2055 patients; RR 1.10, 95% CI 0.88 to 1.38, P = 0.39; moderate quality of evidence) and relapse (three studies, 328 patients; RR 0.99, 95% CI 0.80 to 1.22, P = 0.89; moderate quality of evidence). There was no evidence for difference in the risks of grade 3/4 cardiac toxicity (one study, 160 patients; RR 0.67, 95% CI 0.11 to 3.88, P = 0.65; low quality of evidence) and other grade 3/4 AEs. None of the studies reported on QoL.\nTwo RCTs (N = 211) compared IDA with doxorubicin (DOX). Neither study assessed OS. One study showed that there was no evidence for difference in DFS (63 patients; HR 0.62, 95% CI 0.34 to 1.14, P = 0.12; low quality of evidence). The main meta-analysis for CR rate showed an improved CR rate with IDA (two studies, 187 patients; RR 1.28, 95% CI 1.03 to 1.59, P = 0.02; low quality of evidence). Neither study provided data for the risks of death on induction therapy and relapse. One trial showed that there was no evidence for difference in the risk of grade 3/4 cardiac toxicity (one study, 100 patients; RR 0.31, 95% CI 0.01 to 7.39, P = 0.47; very low quality of evidence). Neither study reported on QoL.\nTwo RCTs (N = 1037) evaluated IDA versus zorubicin (ZRB). Neither study assessed OS. One trial showed that there was no evidence for difference in DFS (one study, 155 patients; HR 1.25, 95% CI 0.83 to 1.88, P = 0.29; low quality of evidence). The main meta-analyses for CR and death on induction therapy both showed that there was no evidence for difference (CR rate: two studies, 964 patients; RR 1.04, 95% CI 0.96 to 1.13, P = 0.31; low quality of evidence. risk of death on induction therapy: two studies, 964 patients; RR 0.75, 95% CI 0.50 to 1.13, P = 0.17; moderate quality of evidence). Neither study reported the risks of relapse and grade 3/4 cardiotoxicity. One trial showed that IDA reduced the risk of grade 3/4 mucositis. Neither study reported on QoL.\nAuthors' conclusions\nCompared with DNR in induction therapy of newly diagnosed AML, IDA prolongs OS and DFS, increases CR rate and reduces relapse rate, although increases the risks of death on induction therapy and grade 3/4 mucositis. The currently available evidence does not show any difference between IDA and MIT used in induction therapy of newly diagnosed AML. There is insufficient evidence regarding IDA versus DOX and IDA versus ZRB to make final conclusions. Additionally, there is no evidence for difference on the effect of IDA compared with DNR, MIT, DOX or ZRB on QoL.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The currently available evidence suggests that in induction therapy of newly diagnosed AML, IDA is superior to DNR in terms of prolonging overall survival and disease-free survival, increasing complete remission rate and reducing relapse rate, although IDA may increase the risks of death on induction therapy and grade 3/4 mucositis. The current evidence does not support the superiority of IDA over MIT. There is insufficient evidence for clarifying the role of IDA versus DOX or ZRB. Additionally, there is no evidence for a difference on the effect of IDA compared with other anthracyclines (DNR, MIT, DOX and ZRB) on quality of life."
}
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query-laysum | 3574 | [
{
"role": "user",
"content": "Abstract: Background\nBetween 40% and 70% of people with treatment-resistant schizophrenia do not respond to clozapine, despite adequate blood levels. For these people, a number of treatment strategies have emerged, including the prescription of a second anti-psychotic drug in combination with clozapine.\nObjectives\nTo determine the clinical effects of various clozapine combination strategies with antipsychotic drugs in people with treatment-resistant schizophrenia both in terms of efficacy and tolerability.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Study-Based Register of Trials (to 28 August 2015) and MEDLINE (November 2008). We checked the reference lists of all identified randomised controlled trials (RCT). For the first version of the review, we also contacted pharmaceutical companies to identify further trials.\nSelection criteria\nWe included only RCTs recruiting people of both sexes, aged 18 years or more, with a diagnosis of treatment-resistant schizophrenia (or related disorders) and comparing clozapine plus another antipsychotic drug with clozapine plus a different antipsychotic drug.\nData collection and analysis\nWe extracted data independently. For dichotomous data, we calculated risk ratios (RRs) and 95% confidence intervals (CI) on an intention-to-treat basis using a random-effects meta-analysis. For continuous data, we calculated mean differences (MD) and 95% CIs. We used GRADE to create 'Summary of findings' tables and assessed risk of bias for included studies.\nMain results\nWe identified two further studies with 169 participants that met our inclusion criteria. This review now includes five studies with 309 participants. The quality of evidence was low, and, due to the high degree of heterogeneity between studies, we were unable to undertake a formal meta-analysis to increase the statistical power.\nFor this update, we specified seven main outcomes of interest: clinical response in mental state (clinically significant response, mean score/change in mental state), clinical response in global state (mean score/change in global state), weight gain, leaving the study early (acceptability of treatment), service utilisation outcomes (hospital days or admissions to hospital) and quality of life.\nWe found some significant differences between clozapine combination strategies for global and mental state (clinically significant response and change), and there were data for leaving the study early and weight gain. We found no data for service utilisation and quality of life.\nClozapine plus aripiprazole versus clozapine plus haloperidol\nThere was no long-term significant difference between aripiprazole and haloperidol combination strategies in change of mental state (1 RCT, n = 105, MD 0.90, 95% CI -4.38 to 6.18, low quality evidence). There were no adverse effect data for weight gain but there was a benefit of aripiprazole for adverse effects measured by the LUNSERS at 12 weeks (1 RCT, n = 105, MD -4.90, 95% CI -8.48 to -1.32) and 24 weeks (1 RCT, n = 105, MD -4.90, 95% CI -8.25 to -1.55), but not 52 weeks (1 RCT, n = 105, MD -4.80, 95% CI -9.79 to 0.19). Similar numbers of participants from each group left the study early (1 RCT, n = 106, RR 1.27, 95% CI 0.72 to 2.22, very low quality evidence).\nClozapine plus amisulpride versus clozapine plus quetiapine\nOne study showed a significant benefit of amisulpride over quetiapine in the short term, for both change in global state (Clinical Global Impression (CGI): 1 RCT, n = 50, MD -0.90, 95% CI -1.38 to -0.42, very low quality evidence) and mental state (Brief Psychiatric Rating Scale (BPRS): 1 RCT, n = 50, MD -4.00, 95% CI -5.86 to -2.14, low quality evidence). Similar numbers of participants from each group left the study early (1 RCT, n = 56, RR 0.20, 95% CI 0.02 to 1.60, very low quality evidence)\nClozapine plus risperidone versus clozapine plus sulpiride\nThere was no difference between risperidone and sulpiride for clinically significant response, defined by the study as 20% to 50% reduction in Positive and Negative Syndrome Scale (PANSS) (1 RCT, n = 60, RR 0.82, 95% CI 0.40 to 1.68, very low quality evidence). There were similar equivocal results for weight gain (1 RCT, n = 60, RR 0.40, 95% CI 0.08 to 1.90, very low quality evidence) and mental state (PANSS total: 1 RCT, n = 60, MD -2.28, 95% CI -7.41 to 2.85, very low quality evidence). No-one left the study early.\nClozapine plus risperidone versus clozapine plus ziprasidone\nThere was no difference between risperidone and ziprasidone for clinically significant response (1 RCT, n = 24, RR 0.80, 95% CI 0.28 to 2.27, very low quality evidence), change in global state CGI-II score (1 RCT, n = 22, MD -0.30, 95% CI -0.82 to 0.22, very low quality evidence), change in PANSS total score (1 RCT, n = 16, MD 1.00, 95% CI -7.91 to 9.91, very low quality evidence) or leaving the study early (1 RCT, n = 24, RR 1.60, 95% CI 0.73 to 3.49, very low quality evidence).\nClozapine plus ziprasidone versus clozapine plus quetiapine\nOne study found, in the medium term, a superior effect for ziprasidone combination compared with quetiapine combination for clinically significant response in mental state (> 50% reduction PANSS: 1 RCT, n = 63, RR 0.54, 95% CI 0.35 to 0.81, low quality evidence), global state (CGI - Severity score: 1 RCT, n = 60, MD -0.70, 95% CI -1.18 to -0.22, low quality evidence) and mental state (PANSS total score: 1 RCT, n = 60, MD -12.30, 95% CI -22.43 to -2.17, low quality evidence). There was no effect for leaving the study early (1 RCT, n = 63, RR 0.52, CI 0.05 to 5.41, very low quality evidence).\nAuthors' conclusions\nThe reliability of results from this review is limited, evidence is of low or very low quality. Furthermore, due to the limited number of included studies, we were unable to undertake formal meta-analyses. As a consequence, any conclusions drawn from these findings are based on single, small-sized RCTs with high risk of type II error. Properly conducted and adequately powered RCTs are required. Future trialists should seek to measure patient-important outcomes such as quality of life, as well as clinical response and adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "It was not possible to perform an overall analysis because the five studies were too different. Therefore, all results were based on data from one study per comparison.\nAripiprazole versus haloperidol combination: there was no overall difference in the effectiveness of the two treatment combinations; however, the aripiprazole combination caused fewer side effects.\nAmisulpride versus quetiapine combination: the amisulpride combination was more effective in treating schizophrenia in comparison with the quetiapine combination.\nRisperidone versus sulpiride combination: there were no overall differences in clinical effectiveness between these combinations.\nRisperidone versus ziprasidone combination: neither combination showed superiority over the other in improving the symptoms of schizophrenia.\nZiprasidone versus quetiapine combination: the ziprasidone combination was more effective in improving both mental and global state than the quetiapine combination."
}
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query-laysum | 3575 | [
{
"role": "user",
"content": "Abstract: Background\nMost vaginal births are associated with trauma to the genital tract. The morbidity associated with perineal trauma can be significant, especially when it comes to third- and fourth-degree tears. Different interventions including perineal massage, warm or cold compresses, and perineal management techniques have been used to prevent trauma. This is an update of a Cochrane review that was first published in 2011.\nObjectives\nTo assess the effect of perineal techniques during the second stage of labour on the incidence and morbidity associated with perineal trauma.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (26 September 2016) and reference lists of retrieved studies.\nSelection criteria\nPublished and unpublished randomised and quasi-randomised controlled trials evaluating perineal techniques during the second stage of labour. Cross-over trials were not eligible for inclusion.\nData collection and analysis\nThree review authors independently assessed trials for inclusion, extracted data and evaluated methodological quality. We checked data for accuracy.\nMain results\nTwenty-two trials were eligible for inclusion (with 20 trials involving 15,181 women providing data). Trials were at moderate to high risk of bias; none had adequate blinding, and most were unclear for both allocation concealment and incomplete outcome data. Interventions compared included the use of perineal massage, warm and cold compresses, and other perineal management techniques.\nMost studies did not report data on our secondary outcomes. We downgraded evidence for risk of bias, inconsistency, and imprecision for all comparisons.\nHands off (or poised) compared to hands on\nHands on or hands off the perineum made no clear difference in incidence of intact perineum (average risk ratio (RR) 1.03, 95% confidence interval (CI) 0.95 to 1.12, two studies, Tau² 0.00, I² 37%, 6547 women; moderate-quality evidence), first-degree perineal tears (average RR 1.32, 95% CI 0.99 to 1.77, two studies, 700 women; low-quality evidence), second-degree tears (average RR 0.77, 95% CI 0.47 to 1.28, two studies, 700 women; low-quality evidence), or third- or fourth-degree tears (average RR 0.68, 95% CI 0.21 to 2.26, five studies, Tau² 0.92, I² 72%, 7317 women; very low-quality evidence). Substantial heterogeneity for third- or fourth-degree tears means these data should be interpreted with caution. Episiotomy was more frequent in the hands-on group (average RR 0.58, 95% CI 0.43 to 0.79, Tau² 0.07, I² 74%, four studies, 7247 women; low-quality evidence), but there was considerable heterogeneity between the four included studies.\nThere were no data for perineal trauma requiring suturing.\nWarm compresses versus control (hands off or no warm compress)\nA warm compress did not have any clear effect on the incidence of intact perineum (average RR 1.02, 95% CI 0.85 to 1.21; 1799 women; four studies; moderate-quality evidence), perineal trauma requiring suturing (average RR 1.14, 95% CI 0.79 to 1.66; 76 women; one study; very low-quality evidence), second-degree tears (average RR 0.95, 95% CI 0.58 to 1.56; 274 women; two studies; very low-quality evidence), or episiotomy (average RR 0.86, 95% CI 0.60 to 1.23; 1799 women; four studies; low-quality evidence). It is uncertain whether warm compress increases or reduces the incidence of first-degree tears (average RR 1.19, 95% CI 0.38 to 3.79; 274 women; two studies; I² 88%; very low-quality evidence).\nFewer third- or fourth-degree perineal tears were reported in the warm-compress group (average RR 0.46, 95% CI 0.27 to 0.79; 1799 women; four studies; moderate-quality evidence).\nMassage versus control (hands off or routine care)\nThe incidence of intact perineum was increased in the perineal-massage group (average RR 1.74, 95% CI 1.11 to 2.73, six studies, 2618 women; I² 83% low-quality evidence) but there was substantial heterogeneity between studies. This group experienced fewer third- or fourth-degree tears (average RR 0.49, 95% CI 0.25 to 0.94, five studies, 2477 women; moderate-quality evidence).\nThere were no clear differences between groups for perineal trauma requiring suturing (average RR 1.10, 95% CI 0.75 to 1.61, one study, 76 women; very low-quality evidence), first-degree tears (average RR 1.55, 95% CI 0.79 to 3.05, five studies, Tau² 0.47, I² 85%, 537 women; very low-quality evidence), or second-degree tears (average RR 1.08, 95% CI 0.55 to 2.12, five studies, Tau² 0.32, I² 62%, 537 women; very low-quality evidence). Perineal massage may reduce episiotomy although there was considerable uncertainty around the effect estimate (average RR 0.55, 95% CI 0.29 to 1.03, seven studies, Tau² 0.43, I² 92%, 2684 women; very low-quality evidence). Heterogeneity was high for first-degree tear, second-degree tear and for episiotomy - data should be interpreted with caution.\nRitgen's manoeuvre versus standard care\nOne study (66 women) found that women receiving Ritgen's manoeuvre were less likely to have a first-degree tear (RR 0.32, 95% CI 0.14 to 0.69; very low-quality evidence), more likely to have a second-degree tear (RR 3.25, 95% CI 1.73 to 6.09; very low-quality evidence), and neither more nor less likely to have an intact perineum (RR 0.17, 95% CI 0.02 to 1.31; very low-quality evidence). One larger study reported that Ritgen's manoeuvre did not have an effect on incidence of third- or fourth-degree tears (RR 1.24, 95% CI 0.78 to 1.96,1423 women; low-quality evidence). Episiotomy was not clearly different between groups (RR 0.81, 95% CI 0.63 to 1.03, two studies, 1489 women; low-quality evidence).\nOther comparisons\nDelivery of posterior versus anterior shoulder first, use of a perineal protection device, different oils/wax, and cold compresses did not show any effects on outcomes with the exception of increased incidence of intact perineum with the perineal device. Only one study contributed to each of these comparisons.\nAuthors' conclusions\nModerate-quality evidence suggests that warm compresses, and massage, may reduce third- and fourth-degree tears but the impact of these techniques on other outcomes was unclear or inconsistent. Poor-quality evidence suggests hands-off techniques may reduce episiotomy, but this technique had no clear impact on other outcomes. There were insufficient data to show whether other perineal techniques result in improved outcomes.\nFurther research could be performed evaluating perineal techniques, warm compresses and massage, and how different types of oil used during massage affect women and babies. It is important for any future research to collect information on women's views.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Trauma to the perineum can cause pain and other problems for women after the birth. The damage is described as first-, second-, third- and fourth-degree tears – first-degree tears being the least damage and fourth-degree tears being the most. Third- and fourth-degree tears, affect the anal sphincter or mucosa, thus causing the most problems. Reducing the use of episiotomies will reduce trauma to the perineum. Also, different perineal techniques are being used to slow down the birth of the baby's head. Massage, warm compresses and different perineal management techniques are widely used by midwives and birth attendants. It is important to know if these do indeed reduce trauma and pain for women."
}
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query-laysum | 3576 | [
{
"role": "user",
"content": "Abstract: Background\nOvulatory disturbance is a key diagnostic feature of polycystic ovarian syndrome (PCOS), leading to infertility and correspondingly heavy disease burden. Many therapeutic strategies have been used to induce ovulation for women with PCOS who are infertile. Ultrasound-guided transvaginal ovarian needle drilling (UTND) is a novel surgical method used to induce ovulation for women with clomiphene-resistant PCOS at the outpatient clinic.\nObjectives\nTo evaluate the efficacy and safety of UTND for subfertile women with clomiphene-resistant PCOS.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, and other databases to December 2020. We checked conference abstracts, reference lists, and clinical trials registries. We also contacted experts and specialists in the field for any additional trials .\nSelection criteria\nWe planned to include randomised controlled trials comparing UTND to laparoscopic ovarian drilling, and UTND combined with gonadotropins to gonadotropins, in women of reproductive age with clomiphene-resistant PCOS and infertility.\nData collection and analysis\nTwo review authors independently screened the trials identified by the search for inclusion, assessed methodological quality and risk of bias, and extracted data. The primary outcomes were live birth rate and incidence of surgical complications (bleeding and infection). Secondary outcomes included pregnancy rate, ovulation rate, and ovarian hyperstimulation syndrome. We planned to calculate odds ratios with 95% confidence intervals for dichotomous data. We would assess overall quality of the evidence by applying the GRADE criteria.\nMain results\nWe did not identify any trials for inclusion in the review. We were unable to assess the benefit or harm of applying UTND for women with clomiphene-resistant PCOS, as no studies could be included in the current review. We moved the previously included trials to studies awaiting classification due to concerns regarding methodology.\nAuthors' conclusions\nSince we did not identify any studies for inclusion, we were unable to assess the benefit or harm of applying UTND for women with clomiphene-resistant PCOS.\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": "No studies could be included for quality evaluation."
}
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query-laysum | 3577 | [
{
"role": "user",
"content": "Abstract: Background\nEndoscopic ultrasound (EUS) and magnetic resonance cholangiopancreatography (MRCP) are tests used in the diagnosis of common bile duct stones in patients suspected of having common bile duct stones prior to undergoing invasive treatment. There has been no systematic review of the accuracy of EUS and MRCP in the diagnosis of common bile duct stones using appropriate reference standards.\nObjectives\nTo determine and compare the accuracy of EUS and MRCP for the diagnosis of common bile duct stones.\nSearch methods\nWe searched MEDLINE, EMBASE, Science Citation Index Expanded, BIOSIS, and Clinicaltrials.gov until September 2012. We searched the references of included studies to identify further studies and of systematic reviews identified from various databases (Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA), Medion, and ARIF (Aggressive Research Intelligence Facility)). We did not restrict studies based on language or publication status, or whether data were collected prospectively or retrospectively.\nSelection criteria\nWe included studies that provided the number of true positives, false positives, false negatives, and true negatives for EUS or MRCP. We only accepted studies that confirmed the presence of common bile duct stones by extraction of the stones (irrespective of whether this was done by surgical or endoscopic methods) for a positive test, and absence of common bile duct stones by surgical or endoscopic negative exploration of the common bile duct or symptom free follow-up for at least six months for a negative test, as the reference standard in people suspected of having common bile duct stones. We included participants with or without prior diagnosis of cholelithiasis; with or without symptoms and complications of common bile duct stones, with or without prior treatment for common bile duct stones; and before or after cholecystectomy. At least two authors independently screened abstracts and selected studies for inclusion.\nData collection and analysis\nTwo authors independently collected the data from each study. We used the bivariate model to obtain pooled estimates of sensitivity and specificity.\nMain results\nWe included a total of 18 studies involving 2366 participants (976 participants with common bile duct stones and 1390 participants without common bile duct stones). Eleven studies evaluated EUS alone, and five studies evaluated MRCP alone. Two studies evaluated both tests. Most studies included patients who were suspected of having common bile duct stones based on abnormal liver function tests; abnormal transabdominal ultrasound; symptoms such as obstructive jaundice, cholangitis, or pancreatitis; or a combination of the above. The proportion of participants who had undergone cholecystectomy varied across studies. Not one of the studies was of high methodological quality. For EUS, the sensitivities ranged between 0.75 and 1.00 and the specificities ranged between 0.85 and 1.00. The summary sensitivity (95% confidence interval (CI)) and specificity (95% CI) of the 13 studies that evaluated EUS (1537 participants; 686 cases and 851 participants without common bile duct stones) were 0.95 (95% CI 0.91 to 0.97) and 0.97 (95% CI 0.94 to 0.99). For MRCP, the sensitivities ranged between 0.77 and 1.00 and the specificities ranged between 0.73 and 0.99. The summary sensitivity and specificity of the seven studies that evaluated MRCP (996 participants; 361 cases and 635 participants without common bile duct stones) were 0.93 (95% CI 0.87 to 0.96) and 0.96 (95% CI 0.90 to 0.98). There was no evidence of a difference in sensitivity or specificity between EUS and MRCP (P value = 0.5). From the included studies, at the median pre-test probability of common bile duct stones of 41% the post-test probabilities (with 95% CI) associated with positive and negative EUS test results were 0.96 (95% CI 0.92 to 0.98) and 0.03 (95% CI 0.02 to 0.06). At the same pre-test probability, the post-test probabilities associated with positive and negative MRCP test results were 0.94 (95% CI 0.87 to 0.97) and 0.05 (95% CI 0.03 to 0.09).\nAuthors' conclusions\nBoth EUS and MRCP have high diagnostic accuracy for detection of common bile duct stones. People with positive EUS or MRCP should undergo endoscopic or surgical extraction of common bile duct stones and those with negative EUS or MRCP do not need further invasive tests. However, if the symptoms persist, further investigations will be indicated. The two tests are similar in terms of diagnostic accuracy and the choice of which test to use will be informed by availability and contra-indications to each test. However, it should be noted that the results are based on studies of poor methodological quality and so the results should be interpreted with caution. Further studies that are of high methodological quality are necessary to determine the diagnostic accuracy of EUS and MRCP for the diagnosis of common bile duct stones.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "All the studies were of low methodological quality, which may undermine the validity of our findings."
}
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query-laysum | 3578 | [
{
"role": "user",
"content": "Abstract: Background\nExposure to rape, sexual assault and sexual abuse has lifelong impacts for mental health and well-being. Prolonged Exposure (PE), Cognitive Processing Therapy (CPT) and Eye Movement Desensitisation and Reprocessing (EMDR) are among the most common interventions offered to survivors to alleviate post-traumatic stress disorder (PTSD) and other psychological impacts. Beyond such trauma-focused cognitive and behavioural approaches, there is a range of low-intensity interventions along with new and emerging non-exposure based approaches (trauma-sensitive yoga, Reconsolidation of Traumatic Memories and Lifespan Integration). This review presents a timely assessment of international evidence on any type of psychosocial intervention offered to individuals who experienced rape, sexual assault or sexual abuse as adults.\nObjectives\nTo assess the effects of psychosocial interventions on mental health and well-being for survivors of rape, sexual assault or sexual abuse experienced during adulthood.\nSearch methods\nIn January 2022, we searched CENTRAL, MEDLINE, Embase, 12 other databases and three trials registers. We also checked reference lists of included studies, contacted authors and experts, and ran forward citation searches.\nSelection criteria\nAny study that allocated individuals or clusters of individuals by a random or quasi-random method to a psychosocial intervention that promoted recovery and healing following exposure to rape, sexual assault or sexual abuse in those aged 18 years and above compared with no or minimal intervention, usual care, wait-list, pharmacological only or active comparison(s). We classified psychosocial interventions according to Cochrane Common Mental Disorders Group’s psychological therapies list.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane.\nMain results\nWe included 36 studies (1991 to 2021) with 3992 participants randomly assigned to 60 experimental groups (3014; 76%) and 23 inactive comparator conditions (978, 24%).\nThe experimental groups consisted of: 32 Cognitive Behavioural Therapy (CBT); 10 behavioural interventions; three integrative therapies; three humanist; five other psychologically oriented interventions; and seven other psychosocial interventions. Delivery involved 1 to 20 (median 11) sessions of traditional face-to-face (41) or other individual formats (four); groups (nine); or involved computer-only interaction (six). Most studies were conducted in the USA (n = 26); two were from South Africa; two from the Democratic Republic of the Congo; with single studies from Australia, Canada, the Netherlands, Spain, Sweden and the UK. Five studies did not disclose a funding source, and all disclosed sources were public funding.\nParticipants were invited from a range of settings: from the community, through the media, from universities and in places where people might seek help for their mental health (e.g. war veterans), in the aftermath of sexual trauma (sexual assault centres and emergency departments) or for problems that accompany the experience of sexual violence (e.g. sexual health/primary care clinics). Participants randomised were 99% women (3965 participants) with just 27 men. Half were Black, African or African-American (1889 participants); 40% White/Caucasian (1530 participants); and 10% represented a range of other ethnic backgrounds (396 participants). The weighted mean age was 35.9 years (standard deviation (SD) 9.6). Eighty-two per cent had experienced rape or sexual assault in adulthood (3260/3992). Twenty-two studies (61%) required fulfilling a measured PTSD diagnostic threshold for inclusion; however, 94% of participants (2239/2370) were reported as having clinically relevant PTSD symptoms at entry.\nThe comparison of psychosocial interventions with inactive controls detected that there may be a beneficial effect at post-treatment favouring psychosocial interventions in reducing PTSD (standardised mean difference (SMD) -0.83, 95% confidence interval (CI) -1.22 to -0.44; 16 studies, 1130 participants; low-certainty evidence; large effect size based on Cohen’s D); and depression (SMD -0.82, 95% CI -1.17 to -0.48; 12 studies, 901 participants; low-certainty evidence; large effect size). Psychosocial interventions, however, may not increase the risk of dropout from treatment compared to controls, with a risk ratio of 0.85 (95% CI 0.51 to 1.44; 5 studies, 242 participants; low-certainty evidence). Seven of the 23 studies (with 801 participants) comparing a psychosocial intervention to an inactive control reported on adverse events, with 21 events indicated. Psychosocial interventions may not increase the risk of adverse events compared to controls, with a risk ratio of 1.92 (95% CI 0.30 to 12.41; 6 studies; 622 participants; very low-certainty evidence).\nWe conducted an assessment of risk of bias using the RoB 2 tool on a total of 49 reported results. A high risk of bias affected 43% of PTSD results; 59% for depression symptoms; 40% for treatment dropout; and one-third for adverse events. The greatest sources of bias were problems with randomisation and missing outcome data. Heterogeneity was also high, ranging from I2 = 30% (adverse events) to I2 = 87% (PTSD).\nAuthors' conclusions\nOur review suggests that survivors of rape, sexual violence and sexual abuse during adulthood may experience a large reduction in post-treatment PTSD symptoms and depressive symptoms after experiencing a psychosocial intervention, relative to comparison groups. Psychosocial interventions do not seem to increase dropout from treatment or adverse events/effects compared to controls. However, the number of dropouts and study attrition were generally high, potentially missing harms of exposure to interventions and/or research participation. Also, the differential effects of specific intervention types needs further investigation.\nWe conclude that a range of behavioural and CBT-based interventions may improve the mental health of survivors of rape, sexual assault and sexual abuse in the short term. Therefore, the needs and preferences of individuals must be considered in selecting suitable approaches to therapy and support. The primary outcome in this review focused on the post-treatment period and the question about whether benefits are sustained over time persists. However, attaining such evidence from studies that lack an active comparison may be impractical and even unethical. Thus, we suggest that studies undertake head-to-head comparisons of different intervention types; in particular, of novel, emerging therapies, with one-year plus follow-up periods. Additionally, researchers should focus on the therapeutic benefits and costs for subpopulations such as male survivors and those living with complex PTSD.\n\nGiven the provided abstract, please respond to the following query: \"About the studies and their participants\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 36 studies that placed consenting adult participants by chance into an intervention or a control group. Participants were invited from a range of settings: community; universities; places where people seek help for their mental health, sexual trauma (e.g. specialist sexual assault centres and emergency departments) or for problems that occur alongside the experience of sexual violence (e.g. primary care clinics); and via media requests. The studies included 3992 survivors; only 27 were men. Sixty per cent of participants were Black or from a minority ethnic or cultural background. The average age was 36 years, and nearly all had symptoms of PTSD.\nMost studies were done in the USA (26); there were two from South Africa; two from the Democratic Republic of the Congo; and single studies from Australia, Canada, the Netherlands, Spain, Sweden and the UK. Five studies did not disclose a funding source; those that did reported public funding.\nOver half the interventions were CBT-based. Support was mostly delivered one-to-one by trained mental health professionals and varied between 1 and 20 sessions."
}
]
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query-laysum | 3579 | [
{
"role": "user",
"content": "Abstract: Background\nAntisocial personality disorder (AsPD) is associated with rule-breaking, criminality, substance use, unemployment, relationship difficulties, and premature death. Certain types of medication (drugs) may help people with AsPD. This review updates a previous Cochrane review, published in 2010.\nObjectives\nTo assess the benefits and adverse effects of pharmacological interventions for adults with AsPD.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, 13 other databases and two trials registers up to 5 September 2019. We also checked reference lists and contacted study authors to identify studies.\nSelection criteria\nRandomised controlled trials in which adults (age 18 years and over) with a diagnosis of AsPD or dissocial personality disorder were allocated to a pharmacological intervention or placebo control condition.\nData collection and analysis\nFour authors independently selected studies and extracted data. We assessed risk of bias and created 'Summary of findings tables' and assessed the certainty of the evidence using the GRADE framework. The primary outcomes were: aggression; reconviction; global state/global functioning; social functioning; and adverse events.\nMain results\nWe included 11 studies (three new to this update), involving 416 participants with AsPD. Most studies (10/11) were conducted in North America. Seven studies were conducted exclusively in an outpatient setting, one in an inpatient setting, and one in prison; two studies used multiple settings. The average age of participants ranged from 28.6 years to 45.1 years (overall mean age 39.6 years). Participants were predominantly (90%) male. Study duration ranged from 6 to 24 weeks, with no follow-up period. Data were available from only four studies involving 274 participants with AsPD. All the available data came from unreplicated, single reports, and did not allow independent statistical analysis to be conducted. Many review findings were limited to descriptive summaries based on analyses carried out and reported by the trial investigators.\nNo study set out to recruit participants on the basis of having AsPD; many participants presented primarily with substance abuse problems. The studies reported on four primary outcomes and six secondary outcomes. Primary outcomes were aggression (six studies) global/state functioning (three studies), social functioning (one study), and adverse events (seven studies). Secondary outcomes were leaving the study early (eight studies), substance misuse (five studies), employment status (one study), impulsivity (one study), anger (three studies), and mental state (three studies). No study reported data on the primary outcome of reconviction or the secondary outcomes of quality of life, engagement with services, satisfaction with treatment, housing/accommodation status, economic outcomes or prison/service outcomes.\nEleven different drugs were compared with placebo, but data for AsPD participants were only available for five comparisons. Three classes of drug were represented: antiepileptic; antidepressant; and dopamine agonist (anti-Parkinsonian) drugs. We considered selection bias to be unclear in 8/11 studies, attrition bias to be high in 7/11 studies, and performance bias to be low in 7/11 studies. Using GRADE, we rated the certainty of evidence for each outcome in this review as very low, meaning that we have very little confidence in the effect estimates reported.\nPhenytoin (antiepileptic) versus placebo\nOne study (60 participants) reported very low-certainty evidence that phenytoin (300 mg/day), compared to placebo, may reduce the mean frequency of aggressive acts per week (phenytoin mean = 0.33, no standard deviation (SD) reported; placebo mean = 0.51, no SD reported) in male prisoners with aggression (skewed data) at endpoint (six weeks). The same study (60 participants) reported no evidence of difference between phenytoin and placebo in the number of participants reporting the adverse event of nausea during week one (odds ratio (OR) 1.00, 95% confidence interval (CI) 0.06 to 16.76; very low-certainty evidence). The study authors also reported that no important side effects were detectable via blood cell counts or liver enzyme tests (very low-certainty evidence).\nThe study did not measure reconviction, global/state functioning or social functioning.\nDesipramine (antidepressant) versus placebo\nOne study (29 participants) reported no evidence of a difference between desipramine (250 to 300 mg/day) and placebo on mean social functioning scores (desipramine = 0.19; placebo = 0.21), assessed with the family-social domain of the Addiction Severity Index (scores range from zero to one, with higher values indicating worse social functioning), at endpoint (12 weeks) (very low-certainty evidence).\nNeither of the studies included in this comparison measured the other primary outcomes: aggression; reconviction; global/state functioning; or adverse events.\nNortriptyline (antidepressant) versus placebo\nOne study (20 participants) reported no evidence of a difference between nortriptyline (25 to 75 mg/day) and placebo on mean global state/functioning scores (nortriptyline = 0.3; placebo = 0.7), assessed with the Symptom Check List-90 (SCL-90) Global Severity Index (GSI; mean of subscale scores, ranging from zero to four, with higher scores indicating greater severity of symptoms), at endpoint (six months) in men with alcohol dependency (very low-certainty evidence).\nThe study measured side effects but did not report data on adverse events for the AsPD subgroup.\nThe study did not measure aggression, reconviction or social functioning.\nBromocriptine (dopamine agonist) versus placebo\nOne study (18 participants) reported no evidence of difference between bromocriptine (15 mg/day) and placebo on mean global state/functioning scores (bromocriptine = 0.4; placebo = 0.7), measured with the GSI of the SCL-90 at endpoint (six months) (very low-certainty evidence).\nThe study did not provide data on adverse effects, but reported that 12 patients randomised to the bromocriptine group experienced severe side effects, five of whom dropped out of the study in the first two days due to nausea and severe flu-like symptoms (very low-certainty evidence).\nThe study did not measure aggression, reconviction and social functioning.\nAmantadine (dopamine agonist) versus placebo\nThe study in this comparison did not measure any of the primary outcomes.\nAuthors' conclusions\nThe evidence summarised in this review is insufficient to draw any conclusion about the use of pharmacological interventions in the treatment of antisocial personality disorder. The evidence comes from single, unreplicated studies of mostly older medications. The studies also have methodological issues that severely limit the confidence we can draw from their results. Future studies should recruit participants on the basis of having AsPD, and use relevant outcome measures, including reconviction.\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": "What are the beneficial and harmful effects of medication on aggression, reconviction (reoffending), and people's ability to function in society?"
}
]
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query-laysum | 3580 | [
{
"role": "user",
"content": "Abstract: Background\nThe hepatitis C virus (HCV) infection affects about 2% of the world's population and can cause chronic liver infection and persistent long-term sequelae such as cirrhosis and liver cancer.\nThe prevalence of HCV infection among people on haemodialysis is often higher than the general population. The virus is easily transmitted parenterally, and blood transfusions have previously played a significant role in transmission; however, erythropoietin therapy has reduced the need for transfusions, and coupled with improved screening of donated blood, has significantly decreased transmission by transfusion. Although control of hospital-acquired infection has improved with the advent of biosafety measures, stopping HCV transmission in haemodialysis units remains challenging.\nIsolating people infected with HCV involves physical separation from others to limit direct or indirect transmission and includes a number of strategies during dialysis. The evidence for isolating people infected with HCV during haemodialysis is sparse with some inconsistencies.\nObjectives\nTo evaluate the benefits and harms of isolation of HCV-infected patients during haemodialysis on the transmission of HCV to other patients.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register to 26 November 2015 through contact with the Information Specialist using search terms relevant to this review. We also searched the Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to 2015), Web of Science Conference Proceedings Citation Index-Science (CPCI-S, 1990 to 2015), ProQuest Dissertations & Theses Database (1990 to 2015), and Open Grey (1990 to 2015).\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs and cluster RCTs evaluating the clinical benefits and harms of isolating HCV-infected patients during haemodialysis on the transmission of HCV to other patients. We considered incidence of dialysis-acquired HCV infection, all-cause mortality, and adverse effects associated with isolation as the primary outcomes.\nData collection and analysis\nSummary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) or standardised mean difference (SMD) and 95% CI for continuous outcomes.\nMain results\nOnly one study, which included 12 centres was identified: four centres used dedicated haemodialysis machines for HCV-infected patients and eight centres used non-dedicated machines. The total number of patients enrolled was 593. One centre was excluded after randomisation. Random sequence generation was not described and allocation concealment was not performed. Participants and personnel were not blinded and blinding of outcome assessors was not reported. Only 74.5% of the patients were followed for 9 months; and 47.3% were followed for an additional 9 months. The authors only reported one outcome, measuring the difference in the incidence of HCV in both groups. The authors did not consider the exposure time, to determine the adjusted rate of seroconversion risk/patient-year.\n\nThe study reported that the incidence of HCV infection during the first follow-up period (9 months) was 1.6% in the dedicated group, and 4.7% in the non-dedicated one (446 patients analysed out of 593 randomised; RR 0.34, 95% CI 0.11 to 1.07). During the second follow-up period (18 months) the incidence was 1.3% in the dedicated group and 5.8% in the control (281 patients analysed out of 593 randomised; RR 0.22, 95% CI 0.05 to 1.02). Therefore, we found no differences in terms of the number of participants developing HCV infection when comparing the dedicated group with the usual care. Moreover, the evidence was of very low quality, which means that we have very little confidence in the effect estimate.\nAuthors' conclusions\nThe benefits and harms of isolation of HCV-infected patients during haemodialysis on the transmission of HCV to other patients are uncertain. Evidence from one short-duration cluster-randomised study with a high risk of bias did not find differences in terms of the number of participants developing HCV infection when comparing the use of dedicated haemodialysis machines for HCV infected patients with the use of non-dedicated machines.\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 conducted an extensive literature search to November 26, 2015, but only found one study looking at isolation as a strategy for controlling the transmission of HCV infection."
}
]
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query-laysum | 3581 | [
{
"role": "user",
"content": "Abstract: Background\nMelanoma is the leading cause of skin cancer-associated mortality. The vast majority of newly diagnosed melanomas are confined to the primary cutaneous site. Surgery represents the mainstay of melanoma treatment. Treatment strategies include wide excision of the primary tumour and sentinel lymph node biopsy (SLNB) to assess the status of the regional nodal basin(s). SLNB has become an important component of initial melanoma management providing accurate disease staging.\nObjectives\nTo assess the effects and safety of SLNB followed by completion lymph node dissection (CLND) for the treatment of localised primary cutaneous melanoma.\nSearch methods\nWe searched the following databases up to February 2015: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2015, Issue 1), MEDLINE (from 1946), EMBASE (from 1974), and LILACS ((Latin American and Caribbean Health Science Information database, from 1982). We also searched the following from inception: African Index Medicus, IndMED of India, Index Medicus for the South-East Asia Region, and six trials registers. We checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials (RCTs). We searched ISI Web of Science Conference Proceedings from inception to February 2015, and we scanned the abstracts of major dermatology and oncology conference proceedings up to 2015.\nSelection criteria\nTwo review authors independently assessed all RCTs comparing SLNB followed by CLND for the treatment of primary localised cutaneous melanoma for inclusion. Primary outcome measures were overall survival and rate of treatment complications and side effects.\nData collection and analysis\nTwo review authors independently extracted and analysed data on survival and recurrence, assessed risk of bias, and collected adverse effect information from included trials.\nMain results\nWe identified and included a single eligible trial comparing SLNB with observation which was published in eight different reports (from 2005 to 2014) with 2001 participants. This trial did not report on our first primary outcome of overall survival (which was also the planned primary outcome of this trial). When contacted for this important data, the trial authors stated \"there are numerous additional analyses that have yet to be reported for the trial\". We were able however to estimate overall survival from data included in the appendix of the published report and found no evidence of benefit for SLNB for overall survival. The overall survival hazard ratio (HR) using ITT (intention-to-treat) analysis was 0.99 95% confidence interval [CI] 0.82 to 1.19, 1661 participants). The overall survival using ITT for intermediate thickness melanomas was (HR 0.92, 95% CI 0.73 to 1.16) and for thick melanomas it was (HR 1.15, 95% CI 0.82 to 1.61).\nThe study did report on our second primary outcome of rate of treatment complications: short-term surgical morbidity (30 days) in 1735 participants showed no difference between SLNB and observation (risk ratio [RR] 1.11, 955 CI 0.9 to 1.37) for wide excision of the tumour site but favoured observation for complications related to the regional nodal basin (RR 14.36, 95% CI 6.74 to 30.59).\nOur secondary outcomes of disease-specific and disease-free survival, local recurrence and distant metastases were reported. There were 1347 participants in the intermediate-thickness melanoma group and 314 in the thick melanoma group.The study did not report the actual 10-year melanoma-specific survival rate for all included participants. Instead, melanoma-specific survival rates for each group of participants: intermediate-thickness melanoma (defined as 1.2 to 3.5 mm) and thick melanomas (defined as 3.50 mm or more) was reported.\nIn the intermediate-thickness melanoma group there was no statistically significant difference in disease-specific survival between study groups at 10 years (81.4 ± 1.5% versus 78.3 ± 2.0%, HR 0.84, 95% CI 0.65 to 1.09). In the thick melanoma group, again there was no statistically significant difference in disease-specific survival between study groups at 10 years (58.9.3 ± 4.1% versus 64.4 ± 4.6%, HR 1.12, 95% CI 0.77 to 1.64). Combining these groups there was some heterogeneity (I² = 34%) but the total HR was not statistically significant (HR 0.92, 95% CI 0.74 to 1.14).\nThe summary estimate for disease-free survival at 10 years favoured SLNB over observation in participants with intermediate-thickness and thick melanomas (HR 0.75, 95% CI 0.63 to 0.89).\nWith regard to the rate of local and regional recurrence as the site of first recurrence, a benefit of SLNB uniformly existed in both groups of participants with intermediate-thickness and thick melanomas (RR 0.56, 95% CI 0.45 to 0.69). This is in contrast with a uniformly unfavourable effect of SLNB with regard to the rate of distant metastases as site of first recurrence, in both groups of participants with intermediate-thickness and thick melanomas (HR 1.33, 95% CI 1.03 to 1.72).\nAuthors' conclusions\nWe found no evidence of improved overall survival or melanoma-specific survival rates for participants with intermediate or thick melanomas who underwent SLNB compared with observation alone.\nDisease-free survival and rate of local and regional recurrence favoured SLNB in both groups of participants with intermediate-thickness and thick melanomas but short-term surgical morbidity was higher in the SLNB group, especially with regard to complications in the nodal basin.\nThe evidence for the outcomes of interest in this review is of low quality due to the risk of bias and imprecision of the estimated effects. Further research may have an important impact on our estimate of the effectiveness of SLNB in managing primary localised cutaneous melanoma. Currently this evidence is not sufficient to document a benefit of SLNB when compared to observation in individuals with primary localised cutaneous melanoma.\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": "Although the authors of the one included study did not report the primary outcome of overall survival, we were able to calculate it from data they included in their report appendix which showed no benefit of SLNB for people with intermediate or thick melanomas. Our one included study also did not report any difference in disease-specific survival for participants who underwent SLNB or observation. Disease-free survival was better in the SLNB treatment group. However, recurrence of the melanoma at a distant site in the body occurred more frequently in participants in the SLNB group than in those in the observation group."
}
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query-laysum | 3582 | [
{
"role": "user",
"content": "Abstract: Background\nAsthma is a chronic respiratory condition characterised by airways inflammation, constriction of airway smooth muscle and structural alteration of the airways that is at least partially reversible. Exacerbations of asthma can be life threatening and place a significant burden on healthcare services. Various guidelines have been published to inform management personnel in the acute setting; several include the use of a single bolus of intravenous magnesium sulfate (IV MgSO4) in cases that do not respond to first-line treatment. However, the effectiveness of this approach remains unclear, particularly in less severe cases.\nObjectives\nTo assess the safety and efficacy of IV MgSO4 in adults treated for acute asthma in the emergency department.\nSearch methods\nWe identified trials from the Cochrane Airways Review Group Specialised Register (CAGR) up to 2 May 2014. We also searched www.ClinicalTrials.gov and reference lists of other reviews, and we contacted trial authors to ask for additional information.\nSelection criteria\nWe included randomised controlled trials (RCTs) of adults treated in the emergency department (ED) for exacerbations of asthma if they compared any dose of IV MgSO4 with placebo.\nData collection and analysis\nAll review authors screened titles and abstracts for inclusion, and at least two review authors independently extracted study characteristics, risk of bias and numerical data. Disagreements were resolved by consensus, and we contacted trial investigators to obtain missing information.\nWe analysed dichotomous data as odds ratios using study participants as the unit of analysis, and we analysed continuous data as mean differences or standardised mean differences using fixed-effect models. We rated all outcomes using GRADE and presented results in Summary of findings table 1.\nWe carried out subgroup analyses on the primary outcome for baseline severity of exacerbations and whether or not ipratropium bromide was given as a co-medication. Unpublished data and studies at high risk of bias for blinding were removed from the main analysis in sensitivity analyses.\nMain results\nFourteen studies met the inclusion criteria, randomly assigning 2313 people with acute asthma to the comparisons of interest in this review.\nMost studies were double-blinded trials comparing a single infusion of 1.2 g or 2 g IV MgSO4 over 15 to 30 minutes versus a matching placebo. Eleven were conducted at a single centre, and three were multi-centre trials. Participants in almost all of the studies had already been given at least oxygen, nebulised short-acting beta2-agonists and IV corticosteroids in the ED; in some studies, investigators also administered ipratropium bromide. Ten studies included only adults, and four included both adults and children; these were included because the mean age of participants was over 18 years.\nIntravenous MgSO4 reduced hospital admissions compared with placebo (odds ratio (OR) 0.75, 95% confidence interval (CI) 0.60 to 0.92; I2 = 28%, P value 0.18; n = 972; high-quality evidence). In absolute terms, this odds ratio translates into a reduction of seven hospital admissions for every 100 adults treated with IV MgSO4 (95% CI two to 13 fewer). The test for subgroup differences revealed no statistical heterogeneity between the three severity subgroups (I2 = 0%, P value 0.73) or between the four studies that administered nebulised ipratropium bromide as a co-medication and those that did not (I2 = 0%, P value 0.82). Sensitivity analyses in which unpublished data and studies at high risk for blinding were removed from the primary analysis did not change conclusions.\nWithin the secondary outcomes, high- and moderate-quality evidence across three spirometric indices suggests some improvement in lung function with IV MgSO4. No difference was found between IV MgSO4and placebo for most of the non-spirometric secondary outcomes, all of which were rated as low or moderate quality (intensive care admissions, ED treatment duration, length of hospital stay, readmission, respiration rate, systolic blood pressure).\nAdverse events were inconsistently reported and were not meta-analysed. The most commonly cited adverse events in the IV MgSO4 groups were flushing, fatigue, nausea and headache and hypotension (low blood pressure).\nAuthors' conclusions\nThis review provides evidence that a single infusion of 1.2 g or 2 g IV MgSO4 over 15 to 30 minutes reduces hospital admissions and improves lung function in adults with acute asthma who have not responded sufficiently to oxygen, nebulised short-acting beta2-agonists and IV corticosteroids. Differences in the ways the trials were conducted made it difficult for the review authors to assess whether severity of the exacerbation or additional co-medications altered the treatment effect of IV MgSO4. Limited evidence was found for other measures of benefit and safety.\nStudies conducted in these populations should clearly define baseline severity parameters and systematically record adverse events. Studies recruiting participants with exacerbations of varying severity should consider subgrouping results on the basis of accepted severity classifications.\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": "Fourteen studies met the inclusion criteria, involving a total of 2313 people. These studies varied in terms of how bad exacerbations had to be for people to be included and in terms of what other treatments were provided before IV MgSO4was given, but almost all trials gave participants at least oxygen, nebulised short-acting medications and steroid tablets or injection.\nOverall, IV MgSO4 reduced the need for hospital admission compared with placebo (seven fewer per 100 treated; 95% confidence interval two to 13 fewer). Not enough information was available to show whether the reduction in hospital admissions was associated with severity of the asthma exacerbation, or whether it made a difference what other treatments were given. Evidence suggests that IV MgSO4 improved some lung function parameters, but for other measures such as heart rate, variation among study findings reduced our confidence in the results. We did not find a difference between IV MgSO4 and placebo in most other measures (including time spent in the ED, respiratory rate and blood pressure), and adverse events generally were poorly reported."
}
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query-laysum | 3583 | [
{
"role": "user",
"content": "Abstract: Background\nObstructive sleep apnoea (OSA) is a common sleep disorder characterised by partial or complete upper airway occlusion during sleep, leading to intermittent cessation (apnoea) or reduction (hypopnoea) of airflow and dips in arterial oxygen saturation during sleep. Many patients with recognised and unrecognised OSA receive hypnotics, sedatives and opiates/opioids to treat conditions including pain, anxiety and difficulty sleeping. Concerns have been expressed that administration of these drugs to people with co-existing OSA may worsen OSA.\nObjectives\nTo investigate whether administration of sedative and hypnotic drugs exacerbates the severity of OSA (as measured by the apnoea-hypopnoea index (AHI) or the 4% oxygen desaturation index (ODI)) in people with known OSA.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register (CAGR) of trials. The search was current as of March 2015.\nSelection criteria\nRandomised, placebo-controlled trials including adult participants with confirmed OSA, where participants were randomly assigned to use opiates or opioids, sedatives, hypnotics or placebo. We included participants already using continuous positive airway pressure (CPAP) or a mandibular advancement device.\nData collection and analysis\nWe used standard methodological procedures as recommended by The Cochrane Collaboration.\nMain results\nFourteen studies examining the effects of 10 drugs and including a total of 293 participants contributed to this review. Trials were small, with only two trials, which used sodium oxybate, recruiting more than 40 participants, and all but three trials were of only one to three nights in duration. Most participants had mild to moderate OSA with a mean AHI of 11 to 25 events/h, and only two trials recruited patients with severe OSA. Two trials investigating the effects of ramelteon, a treatment option for insomnia, recruited adults over 60 years of age with OSA and concomitant insomnia.\nThe drugs studied in this review included remifentanil (infusion) 0.75 mcg/kg/h, eszopiclone 3 mg, zolpidem 10 and 20 mg, brotizolam 0.25 mg, flurazepam 30 mg, nitrazepam 10 mg to 15 mg, temazepam 10 mg, triazolam 0.25 mg, ramelteon 8 mg and 16 mg and sodium oxybate 4.5 g and 9 g. We were unable to pool most of the data, with the exception of data for eszopiclone and ramelteon.\nNone of the drugs in this review produced a significant increase in AHI or ODI. Two trials have shown a beneficial effect on OSA. One study showed that a single administration of eszopiclone 3 mg significantly decreased AHI compared with placebo (24 ± 4 vs 31 ± 5; P value < 0.05), and a second study of sodium oxybate 4.5 g showed a significant decrease in AHI compared with placebo (mean difference (MD) -7.41, 95% confidence interval (CI) -14.17 to -0.65; N = 48).\nOnly four trials reported outcome data on ODI. No significant increase, in comparison with placebo, was shown with eszopiclone (21 (22 to 37) vs 28.0 (15 to 36); P value = NS), zolpidem (0.81 ± 0.29 vs 1.46 ± 0.53; P value = NS), flurazepam (18.6 ± 19 vs 19.6 ± 15.9; P value = NS) and temazepam (6.53 ± 9.4 vs 6.56 ± 8.3; P value = 0.98).\nA significant decrease in minimum nocturnal peripheral capillary oxygen saturation (SpO2) was observed with zolpidem 20 mg (76.8 vs 85.2; P value = 0.002), flurazepam 30 mg (81.7 vs 85.2; P value = 0.002), remifentanil infusion (MD -7.00, 95% CI -11.95 to -2.05) and triazolam 0.25 mg in both rapid eye movement (REM) and non-REM (NREM) sleep (MD -14.00, 95% CI -21.84 to -6.16; MD -10.20, 95% CI -16.08 to -4.32, respectively.\nOne study investigated the effect of an opiate (remifentanil) on patients with moderate OSA. Remifentanil infusion did not significantly change AHI (MD 10.00, 95% CI -9.83 to 29.83); however it did significantly decrease the number of obstructive apnoeas (MD -9.00, 95% CI -17.40 to -0.60) and significantly increased the number of central apnoeas (MD 16.00, 95% CI -2.21 to 34.21). Similarly, although without significant effect on obstructive apnoeas, central apnoeas were increased in the sodium oxybate 9 g treatment group (MD 7.3 (18); P value = 0.005) in a cross-over trial.\nDrugs studied in this review were generally well tolerated, apart from adverse events reported in 19 study participants prescribed remifentanil (n = 1), eszopiclone (n = 6), sodium oxybate (n = 9) or ramelteon (n = 3).\nAuthors' conclusions\nThe findings of this review show that currently no evidence suggests that the pharmacological compounds assessed have a deleterious effect on the severity of OSA as measured by change in AHI or ODI. Significant clinical and statistical decreases in minimum overnight SpO2 were observed with remifentanil, zolpidem 20 mg and triazolam 0.25 mg. Eszopiclone 3 mg and sodium oxybate 4.5 g showed a beneficial effect on the severity of OSA with a reduction in AHI and may merit further assessment as a potential therapeutic option for a subgroup of patients with OSA. Only one trial assessed the effect of an opioid (remifentanil); some studies included CPAP treatment, whilst in a significant number of participants, previous treatment with CPAP was not stated and thus a residual treatment effect of CPAP could not be excluded. Most studies were small and of short duration, with indiscernible methodological quality.Caution is therefore required when such agents are prescribed for patients with OSA, especially outside the severity of the OSA cohorts and the corresponding dose of compounds given in the particular studies. Larger, longer trials involving patients across a broader spectrum of OSA severity are needed to clarify these results.\n\nGiven the provided abstract, please respond to the following query: \"Sedatives and hypnotics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
]
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query-laysum | 3584 | [
{
"role": "user",
"content": "Abstract: Background\nNon-transfusion dependent beta thalassaemia is a subset of inherited haemoglobin disorders characterised by reduced production of the beta globin chain of the haemoglobin molecule leading to anaemia of varying severity. Although blood transfusion is not a necessity for survival, it is required when episodes of chronic anaemia occur. This chronic anaemia can impair growth and affect quality of life. People with non-transfusion dependent beta thalassaemia suffer from iron overload due to their body's increased capability of absorbing iron from food sources. Iron overload becomes more pronounced in those requiring blood transfusion. People with a higher foetal haemoglobin level have been found to require fewer blood transfusions. Hydroxyurea has been used to increase foetal haemoglobin level; however, its efficacy in reducing transfusion, chronic anaemia complications and its safety need to be established.\nObjectives\nTo assess the effectiveness, safety and appropriate dose regimen of hydroxyurea in people with non-transfusion dependent beta thalassaemia (haemoglobin E combined with beta thalassaemia and beta thalassaemia intermedia).\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of relevant journals. We also searched ongoing trials registries and the reference lists of relevant articles and reviews.\nDate of last search: 30 April 2016.\nSelection criteria\nRandomised or quasi-randomised controlled trials of hydroxyurea in people with non-transfusion dependent beta thalassaemia comparing hydroxyurea with placebo or standard treatment or comparing different doses of hydroxyurea.\nData collection and analysis\nTwo authors independently applied the inclusion criteria in order to select trials for inclusion. Both authors assessed the risk of bias of trials and extracted the data. A third author verified these assessments.\nMain results\nNo trials comparing hydroxyurea with placebo or standard care were found. However, we included one randomised controlled trial (n = 61) comparing 20 mg/kg/day with 10 mg/kg/day of hydroxyurea for 24 weeks.\nBoth haemoglobin and foetal haemoglobin levels were lower at 24 weeks in the 20 mg group compared with the 10 mg group, mean difference -2.39 (95% confidence interval - 2.8 to -1.98) and mean difference -1.5 (95% confidence interval -1.83 to -1.17), respectively. Major adverse effects were significantly more common in the 20 mg group, for neutropenia risk ratio 9.93 (95% confidence interval 1.34 to 73.97) and for thrombocytopenia risk ratio 3.68 (95% confidence interval 1.13 to 12.07). No difference was reported for minor adverse effects (gastrointestinal disturbances and raised liver enzymes). The effect of hydroxyurea on transfusion frequency was not reported.\nThe overall quality for the outcomes reported was graded as very low mainly because the outcomes were derived from only one small study with an unclear method of allocation concealment.\nAuthors' conclusions\nThere is no evidence from randomised controlled trials to show whether hydroxyurea has any effect compared with controls on the need for blood transfusion. Administration of 10 mg/kg/day compared to 20 mg/kg/day of hydroxyurea resulted in higher haemoglobin levels and seems safer with fewer adverse effects. It has not been reported whether hydroxyurea is capable of reducing the need for blood transfusion. Large well-designed randomised controlled trials with sufficient duration of follow up are recommended.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out if giving hydroxyurea to people with non-transfusion dependent beta thalassaemia would reduce the need for blood transfusion."
}
]
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query-laysum | 3585 | [
{
"role": "user",
"content": "Abstract: Background\nHip fracture is a major cause of morbidity and mortality in older people, and its impact on society is substantial. After surgery, people require rehabilitation to help them recover. Multidisciplinary rehabilitation is where rehabilitation is delivered by a multidisciplinary team, supervised by a geriatrician, rehabilitation physician or other appropriate physician. This is an update of a Cochrane Review first published in 2009.\nObjectives\nTo assess the effects of multidisciplinary rehabilitation, in either inpatient or ambulatory care settings, for older people with hip fracture.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL, MEDLINE and Embase (October 2020), and two trials registers (November 2019).\nSelection criteria\nWe included randomised and quasi-randomised trials of post-surgical care using multidisciplinary rehabilitation of older people (aged 65 years or over) with hip fracture. The primary outcome – 'poor outcome' – was a composite of mortality and decline in residential status at long-term (generally one year) follow-up. The other 'critical' outcomes were health-related quality of life, mortality, dependency in activities of daily living, mobility, and related pain.\nData collection and analysis\nPairs of review authors independently performed study selection, assessed risk of bias and extracted data. We pooled data where appropriate and used GRADE for assessing the certainty of evidence for each outcome.\nMain results\nThe 28 included trials involved 5351 older (mean ages ranged from 76.5 to 87 years), usually female, participants who had undergone hip fracture surgery. There was substantial clinical heterogeneity in the trial interventions and populations. Most trials had unclear or high risk of bias for one or more items, such as blinding-related performance and detection biases. We summarise the findings for three comparisons below.\nInpatient rehabilitation: multidisciplinary rehabilitation versus 'usual care'\nMultidisciplinary rehabilitation was provided primarily in an inpatient setting in 20 trials.\nMultidisciplinary rehabilitation probably results in fewer cases of 'poor outcome' (death or deterioration in residential status, generally requiring institutional care) at 6 to 12 months' follow-up (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.80 to 0.98; 13 studies, 3036 participants; moderate-certainty evidence). Based on an illustrative risk of 347 people with hip fracture with poor outcome in 1000 people followed up between 6 and 12 months, this equates to 41 (95% CI 7 to 69) fewer people with poor outcome after multidisciplinary rehabilitation. Expressed in terms of numbers needed to treat for an additional harmful outcome (NNTH), 25 patients (95% CI 15 to 100) would need to be treated to avoid one 'poor outcome'. Subgroup analysis by type of multidisciplinary rehabilitation intervention showed no evidence of subgroup differences.\nMultidisciplinary rehabilitation may result in fewer deaths in hospital but the confidence interval does not exclude a small increase in the number of deaths (RR 0.77, 95% CI 0.58 to 1.04; 11 studies, 2455 participants; low-certainty evidence). A similar finding applies at 4 to 12 months' follow-up (RR 0.91, 95% CI 0.80 to 1.05; 18 studies, 3973 participants; low-certainty evidence). Multidisciplinary rehabilitation may result in fewer people with poorer mobility at 6 to 12 months' follow-up (RR 0.83, 95% CI 0.71 to 0.98; 5 studies, 1085 participants; low-certainty evidence).\nDue to very low-certainty evidence, we have little confidence in the findings for marginally better quality of life after multidisciplinary rehabilitation (1 study). The same applies to the mixed findings of some or no difference from multidisciplinary rehabilitation on dependence in activities of daily living at 1 to 4 months' follow-up (measured in various ways by 11 studies), or at 6 to 12 months' follow-up (13 studies). Long-term hip-related pain was not reported.\nAmbulatory setting: supported discharge and multidisciplinary home rehabilitation versus 'usual care'\nThree trials tested this comparison in 377 people mainly living at home. Due to very low-certainty evidence, we have very little confidence in the findings of little to no between-group difference in poor outcome (death or move to a higher level of care or inability to walk) at one year (3 studies); quality of life at one year (1 study); in mortality at 4 or 12 months (2 studies); in independence in personal activities of daily living (1 study); in moving permanently to a higher level of care (2 studies) or being unable to walk (2 studies). Long-term hip-related pain was not reported.\nOne trial tested this comparison in 240 nursing home residents. There is low-certainty evidence that there may be no or minimal between-group differences at 12 months in 'poor outcome' defined as dead or unable to walk; or in mortality at 4 months or 12 months. Due to very low-certainty evidence, we have very little confidence in the findings of no between-group differences in dependency at 4 weeks or at 12 months, or in quality of life, inability to walk or pain at 12 months.\nAuthors' conclusions\nIn a hospital inpatient setting, there is moderate-certainty evidence that rehabilitation after hip fracture surgery, when delivered by a multidisciplinary team and supervised by an appropriate medical specialist, results in fewer cases of 'poor outcome' (death or deterioration in residential status). There is low-certainty evidence that multidisciplinary rehabilitation may result in fewer deaths in hospital and at 4 to 12 months; however, it may also result in slightly more. There is low-certainty evidence that multidisciplinary rehabilitation may reduce the numbers of people with poorer mobility at 12 months. No conclusions can be drawn on other outcomes, for which the evidence is of very low certainty.\nThe generally very low-certainty evidence available for supported discharge and multidisciplinary home rehabilitation means that we are very uncertain whether the findings of little or no difference for all outcomes between the intervention and usual care is true.\nGiven the prevalent clinical emphasis on early discharge, we suggest that research is best orientated towards early supported discharge and identifying the components of multidisciplinary inpatient rehabilitation to optimise patient recovery within hospital and the components of multidisciplinary rehabilitation, including social care, subsequent to hospital discharge.\n\nGiven the provided abstract, please respond to the following query: \"How are hip fractures treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Hip fractures are common but serious injuries in older people. About a third of people with hip fractures die within a year of their injury. People with hip fractures may also have other conditions that slow their recovery. Many do not regain the mobility and independence they had before the fracture, and may need residential care in a nursing home afterwards.\nUsual care for people with hip fracture is surgery, followed by therapy on the hospital ward to restore mobility and basic functions of daily living, such as bathing and dressing. This may involve people from other departments in the hospital. However, people with hip fractures need help with a range of activities, and may suffer mental as well as physical problems after surgery. So, a better approach to help their recovery, or ‘rehabilitation’, may be to involve a team of people with expertise from different areas, or ‘disciplines’. They develop a rehabilitation plan for each person, depending on their needs. This ‘multidisciplinary rehabilitation’ team, which is typically led by a doctor specialising in the care of older people or other medical specialist in rehabilitation, could also include other doctors, nurses, physiotherapists, dieticians, social workers and mental health specialists. Multidisciplinary rehabilitation could take place in hospital, in acute (short-stay treatment) or rehabilitation wards, or in a person's home residence. Some types of multidisciplinary rehabilitation involve early discharge from hospital with support at home."
}
]
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query-laysum | 3586 | [
{
"role": "user",
"content": "Abstract: Background\nApproximately 0.6% to 4% of cholecystectomies are performed because of gallbladder polyps. The decision to perform cholecystectomy is based on presence of gallbladder polyp(s) on transabdominal ultrasound (TAUS) or endoscopic ultrasound (EUS), or both. These polyps are currently considered for surgery if they grow more than 1 cm. However, non-neoplastic polyps (pseudo polyps) do not need surgery, even when they are larger than 1 cm. True polyps are neoplastic, either benign (adenomas) or (pre)malignant (dysplastic polyps/carcinomas). True polyps need surgery, especially if they are premalignant or malignant. There has been no systematic review and meta-analysis on the accuracy of TAUS and EUS in the diagnosis of gallbladder polyps, true gallbladder polyps, and (pre)malignant polyps.\nObjectives\nTo summarise and compare the accuracy of transabdominal ultrasound (TAUS) and endoscopic ultrasound (EUS) for the detection of gallbladder polyps, for differentiating between true and pseudo gallbladder polyps, and for differentiating between dysplastic polyps/carcinomas and adenomas/pseudo polyps of the gallbladder in adults.\nSearch methods\nWe searched the Cochrane Library, MEDLINE, Embase, Science Citation Index Expanded, and trial registrations (last date of search 09 July 2018). We had no restrictions regarding language, publication status, or prospective or retrospective nature of the studies.\nSelection criteria\nStudies reporting on the diagnostic accuracy data (true positive, false positive, false negative and true negative) of the index test (TAUS or EUS or both) for detection of gallbladder polyps, differentiation between true and pseudo polyps, or differentiation between dysplastic polyps/carcinomas and adenomas/pseudo polyps. We only accepted histopathology after cholecystectomy as the reference standard, except for studies on diagnosis of gallbladder polyp. For the latter studies, we also accepted repeated imaging up to six months by TAUS or EUS as the reference standard.\nData collection and analysis\nTwo authors independently screened abstracts, selected studies for inclusion, and collected data from each study. The quality of the studies was evaluated using the QUADAS-2 tool. The bivariate random-effects model was used to obtain summary estimates of sensitivity and specificity, to compare diagnostic performance of the index tests, and to assess heterogeneity.\nMain results\nA total of 16 studies were included. All studies reported on TAUS and EUS as separate tests and not as a combination of tests. All studies were at high or unclear risk of bias, ten studies had high applicability concerns in participant selection (because of inappropriate participant exclusions) or reference standards (because of lack of follow-up for non-operated polyps), and three studies had unclear applicability concerns in participant selection (because of high prevalence of gallbladder polyps) or index tests (because of lack of details on ultrasound equipment and performance). A meta-analysis directly comparing results of TAUS and EUS in the same population could not be performed because only limited studies executed both tests in the same participants. Therefore, the results below were obtained only from indirect test comparisons. There was significant heterogeneity amongst all comparisons (target conditions) on TAUS and amongst studies on EUS for differentiating true and pseudo polyps.\nDetection of gallbladder polyps: Six studies (16,260 participants) used TAUS. We found no studies on EUS. The summary sensitivity and specificity of TAUS for the detection of gallbladder polyps was 0.84 (95% CI 0.59 to 0.95) and 0.96 (95% CI 0.92 to 0.98), respectively. In a cohort of 1000 people, with a 6.4% prevalence of gallbladder polyps, this would result in 37 overdiagnosed and seven missed gallbladder polyps.\nDifferentiation between true polyp and pseudo gallbladder polyp: Six studies (1078 participants) used TAUS; the summary sensitivity was 0.68 (95% CI 0.44 to 0.85) and the summary specificity was 0.79 (95% CI 0.57 to 0.91). Three studies (209 participants) used EUS; the summary sensitivity was 0.85 (95% CI 0.46 to 0.97) and the summary specificity was 0.90 (95% CI 0.78 to 0.96). In a cohort of 1000 participants with gallbladder polyps, with 10% having true polyps, this would result in 189 overdiagnosed and 32 missed true polyps by TAUS, and 90 overdiagnosed and 15 missed true polyps by EUS. There was no evidence of a difference between the diagnostic accuracy of TAUS and EUS (relative sensitivity 1.06, P = 0.70, relative specificity 1.15, P = 0.12).\nDifferentiation between dysplastic polyps/carcinomas and adenomas/pseudo polyps of the gallbladder: Four studies (1,009 participants) used TAUS; the summary sensitivity was 0.79 (95% CI 0.62 to 0.90) and the summary specificity was 0.89 (95% CI 0.68 to 0.97). Three studies (351 participants) used EUS; the summary sensitivity was 0.86 (95% CI 0.76 to 0.92) and the summary specificity was 0.92 (95% CI 0.85 to 0.95). In a cohort of 1000 participants with gallbladder polyps, with 5% having a dysplastic polyp/carcinoma, this would result in 105 overdiagnosed and 11 missed dysplastic polyps/carcinomas by TAUS and 76 overdiagnosed and seven missed dysplastic polyps/carcinomas by EUS. There was no evidence of a difference between the diagnostic accuracy of TAUS and EUS (log likelihood test P = 0.74).\nAuthors' conclusions\nAlthough TAUS seems quite good at discriminating between gallbladder polyps and no polyps, it is less accurate in detecting whether the polyp is a true or pseudo polyp and dysplastic polyp/carcinoma or adenoma/pseudo polyp. In practice, this would lead to both unnecessary surgeries for pseudo polyps and missed cases of true polyps, dysplastic polyps, and carcinomas. There was insufficient evidence that EUS is better compared to TAUS in differentiating between true and pseudo polyps and between dysplastic polyps/carcinomas and adenomas/pseudo polyps. The conclusions are based on heterogeneous studies with unclear criteria for diagnosis of the target conditions and studies at high or unclear risk of bias. Therefore, results should be interpreted with caution. Further studies of high methodological quality, with clearly stated criteria for diagnosis of gallbladder polyps, true polyps, and dysplastic polyps/carcinomas are needed to accurately determine diagnostic accuracy of EUS and TAUS.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The gallbladder is an organ situated close to the liver. It stores bile, produced by the liver, before it is released to the small bowel for digestion. Abnormal growths inside the gallbladder, called 'gallbladder polyps', can develop. Most polyps (90%) are harmless; these are called pseudo polyps. The remaining are true polyps and can be cancerous, have cancer-like parts (precancerous dysplastic polyps), or be benign, but they can potentially turn into cancer. Dysplastic polyps and cancerous polyps should be treated. Most people also treat benign polyps because of their potential to become cancerous. Treatment is done by removal of the gallbladder with the polyp within (cholecystectomy). To decide which patients should undergo surgery, it is important to (1) be certain that a gallbladder polyp is present, (2) know whether it is a true or pseudo polyp, and (3) whether a polyp is (pre)cancerous. Transabdominal ultrasound (TAUS), which uses ultrasound waves to differentiate between tissues, and endoscopic ultrasound (EUS), ultrasound attached to an endoscope introduced into the small intestine through the mouth and stomach, are the two tests currently used to detect gallbladder polyps and identify the type of gallbladder polyps.\nWe performed a thorough search for studies that reported the accuracy (ability) of TAUS and EUS for the detection of gallbladder polyps and for differentiating between true and pseudo polyps, and between (pre)cancerous and benign polyps."
}
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query-laysum | 3587 | [
{
"role": "user",
"content": "Abstract: Background\nAirway oedema (swelling) and mucus plugging are the principal pathological features in infants with acute viral bronchiolitis. Nebulised hypertonic saline solution (≥ 3%) may reduce these pathological changes and decrease airway obstruction. This is an update of a review first published in 2008, and updated in 2010, 2013, and 2017.\nObjectives\nTo assess the effects of nebulised hypertonic (≥ 3%) saline solution in infants with acute bronchiolitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily, Embase, CINAHL, LILACS, and Web of Science on 13 January 2022. We also searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov on 13 January 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs using nebulised hypertonic saline alone or in conjunction with bronchodilators as an active intervention and nebulised 0.9% saline or standard treatment as a comparator in children under 24 months with acute bronchiolitis. The primary outcome for inpatient trials was length of hospital stay, and the primary outcome for outpatients or emergency department (ED) trials was rate of hospitalisation.\nData collection and analysis\nTwo review authors independently performed study selection, data extraction, and assessment of risk of bias in included studies. We conducted random-effects model meta-analyses using Review Manager 5. We used mean difference (MD), risk ratio (RR), and their 95% confidence intervals (CI) as effect size metrics.\nMain results\nWe included six new trials (N = 1010) in this update, bringing the total number of included trials to 34, involving 5205 infants with acute bronchiolitis, of whom 2727 infants received hypertonic saline. Eleven trials await classification due to insufficient data for eligibility assessment. All included trials were randomised, parallel-group, controlled trials, of which 30 were double-blinded. Twelve trials were conducted in Asia, five in North America, one in South America, seven in Europe, and nine in Mediterranean and Middle East regions. The concentration of hypertonic saline was defined as 3% in all but six trials, in which 5% to 7% saline was used. Nine trials had no funding, and five trials were funded by sources from government or academic agencies. The remaining 20 trials did not provide funding sources.\nHospitalised infants treated with nebulised hypertonic saline may have a shorter mean length of hospital stay compared to those treated with nebulised normal (0.9%) saline or standard care (mean difference (MD) −0.40 days, 95% confidence interval (CI) −0.69 to −0.11; 21 trials, 2479 infants; low-certainty evidence). Infants who received hypertonic saline may also have lower postinhalation clinical scores than infants who received normal saline in the first three days of treatment (day 1: MD −0.64, 95% CI −1.08 to −0.21; 10 trials (1 outpatient, 1 ED, 8 inpatient trials), 893 infants; day 2: MD −1.07, 95% CI −1.60 to −0.53; 10 trials (1 outpatient, 1 ED, 8 inpatient trials), 907 infants; day 3: MD −0.89, 95% CI −1.44 to −0.34; 10 trials (1 outpatient, 9 inpatient trials), 785 infants; low-certainty evidence). Nebulised hypertonic saline may reduce the risk of hospitalisation by 13% compared with nebulised normal saline amongst infants who were outpatients and those treated in the ED (risk ratio (RR) 0.87, 95% CI 0.78 to 0.97; 8 trials, 1760 infants; low-certainty evidence). However, hypertonic saline may not reduce the risk of readmission to hospital up to 28 days after discharge (RR 0.83, 95% CI 0.55 to 1.25; 6 trials, 1084 infants; low-certainty evidence). We are uncertain whether infants who received hypertonic saline have a lower number of days to resolution of wheezing compared to those who received normal saline (MD −1.16 days, 95% CI −1.43 to −0.89; 2 trials, 205 infants; very low-certainty evidence), cough (MD −0.87 days, 95% CI −1.31 to −0.44; 3 trials, 363 infants; very low-certainty evidence), and pulmonary moist crackles (MD −1.30 days, 95% CI −2.28 to −0.32; 2 trials, 205 infants; very low-certainty evidence).\nTwenty-seven trials presented safety data: 14 trials (1624 infants; 767 treated with hypertonic saline, of which 735 (96%) co-administered with bronchodilators) did not report any adverse events, and 13 trials (2792 infants; 1479 treated with hypertonic saline, of which 416 (28%) co-administered with bronchodilators and 1063 (72%) hypertonic saline alone) reported at least one adverse event such as worsening cough, agitation, bronchospasm, bradycardia, desaturation, vomiting and diarrhoea, most of which were mild and resolved spontaneously (low-certainty evidence).\nAuthors' conclusions\nNebulised hypertonic saline may modestly reduce length of stay amongst infants hospitalised with acute bronchiolitis and may slightly improve clinical severity score. Treatment with nebulised hypertonic saline may also reduce the risk of hospitalisation amongst outpatients and ED patients. Nebulised hypertonic saline seems to be a safe treatment in infants with bronchiolitis with only minor and spontaneously resolved adverse events, especially when administered in conjunction with a bronchodilator. The certainty of the evidence was low to very low for all outcomes, mainly due to inconsistency and risk of bias.\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 13 January 2022."
}
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query-laysum | 3588 | [
{
"role": "user",
"content": "Abstract: Background\nBacterial keratitis is a serious ocular infectious disease that can lead to severe visual disability. Risk factors for bacterial corneal infection include contact lens wear, ocular surface disease, corneal trauma, and previous ocular or eyelid surgery. Topical antibiotics constitute the mainstay of treatment in cases of bacterial keratitis, whereas the use of topical corticosteroids as an adjunctive therapy to antibiotics remains controversial. Topical corticosteroids are usually used to control inflammation using the smallest amount of the drug. Their use requires optimal timing, concomitant antibiotics, and careful follow-up.\nObjectives\nThe objective of the review was to assess the effectiveness and safety of corticosteroids as adjunctive therapy for bacterial keratitis. Secondary objectives included evaluation of health economic outcomes and quality of life outcomes.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2014), EMBASE (January 1980 to July 2014), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to July 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 14 July 2014. We also searched the Science Citation Index to identify additional studies that had cited the only trial included in the original version of this review, reference lists of included trials, earlier reviews, and the American Academy of Ophthalmology guidelines. We also contacted experts to identify any unpublished and ongoing randomized trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) that had evaluated adjunctive therapy with topical corticosteroids in people with bacterial keratitis who were being treated with antibiotics.\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe found four RCTs that met the inclusion criteria of this review. The total number of included participants was 611 (612 eyes), ranging from 30 to 500 participants per trial. One trial was included in the previous version of the review, and we identified three additional trials through the updated searches in July 2014. One of the three smaller trials was a pilot study of the largest study: the Steroids for Corneal Ulcers Trial (SCUT). All trials compared the treatment of bacterial keratitis with topical corticosteroid and without topical corticosteroid and had follow-up periods ranging from two months to one year. These trials were conducted in the USA, Canada, India, and South Africa.\nAll trials reported data on visual acuity ranging from three weeks to one year, and none of them found any important difference between the corticosteroid group and the control group. The pilot study of the SCUT reported that time to re-epithelialization in the steroid group was 53% slower than the placebo group after adjusting for baseline epithelial defect size (hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.23 to 0.94). However, the SCUT did not find any important difference in time to re-epithelialization (HR 0.92; 95% CI 0.76 to 1.11). For adverse events, none of the three small trials found any important difference between the two treatment groups. The investigators of the largest trial reported that more patients in the control group developed intraocular pressure (IOP) elevation (risk ratio (RR) 0.20; 95% CI 0.04 to 0.90). One trial reported quality of life and concluded that there was no difference between the two groups (data not available). We did not find any reports regarding economic outcomes.\nAlthough the four trials were generally of good methodological design, all trials had considerable losses to follow-up (10% or more) in the final analyses. Further, three of the four trials were underpowered to detect treatment effect differences between groups and inconsistency in outcome measurements precluded meta-analyses for most outcomes relevant to this review.\nAuthors' conclusions\nThere is inadequate evidence as to the effectiveness and safety of adjunctive topical corticosteroids compared with no topical corticosteroids in improving visual acuity, infiltrate/scar size, or adverse events among participants with bacterial keratitis. Current evidence does not support a strong effect of corticosteroid, but may be due to insufficient power to detect a treatment effect.\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 available information regarding the added effect of corticosteroid eye drops in people with bacterial keratitis (corneal ulcers) who were also being treated with antibiotics."
}
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query-laysum | 3589 | [
{
"role": "user",
"content": "Abstract: Background\nPain is prevalent during orthodontics, particularly during the early stages of treatment. To ensure patient comfort and compliance during treatment, the prevention or management of pain is of major importance. While pharmacological means are the first line of treatment for alleviation of orthodontic pain, a range of non-pharmacological approaches have been proposed recently as viable alternatives.\nObjectives\nTo assess the effects of non-pharmacological interventions to alleviate pain associated with orthodontic treatment.\nSearch methods\nCochrane Oral Health’s Information Specialist searched the following databases: Cochrane Oral Health’s Trials Register (to 6 October 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2016, Issue 9), MEDLINE Ovid (1946 to 6 October 2016), Embase Ovid (1980 to 6 October 2016) and EThOS (to 6 October 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials (RCTs) comparing a non-pharmacological orthodontic pain intervention to a placebo, no intervention or another non-pharmacological pain intervention were eligible for inclusion. We included any type of orthodontic treatment but excluded trials involving the use of pre-emptive analgesia or pain relief following orthognathic (jaw) surgery or dental extractions in combination with orthodontic treatment. We excluded split-mouth trials (in which each participant receives two or more treatments, each to a separate section of the mouth) and cross-over trials.\nData collection and analysis\nAt least two review authors independently assessed risk of bias and extracted data. We used the random-effects model and expressed results as mean differences (MD) with 95% confidence intervals (CI). We investigated heterogeneity with reference to both clinical and methodological factors.\nMain results\nWe included 14 RCTs that randomised 931 participants. Interventions assessed included: low-level laser therapy (LLLT) (4 studies); vibratory devices (5 studies); chewing adjuncts (3 studies); brain wave music or cognitive behavioural therapy (1 study) and post-treatment communication in the form of a text message (1 study). Twelve studies involved self-report assessment of pain on a continuous scale and two studies used questionnaires to assess the nature, intensity and location of pain.\nWe combined data from two studies involving 118 participants, which provided low-quality evidence that LLLT reduced pain at 24 hours by 20.27 mm (95% CI -24.50 to -16.04, P < 0.001; I² = 0%). LLLT also appeared to reduce pain at six hours, three days and seven days.\nResults for the other comparisons assessed are inconclusive as the quality of the evidence was very low. Vibratory devices were assessed in five studies (272 participants), four of which were at high risk of bias and one unclear. Chewing adjuncts (chewing gum or a bite wafer) were evaluated in three studies (181 participants); two studies were at high risk of bias and one was unclear. Brain wave music and cognitive behavioural therapy were evaluated in one trial (36 participants) assessed at unclear risk of bias. Post-treatment text messaging (39 participants) was evaluated in one study assessed at high risk of bias.\nAdverse effects were not measured in any of the studies.\nAuthors' conclusions\nOverall, the results are inconclusive. Although available evidence suggests laser irradiation may help reduce pain during orthodontic treatment in the short term, this evidence is of low quality and therefore we cannot rely on the findings. Evidence for other non-pharmacological interventions is either very low quality or entirely lacking. Further prospective research is required to address the lack of reliable evidence concerning the effectiveness of a range of non-pharmacological interventions to manage orthodontic pain. Future studies should use prolonged follow-up and should measure costs and possible harms.\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": "Orthodontic treatment (teeth braces) can be painful, particularly following initial brace placement and later adjustments, for a week or more. We examined the merits of methods to reduce pain during orthodontic treatment without the need for painkillers."
}
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query-laysum | 3590 | [
{
"role": "user",
"content": "Abstract: Background\nLaparoscopic colposuspension was one of the first minimal access operations for treating stress urinary incontinence in women, with the presumed advantages of shorter hospital stays and quicker return to normal activities.\nThis Cochrane Review was last updated in 2010.\nObjectives\nTo assess the effects of laparoscopic colposuspension for urinary incontinence in women; and summarise the principal findings of relevant economic evaluations of these interventions.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register (22 May 2019), which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings.\nSelection criteria\nRandomised controlled trials of women with urinary incontinence that included laparoscopic surgery in at least one arm.\nData collection and analysis\nWe independently extracted data from eligible trials, assessed risk of bias and implemented GRADE.\nMain results\nWe included 26 trials involving 2271 women.\nThirteen trials (1304 women) compared laparoscopic colposuspension to open colposuspension and nine trials (412 women) to midurethral sling procedures. One trial (161 women) compared laparoscopic colposuspension with one suture to laparoscopic colposuspension with two sutures; and three trials (261 women) compared laparoscopic colposuspension with sutures to laparoscopic colposuspension with mesh and staples. The majority of trials did not follow up participants beyond 18 months. Overall, there was unclear risk of selection, performance and detection bias and generally low risk of attrition and reporting bias.\nThere is little difference between laparoscopic colposuspension using sutures and open colposuspension for subjective cure within 18 months (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.99 to 1.08; 6 trials, 755 women; high-quality evidence). We are uncertain whether laparoscopic colposuspension using mesh and staples is better or worse than open colposuspension for subjective cure within 18 months (RR 0.75, 95% CI 0.61 to 0.93; 3 trials, 362 women; very low-quality evidence) or whether there is a greater risk of repeat continence surgery with laparoscopic colposuspension. Laparoscopic colposuspension may have a lower risk of perioperative complications (RR 0.67, 95% CI 0.47 to 0.94; 11 trials, 1369 women; low-quality evidence). There may be similar or higher rates of bladder perforations with laparoscopic colposuspension (RR 1.72, 95% CI 0.90 to 3.29; 10 trials, 1311 women; moderate-quality evidence). Rates for de novo detrusor overactivity (RR 1.29, 95% CI 0.72 to 2.30; 5 trials, 472 women) and voiding dysfunction (RR 0.81, 95% CI 0.50 to 1.31; 5 trials, 507 women) may be similar but we are uncertain due to the wide confidence interval. Five studies reported on quality of life but we could not synthesise the data.\nThere may be little difference between laparoscopic colposuspension using sutures and tension-free vaginal tape (TVT) for subjective cure within 18 months (RR 1.01, 95% CI 0.88 to 1.16; 4 trials, 256 women; low-quality evidence) or between laparoscopic colposuspension using mesh and staples and TVT (RR 0.71, 95% CI 0.55 to 0.91; 1 trial, 121 women; low-quality evidence). For laparoscopic colposuspension compared with midurethral slings, there may be lower rates of repeat continence surgery (RR 0.40, 95% CI 0.04 to 3.62; 1 trial, 70 women; low-quality evidence) and similar risk of perioperative complications (RR 0.99, 95% CI 0.60 to 1.64; 7 trials, 514 women; low-quality evidence) but we are uncertain due to the wide confidence intervals. There may be little difference in terms of de novo detrusor overactivity (RR 0.80, 95% CI 0.34 to 1.88; 4 trials, 326 women; low-quality evidence); and probably little difference in terms of voiding dysfunction (RR 1.06, 95% CI 0.47 to 2.41; 5 trials, 412 women; moderate-quality evidence) although we are uncertain due to the wide confidence interval. Five studies reported on quality of life but we could not synthesise the data. No studies reported on bladder perforations.\nLow-quality evidence indicates that there may be higher subjective cure rates within 18 months with two sutures compared to one suture (RR 1.37, 95% CI 1.14 to 1.64; 1 trial, 158 women). Comparing one suture and two sutures, one suture may have lower rates of repeat continence surgery (RR 0.35, 95% CI 0.01 to 8.37; 1 trial, 157 women) and similar risk of perioperative complications (RR 0.88, 95% CI 0.45 to 1.70) but we are uncertain due to the wide 95% CIs. There may be higher rates of voiding dysfunction with one suture compared to two sutures (RR 2.82; 95% CI 0.30 to 26.54; 1 trial, 158 women; low-quality evidence), but we are uncertain due to the wide confidence interval. This trial did not report bladder perforations, de novo detrusor overactivity or quality of life.\nWe are uncertain whether laparoscopic colposuspension with sutures is better or worse for subjective cure within 18 months compared to mesh and staples (RR 1.24, 95% CI 0.96 to 1.59; 2 trials, 180 women; very low-quality evidence) or in terms of repeat continence surgery (RR 0.97, 95% CI 0.06 to 14.91; 1 trial, 69 women; very low-quality evidence). Laparoscopic colposuspension with sutures may increase the number of perioperative complications compared to mesh and staples (RR 1.94, 95% CI 1.09 to 3.48; 3 trials, 260 women; low-quality evidence) but rates of de novo detrusor overactivity may be similar (RR 0.72, 95% CI 0.17 to 3.06; 2 trials, 122 women; low-quality evidence), however, we are uncertain due to the wide confidence interval. None of the studies reported bladder perforations, voiding dysfunction or quality of life.\nAuthors' conclusions\nThe data indicate that, in terms of subjective cure of incontinence within 18 months, there is probably little difference between laparoscopic colposuspension and open colposuspension, or between laparoscopic colposuspension and midurethral sling procedures. Much of the evidence is low quality, meaning that a considerable degree of uncertainty remains about laparoscopic colposuspension. Future trials should recruit adequate numbers, conduct long-term follow-up and measure clinically important outcomes.\nA brief economic commentary identified three studies. We have not quality-assessed them and they should be interpreted in light of the findings on clinical effectiveness.\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": "High-quality evidence means that we are confident that laparoscopic colposuspension with sutures (keyhole surgery with stitches) is as effective as open colposuspension (traditional surgery) for curing incontinence in the short term (up to 18 months after surgery). However, we are not sure whether there are fewer risks of complications during and after surgery with laparoscopic or open colposuspension.\nProcedures using a midurethral sling (a sort of hammock that supports the neck of the bladder) may be as effective as laparoscopic colposuspension in curing urinary incontinence in the short term and avoiding surgical complications. Women may be less likely to need repeat surgery with a ‘sling’ than with laparoscopic colposuspension. We are not sure about these results because the evidence was low quality.\nLaparoscopic colposuspension with two sutures may be better than with one suture for curing urinary incontinence in the short term, and for reducing the risk of voiding dysfunction and the need for more surgery, but there may be little difference between laparoscopic colposuspension with two sutures or with one in terms of surgical complications. Again, we are not sure about these results because the evidence was low quality.\nWe are very uncertain whether laparoscopic colposuspension with mesh and staples is better than open colposuspension or laparoscopic colposuspension with sutures for curing urinary incontinence. We are also very uncertain whether women who have laparoscopic colposuspension with mesh and staples or with sutures need less repeat surgery. We are very uncertain about the results because the quality of evidence was very low.\nThe evidence that we found relating to the effect of laparoscopic colposuspension on quality of life was inconclusive and could not be generalised."
}
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query-laysum | 3591 | [
{
"role": "user",
"content": "Abstract: Background\nProbiotics may be effective in reducing the duration of acute infectious diarrhoea.\nObjectives\nTo assess the effects of probiotics in proven or presumed acute infectious diarrhoea.\nSearch methods\nWe searched the trials register of the Cochrane Infectious Diseases Group, MEDLINE, and Embase from inception to 17 December 2019, as well as the Cochrane Controlled Trials Register (Issue 12, 2019), in the Cochrane Library, and reference lists from studies and reviews. We included additional studies identified during external review.\nSelection criteria\nRandomized controlled trials comparing a specified probiotic agent with a placebo or no probiotic in people with acute diarrhoea that is proven or presumed to be caused by an infectious agent.\nData collection and analysis\nTwo review authors independently applied inclusion criteria, assessed risk of bias, and extracted data. Primary outcomes were measures of diarrhoea duration (diarrhoea lasting ≥ 48 hours; duration of diarrhoea). Secondary outcomes were number of people hospitalized in community studies, duration of hospitalization in inpatient studies, diarrhoea lasting ≥ 14 days, and adverse events.\nMain results\nWe included 82 studies with a total of 12,127 participants. These studies included 11,526 children (age < 18 years) and 412 adults (three studies recruited 189 adults and children but did not specify numbers in each age group). No cluster-randomized trials were included. Studies varied in the definitions used for \"acute diarrhoea\" and \"end of the diarrhoeal illness\" and in the probiotic(s) tested. A total of 53 trials were undertaken in countries where both child and adult mortality was low or very low, and 26 where either child or adult mortality was high.\nRisk of bias was high or unclear in many studies, and there was marked statistical heterogeneity when findings for the primary outcomes were pooled in meta-analysis. Effect size was similar in the sensitivity analysis and marked heterogeneity persisted. Publication bias was demonstrated from funnel plots for the main outcomes.\nIn our main analysis of the primary outcomes in studies at low risk for all indices of risk of bias, no difference was detected between probiotic and control groups for the risk of diarrhoea lasting ≥ 48 hours (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.91 to 1.09; 2 trials, 1770 participants; moderate-certainty evidence); or for duration of diarrhoea (mean difference (MD) 8.64 hours shorter, 95% CI 29.4 hours shorter to 12.1 hours longer; 6 trials, 3058 participants; very low-certainty evidence).\nEffect size was similar and marked heterogeneity persisted in pre-specified subgroup analyses of the primary outcomes that included all studies. These included analyses limited to the probiotics Lactobacillus rhamnosus GG and Saccharomyces boulardii. In six trials (433 participants) of Lactobacillus reuteri, there was consistency amongst findings (I² = 0%), but risk of bias was present in all included studies. Heterogeneity also was not explained by types of participants (age, nutritional/socioeconomic status captured by mortality stratum, region of the world where studies were undertaken), diarrhoea in children caused by rotavirus, exposure to antibiotics, and the few studies of children who were also treated with zinc. In addition, there were no clear differences in effect size for the primary outcomes in post hoc analyses according to decade of publication of studies and whether or not trials had been registered.\nFor other outcomes, the duration of hospitalization in inpatient studies on average was shorter in probiotic groups than in control groups but there was marked heterogeneity between studies (I² = 96%; MD -18.03 hours, 95% CI -27.28 to -8.78, random-effects model: 24 trials, 4056 participants). No differences were detected between probiotic and control groups in the number of people with diarrhoea lasting ≥ 14 days (RR 0.49, 95% CI 0.16 to 1.53; 9 studies, 2928 participants) or in risk of hospitalization in community studies (RR 1.26, 95% CI 0.84 to 1.89; 6 studies, 2283 participants).\nNo serious adverse events were attributed to probiotics.\nAuthors' conclusions\nProbiotics probably make little or no difference to the number of people who have diarrhoea lasting 48 hours or longer, and we are uncertain whether probiotics reduce the duration of diarrhoea. This analysis is based on large trials with low risk of bias.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are these results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Previous published editions of this review drew conclusions from the many small studies in this field and indicated an effect.\nThis new analysis shows that in this topic there is publication bias, with small studies demonstrating a positive effect more likely to be published, which skews the results. This fresh analysis takes this into account."
}
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query-laysum | 3592 | [
{
"role": "user",
"content": "Abstract: Background\nTrigger finger is a common clinical disorder, characterised by pain and catching as the patient flexes and extends digits because of disproportion between the diameter of flexor tendons and the A1 pulley. The treatment approach may include non-surgical or surgical treatments. Currently there is no consensus about the best surgical treatment approach (open, percutaneous or endoscopic approaches).\nObjectives\nTo evaluate the effectiveness and safety of different methods of surgical treatment for trigger finger (open, percutaneous or endoscopic approaches) in adults at any stage of the disease.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and LILACS up to August 2017.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials that assessed adults with trigger finger and compared any type of surgical treatment with each other or with any other non-surgical intervention. The major outcomes were the resolution of trigger finger, pain, hand function, participant-reported treatment success or satisfaction, recurrence of triggering, adverse events and neurovascular injury.\nData collection and analysis\nTwo review authors independently selected the trial reports, extracted the data and assessed the risk of bias. Measures of treatment effect for dichotomous outcomes calculated risk ratios (RRs), and mean differences (MDs) or standardised mean differences (SMD) for continuous outcomes, with 95% confidence intervals (CIs). When possible, the data were pooled into meta-analysis using the random-effects model. GRADE was used to assess the quality of evidence for each outcome.\nMain results\nFourteen trials were included, totalling 1260 participants, with 1361 trigger fingers. The age of participants included in the studies ranged from 16 to 88 years; and the majority of participants were women (approximately 70%). The average duration of symptoms ranged from three to 15 months, and the follow-up after the procedure ranged from eight weeks to 23 months.\nThe studies reported nine types of comparisons: open surgery versus steroid injections (two studies); percutaneous surgery versus steroid injection (five studies); open surgery versus steroid injection plus ultrasound-guided hyaluronic acid injection (one study); percutaneous surgery plus steroid injection versus steroid injection (one study); percutaneous surgery versus open surgery (five studies); endoscopic surgery versus open surgery (one study); and three comparisons of types of incision for open surgery (transverse incision of the skin in the distal palmar crease, transverse incision of the skin about 2–3 mm distally from distal palmar crease, and longitudinal incision of the skin) (one study).\nMost studies had significant methodological flaws and were considered at high or unclear risk of selection bias, performance bias, detection bias and reporting bias. The primary comparison was open surgery versus steroid injections, because open surgery is the oldest and the most widely used treatment method and considered as standard surgery, whereas steroid injection is the least invasive control treatment method as reported in the studies in this review and is often used as first-line treatment in clinical practice.\nCompared with steroid injection, there was low-quality evidence that open surgery provides benefits with respect to less triggering recurrence, although it has the disadvantage of being more painful. Evidence was downgraded due to study design flaws and imprecision.\nBased on two trials (270 participants) from six up to 12 months, 50/130 (or 385 per 1000) individuals had recurrence of trigger finger in the steroid injection group compared with 8/140 (or 65 per 1000; range 35 to 127) in the open surgery group, RR 0.17 (95% CI 0.09 to 0.33), for an absolute risk difference that 29% fewer people had recurrence of symptoms with open surgery (60% fewer to 3% more individuals); relative change translates to improvement of 83% in the open surgery group (67% to 91% better).\nAt one week, 9/49 (184 per 1000) people had pain on the palm of the hand in the steroid injection group compared with 38/56 (or 678 per 1000; ranging from 366 to 1000) in the open surgery group, RR 3.69 (95% CI 1.99 to 6.85), for an absolute risk difference that 49% more had pain with open surgery (33% to 66% more); relative change translates to worsening of 269% (585% to 99% worse) (one trial, 105 participants).\nBecause of very low quality evidence from two trials we are uncertain whether open surgery improve resolution of trigger finger in the follow-up at six to 12 months, when compared with steroid injection (131/140 observed in the open surgery group compared with 80/130 in the control group; RR 1.48, 95% CI 0.79 to 2.76); evidence was downgraded due to study design flaws, inconsistency and imprecision. Low-quality evidence from two trials and few event rates (270 participants) from six up to 12 months of follow-up, we are uncertain whether open surgery increased the risk of adverse events (incidence of infection, tendon injury, flare, cutaneous discomfort and fat necrosis) (18/140 observed in the open surgery group compared with 17/130 in the control group; RR 1.02, 95% CI 0.57 to 1.84) and neurovascular injury (9/140 observed in the open surgery group compared with 4/130 in the control group; RR 2.17, 95% CI 0.7 to 6.77). Twelve participants (8 versus 4) did not complete the follow-up, and it was considered that they did not have a positive outcome in the data analysis. We are uncertain whether open surgery was more effective than steroid injection in improving hand function or participant satisfaction as studies did not report these outcomes.\nAuthors' conclusions\nLow-quality evidence indicates that, compared with steroid injection, open surgical treatment in people with trigger finger, may result in a less recurrence rate from six up to 12 months following the treatment, although it increases the incidence of pain during the first follow-up week. We are uncertain about the effect of open surgery with regard to the resolution rate in follow-up at six to 12 months, compared with steroid injections, due high heterogeneity and few events occurred in the trials; we are uncertain too about the risk of adverse events and neurovascular injury because of a few events occurred in the studies. Hand function or participant satisfaction were not reported.\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": "Very low quality evidence from two trials means we are uncertain whether open surgery improve resolution of trigger finger in comparison with steroid injection, due the risk of bias in the design of the studies, inconsistencies between studies and the small number of participants in studies. Low-quality evidence from two trials shows that open surgery may result in fewer recurrences of trigger finger compared with steroid injection procedure, although it increases the incidence of pain during the first week after the procedure. Evidence was downgraded to 'low' due to the risk of bias in the design and the small number of participants. No studies measured functional improvement or participant satisfaction in the comparison between open surgery and steroid injection. We are uncertain whether there is a difference in the risk of adverse events or neurovascular injury between treatments, as few events occurred in the studies.\nOnly low and very low-quality evidence was found for other comparisons so we are uncertain if percutaneous surgery has any benefits over steroid injection, or if open surgery is better than steroid plus hyaluronic acid, or if one type of surgery is better than another."
}
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query-laysum | 3593 | [
{
"role": "user",
"content": "Abstract: Background\nDespite substantial improvements in myocardial preservation strategies, coronary artery bypass grafting (CABG) is still associated with severe complications. It has been reported that remote ischaemic preconditioning (RIPC) reduces reperfusion injury in people undergoing cardiac surgery and improves clinical outcome. However, there is a lack of synthesised information and a need to review the current evidence from randomised controlled trials (RCTs).\nObjectives\nTo assess the benefits and harms of remote ischaemic preconditioning in people undergoing coronary artery bypass grafting, with or without valve surgery.\nSearch methods\nIn May 2016 we searched CENTRAL, MEDLINE, Embase and Web of Science. We also conducted a search of ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP). We also checked reference lists of included studies. We did not apply any language restrictions.\nSelection criteria\nWe included RCTs in which people scheduled for CABG (with or without valve surgery) were randomly assigned to receive RIPC or sham intervention before surgery.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, extracted data and checked them for accuracy. We calculated mean differences (MDs), standardised mean differences (SMDs) and risk ratios (RR) using a random-effects model. We assessed quality of the trial evidence for all primary outcomes using the GRADE methodology. We completed a ’Risk of bias’ assessment for all studies and performed sensitivity analysis by excluding studies judged at high or unclear risk of bias for sequence generation, allocation concealment and incomplete outcome data. We contacted authors for missing data. Our primary endpoints were 1) composite endpoint (including all-cause mortality, non-fatal myocardial infarction or any new stroke, or both) assessed at 30 days after surgery, 2) cardiac troponin T (cTnT, ng/L) at 48 hours and 72 hours, and as area under the curve (AUC) 72 hours (µg/L) after surgery, and 3) cardiac troponin I (cTnI, ng/L) at 48 hours, 72 hours, and as area under the curve (AUC) 72 hours (µg/L) after surgery.\nMain results\nWe included 29 studies involving 5392 participants (mean age = 64 years, age range 23 to 86 years, 82% male). However, few studies contributed data to meta-analyses due to inconsistency in outcome definition and reporting. In general, risk of bias varied from low to high risk of bias across included studies, and insufficient detail was provided to inform judgement in several cases. The quality of the evidence of key outcomes ranged from moderate to low quality due to the presence of moderate or high statistical heterogeneity, imprecision of results or due to limitations in the design of individual studies.\nCompared with no RIPC, we found that RIPC has no treatment effect on the rate of the composite endpoint with RR 0.99 (95% confidence interval (CI) 0.78 to 1.25); 2 studies; 2463 participants; moderate-quality evidence. Participants randomised to RIPC showed an equivalent or better effect regarding the amount of cTnT release measured at 72 hours after surgery with SMD -0.32 (95% CI -0.65 to 0.00); 3 studies; 1120 participants; moderate-quality evidence; and expressed as AUC 72 hours with SMD -0.49 (95% CI -0.96 to -0.02); 3 studies; 830 participants; moderate-quality evidence. We found the same result in favour of RIPC for the cTnI release measured at 48 hours with SMD -0.21 (95% CI -0.40 to -0.02); 5 studies; 745 participants; moderate-quality evidence; and measured at 72 hours after surgery with SMD -0.37 (95% CI -0.59 to -0.15); 2 studies; 459 participants; moderate-quality evidence. All other primary outcomes showed no differences between groups (cTnT release measured at 48 hours with SMD -0.14, 95% CI -0.33 to 0.06; 4 studies; 1792 participants; low-quality evidence and cTnI release measured as AUC 72 hours with SMD -0.17, 95% CI -0.48 to 0.14; 2 studies; 159 participants; moderate-quality evidence).\nWe also found no differences between groups for all-cause mortality after 30 days, non-fatal myocardial infarction after 30 days, any new stroke after 30 days, acute renal failure after 30 days, length of stay on the intensive care unit (days), any complications and adverse effects related to ischaemic preconditioning. We did not assess many patient-centred/salutogenic-focused outcomes.\nAuthors' conclusions\nWe found no evidence that RIPC has a treatment effect on clinical outcomes (measured as a composite endpoint including all-cause mortality, non-fatal myocardial infarction or any new stroke, or both, assessed at 30 days after surgery). There is moderate-quality evidence that RIPC has no treatment effect on the rate of the composite endpoint including all-cause mortality, non-fatal myocardial infarction or any new stroke assessed at 30 days after surgery, or both. We found moderate-quality evidence that RIPC reduces the cTnT release measured at 72 hours after surgery and expressed as AUC (72 hours). There is moderate-quality evidence that RIPC reduces the amount of cTnI release measured at 48 hours, and measured 72 hours after surgery. Adequately-designed studies, especially focusing on influencing factors, e.g. with regard to anaesthetic management, are encouraged and should systematically analyse the commonly used medications of people with cardiovascular diseases.\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 used reliable methods to assess the quality of the trial evidence. The quality of the evidence of key outcomes ranged from moderate to low quality due to the presence of moderate or high statistical heterogeneity, imprecision of results or due to limitations in the design of individual studies."
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query-laysum | 3594 | [
{
"role": "user",
"content": "Abstract: Background\nFluid excess may place people undergoing surgery at risk for various complications. Hypertonic salt solution (HS) maintains intravascular volume with less intravenous fluid than isotonic salt (IS) solutions, but may increase serum sodium. This review was published in 2010 and updated in 2016.\nObjectives\nTo determine the benefits and harms of HS versus IS solutions administered for fluid resuscitation to people undergoing surgery.\nSearch methods\nIn this updated review we have searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 4, 2016); MEDLINE (January 1966 to April 2016); EMBASE (January 1980 to April 2016); LILACS (January 1982 to April 2016) and CINAHL (January 1982 to April 2016) without language restrictions. We conducted the original search on April 30th, 2007, and reran it on April 8th, 2016.\nSelection criteria\nWe have included randomized clinical trials (RCTs) comparing HS to IS in people undergoing surgery, irrespective of blinding, language, and publication status.\nData collection and analysis\nTwo independent review authors read studies that met our selection criteria. We collected study information and data using a data collection sheet with predefined parameters. We have assessed the impact of HS administration on mortality, organ failure, fluid balance, serum sodium, serum osmolarity, diuresis and physiologic measures of cardiovascular function. We have pooled the data using the mean difference (MD) for continuous outcomes. We evaluated heterogeneity between studies by I² percentage. We consider studies with an I² of 0% to 30% to have no or little heterogeneity, 30% to 60% as having moderate heterogeneity, and more than 60% as having high heterogeneity. In studies with low heterogeneity we have used a fixed-effect model, and a random-effects model for studies with moderate to high heterogeneity.\nMain results\nWe have included 18 studies with 1087 participants of whom 545 received HS compared to 542 who received IS. All participants were over 18 years of age and all trials excluded high-risk patients (ASA IV). All trials assessed haematological parameters peri-operatively and up to three days post-operatively.\nThere were three (< 1%) deaths reported in the IS group and four (< 1%) in the HS group, as assessed at 90 days in one study. There were no reports of serious adverse events. Most participants were in a positive fluid balance postoperatively (4.4 L IS and 2.5 L HS), with the excess significantly less in HS participants (MD -1.92 L, 95% confidence interval (CI) -2.61 to -1.22 L; P < 0.00001). IS participants received a mean volume of 2.4 L and HS participants received 1.49 L, significantly less fluid than IS-treated participants (MD -0.91 L, 95% CI -1.24 to -0.59 L; P < 0.00001). The maximum average serum sodium ranged between 138.5 and 159 in HS groups compared to between 136 and 143 meq/L in the IS groups. The maximum serum sodium was significantly higher in HS participants (MD 7.73, 95% CI 5.84 to 9.62; P < 0.00001), although the level remained within normal limits (136 to 146 meq/L).\nA high degree of heterogeneity appeared to be related to considerable differences in the dose of HS between studies. The quality of the evidence for the outcomes reported ranged from high to very low. The risk of bias for many of the studies could not be determined for performance and detection bias, criteria that we assess as likely to impact the study outcomes.\nAuthors' conclusions\nHS reduces the volume of intravenous fluid required to maintain people undergoing surgery but transiently increases serum sodium. It is not known if HS affects survival and morbidity, but this should be examined in randomized controlled trials that are designed and powered to test these outcomes.\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 solutions containing more salt than is normally used safe during surgery?"
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query-laysum | 3595 | [
{
"role": "user",
"content": "Abstract: Background\nSince December 2019, the world has struggled with the COVID-19 pandemic. Even after the introduction of various vaccines, this disease still takes a considerable toll. In order to improve the optimal allocation of resources and communication of prognosis, healthcare providers and patients need an accurate understanding of factors (such as obesity) that are associated with a higher risk of adverse outcomes from the COVID-19 infection.\nObjectives\nTo evaluate obesity as an independent prognostic factor for COVID-19 severity and mortality among adult patients in whom infection with the COVID-19 virus is confirmed.\nSearch methods\nMEDLINE, Embase, two COVID-19 reference collections, and four Chinese biomedical databases were searched up to April 2021.\nSelection criteria\nWe included case-control, case-series, prospective and retrospective cohort studies, and secondary analyses of randomised controlled trials if they evaluated associations between obesity and COVID-19 adverse outcomes including mortality, mechanical ventilation, intensive care unit (ICU) admission, hospitalisation, severe COVID, and COVID pneumonia. Given our interest in ascertaining the independent association between obesity and these outcomes, we selected studies that adjusted for at least one factor other than obesity. Studies were evaluated for inclusion by two independent reviewers working in duplicate.\nData collection and analysis\nUsing standardised data extraction forms, we extracted relevant information from the included studies. When appropriate, we pooled the estimates of association across studies with the use of random-effects meta-analyses. The Quality in Prognostic Studies (QUIPS) tool provided the platform for assessing the risk of bias across each included study. In our main comparison, we conducted meta-analyses for each obesity class separately. We also meta-analysed unclassified obesity and obesity as a continuous variable (5 kg/m2 increase in BMI (body mass index)). We used the GRADE framework to rate our certainty in the importance of the association observed between obesity and each outcome. As obesity is closely associated with other comorbidities, we decided to prespecify the minimum adjustment set of variables including age, sex, diabetes, hypertension, and cardiovascular disease for subgroup analysis.\nMain results\nWe identified 171 studies, 149 of which were included in meta-analyses. As compared to 'normal' BMI (18.5 to 24.9 kg/m2) or patients without obesity, those with obesity classes I (BMI 30 to 35 kg/m2), and II (BMI 35 to 40 kg/m2) were not at increased odds for mortality (Class I: odds ratio [OR] 1.04, 95% confidence interval [CI] 0.94 to 1.16, high certainty (15 studies, 335,209 participants); Class II: OR 1.16, 95% CI 0.99 to 1.36, high certainty (11 studies, 317,925 participants)). However, those with class III obesity (BMI 40 kg/m2 and above) may be at increased odds for mortality (Class III: OR 1.67, 95% CI 1.39 to 2.00, low certainty, (19 studies, 354,967 participants)) compared to normal BMI or patients without obesity. For mechanical ventilation, we observed increasing odds with higher classes of obesity in comparison to normal BMI or patients without obesity (class I: OR 1.38, 95% CI 1.20 to 1.59, 10 studies, 187,895 participants, moderate certainty; class II: OR 1.67, 95% CI 1.42 to 1.96, 6 studies, 171,149 participants, high certainty; class III: OR 2.17, 95% CI 1.59 to 2.97, 12 studies, 174,520 participants, high certainty). However, we did not observe a dose-response relationship across increasing obesity classifications for ICU admission and hospitalisation.\nAuthors' conclusions\nOur findings suggest that obesity is an important independent prognostic factor in the setting of COVID-19. Consideration of obesity may inform the optimal management and allocation of limited resources in the care of COVID-19 patients.\n\nGiven the provided abstract, please respond to the following query: \"What is obesity?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Obesity is defined as abnormal or excessive fat accumulation in different parts of the human body and it presents a risk to health. To assess obesity, different indices such as body mass index (BMI) can be used, which is one's weight in kilograms divided by the square of height in metres. The WHO has classified obesity into three classes. According to this classification, class I obesity includes a BMI ranging from 30 to 35 kg/m2, class II from 35 to 40 kg/m2, and class III from 40 kg/m2 and more."
}
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query-laysum | 3596 | [
{
"role": "user",
"content": "Abstract: Background\nBehçet's disease is a chronic inflammatory vasculitis that can affect multiple systems. Mucocutaneous involvement is common, as is the involvement of many other systems such as the central nervous system and skin. Behç̧et's disease can cause significant morbidity, such as loss of sight, and can be life threatening. The frequency of oral ulceration in Behçet's disease is thought to be 97% to 100%. The presence of mouth ulcers can cause difficulties in eating, drinking, and speaking leading to a reduction in quality of life. There is no cure for Behçet's disease and therefore treatment of the oral ulcers that are associated with Behçet's disease is palliative.\nObjectives\nTo determine the clinical effectiveness and safety of interventions on the pain, episode duration, and episode frequency of oral ulcers and on quality of life for patients with recurrent aphthous stomatitis (RAS)-type ulceration associated with Behçet's disease.\nSearch methods\nWe undertook electronic searches of the Cochrane Oral Health Group Trials Register (to 4 October 2013); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9); MEDLINE via Ovid (1946 to 4 October 2013); EMBASE via Ovid (1980 to 4 October 2013); CINAHL via EBSCO (1980 to 4 October 2013); and AMED via Ovid (1985 to 4 October 2013). We searched the US National Institutes of Health trials register (http://clinicaltrials.gov) and the World Health Organization (WHO) Clinical Trials Registry Platform for ongoing trials. There were no restrictions on language or date of publication in the searches of the electronic databases. We contacted authors when necessary to obtain additional information.\nSelection criteria\nWe included randomised controlled trials (RCTs) that looked at pre-specified oral outcome measures to assess the efficacy of interventions for mouth ulcers in Behçet's disease. The oral outcome measures included pain, episode duration, episode frequency, safety, and quality of life. Trials were not restricted by outcomes alone.\nData collection and analysis\nAll studies meeting the inclusion criteria underwent data extraction and an assessment of risk of bias, independently by two review authors and using a pre-standardised data extraction form. We used standard methodological procedures expected by Cochrane.\nMain results\nA total of 15 trials (n = 888 randomised participants) were included, 13 were placebo controlled and three were head to head (two trials had more than two treatment arms). Eleven of the trials were conducted in Turkey, two in Japan, one in Iran and one in the UK. Most trials used the International Study Group criteria for Behçet's disease. Eleven different interventions were assessed. The interventions were grouped into two categories, topical and systemic. Only one study was assessed as being at low risk of bias. It was not possible to carry out a meta-analysis. The quality of the evidence ranged from moderate to very low and there was insufficient evidence to support or refute the use of any included intervention with regard to pain, episode duration, or episode frequency associated with oral ulcers, or safety of the interventions.\nAuthors' conclusions\nDue to the heterogeneity of trials including trial design, choice of intervention, choice and timing of outcome measures, it was not possible to carry out a meta-analysis. Several interventions show promise and future trials should be planned and reported according to the CONSORT guidelines. Whilst the primary aim of many trials for Behç̧et's disease is not necessarily reduction of oral ulceration, reporting of oral ulcers in these studies should be standardised and pre-specified in the methodology. The use of a core outcome set for oral ulcer trials would be beneficial.\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": "Authors from Cochrane Oral Health carried out this review of existing studies and the evidence is current up to 4 October 2013. The review includes 15 studies published from 1980 to 2012 in which 888 participants were randomised. Eleven of the trials were conducted in Turkey, two in Japan, one in Iran, and one in the UK. Thirteen different interventions were assessed, administered either topically or systemically.\nTopical interventions: sucralfate, interferon–alpha (different doses), cyclosporin A, triamcinolone acetonide ointment, phenytoin syrup mouthwash.\nSystemic interventions: aciclovir, thalidomide (different doses), corticosteroids, rebamipide, etanercept, colchicine, interferon–alpha, cyclosporin."
}
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query-laysum | 3597 | [
{
"role": "user",
"content": "Abstract: Background\nCerebral palsy is the most common physical disability in childhood. Mechanically assisted walking training can be provided with or without body weight support to enable children with cerebral palsy to perform repetitive practice of complex gait cycles. It is important to examine the effects of mechanically assisted walking training to identify evidence-based treatments to improve walking performance.\nObjectives\nTo assess the effects of mechanically assisted walking training compared to control for walking, participation, and quality of life in children with cerebral palsy 3 to 18 years of age.\nSearch methods\nIn January 2020, we searched CENTRAL, MEDLINE, Embase, six other databases, and two trials registers. We handsearched conference abstracts and checked reference lists of included studies.\nSelection criteria\nRandomized controlled trials (RCTs) or quasi-RCTs, including cross-over trials, comparing any type of mechanically assisted walking training (with or without body weight support) with no walking training or the same dose of overground walking training in children with cerebral palsy (classified as Gross Motor Function Classification System [GMFCS] Levels I to IV) 3 to 18 years of age.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nThis review includes 17 studies with 451 participants (GMFCS Levels I to IV; mean age range 4 to 14 years) from outpatient settings. The duration of the intervention period (4 to 12 weeks) ranged widely, as did intensity of training in terms of both length (15 minutes to 40 minutes) and frequency (two to five times a week) of sessions. Six studies were funded by grants, three had no funding support, and eight did not report information on funding. Due to the nature of the intervention, all studies were at high risk of performance bias.\nMechanically assisted walking training without body weight support versus no walking training\nFour studies (100 participants) assessed this comparison. Compared to no walking, mechanically assisted walking training without body weight support increased walking speed (mean difference [MD] 0.05 meter per second [m/s] [change scores], 95% confidence interval [CI] 0.03 to 0.07; 1 study, 10 participants; moderate-quality evidence) as measured by the Biodex Gait Trainer 2™ (Biodex, Shirley, NY, USA) and improved gross motor function (standardized MD [SMD] 1.30 [postintervention scores], 95% CI 0.49 to 2.11; 2 studies, 60 participants; low-quality evidence) postintervention. One study (30 participants) reported no adverse events (low-quality evidence). No study measured participation or quality of life.\nMechanically assisted walking training without body weight support versus the same dose of overground walking training\nTwo studies (55 participants) assessed this comparison. Compared to the same dose of overground walking, mechanically assisted walking training without body weight support increased walking speed (MD 0.25 m/s [change or postintervention scores], 95% CI 0.13 to 0.37; 2 studies, 55 participants; moderate-quality evidence) as assessed by the 6-minute walk test or Vicon gait analysis. It also improved gross motor function (MD 11.90% [change scores], 95% CI 2.98 to 20.82; 1 study, 35 participants; moderate-quality evidence) as assessed by the Gross Motor Function Measure (GMFM) and participation (MD 8.20 [change scores], 95% CI 5.69 to 10.71; 1 study, 35 participants; moderate-quality evidence) as assessed by the Pediatric Evaluation of Disability Inventory (scored from 0 to 59), compared to the same dose of overground walking training. No study measured adverse events or quality of life.\nMechanically assisted walking training with body weight support versus no walking training\nEight studies (210 participants) assessed this comparison. Compared to no walking training, mechanically assisted walking training with body weight support increased walking speed (MD 0.07 m/s [change and postintervention scores], 95% CI 0.06 to 0.08; 7 studies, 161 participants; moderate-quality evidence) as assessed by the 10-meter or 8-meter walk test. There were no differences between groups in gross motor function (MD 1.09% [change and postintervention scores], 95% CI -0.57 to 2.75; 3 studies, 58 participants; low-quality evidence) as assessed by the GMFM; participation (SMD 0.33 [change scores], 95% CI -0.27 to 0.93; 2 studies, 44 participants; low-quality evidence); and quality of life (MD 9.50% [change scores], 95% CI -4.03 to 23.03; 1 study, 26 participants; low-quality evidence) as assessed by the Pediatric Quality of Life Cerebral Palsy Module (scored 0 [bad] to 100 [good]). Three studies (56 participants) reported no adverse events (low-quality evidence).\nMechanically assisted walking training with body weight support versus the same dose of overground walking training\nThree studies (86 participants) assessed this comparison. There were no differences between groups in walking speed (MD -0.02 m/s [change and postintervention scores], 95% CI -0.08 to 0.04; 3 studies, 78 participants; low-quality evidence) as assessed by the 10-meter or 5-minute walk test; gross motor function (MD -0.73% [postintervention scores], 95% CI -14.38 to 12.92; 2 studies, 52 participants; low-quality evidence) as assessed by the GMFM; and participation (MD -4.74 [change scores], 95% CI -11.89 to 2.41; 1 study, 26 participants; moderate-quality evidence) as assessed by the School Function Assessment (scored from 19 to 76). No study measured adverse events or quality of life.\nAuthors' conclusions\nCompared with no walking, mechanically assisted walking training probably results in small increases in walking speed (with or without body weight support) and may improve gross motor function (with body weight support). Compared with the same dose of overground walking, mechanically assisted walking training with body weight support may result in little to no difference in walking speed and gross motor function, although two studies found that mechanically assisted walking training without body weight support is probably more effective than the same dose of overground walking training for walking speed and gross motor function. Not many studies reported adverse events, although those that did appeared to show no differences between groups. The results are largely not clinically significant, sample sizes are small, and risk of bias and intensity of intervention vary across studies, making it hard to draw robust conclusions. Mechanically assisted walking training is a means to undertake high-intensity, repetitive, task-specific training and may be useful for children with poor concentration.\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": "Children with cerebral palsy have difficulty walking independently. It is thought that they might benefit from mechanically assisted walking training compared with no walking or overground walking (i.e. without mechanical support). Mechanically assisted walking training includes using motorized devices such as a treadmill, a gait trainer (a wheeled walking aid), or a robotic training device (such as a robotic knee brace) to help children with cerebral palsy to walk further. This training can be provided either with or without body weight support (such as a harness, a handrail, or manual physical support)."
}
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query-laysum | 3598 | [
{
"role": "user",
"content": "Abstract: Background\nBacterial meningitis remains a significant cause of neonatal and childhood morbidity and mortality in many countries of the world, particularly in developing countries. In some instances, children recover but remain impaired as a result of neurological sequelae such as hearing loss, developmental delay and cognitive impairment.\nObjectives\nTo assess the effectiveness and safety of adjunctive corticosteroids in reducing death and neurological sequelae in neonates with bacterial meningitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 7), MEDLINE via PubMed (1966 to July 2015), African Index Medicus (up to January 2015), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (up to July 2015), EMBASE (up to July 2015) and the metaRegister of Controlled Trials (mRCT) for ongoing trials.\nSelection criteria\nAll randomised controlled trials (RCTs) or quasi-RCTs of adjunctive corticosteroids for treatment of neonates with bacterial meningitis.\nData collection and analysis\nTwo review authors independently assessed and extracted data on methods, participants, interventions and outcomes (all-cause death until hospital discharge, presence of sensorineural deafness at one year and presence of neurological deficits or developmental delay at two years, adverse events). Risk ratio (RR), risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB) or number needed to treat for an additional harmful outcome (NNTH) were calculated when appropriate. We assessed quality using the Cochrane risk of bias assessment tool and the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) system.\nMain results\nWe found two trials with 132 participants that met our inclusion criteria. One of the included trials was a quasi-randomised trial.\nAdjunctive corticosteroids reduced the risk of death (typical RR 0.46, 95% confidence interval (CI) 0.24 to 0.88; typical RD -0.19, 95% CI -0.33 to -0.04; NNTB = 6; two studies, 132 participants, very low-quality evidence) but did not have a significant effect on the number of infants with sensorineural deafness at two years (RR 1.80, 95% CI 0.18 to 18.21; RD 0.04, 95% CI -0.12 to 0.21; one study, 38 participants, low-quality evidence). In one trial, dexamethasone reduced the likelihood of hearing loss at four to 10 weeks post discharge (RR 0.41, 95% CI 0.17 to 0.98; RD -0.25, 95% CI -0.48 to -0.01; one study, 59 participants, low-quality evidence). Data reported on the other outcomes of interest were insufficient.\nAuthors' conclusions\nVery low-quality data from two randomised controlled trials suggest that some reduction in death and hearing loss may result from use of adjunctive steroids alongside standard antibiotic therapy for treatment of patients with neonatal meningitis. Benefit is not yet seen with regards to reduction in neurological sequelae. Researchers who wish to clarify these findings must conduct more robustly designed trials with greater numbers of participants, evaluating more relevant outcomes and providing adequate follow-up.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified two studies for inclusion."
}
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query-laysum | 3599 | [
{
"role": "user",
"content": "Abstract: Background\nCognitive impairment in people with traumatic brain injury (TBI) could affect multiple facets of their daily functioning. Cognitive rehabilitation brings about clinically significant improvement in certain cognitive skills. However, it is uncertain if these improved cognitive skills lead to betterments in other key aspects of daily living. We evaluated whether cognitive rehabilitation for people with TBI improves return to work, independence in daily activities, community integration and quality of life.\nObjectives\nTo evaluate the effects of cognitive rehabilitation on return to work, independence in daily activities, community integration (occupational outcomes) and quality of life in people with traumatic brain injury, and to determine which cognitive rehabilitation strategy better achieves these outcomes.\nSearch methods\nWe searched CENTRAL (the Cochrane Library; 2017, Issue 3), MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), and clinical trials registries up to 30 March 2017.\nSelection criteria\nWe identified all available randomized controlled trials of cognitive rehabilitation compared with any other non-pharmacological intervention for people with TBI. We included studies that reported at least one outcome related to : return to work, independence in activities of daily living (ADL), community integration and quality of life.\nData collection and analysis\nTwo review authors independently selected trials. We used standard methodological procedures expected by Cochrane. We evaluated heterogeneity among the included studies and performed meta-analysis only when we could include more than one study in a comparison. We used the online computer programme GRADEpro to assess the quality of evidence, and generate 'Summary of findings' tables.\nMain results\nWe included nine studies with 790 participants. Three trials (160 participants) compared cognitive rehabilitation versus no treatment, four trials (144 participants) compared cognitive rehabilitation versus conventional treatment, one trial (120 participants) compared hospital-based cognitive rehabilitation versus home programme and one trial (366 participants) compared one cognitive strategy versus another. Among the included studies, we judged three to be of low risk of bias.\nThere was no difference between cognitive rehabilitation and no intervention in return to work (risk ratio (RR) 1.80, 95% confidence interval (CI) 0.74 to 4.39, 1 study; very low-quality evidence). There was no difference between biweekly cognitive rehabilitation for eight weeks and no treatment in community integration (Sydney Psychosocial Reintegration Scale): mean difference (MD) -2.90, 95% CI -12.57 to 6.77, 1 study; low-quality evidence). There was no difference in quality of life between cognitive rehabilitation and no intervention immediately following the 12-week intervention(MD 0.30, 95% CI -0.18 to 0.78, 1 study; low-quality evidence). No study reported effects on independence in ADL.\nThere was no difference between cognitive rehabilitation and conventional treatment in return to work status at six months' follow-up in one study (RR 1.43, 95% CI 0.87 to 2.33; low-quality evidence); independence in ADL at three to four weeks' follow-up in two studies (standardized mean difference (SMD) -0.01, 95% CI -0.62 to 0.61; very low-quality evidence); community integration at three weeks' to six months' follow-up in three studies (Community Integration Questionnaire: MD 0.05, 95% CI -1.51 to 1.62; low-quality evidence) and quality of life at six months' follow-up in one study (Perceived Quality of Life scale: MD 6.50, 95% CI -2.57 to 15.57; moderate-quality evidence).\nFor active duty military personnel with moderate-to-severe closed head injury, there was no difference between eight weeks of cognitive rehabilitation administered as a home programme and hospital-based cognitive rehabilitation in achieving return to work at one year' follow-up in one study (RR 0.95, 95% CI 0.85 to 1.05; moderate-quality evidence). The study did not report effects on independence in ADL, community integration or quality of life.\nThere was no difference between one cognitive rehabilitation strategy (cognitive didactic) and another (functional experiential) for adult veterans or active duty military service personnel with moderate-to-severe TBI (one study with 366 participants and one year' follow-up) on return to work (RR 1.10, 95% CI 0.83 to 1.46; moderate-quality evidence), or on independence in ADL (RR 0.90, 95% CI 0.75 to 1.08; low-quality evidence). The study did not report effects on community integration or quality of life.\nNone of the studies reported adverse effects of cognitive rehabilitation.\nAuthors' conclusions\nThere is insufficient good-quality evidence to support the role of cognitive rehabilitation when compared to no intervention or conventional rehabilitation in improving return to work, independence in ADL, community integration or quality of life in adults with TBI. There is moderate-quality evidence that cognitive rehabilitation provided as a home programme is similar to hospital-based cognitive rehabilitation in improving return to work status among active duty military personnel with moderate-to-severe TBI. Moderate-quality evidence suggests that one cognitive rehabilitation strategy (cognitive didactic) is no better than another (functional experiential) in achieving return to work in veterans or military personnel with TBI.\n\nGiven the provided abstract, please respond to the following query: \"Cognitive rehabilitation compared to no treatment\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There was insufficient evidence to conclude that cognitive rehabilitation, as compared to no other treatment, led to better return to work, community integration or quality of life in adults with traumatic brain injury. We judged the quality of this evidence as low or very low because of poor reporting of both the methods used and the results."
}
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query-laysum | 3600 | [
{
"role": "user",
"content": "Abstract: Background\nAge-related macular degeneration (AMD) is a common eye disease and leading cause of sight loss worldwide. Despite its high prevalence and increasing incidence as populations age, AMD remains incurable and there are no treatments for most patients. Mounting genetic and molecular evidence implicates complement system overactivity as a key driver of AMD development and progression. The last decade has seen the development of several novel therapeutics targeting complement in the eye for the treatment of AMD. This review update encompasses the results of the first randomised controlled trials in this field.\nObjectives\nTo assess the effects and safety of complement inhibitors in the prevention or treatment of AMD.\nSearch methods\nWe searched CENTRAL on the Cochrane Library, MEDLINE, Embase, LILACS, Web of Science, ISRCTN registry, ClinicalTrials.gov, and the WHO ICTRP to 29 June 2022 with no language restrictions. We also contacted companies running clinical trials for unpublished data.\nSelection criteria\nWe included randomised controlled trials (RCTs) with parallel groups and comparator arms that studied complement inhibition for advanced AMD prevention/treatment.\nData collection and analysis\nTwo authors independently assessed search results and resolved discrepancies through discussion. Outcome measures evaluated at one year included change in best-corrected visual acuity (BCVA), untransformed and square root-transformed geographic atrophy (GA) lesion size progression, development of macular neovascularisation (MNV) or exudative AMD, development of endophthalmitis, loss of ≥ 15 letters of BCVA, change in low luminance visual acuity, and change in quality of life. We assessed risk of bias and evidence certainty using Cochrane risk of bias and GRADE tools.\nMain results\nTen RCTs with 4052 participants and eyes with GA were included. Nine evaluated intravitreal (IVT) administrations against sham, and one investigated an intravenous agent against placebo. Seven studies excluded patients with prior MNV in the non-study eye, whereas the three pegcetacoplan studies did not. The risk of bias in the included studies was low overall. We also synthesised results of two intravitreal agents (lampalizumab, pegcetacoplan) at monthly and every-other-month (EOM) dosing intervals.\nEfficacy and safety of IVT lampalizumab versus sham for GA\nFor 1932 participants in three studies, lampalizumab did not meaningfully change BCVA given monthly (+1.03 letters, 95% confidence interval (CI) −0.19 to 2.25) or EOM (+0.22 letters, 95% CI −1.00 to 1.44) (high-certainty evidence). For 1920 participants, lampalizumab did not meaningfully change GA lesion growth given monthly (+0.07 mm², 95% CI −0.09 to 0.23; moderate-certainty due to imprecision) or EOM (+0.07 mm², 95% CI −0.05 to 0.19; high-certainty). For 2000 participants, lampalizumab may have also increased MNV risk given monthly (RR 1.77, 95% CI 0.73 to 4.30) and EOM (RR 1.70, 95% CI 0.67 to 4.28), based on low-certainty evidence. The incidence of endophthalmitis in patients treated with monthly and EOM lampalizumab was 4 per 1000 (0 to 87) and 3 per 1000 (0 to 62), respectively, based on moderate-certainty evidence.\nEfficacy and safety of IVT pegcetacoplan versus sham for GA\nFor 242 participants in one study, pegcetacoplan probably did not meaningfully change BCVA given monthly (+1.05 letters, 95% CI −2.71 to 4.81) or EOM (−1.42 letters, 95% CI −5.25 to 2.41), as supported by moderate-certainty evidence. In contrast, for 1208 participants across three studies, pegcetacoplan meaningfully reduced GA lesion growth when given monthly (−0.38 mm², 95% CI −0.57 to −0.19) and EOM (−0.29 mm², 95% CI −0.44 to −0.13), with high certainty. These reductions correspond to 19.2% and 14.8% versus sham, respectively. A post hoc analysis showed possibly greater benefits in 446 participants with extrafoveal GA given monthly (−0.67 mm², 95% CI −0.98 to −0.36) and EOM (−0.60 mm², 95% CI −0.91 to −0.30), representing 26.1% and 23.3% reductions, respectively. However, we did not have data on subfoveal GA growth to undertake a formal subgroup analysis. In 1502 participants, there is low-certainty evidence that pegcetacoplan may have increased MNV risk when given monthly (RR 4.47, 95% CI 0.41 to 48.98) or EOM (RR 2.29, 95% CI 0.46 to 11.35). The incidence of endophthalmitis in patients treated with monthly and EOM pegcetacoplan was 6 per 1000 (1 to 53) and 8 per 1000 (1 to 70) respectively, based on moderate-certainty evidence.\nEfficacy and safety of IVT avacincaptad pegol versus sham for GA\nIn a study of 260 participants with extrafoveal or juxtafoveal GA, monthly avacincaptad pegol probably did not result in a clinically meaningful change in BCVA at 2 mg (+1.39 letters, 95% CI −5.89 to 8.67) or 4 mg (−0.28 letters, 95% CI −8.74 to 8.18), based on moderate-certainty evidence. Despite this, the drug was still found to have probably reduced GA lesion growth, with estimates of 30.5% reduction at 2 mg (−0.70 mm², 95% CI −1.99 to 0.59) and 25.6% reduction at 4 mg (−0.71 mm², 95% CI −1.92 to 0.51), based on moderate-certainty evidence. Avacincaptad pegol may have also increased the risk of developing MNV (RR 3.13, 95% CI 0.93 to 10.55), although this evidence is of low certainty. There were no cases of endophthalmitis reported in this study.\nAuthors' conclusions\nDespite confirmation of the negative findings of intravitreal lampalizumab across all endpoints, local complement inhibition with intravitreal pegcetacoplan meaningfully reduces GA lesion growth relative to sham at one year. Inhibition of complement C5 with intravitreal avacincaptad pegol is also an emerging therapy with probable benefits on anatomical endpoints in the extrafoveal or juxtafoveal GA population. However, there is currently no evidence that complement inhibition with any agent improves functional endpoints in advanced AMD; further results from the phase 3 studies of pegcetacoplan and avacincaptad pegol are eagerly awaited. Progression to MNV or exudative AMD is a possible emergent adverse event of complement inhibition, requiring careful consideration should these agents be used clinically. Intravitreal administration of complement inhibitors is probably associated with a small risk of endophthalmitis, which may be higher than that of other intravitreal therapies. Further research is likely to have an important impact on our confidence in the estimates of adverse effects and may change these. The optimal dosing regimens, treatment duration, and cost-effectiveness of such therapies are yet to be established.\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": "We found that pegcetacoplan given every month or every-other-month reduces the growth of patches of diseased retina, but probably makes little to no difference to vision loss. We also found that avacincaptad pegol may reduce the growth of diseased retina, but also probably makes little to no difference in vision loss. We found that lampalizumab makes little to no difference to any of the outcomes of interest to patients and their clinicians.\nLike other medicines given in the eye, we found that most medicines that block complement are probably associated with a small increase in the risk of serious eye infection or inflammation. We also found that blocking complement in the eye in most studies probably caused an increase in the risk of abnormal blood vessels growing in the retina; these can leak blood or fluid and cause rapid vision loss but can be treated if caught quickly."
}
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query-laysum | 3601 | [
{
"role": "user",
"content": "Abstract: Background\nA variety of minimally invasive surgical approaches are available as an alternative to transurethral resection of the prostate (TURP) for management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Prostatic arterial embolization (PAE) is a relatively new, minimally invasive treatment approach.\nObjectives\nTo assess the effects of PAE compared to other procedures for treatment of LUTS in men with BPH.\nSearch methods\nWe performed a comprehensive search the Cochrane Library, MEDLINE, Embase, three other databases, trials registries, other sources of grey literature, and conference proceedings with no restrictions on language of publication or publication status, up to 8 November 2021.\nSelection criteria\nWe included parallel-group randomized controlled trials (RCTs), as well as non-randomized studies (NRS, limited to prospective cohort studies with concurrent comparison groups) enrolling men over the age of 40 years with LUTS attributed to BPH undergoing PAE versus TURP or other surgical interventions.\nData collection and analysis\nTwo review authors independently classified studies for inclusion or exclusion and abstracted data from the included studies. We performed statistical analyses by using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We used GRADE guidance to rate the certainty of evidence of RCTs and NRSs.\nMain results\nWe found data to inform two comparisons: PAE versus TURP (six RCTs and two NRSs), and PAE versus sham (one RCT). Mean age was 66 years, International Prostate Symptom Score (IPSS) was 22.8, and prostate volume of participants was 72.8 mL. This abstract focuses on the comparison of PAE versus TURP as the primary topic of interest.\nProstatic arterial embolization versus transurethral resection of the prostate\nWe included six RCTs and two NRSs with short-term (up to 12 months) follow-up, and two RCTs and one NRS with long-term follow-up (13 to 24 months).\nShort-term follow-up: based on RCT evidence, there may be little to no difference in urologic symptom score improvement measured by the International Prostatic Symptom Score (IPSS) on a scale from 0 to 35, with higher scores indicating worse symptoms (mean difference [MD] 1.72, 95% confidence interval [CI] –0.37 to 3.81; 6 RCTs, 360 participants; I² = 78%; low-certainty evidence). There may be little to no difference in quality of life as measured by the IPSS-quality of life question on a scale from 0 to 6, with higher scores indicating worse quality of life between PAE and TURP, respectively (MD 0.28, 95% CI –0.28 to 0.84; 5 RCTs, 300 participants; I² = 63%; low-certainty evidence). While we are very uncertain about the effects of PAE on major adverse events (risk ratio [RR] 0.75, 95% CI 0.19 to 2.97; 4 RCTs, 250 participants; I² = 24%; very low-certainty evidence), PAE likely increases retreatments (RR 3.20, 95% CI 1.41 to 7.27; 4 RCTs, 303 participants; I² = 0%; moderate-certainty evidence). PAE may make little to no difference in erectile function measured by the International Index of Erectile Function-5 on a scale from 1 to 25, with higher scores indicating better function (MD –0.50 points, 95% CI –5.88 to 4.88; 2 RCTs, 120 participants; I² = 68%; low-certainty evidence). Based on NRS evidence, PAE may reduce the occurrence of ejaculatory disorders (RR 0.51, 95% CI 0.35 to 0.73; 1 NRS, 260 participants; low-certainty evidence).\nLong-term follow-up: based on RCT evidence, PAE may result in little to no difference in urologic symptom scores (MD 2.58 points, 95% CI –1.54 to 6.71; 2 RCTs, 176 participants; I² = 73%; low-certainty evidence) and quality of life (MD 0.50 points, 95% CI –0.03 to 1.04; 2 RCTs, 176 participants; I² = 29%; low-certainty evidence). We are very uncertain about major adverse events (RR 0.91, 95% CI 0.20 to 4.05; 2 RCTs, 206 participants; I² = 72%; very low-certainty evidence). PAE likely increases retreatments (RR 3.80, 95% CI 1.32 to 10.93; 1 RCT, 81 participants; moderate-certainty evidence). While PAE may result in little to no difference in erectile function (MD 3.09 points, 95% CI –0.76 to 6.94; 1 RCT, 81 participants; low-certainty evidence), PAE may reduce the occurrence of ejaculatory disorders (RR 0.67, 95% CI 0.45 to 0.98; 1 RCT, 50 participants; low-certainty evidence).\nAuthors' conclusions\nCompared to TURP, PAE may provide similar improvement in urologic symptom scores and quality of life. While we are very uncertain about major adverse events, PAE likely increases retreatment rates. While erectile function may be similar, PAE may reduce ejaculatory disorders. Certainty of evidence for the outcomes of this review was low or very low except for retreatment (moderate-certainty evidence), signaling that our confidence in the reported effect size is limited or very limited, and that this topic should be better informed by 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": "An enlarged prostate may cause difficulty with urination such as a weak stream or the need to urinate often during the day or at night. This can be treated by medications or by different types of surgery. One main type of surgery is called transurethral resection of the prostate. This involves going inside the urethra through the penis and removing prostate tissue. Prostatic arterial embolization is another form of treatment that works by stopping blood flow to parts of the prostate. We did this study to compare how prostatic arterial embolization compares to transurethral resection of the prostate and other procedures used in men with an enlarged prostate."
}
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query-laysum | 3602 | [
{
"role": "user",
"content": "Abstract: Background\nChronic venous insufficiency (CVI) is a progressive and common disease that affects the superficial and deep venous systems of the lower limbs. CVI is characterised by valvular incompetence, reflux, venous obstruction or a combination of these symptoms, with consequent distal venous hypertension. Clinical manifestations of CVI include oedema, pain, skin changes, ulcerations and dilated skin veins in the lower limbs. It places a large financial burden on health systems. There is a wide variety of treatment options for CVI, ranging from surgery and medication to compression and physiotherapy. Balneotherapy (treatments involving water) may be a relatively cheap and efficient way to deliver physiotherapy to people with CVI. This is an update of a review first published in 2019.\nObjectives\nTo assess the effectiveness and safety of balneotherapy for the treatment of people with chronic venous insufficiency.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 28 June 2022.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials comparing balneotherapy to no treatment or other types of treatment for CVI. We also included studies that used a combination of treatments.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. disease severity, 2. health-related quality of life (HRQoL) and 3. adverse effects. Our secondary outcomes were 1. pain, 2. oedema, 3. leg ulcer incidence and 4. skin pigmentation changes. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included nine randomised controlled trials involving 1126 participants with CVI. Seven studies evaluated balneotherapy versus no treatment, one study evaluated balneotherapy versus a phlebotonic drug (melilotus officinalis), and one study evaluated balneotherapy versus dryland exercises. We downgraded our certainty in the evidence due to a lack of blinding of participants and investigators, participant-reported outcomes and imprecision.\nBalneotherapy versus no treatment\nBalneotherapy compared to no treatment probably results in slightly improved disease severity signs and symptoms scores as assessed by the Venous Clinical Severity Score (VCSS; mean difference (MD) −1.75, 95% confidence interval (CI) −3.02 to −0.49; 3 studies, 671 participants; moderate-certainty evidence).\nBalneotherapy compared to no treatment may improve HRQoL as assessed by the Chronic Venous Insufficiency Quality of Life Questionnaire 2 (CIVIQ2) at three months, but we are very uncertain about the results (MD −10.46, 95% CI −19.21 to −1.71; 2 studies, 153 participants; very low-certainty evidence). The intervention may improve HRQoL at 12 months (MD −4.48, 95% CI −8.61 to −0.36; 2 studies, 417 participants; low-certainty evidence). It is unclear if the intervention has an effect at six months (MD −2.99, 95% CI −6.53 to 0.56; 2 studies, 436 participants; low-certainty evidence) or nine months (MD −6.40, 95% CI −13.84 to 1.04; 1 study, 59 participants; very low-certainty evidence).\nBalneotherapy compared with no treatment may have little or no effect on the occurrence of adverse effects. The main adverse effects were thromboembolic events (odds radio (OR) 0.35, 95% CI 0.09 to 1.42; 3 studies, 584 participants; low-certainty evidence), erysipelas (OR 2.58, 95% CI 0.65 to 10.22; 2 studies, 519 participants; low-certainty evidence) and palpitations (OR 0.33, 95% CI 0.01 to 8.52; 1 study, 59 participants; low-certainty evidence). No studies reported any serious adverse effects.\nBalneotherapy compared with no treatment may improve pain scores slightly at three months (MD −1.12, 95% CI −1.35 to −0.88; 2 studies, 354 participants; low-certainty evidence); and six months (MD −1.02, 95% CI −1.25 to −0.78; 2 studies, 352 participants; low-certainty evidence).\nBalneotherapy compared with no treatment may have little or no effect on oedema (measured by leg circumference) at 24 days to three months, but we are very uncertain about the results (standardised mean difference (SMD) 0.32 cm, 95% CI −0.70 to 1.34; 3 studies, 369 participants; very low-certainty evidence).\nBalneotherapy compared with no treatment may have little or no effect on the incidence of leg ulcers at 12 months, but we are very uncertain about the results (OR 1.06, 95% CI 0.27 to 4.14; 2 studies, 449 participants; very low-certainty evidence).\nBalneotherapy compared with no treatment may slightly reduce skin pigmentation changes as measured by the pigmentation index at 12 months (MD −3.60, 95% CI −5.95 to −1.25; 1 study, 59 participants; low-certainty evidence).\nBalneotherapy versus melilotus officinalis\nFor the comparison balneotherapy versus a phlebotonic drug (melilotus officinalis), there was little or no difference in pain symptoms (OR 0.29, 95% CI 0.03 to 2.87; 1 study, 35 participants; very low-certainty evidence) or oedema (OR 0.21, 95% CI 0.02 to 2.27; 1 study, 35 participants; very low-certainty evidence), but we are very uncertain about the results. The study reported no other outcomes of interest.\nBalneotherapy versus dryland exercise\nFor the comparison balneotherapy versus dryland exercise, evidence from one study showed that balneotherapy may improve HRQoL as assessed by the Varicose Vein Symptom Questionnaire (VVSymQ), but we are very uncertain about the results (MD −3.00, 95% CI −3.80 to −2.20; 34 participants, very low-certainty evidence). Balneotherapy compared with dryland exercises may reduce oedema (leg volume) after five sessions of treatment (right leg: MD −840.70, 95% CI −1053.26 to −628.14; left leg: MD −767.50, 95% CI −910.07 to −624.93; 1 study, 34 participants, low-certainty evidence). The study reported no other outcomes of interest.\nAuthors' conclusions\nFor the comparison balneotherapy versus no treatment, we identified moderate-certainty evidence that the intervention improves disease severity signs and symptoms scores slightly, low-certainty evidence that it improves pain and skin pigmentation changes, and very low-certainty evidence that it improves HRQoL. Balneotherapy compared with no treatment made little or no difference to adverse effects, oedema or incidence of leg ulcers. Evidence comparing balneotherapy with other interventions was very limited. To ensure adequate comparison between trials, future trials should standardise measurements of outcomes (e.g. disease severity signs and symptoms score, HRQoL, pain and oedema) and follow-up time points.\n\nGiven the provided abstract, please respond to the following query: \"How is chronic venous insufficiency treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is a wide variety of management options or therapies for chronic venous insufficiency, including compression (applying force), physiotherapy, medicine and surgery. Balneotherapy is one way to deliver physiotherapy to people with chronic venous insufficiency. Balneotherapy is a traditional medical technique that involves water and is usually practised in spas. It consists of immersion in thermal or mineral water or mud loaded with minerals. It may or may not include exercises."
}
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query-laysum | 3603 | [
{
"role": "user",
"content": "Abstract: Background\nWithout a phase of retention after successful orthodontic treatment, teeth tend to 'relapse', that is, to return to their initial position. Retention is achieved by fitting fixed or removable retainers to provide stability to the teeth while avoiding damage to teeth and gums. Removable retainers can be worn full- or part-time. Retainers vary in shape, material, and the way they are made. Adjunctive procedures are sometimes used to try to improve retention, for example, reshaping teeth where they contact ('interproximal reduction'), or cutting fibres around teeth ('percision').\nThis review is an update of one originally published in 2004 and last updated in 2016.\nObjectives\nTo evaluate the effects of different retainers and retention strategies used to stabilise tooth position after orthodontic braces.\nSearch methods\nAn information specialist searched Cochrane Oral Health Trials Register, CENTRAL, MEDLINE, Embase and OpenGrey up to 27 April 2022 and used additional search methods to identify published, unpublished and ongoing studies.\nSelection criteria\nRandomised controlled trials (RCTs) involving children and adults who had retainers fitted or adjunctive procedures undertaken to prevent relapse following orthodontic treatment with braces. We excluded studies with aligners.\nData collection and analysis\nTwo review authors independently screened eligible studies, assessed risk of bias and extracted data. Outcomes were stability or relapse of tooth position, retainer failure (i.e. broken, detached, worn out, ill-fitting or lost), adverse effects on teeth and gums (i.e. plaque, gingival and bleeding indices), and participant satisfaction. We calculated mean differences (MD) for continuous data, risk ratios (RR) or risk differences (RD) for dichotomous data, and hazard ratios (HR) for survival data, all with 95% confidence intervals (CI). We conducted meta-analyses when similar studies reported outcomes at the same time point; otherwise results were reported as mean ranges. We prioritised reporting of Little's Irregularity Index (crookedness of anterior teeth) to measure relapse, judging the minimum important difference to be 1 mm.\nMain results\nWe included 47 studies, with 4377 participants. The studies evaluated: removable versus fixed retainers (8 studies); different types of fixed retainers (22 studies) or bonding materials (3 studies); and different types of removable retainers (16 studies). Four studies evaluated more than one comparison. We judged 28 studies to have high risk of bias, 11 to have low risk, and eight studies as unclear.\nWe focused on 12-month follow-up.\nThe evidence is low or very low certainty. Most comparisons and outcomes were evaluated in only one study at high risk of bias, and most studies measured outcomes after less than a year.\nRemovable versus fixed retainers\nRemovable (part-time) versus fixed\nOne study reported that participants wearing clear plastic retainers part-time in the lower arch had more relapse than participants with multistrand fixed retainers, but the amount was not clinically significant (Little's Irregularity Index (LII) MD 0.92 mm, 95% CI 0.23 to 1.61; 56 participants). Removable retainers were more likely to cause discomfort (RR 12.22; 95% CI 1.69 to 88.52; 57 participants), but were associated with less retainer failure (RR 0.44, 95% CI 0.20 to 0.98; 57 participants) and better periodontal health (Gingival Index (GI) MD −0.34, 95% CI −0.66 to −0.02; 59 participants).\nRemovable (full-time) versus fixed\nOne study reported that removable clear plastic retainers worn full-time in the lower arch did not provide any clinically significant benefit for tooth stability over fixed retainers (LII MD 0.60 mm, 95% CI 0.17 to 1.03; 84 participants). Participants with clear plastic retainers had better periodontal health (gingival bleeding RR 0.53, 95% CI 0.31 to 0.88; 84 participants), but higher risk of retainer failure (RR 3.42, 95% CI 1.38 to 8.47; 77 participants). The study found no difference between retainers for caries.\nDifferent types of fixed retainers\nComputer-aided design/computer-aided manufacturing (CAD/CAM) nitinol versus conventional/analogue multistrand\nOne study reported that CAD/CAM nitinol fixed retainers were better for tooth stability, but the difference was not clinically significant (LII MD −0.46 mm, 95% CI −0.72 to −0.21; 66 participants). There was no evidence of a difference between retainers for periodontal health (GI MD 0.00, 95% CI -0.16 to 0.16; 2 studies, 107 participants), or retainer survival (RR 1.29, 95% CI 0.67 to 2.49; 1 study, 41 participants).\nFibre-reinforced composite versus conventional multistrand/spiral wire\nOne study reported that fibre-reinforced composite fixed retainers provided better stability than multistrand retainers, but this was not of a clinically significant amount (LII MD −0.70 mm, 95% CI −1.17 to −0.23; 52 participants). The fibre-reinforced retainers had better patient satisfaction with aesthetics (MD 1.49 cm on a visual analogue scale, 95% CI 0.76 to 2.22; 1 study, 32 participants), and similar retainer survival rates (RR 1.01, 95% CI 0.84 to 1.21; 7 studies; 1337 participants) at 12 months. However, failures occurred earlier (MD −1.48 months, 95% CI −1.88 to −1.08; 2 studies, 103 participants; 24-month follow-up) and more gingival inflammation at six months, though bleeding on probing (BoP) was similar (GI MD 0.59, 95% CI 0.13 to 1.05; BoP MD 0.33, 95% CI −0.13 to 0.79; 1 study, 40 participants).\nDifferent types of removable retainers\nClear plastic versus Hawley\nWhen worn in the lower arch for six months full-time and six months part-time, clear plastic provided similar stability to Hawley retainers (LII MD 0.01 mm, 95% CI −0.65 to 0.67; 1 study, 30 participants). Hawley retainers had lower risk of failure (RR 0.60, 95% CI 0.43 to 0.83; 1 study, 111 participants), but were less comfortable at six months (VAS MD -1.86 cm, 95% CI -2.19 to -1.53; 1 study, 86 participants).\nPart-time versus full-time wear of Hawley\nThere was no evidence of a difference in stability between part-time and full-time use of Hawley retainers (MD 0.20 mm, 95% CI −0.28 to 0.68; 1 study, 52 participants).\nAuthors' conclusions\nThe evidence is low to very low certainty, so we cannot draw firm conclusions about any one approach to retention over another. More high-quality studies are needed that measure tooth stability over at least two years, and measure how long retainers last, patient satisfaction and negative side effects from wearing retainers, such as tooth decay and gum disease.\n\nGiven the provided abstract, please respond to the following query: \"What is the problem?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Teeth can become crooked again after being straightened with orthodontic braces ('relapse'). Orthodontists try to prevent this using different ways of holding the teeth straight ('retention procedures'). Retention procedures can include wearing custom-made fixed or removable retainers, usually made of wires or clear plastic, after orthodontic braces have been removed. Removable retainers can be worn full- or part-time. Retainers fit over or around teeth, or stick onto the back of teeth. Orthodontists may also use extra treatments ('adjunctive procedures') such as smoothing contacts between the teeth ('interproximal enamel reduction'), or cutting fibres that connect the gum and the neck of the tooth ('pericision')."
}
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query-laysum | 3604 | [
{
"role": "user",
"content": "Abstract: Background\nThe liver is affected by two of the most common groups of malignant tumours: primary liver tumours and liver metastases from colorectal carcinoma or other extrahepatic primary cancers. Liver metastases are significantly more common than primary liver cancer, and the reported long-term survival rate after radical surgical treatment is approximately 50%. However, R0 resection (resection for cure) is not feasible in the majority of patients; therefore, other treatments have to be considered. One of these is percutaneous ethanol injection (PEI), which causes dehydration and necrosis of tumour cells, accompanied by small-vessel thrombosis, leading to tumour ischaemia and destruction of the tumour.\nObjectives\nTo assess the beneficial and harmful effects of percutaneous ethanol injection (PEI) compared with no intervention, other ablation methods, or systemic treatments in people with liver metastases.\nSearch methods\nWe searched the following databases up to 10 September 2019: the Cochrane Hepato-Biliary Group Controlled Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE Ovid; Embase Ovid; Science Citation Index Expanded; Conference Proceedings Citation Index – Science; Latin American Caribbean Health Sciences Literature (LILACS); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). We also searched clinical trials registers such as ClinicalTrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the US Food and Drug Administration (FDA) (17 September 2019).\nSelection criteria\nRandomised clinical trials assessing beneficial and harmful effects of percutaneous ethanol injection and its comparators (no intervention, other ablation methods, systemic treatments) for liver metastases.\nData collection and analysis\nWe followed standard methodological procedures as outlined by Cochrane. We extracted information on participant characteristics, interventions, study outcomes, study design, and trial methods. Two review authors performed data extraction and assessed risk of bias independently. We assessed the certainty of evidence by using GRADE. We resolved disagreements by discussion.\nMain results\nWe identified only one randomised clinical trial comparing percutaneous intratumour ethanol injection (PEI) in addition to transcatheter arterial chemoembolisation (TACE) versus TACE alone. The trial was conducted in China and included 48 trial participants with liver metastases: 25 received PEI plus TACE, and 23 received TACE alone. The trial included 37 male and 11 female participants. Mean participant age was 49.3 years. Sites of primary tumours included colon (27 cases), stomach (12 cases), pancreas (3 cases), lung (3 cases), breast (2 cases), and ovary (1 case). Seven participants had a single tumour, 15 had two tumours, and 26 had three or more tumours in the liver. The bulk diameter of the tumour on average was 3.9 cm, ranging from 1.2 cm to 7.6 cm.\nParticipants were followed for 10 months to 43 months. The trial reported survival data after one, two, and three years. In the PEI + TACE group, 92%, 80%, and 64% of participants survived after one year, two years, and three years; in the TACE alone group, these percentages were 78.3%, 65.2%, and 47.8%, respectively. Upon conversion of these data to mortality rates, the calculated risk ratio (RR) for mortality at last follow-up when PEI plus TACE was compared with TACE alone was 0.69 (95% confidence interval (CI) 0.36 to 1.33; very low-certainty evidence) after three years of follow-up. Local recurrence was 16% in the PEI plus TACE group and 39.1% in the TACE group, resulting in an RR of 0.41 (95% CI 0.15 to 1.15; very low-certainty evidence). Forty-five out of a total of 68 tumours (66.2%) shrunk by at least 25% in the PEI plus TACE group versus 31 out of a total of 64 tumours (48.4%) in the TACE group. Trial authors reported some adverse events but provided very few details. We did not find data on time to mortality, failure to clear liver metastases, recurrence of liver metastases, health-related quality of life, or time to progression of liver metastases.\nThe single included trial did not provide information on funding nor on conflict of interest.\nAuthors' conclusions\nEvidence for the effectiveness of PEI plus TACE versus TACE in people with liver metastases is of very low certainty and is based on one small randomised clinical trial at high risk of bias. Currently, it cannot be determined whether adding PEI to TACE makes a difference in comparison to using TACE alone. Evidence for benefits or harms of PEI compared with no intervention, other ablation methods, or systemic treatments is lacking.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We judged the evidence to be of very low certainty because the identified study was at high risk of bias, had a relatively small sample size, described few events overall, and reported inconclusive results."
}
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query-laysum | 3605 | [
{
"role": "user",
"content": "Abstract: Background\nTraumatic hyphema is the entry of blood into the anterior chamber, the space between the cornea and iris, following significant injury to the eye. Hyphema may be associated with significant complications that uncommonly cause permanent vision loss. Complications include elevated intraocular pressure, corneal blood staining, anterior and posterior synechiae, and optic nerve atrophy. People with sickle cell trait or disease may be particularly susceptible to increases in intraocular pressure and optic atrophy. Rebleeding is associated with an increase in the rate and severity of complications.\nObjectives\nTo assess the effectiveness of various medical interventions in the management of traumatic hyphema.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2022, Issue 3); MEDLINE Ovid; Embase.com; PubMed (1948 to March 2022); the ISRCTN registry; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). The last date of the search was 22 March 2022.\nSelection criteria\nTwo review authors independently assessed the titles and abstracts of all reports identified by the electronic and manual searches. We included randomized and quasi-randomized trials that compared various medical (non-surgical) interventions versus other medical interventions or control groups for the treatment of traumatic hyphema following closed-globe trauma. We applied no restrictions on age, gender, severity of the closed-globe trauma, or level of visual acuity at time of enrollment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and assessed the certainty of evidence using GRADE.\nMain results\nWe included 23 randomized and seven quasi-randomized studies with a total of 2969 participants. Interventions included antifibrinolytic agents (systemic and topical aminocaproic acid, tranexamic acid, and aminomethylbenzoic acid), corticosteroids (systemic and topical), cycloplegics, miotics, aspirin, conjugated estrogens, traditional Chinese medicine, monocular versus bilateral patching, elevation of the head, and bed rest.\nWe found no evidence of an effect on visual acuity for any intervention, whether measured within two weeks (short term) or for longer periods. In a meta-analysis of two trials, we found no evidence of an effect of aminocaproic acid on long-term visual acuity (RR 1.03, 95% confidence interval (CI) 0.82 to 1.29) or final visual acuity measured up to three years after the hyphema (RR 1.05, 95% CI 0.93 to 1.18). Oral tranexamic acid appeared to provide little to no benefit on visual acuity in four trials (RR 1.12, 95% CI 1.00 to 1.25). The remaining trials evaluated the effects of various interventions on short-term visual acuity; none of these interventions was measured in more than one trial. No intervention showed a statistically significant effect (RRs ranged from 0.75 to 1.10). Similarly, visual acuity measured for longer periods in four trials evaluating different interventions was also not statistically significant (RRs ranged from 0.82 to 1.02). The evidence supporting these findings was of low or very low certainty.\nSystemic aminocaproic acid reduced the rate of recurrent hemorrhage (RR 0.28, 95% CI 0.13 to 0.60), as assessed in six trials with 330 participants. A sensitivity analysis omitting two studies not using an intention-to-treat analysis reduced the strength of the evidence (RR 0.43, 95% CI 0.17 to 1.08). We obtained similar results for topical aminocaproic acid (RR 0.48, 95% CI 0.20 to 1.10) in two trials with 131 participants. We assessed the certainty of the evidence as low. Systemic tranexamic acid had a significant effect in reducing the rate of secondary hemorrhage (RR 0.33, 95% CI 0.21 to 0.53) in seven trials with 754 participants, as did aminomethylbenzoic acid (RR 0.10, 95% CI 0.02 to 0.41), as reported in one study. Evidence to support an associated reduction in risk of complications from secondary hemorrhage (i.e. corneal blood staining, peripheral anterior synechiae, elevated intraocular pressure, and development of optic atrophy) by antifibrinolytics was limited by the small number of these events. Use of aminocaproic acid was associated with increased nausea, vomiting, and other adverse events compared with placebo. We found no evidence of an effect on the number of adverse events with the use of systemic versus topical aminocaproic acid or with standard versus lower drug dose.\nThe number of days for the primary hyphema to resolve appeared to be longer with the use of systemic aminocaproic acid compared with no use, but this outcome was not altered by any other intervention.\nThe available evidence on usage of systemic or topical corticosteroids, cycloplegics, or aspirin in traumatic hyphema was limited due to the small numbers of participants and events in the trials.\nWe found no evidence of an effect between a single versus binocular patch on the risk of secondary hemorrhage or time to rebleed. We also found no evidence of an effect on the risk of secondary hemorrhage between ambulation and complete bed rest.\nAuthors' conclusions\nWe found no evidence of an effect on visual acuity of any of the interventions evaluated in this review. Although the evidence was limited, people with traumatic hyphema who receive aminocaproic acid or tranexamic acid are less likely to experience secondary hemorrhage. However, hyphema took longer to clear in people treated with systemic aminocaproic acid.\nThere is no good evidence to support the use of antifibrinolytic agents in the management of traumatic hyphema, other than possibly to reduce the rate of secondary hemorrhage. The potentially long-term deleterious effects of secondary hemorrhage are unknown. Similarly, there is no evidence to support the use of corticosteroids, cycloplegics, or non-drug interventions (such as patching, bed rest, or head elevation) in the management of traumatic hyphema. As these multiple interventions are rarely used in isolation, further research to assess the additive effect of these interventions might be of value.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 30 studies with a total of 2969 participants addressing our review question. Studies were conducted in the USA, Canada, Sweden, Denmark, China, South Africa, Malaysia, Iran, and Israel. The studies included more males than females, and participants tended to be children or young adults. Treatments included antifibrinolytic agents taken orally or applied directly to the eye (aminocaproic acid, tranexamic acid, and aminomethylbenzoic acid), oral or topical corticosteroids, other kinds of eye drops, aspirin, estrogens, traditional Chinese medicine, patching, elevation of the head, and bed rest. Most studies looked at how often fresh bleeding occurred, because this secondary bleeding is often associated with more complications. Other outcomes examined included visual acuity and the length of time it took for the blood in the eye to be absorbed."
}
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query-laysum | 3606 | [
{
"role": "user",
"content": "Abstract: Background\nLow-molecular-weight heparins (LMWHs) and heparinoids are anticoagulants that may have more powerful antithrombotic effects than standard unfractionated heparin (UFH) but a lower risk of bleeding complications. This is an update of the original Cochrane Review of these agents, first published in 2001 and last updated in 2008.\nObjectives\nTo determine whether antithrombotic therapy with LMWHs or heparinoids is associated with a reduction in the proportion of people who are dead or dependent for activities in daily living compared with UFH.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched February 2017), the Cochrane Central Register of Controlled Trials (CENTRAL: the Cochrane Library Issue 1, 2017), MEDLINE (1966 to February 2017), and Embase (1980 to February 2017). We also searched trials registers to February 2017: ClinicalTrials.gov, EU Clinical Trials Register, Stroke Trials Registry, ISRCTN Registry and the World Health Organization (WHO) International Clinical Trials Registry Platform.\nSelection criteria\nUnconfounded randomised trials comparing LMWH or heparinoids with standard UFH in people with acute ischaemic stroke, in which participants were recruited within 14 days of stroke onset.\nData collection and analysis\nTwo review authors independently chose studies for inclusion, assessed risk of bias and trial quality, extracted and analysed the data. Differences were resolved by discussion.\nMain results\nWe included nine trials involving 3137 participants. We did not identify any new trials for inclusion in this updated review. None of the studies reported data on the primary outcome in sufficient detail to enable analysis for the review. Overall, there was a moderate risk of bias in the included studies. Compared with UFH, there was no evidence of an effect of LMWH or heparinoids on death from all causes during the treatment period (96/1616 allocated LMWH/heparinoid versus 78/1486 allocated UFH; odds ratio (OR) 1.06, 95% CI 0.78 to 1.47; 8 trials, 3102 participants, low quality evidence). LMWH or heparinoid were associated with a significant reduction in deep vein thrombosis (DVT) compared with UFH (OR 0.55, 95% CI 0.44 to 0.70, 7 trials, 2585 participants, low quality evidence). However, the number of the major clinical events such as pulmonary embolism (PE) and intracranial haemorrhage was too small to provide a reliable estimate of the effects.\nAuthors' conclusions\nTreatment with a LMWH or heparinoid after acute ischaemic stroke appears to decrease the occurrence of DVT compared with standard UFH, but there are too few data to provide reliable information on their effects on other important outcomes, including functional outcome, death and intracranial haemorrhage.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We looked for randomised controlled trials in people with recent onset of stroke symptoms that compared LMWH or heparinoids with UFH."
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query-laysum | 3607 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple sclerosis (MS) is a chronic immune-mediated disease of the central nervous system, with an unpredictable course. Current MS therapies such as disease-modifying therapies focus on treating exacerbations, preventing new exacerbations and avoiding the progression of disability. Siponimod (BAF312) is an oral treatment, a selective sphingosine-1-phosphate (S1P) receptor modulator, for the treatment of adults with relapsing forms of MS including active, secondary progressive MS with relapses.\nObjectives\nTo assess the benefits and adverse effects of siponimod as monotherapy or combination therapy versus placebo or any active comparator for people diagnosed with MS.\nSearch methods\nWe searched the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Trials Register, which contains studies from CENTRAL, MEDLINE and Embase, and the trials registry databases ClinicalTrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) on 10 September 2021. We also handsearched relevant journals and screened the reference lists of published reviews and retrieved articles and searched reports (2004 to September 2021) from the MS societies in Europe and America.\nSelection criteria\nWe included randomised parallel controlled clinical trials (RCTs) that evaluated siponimod, as monotherapy or combination therapy, versus placebo or any active comparator in people with MS. There were no restrictions on dose or administration frequency.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We discussed disagreements and resolved them by consensus among the review authors. Our primary outcomes wereworsening disability , relapse and adverse events, and secondary outcomes were annualised relapse rate, gadolinium-enhancing lesions, new lesions or enlarged pre-existing lesions and mean change of brain volume. We independently evaluated the certainty of evidence using the GRADE approach. We contacted principal investigators of included studies for additional data or confirmation of data.\nMain results\nTwo studies (1948 participants) met our selection criteria, 608 controls and 1334 treated with siponimod. The included studies compared siponimod with placebo. Overall, all studies had a high risk of bias due to selective reporting and attrition bias.\nComparing siponimod administered at a dose of 2 mg to placebo, we found that siponimod may reduce the number of participants with disability progression at six months (56 fewer people per 1000; risk ratio (RR) 0.78, 95% confidence interval (CI) 0.65 to 0.94; 1 study, 1641 participants; low-certainty evidence) and annualised relapse rate (RR 0.43, 95% CI 0.34 to 0.56; 2 studies, 1739 participants; low-certainty evidence). But it might lead to little reduction in the number of participants with new relapse (166 fewer people per 1000; RR 0.38, 95% CI 0.15 to 1.00; 1 study, 94 participants; very low-certainty evidence). We observed no evidence of a difference due to adverse events for siponimod at 2 mg compared to placebo (14 more people per 1000; RR 1.52, 95% CI 0.85 to 2.71; 2 studies, 1739 participants, low-certainty evidence). In addition, due to the high risk of inaccurate magnetic resonance imaging (MRI) data in the two included studies, we could not combine data for active lesions on MRI scans. Both studies had high attrition bias resulting from the unbalanced reasons for dropouts among groups and high risk of bias due to conflicts of interest. Siponimod may reduce the number of gadolinium-enhancing T1-weighted lesions at two years of follow-up (RR 0.14, 95% CI 0.10 to 0.19; P < 0.0001; 1 study, 1641 participants; very low-certainty evidence). There may be no evidence of a difference between groups in the number of participants with at least one serious adverse event excluding relapses (113 more people per 1000; RR 1.80, 95% CI 0.37 to 8.77; 2 studies, 1739 participants; low-certainty evidence) at six months. No data were available regarding cardiac adverse events.\nIn terms of safety profile, the most common adverse events associated with siponimod were headache, back pain, bradycardia, dizziness, fatigue, influenza, urinary tract infection, lymphopenia, nausea, alanine amino transferase increase and upper respiratory tract infection. These adverse events have dose-related effects and rarely led to discontinuation of treatment.\nAuthors' conclusions\nBased on the findings of the RCTs included in this review, we are uncertain whether siponimod interventions are beneficial for people with MS. There was low-certainty evidence to support that siponimod at a dose of 2 mg orally once daily as monotherapy compared with placebo may reduce the annualised relapse rate and the number of participants who experienced disability worsening, at 6 months. However, the certainty of the evidence to support the benefit in reducing the number of people with a relapse is very low.\nThe risk of withdrawals due to adverse events requires careful monitoring of participants over time. The duration of all studies was less than 24 months, so the efficacy and safety of siponimod over 24 months are still uncertain, and further exploration is needed in the future. There is no high-certainty data available to evaluate the benefit on MRI outcomes. We assessed the certainty of the body of evidence for all outcomes was low to very low, downgraded due to serious study limitations, imprecision and indirectness. We are uncertain whether siponimod is beneficial for people with MS.\nMore new studies with robust methodology and longer follow-up are needed to evaluate the benefit of siponimod for the management of MS and to observe long-term adverse effects. Also, in addition to comparing with placebo, more new studies are needed to evaluate siponimod versus other therapeutic options.\n\nGiven the provided abstract, please respond to the following query: \"What is multiple sclerosis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Multiple sclerosis (MS) is a condition caused when the body’s immune system – which defends the body against disease and infection – mistakenly attacks parts of the central nervous system (the brain and spinal cord). Symptoms include problems with balance and walking, and blurred vision. MS is a lifelong condition that can cause serious disability. Some people’s symptoms may develop gradually. However, most people experience ‘attacks’ when new symptoms develop or existing symptoms worsen (called ‘relapse’), followed by periods with no changes to their symptoms (called ‘remittance’). This type of MS is called ‘relapsing remitting’ MS. Eventually, the course of their MS may change. These periods when there are no symptoms, or no worsening of symptoms, may stop and then symptoms may worsen continually. This is called ‘secondary progressive MS’."
}
]
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query-laysum | 3608 | [
{
"role": "user",
"content": "Abstract: Background\nOver the counter (OTC) artificial tears historically have been the first line of treatment for dry eye syndrome and dry eye-related conditions like contact lens discomfort, yet currently we know little regarding the overall efficacy of individual, commercially available artificial tears. This review provides a much needed meta-analytical look at all randomized and quasi-randomized clinical trials that have analyzed head-to-head comparisons of OTC artificial tears.\nObjectives\nTo evaluate the effectiveness and toxicity of OTC artificial tear applications in the treatment of dry eye syndrome compared with another class of OTC artificial tears, no treatment, or placebo.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 12), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to December 2015), EMBASE (January 1980 to December 2015), Latin American and Caribbean Health Sciences (LILACS) (January 1982 to December 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) and the US Food and Drugs Administration (FDA) website (www.fda.gov). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 4 December 2015. We searched reference lists of included trials for any additional trials not identified by the electronic searches.\nSelection criteria\nThis review includes randomized controlled trials with adult participants who were diagnosed with dry eye, regardless of race and gender. We included trials in which the age of participants was not reported, and clinical trials comparing OTC artificial tears with another class of OTC artificial tears, placebo, or no treatment. This review did not consider head-to-head comparisons of artificial tears with another type of dry-eye therapy.\nData collection and analysis\nWe followed the standard methodological procedures expected by Cochrane. Two authors independently screened the search results, reviewed full-text copies for eligibility, examined risk of bias, and extracted data. We performed meta-analysis for trials that compared similar interventions and reported comparable outcomes with sufficient data. We summarized all other included trial results in the text.\nMain results\nWe included 43 randomized controlled trials (3497 participants with dry eye). Due to the heterogeneity of study characteristics among the included trials with respect to types of diagnostic criteria, interventions, comparisons, and measurements taken, our ability to perform meta-analyses was limited. The review found that, in general, there was uncertainty whether different OTC artificial tears provide similar relief of signs and symptoms when compared with each other or placebo. Nevertheless, we found that 0.2% polyacrylic acid-based artificial tears were consistently more effective at treating dry eye symptoms than 1.4% polyvinyl alcohol-based artificial tears in two trials assessing this comparison (175 participants). All other included artificial tears produced contradictory between-group results or found no between-group differences. Our review also found that OTC artificial tears may be generally safe, but not without adverse events. Overall, we assessed the quality of evidence as low due to high risks of bias among included trials and poor reporting of outcome measures which were insufficient for quantitative analysis. Furthermore, we identified an additional 18 potentially eligible trials that were reported only in clinical trial registers with no associated results or publications. These trials reportedly enrolled 2079 total participants for whom no data are available. Such lack of reporting of trial results represents a high risk of publication bias.\nAuthors' conclusions\nOTC artificial tears may be safe and effective means for treating dry eye syndrome; the literature indicates that the majority of OTC artificial tears may have similar efficacies. This conclusion could be greatly skewed by the inconsistencies in study designs and inconsistencies in reporting trial results. Additional research is therefore needed before we can draw robust conclusions about the effectiveness of individual OTC artificial tear formulations.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The overall quality of the evidence was low for the various OTC artificial tear formulations compared in this review. This finding indicates that future published research may have an important impact on the conclusions currently provided in this review."
}
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query-laysum | 3609 | [
{
"role": "user",
"content": "Abstract: Background\nIllicit drug use in pregnancy is a complex social and public health problem. The consequences of drug use in pregnancy are high for both the woman and her child. Therefore, it is important to develop and evaluate effective treatments. There is evidence for the effectiveness of psychosocial interventions in drug treatment but it is unclear whether they are effective in pregnant women. This is an update of a Cochrane review originally published in 2007.\nObjectives\nTo evaluate the effectiveness of psychosocial interventions in pregnant women enrolled in illicit drug treatment programmes on birth and neonatal outcomes, on attendance and retention in treatment, as well as on maternal and neonatal drug abstinence. In short, do psychosocial interventions translate into less illicit drug use, greater abstinence, better birth outcomes, or greater clinic attendance?\nSearch methods\nWe conducted the original literature search in May 2006 and performed the search update up to January 2015. For both review stages (original and update), we searched the Cochrane Drugs and Alcohol Group Trial's register (May 2006 and January 2015); the Cochrane Central Register of Trials (CENTRAL; the Cochrane Library 2015, Issue 1); PubMed (1996 to January 2015); EMBASE (1996 to January 2015); and CINAHL (1982 to January 2015).\nSelection criteria\nWe included randomized controlled trials comparing any psychosocial intervention vs. a control intervention that could include pharmacological treatment, such as methadone maintenance, a different psychosocial intervention, counselling, prenatal care, STD counselling and testing, transportation, or childcare.\nData collection and analysis\nWe used standard methodological procedures expected by the Cochrane Collaboration. We performed analyses based on three comparisons: any psychosocial intervention vs. control, contingency management (CM) interventions vs. control, and motivational interviewing based (MIB) interventions vs. control.\nMain results\nIn total, we included 14 studies with 1298 participants: nine studies (704 participants) compared CM vs. control, and five studies (594 participants) compared MIB interventions vs. control. We did not find any studies that assessed other types of psychosocial interventions. For the most part, it was unclear if included studies adequately controlled for biases within their studies as such information was not often reported. We assessed risk of bias in the included studies relating to participant selection, allocation concealment, personnel and outcome assessor blinding, and attrition.\nThe included trials rarely captured maternal and neonatal outcomes. For studies that did measure such outcomes, no difference was observed in pre-term birth rates (RR 0.71, 95% confidence interval (CI) 0.34 to 1.51; three trials, 264 participants, moderate quality evidence), maternal toxicity at delivery (RR 1.18, 95% CI 0.52 to 2.65; two trials, 217 participants, moderate quality evidence), or low birth weight (RR 0.72, 95% CI 0.36 to 1.43; one trial, 160 participants, moderate quality evidence). However, the results did show that neonates remained in hospital for fewer days after delivery in CM intervention groups (RR -1.27, 95% CI -2.52 to -0.03; two trials, 103 participants, moderate quality evidence). There were no differences observed at the end of studies in retention or abstinence (as assessed by positive drug test at the end of treatment) in any psychosocial intervention group compared to control (Retention: RR 0.99, 95% CI 0.93 to 1.06, nine trials, 743 participants, low quality evidence; and Abstinence: RR 1.14, 95% CI 0.75 to 1.73, three trials, 367 participants, low quality evidence). These results held for both CM and MIB combined. Overall, the quality of the evidence was low to moderate.\nAuthors' conclusions\nThe present evidence suggests that there is no difference in treatment outcomes to address drug use in pregnant women with use of psychosocial interventions, when taken in the presence of other comprehensive care options. However, few studies evaluated obstetrical or neonatal outcomes and rarely did so in a systematic way, making it difficult to assess the effect of psychosocial interventions on these clinically important outcomes. It is important to develop a better evidence base to evaluate psychosocial modalities of treatment in this important population.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about the effect of psychosocial interventions, such as contingency management (CM) and motivational interviewing based (MIB) techniques vs. usual care for pregnant women in outpatient illicit drug treatment programmes."
}
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query-laysum | 3610 | [
{
"role": "user",
"content": "Abstract: Background\nPostoperative pain remains a significant issue with poor perioperative pain management associated with an increased risk of morbidity and mortality. Liposomal bupivacaine is an analgesic consisting of bupivacaine hydrochloride encapsulated within multiple, non-concentric lipid bi-layers offering a novel method of sustained release.\nObjectives\nTo assess the analgesic efficacy and adverse effects of liposomal bupivacaine infiltration peripheral nerve block for the management of postoperative pain.\nSearch methods\nWe identified randomised trials of liposomal bupivacaine peripheral nerve block for the management of postoperative pain. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 1), Ovid MEDLINE (1946 to January Week 1 2016), Ovid MEDLINE In-Process (14 January 2016), EMBASE (1974 to 13 January 2016), ISI Web of Science (1945 to 14 January 2016), and reference lists of retrieved articles. We sought unpublished studies from Internet sources, and searched clinical trials databases for ongoing trials. The date of the most recent search was 15 January 2016.\nSelection criteria\nRandomised, double-blind, placebo- or active-controlled clinical trials of a single dose of liposomal bupivacaine administered as a peripheral nerve block in adults aged 18 years or over undergoing elective surgery at any surgical site. We included trials if they had at least two comparison groups for liposomal bupivacaine peripheral nerve block compared with placebo or other types of analgesia.\nData collection and analysis\nTwo review authors independently considered trials for inclusion in the review, assessed risk of bias, and extracted data. We performed analyses using standard statistical techniques as described in the Cochrane Handbook for Systematic Reviews of Interventions, using Review Manager 5. We planned to perform a meta-analysis, however there were insufficient data to ensure a clinically meaningful answer; as such we have produced a 'Summary of findings' table in a narrative format, and where possible we assessed the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation).\nMain results\nWe identified seven studies that met inclusion criteria for this review. Three were recorded as completed (or terminated) but no results were published. Of the remaining four studies (299 participants): two investigated liposomal bupivacaine transversus abdominis plane (TAP) block, one liposomal bupivacaine dorsal penile nerve block, and one ankle block. The study investigating liposomal bupivacaine ankle block was a Phase II dose-escalating/de-escalating trial presenting pooled data that we could not use in our analysis.\nThe studies did not report our primary outcome, cumulative pain score between 0 and 72 hours, and secondary outcomes, mean pain score at 12, 24, 48, 72, or 96 hours. One study reported no difference in mean pain score during the first, second, and third postoperative 24-hour periods in participants receiving liposomal bupivacaine TAP block compared to no TAP block. Two studies, both in people undergoing laparoscopic surgery under TAP block, investigated cumulative postoperative opioid dose, reported opposing findings. One found a lower cumulative opioid consumption between 0 and 72 hours compared to bupivacaine hydrochloride TAP block and one found no difference during the first, second, and third postoperative 24-hour periods compared to no TAP block. No studies reported time to first postoperative opioid or percentage not requiring opioids over the initial 72 hours. No studies reported a health economic analysis or patient-reported outcome measures (outside of pain). The review authors sought data regarding adverse events but none were available, however there were no withdrawals reported to be due to adverse events.\nUsing GRADE, we considered the quality of evidence to be very low with any estimate of effect very uncertain and further research very likely to have an important impact on our confidence in the estimate of effect. All studies were at high risk of bias due to their small sample size (fewer than 50 participants per arm) leading to uncertainty around effect estimates. Additionally, inconsistency of results and sparseness of data resulted in further downgrading of the quality of the data.\nAuthors' conclusions\nA lack of evidence has prevented an assessment of the efficacy of liposomal bupivacaine administered as a peripheral nerve block. At present there is a lack of data to support or refute the use of liposomal bupivacaine administered as a peripheral nerve block for the management of postoperative pain. Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.\n\nGiven the provided abstract, please respond to the following query: \"Authors' conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is currently a lack of evidence around the use of liposomal bupivacaine as a nerve block to treat pain after surgery. Further large studies are required to see if there is a role for liposomal bupivacaine to treat pain after surgery."
}
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query-laysum | 3611 | [
{
"role": "user",
"content": "Abstract: Background\nPneumothorax occurs more frequently in the neonatal period than at any other time of life and is associated with increased mortality and morbidity. It can be treated with either aspiration with a syringe (using a needle or an angiocatheter) or a chest tube inserted in the anterior pleural space and then connected to a Heimlich valve or an underwater seal with continuous suction.\nObjectives\nTo compare the efficacy and safety of needle aspiration (either with immediate removal of the needle or with the needle left in situ) to intercostal tube drainage in the management of neonatal pneumothorax (PTX).\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 5), MEDLINE via PubMed (1966 to 4 June 2018), Embase (1980 to 4 June 2018), and CINAHL (1982 to 4 June 2018). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised controlled trials, quasi-randomised controlled trials and cluster trials comparing needle aspiration (either with the needle or angiocatheter left in situ or removed immediately after aspiration) to intercostal tube drainage in newborn infants with pneumothorax.\nData collection and analysis\nFor each of the included trials, two authors independently extracted data (e.g. number of participants, birth weight, gestational age, kind of needle and chest tube, choice of intercostal space, pressure and device for drainage) and assessed the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow-up). The primary outcomes considered in this review are mortality during the neonatal period and during hospitalisation.\nWe used the GRADE approach to assess the quality of evidence.\nMain results\nTwo randomised controlled trials (142 infants) met the inclusion criteria of this review. We found no differences in the rates of mortality when the needle was removed immediately after aspiration (risk ratio (RR) 3.92, 95% confidence interval (CI) 0.88 to 17.58; participants = 70; studies = 1) or left in situ (RR 1.50, 95% CI 0.27 to 8.45; participants = 72; studies = 1) or complications related to the procedure. With immediate removal of the needle following aspiration, 30% of the newborns did not require the placement of an intercostal tube drainage. None of the 36 newborns treated with needle aspiration with the angiocatheter left in situ required the placement of an intercostal tube drainage. Overall, the quality of the evidence supporting this finding is very low.\nAuthors' conclusions\nThere is insufficient evidence to establish the efficacy and safety of needle aspiration and intercostal tube drainage in the management of neonatal pneumothorax. The two included trials showed no differences in mortality; however the information size is low. Needle aspiration reduces the need for intercostal tube drainage placement. Limited or no evidence is available on other clinically relevant 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"
},
{
"role": "assistant",
"content": "Pneumothorax is the presence of air in the pleural space (the space between the lung and the chest wall). It is a serious condition in the newborn and may be treated by needle aspiration or chest tube placement. The former is less invasive and might avoid the need for the insertion of a chest tube, thus reducing the duration of hospital stay. However the failure of needle aspiration might subsequently lead to the need for chest tube insertion, an additional invasive procedure. This systematic review evaluates the available evidence on the effectiveness of these two techniques in treating pneumothorax in neonates."
}
]
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query-laysum | 3612 | [
{
"role": "user",
"content": "Abstract: Background\nColchicine is an anti-inflammatory drug that is used for a wide range of inflammatory diseases. Cardiovascular disease also has an inflammatory component but the effects of colchicine on cardiovascular outcomes remain unclear. Previous safety analyses were restricted to specific patient populations.\nObjectives\nTo evaluate potential cardiovascular benefits and harms of a continuous long-term treatment with colchicine in any population, and specifically in people with high cardiovascular risk.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ClinicalTrials.gov, WHO International Clinical Trials Registry, citations of key papers, and study references in January 2015. We also contacted investigators to gain unpublished data.\nSelection criteria\nRandomised controlled trials (parallel-group or cluster design or first phases of cross-over studies) comparing colchicine over at least six months versus any control in any adult population.\nData collection and analysis\nPrimary outcomes were all-cause mortality, myocardial infarction, and adverse events. Secondary outcomes were cardiovascular mortality, stroke, heart failure, non-scheduled hospitalisations, and non-scheduled cardiovascular interventions. We conducted predefined subgroup analyses, in particular for participants with high cardiovascular risk. .\nMain results\nWe included 39 randomised parallel-group trials with 4992 participants. Colchicine had no effect on all-cause mortality (RR 0.94, 95% CI 0.82 to 1.09; participants = 4174; studies = 30; I² = 27%; moderate quality of evidence). There is uncertainty surrounding the effect of colchicine in reducing cardiovascular mortality (RR 0.34, 95% CI 0.09 to 1.21, I² = 9%; participants = 1132; studies = 7; moderate quality of evidence). Colchicine reduced the risk for total myocardial infarction (RR 0.20, 95% CI 0.07 to 0.57; participants = 652; studies = 2; moderate quality of evidence). There was no effect on total adverse events (RR 1.52, 95% CI 0.93 to 2.46; participants = 1313; studies = 11; I² = 45%; very low quality of evidence) but gastrointestinal intolerance was increased (RR 1.83, 95% CI 1.03 to 3.26; participants = 1258; studies = 11; I² = 74%; low quality of evidence). Colchicine showed no effect on heart failure (RR 0.62, 95% CI 0.10 to 3.88; participants = 462; studies = 3; I² = 45%; low quality of evidence) and no effect on stroke (RR 0.38, 95% CI 0.09 to 1.70; participants = 874; studies = 3; I² = 45%; low quality of evidence). Reporting of serious adverse events was inconsistent; no event occurred over 824 patient-years (4 trials). Effects on other outcomes were very uncertain. Summary effects of RCTs specifically focusing on participants with high cardiovascular risk were similar (4 trials; 1230 participants).\nAuthors' conclusions\nThere is much uncertainty surrounding the benefits and harms of colchicine treatment. Colchicine may have substantial benefits in reducing myocardial infarction in selected high-risk populations but uncertainty about the size of the effect on survival and other cardiovascular outcomes is high, especially in the general population from which most of the studies in our review were drawn. Colchicine is associated with gastrointestinal side effects based on low-quality evidence. More evidence from large-scale randomised trials is 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": "We included 39 trials with 4992 participants in our analyses. Four trials included 1230 participants in total with heart disease. Colchicine treatment had no effect on death from any cause. There is uncertainty around the effect of colchicine on cardiovascular (heart-related) death. Results showed that cardiovascular death may be reduced, but this was not clear because some of our analyses showed a reduced risk while others did not. The risk for myocardial infarctions (heart attacks) was reduced, but this finding was based on only two studies and a total of 22 events. Colchicine did not clearly increase the risk of total harms but colchicine increased the risk for gastrointestinal intolerance, which was typically described as mild and short-lived. We found no clear effects on strokes, heart failure, emergency hospitalisations or unplanned invasive cardiac treatments.\nFour of the 39 studies reported that they systematically looked for serious side effects linked to use of colchicine. Serious side effects can be life-threatening or require hospitalisation. No participant in these four studies was reported to have such a serious side effect. This means that possible serious side effects seem to be relatively rare: for example, the results indicate that among 800 people who are treated for one year, none would suffer a serious side effect. However, we have some concerns about the certainty of this result, because the reporting of serious harms in the studies was not ideal; for example, because the definitions of serious adverse events differed between studies, and it was not always clear what would be considered a serious adverse event. We found no difference in effects of colchicine in people at high cardiovascular risk.\nThe evidence is current to January 2015."
}
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query-laysum | 3613 | [
{
"role": "user",
"content": "Abstract: Background\nComplex regional pain syndrome (CRPS) is a painful and disabling condition that usually manifests in response to trauma or surgery and is associated with significant pain and disability. CRPS can be classified into two types: type I (CRPS I) in which a specific nerve lesion has not been identified and type II (CRPS II) where there is an identifiable nerve lesion. Guidelines recommend the inclusion of a variety of physiotherapy interventions as part of the multimodal treatment of people with CRPS. This is the first update of the review originally published in Issue 2, 2016.\nObjectives\nTo determine the effectiveness of physiotherapy interventions for treating pain and disability associated with CRPS types I and II in adults.\nSearch methods\nFor this update we searched CENTRAL (the Cochrane Library), MEDLINE, Embase, CINAHL, PsycINFO, LILACS, PEDro, Web of Science, DARE and Health Technology Assessments from February 2015 to July 2021 without language restrictions, we searched the reference lists of included studies and we contacted an expert in the field. We also searched additional online sources for unpublished trials and trials in progress.\nSelection criteria\nWe included randomised controlled trials (RCTs) of physiotherapy interventions compared with placebo, no treatment, another intervention or usual care, or other physiotherapy interventions in adults with CRPS I and II. Primary outcomes were pain intensity and disability. Secondary outcomes were composite scores for CRPS symptoms, health-related quality of life (HRQoL), patient global impression of change (PGIC) scales and adverse effects.\nData collection and analysis\nTwo review authors independently screened database searches for eligibility, extracted data, evaluated risk of bias and assessed the certainty of evidence using the GRADE system.\nMain results\nWe included 16 new trials (600 participants) along with the 18 trials from the original review totalling 34 RCTs (1339 participants). Thirty-three trials included participants with CRPS I and one trial included participants with CRPS II. Included trials compared a diverse range of interventions including physical rehabilitation, electrotherapy modalities, cortically directed rehabilitation, electroacupuncture and exposure-based approaches. Most interventions were tested in small, single trials. Most were at high risk of bias overall (27 trials) and the remainder were at 'unclear' risk of bias (seven trials). For all comparisons and outcomes where we found evidence, we graded the certainty of the evidence as very low, downgraded due to serious study limitations, imprecision and inconsistency. Included trials rarely reported adverse effects.\nPhysiotherapy compared with minimal care for adults with CRPS I\nOne trial (135 participants) of multimodal physiotherapy, for which pain data were unavailable, found no between-group differences in pain intensity at 12-month follow-up. Multimodal physiotherapy demonstrated a small between-group improvement in disability at 12 months follow-up compared to an attention control (Impairment Level Sum score, 5 to 50 scale; mean difference (MD) -3.7, 95% confidence interval (CI) -7.13 to -0.27) (very low-certainty evidence). Equivalent data for pain were not available. Details regarding adverse events were not reported.\nPhysiotherapy compared with minimal care for adults with CRPS II\nWe did not find any trials of physiotherapy compared with minimal care for adults with CRPS II.\nAuthors' conclusions\nThe evidence is very uncertain about the effects of physiotherapy interventions on pain and disability in CRPS. This conclusion is similar to our 2016 review. Large-scale, high-quality RCTs with longer-term follow-up are required to test the effectiveness of physiotherapy-based interventions for treating pain and disability in adults with CRPS I and II.\n\nGiven the provided abstract, please respond to the following query: \"Treating pain and disability in adults with complex regional pain syndrome\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Complex regional pain syndrome is a painful and disabling condition that can occur after trauma or surgery and is associated with significant pain and disability. CRPS can be classified into two types: type I (CRPS I) in which a specific nerve injury has not been identified and type II (CRPS II) where there is an identifiable nerve injury. Guidelines recommend that physiotherapy rehabilitation should be included as part of the treatment for CRPS. Physiotherapy for CRPS could include a range of treatments and rehabilitation approaches, such as exercise, pain management, manual therapy, electrotherapy or advice and education, either used alone or in combination. Physiotherapy is recommended because it is thought that it may improve the pain and disability associated with CRPS."
}
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query-laysum | 3614 | [
{
"role": "user",
"content": "Abstract: Background\nManagement of breech presentation is controversial, particularly in regard to manipulation of the position of the fetus by external cephalic version (ECV). ECV may reduce the number of breech presentations and caesarean sections, but there also have been reports of complications with the procedure.\nObjectives\nThe objective of this review was to assess the effects of ECV at or near term on measures of pregnancy outcome. Methods of facilitating ECV, and ECV before term are reviewed separately.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Trials Register (28 February 2015) and reference lists of retrieved studies.\nSelection criteria\nRandomised trials of ECV at or near term (with or without tocolysis) compared with no attempt at ECV in women with breech presentation.\nData collection and analysis\nTwo review authors assessed eligibility and trial quality, and extracted the data.\nMain results\nWe included eight studies, with a total of 1308 women randomised. The pooled data from these studies show a statistically significant and clinically meaningful reduction in non-cephalic presentation at birth (average risk ratio (RR) 0.42, 95% confidence interval (CI) 0.29 to 0.61, eight trials, 1305 women); vaginal cephalic birth not achieved (average RR 0.46, 95% CI 0.33 to 0.62, seven trials, 1253 women, evidence graded very low); and caesarean section (average RR 0.57, 95% CI 0.40 to 0.82, eight trials, 1305 women, evidence graded very low) when ECV was attempted in comparison to no ECV attempted. There were no significant differences in the incidence of Apgar score ratings below seven at one minute (average RR 0.67, 95% CI 0.32 to 1.37, three trials, 168 infants) or five minutes (RR 0.63, 95% CI 0.29 to 1.36, five trials, 428 infants, evidence graded very low), low umbilical vein pH levels (RR 0.65, 95% CI 0.17 to 2.44, one trial, 52 infants, evidence graded very low), neonatal admission (RR 0.80, 95% CI 0.48 to 1.34, four trials, 368 infants, evidence graded very low), perinatal death (RR 0.39, 95% CI 0.09 to 1.64, eight trials, 1305 infants, evidence graded low), nor time from enrolment to delivery (mean difference -0.25 days, 95% CI -2.81 to 2.31, two trials, 256 women).\nAll of the trials included in this review had design limitations, and the level of evidence was graded low or very low. No studies attempted to blind the intervention, and the process of random allocation was suboptimal in several studies. Three of the eight trials had serious design limitations, however excluding these studies in a sensitivity analysis for outcomes with substantial heterogeneity did not alter the results.\nAuthors' conclusions\nAttempting cephalic version at term reduces the chance of non-cephalic presentation at birth, vaginal cephalic birth not achieved and caesarean section. There is not enough evidence from randomised trials to assess complications of ECV at term. Large observational studies suggest that complications are rare.\nA visual summary of some of the results from this review can be found here.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 8 studies involving 1308 women. (We included studies up to 28 February 2015.) All the studies were randomised and involved women with low-risk pregnancies. Using ECV around 36 weeks or more increased the chance that babies were born head-first and reduced the risk of having a caesarean section. There were no clear differences in other outcomes such as the risk of babies dying. The quality of the studies and therefore the strength of the evidence was varied."
}
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query-laysum | 3615 | [
{
"role": "user",
"content": "Abstract: Background\nThe partograph (sometimes known as partogram) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partograph is to provide a pictorial overview of labour, and to alert midwives and obstetricians to deviations in maternal or fetal well-being and labour progress. Charts have traditionally contained pre-printed alert and action lines. An alert line, which is based on the slowest 10% of primigravid women's labours, signifies slow progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour.\nThis review is an update of a review last published in 2013.\nObjectives\nThe primary objective was to determine the effectiveness and safety of partograph use on perinatal and maternal morbidity and mortality. The secondary objective was to determine which partograph design is most effective for perinatal and maternal morbidity and mortality outcomes.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (31 August 2017) and reference lists of retrieved studies.\nSelection criteria\nRandomised, cluster-randomised, and quasi-randomised controlled trials involving a comparison of partograph use with no partograph, or comparison between different partograph designs.\nData collection and analysis\nThree review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining review authors assessed the studies independently. We assessed the evidence using the GRADE approach.\nMain results\nWe have included 11 studies, involving 9475 women in this review; three studies assessed partograph use versus no partograph, seven assessed different partograph designs, and one assessed partograph use versus labour scale. Risk of bias varied in all studies. It was infeasible to blind staff or women to the intervention. Two studies did not adequately conceal allocation. Loss to follow-up was low in all studies. We assessed the evidence for partograph use versus no partograph using the GRADE approach; downgrading decisions were due to study design, inconsistency, indirectness, and imprecision of effect estimates.\nMost trials reported caesarean section rates and Apgar scores less than 7 at five minutes; all other outcomes were not consistently reported (e.g. duration of first stage of labour and maternal experience of childbirth).\nPartograph versus no partograph (3 trials, 1813 women)\nIt is uncertain whether there is any clear difference between partograph use and no partograph in caesarean section rates (average risk ratio (RR) 0.77, 95% confidence interval (CI) 0.40 to 1.46; n = 1813; 3 trials; I² = 87%; very low-quality evidence); oxytocin augmentation (RR 1.02, 95% CI 0.95 to 1.10; n = 1156; 1 trial; moderate-quality evidence); duration of first stage of labour (mean difference (MD) 0.80 hours, 95% CI -0.06 to 1.66; n = 1156; 1 trial; low-quality evidence); or Apgar score less than 7 at five minutes (RR 0.76, 95% CI 0.29 to 2.03; n = 1596; 2 trials; I² = 87%; very low-quality evidence).\nPartograph with different placement of action lines (4 trials, 5051 women)\nWhen compared to a four-hour action line, women in the two-hour action line group were more likely to receive oxytocin augmentation (average RR 2.44, 95% CI 1.36 to 4.35; n = 4749; 4 trials; I² = 96%). There was no clear difference in caesarean section rates (RR 1.06, 95% CI 0.88 to 1.28; n = 4749; 4 trials); duration of first stage of labour (RR 0.81 hours, 95% CI 0.32 to 2.04; n = 948; 1 trial); maternal experience of childbirth (average RR 0.61, 95% CI 0.28 to 1.35; n = 2269; 2 trials; I² = 83%); or Apgar score less than 7 at five minutes (RR 0.93, 95% CI 0.61 to 1.42; n = 4749; 4 trials) between the two- and four-hour action line.\nThe following comparisons only include data from single studies. Fewer women reported negative childbirth experiences in the two-hour action line group compared to the three-hour action line group (RR 0.49, 95% CI 0.27 to 0.90; n = 348; 1 trial). When we compared the three- and four-hour action line groups, the caesarean section rate was higher in the three-hour action line group (RR 1.70, 95% CI 1.07 to 2.70; n = 613; 1 trial). We did not observe any clear differences in any of the other outcomes in these comparisons.\nPartograph with alert line only versus partograph with alert and action line (1 trial, 694 women)\nThe caesarean section rate was lower in the alert line only group (RR 0.68, 95% CI 0.50 to 0.93). There were no clear differences between groups for oxytocin augmentation, low Apgar score, instrumental vaginal birth and perinatal death.\nPartograph with latent phase (composite) versus partograph without latent phase (modified) (1 trial, 743 women)\nThe caesarean section and oxytocin augmentation rates were higher in the partograph with a latent phase (RR 2.45, 95% CI 1.72 to 3.50; and RR 2.18, 95% CI 1.67 to 2.83, respectively). There were no clear differences between groups for oxytocin augmentation, and Apgar score less than 7 at five minutes.\nPartograph with two-hour action line versus partograph with stepped dystocia line (1 trial, 99 women)\nFewer women received oxytocin augmentation in the dystocia line group (RR 0.62, 95% CI 0.39 to 0.98). We did not observe any clear differences in any of the other primary outcomes in this comparison.\nPartograph versus labour scale (1 trial, 122 women)\nThe use of the partograph compared with the labour scale resulted in fewer women receiving oxytocin augmentation (RR 0.32, 95% CI 0.18 to 0.54), but did not produce any clear differences for any of the other primary outcomes.\nAuthors' conclusions\nOn the basis of the findings of this review, we cannot be certain of the effects of routine use of the partograph as part of standard labour management and care, or which design, if any, are most effective. Further trial evidence is required to establish the efficacy of partograph use per se and its optimum design.\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": "On the basis of the findings of this review, we cannot be certain of the effects of routine use of the partograph as part of standard labour care, or of the different partograph designs. Further trial evidence is required to establish the efficacy of partograph use per se and its optimum design."
}
]
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query-laysum | 3616 | [
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease (SCD), one of the most common inherited disorders, is associated with vaso-occlusive pain episodes and haemolysis leading to recurrent morbidity, hospital admissions and work or school absenteeism. The crises are conventionally treated with opioids, non-opioids and other adjuvants with the risk of developing complications, addictions and drug-seeking behaviour. Different non-pharmacological treatments, such as transcutaneous electrical nerve stimulation (TENS) have been used for managing pain in other painful conditions. Hence, the efficacy of TENS for managing pain in SCD needs to be reviewed.\nObjectives\nTo assess the benefits and harms of TENS for managing pain in people with SCD who experience pain crises or chronic pain (or both).\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Register, comprising of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched online trial registries and the reference lists of relevant articles and reviews.\nDate of the last search: 26 Febraury 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs, where TENS was evaluated for managing pain in people with SCD.\nData collection and analysis\nTwo review authors independently assessed the eligibility of the trials identified by the literature searches according to the inclusion criteria. Two review authors then independently extracted data, assessed for risk of bias using the Cochrane standard tool and rated the quality of evidence using the GRADE guidelines.\nMain results\nOne double-blind cross-over RCT with 22 participants with SCD (aged 12 to 27 years) was eligible for inclusion. Following stratification into four pain crises severity grades, participants were then randomised to receive TENS or placebo (sham TENS). The trial was concluded after 60 treatment episodes (30 treatment episodes of each treatment group).\nThere is a lack of clarity regarding the trial design and the analysis of the cross-over data. If a participant was allocated to TENS treatment for an episode of pain and subsequently returned with a further episode of a similar degree of pain, they would then receive the sham TENS treatment (cross-over design). For those experiencing a pain episode of a different severity, it is not clear whether they were re-randomised or given the alternate treatment. Reporting and analysis was based on the total number pain events and not on the number of participants. It is unclear how many participants were crossed over from the TENS group to the sham TENS group and vice versa. The trial had a high risk of bias regarding random sequence generation and allocation concealment; an unclear risk regarding the blinding of participants and personnel; and a low risk regarding the blinding of the outcome assessors and selective outcome reporting.\nThe trial was small and of very low quality; furthermore, given the issue with trial design we were unable to quantitatively analyse the data. Therefore, we present only a narrative summary and caution is advised in interpreting the results. In relation to our pre-defined primary outcomes, the included trial did not report pain relief at two to four weeks post intervention. The trial authors reported that no difference was found in the changes in pain ratings (recorded at one hour and four hours post intervention) between the TENS and the placebo groups. In relation to our secondary outcomes, the analgesic usage during the trial also did not show any difference between groups. Given the quality of the evidence, we are uncertain whether TENS improves overall satisfaction as compared to sham TENS. The ability to cope with activities of daily living was not evaluated. Regarding adverse events, although one case of itching was reported in the TENS group, the site and nature of itching was not clearly stated; hence it cannot be clearly attributed to TENS. Also, two participants receiving 'sham' TENS reported a worsening of pain with the intervention.\nAuthors' conclusions\nSince we have only included one small and very low-quality trial, with a high risk of bias across several domains, we are unable to conclude whether TENS is harmful or beneficial for managing pain in people with SCD. There is a need for a well-designed, adequately-powered, RCT to evaluate the role of TENS in managing pain in people with SCD.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "30 episodes (across 22 participants) of TENS treatment and 30 of 'sham' TENS treatment were analysed. Due to low-quality data and issues with the trial design, we can only report in a descriptive way without any formal analysis. Caution should be used in interpreting these results. In the included trial no difference was found in the rating of pain on a scale of 1 to 10 at the end of one hour and four hours between the TENS and 'sham' TENS treatment groups. There was no difference between groups as to how much pain medication was used. Given the very low quality of the evidence, we are also uncertain whether TENS improves overall satisfaction as compared to 'sham' TENS. A minor adverse effect of itching was reported by only one person receiving TENS, whereas two people receiving 'sham' TENS reported a worsening of pain with the intervention. Since there is only one included trial with very low-quality evidence, we cannot state whether TENS makes any difference to managing pain in people with SCD."
}
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query-laysum | 3617 | [
{
"role": "user",
"content": "Abstract: Background\nTraditionally, laparoscopic cholecystectomy is performed using two 10-mm ports and two 5-mm ports. Recently, a reduction in the number of ports has been suggested as a modification of the standard technique with a view to decreasing pain and improving cosmesis. The safety and effectiveness of using fewer-than-four ports has not yet been established.\nObjectives\nTo assess the benefits (such as improvement in cosmesis and earlier return to activity) and harms (such as increased complications) of using fewer-than-four ports (fewer-than-four-ports laparoscopic cholecystectomy) versus four ports in people undergoing laparoscopic cholecystectomy for any reason (symptomatic gallstones, acalculous cholecystitis, gallbladder polyp, or any other condition).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2013), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization International Clinical Trials Registry Platform portal to September 2013.\nSelection criteria\nWe included all randomised clinical trials comparing fewer-than-four ports versus four ports, that is, with standard laparoscopic cholecystectomy that is performed with two ports of at least 10-mm incision and two ports of at least 5-mm incision.\nData collection and analysis\nTwo review authors independently identified the trials and extracted the data. We analysed the data using both the fixed-effect and the random-effects models. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) based on intention-to-treat analysis, whenever possible.\nMain results\nWe found nine trials with 855 participants that randomised participants to fewer-than-four-ports laparoscopic cholecystectomy (n = 427) versus four-port laparoscopic cholecystectomy (n = 428). Most trials included low anaesthetic risk participants undergoing elective laparoscopic cholecystectomy. Seven of the nine trials used a single port laparoscopic cholecystectomy and the remaining two trials used three-port laparoscopic cholecystectomy as the experimental intervention. Only one trial including 70 participants had low risk of bias. Fewer-than-four-ports laparoscopic cholecystectomy could be completed successfully in more than 90% of participants in most trials. The remaining participants were mostly converted to four-port laparoscopic cholecystectomy but some participants had to undergo open cholecystectomy.\nThere was no mortality in either group in the seven trials that reported mortality (318 participants in fewer-than-four-ports laparoscopic cholecystectomy group and 316 participants in four-port laparoscopic cholecystectomy group). The proportion of participants with serious adverse events was low in both treatment groups and the estimated RR was compatible with a reduction and substantial increased risk with the fewer-than-four-ports group (6/318 (1.9%)) and four-port laparoscopic cholecystectomy group (0/316 (0%)) (RR 3.93; 95% CI 0.86 to 18.04; 7 trials; 634 participants; very low quality evidence). The estimated difference in the quality of life (measured between 10 and 30 days) was imprecise (standardised mean difference (SMD) 0.18; 95% CI -0.05 to 0.42; 4 trials; 510 participants; very low quality evidence), as was the proportion of participants in whom the laparoscopic cholecystectomy had to be converted to open cholecystectomy between the groups (fewer-than-four ports 3/289 (adjusted proportion 1.2%) versus four port: 5/292 (1.7%); RR 0.68; 95% CI 0.19 to 2.35; 5 trials; 581 participants; very low quality evidence). The fewer-than-four-ports laparoscopic cholecystectomy took 14 minutes longer to complete (MD 14.44 minutes; 95% CI 5.95 to 22.93; 9 trials; 855 participants; very low quality evidence). There was no clear difference in hospital stay between the groups (MD -0.01 days; 95% CI -0.28 to 0.26; 6 trials; 731 participants) or in the proportion of participants discharged as day surgery (RR 0.92; 95% CI 0.70 to 1.22; 1 trial; 50 participants; very low quality evidence) between the two groups. The times taken to return to normal activity and work were shorter by two days in the fewer-than-four-ports group compared with four-port laparoscopic cholecystectomy (return to normal activity: MD -1.20 days; 95% CI -1.58 to -0.81; 2 trials; 325 participants; very low quality evidence; return to work: MD -2.00 days; 95% CI -3.31 to -0.69; 1 trial; 150 participants; very low quality evidence). There was no significant difference in cosmesis scores at 6 to 12 months between the two groups (SMD 0.37; 95% CI -0.10 to 0.84; 2 trials; 317 participants; very low quality evidence).\nAuthors' conclusions\nThere is very low quality evidence that is insufficient to determine whether there is any significant clinical benefit in using fewer-than-four-ports laparoscopic cholecystectomy compared with four-port laparoscopic cholecystectomy. The safety profile of using fewer-than-four ports is yet to be established and fewer-than-four-ports laparoscopic cholecystectomy should be reserved for well-designed randomised clinical trials.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most of the trials were of high risk of bias, that is, there is possibility of arriving at wrong conclusions because of the way that the trial was conducted. The overall quality of evidence was very low."
}
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query-laysum | 3618 | [
{
"role": "user",
"content": "Abstract: Background\nDiffuse large B-cell lymphoma (DLBCL) is an aggressive cancer of the lymphatic system. About 30% to 40% of people with DLBCL experience relapse and 10% are refractory to first-line treatment usually consisting of R-CHOP chemotherapy. Of those eligible for second-line treatment, commonly consisting of salvage chemotherapy followed by autologous stem-cell transplantation (ASCT), around 50% experience relapse. With a median overall survival of less than six to 12 months, the prognosis of individuals who relapse or are refractory (r/r) to advanced lines of treatment or of those who are ineligible for ASCT, is very poor. With the introduction of chimeric antigen receptor (CAR) T-cell therapy, a novel treatment option for these people is available.\nObjectives\nTo assess the benefits and harms of chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory (r/r) DLBCL.\nSearch methods\nAn experienced information specialist performed a systematic database search for relevant articles on CENTRAL, MEDLINE and Embase until September 11th, 2020. We also searched trial registries and reference lists of identified studies up to this date. All search results were screened by two authors independently and a third author was involved in case of discrepancies.\nSelection criteria\nWe included prospectively planned trials evaluating CAR T-cell therapy for people with r/r DLBCL. We had planned to include randomised controlled trials (RCTs) and we flexibly adapted eligibility criteria to the most reliable study designs available. We excluded studies involving fewer than 10 participants with r/r DLBCL and studies with a proportion of participants with r/r DLBCL below 70%, unless data were reported separately for this subgroup.\nData collection and analysis\nTwo review authors extracted data and performed risk of bias ratings independently. A third author was involved in case of disagreements. As our search did not yield any completed RCTs, prospective controlled non-randomised studies of interventions (NRSIs) or prospective observational studies with a control group, we did not meta-analyse data and reported all results narratively. We adopted the GRADE approach to assess the certainty of the evidence for prioritised outcomes.\nMain results\nWe identified 13 eligible uncontrolled studies evaluating a single or multiple arms of CAR T-cell therapies. We also identified 38 ongoing studies, including three RCTs. Ten studies are awaiting classification due to completion with no retrievable results data or insufficient data to justify inclusion. The mean number of participants enrolled, treated with CAR T-cell therapy and evaluated in the included studies were 79 (range 12 to 344; data unavailable for two studies), 61 (range 12 to 294; data unavailable for one study) and 52 (range 11 to 256), respectively.\nMost studies included people with r/r DLBCL among people with other haematological B-cell malignancies. Participants had received at least a median of three prior treatment lines (data unavailable for four studies), 5% to 50% had undergone ASCT (data unavailable for five studies) and, except for two studies, 3% to 18% had undergone allogenic stem-cell transplantation (data unavailable for eight studies).\nThe overall risk of bias was high for all studies, in particular, due to incomplete follow-up and the absence of blinding. None of the included studies had a control group so that no adequate comparative effect measures could be calculated. The duration of follow-up varied substantially between studies, in particular, for harms. Our certainty in the evidence is very low for all outcomes.\nOverall survival was reported by eight studies (567 participants). Four studies reported survival rates at 12 months which ranged between 48% and 59%, and one study reported an overall survival rate of 50.5% at 24 months. The evidence is very uncertain about the effect of CAR T-cell therapy on overall survival.\nTwo studies including 294 participants at baseline and 59 participants at the longest follow-up (12 months or 18 months) described improvements of quality of life measured with the EuroQol 5-Dimension 5-Level visual analogue scale (EQ-5D-5L VAS) or Function Assessment of Cancer Therapy-Lymphoma (FACT-Lym). The evidence is very uncertain about the effect of CAR T-cell therapy on quality of life.\nNone of the studies reported treatment-related mortality.\nFive studies (550 participants) reported the occurrence of adverse events among participants, ranging between 99% and 100% for any grade adverse events and 68% to 98% for adverse events grade ≥ 3. In three studies (253 participants), 56% to 68% of participants experienced serious adverse events, while in one study (28 participants), no serious adverse events occurred. CAR T-cell therapy may increase the risk of adverse events and serious adverse events but the evidence is very uncertain about the exact risk.\nThe occurrence of cytokine release syndrome (CRS) was reported in 11 studies (675 participants) under use of various grading criteria. Five studies reported between 42% and 100% of participants experiencing CRS according to criteria described in Lee 2014. CAR T-cell therapy may increase the risk of CRS but the evidence is very uncertain about the exact risk.\nNine studies (575 participants) reported results on progression-free survival, disease-free survival or relapse-free survival. Twelve-month progression-free survival rates were reported by four studies and ranged between 44% and 75%. In one study, relapse-free survival remained at a rate of 64% at both 12 and 18 months. The evidence is very uncertain about the effect of CAR T-cell therapy on progression-free survival.\nThirteen studies (620 participants) provided data on complete response rates. At six months, three studies reported complete response rates between 40% and 45%. The evidence is very uncertain about the effect of CAR T-cell therapy on complete response rates.\nAuthors' conclusions\nThe available evidence on the benefits and harms of CAR T-cell therapy for people with r/r DLBCL is limited, mainly because of the absence of comparative clinical trials. The results we present should be regarded in light of this limitation and conclusions should be drawn very carefully. Due to the uncertainty in the current evidence, a large number of ongoing investigations and a risk of substantial and potentially life-threatening complications requiring supplementary treatment, it is critical to continue evaluating the evidence on this new therapy.\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": "The evidence on CAR T-cells in the treatment of relapsed or refractory DLBCL is very uncertain. This is mainly because, today, there are no direct comparisons of CAR T-cells with other treatments. People who receive CAR T-cells can have severe adverse events that require additional treatment. We identified many ongoing studies and some of them compare CAR T-cells with standard care. We will keep evaluating the evidence on this novel therapy."
}
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query-laysum | 3619 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetic macular oedema (DMO) is a common complication of diabetic retinopathy. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) can reduce oedema, improve vision, and prevent further visual loss. These drugs have replaced laser photocoagulation as the standard of care for people with DMO. In the previous update of this review, we found moderate-quality evidence that, at 12 months, aflibercept was slightly more effective than ranibizumab and bevacizumab for improving vision in people with DMO, although the difference may have been clinically insignificant (less than 0.1 logarithm of the minimum angle of resolution (logMAR), or five Early Treatment Diabetic Retinopathy Study (ETDRS) letters, or one ETDRS line).\nObjectives\nThe objective of this updated review was to compare the effectiveness and safety of the different anti-VEGF drugs in RCTs at longer follow-up (24 months).\nSearch methods\nWe searched various electronic databases on 8 July 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared any anti-angiogenic drug with an anti-VEGF mechanism of action versus another anti-VEGF drug, another treatment, sham, or no treatment in people with DMO.\nData collection and analysis\nWe used standard Cochrane methods for pairwise meta-analysis and we augmented this evidence using network meta-analysis (NMA) methods. We used the Stata 'network' meta-analysis package for all analyses. We used the CINeMA (Confidence in Network Meta-Analysis) web application to grade the certainty of the evidence.\nMain results\nWe included 23 studies (13 with industry funding) that enrolled 3513 people with DMO (median central retinal thickness (CRT) 460 microns, interquartile range (IQR) 424 to 482) and moderate vision loss (median best-corrected visual acuity (BCVA) 0.48 logMAR, IQR 0.42 to 0.55). One study that investigated ranibizumab versus sham and one study that mainly enrolled people with subclinical DMO and normal BCVA were not suitable for inclusion in the efficacy NMA.\nConsistent with the previous update of this review, we used ranibizumab as the reference drug for efficacy, and control (including laser, observation, and sham) as the reference for systemic safety.\nEight trials provided data on the primary outcome (change in BCVA at 24 months, in logMAR: lower is better). We found no evidence of a difference between the following interventions and ranibizumab alone: aflibercept (mean difference (MD) −0.05 logMAR, 95% confidence interval (CI) −0.12 to 0.02; moderate certainty); bevacizumab (MD -0.01 logMAR, 95% CI −0.13 to 0.10; low certainty), brolucizumab (MD 0.00 logMAR, 95% CI −0.08 to 0.07; low certainty), ranibizumab plus deferred laser (MD 0.00 logMAR, 95% CI −0.11 to 0.10; low certainty), and ranibizumab plus prompt laser (MD 0.03 logMAR, 95% CI −0.04 to 0.09; very low certainty).\nWe also analysed BCVA change at 12 months, finding moderate-certainty evidence of increased efficacy with brolucizumab (MD −0.07 logMAR, 95%CI −0.10 to −0.03 logMAR), faricimab (MD −0.08 logMAR, 95% CI −0.12 to −0.05), and aflibercept (MD −0.07 logMAR, 95 % CI −0.10 to −0.04) compared to ranibizumab alone, but the difference could be clinically insignificant.\nCompared to ranibizumab alone, NMA of six trials showed no evidence of a difference with aflibercept (moderate certainty), bevacizumab (low certainty), or ranibizumab with prompt (very low certainty) or deferred laser (low certainty) regarding improvement by three or more ETDRS lines at 24 months.\nThere was moderate-certainty evidence of greater CRT reduction at 24 months with brolucizumab (MD −23 microns, 95% CI −65 to −1 9) and aflibercept (MD −26 microns, 95% CI −53 to 0.9) compared to ranibizumab. There was moderate-certainty evidence of lesser CRT reduction with bevacizumab (MD 28 microns, 95% CI 0 to 56), ranibizumab plus deferred laser (MD 63 microns, 95% CI 18 to 109), and ranibizumab plus prompt laser (MD 72 microns, 95% CI 25 to 119) compared with ranibizumab alone.\nRegarding all-cause mortality at the longest available follow-up (20 trials), we found no evidence of increased risk of death for any drug compared to control, although effects were in the direction of an increase, and clinically relevant increases could not be ruled out. The certainty of this evidence was low for bevacizumab (risk ratio (RR) 2.10, 95% CI 0.75 to 5.88), brolucizumab (RR 2.92, 95% CI 0.68 to 12.58), faricimab (RR 1.91, 95% CI 0.45 to 8.00), ranibizumab (RR 1.26, 95% CI 0.68 to 2.34), and very low for conbercept (RR 0.33, 95% CI 0.01 to 8.81) and aflibercept (RR 1.48, 95% CI 0.79 to 2.77). Estimates for Antiplatelet Trialists Collaboration arterial thromboembolic events at 24 months did not suggest an increase with any drug compared to control, but the NMA was overall incoherent and the evidence was of low or very low certainty.\nOcular adverse events were rare and poorly reported and could not be assessed in NMAs.\nAuthors' conclusions\nThere is limited evidence of the comparative efficacy and safety of anti-VEGF drugs beyond one year of follow-up. We found no clinically important differences in visual outcomes at 24 months in people with DMO, although there were differences in CRT change. We found no evidence that any drug increases all-cause mortality compared to control, but estimates were very imprecise. Evidence from RCTs may not apply to real-world practice, where people in need of antiangiogenic treatment are often under-treated, and the individuals exposed to these drugs may be less healthy than trial participants.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane Review was to find out which is the best type of anti-vascular endothelial growth factor (anti-VEGF) medicine for diabetic macular oedema (DMO) two years after treatment initiation."
}
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query-laysum | 3620 | [
{
"role": "user",
"content": "Abstract: Background\nBiologic disease-modifying anti-rheumatic drugs (DMARDs: referred to as biologics) are effective in treating rheumatoid arthritis (RA), however there are few head-to-head comparison studies. Our systematic review, standard meta-analysis and network meta-analysis (NMA) updates the 2009 Cochrane overview, 'Biologics for rheumatoid arthritis (RA)' and adds new data. This review is focused on biologic or tofacitinib therapy in people with RA who had previously been treated unsuccessfully with biologics.\nObjectives\nTo compare the benefits and harms of biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab) and small molecule tofacitinib versus comparator (placebo or methotrexate (MTX)/other DMARDs) in people with RA, previously unsuccessfully treated with biologics.\nMethods\nOn 22 June 2015 we searched for randomized controlled trials (RCTs) in CENTRAL, MEDLINE, and Embase; and trials registries (WHO trials register, Clinicaltrials.gov). We carried out article selection, data extraction, and risk of bias and GRADE assessments in duplicate. We calculated direct estimates with 95% confidence intervals (CI) using standard meta-analysis. We used a Bayesian mixed treatment comparison (MTC) approach for NMA estimates with 95% credible intervals (CrI). We converted odds ratios (OR) to risk ratios (RR) for ease of understanding. We have also presented results in absolute measures as risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB). Outcomes measured included four benefits (ACR50, function measured by Health Assessment Questionnaire (HAQ) score, remission defined as DAS < 1.6 or DAS28 < 2.6, slowing of radiographic progression) and three harms (withdrawals due to adverse events, serious adverse events, and cancer).\nMain results\nThis update includes nine new RCTs for a total of 12 RCTs that included 3364 participants. The comparator was placebo only in three RCTs (548 participants), MTX or other traditional DMARD in six RCTs (2468 participants), and another biologic in three RCTs (348 participants). Data were available for four tumor necrosis factor (TNF)-biologics: (certolizumab pegol (1 study; 37 participants), etanercept (3 studies; 348 participants), golimumab (1 study; 461 participants), infliximab (1 study; 27 participants)), three non-TNF biologics (abatacept (3 studies; 632 participants), rituximab (2 studies; 1019 participants), and tocilizumab (2 studies; 589 participants)); there was only one study for tofacitinib (399 participants). The majority of the trials (10/12) lasted less than 12 months.\nWe judged 33% of the studies at low risk of bias for allocation sequence generation, allocation concealment and blinding, 25% had low risk of bias for attrition, 92% were at unclear risk for selective reporting; and 92% had low risk of bias for major baseline imbalance. We downgraded the quality of the evidence for most outcomes to moderate or low due to study limitations, heterogeneity, or rarity of direct comparator trials.\nBiologic monotherapy versus placebo\nCompared to placebo, biologics were associated with clinically meaningful and statistically significant improvement in RA as demonstrated by higher ACR50 and RA remission rates. RR was 4.10 for ACR50 (95% CI 1.97 to 8.55; moderate-quality evidence); absolute benefit RD 14% (95% CI 6% to 21%); and NNTB = 8 (95% CI 4 to 23). RR for RA remission was 13.51 (95% CI 1.85 to 98.45, one study available; moderate-quality evidence); absolute benefit RD 9% (95% CI 5% to 13%); and NNTB = 11 (95% CI 3 to 136). Results for withdrawals due to adverse events and serious adverse events did not show any statistically significant or clinically meaningful differences. There were no studies available for analysis for function measured by HAQ, radiographic progression, or cancer outcomes. There were not enough data for any of the outcomes to look at subgroups.\nBiologic + MTX versus active comparator (MTX/other traditional DMARDs)\nCompared to MTX/other traditional DMARDs, biologic + MTX was associated with a clinically meaningful and statistically significant improvement in ACR50, function measured by HAQ, and RA remission rates in direct comparisons. RR for ACR50 was 4.07 (95% CI 2.76 to 5.99; high-quality evidence); absolute benefit RD 16% (10% to 21%); NNTB = 7 (95% CI 5 to 11). HAQ scores showed an improvement with a mean difference (MD) of 0.29 (95% CI 0.21 to 0.36; high-quality evidence); absolute benefit RD 9.7% improvement (95% CI 7% to 12%); and NNTB = 5 (95% CI 4 to 7). Remission rates showed an improved RR of 20.73 (95% CI 4.13 to 104.16; moderate-quality evidence); absolute benefit RD 10% (95% CI 8% to 13%); and NNTB = 17 (95% CI 4 to 96), among the biologic + MTX group compared to MTX/other DMARDs. There were no studies for radiographic progression. Results were not clinically meaningful or statistically significantly different for withdrawals due to adverse events or serious adverse events, and were inconclusive for cancer.\nTofacitinib monotherapy versus placebo\nThere were no published data.\nTofacitinib + MTX versus active comparator (MTX)\nIn one study, compared to MTX, tofacitinib + MTX was associated with a clinically meaningful and statistically significant improvement in ACR50 (RR 3.24; 95% CI 1.78 to 5.89; absolute benefit RD 19% (95% CI 12% to 26%); NNTB = 6 (95% CI 3 to 14); moderate-quality evidence), and function measured by HAQ, MD 0.27 improvement (95% CI 0.14 to 0.39); absolute benefit RD 9% (95% CI 4.7% to 13%), NNTB = 5 (95% CI 4 to 10); high-quality evidence). RA remission rates were not statistically significantly different but the observed difference may be clinically meaningful (RR 15.44 (95% CI 0.93 to 256.1; high-quality evidence); absolute benefit RD 6% (95% CI 3% to 9%); NNTB could not be calculated. There were no studies for radiographic progression. There were no statistically significant or clinically meaningful differences for withdrawals due to adverse events and serious adverse events, and results were inconclusive for cancer.\nAuthors' conclusions\nBiologic (with or without MTX) or tofacitinib (with MTX) use was associated with clinically meaningful and statistically significant benefits (ACR50, HAQ, remission) compared to placebo or an active comparator (MTX/other traditional DMARDs) among people with RA previously unsuccessfully treated with biologics.\nNo studies examined radiographic progression. Results were not clinically meaningful or statistically significant for withdrawals due to adverse events and serious adverse events, and were inconclusive for cancer.\n\nGiven the provided abstract, please respond to the following query: \"Biologic + MTX versus MTX/other traditional DMARDs\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "104 people out of 1000 who were on biologic + MTX had their RA symptoms disappear compared to 3 people out of 1000 who were on MTX/DMARD (10% absolute improvement)."
}
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query-laysum | 3621 | [
{
"role": "user",
"content": "Abstract: Background\nContraception provides significant benefits for women's and children's health, yet many women have an unmet need for contraception. Rapid expansion in the use of mobile phones in recent years has had a dramatic impact on interpersonal communication. Within the health domain text messages and smartphone applications offer means of communication between clients and healthcare providers. This review focuses on interventions delivered by mobile phone and their effect on use of contraception.\nObjectives\nTo evaluate the benefits and harms of mobile phone-based interventions for improving contraception use.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was August 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) of mobile phone-based interventions to improve forms of contraception use amongst users or potential users of contraception.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. uptake of contraception, 2. uptake of a specific method of contraception, 3. adherence to contraception method, 4. safe method switching, 5. discontinuation of contraception and 6. pregnancy or abortion. Our secondary outcomes were 7. road traffic accidents, 8. any physical or psychological effect reported and 9. violence or domestic abuse.\nMain results\nTwenty-three RCTs (12,793 participants) from 11 countries met our inclusion criteria. Eleven studies were conducted in high-income resource settings and 12 were in low-income settings. Thirteen studies used unidirectional text messaging-based interventions, six studies used interactive text messaging, four used voice message-based interventions and two used mobile-phone apps to improve contraception use. All studies received funding from non-commercial bodies.\nMobile phone-based interventions probably increase contraception use compared to the control (odds ratio (OR) 1.30, 95% confidence interval (CI) 1.06 to 1.60; 16 studies, 8972 participants; moderate-certainty evidence).\nThere may be little or no difference in rates of unintended pregnancy with the use of mobile phone-based interventions compared to control (OR 0.82, 95% CI 0.48 to 1.38; 8 trials, 2947 participants; moderate-certainty evidence).\nSubgroup analysis assessing unidirectional mobile phone interventions versus interactive mobile phone interventions found evidence of a difference between the subgroups favouring interactive interventions (P = 0.003, I2 = 88.5%). Interactive interventions had an OR of 1.71 (95% CI 1.28 to 2.29; P = 0.0003, I2 = 63%; 8 trials, 3089 participants) whilst unidirectional interventions had an OR of 1.03 (95% CI 0.87 to 1.22; P = 0.72, I2 = 17%; 9 trials, 5883 participants).\nSubgroup analysis assessing high-income versus low-income trial settings found no difference between groups (subgroup difference test: P = 0.70, I2 = 0%).\nOnly six trials reported on safety and unintended outcomes; one trial reported increased partner violence whilst another four trials reported no difference in physical violence rates between control and intervention groups. One trial reported no road traffic accidents with mobile phone intervention use.\nAuthors' conclusions\nThis review demonstrates there is evidence to support the use of mobile phone-based interventions in improving the use of contraception, with moderate-certainty evidence. Interactive mobile phone interventions appear more effective than unidirectional methods.\nThe cost-effectiveness, cost benefits, safety and long-term effects of these interventions remain unknown, as does the evidence of this approach to support contraception use among specific populations.\nFuture research should investigate the effectiveness and safety of mobile phone-based interventions with better quality trials to help establish the effects of interventions delivered by mobile phone on contraception use. This review is limited by the quality of the studies due to flaws in methodology, bias or imprecision of results.\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"
},
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"role": "assistant",
"content": "This review updates our previous review. The evidence is up to date to August 2022."
}
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query-laysum | 3622 | [
{
"role": "user",
"content": "Abstract: Background\nPelvimetry assesses the size of a woman's pelvis aiming to predict whether she will be able to give birth vaginally or not. This can be done by clinical examination, or by conventional X-rays, computerised tomography (CT) scanning, or magnetic resonance imaging (MRI).\nObjectives\nTo assess the effects of pelvimetry (performed antenatally or intrapartum) on the method of birth, on perinatal mortality and morbidity, and on maternal morbidity. This review concentrates exclusively on women whose fetuses have a cephalic presentation.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2017) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (including quasi-randomised) assessing the use of pelvimetry versus no pelvimetry or assessing different types of pelvimetry in women with a cephalic presentation at or near term were included. Cluster trials were eligible for inclusion, but none were identified.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of the evidence using the GRADE approach.\nMain results\nFive trials with a total of 1159 women were included. All used X-ray pelvimetry to assess the pelvis. X-ray pelvimetry versus no pelvimetry or clinical pelvimetry is the only comparison included in this review due to the lack of trials identified that examined other types of radiological pelvimetry or that compared clinical pelvimetry versus no pelvimetry.\nThe included trials were generally at high risk of bias. There is an overall high risk of performance bias due to lack of blinding of women and staff. Two studies were also at high risk of selection bias. We used GRADEpro software to grade evidence for our selected outcomes; for caesarean section we rated the evidence low quality and all the other outcomes (perinatal mortality, wound sepsis, blood transfusion, scar dehiscence and admission to special care baby unit) as very low quality. Downgrading was due to risk of bias relating to lack of allocation concealment and blinding, and imprecision of effect estimates.\nWomen undergoing X-ray pelvimetry were more likely to have a caesarean section (risk ratio (RR) 1.34, 95% confidence interval (CI) 1.19 to 1.52; 1159 women; 5 studies; low-quality evidence). There were no clear differences between groups for perinatal outcomes: perinatal mortality (RR 0.53, 95% CI 0.19 to 1.45; 1159 infants; 5 studies; very low-quality evidence), perinatal asphyxia (RR 0.66, 95% CI 0.39 to 1.10; 305 infants; 1 study), and admission to special care baby unit (RR 0.20, 95% CI 0.01 to 4.13; 288 infants; 1 study; very low-quality evidence). Other outcomes assessed were wound sepsis (RR 0.83, 95% CI 0.26 to 2.67; 288 women; 1 study; very low-quality evidence), blood transfusion (RR 1.00, 95% CI 0.39 to 2.59; 288 women; 1 study; very low-quality evidence), and scar dehiscence (RR 0.59, 95% CI 0.14 to 2.46; 390 women; 2 studies; very low-quality evidence). Again, no clear differences were found for these outcomes between the women who received X-ray pelvimetry and those who did not. Apgar score less than seven at five minutes was not reported in any study.\nAuthors' conclusions\nX-ray pelvimetry versus no pelvimetry or clinical pelvimetry is the only comparison included in this review due to the lack of trials identified that used other types or pelvimetry (other radiological examination or clinical pelvimetry versus no pelvimetry). There is not enough evidence to support the use of X-ray pelvimetry for deciding on mode of delivery in women whose fetuses have a cephalic presentation. Women who undergo an X-ray pelvimetry may be more likely to have a caesarean section.\nFurther research should be directed towards defining whether there are specific clinical situations in which pelvimetry can be shown to be of value. Newer methods of pelvimetry (CT, MRI) should be subjected to randomised trials to assess their value. Further trials of X-ray pelvimetry in cephalic presentations would be of value if large enough to assess the effect on perinatal mortality.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is too little evidence (the majority of which is low quality) to show whether measuring the size of the woman's pelvis (pelvimetry) is beneficial and safe when the baby is in a head-down position. The number of women having a caesarean section increased if women had X-ray pelvimetry but there was insufficient good-quality evidence to show if pelvimetry improves outcomes for the baby. More research is needed."
}
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query-laysum | 3623 | [
{
"role": "user",
"content": "Abstract: Background\nPancreatic cancer is the fourth-leading cause of cancer death for both, men and women. The standard treatment for resectable tumours consists of a classic Whipple (CW) operation or a pylorus-preserving pancreaticoduodenectomy (PPW). It is unclear which of these procedures is more favourable in terms of survival, postoperative mortality, complications, and quality of life.\nObjectives\nThe objective of this systematic review was to compare the effectiveness of CW and PPW techniques for surgical treatment of cancer of the pancreatic head and the periampullary region.\nSearch methods\nWe conducted searches on 28 March 2006, 11 January 2011, 9 January 2014, and 18 August 2015 to identify all randomised controlled trials (RCTs), while applying no language restrictions. We searched the following electronic databases on 18 August 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effects (DARE) from the Cochrane Library (2015, Issue 8); MEDLINE (1946 to August 2015); and EMBASE (1980 to August 2015). We also searched abstracts from Digestive Disease Week and United European Gastroenterology Week (1995 to 2010); we did not update this part of the search for the 2014 and 2015 updates because the prior searches did not contribute any additional information. We identified two additional trials through the updated search in 2015.\nSelection criteria\nRCTs comparing CW versus PPW including participants with periampullary or pancreatic carcinoma.\nData collection and analysis\nTwo review authors independently extracted data from the included trials. We used a random-effects model for pooling data. We compared binary outcomes using odds ratios (ORs), pooled continuous outcomes using mean differences (MDs), and used hazard ratios (HRs) for meta-analysis of survival. Two review authors independently evaluated the methodological quality and risk of bias of included trials according to the standards of The Cochrane Collaboration.\nMain results\nWe included eight RCTs with a total of 512 participants. Our critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. Postoperative mortality (OR 0.64, 95% confidence interval (CI) 0.26 to 1.54; P = 0.32), overall survival (HR 0.84, 95% CI 0.61 to 1.16; P = 0.29), and morbidity showed no significant differences, except of delayed gastric emptying, which significantly favoured CW (OR 3.03, 95% CI 1.05 to 8.70; P = 0.04). Furthermore, we noted that operating time (MD -45.22 minutes, 95% CI -74.67 to -15.78; P = 0.003), intraoperative blood loss (MD -0.32 L, 95% CI -0.62 to -0.03; P = 0.03), and red blood cell transfusion (MD -0.47 units, 95% CI -0.86 to -0.07; P = 0.02) were significantly reduced in the PPW group. All significant results were associated with low-quality evidence based on GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria.\nAuthors' conclusions\nCurrent evidence suggests no relevant differences in mortality, morbidity, and survival between the two operations. However, some perioperative outcome measures significantly favour the PPW procedure. Given obvious clinical and methodological heterogeneity, future high-quality RCTs of complex surgical interventions based on well-defined outcome parameters are required.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included eight randomised controlled trials with a total of 512 participants in this review. The included trials revealed vast differences in sample size as well as clinical and methodological quality."
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query-laysum | 3624 | [
{
"role": "user",
"content": "Abstract: Background\nNasolacrimal duct obstruction (NLDO) is a condition that results in the overflow of tears (epiphora) or infection of the nasolacrimal sac (dacryocystitis). The etiology of acquired NLDO is multifactorial and is not fully understood. Dacryocystorhinostomy (DCR) is the surgical correction of NLDO, which aims to establish a new drainage pathway between the lacrimal sac and the nose. The success of DCR is variable; the most common cause of failure is fibrosis and stenosis of the surgical ostium. Antimetabolites such as mitomycin-C (MMC) and 5-fluorouracil (5-FU) have been shown to be safe and effective in reducing fibrosis and improving clinical outcomes in other ophthalmic surgery settings (e.g. glaucoma and cornea surgery). Application of antimetabolites at the time of DCR has been studied, but the utility of these treatments remains uncertain.\nObjectives\nPrimary objective: To determine if adjuvant treatment with antimetabolites improves functional success in the setting of DCR compared to DCR alone.\nSecondary objectives: To determine if anatomic success of DCR is increased with the use of antimetabolites, and if the surgical ostium is larger in participants treated with antimetabolites.\nSearch methods\nWe searched the Cochrane Register for Controlled Trials (CENTRAL) (which contains the Cochrane Eye and Vision Trials Register) (2019, Issue 9), Ovid MEDLINE, Embase.com, PubMed, LILACS (Latin American and Caribbean Health Sciences Literature database), ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic searches. We last searched the electronic databases on 6 September 2019.\nSelection criteria\nWe only included randomized controlled trials. Eligible studies were those that compared the administration of antimetabolites of any dose and concentration versus placebo or another active treatment in participants with NLDO undergoing primary DCR and reoperation. We only included studies that had enrolled adults 18 years or older. We also included studies that used silicone intubation as part of the DCR procedure.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently screened the search results, assessed risk of bias, and extracted data from the included studies using an electronic data collection form.\nMain results\nWe included 31 studies in the review, of which 23 (1309 participants) provided data relating to our primary and secondary outcomes. Many of the 23 studies evaluated functional success, while others also assessed our secondary outcomes of anatomic success or ostium size, or both.\nStudy characteristics\nParticipant characteristics varied across studies, with the age of participants ranging from 30 to 70 years. Participants were predominantly women. These demographics correspond to those most frequently affected by nasolacrimal duct obstruction. Almost all of the studies utilized MMC as the antimetabolite, with only one using 5-FU. We assessed most trials as at unclear risk of bias for most domains. Conflicts of interest were not frequently reported, although the antimetabolites used are generic medications, and studies were not likely to be conducted for financial interest.\nFindings\nTwenty studies provided data on the primary outcome of functional success, of which 7 (356 participants) provided data at 6 months and 14 (909 participants) provided data beyond 6 months. At six months, the results showed no evidence of effect of antimetabolite on functional success (risk ratio (RR) 1.12, 95% confidence interval (CI) 0.98 to 1.29; low-certainty evidence). Beyond six months, the results favored the antimetabolite group (RR 1.15, 95% CI 1.07 to 1.25; moderate-certainty evidence).\nFourteen studies reported data on the secondary outcome of anatomic success, of which 4 (306 participants) reported data at 6 months and 12 (831 participants) provided data beyond 6 months. Results at six months showed no evidence of effect of antimetabolite on anatomic success (RR 1.02, 95% CI 0.95 to 1.11; low-certainty evidence). Beyond six months, participants in the antimetabolite group were more likely to achieve anatomic success than those receiving DCR alone (RR 1.09, 95% CI 1.04 to 1.15; moderate-certainty evidence).\nAt six months and beyond six months follow-up, two studies reported mean change in ostium size. We did not conduct meta-analysis for the various follow-up periods due to clinical, methodological, and statistical heterogeneity. However, point estimates from these studies at six months consistently favored participants in the antimetabolite group (low-certainty evidence). Beyond six months, while point estimates from one study favored participants in the antimetabolite group, estimates from another study showed no evidence of a difference between the two groups. The certainty of evidence at both time points was low.\nAdverse events\nAdverse events were rare. One study reported that one participant in the MMC group experienced delayed wound healing. Other studies reported no significant adverse events related to the application of antimetabolites.\nAuthors' conclusions\nThere is moderate-certainty evidence that application of antimetabolites at the time of DCR increases functional and anatomic success of DCR when patients are followed for more than six months after surgery, but no evidence of a difference at six months, low-certainty of evidence. There is low-certainty evidence that combining antimetabolite with DCR increases the size of the lacrimal ostium at six months. However, beyond six months, the evidence remain uncertain. Adverse effects of the application of antimetabolites were minimal.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed studies published up to 6 September 2019."
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query-laysum | 3625 | [
{
"role": "user",
"content": "Abstract: Background\nChinese herbal medicine (CHM) usage is expected to increase as women suffering from menopausal symptoms are seeking alternative therapy due to concerns from the adverse effects (AEs) associated with hormone therapy (HT). Scientific evidence for their effectiveness and safety is needed.\nObjectives\nTo evaluate the effectiveness and safety of CHM in the treatment of menopausal symptoms.\nSearch methods\nWe searched the Gynaecology and Fertility Group's Specialised Register of controlled trials, Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 3), MEDLINE, Embase, CINAHL, AMED, and PsycINFO (from inception to March 2015). Others included Current Control Trials, Citation Indexes, conference abstracts in the ISI Web of Knowledge, LILACS database, PubMed, OpenSIGLE database, and China National Knowledge Infrastructure database (CNKI, 1999 to 2015). Other resources included reference lists of articles as well as direct contact with authors.\nSelection criteria\nRandomised controlled trials (RCTs) comparing the effectiveness of CHM with placebo, HT, pharmaceutical drugs, acupuncture, or another CHM formula in women over 18 years of age, and suffering from menopausal symptoms.\nData collection and analysis\nTwo review authors independently assessed 864 studies for eligibility. Data extractions were performed by them with disagreements resolved through group discussion and clarification of data or direct contact with the study authors. Data analyses were performed in accordance with Cochrane Collaboration guidelines.\nMain results\nWe included 22 RCTs (2902 women). Participants were from different ethnic backgrounds with the majority of Chinese origin.\nWhen CHM was compared with placebo (eight RCTs), there was little or no evidence of a difference between the groups for the following pooled outcomes: hot flushes per day (MD 0.00, 95% CI -0.88 to 0.89; 2 trials, 199 women; moderate quality evidence); hot flushes per day assessed by an overall hot flush score in which a difference of one point equates to one mild hot flush per day (MD -0.81 points, 95% CI -2.08 to 0.45; 3 RCTs, 263 women; low quality evidence); and overall vasomotor symptoms per month measured by the Menopause-Specific Quality of Life questionnaire (MENQOL, scale 0 to 6) (MD -0.42 points; 95% CI -1.52 to 0.68; 3 RCTs, 256 women; low quality evidence).\nIn addition, results from individual studies suggested there was no evidence of a difference between the groups for daily hot flushes assessed by severity (MD -0.70 points, 95% CI -1.00, -0.40; 1 RCT, 108 women; moderate quality evidence); or overall monthly hot flushes scores (MD -2.80 points, 95% CI -8.93 to 3.33; 1 RCT, 84 women; very low quality evidence); or overall daily night sweats scores (MD 0.07 points, 95% CI -0.19 to 0.33, 1 RCT, 64 women; low quality evidence); or overall monthly night sweats scores (MD 1.30 points, 95% CI -1.76 to 4.36, 1 RCT, 84 women; very low quality evidence). However one study using the Kupperman Index reported that overall monthly vasomotor symptom scores were lower in the CHM group (MD -4.79 points, 95% CI -5.52 to -4.06; 1 RCT, 69 women; low quality evidence).\nWhen CHM was compared with hormone therapy (HT) (10 RCTs), only two RCTs reported monthly vasomotor symptoms using MENQOL. It was uncertain whether CHM reduces vasomotor symptoms (MD 0.47 points, 95% CI -0.50 to 1.44; 2 RCTs, 127 women; very low quality evidence).\nAdverse effects were not fully reported in the included studies. Adverse events reported by women taking CHM included mild diarrhoea, breast tenderness, gastric discomfort and an unpleasant taste. Effects were inconclusive because of imprecise estimates of effects: CHM versus placebo (RR 1.51; 95% CI 0.69 to 3.33; 7 trials, 705 women; I² = 40%); CHM versus HT (RR 0.96; 95% CI 0.66 to 1.39; 2 RCTs, 864 women; I² = 0%); and CHM versus specific conventional medications (such as Fluoxetine and Estazolam) (RR 0.20; 95% CI 0.03 to 1.17; 2 RCTs, 139 women; I² = 61%).\nAuthors' conclusions\nWe found insufficient evidence that Chinese herbal medicines were any more or less effective than placebo or HT for the relief of vasomotor symptoms. Effects on safety were inconclusive. The quality of the evidence ranged from very low to moderate; there is a need for well-designed randomised controlled studies.\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": "Are Chinese herbal medicines effective and safe for relieving menopausal symptoms?"
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query-laysum | 3626 | [
{
"role": "user",
"content": "Abstract: Background\nThe anaemia seen in chronic kidney disease (CKD) may be exacerbated by iron deficiency. Iron can be provided through different routes, with advantages and drawbacks of each route. It remains unclear whether the potential harms and additional costs of intravenous (IV) compared with oral iron are justified. This is an update of a review first published in 2012.\nObjectives\nTo determine the benefits and harms of IV iron supplementation compared with oral iron for anaemia in adults and children with CKD, including participants on dialysis, with kidney transplants and CKD not requiring dialysis.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 7 December 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\nWe included randomised controlled trials (RCTs) and quasi-RCTs in which IV and oral routes of iron administration were compared in adults and children with CKD.\nData collection and analysis\nTwo authors independently assessed study eligibility, risk of bias, and extracted data. Results were reported as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes. For continuous outcomes the mean difference (MD) was used or standardised mean difference (SMD) if different scales had been used. Statistical analyses were performed using the random-effects model. Subgroup analysis and univariate meta-regression were performed to investigate between study differences. The certainty of the evidence was assessed using GRADE.\nMain results\nWe included 39 studies (3852 participants), 11 of which were added in this update. A low risk of bias was attributed to 20 (51%) studies for sequence generation, 14 (36%) studies for allocation concealment, 22 (56%) studies for attrition bias and 20 (51%) for selective outcome reporting. All studies were at a high risk of performance bias. However, all studies were considered at low risk of detection bias because the primary outcome in all studies was laboratory-based and unlikely to be influenced by lack of blinding.\nThere is insufficient evidence to suggest that IV iron compared with oral iron makes any difference to death (all causes) (11 studies, 1952 participants: RR 1.12, 95% CI 0.64, 1.94) (absolute effect: 33 participants per 1000 with IV iron versus 31 per 1000 with oral iron), the number of participants needing to start dialysis (4 studies, 743 participants: RR 0.81, 95% CI 0.41, 1.61) or the number needing blood transfusions (5 studies, 774 participants: RR 0.86, 95% CI 0.55, 1.34) (absolute effect: 87 per 1,000 with IV iron versus 101 per 1,000 with oral iron). These analyses were assessed as having low certainty evidence. It is uncertain whether IV iron compared with oral iron reduces cardiovascular death because the certainty of this evidence was very low (3 studies, 206 participants: RR 1.71, 95% CI 0.41 to 7.18). Quality of life was reported in five studies with four reporting no difference between treatment groups and one reporting improvement in participants treated with IV iron.\nIV iron compared with oral iron may increase the numbers of participants, who experience allergic reactions or hypotension (15 studies, 2607 participants: RR 3.56, 95% CI 1.88 to 6.74) (absolute harm: 24 per 1000 with IV iron versus 7 per 1000) but may reduce the number of participants with all gastrointestinal adverse effects (14 studies, 1986 participants: RR 0.47, 95% CI 0.33 to 0.66) (absolute benefit: 150 per 1000 with IV iron versus 319 per 1000). These analyses were assessed as having low certainty evidence.\nIV iron compared with oral iron may increase the number of participants who achieve target haemoglobin (13 studies, 2206 participants: RR 1.71, 95% CI 1.43 to 2.04) (absolute benefit: 542 participants per 1,000 with IV iron versus 317 per 1000 with oral iron), increased haemoglobin (31 studies, 3373 participants: MD 0.72 g/dL, 95% CI 0.39 to 1.05); ferritin (33 studies, 3389 participants: MD 224.84 µg/L, 95% CI 165.85 to 283.83) and transferrin saturation (27 studies, 3089 participants: MD 7.69%, 95% CI 5.10 to 10.28), and may reduce the dose required of erythropoietin-stimulating agents (ESAs) (11 studies, 522 participants: SMD -0.72, 95% CI -1.12 to -0.31) while making little or no difference to glomerular filtration rate (8 studies, 1052 participants: 0.83 mL/min, 95% CI -0.79 to 2.44). All analyses were assessed as having low certainty evidence. There were moderate to high degrees of heterogeneity in these analyses but in meta-regression, definite reasons for this could not be determined.\nAuthors' conclusions\nThe included studies provide low certainty evidence that IV iron compared with oral iron increases haemoglobin, ferritin and transferrin levels in CKD participants, increases the number of participants who achieve target haemoglobin and reduces ESA requirements. However, there is insufficient evidence to determine whether IV iron compared with oral iron influences death (all causes), cardiovascular death and quality of life though most studies reported only short periods of follow-up. Adverse effects were reported in only 50% of included studies. We therefore suggest that further studies that focus on patient-centred outcomes with longer follow-up periods are needed to determine if the use of IV iron is justified on the basis of reductions in ESA dose and cost, improvements in patient quality of life, and with few serious adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We reviewed 39 studies (3852 participants) which compared IV iron supplements with oral iron in participants with chronic kidney disease."
}
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query-laysum | 3627 | [
{
"role": "user",
"content": "Abstract: Background\nPreterm infants are born with low glycogen stores and require higher glucose intake to match fetal accretion rates. In spite of the myriad benefits of breast milk for preterm infants, it may not adequately meet the needs of these rapidly growing infants. Supplementing human milk with carbohydrates may help. However, there is a paucity of data on assessment of benefits or harms of carbohydrate supplementation of human milk to promote growth in preterm infants. This is a 2020 update of a Cochrane Review first published in 1999.\nObjectives\nTo determine whether human milk supplemented with carbohydrate compared with unsupplemented human milk fed to preterm infants improves growth, body composition, and cardio-metabolic and neurodevelopmental outcomes without significant adverse effects.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 8) in the Cochrane Library and MEDLINE via PubMed on 22 August 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nPublished and unpublished controlled trials were eligible if they used random or quasi-random methods to allocate preterm infants in hospital fed human milk to supplementation or no supplementation with additional carbohydrate.\nData collection and analysis\nTwo review authors independently abstracted data and assessed trial quality and the quality of evidence at the outcome level using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method. We planned to perform meta-analyses using risk ratios (RRs) for dichotomous data and mean differences (MDs) for continuous data, with their respective 95% confidence intervals (CIs). We planned to use a fixed-effect model and to explore potential causes of heterogeneity via sensitivity analyses. We contacted study authors for additional information.\nMain results\nOne unblinded, quasi-randomised controlled trial (RCT) assessing effects of carbohydrate supplementation of human milk in the form of a prebiotic in 75 preterm infants was eligible for inclusion in this review. We identified two publications of the same trial, which reported different methods regarding blinding and randomisation. Study authors confirmed that these publications pertain to the same trial, but they have not yet clarified which method is correct. Our analyses showed very low certainty evidence of an effect of carbohydrate supplementation on weight by 30 days of age age (MD 160.4 grams, 95% CI 12.4 to 308.4 grams), and no effect on risk of feeding intolerance (RR 0.64, 95% CI 0.36 to 1.15) or necrotising enterocolitis (NEC) (RR 0.2, 95% CI 0.02 to 1.3). Duration of hospital stay was shorter in the prebiotic group than in the control group (median difference 9 days). No data were available for assessing effects of carbohydrate supplementation on long-term growth and neurodevelopment.\nAuthors' conclusions\nWe are uncertain whether carbohydrate supplementation of human milk affects any outcomes in preterm infants. The only trial included in this review presented very low-quality evidence, and study authors provided uncertain information about study methods and analysis. The evidence may be limited in its applicability because researchers included a small sample of preterm infants from a single centre. Future trials could assess the safety and efficacy of different types and concentrations of carbohydrate supplementation for preterm infants fed human milk. However, we do not envisage that further trials of digestible carbohydrates will be conducted, as this is currently done as a component of multi-nutrient human milk fortification.\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": "Not enough carbohydrate intake in preterm infants may result in poor growth and development. Breast milk is the best food for preterm infants, but feeding them only breast milk may be nutritionally inadequate. Adding carbohydrate to breast milk may help. However, not enough data can be found on assessing the benefits and harms of adding carbohydrate to breast milk to promote growth in preterm infants."
}
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query-laysum | 3628 | [
{
"role": "user",
"content": "Abstract: Background\nMénière's disease is an incapacitating disease in which recurrent attacks of vertigo are accompanied by hearing loss, tinnitus and/or aural fullness, all of which are discontinuous and variable in intensity. A number of different therapies have been identified for patients with this disease, ranging from dietary measures (e.g. a low-salt diet) and medication (e.g. betahistine (Serc®), diuretics) to extensive surgery (e.g. endolymphatic sac surgery). The Meniett® low-pressure pulse generator (Medtronic ENT, 1999) is a device that is designed to generate a computer-controlled sequence of low-pressure (micro-pressure) pulses, which are thought to be transmitted to the vestibular system of the inner ear. The pressure pulse passes via a tympanostomy tube (grommet) to the middle ear, and hence to the inner ear via the round and/or oval window. The hypothesis is that these low-pressure pulses reduce endolymphatic hydrops.\nObjectives\nTo assess the effects of positive pressure therapy (e.g. the Meniett device) on the symptoms of Ménière's disease or syndrome.\nSearch methods\nWe searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 6 June 2014.\nSelection criteria\nRandomised controlled trials (RCTs) comparing positive pressure therapy (using the Meniett or a similar device) with placebo in patients with Ménière's disease. The primary outcome was control of vertigo; secondary outcomes were loss or gain of hearing, severity of tinnitus, perception of aural fullness, functional level, complications or adverse effects, and sick days.\nData collection and analysis\nTwo authors independently selected studies, assessed risk of bias and extracted data. We contacted authors for additional data. Where possible, we pooled study results using a fixed-effect, mean difference (MD) meta-analysis and tested for statistical heterogeneity using both the Chi² test and I² statistic. This was only possible for the secondary outcomes loss or gain of hearing and sick days. We presented results using forest plots with 95% confidence intervals (Cl).\nMain results\nWe included five randomised clinical trials with 265 participants. All trials were prospective, double-blind, placebo-controlled randomised controlled trials on the effects of positive pressure therapy on vertigo complaints in Ménière's disease. Overall, the risk of bias varied: three out of five studies were at low risk, one was at unclear risk and one was at high risk of bias.\nControl of vertigo\nFor the primary outcome, control of vertigo, it was not possible to pool data due to heterogeneity in the measurement of the outcome measures. In most studies, no significant difference was found between the positive pressure therapy group and the placebo group in vertigo scores or vertigo days. Only one study, at low risk of bias, showed a significant difference in one measure of vertigo control in favour of positive pressure therapy. In this study, the mean visual analogue scale (VAS) score for vertigo after eight weeks of treatment was 25.5 in the positive pressure therapy group and 46.6 in the placebo group (mean difference (MD) -21.10, 95% CI -35.47 to -6.73; scale not stated - presumed to be 0 to 100).\nSecondary outcomes\nFor the secondary outcomes, we carried out two pooled analyses. We found statistically significant results for loss or gain of hearing . Hearing was 7.38 decibels better in the placebo group compared to the positive pressure therapy group (MD) (95% CI 2.51 to 12.25; two studies, 123 participants). The severity of tinnitus and perception of aural fullness were either not measured or inadequate data were provided in the included studies. For the secondary outcome functional level , it was not possible to perform a pooled analysis. One included study showed less functional impairment in the positive pressure group than the placebo group (AAO-HNS criteria, one- to six-point scale: MD -1.10, 95% CI -1.81 to -0.39, 40 participants); another study did not show any significant results. In addition to the predefined secondary outcome measures, we included sick days as an additional outcome measure, as two studies used this outcome measure and it is a complementary measurement of impairment due to Ménière's disease. We did not find a statistically significant difference in sick days. No complications or adverse effects were noted by any study.\nAuthors' conclusions\nThere is no evidence, from five included studies, to show that positive pressure therapy is effective for the symptoms of Ménière's disease. There is some moderate quality evidence, from two studies, that hearing levels are worse in patients who use this therapy. The positive pressure therapy device itself is minimally invasive. However, in order to use it, a tympanostomy tube (grommet) needs to be inserted, with the associated risks. These include the risks of anaesthesia, the general risks of any surgery and the specific risks of otorrhoea and tympanosclerosis associated with the insertion of a tympanostomy tube. Notwithstanding these comments, no complications or adverse effects were noted in any of the included studies.\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": "For our primary outcome, control of vertigo, we could not combine the results from the different studies because of differences in the way the outcome was measured. None of the included studies showed significant differences between the active groups and placebo groups in terms of vertigo days. Only one study found significantly lower subjective scores for vertigo in favour of the positive pressure therapy group when compared to the placebo group.\nWhen we combined the results from two studies we found that after treatment patients in the placebo group had better hearing levels compared to those in the positive pressure therapy group. The severity of tinnitus and perception of aural fullness were either not measured or the included studies did not provide enough information for us to comment on them. We did not find an overall statistically significant result for functional level. We also looked at 'sick days' but we did not find a statistically significant difference between groups in the two studies that measured this. No complications or adverse effects were noted by any study."
}
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query-laysum | 3629 | [
{
"role": "user",
"content": "Abstract: Background\nEndoscopic sinus surgery (ESS) is often recommended for symptomatic patients with recurrent acute or chronic rhinosinusitis who have failed conservative treatment. Postoperative care has been felt to be critical for both maintaining the surgical patency of the operated sinuses and improving patient symptoms. Debridement of the sinonasal cavities is one such postoperative care measure that has frequently been studied in the literature, often with conflicting conclusions.\nObjectives\nTo assess the effects of postoperative sinonasal debridement versus no debridement following endoscopic sinus surgery.\nSearch methods\nThe Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL, via the Cochrane Register of Studies); PubMed; EMBASE; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 21 May 2018.\nSelection criteria\nRandomised controlled trials comparing postoperative nasal debridement versus no debridement in adult patients with recurrent acute or chronic rhinosinusitis undergoing endoscopic sinus surgery. We included studies in which the patients acted as self-controls (i.e. one side of the nose underwent debridement and the other side did not) only for the secondary endoscopy outcomes.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcome measures were: health-related quality of life, disease severity (patient-reported symptom scores) and significant adverse effects (bleeding requiring intervention, severe pain, iatrogenic injury). Secondary outcomes were: postoperative endoscopic appearance of the sinonasal surgical cavities (endoscopic scores), recorded use of postoperative medical treatment and rate of revision surgery. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included four studies (152 participants), with a follow-up duration ranging from three months to 12 months. In two studies patients acted as self-controls, i.e. one side of the nose underwent debridement and the other side did not ('split-nose' studies). The risk of bias in all studies was high, mostly due to the inability to blind the patients to the debridement procedure.\nPrimary outcomes\nDisease-specific health-related quality of life scores\nOnly one study (58 participants) provided data for disease-specific health-related quality of life. At six months follow-up, lower disease-specific health-related quality of life scores, measured using the Sino-Nasal Outcome Test-22 (SNOT-22, range 0 to 110), were noted in the debridement group but the difference was not statistically significant (9.7 in the debridement group versus 10.3 in the control group, P = 0.47) (low-quality evidence).\nDisease severity (patient-reported symptom score)\nOnly one study (60 participants) provided data for disease severity measured by visual analogue scale (VAS) score. No significant differences in total symptom score were observed between groups postoperatively (low-quality evidence).\nSignificant adverse effects\nSignificant adverse effects related to the debridement procedure were not reported in any of the included studies, however it is not clear whether data regarding adverse effects were not collected or if none were indeed observed in any of the included studies.\nSecondary outcomes\nAll four studies assessed thepostoperative endoscopic appearance of the sinonasal cavities using the Lund-Kennedy score (range 0 to 10). A pooled analysis of endoscopic scores in the two non 'split-nose' studies revealed better endoscopic scores in the debridement group, however this was not a statistically significant difference (mean difference -0.31, 95% confidence interval (CI) -1.35 to 0.72; I² = 0%; two studies; 118 participants) (low-quality evidence). A sub-analysis of the adhesion formation component of the endoscopic score was available for all four studies and revealed a significantly lower adhesion rate in the debridement group (risk ratio 0.43, 95% CI 0.28 to 0.68; I² = 29%; four studies; 152 participants). Analysis of the number needed to treat to benefit revealed that for every three patients undergoing debridement, the endoscopic score would be decreased by one point in one patient. For every five patients undergoing debridement adhesion formation would be prevented in one patient.\nUse of postoperative medical treatment was reported in all studies, all of which recommended nasal douching. Steroids (systemic or nasal) were administered in two studies. However, the data were very limited and heterogeneous, therefore we could not analyse the impact of concomitant postoperative medical treatment.\nThe rate of revision surgery was not reported in any of the included studies, however it is not clear whether these data were not recorded or if there were no revision surgeries in any of the included studies.\nAuthors' conclusions\nWe are uncertain about the effects of postoperative sinonasal debridement due to high risk of bias in the included studies and the low quality of the evidence. Sinonasal debridement may make little or no difference to disease-specific health-related quality of life or disease severity. Low-quality evidence suggests that postoperative debridement is associated with a significantly lower risk of adhesions at three months follow-up. Whether this has any impact on longer-term outcomes is unknown.\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": "We identified several problems or potential problems in these studies. The most important was that in each study a different protocol was used for the number of debridement interventions performed per patient and the time interval between each such intervention. In addition, the numbers of patients in the study groups were relatively small. We therefore determined the overall quality of the evidence to be low for all outcomes. The evidence in this review is up to date to May 2018."
}
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query-laysum | 3630 | [
{
"role": "user",
"content": "Abstract: Background\nTargeting the immunoglobulin E pathway and the interleukin-5 pathway with specific monoclonal antibodies directed against the cytokines or their receptors is effective in patients with severe asthma. However, there are patients who have suboptimal responses to these biologics. Since interleukin-4 and interleukin-13, signalling through the interleukin-4 receptor, have multiple effects on the biology of asthma, therapies targeting interleukin-4 and -13 (both individually and combined) have been developed.\nObjectives\nTo assess the efficacy and safety of anti-interleukin-13 or anti-interleukin-4 agents, compared with placebo, anti-immunoglobulin E agents, or anti-interleukin-5 agents, for the treatment of children, adolescents, or adults with asthma.\nSearch methods\nWe identified studies from the Cochrane Airways Trials Register, which is maintained by the Information Specialist for the Group and through searches of the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. The search was carried out on the 16 October 2020.\nSelection criteria\nWe included parallel-group randomised controlled trials that compared anti-interleukin-13 or -4 agents (or agents that target both interleukin-13 and interleukin-4) with placebo in adolescents and adults (aged 16 years or older) or children (younger than 16 years), with a diagnosis of asthma; participants could receive their usual short- or long-acting medications (e.g. inhaled corticosteroids (ICS), long-acting beta adrenoceptor agonists (LABA), long-acting muscarinic antagonists (LAMA), and/or leukotriene receptor antagonists) provided that they were not part of the randomised treatment.\nData collection and analysis\nWe used standard methods expected by Cochrane.\nMain results\nWe identified and included 41 RCTs. Of these, 29 studies contributed data to the quantitative analyses, randomly assigning 10,604 people with asthma to receive an anti-interleukin-13 (intervention) or anti-interleukin-4 agent (intervention), or placebo (comparator). No relevant studies were identified where the comparator was an anti-immunoglobulin agent or an anti-interleukin-5 agent. Studies had a duration of between 2 and 52 (median 16) weeks. The mean age of participants across the included studies ranged from 22 to 55 years. Only five studies permitted enrolment of children and adolescents, accounting for less than 5% of the total participants contributing data to the present review. The majority of participants had moderate or severe uncontrolled asthma. Concomitant ICS use was permitted or required in the majority (21 of 29) of the included studies. The use of maintenance systemic corticosteroids was not permitted in 19 studies and was permitted or required in five studies (information not reported in five studies). Regarding the most commonly assessed anti-interleukin-13/-4 agents, four studies evaluated dupilumab (300 mg once every week (Q1W), 200 mg once every two weeks (Q2W), 300 mg Q2W, 200 mg once every four weeks (Q4W), 300 mg Q4W, each administered by subcutaneous (SC) injection); eight studies evaluated lebrikizumab (37.5 mg Q4W, 125 mg Q4W, 250 mg Q4W each administered by SC injection); and nine studies (3259 participants) evaluated tralokinumab (75 mg Q1W, 150 mg Q1W, 300 mg Q1W, 150 mg Q2W, 300 mg Q2W, 600 mg Q2W, 300 mg Q4W, each administered by SC injection; 1/5/10 mg/kg administered by intravenous (IV) injection); all anti-interleukin-13 or-4 agents were compared with placebo.\nThe risk of bias was generally considered to be low or unclear (insufficient detail provided); nine studies were considered to be at high risk for attrition bias and three studies were considered to be at high risk for reporting bias.\nThe following results relate to the primary outcomes. The rate of exacerbations requiring hospitalisation or emergency department (ED) visit was probably lower in participants receiving tralokinumab versus placebo (rate ratio 0.68, 95% CI 0.47 to 0.98; moderate-certainty evidence; data available for tralokinumab (anti-interleukin-13) only). In participants receiving an anti-interleukin-13/-4 agent, the mean improvement versus placebo in adjusted asthma quality of life questionnaire score was 0.18 units (95% CI 0.12 to 0.24; high-certainty evidence); however, this finding was deemed not to be a clinically relevant improvement. There was likely little or no difference between groups in the proportion of patients who reported all-cause serious adverse events (anti-interleukin-13/-4 agents versus placebo, OR 0.91, 95% CI 0.76 to 1.09; moderate-certainty evidence).\nIn terms of secondary outcomes, there may be little or no difference between groups in the proportion of patients who experienced exacerbations requiring oral corticosteroids (anti-interleukin-13/-4 agents versus placebo, rate ratio 0.98, 95% CI 0.72 to 1.32; low-certainty evidence). Anti-interleukin-13/-4 agents probably improve asthma control based on asthma control questionnaire score (anti-interleukin-13/-4 agents versus placebo, mean difference -0.19; 95% CI -0.24 to -0.14); however, the magnitude of this result was deemed not to be a clinically relevant improvement. The proportion of patients experiencing any adverse event was greater in those receiving anti-interleukin-13/-4 agents compared with those receiving placebo (OR 1.16, 95% CI 1.04 to 1.30; high-certainty evidence); the most commonly reported adverse events in participants treated with anti-interleukin-13/-4 agents were upper respiratory tract infection, nasopharyngitis, headache and injection site reaction. The pooled results for the exploratory outcome, the rate of exacerbations requiring oral corticosteroids (OCS) or hospitalisation or emergency department visit, may be lower in participants receiving anti-interleukin-13/-4 agents versus placebo (rate ratio 0.71, 95% CI 0.65 to 0.77; low-certainty evidence).\nResults were generally consistent across subgroups for different classes of agent (anti-interleukin-13 or anti-interleukin-4), durations of study and severity of disease. Subgroup analysis based on category of T helper 2 (TH2) inflammation suggested greater efficacy in patients with higher levels of inflammatory biomarkers (blood eosinophils, exhaled nitric oxide and serum periostin).\nAuthors' conclusions\nBased on the totality of the evidence, compared with placebo, anti-interleukin-13/-4 agents are probably associated with a reduction in exacerbations requiring hospitalisation or ED visit, at the cost of increased adverse events, in patients with asthma. No clinically relevant improvements in health-related quality of life or asthma control were identified. Therefore, anti-interleukin-13 or anti-interleukin-4 agents may be appropriate for adults with moderate-to-severe uncontrolled asthma who have not responded to other treatments. These conclusions are generally supported by moderate or high-certainty evidence based on studies with an observation period of up to one year.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "When we pooled the information provided by the 29 studies, we showed that these drugs reduced the number of people having asthma attacks and improved lung function to a level where a person would feel the benefit. Small improvements in health-related quality of life and asthma control were also seen, but the size of these effects was not great enough for a person with asthma to feel the benefit. A 16 per cent reduction in the dose of oral corticosteroids was also observed, although our confidence in this finding is low. Although no increase in serious side effects was found (i.e. any untoward medical occurrence that results in death; is life threatening; requires hospitalisation; results in persistent or significant disability/incapacity; or is a birth defect), the number of people who had any side effect was increased compared with people who took placebo. The most commonly reported side effects in participants treated with anti-interleukin-13/-4 agents were upper respiratory tract infections, colds, headaches or injection site reactions. The results also showed that information about blood markers (blood eosinophils and serum periostin) and the exhaled nitric oxide levels may help predict the efficacy of these medications in an individual with asthma. In summary, these drugs are likely helpful for some people with severe or uncontrolled asthma when other treatments have not worked and the purpose of the treatment is to reduce the number of asthma attacks experienced."
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query-laysum | 3631 | [
{
"role": "user",
"content": "Abstract: Background\nPulmonary hypertension (PH) is an important cause of morbidity and mortality, which leads to a substantial loss of exercise capacity. PH ultimately leads to right ventricular overload and subsequent heart failure and early death. Although early detection and treatment of PH are recommended, due to the limited responsiveness to therapy at late disease stages, many patients are diagnosed at a later stage of the disease because symptoms and signs of PH are nonspecific at earlier stages. While direct pressure measurement with right-heart catheterisation is the clinical reference standard for PH, it is not routinely used due to its invasiveness and complications. Trans-thoracic Doppler echocardiography is less invasive, less expensive, and widely available compared to right-heart catheterisation; it is therefore recommended that echocardiography be used as an initial diagnosis method in guidelines. However, several studies have questioned the accuracy of noninvasively measured pulmonary artery pressure. There is substantial uncertainty about the diagnostic accuracy of echocardiography for the diagnosis of PH.\nObjectives\nTo determine the diagnostic accuracy of trans-thoracic Doppler echocardiography for detecting PH.\nSearch methods\nWe searched MEDLINE, Embase, Web of Science Core Collection, ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform from database inception to August 2021, reference lists of articles, and contacted study authors. We applied no restrictions on language or type of publication.\nSelection criteria\nWe included studies that evaluated the diagnostic accuracy of trans-thoracic Doppler echocardiography for detecting PH, where right-heart catheterisation was the reference standard. We excluded diagnostic case-control studies (two-gate design), studies where right-heart catheterisation was not the reference standard, and those in which the reference standard threshold differed from 25 mmHg. We also excluded studies that did not provide sufficient diagnostic test accuracy data (true-positive [TP], false-positive [FP], true-negative [TN], and false-negative [FN] values, based on the reference standard). We included studies that provided data from which we could extract TP, FP, TN, and FN values, based on the reference standard. Two authors independently screened and assessed the eligibility based on the titles and abstracts of records identified by the search. After the title and abstract screening, the full-text reports of all potentially eligible studies were obtained, and two authors independently assessed the eligibility of the full-text reports.\nData collection and analysis\nTwo review authors independently assessed the risk of bias and extracted data from each of the included studies. We contacted the authors of the included studies to obtain missing data. We assessed the methodological quality of studies using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We estimated a summary receiver operating characteristic (SROC) curve by fitting a hierarchical summary ROC (HSROC) non-linear mixed model. We explored sources of heterogeneity regarding types of PH, methods to estimate the right atrial pressure, and threshold of index test to diagnose PH. All analyses were performed using the Review Manager 5, SAS and STATA statistical software.\nMain results\nWe included 17 studies (comprising 3656 adult patients) assessing the diagnostic accuracy of Doppler trans-thoracic echocardiography for the diagnosis of PH. The included studies were heterogeneous in terms of patient distribution of age, sex, WHO classification, setting, country, positivity threshold, and year of publication. The prevalence of PH reported in the included studies varied widely (from 6% to 88%). The threshold of index test for PH diagnosis varied widely (from 30 mmHg to 47 mmHg) and was not always prespecified. No study was assigned low risk of bias or low concern in each QUADAS-2 domain assessed. Poor reporting, especially in the index test and reference standard domains, hampered conclusive judgement about the risk of bias. There was little consistency in the thresholds used in the included studies; therefore, common thresholds contained very sparse data, which prevented us from calculating summary points of accuracy estimates. With a fixed specificity of 86% (the median specificity), the estimated sensitivity derived from the median value of specificity using HSROC model was 87% (95% confidence interval [CI]: 78% to 96%). Using a prevalence of PH of 68%, which was the median among the included studies conducted mainly in tertiary hospitals, diagnosing a cohort of 1000 adult patients under suspicion of PH would result in 88 patients being undiagnosed with PH (false negatives) and 275 patients would avoid unnecessary referral for a right-heart catheterisation (true negatives). In addition, 592 of 1000 patients would receive an appropriate and timely referral for a right-heart catheterisation (true positives), while 45 patients would be wrongly considered to have PH (false positives). Conversely, when we assumed low prevalence of PH (10%), as in the case of preoperative examinations for liver transplantation, the number of false negatives and false positives would be 13 and 126, respectively.\nAuthors' conclusions\nOur evidence assessment of echocardiography for the diagnosis of PH in adult patients revealed several limitations. We were unable to determine the average sensitivity and specificity at any particular index test threshold and to explain the observed variability in results. The high heterogeneity of the collected data and the poor methodological quality would constrain the implementation of this result into clinical practice. Further studies relative to the accuracy of Doppler trans-thoracic echocardiography for the diagnosis of PH in adults, that apply a rigorous methodology for conducting diagnostic test accuracy studies, are needed.\n\nGiven the provided abstract, please respond to the following query: \"What was the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To evaluate evidence on the ability of echocardiography to identify pulmonary hypertension in adults compared to right-heart catheterisation."
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query-laysum | 3632 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetic ketoacidosis (DKA) is an acute, life-threatening complication of uncontrolled diabetes that mainly occurs in individuals with autoimmune type 1 diabetes, but it is not uncommon in some people with type 2 diabetes. The treatment of DKA is traditionally accomplished by the administration of intravenous infusion of regular insulin that is initiated in the emergency department and continued in an intensive care unit or a high-dependency unit environment. It is unclear whether people with DKA should be treated with other treatment modalities such as subcutaneous rapid-acting insulin analogues.\nObjectives\nTo assess the effects of subcutaneous rapid-acting insulin analogues for the treatment of diabetic ketoacidosis.\nSearch methods\nWe identified eligible trials by searching MEDLINE, PubMed, EMBASE, LILACS, CINAHL, and the Cochrane Library. We searched the trials registers WHO ICTRP Search Portal and ClinicalTrials.gov. The date of last search for all databases was 27 October 2015. We also examined reference lists of included randomised controlled trials (RCTs) and systematic reviews, and contacted trial authors.\nSelection criteria\nWe included trials if they were RCTs comparing subcutaneous rapid-acting insulin analogues versus standard intravenous infusion in participants with DKA of any age or sex with type 1 or type 2 diabetes, and in pregnant women.\nData collection and analysis\nTwo review authors independently extracted data, assessed studies for risk of bias, and evaluated overall study quality utilising the GRADE instrument. We assessed the statistical heterogeneity of included studies by visually inspecting forest plots and quantifying the diversity using the I² statistic. We synthesised data using random-effects model meta-analysis or descriptive analysis, as appropriate.\nMain results\nFive trials randomised 201 participants (110 participants to subcutaneous rapid-acting insulin analogues and 91 to intravenous regular insulin). The criteria for DKA were consistent with the American Diabetes Association criteria for mild or moderate DKA. The underlying cause of DKA was mostly poor compliance with diabetes therapy. Most trials did not report on type of diabetes. Younger diabetic participants and children were underrepresented in our included trials (one trial only). Four trials evaluated the effects of the rapid-acting insulin analogue lispro, and one the effects of the rapid-acting insulin analogue aspart. The mean follow-up period as measured by mean hospital stay ranged between two and seven days. Overall, risk of bias of the evaluated trials was unclear in many domains and high for performance bias for the outcome measure time to resolution of DKA.\nNo deaths were reported in the included trials (186 participants; 3 trials; moderate- (insulin lispro) to low-quality evidence (insulin aspart)). There was very low-quality evidence to evaluate the effects of subcutaneous insulin lispro versus intravenous regular insulin on the time to resolution of DKA: mean difference (MD) 0.2 h (95% CI -1.7 to 2.1); P = 0.81; 90 participants; 2 trials. In one trial involving children with DKA, the time to reach a glucose level of 250 mg/dL was similar between insulin lispro and intravenous regular insulin. There was very low-quality evidence to evaluate the effects of subcutaneous insulin aspart versus intravenous regular insulin on the time to resolution of DKA: MD -1 h (95% CI -3.2 to 1.2); P = 0.36; 30 participants; 1 trial. There was low-quality evidence to evaluate the effects of subcutaneous rapid-acting insulin analogues versus intravenous regular insulin on hypoglycaemic episodes: 6 of 80 insulin lispro-treated participants compared with 9 of 76 regular insulin-treated participants reported hypoglycaemic events; risk ratio (RR) 0.59 (95% CI 0.23 to 1.52); P = 0.28; 156 participants; 4 trials. For insulin aspart compared with regular insulin, RR for hypoglycaemic episodes was 1.00 (95% CI 0.07 to 14.55); P = 1.0; 30 participants; 1 trial; low-quality evidence. Socioeconomic effects as measured by length of mean hospital stay for insulin lispro compared with regular insulin showed a MD of -0.4 days (95% CI -1 to 0.2); P = 0.22; 90 participants; 2 trials; low-quality evidence and for insulin aspart compared with regular insulin 1.1 days (95% CI -3.3 to 1.1); P = 0.32; low-quality evidence. Data on morbidity were limited, but no specific events were reported for the comparison of insulin lispro with regular insulin. No trial reported on adverse events other than hypoglycaemic episodes, and no trial investigated patient satisfaction.\nAuthors' conclusions\nOur review, which provided mainly data on adults, suggests on the basis of mostly low- to very low-quality evidence that there are neither advantages nor disadvantages when comparing the effects of subcutaneous rapid-acting insulin analogues versus intravenous regular insulin for treating mild or moderate DKA.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found five randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with a total of 201 participants. Most trials did not report on type of diabetes. Younger diabetic participants and children were underrepresented in our included trials (one trial only). Participants in four trials received treatment with insulin lispro, and one trial with 45 participants investigated insulin aspart. The average follow-up as measured by mean hospital stay ranged between two and seven days. The study authors termed the diabetic ketoacidosis being treated with insulin analogues or regular insulin as mild or moderate. This evidence is up to date as of October 2015."
}
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query-laysum | 3633 | [
{
"role": "user",
"content": "Abstract: Background\nPain in the neonate is associated with acute behavioural and physiological changes. Cumulative pain is associated with morbidities, including adverse neurodevelopmental outcomes. Studies have shown a reduction in changes in physiological parameters and pain score measurements following pre-emptive analgesic administration in neonates experiencing pain or stress. Non-pharmacological measures (such as holding, swaddling and breastfeeding) and pharmacological measures (such as acetaminophen, sucrose and opioids) have been used for analgesia. This is an update of a review first published in 2006 and updated in 2012.\nObjectives\nThe primary objective was to evaluate the effectiveness of breastfeeding or supplemental breast milk in reducing procedural pain in neonates. The secondary objective was to conduct subgroup analyses based on the type of control intervention, gestational age and the amount of supplemental breast milk given.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL and trial registries (ICTRP, ISRCTN and clinicaltrials.gov) in August 2022; searches were limited from 2011 forwards. We checked the reference lists of included studies and relevant systematic reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs of breastfeeding or supplemental breast milk versus no treatment/other measures in neonates. We included both term (≥ 37 completed weeks postmenstrual age) and preterm infants (< 37 completed weeks' postmenstrual age) up to a maximum of 44 weeks' postmenstrual age. The study must have reported on either physiological markers of pain or validated pain scores.\nData collection and analysis\nWe assessed the methodological quality of the trials using the information provided in the studies and by personal communication with the authors. We extracted data on relevant outcomes, estimated the effect size and reported this as a mean difference (MD). We used the GRADE approach to assess the certainty of evidence.\nMain results\nOf the 66 included studies, 36 evaluated breastfeeding, 29 evaluated supplemental breast milk and one study compared them against each other. The procedures conducted in the studies were: heel lance (39), venipuncture (11), intramuscular vaccination (nine), eye examination for retinopathy of prematurity (four), suctioning (four) and adhesive tape removal as procedure (one). We noted marked heterogeneity in the control interventions and pain assessment measures amongst the studies. Since many studies included multiple arms with breastfeeding/supplemental breast milk as the main comparator, we were not able to synthesise all interventions together. Individual interventions are compared to breastfeeding/supplemental breast milk and reported. The numbers of studies/participants presented with the findings are not taken from pooled analyses (as is usual in Cochrane Reviews), but are the overall totals in each comparison.\nOverall, the included studies were at low risk of bias except for masking of intervention and outcome assessment, where nearly one-third of studies were at high risk of bias.\nBreastfeeding versus control\nBreastfeeding may reduce the increase in heart rate compared to holding by mother, skin-to-skin contact, bottle feeding mother's milk, moderate concentration of sucrose/glucose (20% to 33%) with skin-to-skin contact (low-certainty evidence, 8 studies, 784 participants).\nBreastfeeding likely reduces the duration of crying compared to no intervention, lying on table, rocking, heel warming, holding by mother, skin-to-skin contact, bottle feeding mother's milk and moderate concentration of glucose (moderate-certainty evidence, 16 studies, 1866 participants).\nBreastfeeding may reduce percentage time crying compared to holding by mother, skin-to-skin contact, bottle feeding mother's milk, moderate concentration sucrose and moderate concentration of sucrose with skin-to-skin contact (low-certainty evidence, 4 studies, 359 participants).\nBreastfeeding likely reduces the Neonatal Infant Pain Scale (NIPS) score compared to no intervention, holding by mother, heel warming, music, EMLA cream, moderate glucose concentration, swaddling, swaddling and holding (moderate-certainty evidence, 12 studies, 1432 participants).\nBreastfeeding may reduce the Neonatal Facial Coding System (NFCS) score compared to no intervention, holding, pacifier and moderate concentration of glucose (low-certainty evidence, 2 studies, 235 participants).\nBreastfeeding may reduce the Douleur Aigue Nouveau-né (DAN) score compared to positioning, holding or placebo (low-certainty evidence, 4 studies, 709 participants).\nIn the majority of the other comparisons there was little or no difference between the breastfeeding and control group in any of the outcome measures.\nSupplemental breast milk versus control\nSupplemental breast milk may reduce the increase in heart rate compared to water or no intervention (low-certainty evidence, 5 studies, 336 participants).\nSupplemental breast milk likely reduces the duration of crying compared to positioning, massage or placebo (moderate-certainty evidence, 11 studies, 1283 participants).\nSupplemental breast milk results in little or no difference in percentage time crying compared to placebo or glycine (low-certainty evidence, 1 study, 70 participants).\nSupplemental breast milk results in little or no difference in NIPS score compared to no intervention, pacifier, moderate concentration of sucrose, eye drops, gentle touch and verbal comfort, and breast milk odour and verbal comfort (low-certainty evidence, 3 studies, 291 participants).\nSupplemental breast milk may reduce NFCS score compared to glycine (overall low-certainty evidence, 1 study, 40 participants). DAN scores were lower when compared to massage and water; no different when compared to no intervention, EMLA and moderate concentration of sucrose; and higher when compared to rocking or pacifier (low-certainty evidence, 2 studies, 224 participants).\nDue to the high number of comparator interventions, other measures of pain were assessed in a very small number of studies in both comparisons, rendering the evidence of low certainty.\nThe majority of studies did not report on adverse events, considering the benign nature of the intervention. Those that reported on adverse events identified none in any participants.\nSubgroup analyses were not conducted due to the small number of studies.\nAuthors' conclusions\nModerate-/low-certainty evidence suggests that breastfeeding or supplemental breast milk may reduce pain in neonates undergoing painful procedures compared to no intervention/positioning/holding or placebo or non-pharmacological interventions. Low-certainty evidence suggests that moderate concentration (20% to 33%) glucose/sucrose may lead to little or no difference in reducing pain compared to breastfeeding. The effectiveness of breast milk for painful procedures should be studied in the preterm population, as there are currently a limited number of studies that have assessed its effectiveness in this population.\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 the medical literature thoroughly up to 1 August 2022 for studies that investigated the pain-relieving effect of breastfeeding or supplemental breast milk for minor medical procedures in newborn full-term and preterm neonates We included randomised trials only, as they provide the most reliable medical evidence. We identified 66 studies that reported on a total of more than 6200 infants in this Cochrane Review. Thirty-six studies evaluated breastfeeding, 29 studies evaluated supplemental breast milk, while one study compared both against each other. In over half of the studies, pain relief was during a heel prick procedure. In others, it was during vaccination, drawing blood from a vein or other procedures. The studies used a variety of comparative groups, for example, placebo, no intervention, maternal holding, skin-to-skin contact, similar volume of water, a pacifier, routine care, various concentrations of sucrose or glucose, 'facilitated tucking' (holding the infant in a flexed position with arms close to the body and hands placed to promote sucking), swaddling, heel warmth, anaesthetic cream for the skin, or a combination of these. The studies used a wide variety of pain scales as well as changes in heart rate and blood pressure and cry duration to assess pain."
}
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query-laysum | 3634 | [
{
"role": "user",
"content": "Abstract: Background\n'Standard Precautions' refers to a system of actions, such as using personal protective equipment or adhering to safe handling of needles, that healthcare workers take to reduce the spread of germs in healthcare settings such as hospitals and nursing homes.\nObjectives\nTo assess the effectiveness of interventions that target healthcare workers to improve adherence to Standard Precautions in patient care.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, two other databases, and two trials registers. We applied no language restrictions. The date of the most recent search was 14 February 2017.\nSelection criteria\nWe included randomised trials of individuals, cluster-randomised trials, non-randomised trials, controlled before-after studies, and interrupted time-series studies that evaluated any intervention to improve adherence to Standard Precautions by any healthcare worker with responsibility for patient care in any hospital, long-term care or community setting, or artificial setting, such as a classroom or a learning laboratory.\nData collection and analysis\nTwo review authors independently screened search results, extracted data from eligible trials, and assessed risk of bias for each included study, using standard methodological procedures expected by Cochrane. Because of substantial heterogeneity among interventions and outcome measures, meta-analysis was not warranted. We used the GRADE approach to assess certainty of evidence and have presented results narratively in 'Summary of findings' tables.\nMain results\nWe included eight studies with a total of 673 participants; three studies were conducted in Asia, two in Europe, two in North America, and one in Australia. Five studies were randomised trials, two were cluster-randomised trials, and one was a non-randomised trial. Three studies compared different educational approaches versus no education, one study compared education with visualisation of respiratory particle dispersion versus education alone, two studies compared education with additional infection control support versus no intervention, one study compared peer evaluation versus no intervention, and one study evaluated use of a checklist and coloured cues. We considered all studies to be at high risk of bias with different risks. All eight studies used different measures to assess healthcare workers' adherence to Standard Precautions. Three studies also assessed healthcare workers' knowledge, and one measured rates of colonisation with methicillin-resistant Staphylococcus aureus (MRSA) among residents and staff of long-term care facilities. Because of heterogeneity in interventions and outcome measures, we did not conduct a meta-analysis.\nEducation may slightly improve both healthcare workers' adherence to Standard Precautions (three studies; four centres) and their level of knowledge (two studies; three centres; low certainty of evidence for both outcomes).\nEducation with visualisation of respiratory particle dispersion probably improves healthcare workers' use of facial protection but probably leads to little or no difference in knowledge (one study; 20 nurses; moderate certainty of evidence for both outcomes).\nEducation with additional infection control support may slightly improve healthcare workers' adherence to Standard Precautions (two studies; 44 long-term care facilities; low certainty of evidence) but probably leads to little or no difference in rates of health care-associated colonisation with MRSA (one study; 32 long-term care facilities; moderate certainty of evidence).\nPeer evaluation probably improves healthcare workers' adherence to Standard Precautions (one study; one hospital; moderate certainty of evidence).\nChecklists and coloured cues probably improve healthcare workers' adherence to Standard Precautions (one study; one hospital; moderate certainty of evidence).\nAuthors' conclusions\nConsiderable variation in interventions and in outcome measures used, along with high risk of bias and variability in the certainty of evidence, makes it difficult to draw conclusions about effectiveness of the interventions. This review underlines the need to conduct more robust studies evaluating similar types of interventions and using similar outcome measures.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Review authors found eight relevant studies with a total of 673 participants. Three studies were reported from Asia, two from Europe, two from North America, and one from Australia. Intevention strategies consisted of education for healthcare workers, given alone or with other types of education, such as showing how respiratory droplets are spread, or with additional infection control supports. Other intervention strategies were peer evaluation and use of a checklist and coloured cues. All studies used different measures to assess how well healthcare workers followed or adhered to Standard Precautions. Two studies also assessed whether there was any improvement in healthcare workers' knowledge (of Standard Precautions), and one measured rates of colonisation of MRSA (carriage of MRSA with increased potential for infection) among residents and staff of long-term care facilities\nEducation showing spread of respiratory droplets, peer evaluation, and use of checklists and coloured cues probably improve adherence to Standard Precautions, and education alone and education with additional infection control support may slightly improve adherence to Standard Precautions.\nEducation alone may slightly improve knowledge, and education showing spread of respiratory droplets probably leads to little or no difference in knowledge. Education with additional infection control support probably leads to little or no difference in rates of MRSA colonisation."
}
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query-laysum | 3635 | [
{
"role": "user",
"content": "Abstract: Background\nMany nations require child-serving professionals to report known or suspected cases of significant child abuse and neglect to statutory child protection or safeguarding authorities. Considered globally, there are millions of professionals who fulfil these roles, and many more who will do so in future. Ensuring they are trained in reporting child abuse and neglect is a key priority for nations and organisations if efforts to address violence against children are to succeed.\nObjectives\nTo assess the effectiveness of training aimed at improving reporting of child abuse and neglect by professionals and to investigate possible components of effective training interventions.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, 18 other databases, and one trials register up to 4 June 2021. We also handsearched reference lists, selected journals, and websites, and circulated a request for studies to researchers via an email discussion list.\nSelection criteria\nAll randomised controlled trials (RCTs), quasi-RCTs, and controlled before-and-after studies examining the effects of training interventions for qualified professionals (e.g. teachers, childcare professionals, doctors, nurses, and mental health professionals) to improve reporting of child abuse and neglect, compared with no training, waitlist control, or alternative training (not related to child abuse and neglect).\nData collection and analysis\nWe used methodological procedures described in the Cochrane Handbook for Systematic Reviews of Interventions. We synthesised training effects in meta-analysis where possible and summarised findings for primary outcomes (number of reported cases of child abuse and neglect, quality of reported cases, adverse events) and secondary outcomes (knowledge, skills, and attitudes towards the reporting duty). We used the GRADE approach to rate the certainty of the evidence.\nMain results\nWe included 11 trials (1484 participants), using data from 9 of the 11 trials in quantitative synthesis. Trials took place in high-income countries, including the USA, Canada, and the Netherlands, with qualified professionals. In 8 of the 11 trials, interventions were delivered in face-to-face workshops or seminars, and in 3 trials interventions were delivered as self-paced e-learning modules. Interventions were developed by experts and delivered by specialist facilitators, content area experts, or interdisciplinary teams. Only 3 of the 11 included studies were conducted in the past 10 years.\nPrimary outcomes\nThree studies measured the number of cases of child abuse and neglect via participants’ self-report of actual cases reported, three months after training. The results of one study (42 participants) favoured the intervention over waitlist, but the evidence is very uncertain (standardised mean difference (SMD) 0.81, 95% confidence interval (CI) 0.18 to 1.43; very low-certainty evidence).\nThree studies measured the number of cases of child abuse and neglect via participants’ responses to hypothetical case vignettes immediately after training. A meta-analysis of two studies (87 participants) favoured training over no training or waitlist for training, but the evidence is very uncertain (SMD 1.81, 95% CI 1.30 to 2.32; very low-certainty evidence).\nWe identified no studies that measured the number of cases of child abuse and neglect via official records of reports made to child protection authorities, or adverse effects of training.\nSecondary outcomes\nFour studies measured professionals’ knowledge of reporting duty, processes, and procedures postintervention. The results of one study (744 participants) may favour the intervention over waitlist for training (SMD 1.06, 95% CI 0.90 to 1.21; low-certainty evidence).\nFour studies measured professionals' knowledge of core concepts in all forms of child abuse and neglect postintervention. A meta-analysis of two studies (154 participants) favoured training over no training, but the evidence is very uncertain (SMD 0.68, 95% CI 0.35 to 1.01; very low-certainty evidence).\nThree studies measured professionals' knowledge of core concepts in child sexual abuse postintervention. A meta-analysis of these three studies (238 participants) favoured training over no training or waitlist for training, but the evidence is very uncertain (SMD 1.44, 95% CI 0.43 to 2.45; very low-certainty evidence).\nOne study (25 participants) measured professionals' skill in distinguishing reportable and non-reportable cases postintervention. The results favoured the intervention over no training, but the evidence is very uncertain (SMD 0.94, 95% CI 0.11 to 1.77; very low-certainty evidence).\nTwo studies measured professionals' attitudes towards the duty to report child abuse and neglect postintervention. The results of one study (741 participants) favoured the intervention over waitlist, but the evidence is very uncertain (SMD 0.61, 95% CI 0.47 to 0.76; very low-certainty evidence).\nAuthors' conclusions\nThe studies included in this review suggest there may be evidence of improvements in training outcomes for professionals exposed to training compared with those who are not exposed. However, the evidence is very uncertain. We rated the certainty of evidence as low to very low, downgrading due to study design and reporting limitations. Our findings rest on a small number of largely older studies, confined to single professional groups. Whether similar effects would be seen for a wider range of professionals remains unknown. Considering the many professional groups with reporting duties, we strongly recommend further research to assess the effectiveness of training interventions, with a wider range of child-serving professionals. There is a need for larger trials that use appropriate methods for group allocation, and statistical methods to account for the delivery of training to professionals in workplace groups.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- Due to a lack of strong evidence, it is unclear whether child protection training is better than no training or alternative training (e.g. cultural sensitivity training) at improving professionals’ reporting of child abuse and neglect.\n- Larger, well-designed studies are needed to assess the effects of training with a wider range of professional groups.\n- Future research should compare face-to-face with e-learning interventions."
}
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query-laysum | 3636 | [
{
"role": "user",
"content": "Abstract: Background\nEndoscopic ultrasound (EUS) and magnetic resonance cholangiopancreatography (MRCP) are tests used in the diagnosis of common bile duct stones in patients suspected of having common bile duct stones prior to undergoing invasive treatment. There has been no systematic review of the accuracy of EUS and MRCP in the diagnosis of common bile duct stones using appropriate reference standards.\nObjectives\nTo determine and compare the accuracy of EUS and MRCP for the diagnosis of common bile duct stones.\nSearch methods\nWe searched MEDLINE, EMBASE, Science Citation Index Expanded, BIOSIS, and Clinicaltrials.gov until September 2012. We searched the references of included studies to identify further studies and of systematic reviews identified from various databases (Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA), Medion, and ARIF (Aggressive Research Intelligence Facility)). We did not restrict studies based on language or publication status, or whether data were collected prospectively or retrospectively.\nSelection criteria\nWe included studies that provided the number of true positives, false positives, false negatives, and true negatives for EUS or MRCP. We only accepted studies that confirmed the presence of common bile duct stones by extraction of the stones (irrespective of whether this was done by surgical or endoscopic methods) for a positive test, and absence of common bile duct stones by surgical or endoscopic negative exploration of the common bile duct or symptom free follow-up for at least six months for a negative test, as the reference standard in people suspected of having common bile duct stones. We included participants with or without prior diagnosis of cholelithiasis; with or without symptoms and complications of common bile duct stones, with or without prior treatment for common bile duct stones; and before or after cholecystectomy. At least two authors independently screened abstracts and selected studies for inclusion.\nData collection and analysis\nTwo authors independently collected the data from each study. We used the bivariate model to obtain pooled estimates of sensitivity and specificity.\nMain results\nWe included a total of 18 studies involving 2366 participants (976 participants with common bile duct stones and 1390 participants without common bile duct stones). Eleven studies evaluated EUS alone, and five studies evaluated MRCP alone. Two studies evaluated both tests. Most studies included patients who were suspected of having common bile duct stones based on abnormal liver function tests; abnormal transabdominal ultrasound; symptoms such as obstructive jaundice, cholangitis, or pancreatitis; or a combination of the above. The proportion of participants who had undergone cholecystectomy varied across studies. Not one of the studies was of high methodological quality. For EUS, the sensitivities ranged between 0.75 and 1.00 and the specificities ranged between 0.85 and 1.00. The summary sensitivity (95% confidence interval (CI)) and specificity (95% CI) of the 13 studies that evaluated EUS (1537 participants; 686 cases and 851 participants without common bile duct stones) were 0.95 (95% CI 0.91 to 0.97) and 0.97 (95% CI 0.94 to 0.99). For MRCP, the sensitivities ranged between 0.77 and 1.00 and the specificities ranged between 0.73 and 0.99. The summary sensitivity and specificity of the seven studies that evaluated MRCP (996 participants; 361 cases and 635 participants without common bile duct stones) were 0.93 (95% CI 0.87 to 0.96) and 0.96 (95% CI 0.90 to 0.98). There was no evidence of a difference in sensitivity or specificity between EUS and MRCP (P value = 0.5). From the included studies, at the median pre-test probability of common bile duct stones of 41% the post-test probabilities (with 95% CI) associated with positive and negative EUS test results were 0.96 (95% CI 0.92 to 0.98) and 0.03 (95% CI 0.02 to 0.06). At the same pre-test probability, the post-test probabilities associated with positive and negative MRCP test results were 0.94 (95% CI 0.87 to 0.97) and 0.05 (95% CI 0.03 to 0.09).\nAuthors' conclusions\nBoth EUS and MRCP have high diagnostic accuracy for detection of common bile duct stones. People with positive EUS or MRCP should undergo endoscopic or surgical extraction of common bile duct stones and those with negative EUS or MRCP do not need further invasive tests. However, if the symptoms persist, further investigations will be indicated. The two tests are similar in terms of diagnostic accuracy and the choice of which test to use will be informed by availability and contra-indications to each test. However, it should be noted that the results are based on studies of poor methodological quality and so the results should be interpreted with caution. Further studies that are of high methodological quality are necessary to determine the diagnostic accuracy of EUS and MRCP for the diagnosis of common bile duct stones.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We performed a thorough search for studies that reported the accuracy of EUS or MRCP in the diagnosis of CBD stones. We included a total of 18 studies involving 2532 participants. Eleven studies evaluated EUS alone, five studies evaluated MRCP alone, and two studies evaluated both tests. A total of 1537 participants were included in the 13 studies that evaluated EUS and 995 participants were included in the seven studies that evaluated MRCP. Most studies included patients who were suspected of having CBD stones based on abnormal blood tests, abnormal ultrasound, or symptoms such as jaundice or pancreatitis, or a combination of the above. The proportion of participants who had undergone previous gallbladder removal varied across studies."
}
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query-laysum | 3637 | [
{
"role": "user",
"content": "Abstract: Background\nIn myasthenia gravis, antibody-mediated blockade of acetylcholine receptors at the neuromuscular junction abolishes the naturally occurring ‘safety factor’ of synaptic transmission. Acetylcholinesterase inhibitors provide temporary symptomatic treatment of muscle weakness but there is controversy about their long-term efficacy, dosage and side effects. This is the second update of a review published in The Cochrane Library Issue 2, 2011.\nObjectives\nTo evaluate the efficacy of acetylcholinesterase inhibitors in all forms of myasthenia gravis.\nSearch methods\nOn 8 July 2014 we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL, MEDLINE and EMBASE for randomised controlled trials and quasi-randomised controlled trials regarding usage of acetylcholinesterase inhibitors in myasthenia gravis. Two authors scanned the articles for any study eligible for inclusion. We also contacted the authors and known experts in the field to identify additional published or unpublished data and searched clinical trials registries for ongoing trials.\nSelection criteria\nThe types of studies were randomised or quasi-randomised trials. Participants were myasthenia gravis patients diagnosed by an internationally accepted definition. The intervention was treatment with any form of acetylcholinesterase inhibitor.\nTypes of outcome measures\nPrimary outcome measure\nImprovement in the presenting symptoms within one to 14 days of the start of treatment.\nSecondary outcome measures\n(1) Improvement in the presenting symptoms more than 14 days after the start of treatment.\n(2) Change in impairment measured by a recognised and preferably validated scale, such as the quantitative myasthenia gravis score, within one to 14 days and more than 14 days after the start of treatment.\n(3) Myasthenia Gravis Association of America post-intervention status more than 14 days after start of treatment.\n(4) Adverse events including muscarinic side effects.\nData collection and analysis\nOne author (MMM) extracted the data, which were checked by a second author. We contacted study authors for extra information and collected data on adverse effects from the trials.\nMain results\nWe did not find any large randomised or quasi-randomised trials of acetylcholinesterase inhibitors in generalised myasthenia gravis either for the first version of this review or this update. One cross-over randomised trial using intranasal neostigmine in a total of 10 participants was only available as an abstract. It included three participants with ocular myasthenia gravis and seven with generalised myasthenia gravis. Symptoms of myasthenia gravis (measured as improvement in at least one muscle function) improved in nine of the 10 participants after the two-week neostigmine treatment phase. No participant improved after the placebo phase. Lack of detail in the report meant that the risk of bias was unclear. Adverse events were minor.\nAuthors' conclusions\nExcept for one small and inconclusive trial of intranasal neostigmine, no other randomised controlled trials have been conducted on the use of acetylcholinesterase inhibitors in myasthenia gravis. The response to acetylcholinesterase inhibitors in observational studies is so clear that a randomised controlled trial depriving participants in a placebo arm of treatment would be difficult to justify.\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": "Myasthenia gravis is a rare autoimmune condition in which antibodies produced by the immune system attack the connection between nerves and muscles (the neuromuscular junction). Nerve impulses become blocked, causing muscles to become weak and easily tired. Symptoms fluctuate in severity. Acetylcholine is a chemical messenger that carries signals between nerve and muscle. An enzyme called acetylcholinesterase breaks down acetylcholine. Some drugs that are used to treat myasthenia gravis act on acetylcholinesterase to stop the breakdown of acetylcholine. These acetylcholinesterase inhibitors increase the amount of acetylcholine available and so help muscle activation and contraction."
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query-laysum | 3638 | [
{
"role": "user",
"content": "Abstract: Background\nEar discharge (otorrhoea) is common in children with grommets (ventilation/tympanostomy tubes); the proportion of children developing discharge ranges from 25% to 75%. The most common treatment strategies include oral broad-spectrum antibiotics, antibiotic eardrops or those containing a combination of antibiotic(s) and a corticosteroid, and initial observation. Important drivers for one strategy over the other are concerns over the side effects of oral antibiotics and the potential ototoxicity of antibiotic eardrops.\nObjectives\nTo assess the benefits and harms of current treatment strategies for children with ear discharge occurring at least two weeks following grommet (ventilation tube) insertion.\nSearch methods\nThe Cochrane ENT Information Specialist searched the ENT Trials Register, CENTRAL (2016, Issue 5), multiple databases and additional sources for published and unpublished trials (search date 23 June 2016).\nSelection criteria\nRandomised controlled trials comparing at least two of the following: oral antibiotics, oral corticosteroids, antibiotic eardrops (with or without corticosteroid), corticosteroid eardrops, microsuction cleaning of the ear canal, saline rinsing of the ear canal, placebo or no treatment. The main comparison of interest was antibiotic eardrops (with or without corticosteroid) versus oral antibiotics.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Primary outcomes were: proportion of children with resolution of ear discharge at short-term follow-up (less than two weeks), adverse events and serious complications. Secondary outcomes were: proportion of children with resolution of ear discharge at intermediate- (two to four weeks) and long-term (four to 12 weeks) follow-up, proportion of children with resolution of ear pain and fever at short-term follow-up, duration of ear discharge, proportion of children with chronic ear discharge, ear discharge recurrences, tube blockage, tube extrusion, health-related quality of life and hearing. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included nine studies, evaluating a range of treatments, with 2132 children who developed acute ear discharge beyond the immediate postoperative period. We judged the risk of bias to be low to moderate in most studies.\nAntibiotic eardrops (with or without corticosteroid) versus oral antibiotics\nAntibiotic eardrops with or without corticosteroid were more effective than oral antibiotics in terms of:\n- resolution of discharge at one week (one study, 42 children, ciprofloxacin eardrops versus amoxicillin: 77% versus 30%; risk ratio (RR) 2.58, 95% confidence interval (CI) 1.27 to 5.22; moderate-quality evidence);\n- resolution of discharge at two weeks (one study, 153 children, bacitracin-colistin-hydrocortisone eardrops versus amoxicillin-clavulanate: 95% versus 56%; RR 1.70, 95% CI 1.38 to 2.08; moderate-quality evidence);\n- duration of discharge (two studies, 233 children, ciprofloxacin eardrops versus amoxicillin: median 4 days versus 7 days and bacitracin-colistin-hydrocortisone eardrops versus amoxicillin-clavulanate: 4 days versus 5 days; moderate-quality evidence);\n- ear discharge recurrences (one study, 148 children, bacitracin-colistin-hydrocortisone eardrops versus amoxicillin-clavulanate: 0 versus 1 episode at six months; low-quality evidence); and\n- disease-specific quality of life (one study, 153 children, bacitracin-colistin-hydrocortisone eardrops versus amoxicillin-clavulanate: difference in change in median Otitis Media-6 total score (range 6 to 42) at two weeks: -2; low-quality evidence).\nWe found no evidence that antibiotic eardrops were more effective in terms of the proportion of children developing chronic ear discharge or tube blockage, generic quality of life or hearing.\nAdverse events occurred at similar rates in children treated with antibiotic eardrops and those treated with oral antibiotics, while no serious complications occurred in either of the groups.\nOther comparisons\n(a) Antibiotic eardrops with or without corticosteroid were more effective thancorticosteroid eardrops in terms of:\n- duration of ear discharge (one study, 331 children, ciprofloxacin versus ciprofloxacin-fluocinolone acetonide versus fluocinolone acetonide eardrops: median 5 days versus 7 days versus 22 days; moderate-quality evidence).\n(b) Antibiotic eardrops were more effective than saline rinsing of the ear canal in terms of:\n- resolution of ear discharge at one week (one study, 48 children, ciprofloxacin eardrops versus saline rinsing: 77% versus 46%; RR 1.67, 95% CI 1.04 to 2.69; moderate-quality evidence);\nbut not in terms of tube blockage. Since the lower limit of the 95% CI for the effect size for resolution of ear discharge at one week approaches unity, a trivial or clinically irrelevant difference cannot be excluded.\n(c) Eardrops containing two antibiotics and a corticosteroid (bacitracin-colistin-hydrocortisone) were more effective than no treatment in terms of:\n- resolution of discharge at two weeks (one study; 151 children: 95% versus 45%; RR 2.09, 95% CI 1.62 to 2.69; moderate-quality evidence);\n- duration of discharge (one study; 147 children, median 4 days versus 12 days; moderate-quality evidence);\n- chronic discharge (one study; 147 children; RR 0.08, 95% CI 0.01 to 0.62; low-quality evidence); and\n- disease-specific quality of life (one study, 153 children, difference in change in median Otitis Media-6 total score (range 6 to 42) between groups at two weeks: -1.5; low-quality evidence).\nWe found no evidence that antibiotic eardrops were more effective in terms of ear discharge recurrences or generic quality of life.\n(d) Eardrops containing a combination of an antibiotic and a corticosteroid were more effective than eardrops containing antibiotics (low-quality evidence) in terms of:\n- resolution of ear discharge at short-term follow-up (two studies, 590 children: 35% versus 20%; RR 1.76, 95% CI 1.33 to 2.31); and\n- duration of discharge (three studies, 813 children);\nbut not in terms of resolution of discharge at intermediate-term follow-up or proportion of children with tube blockage. However, there is a substantial risk of publication bias, therefore these findings should be interpreted with caution.\nAuthors' conclusions\nWe found moderate to low-quality evidence that antibiotic eardrops (with or without corticosteroid) are more effective than oral antibiotics, corticosteroid eardrops and no treatment in children with ear discharge occurring at least two weeks following grommet insertion. There is some limited, inconclusive evidence that antibiotic eardrops are more effective than saline rinsing. There is uncertainty whether antibiotic-corticosteroid eardrops are more effective than eardrops containing antibiotics only.\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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"content": "This review includes evidence up to 23 June 2016. We included nine studies with a total of 2132 children who developed acute ear discharge beyond the immediate postoperative period. The studies evaluated a range of treatments."
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