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query-laysum | 2728 | [
{
"role": "user",
"content": "Abstract: Background\nDental implants are used for replacing missing teeth. Placing dental implants is limited by the presence of adequate bone volume permitting their anchorage. Several bone augmentation procedures have been developed to solve this problem. Zygomatic implants are long screw-shaped implants developed as a partial or complete alternative to bone augmentation procedures for the severely atrophic maxilla. One to three zygomatic implants can be inserted through the posterior alveolar crest passing through the maxillary sinus, or externally to it, to engage the body of the zygomatic bone. A couple of conventional dental implants may also be needed in the frontal region of the maxilla to stabilise the prosthesis. The potential main advantages of zygomatic implants could be that bone grafting may not be needed and a fixed prosthesis could be fitted sooner. Another specific indication for zygomatic implants could be maxillary reconstruction after maxillectomy in cancer patients.\nObjectives\nTo assess the effects of zygomatic implants with and without bone augmenting procedures in comparison with conventional dental implants in augmented bone for the rehabilitation with implant-supported prostheses of severely resorbed maxillae.\nSearch methods\nWe searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 17 June 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 5), MEDLINE via OVID (1946 to 17 June 2013) and EMBASE via OVID (1980 to 17 June 2013). Personal contacts and all known zygomatic implant manufacturers were contacted to identify unpublished trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials (RCTs) including participants with severely resorbed maxillae, who could not be rehabilitated with conventional dental implants, treated with zygomatic implants with and without bone grafts versus participants treated with bone augmentation procedures and conventional dental implants, with a follow-up of at least one year in function.\nData collection and analysis\nTwo review authors would have extracted data from eligible studies and assessed their risk of bias independently and in duplicate. The results of included studies were to be combined in meta-analyses using random-effects models where there were more than four studies, and fixed-effect models where there were less than four studies. We would have expressed the estimate of the intervention effect as mean difference for continuous outcomes and risk ratio for dichotomous outcomes, with 95% confidence intervals. Heterogeneity was to be investigated including both clinical and methodological factors.\nMain results\nWe did not identify any RCTs which were eligible for inclusion in this review.\nAuthors' conclusions\nThere is a need for RCTs in this area to assess whether zygomatic implants offer some advantages over alternative bone augmentation techniques for treating atrophic maxillae.\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": "A search was done on 17 June 2013 and the review team found no trials comparing the outcomes of zygomatic implants with conventional bone grafting."
}
]
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query-laysum | 2729 | [
{
"role": "user",
"content": "Abstract: Background\nSchizophrenia is a chronic, disabling and severe mental disorder, characterised by disturbance in perception, thought, language, affect and motor behaviour. Chlorpromazine and clotiapine are among antipsychotic drugs used for the treatment of people with schizophrenia.\nObjectives\nTo determine the clinical effects, safety and cost-effectiveness of chlorpromazine compared with clotiapine for adults with schizophrenia.\nSearch methods\nWe searched Cochrane Schizophrenia's Trials Register (last update search 16/01/2016), which is based on regular searches of CINAHL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO and clinical trials registries. There are no language, date, document type, or publication status limitations for inclusion of records in the Register.\nSelection criteria\nAll randomised clinical trials focusing on chlorpromazine versus clotiapine for schizophrenia. We included trials meeting our selection criteria and reporting useable data.\nData collection and analysis\nWe extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a random-effects model for analyses. We assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE.\nMain results\nWe have included four studies, published between 1974 and 2003, randomising 276 people with schizophrenia to receive either chlorpromazine or clotiapine. The studies were poor at concealing allocation of treatment and blinding of outcome assessment. Our main outcomes of interest were clinically important change in global and mental state, specific change in negative symptoms, incidence of movement disorder (dyskinesia), leaving the study early for any reason, and costs. All reported data were short-term (under six months' follow-up).\nThe trials did not report data for the important outcomes of clinically important change in global or mental state, or cost of care. Improvement in mental state was reported using the Positive and Negative Syndrome Scale (PANSS). When chlorpromazine was compared with clotiapine the average improvement scores for mental state using the PANSS total was higher in the clotiapine group (1 RCT, N = 31, MD 11.50 95% CI 9.42 to 13.58, very low-quality evidence). The average change scores on the PANSS negative sub-scale were similar between treatment groups (1 RCT, N = 21, MD -0.97 95% CI -2.76 to 0.82, very low-quality evidence). There was no clear difference in incidence of dyskinesia (1 RCT, N = 68, RR 3.00 95% CI 0.13 to 71.15, very low-quality evidence). Similar numbers of participants left the study early from each treatment group (3 RCTs, N = 158, RR 0.68 95% CI 0.24 to 1.88, very low-quality evidence).\nAuthors' conclusions\nClinically important changes in global and mental state were not reported. Only one trial reported the average change in overall mental state; results favour clotiapine but these limited data are very difficult to trust due to methodological limitations of the study. The comparative effectiveness of chlorpromazine compared to clotiapine on change in global state remains unanswered. Results in this review suggest chlorpromazine and clotiapine cause similar adverse effects, although again, the quality of evidence for this is poor, making firm conclusions difficult.\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": "The aim of this review was to find good quality evidence comparing the efficacy of chlorpromazine versus clotiapine for schizophrenia."
}
]
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query-laysum | 2730 | [
{
"role": "user",
"content": "Abstract: Background\nHaemophilia is a genetic disorder characterized by spontaneous or provoked, often uncontrolled, bleeding into joints, muscles and other soft tissues. Current methods of treatment are expensive, challenging and involve regular administration of clotting factors. Gene therapy for haemophilia is a curative treatment modality currently under investigation. This is an update of a published Cochrane Review.\nObjectives\nTo evaluate the safety and efficacy of gene therapy for treating people with haemophilia A or B.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis & Genetic Disorders Group's Coagulopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews.\nDate of last search: 17 April 2020.\nSelection criteria\nEligible trials include randomised or quasi-randomised clinical trials, including controlled clinical trials comparing gene therapy (with or without standard treatment) with standard treatment (factor replacement) or other 'curative' treatment such as stem cell transplantation for individuals with haemophilia A or B of all ages who do not have inhibitors to factor VIII or IX.\nData collection and analysis\nNo trials of gene therapy for haemophilia matching the inclusion criteria were identified.\nMain results\nNo trials of gene therapy for haemophilia matching the inclusion criteria were identified.\nAuthors' conclusions\nNo randomised or quasi-randomised clinical trials of gene therapy for haemophilia were identified. Thus, we are unable to determine the safety and efficacy of gene therapy for haemophilia. Gene therapy for haemophilia is still in clinical investigation and there is a need for well-designed clinical trials to assess the long-term feasibility, success and risks of gene therapy for people with haemophilia.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to: 17 April 2020."
}
]
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query-laysum | 2731 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the Cochrane systematic review of shared decision-making (SMD) making published in 2013. Children's rights to have their views heard in matters that affect their lives are now well established since the publication of the UN Convention treaty (1989). Children with cancer generally prefer to be involved in decision-making and consider it important that they have the opportunity to take part in decision-making concerning their health care, even in end-of-life decisions. There is considerable support for involving children in healthcare decision-making at a level commensurate with their experience, age and abilities. Thus, healthcare professionals and parents need to know how they should involve children in decision-making and what interventions are most effective in promoting SDM for children with cancer.\nObjectives\nTo examine the effects of SDM interventions on the process of SDM for children with cancer who are aged four to 18 years.\nSearch methods\nWe searched the following sources for the review: Cochrane Central Register of Controlled Studies (CENTRAL) (the Cochrane Library 2016, Issue 1); PubMed (NLM) (1946 to February 2016); Embase (Ovid) (1974 to February 2016); CINAHL (EBSCO) (1982 to February 2016); ERIC (ProQuest) (1966 to February 2016); PsycINFO (EBSCO) (1806 to February 2016); BIOSIS (Thomson Reuters) (1980 to December 2009 - subscription ceased at that date); ProQuest Dissertations and Theses (1637 to February 2016); and Sociological Abstracts (ProQuest) (1952 to February 2016). In addition we searched the reference lists of relevant articles and review articles and the following conference proceedings (2005 up to and including 2015): American Academy on Communication in Healthcare (AACH), European Society for Medical Oncology (ESMO), European CanCer Organisation (ECCO), European Association for Communication in Healthcare (EACH), International Conference on Communication in Healthcare (ICCH), International Shared Decision Making Conference (ISDM), Annual Conference of the International Society for Paediatric Oncology (SIOP) and Annual Scientific Meeting of the Society for Medical Decision Making (SMDM). We scanned the ISRCTN (International Standard Randomised Controlled Trial Number) register and the National Institutes of Health (NIH) Register for ongoing trials on 29 February 2016.\nSelection criteria\nFor this update, we included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) of SDM interventions for children with cancer aged four to 18 years. The types of decisions included were: treatment, health care and research participation decisions. The primary outcome was SDM as measured with any validated scale.\nData collection and analysis\nTwo review authors undertook the searches, and three review authors independently assessed the studies obtained. We contacted study authors for additional information.\nMain results\nNo studies met the inclusion criteria, and hence no analysis could be undertaken.\nAuthors' conclusions\nNo conclusions can be made on the effects of interventions to promote SDM for children with cancer aged four to 18 years. This review has highlighted the dearth of high-quality quantitative research on interventions to promote participation in SDM for children with cancer. There are many potential reasons for the lack of SDM intervention studies with children. Attitudes towards children's participation are slowly changing in society and such changes may take time to be translated or adopted in healthcare settings. The priority may be on developing interventions that promote children's participation in communication interactions since information-sharing is a prerequisite for SDM. Restricting this review to RCTs was a limitation and extending the review to non-randomised studies (NRS) may have produced more evidence. For this update, we included only RCTs and CCTs. Clearly more research is needed.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about what helps children with cancer to take part in decisions about their health care. We found no studies."
}
]
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query-laysum | 2732 | [
{
"role": "user",
"content": "Abstract: Background\nPelvic organ prolapse (POP) affects as many as 50% of parous women, with 14% to 19% of women undergoing a surgical correction. Although surgery for the treatment of POP is common, limited supportive data can be found in the literature regarding the preoperative and postoperative interventions related to these procedures. The main goal of perioperative interventions is to reduce the rate of adverse events while improving women's outcomes following surgical intervention for prolapse. A broad spectrum of perioperative interventions are available, and although the benefits of interventions such as prophylactic antibiotics before abdominal surgery are well established, others are unique to women undergoing POP surgeries and as such need to be investigated separately.\nObjectives\nThe aim of this review is to compare the safety and effectiveness of a range of perioperative interventions versus other interventions or no intervention (control group) at the time of surgery for pelvic organ prolapse.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In Process, ClinicalTrials.gov, WHO ICTRP, handsearching of journals and conference proceedings (searched 30 November 2017), and reference lists of relevant articles. We also contacted researchers in the field.\nSelection criteria\nWe included randomised controlled trials (RCTs) of women undergoing surgical treatment for symptomatic pelvic organ prolapse that compared a perioperative intervention related to pelvic organ prolapse surgery versus no treatment or another intervention.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Our primary outcomes were objective failure at any site and subjective postoperative prolapse symptoms. We also measured adverse effects, focusing on intraoperative blood loss and blood transfusion, intraoperative ureteral injury, and postoperative urinary tract infection.\nMain results\nWe included 15 RCTs that compared eight different interventions versus no treatment for 1992 women in five countries. Most interventions were assessed by only one RCT with evidence quality ranging from very low to moderate. The main limitation was imprecision, associated with small sample sizes and low event rates.\nPelvic floor muscle training (PFMT) compared with no treatment (three RCTs) - peri-operative intervention\nThe simplest of the PFMT programmes required women to attend six perioperative consultations in the three months surrounding prolapse surgery. Trial results provided no clear evidence of a difference between groups in objective failure at any site at 12 to 24 months (odds ratio (OR) 0.93, 95% confidence interval (CI) 0.56 to 1.54; two RCTs, 327 women; moderate-quality evidence). With respect to awareness of prolapse, findings were inconsistent. One RCT found no evidence of a difference between groups at 24 months (OR 1.07, 95% CI 0.61 to 1.87; one RCT, 305 women; low-quality evidence), and a second small RCT reported symptom reduction from the Pelvic Organ Prolapse Symptom Questionnaire completed by the intervention group at 12 months (mean difference (MD) -3.90, 95% CI -6.11 to -1.69; one RCT, 27 women; low-quality evidence). Researchers found no clear differences between groups at 24-month follow-up in rates of repeat surgery (or pessary) for prolapse (OR 1.92, 95% CI 0.74 to 5.02; one RCT, 316 women; low-quality evidence).\nOther interventions\nSingle RCTs evaluated the following interventions: preoperative guided imagery (N = 44); injection of vasoconstrictor agent at commencement of vaginal prolapse surgery (N = 76); ureteral stent placement during uterosacral ligament suspension (N = 91); vaginal pack (N = 116); prophylactic antibiotics for women requiring postoperative urinary catheterisation (N = 159); and postoperative vaginal dilators (N = 60).\nTwo RCTs evaluated bowel preparation (N = 298), and four RCTs assessed the method and timing of postoperative catheterisation (N = 514) - all in different comparisons.\nNone of these studies reported our primary review outcomes. One study reported intraoperative blood loss and suggested that vaginal injection of vasoconstrictors at commencement of surgery may reduce blood loss by a mean of about 30 mL. Another study reported intraoperative ureteral injury and found no clear evidence that ureteral stent placement reduces ureteral injury. Three RCTs reported postoperative urinary tract infection and found no conclusive evidence that rates of urinary tract infection were influenced by use of a vaginal pack, prophylactic antibiotics, or vaginal dilators. Other studies did not report these outcomes.\nAuthors' conclusions\nThere was a paucity of data about perioperative interventions in pelvic organ prolapse surgery. A structured programme of pelvic floor muscle training before and after prolapse surgery did not consistently demonstrate any benefit for the intervention; however, this finding is based on the results of two small studies. With regard to other interventions (preoperative bowel preparation and injection of vasoconstrictor agent, ureteral stent placement during uterosacral ligament suspension, postoperative vaginal pack insertion, use of vaginal dilators, prophylactic antibiotics for postoperative catheter care), we found no evidence regarding rates of recurrent prolapse and no clear evidence that these interventions were associated with clinically meaningful reductions in adverse effects, such as intraoperative or postoperative blood transfusion, intraoperative ureteral injury, or postoperative urinary tract infection.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence ranged from very low to moderate. The main limitation was imprecision, associated with small sample sizes and low event rates."
}
]
|
query-laysum | 2733 | [
{
"role": "user",
"content": "Abstract: Background\nThe pharmacological profiles and mechanisms of antidepressants are varied. However, there are common reasons why they might help people to stop smoking tobacco: nicotine withdrawal can produce short-term low mood that antidepressants may relieve; and some antidepressants may have a specific effect on neural pathways or receptors that underlie nicotine addiction.\nObjectives\nTo assess the evidence for the efficacy, harms, and tolerability of medications with antidepressant properties in assisting long-term tobacco smoking cessation in people who smoke cigarettes.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialised Register, most recently on 29 April 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) in people who smoked, comparing antidepressant medications with placebo or no pharmacological treatment, an alternative pharmacotherapy, or the same medication used differently. We excluded trials with fewer than six months of follow-up from efficacy analyses. We included trials with any follow-up length for our analyses of harms.\nData collection and analysis\nWe extracted data and assessed risk of bias using standard Cochrane methods.\nOur primary outcome measure was smoking cessation after at least six months' follow-up. We used the most rigorous definition of abstinence available in each trial, and biochemically validated rates if available. Our secondary outcomes were harms and tolerance outcomes, including adverse events (AEs), serious adverse events (SAEs), psychiatric AEs, seizures, overdoses, suicide attempts, death by suicide, all-cause mortality, and trial dropouts due to treatment. We carried out meta-analyses where appropriate.\nMain results\nWe included a total of 124 studies (48,832 participants) in this review, with 10 new studies added to this update version. Most studies recruited adults from the community or from smoking cessation clinics; four studies focused on adolescents (with participants between 12 and 21 years old). We judged 34 studies to be at high risk of bias; however, restricting analyses only to studies at low or unclear risk of bias did not change clinical interpretation of the results.\nThere was high-certainty evidence that bupropion increased smoking cessation rates when compared to placebo or no pharmacological treatment (RR 1.60, 95% CI 1.49 to 1.72; I2 = 16%; 50 studies, 18,577 participants). There was moderate-certainty evidence that a combination of bupropion and varenicline may have resulted in superior quit rates to varenicline alone (RR 1.21, 95% CI 0.95 to 1.55; I2 = 15%; 3 studies, 1057 participants). However, there was insufficient evidence to establish whether a combination of bupropion and nicotine replacement therapy (NRT) resulted in superior quit rates to NRT alone (RR 1.17, 95% CI 0.95 to 1.44; I2 = 43%; 15 studies, 4117 participants; low-certainty evidence).\nThere was moderate-certainty evidence that participants taking bupropion were more likely to report SAEs than those taking placebo or no pharmacological treatment. However, results were imprecise and the CI also encompassed no difference (RR 1.16, 95% CI 0.90 to 1.48; I2 = 0%; 23 studies, 10,958 participants). Results were also imprecise when comparing SAEs between people randomised to a combination of bupropion and NRT versus NRT alone (RR 1.52, 95% CI 0.26 to 8.89; I2 = 0%; 4 studies, 657 participants) and randomised to bupropion plus varenicline versus varenicline alone (RR 1.23, 95% CI 0.63 to 2.42; I2 = 0%; 5 studies, 1268 participants). In both cases, we judged evidence to be of low certainty.\nThere was high-certainty evidence that bupropion resulted in more trial dropouts due to AEs than placebo or no pharmacological treatment (RR 1.44, 95% CI 1.27 to 1.65; I2 = 2%; 25 studies, 12,346 participants). However, there was insufficient evidence that bupropion combined with NRT versus NRT alone (RR 1.67, 95% CI 0.95 to 2.92; I2 = 0%; 3 studies, 737 participants) or bupropion combined with varenicline versus varenicline alone (RR 0.80, 95% CI 0.45 to 1.45; I2 = 0%; 4 studies, 1230 participants) had an impact on the number of dropouts due to treatment. In both cases, imprecision was substantial (we judged the evidence to be of low certainty for both comparisons).\nBupropion resulted in inferior smoking cessation rates to varenicline (RR 0.73, 95% CI 0.67 to 0.80; I2 = 0%; 9 studies, 7564 participants), and to combination NRT (RR 0.74, 95% CI 0.55 to 0.98; I2 = 0%; 2 studies; 720 participants). However, there was no clear evidence of a difference in efficacy between bupropion and single-form NRT (RR 1.03, 95% CI 0.93 to 1.13; I2 = 0%; 10 studies, 7613 participants). We also found evidence that nortriptyline aided smoking cessation when compared with placebo (RR 2.03, 95% CI 1.48 to 2.78; I2 = 16%; 6 studies, 975 participants), and some evidence that bupropion resulted in superior quit rates to nortriptyline (RR 1.30, 95% CI 0.93 to 1.82; I2 = 0%; 3 studies, 417 participants), although this result was subject to imprecision.\nFindings were sparse and inconsistent as to whether antidepressants, primarily bupropion and nortriptyline, had a particular benefit for people with current or previous depression.\nAuthors' conclusions\nThere is high-certainty evidence that bupropion can aid long-term smoking cessation. However, bupropion may increase SAEs (moderate-certainty evidence when compared to placebo/no pharmacological treatment). There is high-certainty evidence that people taking bupropion are more likely to discontinue treatment compared with people receiving placebo or no pharmacological treatment. Nortriptyline also appears to have a beneficial effect on smoking quit rates relative to placebo, although bupropion may be more effective. Evidence also suggests that bupropion may be as successful as single-form NRT in helping people to quit smoking, but less effective than combination NRT and varenicline. In most cases, a paucity of data made it difficult to draw conclusions regarding harms and tolerability.\nFurther studies investigating the efficacy of bupropion versus placebo are unlikely to change our interpretation of the effect, providing no clear justification for pursuing bupropion for smoking cessation over other licensed smoking cessation treatments; namely, NRT and varenicline. However, it is important that future studies of antidepressants for smoking cessation measure and report on harms and tolerability.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review includes 124 studies, including 48,832 participants, looking at how helpful and safe different antidepressants are when used to quit smoking. Most studies were conducted in adults who smoked tobacco, with and without a history of mental illness. Four studies recruited young people aged 12 to 21 years. Most participants were motivated to quit smoking."
}
]
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query-laysum | 2734 | [
{
"role": "user",
"content": "Abstract: Background\nHospital-acquired pneumonia is one of the most common hospital-acquired infections in children worldwide. Most of our understanding of hospital-acquired pneumonia in children is derived from adult studies. To our knowledge, no systematic review with meta-analysis has assessed the benefits and harms of different antibiotic regimens in neonates and children with hospital-acquired pneumonia.\nObjectives\nTo assess the beneficial and harmful effects of different antibiotic regimens for hospital-acquired pneumonia in neonates and children.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, three other databases, and two trial registers to February 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies.\nSelection criteria\nWe included randomised clinical trials comparing one antibiotic regimen with any other antibiotic regimen for hospital-acquired pneumonia in neonates and children.\nData collection and analysis\nThree review authors independently assessed studies for inclusion, extracted data, and assessed risk of bias. We assessed the certainty of the evidence using the GRADE approach. Our primary outcomes were all-cause mortality and serious adverse events; our secondary outcomes were health-related quality of life, pneumonia-related mortality, non-serious adverse events, and treatment failure. Our primary time point of interest was at maximum follow-up.\nMain results\nWe included four randomised clinical trials (84 participants). We assessed all trials as having high risk of bias.\nWe did not conduct any meta-analyses, as the included trials did not compare similar antibiotic regimens.\nEach of the four trials assessed a different comparison, as follows: cefepime versus ceftazidime; linezolid versus vancomycin; meropenem versus cefotaxime; and ceftobiprole versus cephalosporin.\nOnly one trial reported our primary outcomes of all-cause mortality and serious adverse events. Three trials reported our secondary outcome of treatment failure. Two trials primarily included community-acquired pneumonia and hospitalised children with bacterial infections, hence the children with hospital-acquired pneumonia constituted subgroups of the total sample sizes.\nWhere outcomes were reported, the certainty of the evidence was very low for each of the comparisons. We are unable to draw meaningful conclusions from the numerical results.\nNone of the included trials assessed health-related quality of life, pneumonia-related mortality, or non-serious adverse events.\nAuthors' conclusions\nThe relative beneficial and harmful effects of different antibiotic regimens remain unclear due to the very low certainty of the available evidence. The current evidence is insufficient to support any antibiotic regimen being superior to another. Randomised clinical trials assessing different antibiotic regimens for hospital-acquired pneumonia in children and neonates are warranted.\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 available evidence does not suggest that one antibiotic regimen is safer and more effective than another in treating newborns and children with hospital-acquired pneumonia. Further research is needed."
}
]
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query-laysum | 2735 | [
{
"role": "user",
"content": "Abstract: Background\nThere is a large body of evidence evaluating quality improvement (QI) programmes to improve care for adults living with diabetes. These programmes are often comprised of multiple QI strategies, which may be implemented in various combinations. Decision-makers planning to implement or evaluate a new QI programme, or both, need reliable evidence on the relative effectiveness of different QI strategies (individually and in combination) for different patient populations.\nObjectives\nTo update existing systematic reviews of diabetes QI programmes and apply novel meta-analytical techniques to estimate the effectiveness of QI strategies (individually and in combination) on diabetes quality of care.\nSearch methods\nWe searched databases (CENTRAL, MEDLINE, Embase and CINAHL) and trials registers (ClinicalTrials.gov and WHO ICTRP) to 4 June 2019. We conducted a top-up search to 23 September 2021; we screened these search results and 42 studies meeting our eligibility criteria are available in the awaiting classification section.\nSelection criteria\nWe included randomised trials that assessed a QI programme to improve care in outpatient settings for people living with diabetes. QI programmes needed to evaluate at least one system- or provider-targeted QI strategy alone or in combination with a patient-targeted strategy.\n- System-targeted: case management (CM); team changes (TC); electronic patient registry (EPR); facilitated relay of clinical information (FR); continuous quality improvement (CQI).\n- Provider-targeted: audit and feedback (AF); clinician education (CE); clinician reminders (CR); financial incentives (FI).\n- Patient-targeted: patient education (PE); promotion of self-management (PSM); patient reminders (PR). Patient-targeted QI strategies needed to occur with a minimum of one provider or system-targeted strategy.\nData collection and analysis\nWe dual-screened search results and abstracted data on study design, study population and QI strategies. We assessed the impact of the programmes on 13 measures of diabetes care, including: glycaemic control (e.g. mean glycated haemoglobin (HbA1c)); cardiovascular risk factor management (e.g. mean systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), proportion of people living with diabetes that quit smoking or receiving cardiovascular medications); and screening/prevention of microvascular complications (e.g. proportion of patients receiving retinopathy or foot screening); and harms (e.g. proportion of patients experiencing adverse hypoglycaemia or hyperglycaemia). We modelled the association of each QI strategy with outcomes using a series of hierarchical multivariable meta-regression models in a Bayesian framework. The previous version of this review identified that different strategies were more or less effective depending on baseline levels of outcomes. To explore this further, we extended the main additive model for continuous outcomes (HbA1c, SBP and LDL-C) to include an interaction term between each strategy and average baseline risk for each study (baseline thresholds were based on a data-driven approach; we used the median of all baseline values reported in the trials). Based on model diagnostics, the baseline interaction models for HbA1c, SBP and LDL-C performed better than the main model and are therefore presented as the primary analyses for these outcomes. Based on the model results, we qualitatively ordered each QI strategy within three tiers (Top, Middle, Bottom) based on its magnitude of effect relative to the other QI strategies, where 'Top' indicates that the QI strategy was likely one of the most effective strategies for that specific outcome. Secondary analyses explored the sensitivity of results to choices in model specification and priors.\nAdditional information about the methods and results of the review are available as Appendices in an online repository. This review will be maintained as a living systematic review; we will update our syntheses as more data become available.\nMain results\nWe identified 553 trials (428 patient-randomised and 125 cluster-randomised trials), including a total of 412,161 participants. Of the included studies, 66% involved people living with type 2 diabetes only. Participants were 50% female and the median age of participants was 58.4 years. The mean duration of follow-up was 12.5 months. HbA1c was the commonest reported outcome; screening outcomes and outcomes related to cardiovascular medications, smoking and harms were reported infrequently. The most frequently evaluated QI strategies across all study arms were PE, PSM and CM, while the least frequently evaluated QI strategies included AF, FI and CQI. Our confidence in the evidence is limited due to a lack of information on how studies were conducted.\nFour QI strategies (CM, TC, PE, PSM) were consistently identified as 'Top' across the majority of outcomes. All QI strategies were ranked as 'Top' for at least one key outcome. The majority of effects of individual QI strategies were modest, but when used in combination could result in meaningful population-level improvements across the majority of outcomes. The median number of QI strategies in multicomponent QI programmes was three.\nCombinations of the three most effective QI strategies were estimated to lead to the below effects:\n- PR + PSM + CE: decrease in HbA1c by 0.41% (credibility interval (CrI) -0.61 to -0.22) when baseline HbA1c < 8.3%;\n- CM + PE + EPR: decrease in HbA1c by 0.62% (CrI -0.84 to -0.39) when baseline HbA1c > 8.3%;\n- PE + TC + PSM: reduction in SBP by 2.14 mmHg (CrI -3.80 to -0.52) when baseline SBP < 136 mmHg;\n- CM + TC + PSM: reduction in SBP by 4.39 mmHg (CrI -6.20 to -2.56) when baseline SBP > 136 mmHg;\n- TC + PE + CM: LDL-C lowering of 5.73 mg/dL (CrI -7.93 to -3.61) when baseline LDL < 107 mg/dL;\n- TC + CM + CR: LDL-C lowering by 5.52 mg/dL (CrI -9.24 to -1.89) when baseline LDL > 107 mg/dL.\nAssuming a baseline screening rate of 50%, the three most effective QI strategies were estimated to lead to an absolute improvement of 33% in retinopathy screening (PE + PR + TC) and 38% absolute increase in foot screening (PE + TC + Other).\nAuthors' conclusions\nThere is a significant body of evidence about QI programmes to improve the management of diabetes. Multicomponent QI programmes for diabetes care (comprised of effective QI strategies) may achieve meaningful population-level improvements across the majority of outcomes. For health system decision-makers, the evidence summarised in this review can be used to identify strategies to include in QI programmes. For researchers, this synthesis identifies higher-priority QI strategies to examine in further research regarding how to optimise their evaluation and effects. We will maintain this as a living systematic review.\n\nGiven the provided abstract, please respond to the following query: \"Why is improving diabetes care important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Diabetes, a disorder of how sugar is managed by the body, can lead to complications such as heart disease and blindness. If people with diabetes get the best possible treatment, their risk for these and other diabetes-related complications will be lowered. Unfortunately, many people with diabetes do not get the best possible treatment."
}
]
|
query-laysum | 2736 | [
{
"role": "user",
"content": "Abstract: Background\nDual practice, whereby health workers hold two or more jobs, is a common phenomenon globally. In resource constrained low- and middle-income countries dual practice poses an ongoing threat to the efficiency, quality and equity of health services, especially in the public sector. Identifying effective interventions to manage dual practice is important.\nObjectives\nTo assess the effects of regulations implemented to manage dual practice.\nSearch methods\nDatabases searched included: The Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library. www.thecochranelibrary.com, including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (searched 26 May 2011); MEDLINE In-Process & Other Non-Indexed Citations May 24, 2011 (searched 26 May 2011); MEDLINE, Ovid (1948 to May week 2 2011) (searched 26 May 2011); EMBASE, Ovid (1980 to 2011 week 20) (searched 26 May 2011); Science Citation Index and Social Sciences Citation Index, ISI Web of Science (1975 to present) (searched 04 December 2009); LILACS (searched January 2010); and AIM (December 2009) (searched 18 December 2009).\nSelection criteria\nRandomized controlled trials, non-randomized controlled trials, controlled before-and-after studies and interrupted-time-series studies. Dual practice was defined as holding more than one job. Studies for inclusion were those focusing on interventions to manage dual practice among health professionals employed in the public health sector.\nData collection and analysis\nTwo review authors independently applied the criteria for inclusion and exclusion of studies when scanning the identified titles and abstracts. The same two review authors independently screened full reports of selected citations. At each stage, results were compared and discrepancies settled through discussion.\nMain results\nNo studies were found which were eligible for inclusion in this review.\nAuthors' conclusions\nThere is a need to rigorously evaluate the effects of interventions implemented to manage dual practice among health workers. However, there is still much that is unknown about dual practice itself. The designing of studies to evaluate the effects of interventions to manage dual practice could benefit from prior studies to assess the various manifestations of dual practice, their prevalence and their likely impacts on health services delivery. These findings would then inform the design of studies to evaluate interventions to manage dual practice.\n\nGiven the provided abstract, please respond to the following query: \"What happens when efforts are made to regulate dual practice?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "These efforts to regulate health worker dual practice have not been properly evaluated, therefore the review authors were not able to find any studies that met their stated requirements for types of study designs. The review shows that there is a huge gap in our knowledge about the effectiveness of policy interventions that attempt to regulate health worker dual practice."
}
]
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query-laysum | 2737 | [
{
"role": "user",
"content": "Abstract: Background\nThe prevalence of children diagnosed with thrombotic events has been increasing in the last decades. The most common thrombosis risk factor in neonates, infants and children is the placement of a central venous catheter (CVC). It is unknown if anticoagulation prophylaxis with low molecular weight heparin (LMWH) decreases CVC-related thrombosis in children. This is an update of the Cochrane Review published in 2014.\nObjectives\nTo determine the effect of LMWH prophylaxis on the incidence of CVC-related thrombosis and major and minor bleeding complications in children. Further objectives were to determine the effect of LMWH on occlusion of CVCs, number of days of CVC patency, episodes of catheter-related bloodstream infection (CRBSI), other side effects of LMWH (allergic reactions, abnormal coagulation profile, heparin-induced thrombocytopaenia and osteoporosis) and mortality during therapy.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 7 May 2019. We undertook reference checking of identified trials to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-randomised trials comparing LMWH to no prophylaxis (placebo or no treatment), or low-dose unfractionated heparin (UFH) either as continuous infusion or flushes (low-dose UFH aims to ensure the patency of the central line but has no systemic anticoagulation activity), given to prevent CVC-related thrombotic events in children. We selected studies conducted in children aged 0 to 18 years.\nData collection and analysis\nTwo review authors independently identified eligible studies, which were assessed for study methodology including bias, and extracted unadjusted data where available. In the data analysis step, all outcomes were analysed as binary or dichotomous outcomes. The effects of interventions were summarised with risk ratios (RR) and their respective 95% confidence intervals (CI). We assessed the certainty of evidence for each outcome using the GRADE approach.\nMain results\nOne additional study was included for this update bringing the total to two included studies (with 1135 participants). Both studies were open-label RCTs comparing LMWH with low-dose UFH to prevent CVC-related thrombosis in children. We identified no studies comparing LMWH with placebo or no treatment. Meta-analysis found insufficient evidence of an effect of LMWH prophylaxis in reducing the incidence of CVC-related thrombosis in children with CVC, compared to low-dose UFH (RR 0.68, 95% CI 0.27 to 1.75; 2 studies; 787 participants; low-certainty evidence). One study (158 participants) reported symptomatic and asymptomatic CVC-related thrombosis separately and detected no evidence of a difference between LMWH and low-dose UFH (RR 1.03, 95% CI 0.21 to 4.93; low-certainty evidence; RR 1.17, 95% CI 0.45 to 3.08; low-certainty evidence; for symptomatic and asymptomatic participants respectively). There was insufficient evidence to determine whether LMWH impacts the risk of major bleeding (RR 0.27, 95% CI 0.05 to 1.67; 2 studies; 813 participants; low-certainty evidence); or minor bleeding. One study reported minor bleeding in 53.3% of participants in the LMWH arm and in 44.7% of participants in the low-dose UFH arm (RR 1.20, 95% CI 0.91 to 1.58; 1 study; 158 participants; very low-certainty evidence), and the other study reported no minor bleeding in either group (RR: not estimable). Mortality during the study period was reported in one study, where two deaths occurred during the study period. Both were unrelated to thrombotic events and occurred in the low-dose UFH arm. The second study did not report mortality during therapy per arm but showed similar 5-year overall survival (low-certainty evidence). No additional adverse effects were reported. Other pre-specified outcomes (including CVC occlusion, patency and CRBSI) were not reported.\nAuthors' conclusions\nPooling data from two RCTs did not provide evidence to support the use of prophylactic LWMH for preventing CVC-related thrombosis in children (low-certainty evidence). Evidence was also insufficient to confirm or exclude a difference in the incidence of major and minor bleeding complications in the LMWH prophylaxis group compared to low-dose UFH (low and very low certainty respectively). No evidence of a clear difference in overall mortality was seen. Studies did not report on the outcomes catheter occlusion, days of catheter patency, episodes of CRBSI and other side effects of LMWH (allergic reactions, abnormal coagulation profile, heparin-induced thrombocytopaenia and osteoporosis). The certainty of the evidence was downgraded due to risk of bias of the included studies, imprecision and inconsistency, preventing conclusions in regards to the efficacy of LMWH prophylaxis to prevent CVC-related thrombosis in children.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We judged the certainty of the evidence to be low for blood clots, low for major bleeding, very low for minor bleeding, and low for mortality. The certainty of the evidence was low or very low because:\n⦁ there were differences in the way blood clots, bleeding and mortality were measured between studies;\n⦁ there were few studies and events; and\n⦁ the researchers and children in the studies knew who was receiving LMWH and who was not, which can influence results.\nIt is likely that future studies will have an important impact on our understanding of the role of LMWH to prevent blood clots and its side effects."
}
]
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query-laysum | 2738 | [
{
"role": "user",
"content": "Abstract: Background\nPsychotic disorders can lead some people to become agitated. Characterised by restlessness, excitability and irritability, this can result in verbal and physically aggressive behaviour - and both can be prolonged. Aggression within the psychiatric setting imposes a significant challenge to clinicians and risk to service users; it is a frequent cause for admission to inpatient facilities. If people continue to be aggressive it can lengthen hospitalisation. Haloperidol is used to treat people with long-term aggression.\nObjectives\nTo examine whether haloperidol alone, administered orally, intramuscularly or intravenously, is an effective treatment for long-term/persistent aggression in psychosis.\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register (July 2011 and April 2015).\nSelection criteria\nWe included randomised controlled trials (RCT) or double blind trials (implying randomisation) with useable data comparing haloperidol with another drug or placebo for people with psychosis and long-term/persistent aggression.\nData collection and analysis\nOne review author (AK) extracted data. For dichotomous data, one review author (AK) calculated risk ratios (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis based on a fixed-effect model. One review author (AK) assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE.\nMain results\nWe have no good-quality evidence of the absolute effectiveness of haloperidol for people with long-term aggression. One study randomising 110 chronically aggressive people to three different antipsychotic drugs met the inclusion criteria. When haloperidol was compared with olanzapine or clozapine, skewed data (n=83) at high risk of bias suggested some advantage in terms of scale scores of unclear clinical meaning for olanzapine/clozapine for 'total aggression'. Data were available for only one other outcome, leaving the study early. When compared with other antipsychotic drugs, people allocated to haloperidol were no more likely to leave the study (1 RCT, n=110, RR 1.37, CI 0.84 to 2.24, low-quality evidence). Although there were some data for the outcomes listed above, there were no data on most of the binary outcomes and none on service outcomes (use of hospital/police), satisfaction with treatment, acceptance of treatment, quality of life or economics.\nAuthors' conclusions\nOnly one study could be included and most data were heavily skewed, almost impossible to interpret and oflow quality. There were also some limitations in the study design with unclear description of allocation concealment and high risk of bias for selective reporting, so no firm conclusions can be made. This review shows how trials in this group of people are possible - albeit difficult. Further relevant trials are needed to evaluate use of haloperidol in treatment of long-term/persistent aggression in people living with psychosis.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of evidence available is low, only one study with a high risk of selective reporting of results provided data. No firm conclusions can be made until further good-quality data are available."
}
]
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query-laysum | 2739 | [
{
"role": "user",
"content": "Abstract: Background\nGestational diabetes with onset or first recognition during pregnancy is an increasing problem worldwide. Myo-inositol, an isomer of inositol, is a naturally occurring sugar commonly found in cereals, corn, legumes and meat. Myo-inositol is one of the intracellular mediators of the insulin signal and correlates with insulin sensitivity in type 2 diabetes. The potential beneficial effect of improving insulin sensitivity suggests that myo-inositol may be useful for women in preventing gestational diabetes. This is an update of a review first published in 2015.\nObjectives\nTo assess if antenatal dietary supplementation with myo-inositol is safe and effective, for the mother and fetus, in preventing gestational diabetes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, WHO ICTRP (17 March 2022) and the reference lists of retrieved studies.\nSelection criteria\nWe included published and unpublished randomised controlled trials (RCTs) including cluster-RCTs and conference abstracts, assessing the effects of myo-inositol for the prevention of gestational diabetes in pregnant women. We included studies that compared any dose of myo-inositol, alone or in a combination preparation, with no treatment, placebo or another intervention. Quasi-randomised and cross-over trials were not eligible. We excluded women with pre-existing type 1 or type 2 diabetes.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, assessed risk of bias and extracted the data. We checked the data for accuracy. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included seven RCTs (one conducted in Ireland, six conducted in Italy) reporting on 1319 women who were 10 weeks to 24 weeks pregnant at the start of the studies. The studies had relatively small sample sizes and the overall risk of bias was low.\nFor the primary maternal outcomes, meta-analysis showed that myo-inositol may reduce the incidence of gestational diabetes (risk ratio (RR) 0.53, 95% confidence interval (CI) 0.31 to 0.90; 6 studies, 1140 women) and hypertensive disorders of pregnancy (RR 0.34, 95% CI 0.19 to 0.61; 5 studies, 1052 women). However, the certainty of the evidence was low to very low. For the primary neonatal outcomes, only one study measured the risk of a large-for-gestational-age infant and found myo-inositol was associated with both appreciable benefit and harm (RR 1.40, 95% CI 0.65 to 3.02; 1 study, 234 infants; low-certainty evidence). None of the included studies reported on the other primary neonatal outcomes (perinatal mortality, mortality or morbidity composite).\nFor the secondary maternal outcomes, we are unclear about the effect of myo-inositol on weight gain during pregnancy (mean difference (MD) -0.25 kilogram (kg), 95% CI -1.26 to 0.75 kg; 4 studies, 831 women) and perineal trauma (RR 4.0, 95% CI 0.45 to 35.25; 1 study, 234 women) because the evidence was assessed as being very low-certainty. Further, myo-inositol may result in little to no difference in caesarean section (RR 0.91, 95% CI 0.77 to 1.07; 4 studies, 829 women; low-certainty evidence). None of the included studies reported on the other secondary maternal outcomes (postnatal depression and the development of subsequent type 2 diabetes mellitus). For the secondary neonatal outcomes, meta-analysis showed no neonatal hypoglycaemia (RR 3.07, 95% CI 0.90 to 10.52; 4 studies; 671 infants; very low-certainty evidence). However, myo-inositol may be associated with a reduction in the incidence of preterm birth (RR 0.35, 95% CI 0.17 to 0.70; 4 studies; 829 infants). There were insufficient data for a number of maternal and neonatal secondary outcomes, and no data were reported for any of the long-term childhood or adulthood outcomes, or for health service utilisation outcomes.\nAuthors' conclusions\nEvidence from seven studies shows that antenatal dietary supplementation with myo-inositol during pregnancy may reduce the incidence of gestational diabetes, hypertensive disorders of pregnancy and preterm birth. Limited data suggest that supplementation with myo-inositol may not reduce the risk of a large-for-gestational-age infant.\nThe current evidence is based on small studies that were not powered to detect differences in outcomes such as perinatal mortality and serious infant morbidity. Six of the included studies were conducted in Italy and one in Ireland, which raises concerns about the lack of generalisability to other settings. There is evidence of inconsistency among doses of myo-inositol, the timing of administration and study population. As a result, we downgraded the certainty of the evidence for many outcomes to low or very low certainty.\nFurther studies for this promising antenatal intervention for preventing gestational diabetes are encouraged and should include pregnant women of different ethnicities and varying risk factors. Myo-inositol at different doses, frequency and timing of administration, should be compared with placebo, diet and exercise, and pharmacological interventions. Long-term follow-up should be considered and outcomes should include potential harms, including 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"
},
{
"role": "assistant",
"content": "We searched for studies that compared myo-inositol (given alone or in combination with another treatment) with no treatment or another treatment. We compared and summarized the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes."
}
]
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query-laysum | 2740 | [
{
"role": "user",
"content": "Abstract: Background\nAcute respiratory distress syndrome (ARDS) is a significant cause of hospitalisation and death in young children. Positioning and mechanical ventilation have been regularly used to reduce respiratory distress and improve oxygenation in hospitalised patients. Due to the association of prone positioning (lying on the abdomen) with sudden infant death syndrome (SIDS) within the first six months, it is recommended that young infants be placed on their back (supine). However, prone positioning may be a non-invasive way of increasing oxygenation in individuals with acute respiratory distress, and offers a more significant survival advantage in those who are mechanically ventilated. There are substantial differences in respiratory mechanics between adults and infants. While the respiratory tract undergoes significant development within the first two years of life, differences in airway physiology between adults and children become less prominent by six to eight years old. However, there is a reduced risk of SIDS during artificial ventilation in hospitalised infants. Thus, an updated review focusing on positioning for infants and young children with ARDS is warranted. This is an update of a review published in 2005, 2009, and 2012.\nObjectives\nTo compare the effects of different body positions in hospitalised infants and children with acute respiratory distress syndrome aged between four weeks and 16 years.\nSearch methods\nWe searched CENTRAL, which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE, Embase, and CINAHL from January 2004 to July 2021.\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs comparing two or more positions for the management of infants and children hospitalised with ARDS.\nData collection and analysis\nTwo review authors independently extracted data from each study. We resolved differences by consensus, or referred to a third contributor to arbitrate. We analysed bivariate outcomes using an odds ratio (OR) and 95% confidence interval (CI). We analysed continuous outcomes using a mean difference (MD) and 95% CI. We used a fixed-effect model, unless heterogeneity was significant (I2 statistic > 50%), when we used a random-effects model.\nMain results\nWe included six trials: four cross-over trials, and two parallel randomised trials, with 198 participants aged between 4 weeks and 16 years, all but 15 of whom were mechanically ventilated. Four trials compared prone to supine positions. One trial compared the prone position to good-lung dependent (where the person lies on the side of the healthy lung, e.g. if the right lung was healthy, they were made to lie on the right side), and independent (or non-good-lung independent, where the person lies on the opposite side to the healthy lung, e.g. if the right lung was healthy, they were made to lie on the left side) position. One trial compared good-lung independent to good-lung dependent positions.\nWhen the prone (with ventilators) and supine positions were compared, there was no information on episodes of apnoea or mortality due to respiratory events. There was no conclusive result in oxygen saturation (SaO2; MD 0.40 mmHg, 95% CI -1.22 to 2.66; 1 trial, 30 participants; very low certainty evidence); blood gases, PCO2 (MD 3.0 mmHg, 95% CI -1.93 to 7.93; 1 trial, 99 participants; low certainty evidence), or PO2 (MD 2 mmHg, 95% CI -5.29 to 9.29; 1 trial, 99 participants; low certainty evidence); or lung function (PaO2/FiO2 ratio; MD 28.16 mmHg, 95% CI -9.92 to 66.24; 2 trials, 121 participants; very low certainty evidence). However, there was an improvement in oxygenation index (FiO2% X MPAW/ PaO2) with prone positioning in both the parallel trials (MD -2.42, 95% CI -3.60 to -1.25; 2 trials, 121 participants; very low certainty evidence), and the cross-over study (MD -8.13, 95% CI -15.01 to -1.25; 1 study, 20 participants).\nDerived indices of respiratory mechanics, such as tidal volume, respiratory rate, and positive end-expiratory pressure (PEEP) were reported. There was an apparent decrease in tidal volume between prone and supine groups in a parallel study (MD -0.60, 95% CI -1.05 to -0.15; 1 study, 84 participants; very low certainty evidence). When prone and supine positions were compared in a cross-over study, there were no conclusive results in respiratory compliance (MD 0.07, 95% CI -0.10 to 0.24; 1 study, 10 participants); changes in PEEP (MD -0.70 cm H2O, 95% CI -2.72 to 1.32; 1 study, 10 participants); or resistance (MD -0.00, 95% CI -0.05 to 0.04; 1 study, 10 participants).\nOne study reported adverse events. There were no conclusive results for potential harm between groups in extubation (OR 0.57, 95% CI 0.13 to 2.54; 1 trial, 102 participants; very low certainty evidence); obstructions of the endotracheal tube (OR 5.20, 95% CI 0.24 to 111.09; 1 trial, 102 participants; very low certainty evidence); pressure ulcers (OR 1.00, 95% CI 0.41 to 2.44; 1 trial, 102 participants; very low certainty evidence); and hypercapnia (high levels of arterial carbon dioxide; OR 3.06, 95% CI 0.12 to 76.88; 1 trial, 102 participants; very low certainty evidence).\nOne study (50 participants) compared supine positions to good-lung dependent and independent positions. There was no conclusive evidence that PaO2 was different between supine and good-lung dependent positioning (MD 3.44 mm Hg, 95% CI -23.12 to 30.00; 1 trial, 25 participants; very low certainty evidence). There was also no conclusive evidence for supine position and good-lung independent positioning (MD -2.78 mmHg, 95% CI -28.84, 23.28; 25 participants; very low certainty evidence); or between good-lung dependent and independent positioning (MD 6.22, 95% CI -21.25 to 33.69; 1 trial, 25 participants; very low certainty evidence).\nAs most trials did not describe how possible biases were addressed, the potential for bias in these findings is unclear.\nAuthors' conclusions\nAlthough included studies suggest that prone positioning may offer some advantage, there was little evidence to make definitive recommendations. There appears to be low certainty evidence that positioning improves oxygenation in mechanically ventilated children with ARDS. Due to the increased risk of SIDS with prone positioning and lung injury with artificial ventilation, it is recommended that hospitalised infants and children should only be placed in this position while under continuous cardiorespiratory monitoring.\n\nGiven the provided abstract, please respond to the following query: \"It is important to remember that these children were hospitalised, and on assisted breathing. Because of the association between lying on their abdomen and SIDS, children should not be positioned on their abdomen unless they are in hospital, and their breathing is constantly monitored.\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
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query-laysum | 2741 | [
{
"role": "user",
"content": "Abstract: Background\nAsthma is one of the most common reasons for hospital admission among children and constitutes a significant economic burden. Use of non-invasive positive pressure ventilation (NPPV) in the care of children with acute asthma has increased even though evidence supporting the intervention has been considered weak and clinical guidelines do not recommend the intervention. NPPV might be an effective intervention for acute asthma, but no systematic review has been conducted to assess the effects of NPPV as an add-on therapy to usual care in children with acute asthma.\nObjectives\nTo assess the benefits and harms of NPPV as an add-on therapy to usual care (e.g. bronchodilators and corticosteroids) in children with acute asthma.\nSearch methods\nWe identified trials from the Cochrane Airways Group Specialised Register (CAGR). The Register contains trial reports identified through systematic searches of bibliographic databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, AMED and PsycINFO, and by handsearching of respiratory journals and meeting abstracts. We also conducted a search of ClinicalTrials.gov (www.ClinicalTrials.gov) and the WHO trials portal (www.who.int/ictrp/en/). We searched all databases from their inception to February 2016, with no restriction on language of publication.\nSelection criteria\nWe included randomised clinical trials (RCTs) assessing NPPV as add-on therapy to usual care versus usual care for children (age < 18 years) hospitalised for an acute asthma attack.\nData collection and analysis\nTwo review authors independently screened titles and abstracts. We retrieved all relevant full-text study reports, independently screened the full text, identified trials for inclusion and identified and recorded reasons for exclusion of ineligible trials. We resolved disagreements through discussion or, if required, consulted a third review author. We recorded the selection process in sufficient detail to complete a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) flow diagram and 'Characteristics of excluded studies' table. We identified the risk of bias of included studies to reduce the risk of systematic error. We contacted relevant study authors when data were missing.\nMain results\nWe included two RCTs that randomised 20 participants to NPPV and 20 participants to control. We assessed both studies as having high risk of bias; both trials assessed effects of bilateral positive airway pressure (BiPAP). Neither trial used continuous positive airway pressure (CPAP). Controls received standard care. Investigators reported no deaths and no serious adverse events (Grades of Recommendation, Assessment, Development and Evaluation (GRADE): very low quality of evidence due to serious risk of bias and serious imprecision of results). Both trials showed a statistically significant reduction in symptom score. One trial did not report a standard deviation (SD), but by using an estimated SD, we found a statistically significantly reduced asthma symptom score (mean difference (MD) -2.50, 95% confidence interval (CI) -4.70 to -0.30, P = 0.03, 19 participants, GRADE: very low quality of evidence). In the other trial, NPPV was associated with a lower total symptom score (5.6 vs 1.9, 16 participants, very low quality of evidence) before cross-over, but investigators did not report an SD, nor could it be estimated from the first phase of the trial, before the cross-over. These gains could be clinically relevant, as a reduction of three or more points in symptom score is considered a clinically meaningful change. Researchers documented five dropouts (12.5%), four of which were due to intolerance to NPPV, and one to respiratory failure requiring intubation. Owing to insufficient reporting in the latter trial and use of different scoring systems, it was not possible to conduct a meta-analysis nor a Trial Sequential Analysis.\nAuthors' conclusions\nCurrent evidence does not permit confirmation or rejection of the effects of NPPV for acute asthma in children. Large RCTs with low risk of bias are warranted.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed available evidence on non-invasive positive pressure ventilation (NPPV) for children with acute asthma."
}
]
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query-laysum | 2742 | [
{
"role": "user",
"content": "Abstract: Background\nStrabismus (misalignment of the eyes) is a risk factor for impaired visual development both of visual acuity and of stereopsis. Detection of strabismus in the community by non-expert examiners may be performed using a number of different index tests that include direct measures of misalignment (corneal or fundus reflex tests), or indirect measures such as stereopsis and visual acuity. The reference test to detect strabismus by trained professionals is the cover‒uncover test.\nObjectives\nTo assess and compare the accuracy of tests, alone or in combination, for detection of strabismus in children aged 1 to 6 years, in a community setting by non-expert screeners or primary care professionals to inform healthcare commissioners setting up childhood screening programmes.\nSecondary objectives were to investigate sources of heterogeneity of diagnostic accuracy.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 12) (which contains the Cochrane Eyes and Vision Trials Register) in the Cochrane Library, the Health Technology Assessment Database (HTAD) in the Cochrane Library (2016, Issue 4), MEDLINE Ovid (1946 to 5 January 2017), Embase Ovid (1947 to 5 January 2017), CINAHL (January 1937 to 5 January 2017), Web of Science Conference Proceedings Citation Index-Science (CPCI-S) (January 1990 to 5 January 2017), BIOSIS Previews (January 1969 to 5 January 2017), MEDION (to 18 August 2014), the Aggressive Research Intelligence Facility database (ARIF) (to 5 January 2017), the ISRCTN registry (www.isrctn.com/editAdvancedSearch); searched 5 January 2017, ClinicalTrials.gov (www.clinicaltrials.gov); searched 5 January 2017 and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 5 January 2017. We did not use any date or language restrictions in the electronic searches for trials. In addition, orthoptic journals and conference proceedings without electronic listings were searched.\nSelection criteria\nAll prospective or retrospective population-based test accuracy studies of consecutive participants were included. Studies compared a single or combination of index tests with the reference test. Only those studies with sufficient data for analysis were included specifically to calculate sensitivity and specificity and determine diagnostic accuracy.\nParticipants were aged 1 to 6 years. Studies reporting participants outside this range were included if subgroup data were available.\nPermitted settings included population-based vision screening programmes or opportunistic screening programmes, such as those performed in schools.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. In brief, two review authors independently assessed titles and abstracts for eligibility and extracted the data, with a third senior author resolving any disagreement. We analysed data primarily for specificity and sensitivity.\nMain results\nOne study from a total of 1236 papers, abstracts and trials was eligible for inclusion with a total number of participants of 335 of which 271 completed both the screening test and the gold standard test. The screening test using an automated photoscreener had a sensitivity of 0.46 (95% confidence interval (CI) 0.19 to 0.75) and specificity of 0.97 (CI 0.94 to 0.99). The overall number affected by strabismus was low at 13 (4.8%).\nAuthors' conclusions\nThere is very limited data in the literature to ascertain the accuracy of tests for detecting strabismus in the community as performed by non-expert screeners. A large prospective study to compare methods would be required to determine which tests have the greatest accuracy.\n\nGiven the provided abstract, please respond to the following query: \"Results and conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Only one study was found that met the standards to be included in this review. This study used a photoscreener (a type of camera that measures refractive error and misalignment). Following screening, all children were offered an examination by an eye-care specialist to confirm which children did have strabismus. The photoscreener was very accurate in identifying those children without strabismus (highly specific) but not accurate in correctly identifying those children with strabismus (low sensitivity only).\nAs only one study could be included in this review, it was not possible to conclude which test is the most accurate for screening for strabismus. Further studies would be needed to determine this. However, they would need to include very large numbers of children to be able to make statistically valid conclusions."
}
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query-laysum | 2743 | [
{
"role": "user",
"content": "Abstract: Background\nCaries is one of the most prevalent, preventable conditions worldwide. A wide variety of management options are available at different thresholds of disease, ranging from non-operative preventive strategies such as improved oral hygiene, reduced sugar diet, and application of topical fluoride, to minimally invasive treatments for early lesions which are limited to enamel, through to selective removal and restoration for extensive lesions. The cornerstone of caries detection is a visual and tactile dental examination, however, an increasing array of methods of caries lesion detection have been proposed that could potentially support traditional methods of detection and diagnosis. Earlier identification of disease could afford patients the opportunity of less invasive treatment with less destruction of tooth tissue, reduce the need for treatment with aerosol-generating procedures, and potentially result in a reduced cost of care to the patient and to healthcare services.\nObjectives\nOur primary objective was to determine the diagnostic accuracy of different electrical conductance devices for the detection and diagnosis of non-cavitated coronal dental caries in different populations (children, adolescents, and adults) and when tested against different reference standards.\nSearch methods\nCochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 26 April 2019); Embase Ovid (1980 to 26 April 2019); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 26 April 2019); and the World Health Organization International Clinical Trials Registry Platform (to 26 April 2019). We studied reference lists as well as published systematic review articles.\nSelection criteria\nWe included diagnostic accuracy studies that compared electrical conductance devices with a reference standard of histology or an enhanced visual examination. This included prospective studies that evaluated the diagnostic accuracy of single index tests and studies that directly compared two or more index tests. We included studies using previously extracted teeth or those that recruited participants with teeth believed to be sound or with early lesions limited to enamel.\nStudies that explicitly recruited participants with more advanced lesions that were obviously into dentine or frankly cavitated were excluded.\nData collection and analysis\nTwo review authors extracted data independently using a piloted study data extraction form based on the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). Sensitivity and specificity with 95% confidence intervals (CIs) were reported for each study. This information was displayed as coupled forest plots, and plotted as summary receiver operating characteristic (SROC) plots, displaying the sensitivity-specificity points for each study. Due to variability in thresholds we estimated diagnostic accuracy using hierarchical summary receiver operating characteristic (HSROC) methods.\nMain results\nWe included seven studies reporting a total of 719 tooth sites or surfaces, with an overall prevalence of the target condition of 73% (528 tooth sites or surfaces). The included studies evaluated two index tests: the electronic caries monitor (ECM) (four studies, 475 tooth surfaces) and CarieScan Pro (three studies, 244 tooth surfaces). Six studies used histology as the reference standard, one used an enhanced visual examination. No study was considered to be at low risk of bias across all four domains or low concern for applicability or both. All studies were at high (five studies) or unclear (two studies) risk of bias for the patient selection domain. We judged two studies to be at unclear risk of bias for the index test domain, and one study to be at high risk of bias for the reference standard and flow and timing domains. We judged three studies to be at low concern for applicability for patient selection, and all seven studies to be of low concern for reference standard and flow and timing domains.\nStudies were synthesised using a hierarchical method for meta-analysis. There was variability in the results of the individual studies, with sensitivities which ranged from 0.55 to 0.98 and specificities from 0 to 1.00. These extreme values of specificity may be explained by a low number of healthy tooth surfaces in the included samples. The diagnostic odds ratio (DOR) was 15.65 (95% CI 1.43 to 171.15), and indicative of the variability in the included studies. Through meta-regression we observed no meaningful difference in accuracy according to device type or dentition. Due to the small number of studies we were unable to formally investigate other potential sources of heterogeneity.\nWe judged the certainty of the evidence as very low, and downgraded for risk of bias due to limitations in the design and conduct of the included studies, imprecision arising from the relatively small number of surfaces studied, and inconsistency due to the variability of results.\nAuthors' conclusions\nThe design and conduct of studies to determine the diagnostic accuracy of methods to detect and diagnose caries in situ is particularly challenging. The evidence base to support the detection and diagnosis of caries with electrical conductance devices is sparse. Newer electrical conductance devices show promise and further research at the enamel caries threshold using a robust study design to minimise bias is warranted. In terms of applicability, any future studies should be carried out in a clinical setting to provide a realistic assessment within the oral cavity where plaque, staining, and restorations can be problematic.\n\nGiven the provided abstract, please respond to the following query: \"Why is it important to improve dental caries (tooth decay) detection?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Dentists often aim to identify tooth decay that has already advanced to a level which needs a filling. If dentists were able to find tooth decay when it has only affected the outer layer of the tooth (enamel) then it is possible to stop the decay from spreading any further and prevent the need for fillings. It is also important to avoid a false-positive result, when treatment may be provided when caries is absent."
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query-laysum | 2744 | [
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"role": "user",
"content": "Abstract: Background\nAsthma is a chronic disease in which inflammation of the airways causes symptomatic wheezing, coughing and difficult breathing. Macrolides are antibiotics with antimicrobial and anti-inflammatory activities that have been explored for the long-term control of asthma symptoms.\nObjectives\nTo assess the effects of macrolides compared with placebo for managing chronic asthma.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register up to March 2021. We also manually searched bibliographies of previously published reviews and conference proceedings and contacted study authors. We included records published in any language in the search.\nSelection criteria\nWe included randomised controlled clinical trials (RCTs) involving both children and adults with asthma treated with macrolides versus placebo for four or more weeks. Primary outcomes were exacerbation requiring hospitalisation, severe exacerbations (exacerbations requiring emergency department (ED) visits or systemic steroids, or both), symptom scales, asthma control questionnaire (ACQ, score from 0 totally controlled, to 6 severely uncontrolled), Asthma Quality of Life Questionnaire (AQLQ, with score from 1 to 7 with higher scores indicating better QoL), rescue medication puffs per day, morning and evening peak expiratory flow (PEF; litres per minutes), forced expiratory volume in one second (FEV1; litres), bronchial hyperresponsiveness, and oral corticosteroid dose. Secondary outcomes were adverse events (including mortality), withdrawal, blood eosinophils, sputum eosinophils, eosinophil cationic protein (ECP) in serum, and ECP in sputum.\nData collection and analysis\nTwo review authors independently examined all records identified in the searches then reviewed the full text of all potentially relevant articles before extracting data in duplicate from all included studies. As per protocol, we used a fixed-effect model. We conducted a sensitivity analysis for analyses with high heterogeneity (I2 greater than 30%). GRADE was used to assess the certainty of the body of evidence.\nMain results\nTwenty-five studies met the inclusion criteria, randomising 1973 participants to receive macrolide or placebo for at least four weeks. Most of the included studies reported data from adults (mean age 21 to 61 years) with persistent or severe asthma, while four studies included children. All participants were recruited in outpatient settings. Inclusion criteria, interventions and outcomes were highly variable.\nThe evidence suggests macrolides probably deliver a moderately sized reduction in exacerbations requiring hospitalisations compared to placebo (odds ratio (OR) 0.47, 95% confidence interval (CI) 0.20 to 1.12; studies = 2, participants = 529; moderate-certainty evidence). Macrolides probably reduce exacerbations requiring ED visits and/or treatment with systemic steroids (rate ratio (RaR) 0.65, 95% CI 0.53 to 0.80; studies = 4, participants = 640; moderate-certainty evidence). Macrolides may reduce symptoms (as measured on symptom scales) (standardised mean difference (SMD) −0.46, 95% CI −0.81 to −0.11; studies = 4, participants = 136 ; very low-certainty evidence). Macrolides may result in a little improvement in ACQ (SMD −0.17, 95% CI −0.31 to −0.03; studies = 5, participants = 773; low-certainty evidence). Macrolides may have little to no effect on AQLQ (mean difference (MD) 0.24, 95% CI 0.12 to 0.35; studies = 6, participants = 802; very low-certainty evidence). For both the ACQ and the AQLQ the suggested effect of macrolides versus placebo did not reach a minimal clinically important difference (MCID, 0.5 for ACQ and AQLQ) (ACQ: low-certainty evidence; AQLQ: very low-certainty evidence). Due to high heterogeneity (I2 > 30%), we conducted sensitivity analyses on the above results, which reduced the size of the suggested effects by reducing the weighting on the large, high quality studies.\nMacrolides may result in a small effect compared to placebo in reducing need for rescue medication (MD −0.43 puffs/day, 95% CI −0.81 to −0.04; studies = 4, participants = 314; low-certainty evidence). Macrolides may increase FEV1, but the effect is almost certainly below a level discernible to patients (MD 0.04 L, 95% CI 0 to 0.08; studies = 10, participants = 1046; low-certainty evidence). It was not possible to pool outcomes for non-specific bronchial hyperresponsiveness or lowest tolerated oral corticosteroid dose (in people requiring oral corticosteroids at baseline). There was no evidence of a difference in severe adverse events (including mortality), although less than half of the studies reported the outcome (OR 0.80, 95% CI 0.49 to 1.31; studies = 8, participants = 854; low-certainty evidence). Reporting of specific adverse effects was too inconsistent across studies for a meaningful analysis.\nAuthors' conclusions\nExisting evidence suggests an effect of macrolides compared with placebo on the rate of exacerbations requiring hospitalisation. Macrolides probably reduce severe exacerbations (requiring ED visit and/or treatment with systemic steroids) and may reduce symptoms. However, we cannot rule out the possibility of other benefits or harms because the evidence is of very low quality due to heterogeneity among patients and interventions, imprecision and reporting biases. The results were mostly driven by a well-designed, well powered RCT, indicating that azithromycin may reduce exacerbation rate and improve symptom scores in severe asthma.\nThe review highlights the need for researchers to report outcomes accurately and according to standard definitions. Macrolides can reduce exacerbation rate in people with severe asthma. Future trials could evaluate if this effect is sustained across all the severe asthma phenotypes, the comparison with newer biological drugs, whether effects persist or wane after treatment cessation and whether effects are associated with infection biomarkers.\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": "Asthma is a chronic disease in which inflammation of the airways leads to coughing, wheezing and breathing problems. There are probably different reasons for this inflammation and why it persists, and these may require different treatments. Infection in the lungs may be one cause, and macrolides are a type of antibiotic that may be used long term as a way of improving symptoms for these people."
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query-laysum | 2745 | [
{
"role": "user",
"content": "Abstract: Background\nCorticosteroids are medications with anti-inflammatory and immunosuppressant properties. Systemic corticosteroids administered through the oral, intravenous, or intramuscular routes have been used to treat various types of low back pain, including radicular back pain (not due to spinal stenosis), non-radicular back pain, and spinal stenosis. However, there is uncertainty about the benefits and harms of systemic corticosteroids for low back pain.\nObjectives\nTo evaluate the benefits and harms of systemic corticosteroids versus placebo or no corticosteroid for radicular low back pain, non-radicular low back pain, and symptomatic spinal stenosis in adults.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was September 2021.\nSelection criteria\nWe included randomized and quasi-randomized trials in adults of systematic corticosteroids versus placebo or no corticosteroid.\nData collection and analysis\nWe used standard Cochrane methods. The major outcomes were pain, function, need for surgery, serious adverse effect, and presence of hyperglycemia. The minor outcomes were quality of life, successful outcomes, non-serious adverse events, and withdrawal due to adverse events. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nThirteen trials (1047 participants) met the inclusion criteria. Nine trials included participants with radicular low back pain, two trial with low back pain, and two trials with spinal stenosis. All trials blinded participants to receipt of systemic corticosteroids. Seven trials were at low risk of bias, five at unclear risk, and one at high risk of selection bias. Two trials were at high risk of attrition bias. Doses and duration of systemic corticosteroid therapy varied.\nRadicular low back pain\nFor radicular low back pain, moderate-certainty evidence indicated that systemic corticosteroids probably slightly decrease pain versus placebo at short-term follow-up (mean difference (MD) 0.56 points better, 95% confidence interval (CI) 1.08 to 0.04 on a 0 to 10 scale) and may slightly increase the likelihood of experiencing improvement in pain at short-term follow-up (risk ratio (RR) 1.21, 95% CI 0.88 to 1.66; absolute effect 5% better (95% CI 5% worse to 15% better).\nSystemic corticosteroids may not improve function at short-term follow-up (standardized mean difference (SMD) 0.14 better; range 0.49 better to 0.21 worse) and probably increase the likelihood of improvement in function at short-term follow-up (RR 1.52, 95% CI 1.22 to 1.91; absolute effect 19% better, 95% CI 8% better to 30% better). Systemic corticosteroids were associated with greater improvement in function versus placebo at long-term follow-up (MD −7.40, 95% CI −12.55 to −2.25 on the 0 to 100 Oswestry Disability Index) and greater likelihood of functional improvement (RR 1.29, 95% CI 1.06 to 1.56), based on a single trial. There was no difference in likelihood of surgery (RR 1.00, 95% CI 0.68 to 1.47).\nEvidence indicated that systemic corticosteroids (administered as a single dose or as a short course of therapy) are not associated with increased risk of any adverse event, serious adverse events, withdrawal due to adverse events, or hyperglycemia, but estimates were imprecise as some trials did not report harms, and harms reporting was suboptimal in trials that did provide data. Limitations included variability across trials in interventions (e.g. corticosteroid used, dose and duration of treatment), clinical settings, and participants (e.g. duration of symptoms, methods for diagnosis); limited utility of subgroup analyses due to small numbers of trials; methodologic limitations or suboptimal reporting of methods by some trials; and too few trials to formally assess for publication bias using graphical or statistical tests for small sample effects.\nNon-radicular low back pain\nEvidence on systemic corticosteroids versus placebo for non-radicular pain was limited and suggested that systemic corticosteroids may be associated with slightly worse short-term pain but slightly better function.\nSpinal stenosis\nFor spinal stenosis, limited evidence indicated that systemic corticosteroids are probably no more effective than placebo for short-term pain or function.\nAuthors' conclusions\nSystemic corticosteroids appear to be slightly effective at improving short-term pain and function in people with radicular low back pain not due to spinal stenosis, and might slightly improve long-term function. The effects of systemic corticosteroids in people with non-radicular low back pain are unclear and systemic corticosteroids are probably ineffective for spinal stenosis. A single dose or short course of systemic corticosteroids for low back pain does not appear to cause serious harms, but evidence is limited.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "For radicular low back pain, we are moderately confident about effects on short-term pain, short-term function, long-term function (but based on only one study), likelihood of surgery, and short-term quality of life. For spinal stenosis, we are moderately confident only about effects on short-term pain and function. For other time points and outcomes and for non-radicular low back pain, we have little confidence about the evidence. Factors that decreased confidence in findings included flaws in how the studies were designed (patients were not assigned to treatments randomly, a lot of patients dropped out of the study, or there were large differences between patients assigned to different treatments), not having enough studies or participants to be certain about the results, and variations between studies in results and methods.\nFor people with radicular low back pain, studies are needed to determine the optimal dose and duration of systemic corticosteroid therapy, how effectiveness varies according to symptom duration, and whether imaging is needed to confirm the diagnosis of a bulging or slipped disc before using systemic corticosteroids. Studies are also needed to clarify effects of systemic corticosteroids on quality of life, long-term outcomes, and harms.\nFor people with non-radicular low back pain or spinal stenosis, research showing that some people have an inflammatory component would be helpful to determine whether well-designed clinical trials should be conducted, and which people should be included in them."
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query-laysum | 2746 | [
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"role": "user",
"content": "Abstract: Background\nTraditionally inhaled treatment for asthma has used separate preventer and reliever therapies. The combination of formoterol and budesonide in one inhaler has made possible a single inhaler for both prevention and relief of symptoms (single inhaler therapy or SiT).\nObjectives\nTo assess the efficacy and safety of budesonide and formoterol in a single inhaler for maintenance and reliever therapy in asthma compared with maintenance with inhaled corticosteroids (ICS) (alone or as part of current best practice) and any reliever therapy.\nSearch methods\nWe searched the Cochrane Airways Group trials register in February 2013.\nSelection criteria\nParallel, randomised controlled trials of 12 weeks or longer in adults and children with chronic asthma. Studies had to assess the combination of formoterol and budesonide as SiT, against a control group that received inhaled steroids and a separate reliever inhaler.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 13 trials involving 13,152 adults and one of the trials also involved 224 children (which have been separately reported). All studies were sponsored by the manufacturer of the SiT inhaler. We considered the nine studies assessing SiT against best practice to be at a low risk of selection bias, but a high risk of detection bias as they were unblinded.\nIn adults whose asthma was not well-controlled on ICS, the reduction in hospital admission with SiT did not reach statistical significance (Peto odds ratio (OR) 0.81; 95% confidence interval (CI) 0.45 to 1.44, eight trials, N = 8841, low quality evidence due to risk of detection bias in open studies and imprecision). The rates of hospital admission were low; for every 1000 people treated with current best practice six would experience a hospital admission over six months compared with between three and eight treated with SiT. The odds of experiencing exacerbations needing treatment with oral steroids were lower with SiT compared with control (OR 0.83; 95% CI 0.70 to 0.98, eight trials, N = 8841, moderate quality evidence due to risk of detection bias). For every 100 adults treated with current best practice over six months, seven required a course of oral steroids, whilst for SiT there would be six (95% CI 5 to 7). The small reduction in time to first severe exacerbation needing medical intervention was not statistically significant (hazard ratio (HR) 0.94; 95% CI 0.85 to 1.04, five trials, N = 7355). Most trials demonstrated a reduction in the mean total daily dose of ICS with SiT (mean reduction was based on self-reported data from patient diaries and ranged from 107 to 385 µg/day). Withdrawals due to adverse events were more common in people treated with SiT in comparison to current best practice (OR 2.85; 95% CI 1.89 to 4.30, moderate quality evidence due to risk of detection bias).\nThree studies including 4209 adults compared SiT with higher dose budesonide maintenance and terbutaline for symptom relief. The studies were considered as low risk of bias. The run-in for these studies involved withdrawal of LABA, and patients were recruited who were symptomatic during run-in. The reduction in the odds of hospitalisation with SiT compared with higher dose ICS did not reach statistical significance (Peto OR; 0.56; 95% CI 0.28 to 1.09, moderate quality evidence due to imprecision). Fewer patients on SiT needed a course of oral corticosteroids (OR 0.54; 95% CI 0.45 to 0.64, high quality evidence). For every 100 adults treated with ICS over 11 months, 18 required a course of oral steroids, whilst for SiT there would be 11 (95% CI 9 to 12). Withdrawals due to adverse events were less common in people treated with SiT in comparison to higher dose budesonide maintenance (OR 0.57; 95% CI 0.35 to 0.93, high quality evidence).\nOne study included children (N = 224), in which SiT was compared with higher dose budesonide. There was a significant reduction in participants who needed an increase in their inhaled steroids with SiT, but there were only two hospitalisations for asthma and no separate data on courses of oral corticosteroids. Less inhaled and oral corticosteroids were used in the SiT group and the annual height gain was also 1 cm greater in the SiT group, (95% CI 0.3 cm to 1.7 cm).\nThe results for fatal serious adverse events were too rare to rule out either treatment being harmful. There was no significant difference found in non-fatal serious adverse events for any of the comparisons.\nAuthors' conclusions\nSingle inhaler therapy has now been demonstrated to reduce exacerbations requiring oral corticosteroids against current best practice strategies and against a fixed higher dose of inhaled steroids. The strength of evidence that SiT reduces hospitalisation against these same treatments is weak. There were more discontinuations due to adverse events on SiT compared to current best practice, but no significant differences in serious adverse events. Our confidence in these conclusions is limited by the open-label design of the trials, and by the unknown adherence to treatment in the current best practice arms of the trials.\nSingle inhaler therapy can reduce the risk of asthma exacerbations needing oral corticosteroids in comparison with fixed dose maintenance ICS and separate relief medication. The reduced odds of exacerbations with SiT compared with higher dose ICS should be viewed in the context of the possible impact of LABA withdrawal during study run-in. This may have made the study populations more likely to respond to SiT.\nSingle inhaler therapy is not currently licensed for children under 18 years of age in the United Kingdom and there is currently very little research evidence for this approach in children or adolescents.\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": "What did we do?We reviewed the clinical trials that looked at SiT against inhaled steroids and reliever medication given as two separate inhalers (sometimes called current best practice).What did we find out?We found 13 trials on 13,152 adults and one trial also included 224 children, up to February 2013. The trials were all sponsored by the manufacturer of the single inhaler.When compared with current best practice or higher doses of inhaled steroid, we found that SiT probably reduces the number of flare-ups that will need treatment with an oral steroid in adults but we are uncertain whether the number of adults admitted to hospital would be reduced. When compared with high doses of inhaled steroids, we found that fewer people experienced a flare-up that needed treatment with an oral steroid.The results for death (1 per 1000 people given either treatment), or life threatening problems (just under 50 per 1000 people given either treatment), were too imprecise to enable us to rule out either treatment being more harmful than the other. More adults left the trial early because they experienced adverse effects in the group taking single inhalers. There was only one small trial in children, so we are unable to make any firm conclusions in children.The studies were generally well-designed, although in the studies which compared SiT against current best practice people knew which treatment they were getting, and this could have affected the reliability of the results. The studies comparing SiT against inhaled steroids were designed differently and were more reliable. Overall, we think that more evidence from future trials might change the strength of the conclusions for the question of whether SiT is better than current best practice. We believe that there is good quality evidence that SiT is more effective than high dose inhaled steroids, although the studies recruited people who were likely to respond."
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"content": "Abstract: Background\nFoot ulcers are a major complication of diabetes mellitus, often leading to amputation. Growth factors derived from blood platelets, endothelium, or macrophages could potentially be an important treatment for these wounds but they may also confer risks.\nObjectives\nTo assess the benefits and harms of growth factors for foot ulcers in patients with type 1 or type 2 diabetes mellitus.\nSearch methods\nIn March 2015 we searched the Cochrane Wounds Group Specialised Register, The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations, Ovid EMBASE and EBSCO CINAHL. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nRandomised clinical trials in any setting, recruiting people with type 1 or type 2 diabetes mellitus diagnosed with a foot ulcer. Trials were eligible for inclusion if they compared a growth factor plus standard care (e.g., antibiotic therapy, debridement, wound dressings) versus placebo or no growth factor plus standard care, or compared different growth factors against each other. We considered lower limb amputation (minimum of one toe), complete healing of the foot ulcer, and time to complete healing of the diabetic foot ulcer as the primary outcomes.\nData collection and analysis\nIndependently, we selected randomised clinical trials, assessed risk of bias, and extracted data in duplicate. We estimated risk ratios (RR) for dichotomous outcomes. We measured statistical heterogeneity using the I2 statistic. We subjected our analyses to both fixed-effect and random-effects model analyses.\nMain results\nWe identified 28 randomised clinical trials involving 2365 participants. The cause of foot ulcer (neurologic, vascular, or combined) was poorly defined in all trials. The trials were conducted in ten countries. The trials assessed 11 growth factors in 30 comparisons: platelet-derived wound healing formula, autologous growth factor, allogeneic platelet-derived growth factor, transforming growth factor β2, arginine-glycine-aspartic acid peptide matrix, recombinant human platelet-derived growth factor (becaplermin), recombinant human epidermal growth factor, recombinant human basic fibroblast growth factor, recombinant human vascular endothelial growth factor, recombinant human lactoferrin, and recombinant human acidic fibroblast growth factor. Topical intervention was the most frequent route of administration. All the trials were underpowered and had a high risk of bias. Pharmaceutical industry sponsored 50% of the trials.\nAny growth factor compared with placebo or no growth factor increased the number of participants with complete wound healing (345/657 (52.51%) versus 167/482 (34.64%); RR 1.51, 95% CI 1.31 to 1.73; I2 = 51%, 12 trials; low quality evidence). The result is mainly based on platelet-derived wound healing formula (36/56 (64.28%) versus 7/27 (25.92%); RR 2.45, 95% 1.27 to 4.74; I2 = 0%, two trials), and recombinant human platelet-derived growth factor (becaplermin) (205/428 (47.89%) versus 109/335 (32.53%); RR 1.47, 95% CI 1.23 to 1.76, I2= 74%, five trials).\nIn terms of lower limb amputation (minimum of one toe), there was no clear evidence of a difference between any growth factor and placebo or no growth factor (19/150 (12.66%) versus 12/69 (17.39%); RR 0.74, 95% CI 0.39 to 1.39; I2 = 0%, two trials; very low quality evidence). One trial involving 55 participants showed no clear evidence of a difference between recombinant human vascular endothelial growth factor and placebo in terms of ulcer-free days following treatment for diabetic foot ulcers (RR 0.64, 95% CI 0.14 to 2.94; P value 0.56, low quality of evidence)\nAlthough 11 trials reported time to complete healing of the foot ulcers in people with diabetes , meta-analysis was not possible for this outcome due to the unique comparisons within each trial, failure to report data, and high number of withdrawals. Data on quality of life were not reported. Growth factors showed an increasing risk of overall adverse event rate compared with compared with placebo or no growth factor (255/498 (51.20%) versus 169/332 (50.90%); RR 0.83; 95% CI 0.72 to 0.96; I2 = 48%; eight trials; low quality evidence). Overall, safety data were poorly reported and adverse events may have been underestimated.\nAuthors' conclusions\nThis Cochrane systematic review analysed a heterogeneous group of trials that assessed 11 different growth factors for diabetic foot ulcers. We found evidence suggesting that growth factors may increase the likelihood that people will have complete healing of foot ulcers in people with diabetes. However, this conclusion is based on randomised clinical trials with high risk of systematic errors (bias). Assessment of the quality of the available evidence (GRADE) showed that further trials investigating the effect of growth factors are needed before firm conclusions can be drawn. The safety profiles of the growth factors are unclear. Future trials should be conducted according to SPIRIT statement and reported according to the CONSORT statement by independent investigators and using the Foundation of Patient-Centered Outcomes Research recommendations.\n\nGiven the provided abstract, please respond to the following query: \"The purpose of this review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This Cochrane review tried to identify the benefits and harms of treating diabetic foot ulcers with growth factors in addition to providing standard care (i.e. pressure relief, removal of dead tissue from the wound, infection control and application of dressings)."
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query-laysum | 2748 | [
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"content": "Abstract: Background\nTracheal intubation during induction of general anaesthesia is a vital procedure performed to secure a patient's airway. Several studies have identified difficult tracheal intubation (DTI) or failed tracheal intubation as one of the major contributors to anaesthesia-related mortality and morbidity. Use of neuromuscular blocking agents (NMBA) to facilitate tracheal intubation is a widely accepted practice. However, because of adverse effects, NMBA may be undesirable. Cohort studies have indicated that avoiding NMBA is an independent risk factor for difficult and failed tracheal intubation. However, no systematic review of randomized trials has evaluated conditions for tracheal intubation, possible adverse effects, and postoperative discomfort.\nObjectives\nTo evaluate the effects of avoiding neuromuscular blocking agents (NMBA) versus using NMBA on difficult tracheal intubation (DTI) for adults and adolescents allocated to tracheal intubation with direct laryngoscopy. To look at various outcomes, conduct subgroup and sensitivity analyses, examine the role of bias, and apply trial sequential analysis (TSA) to examine the level of available evidence for this intervention.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, BIOSIS, International Web of Science, LILACS, advanced Google, CINAHL, and the following trial registries: Current Controlled Trials; ClinicalTrials.gov; and www.centerwatch.com, up to January 2017. We checked the reference lists of included trials and reviews to look for unidentified trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared the effects of avoiding versus using NMBA in participants 14 years of age or older.\nData collection and analysis\nTwo review authors extracted data independently. We conducted random-effects and fixed-effect meta-analyses and calculated risk ratios (RRs) and their 95% confidence intervals (CIs). We used published data and data obtained by contacting trial authors. To minimize the risk of systematic error, we assessed the risk of bias of included trials. To reduce the risk of random errors caused by sparse data and repetitive updating of cumulative meta-analyses, we applied TSA.\nMain results\nWe identified 34 RCTs with 3565 participants that met our inclusion criteria. All trials reported on conditions for tracheal intubation; seven trials with 846 participants described ‘events of upper airway discomfort or injury’, and 13 trials with 1308 participants reported on direct laryngoscopy. All trials used a parallel design. We identified 18 dose-finding studies that included more interventions or control groups or both. All trials except three included only American Society of Anesthesiologists (ASA) class I and II participants, 25 trials excluded participants with anticipated DTI, and obesity or overweight was an excluding factor in 13 studies. Eighteen trials used suxamethonium, and 18 trials used non-depolarizing NMBA.\nTrials with an overall low risk of bias reported significantly increased risk of DTI with no use of NMBA (random-effects model) (RR 13.27, 95% CI 8.19 to 21.49; P < 0.00001; 508 participants; four trials; number needed to treat for an additional harmful outcome (NNTH) = 1.9, I2 = 0%, D2 = 0%, GRADE = moderate). The TSA-adjusted CI for the RR was 1.85 to 95.04. Inclusion of all trials resulted in confirmation of results and of significantly increased risk of DTI when an NMBA was avoided (random-effects model) (RR 5.00, 95% CI 3.49 to 7.15; P < 0.00001; 3565 participants; 34 trials; NNTH = 6.3, I2 = 70%, D2 = 82%, GRADE = low). Again the cumulative z-curve crossed the TSA monitoring boundary, demonstrating harmful effects of avoiding NMBA on the proportion of DTI with minimal risk of random error. We categorized only one trial reporting on upper airway discomfort or injury as having overall low risk of bias. Inclusion of all trials revealed significant risk of upper airway discomfort or injury when an NMBA was avoided (random-effects model) (RR 1.37, 95% CI 1.09 to 1.74; P = 0.008; 846 participants; seven trials; NNTH = 9.1, I2 = 13%, GRADE = moderate). The TSA-adjusted CI for the RR was 1.00 to 1.85. None of these trials reported mortality. In terms of our secondary outcome 'difficult laryngoscopy', we categorized only one trial as having overall low risk of bias. All trials avoiding NMBA were significantly associated with difficult laryngoscopy (random-effects model) (RR 2.54, 95% CI 1.53 to 4.21; P = 0.0003; 1308 participants; 13 trials; NNTH = 25.6, I2 = 0%, D2= 0%, GRADE = low); however, TSA showed that only 6% of the information size required to detect or reject a 20% relative risk reduction (RRR) was accrued, and the trial sequential monitoring boundary was not crossed.\nAuthors' conclusions\nThis review supports that use of an NMBA may create the best conditions for tracheal intubation and may reduce the risk of upper airway discomfort or injury following tracheal intubation. Study results were characterized by indirectness, heterogeneity, and high or uncertain risk of bias concerning our primary outcome describing difficult tracheal intubation. Therefore, we categorized the GRADE classification of quality of evidence as moderate to low. In light of defined outcomes of individual included trials, our primary outcomes may not reflect a situation that many clinicians consider to be an actual difficult tracheal intubation by which the patient's life or health may be threatened.\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": ""
}
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query-laysum | 2749 | [
{
"role": "user",
"content": "Abstract: Background\nResearch suggests that the number of intellectually disabled people with children is increasing. Intellectual disabilities do not inevitably cause parenting difficulties, but it may impact on an individual's capacity to parent a child effectively. Children of parents with intellectual disabilities may be at increased risk of neglectful care, which could lead to health, developmental and behavioural problems, or increased risk of intellectual disability. Compared with other parents, those with intellectual disabilities are more likely to be involved in care proceedings.\nObjectives\nTo assess the effectiveness of parent training interventions for parents with intellectual disabilities designed to support parenting, parent-child relations, safe parenting or family environments, or to develop parenting skills.\nSearch methods\nIn July 2017, we searched CENTRAL, Ovid MEDLINE, Embase, CINAHL and six other databases as well as two trials registers. We also searched reference lists of included studies and contacted experts in the field to identify additional ongoing and unpublished studies.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs comparing parent training interventions for parents with intellectual disabilities with treatment as usual or a control group.\nData collection and analysis\nWe used standardised Cochrane methods.\nMain results\nAs of July 2017, we identified four trials with 192 participants that met the review inclusion criteria. Participating parents were mostly mothers (seven fathers were included in two studies), and children's ages ranged from one month to six years and five months.\nOne study was conducted in Australia, one in Canada, one in the Netherlands, and one in the USA. Each studied a different intervention and considered different outcomes. Three interventions were delivered at home, and one in a community venue (e.g. a church). Interventions varied in duration from seven weeks to 12 months. They included a range of practical childcare skills, home safety and developing parents' ability to respond sensitively to their children. Parents in the comparison groups included in the review received treatment as usual and most of these received the index intervention after the study was complete.\nOne study was funded by the Ontario Mental Health Foundation and the Ontario Ministry of Community and Social Services Research Grants Program; one by the Alabama Development Disabilities Council; one by the Best Practice Parenting Education Initiative of the Commonwealth Department of Family and Community Services and the New South Wales Aging and Disability Department; and one by ZonMw, The Netherlands Organisation for Health Research and Development.\nIt was not possible for us to conduct a meta-analysis. The GRADE quality assessment varied from very low to moderate across the studies.\nPrimary outcomes\nNo study reported on the 'attainment of specific parenting skill targets'.\n'Safe home practices' and 'understanding of child health': one study (30 parents, very low-quality evidence) reported some improvements in parents' knowledge of life-threatening emergencies, ability to recognise dangers, and identify precautions, in favour of the intervention group. It also found limited, very low-quality evidence that parent training improved parents' ability to understand child health, implement precautions, use medicines safely, recognise child illness and symptoms, and seek medical advice (i.e. visit the doctor). Another study (22 mothers, very low-quality evidence) reported improved attainment of skills related to childcare and safety, in favour of the intervention group.\nSecondary outcomes\n'Parent-child interaction': one study (40 mothers, very low-quality evidence) reported improved maternal-child interaction following parent training at 12 months follow-up. Another study (83 mothers, 2 fathers, moderate-quality evidence) reported that inclusion in the intervention group led to a steeper decline in parenting stress related to the child compared to the control group.\n'Parents' retention of child': one study (22 participants; very low-quality evidence) reported that before joining the programme nine of 11 (82%) families with a previous child had had the child removed from their care by child protection authorities due to maternal maltreatment, compared with only four of 22 (19%) families after participating in the programme (only one of these four mothers had also had a previous child removed).\nNo study reported data on: 'return to independent care of child' or 'lifting of child-related court order'.\nAuthors' conclusions\nThere is some very low-quality evidence that some parents, mainly mothers, with intellectual disabilities are able to provide adequate parenting if they are given appropriate training and support to learn the parenting skills they need. However, there are few studies exploring how interventions might work, for whom and in what circumstances. In particular, there have been few studies that include fathers with intellectual disabilities, or that explore the views of parents themselves.\nThere is a need for larger RCTs of parenting interventions, with longer follow-up, before conclusions can be drawn about the effectiveness of parent training for this group of parents.\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": "Compared to those parents without parent training, the studies reported some improvements in parents in the intervention group. One study reported improvement in safe home practices, recognition of child illness and safe use of medicines, in favour of the intervention group. Another study reported improvements in childcare and safety, also in favour of the intervention group; and a third study found that parents who had attended parent training reported less child-related parenting stress compared to the control group.\nA fourth study reported improvement in mother-child interaction in the intervention group compared with the control group. No study reported that interventions caused harm."
}
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query-laysum | 2750 | [
{
"role": "user",
"content": "Abstract: Background\nIntra-uterine insemination (IUI), in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) are frequently used fertility treatments for couples with male subfertility. The use of these treatments has been subject of discussion. Knowledge on the effectiveness of fertility treatments for male subfertility with different grades of severity is limited. Possibly, couples are exposed to unnecessary or ineffective treatments on a large scale.\nObjectives\nTo evaluate the effectiveness and safety of different fertility treatments (expectant management, timed intercourse (TI), IUI, IVF and ICSI) for couples whose subfertility appears to be due to abnormal sperm parameters.\nSearch methods\nWe searched for all publications that described randomised controlled trials (RCTs) of the treatment for male subfertility. We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PsycINFO and the National Research Register from inception to 14 April 2015, and web-based trial registers from January 1985 to April 2015. We applied no language restrictions. We checked all references in the identified trials and background papers and contacted authors to identify relevant published and unpublished data.\nSelection criteria\nWe included RCTs comparing different treatment options for male subfertility. These were expectant management, TI (with or without ovarian hyperstimulation (OH)), IUI (with or without OH), IVF and ICSI. We included only couples with abnormal sperm parameters.\nData collection and analysis\nTwo review authors independently selected the studies, extracted data and assessed risk of bias. They resolved disagreements by discussion with the rest of the review authors. We performed statistical analyses in accordance with the guidelines for statistical analysis developed by The Cochrane Collaboration. The quality of the evidence was rated using the GRADE methods. Primary outcomes were live birth and ovarian hyperstimulation syndrome (OHSS) per couple randomised.\nMain results\nThe review included 10 RCTs (757 couples). The quality of the evidence was low or very low for all comparisons. The main limitations in the evidence were failure to describe study methods, serious imprecision and inconsistency.\nIUI versus TI (five RCTs)\nTwo RCTs compared IUI with TI in natural cycles. There were no data on live birth or OHSS. We found no evidence of a difference in pregnancy rates (2 RCTs, 62 couples: odds ratio (OR) 4.57, 95% confidence interval (CI) 0.21 to 102, very low quality evidence; there were no events in one of the studies).\nThree RCTs compared IUI with TI both in cycles with OH. We found no evidence of a difference in live birth rates (1 RCT, 81 couples: OR 0.89, 95% CI 0.30 to 2.59; low quality evidence) or pregnancy rates (3 RCTs, 202 couples: OR 1.51, 95% CI 0.74 to 3.07; I2 = 11%, very low quality evidence). One RCT reported data on OHSS. None of the 62 women had OHSS.\nOne RCT compared IUI in cycles with OH with TI in natural cycles. We found no evidence of a difference in live birth rates (1 RCT, 44 couples: OR 3.14, 95% CI 0.12 to 81.35; very low quality evidence). Data on OHSS were not available.\nIUI in cycles with OH versus IUI in natural cycles (five RCTs)\nWe found no evidence of a difference in live birth rates (3 RCTs, 346 couples: OR 1.34, 95% CI 0.77 to 2.33; I2 = 0%, very low quality evidence) and pregnancy rates (4 RCTs, 399 couples: OR 1.68, 95% CI 1.00 to 2.82; I2 = 0%, very low quality evidence). There were no data on OHSS.\nIVF versus IUI in natural cycles or cycles with OH (two RCTs)\nWe found no evidence of a difference in live birth rates between IVF versus IUI in natural cycles (1 RCT, 53 couples: OR 0.77, 95% CI 0.25 to 2.35; low quality evidence) or IVF versus IUI in cycles with OH (2 RCTs, 86 couples: OR 1.03, 95% CI 0.43 to 2.45; I2 = 0%, very low quality evidence). One RCT reported data on OHSS. None of the women had OHSS.\nOverall, we found no evidence of a difference between any of the groups in rates of live birth, pregnancy or adverse events (multiple pregnancy, miscarriage). However, most of the evidence was very low quality.\nThere were no studies on IUI in natural cycles versus TI in stimulated cycles, IVF versus TI, ICSI versus TI, ICSI versus IUI (with OH) or ICSI versus IVF.\nAuthors' conclusions\nWe found insufficient evidence to determine whether there was any difference in safety and effectiveness between different treatments for male subfertility. More research is needed.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched medical databases for randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) investigating male subfertility. We found 10 randomised controlled trials, all comparing different treatments for couples with male subfertility, with a total of 757 couples. The studies evaluated the following treatment options: timed intercourse (TI; where sex occurred at a recommended time in the menstrual cycle) (with or without OH), IUI (with or without OH), IVF and ICSI. The evidence was current to April 2015. We were mainly interested in how many women had live births and OHSS."
}
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query-laysum | 2751 | [
{
"role": "user",
"content": "Abstract: Background\nNeonatal hypoglycaemia is a common condition that can be associated with brain injury. Current practice usually includes early identification of at-risk infants (e.g. infants of diabetic mothers; preterm, small- or large-for-gestational-age infants), and prophylactic measures are advised. However, these measures usually involve use of formula milk or admission to the neonatal unit. Dextrose gel is non-invasive, inexpensive and effective for treatment of neonatal hypoglycaemia. Prophylactic dextrose gel can reduce the incidence of neonatal hypoglycaemia, thus potentially reducing separation of mother and baby and supporting breastfeeding, as well as preventing brain injury.\nThis is an update of a previous Cochrane Review published in 2017.\nObjectives\nTo assess the effectiveness and safety of oral dextrose gel given to newborn infants at risk of hypoglycaemia in preventing hypoglycaemia and reducing long-term neurodevelopmental impairment.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2020, Issue 10) in the Cochrane Library; and Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R) on 19 October 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing oral dextrose gel versus placebo, no intervention, or other therapies for the prevention of neonatal hypoglycaemia.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias. We contacted investigators to obtain additional information. We used fixed-effect meta-analyses. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included two studies conducted in high-income countries comparing oral dextrose gel versus placebo in 2548 infants at risk of neonatal hypoglycaemia. Of these, one study was included in the previous version of this review. We judged these two studies to be at low risk of bias, and that the evidence for most outcomes was of moderate certainty.\nMeta-analysis of the two studies showed that oral dextrose gel reduces the risk of hypoglycaemia (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.79 to 0.95; risk difference (RD) -0.06, 95% CI -0.10 to -0.02; 2548 infants; high certainty evidence). One study reported that oral dextrose gel probably reduces the risk of major neurological disability at two years' corrected age (RR 0.21, 95% CI 0.05 to 0.78; RD -0.05, 95% CI -0.09 to 0.00; 360 infants; moderate certainty evidence).\nMeta-analysis of the two studies showed that oral dextrose gel probably reduces the risk of receipt of treatment for hypoglycaemia during initial hospital stay (RR 0.89, 95% CI 0.79 to 1.00; 2548 infants; moderate certainty evidence) but makes little or no difference to the risk of receipt of intravenous treatment for hypoglycaemia (RR 1.01, 0.68 to 1.49; 2548 infants; moderate certainty evidence). Oral dextrose gel may have little or no effect on the risk of separation from the mother for treatment of hypoglycaemia (RR 1.12, 95% CI 0.81 to 1.55; two studies, 2548 infants; low certainty evidence).\nThere is probably little or no difference in the risk of adverse events in infants who receive oral dextrose gel compared to placebo gel (RR 1.22, 95% CI 0.64 to 2.33; two studies, 2510 infants; moderate certainty evidence), but there are no studies comparing oral dextrose with other comparators such as no treatment, standard care or other therapies.\nNo data were available on exclusive breastfeeding after discharge.\nAuthors' conclusions\nOral dextrose gel reduces the risk of neonatal hypoglycaemia in at-risk infants and probably reduces the risk of major neurological disability at two years of age or greater without increasing the risk of adverse events compared to placebo gel. Additional large follow-up studies at two years of age or older are required. Future research should also be undertaken in low- and middle-income countries, preterm infants, using other dextrose gel preparations, and using comparators other than placebo gel. There are three studies awaiting classification and one ongoing study which may alter the conclusions of the review when published.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We graded the certainty of the evidence as moderate for all outcomes except risk of low blood glucose levels (assessed as high certainty) and separation from mother (assessed as low certainty)."
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query-laysum | 2752 | [
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease is one of the commonest severe monogenic disorders in the world, due to the inheritance of two abnormal haemoglobin (beta globin) genes. Sickle cell disease can cause severe pain, significant end-organ damage, pulmonary complications, and premature death. Stroke affects around 10% of children with sickle cell anaemia (HbSS). Chronic blood transfusions may reduce the risk of vaso-occlusion and stroke by diluting the proportion of sickled cells in the circulation.\nThis is an update of a Cochrane Review first published in 2002, and last updated in 2017.\nObjectives\nTo assess risks and benefits of chronic blood transfusion regimens in people with sickle cell disease for primary and secondary stroke prevention (excluding silent cerebral infarcts).\nSearch methods\nWe searched for relevant trials in the Cochrane Library, MEDLINE (from 1946), Embase (from 1974), the Transfusion Evidence Library (from 1980), and ongoing trial databases; all searches current to 8 October 2019.\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register: 19 September 2019.\nSelection criteria\nRandomised controlled trials comparing red blood cell transfusions as prophylaxis for stroke in people with sickle cell disease to alternative or standard treatment. There were no restrictions by outcomes examined, language or publication status.\nData collection and analysis\nTwo authors independently assessed trial eligibility and the risk of bias and extracted data.\nMain results\nWe included five trials (660 participants) published between 1998 and 2016. Four of these trials were terminated early. The vast majority of participants had the haemoglobin (Hb)SS form of sickle cell disease.\nThree trials compared regular red cell transfusions to standard care in primary prevention of stroke: two in children with no previous long-term transfusions; and one in children and adolescents on long-term transfusion.\nTwo trials compared the drug hydroxyurea (hydroxycarbamide) and phlebotomy to long-term transfusions and iron chelation therapy: one in primary prevention (children); and one in secondary prevention (children and adolescents).\nThe quality of the evidence was very low to moderate across different outcomes according to GRADE methodology. This was due to the trials being at a high risk of bias due to lack of blinding, indirectness and imprecise outcome estimates.\nRed cell transfusions versus standard care\nChildren with no previous long-term transfusions\nLong-term transfusions probably reduce the incidence of clinical stroke in children with a higher risk of stroke (abnormal transcranial doppler velocities or previous history of silent cerebral infarct), risk ratio 0.12 (95% confidence interval 0.03 to 0.49) (two trials, 326 participants), moderate quality evidence.\nLong-term transfusions may: reduce the incidence of other sickle cell disease-related complications (acute chest syndrome, risk ratio 0.24 (95% confidence interval 0.12 to 0.48)) (two trials, 326 participants); increase quality of life (difference estimate -0.54, 95% confidence interval -0.92 to -0.17) (one trial, 166 participants); but make little or no difference to IQ scores (least square mean: 1.7, standard error 95% confidence interval -1.1 to 4.4) (one trial, 166 participants), low quality evidence.\nWe are very uncertain whether long-term transfusions: reduce the risk of transient ischaemic attacks, Peto odds ratio 0.13 (95% confidence interval 0.01 to 2.11) (two trials, 323 participants); have any effect on all-cause mortality, no deaths reported (two trials, 326 participants); or increase the risk of alloimmunisation, risk ratio 3.16 (95% confidence interval 0.18 to 57.17) (one trial, 121 participants), very low quality evidence.\nChildren and adolescents with previous long-term transfusions (one trial, 79 participants)\nWe are very uncertain whether continuing long-term transfusions reduces the incidence of: stroke, risk ratio 0.22 (95% confidence interval 0.01 to 4.35); or all-cause mortality, Peto odds ratio 8.00 (95% confidence interval 0.16 to 404.12), very low quality evidence.\nSeveral review outcomes were only reported in one trial arm (sickle cell disease-related complications, alloimmunisation, transient ischaemic attacks).\nThe trial did not report neurological impairment, or quality of life.\nHydroxyurea and phlebotomy versus red cell transfusions and chelation\nNeither trial reported on neurological impairment, alloimmunisation, or quality of life.\nPrimary prevention, children (one trial, 121 participants)\nSwitching to hydroxyurea and phlebotomy may have little or no effect on liver iron concentrations, mean difference -1.80 mg Fe/g dry-weight liver (95% confidence interval -5.16 to 1.56), low quality evidence.\nWe are very uncertain whether switching to hydroxyurea and phlebotomy has any effect on: risk of stroke (no strokes); all-cause mortality (no deaths); transient ischaemic attacks, risk ratio 1.02 (95% confidence interval 0.21 to 4.84); or other sickle cell disease-related complications (acute chest syndrome, risk ratio 2.03 (95% confidence interval 0.39 to 10.69)), very low quality evidence.\nSecondary prevention, children and adolescents (one trial, 133 participants)\nSwitching to hydroxyurea and phlebotomy may: increase the risk of sickle cell disease-related serious adverse events, risk ratio 3.10 (95% confidence interval 1.42 to 6.75); but have little or no effect on median liver iron concentrations (hydroxyurea, 17.3 mg Fe/g dry-weight liver (interquartile range 10.0 to 30.6)); transfusion 17.3 mg Fe/g dry-weight liver (interquartile range 8.8 to 30.7), low quality evidence.\nWe are very uncertain whether switching to hydroxyurea and phlebotomy: increases the risk of stroke, risk ratio 14.78 (95% confidence interval 0.86 to 253.66); or has any effect on all-cause mortality, Peto odds ratio 0.98 (95% confidence interval 0.06 to 15.92); or transient ischaemic attacks, risk ratio 0.66 (95% confidence interval 0.25 to 1.74), very low quality evidence.\nAuthors' conclusions\nThere is no evidence for managing adults, or children who do not have HbSS sickle cell disease.\nIn children who are at higher risk of stroke and have not had previous long-term transfusions, there is moderate quality evidence that long-term red cell transfusions reduce the risk of stroke, and low quality evidence they also reduce the risk of other sickle cell disease-related complications.\nIn primary and secondary prevention of stroke there is low quality evidence that switching to hydroxyurea with phlebotomy has little or no effect on the liver iron concentration.\nIn secondary prevention of stroke there is low-quality evidence that switching to hydroxyurea with phlebotomy increases the risk of sickle cell disease-related events.\nAll other evidence in this review is of very low quality.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In children at higher risk of stroke who have not had previous long-term transfusions, there is moderate quality evidence that long-term red cell transfusions reduce the risk of stroke. The quality of evidence was rated as low to very low for the rest of the outcomes due to trials being at high risk of bias and because there were a small number of trials and a small number of participants included in the trials."
}
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query-laysum | 2753 | [
{
"role": "user",
"content": "Abstract: Background\nThe reduction of lung inflammation is one of the goals of cystic fibrosis therapy. Inhaled corticosteroids are often used in this respect to treat children and adults with cystic fibrosis. The rationale for this is their potential to reduce lung damage arising from inflammation, as well as their effect on symptomatic wheezing. It is important to establish the current level of evidence for the risks and benefits of inhaled corticosteroids, especially in the light of their known adverse effects on growth. This is an update of a previously published review; however, due to the lack of research in this area, we do not envisage undertaking any further updates.\nObjectives\nTo assess the effectiveness of taking regular inhaled corticosteroids compared to not taking them in children and adults with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We requested information from pharmaceutical companies manufacturing inhaled corticosteroids and authors of identified trials.\nDate of most recent search of the Group's Trials Register: 19 November 2018.\nSelection criteria\nRandomised or quasi-randomised trials, published and unpublished, comparing inhaled corticosteroids to placebo or standard treatment in individuals with cystic fibrosis.\nData collection and analysis\nTwo independent authors assessed methodological quality and risk of bias in trials using established criteria and extracted data using standard pro formas. The quality of the evidence was assessed using the GRADE criteria.\nMain results\nThe searches identified 35 citations, of which 27 (representing 13 trials) were eligible for inclusion. These 13 trials reported the use of inhaled corticosteroids in 525 people with cystic fibrosis aged between 6 and 55 years. One was a withdrawal trial in 171 individuals who were already taking inhaled corticosteroids. Methodological quality and risk of bias were difficult to assess from published information.\nObjective measures of airway function were reported in most trials but were often incomplete and reported at different time points. We found no difference in forced expiratory volume in one second (FEV1) or forced vital capacity (FVC) % predicted in any of the trials, although the quality of the evidence was low due to risks of bias within the included trials and low participant numbers. We are uncertain whether inhaled corticosteroids result in an improvement in exercise tolerance, bronchial hyperreactivity or exacerbations as the quality of the evidence was very low. Data from one trial suggested that inhaled corticosteroids may make little or no difference to quality of life (low-quality evidence).\nThree trials reported adverse effects, but the quality of the evidence is low and so we are uncertain whether inhaled corticosteroids increase the risk of adverse effects. However, one study did show that growth was adversely affected by high doses of inhaled corticosteroids.\nAuthors' conclusions\nEvidence from these trials is of low to very low quality and insufficient to establish whether inhaled corticosteroids are beneficial in cystic fibrosis, but withdrawal in those already taking them has been shown to be safe. There is some evidence they may cause harm in terms of growth. It has not been established whether long-term use is beneficial in reducing lung inflammation, which should improve survival, but it is unlikely this will be proven conclusively in a randomised controlled trial.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We reviewed the evidence about the effect of inhaled corticosteroids in people with cystic fibrosis."
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query-laysum | 2754 | [
{
"role": "user",
"content": "Abstract: Background\nThis is the second update of this systematic review. High blood pressure represents a major public health problem. Worldwide, approximately one-fourth of the adult population has hypertension. Epidemiological and experimental studies suggest a link between hyperuricaemia and hypertension. Hyperuricaemia affects 25% to 40% of those with untreated hypertension; a much lower prevalence has been reported in those with normotension or in the general population. However, whether lowering serum uric acid (UA) might lower blood pressure (BP), is an unanswered question.\nObjectives\nTo determine whether UA-lowering agents reduce BP in people with primary hypertension or prehypertension, compared with placebo.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to May 2020: the Cochrane Hypertension Specialised Register, CENTRAL 2018, Issue 12, MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also searched LILACS (1982 to May 2020), and contacted authors of relevant papers regarding further published and unpublished work. The searches had no language or date restrictions.\nSelection criteria\nTo be included in this updated review, the studies had to meet the following criteria: 1) randomised or quasi-randomised, with a group assigned to receive a UA-lowering agent and another group assigned to receive placebo; 2) double-blind, single-blind, or open-label; 3) parallel or cross-over trial design; 4) cross-over trials had to have a washout period of at least two weeks; 5) minimum treatment duration of four weeks; 6) participants had to have a diagnosis of essential hypertension or prehypertension plus hyperuricaemia (serum UA greater than 6 mg/dL in women, 7 mg/dL in men, and 5.5 mg/dL in children or adolescents); 7) outcome measures included change in 24-hour ambulatory systolic or diastolic BP, or both; or clinic-measured systolic or diastolic BP, or both.\nData collection and analysis\nThe two review authors independently collected the data using a data extraction form, and resolved any disagreements via discussion. We assessed risk of bias using the Cochrane 'Risk of bias' tool. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nIn this review update, we screened 722 records, selected 26 full-text reports for evaluation. We identified no ongoing studies and did not add any new studies. We included three randomised controlled trials (RCTs), enrolling 211 people with hypertension or prehypertension, plus hyperuricaemia.\nLow-certainty evidence from three RCTs found inconclusive results between those who received UA-lowering drugs and placebo, in 24-hour ambulatory systolic (MD -6.2 mmHg, 95% CI -12.8 to 0.5) or diastolic BP (-3.9 mmHg, 95% CI -9.2 to 1.4).\nLow-certainty evidence from two RCTs found that UA-lowering drugs reduced clinic-measured systolic BP (-8.43 mmHg, 95% CI -15.24 to -1.62) but results for clinic-measured diastolic BP were inconclusive (-6.45 mmHg, 95% CI -13.60 to 0.70).\nHigh-certainty evidence from three RCTs found that serum UA levels were reduced by 3.1 mg/dL (95% CI 2.4 to 3.8) in the participants that received UA-lowering drugs.\nLow-certainty evidence from three RCTs found inconclusive results regarding the occurrence of adverse events between those who received UA-lowering drugs and placebo (RR 1.86, 95% CI 0.43 to 8.10).\nAuthors' conclusions\nIn this updated Cochrane Review, the current RCT data are insufficient to know whether UA-lowering therapy lowers BP. More studies are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This is the second update of this Cochrane Review. The evidence is current to May 2020.\nUric acid is the natural end product of the breakdown of the body's tissues and a person's food, particularly protein. Uric acid is usually removed from the blood by the kidneys, and removed from the body in the urine. If too much uric acid is produced, or the kidneys are not able to remove it from the blood, uric acid levels in the blood increase (termed hyperuricaemia). A link between hyperuricaemia and high blood pressure (hypertension) has been recognized since the 19th century. This review aims to evaluate whether lowering uric acid levels in the blood could also lower blood pressure."
}
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query-laysum | 2755 | [
{
"role": "user",
"content": "Abstract: Background\nDifferent forms of vaccines have been developed to prevent the SARS-CoV-2 virus and subsequent COVID-19 disease. Several are in widespread use globally.\nObjectives\nTo assess the efficacy and safety of COVID-19 vaccines (as a full primary vaccination series or a booster dose) against SARS-CoV-2.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register and the COVID-19 L·OVE platform (last search date 5 November 2021). We also searched the WHO International Clinical Trials Registry Platform, regulatory agency websites, and Retraction Watch.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing COVID-19 vaccines to placebo, no vaccine, other active vaccines, or other vaccine schedules.\nData collection and analysis\nWe used standard Cochrane methods. We used GRADE to assess the certainty of evidence for all except immunogenicity outcomes.\nWe synthesized data for each vaccine separately and presented summary effect estimates with 95% confidence intervals (CIs).\nMain results\nWe included and analyzed 41 RCTs assessing 12 different vaccines, including homologous and heterologous vaccine schedules and the effect of booster doses. Thirty-two RCTs were multicentre and five were multinational. The sample sizes of RCTs were 60 to 44,325 participants. Participants were aged: 18 years or older in 36 RCTs; 12 years or older in one RCT; 12 to 17 years in two RCTs; and three to 17 years in two RCTs. Twenty-nine RCTs provided results for individuals aged over 60 years, and three RCTs included immunocompromized patients. No trials included pregnant women. Sixteen RCTs had two-month follow-up or less, 20 RCTs had two to six months, and five RCTs had greater than six to 12 months or less. Eighteen reports were based on preplanned interim analyses.\nOverall risk of bias was low for all outcomes in eight RCTs, while 33 had concerns for at least one outcome.\nWe identified 343 registered RCTs with results not yet available.\nThis abstract reports results for the critical outcomes of confirmed symptomatic COVID-19, severe and critical COVID-19, and serious adverse events only for the 10 WHO-approved vaccines. For remaining outcomes and vaccines, see main text. The evidence for mortality was generally sparse and of low or very low certainty for all WHO-approved vaccines, except AD26.COV2.S (Janssen), which probably reduces the risk of all-cause mortality (risk ratio (RR) 0.25, 95% CI 0.09 to 0.67; 1 RCT, 43,783 participants; high-certainty evidence).\nConfirmed symptomatic COVID-19\nHigh-certainty evidence found that BNT162b2 (BioNtech/Fosun Pharma/Pfizer), mRNA-1273 (ModernaTx), ChAdOx1 (Oxford/AstraZeneca), Ad26.COV2.S, BBIBP-CorV (Sinopharm-Beijing), and BBV152 (Bharat Biotect) reduce the incidence of symptomatic COVID-19 compared to placebo (vaccine efficacy (VE): BNT162b2: 97.84%, 95% CI 44.25% to 99.92%; 2 RCTs, 44,077 participants; mRNA-1273: 93.20%, 95% CI 91.06% to 94.83%; 2 RCTs, 31,632 participants; ChAdOx1: 70.23%, 95% CI 62.10% to 76.62%; 2 RCTs, 43,390 participants; Ad26.COV2.S: 66.90%, 95% CI 59.10% to 73.40%; 1 RCT, 39,058 participants; BBIBP-CorV: 78.10%, 95% CI 64.80% to 86.30%; 1 RCT, 25,463 participants; BBV152: 77.80%, 95% CI 65.20% to 86.40%; 1 RCT, 16,973 participants).\nModerate-certainty evidence found that NVX-CoV2373 (Novavax) probably reduces the incidence of symptomatic COVID-19 compared to placebo (VE 82.91%, 95% CI 50.49% to 94.10%; 3 RCTs, 42,175 participants).\nThere is low-certainty evidence for CoronaVac (Sinovac) for this outcome (VE 69.81%, 95% CI 12.27% to 89.61%; 2 RCTs, 19,852 participants).\nSevere or critical COVID-19\nHigh-certainty evidence found that BNT162b2, mRNA-1273, Ad26.COV2.S, and BBV152 result in a large reduction in incidence of severe or critical disease due to COVID-19 compared to placebo (VE: BNT162b2: 95.70%, 95% CI 73.90% to 99.90%; 1 RCT, 46,077 participants; mRNA-1273: 98.20%, 95% CI 92.80% to 99.60%; 1 RCT, 28,451 participants; AD26.COV2.S: 76.30%, 95% CI 57.90% to 87.50%; 1 RCT, 39,058 participants; BBV152: 93.40%, 95% CI 57.10% to 99.80%; 1 RCT, 16,976 participants).\nModerate-certainty evidence found that NVX-CoV2373 probably reduces the incidence of severe or critical COVID-19 (VE 100.00%, 95% CI 86.99% to 100.00%; 1 RCT, 25,452 participants).\nTwo trials reported high efficacy of CoronaVac for severe or critical disease with wide CIs, but these results could not be pooled.\nSerious adverse events (SAEs)\nmRNA-1273, ChAdOx1 (Oxford-AstraZeneca)/SII-ChAdOx1 (Serum Institute of India), Ad26.COV2.S, and BBV152 probably result in little or no difference in SAEs compared to placebo (RR: mRNA-1273: 0.92, 95% CI 0.78 to 1.08; 2 RCTs, 34,072 participants; ChAdOx1/SII-ChAdOx1: 0.88, 95% CI 0.72 to 1.07; 7 RCTs, 58,182 participants; Ad26.COV2.S: 0.92, 95% CI 0.69 to 1.22; 1 RCT, 43,783 participants); BBV152: 0.65, 95% CI 0.43 to 0.97; 1 RCT, 25,928 participants). In each of these, the likely absolute difference in effects was fewer than 5/1000 participants.\nEvidence for SAEs is uncertain for BNT162b2, CoronaVac, BBIBP-CorV, and NVX-CoV2373 compared to placebo (RR: BNT162b2: 1.30, 95% CI 0.55 to 3.07; 2 RCTs, 46,107 participants; CoronaVac: 0.97, 95% CI 0.62 to 1.51; 4 RCTs, 23,139 participants; BBIBP-CorV: 0.76, 95% CI 0.54 to 1.06; 1 RCT, 26,924 participants; NVX-CoV2373: 0.92, 95% CI 0.74 to 1.14; 4 RCTs, 38,802 participants).\nFor the evaluation of heterologous schedules, booster doses, and efficacy against variants of concern, see main text of review.\nAuthors' conclusions\nCompared to placebo, most vaccines reduce, or likely reduce, the proportion of participants with confirmed symptomatic COVID-19, and for some, there is high-certainty evidence that they reduce severe or critical disease. There is probably little or no difference between most vaccines and placebo for serious adverse events. Over 300 registered RCTs are evaluating the efficacy of COVID-19 vaccines, and this review is updated regularly on the COVID-NMA platform (covid-nma.com).\nImplications for practice\nDue to the trial exclusions, these results cannot be generalized to pregnant women, individuals with a history of SARS-CoV-2 infection, or immunocompromized people. Most trials had a short follow-up and were conducted before the emergence of variants of concern.\nImplications for research\nFuture research should evaluate the long-term effect of vaccines, compare different vaccines and vaccine schedules, assess vaccine efficacy and safety in specific populations, and include outcomes such as preventing long COVID-19. Ongoing evaluation of vaccine efficacy and effectiveness against emerging variants of concern is also vital.\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": "– Most vaccines reduce, or probably reduce, the number of people who get COVID-19 disease and severe COVID-19 disease.\n– Many vaccines likely increase number of people experiencing events such as fever or headache compared to placebo (sham vaccine that contains no medicine but looks identical to the vaccine being tested). This is expected because these events are mainly due to the body's response to the vaccine; they are usually mild and short-term.\n– Many vaccines have little or no difference in the incidence of serious adverse events compared to placebo.\n– There is insufficient evidence to determine whether there was a difference between the vaccine and placebo in terms of death because the numbers of deaths were low in the trials.\n– Most trials assessed vaccine efficacy over a short time, and did not evaluate efficacy to the COVID variants of concern."
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query-laysum | 2756 | [
{
"role": "user",
"content": "Abstract: Background\nIntrahepatic cholestasis of pregnancy is a pregnancy-specific liver disorder, possibly associated with an increased risk of severe fetal adverse events. Total serum bile acids (TSBA) concentration, alone or in combination with serum aminotransferases, have been the most often used biomarkers for the diagnosis of intrahepatic cholestasis of pregnancy in clinical practice. Serum bile acid profile, composed of primary or secondary, conjugated or non-conjugated bile acids, may provide more specific disease information.\nObjectives\nTo assess and compare, independently or in combination, the diagnostic accuracy of total serum bile acids or serum bile acids profile, or both, for the diagnosis of intrahepatic cholestasis of pregnancy in pregnant women, presenting with pruritus. To define the optimal cut-off values for components of serum bile acid profile; to investigate possible sources of heterogeneity.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Hepato-Biliary Group Diagnostic Test Accuracy Studies Register, the Cochrane Library, MEDLINE Ovid, Embase Ovid, Science Citation Index Expanded, Conference Proceedings Citation Index – Science, BIOSIS, CINAHL, two Chinese databases (CKNI, VIP), Latin American and Caribbean Health Sciences Literature (LILACS), Scientific Electronic Library Online (SciELO), Evidence Search: Health and Social Care by the National Institute for Health and Care Excellence (NICE), the World Health Organization (WHO) Reproductive Health Library (RHL), and the Turning Research into Practice database (TRIP). The most recent date of search was 6 May 2019. We identified additional references by handsearching the references of articles, meta-analyses, and evidence-based guidelines retrieved from the computerised databases, on-line trial registries, and grey literature through OpenSIGLE, National Technical Information Service (NTIS), ProQuest Dissertations & Thesis Database, and Index to Theses in Great Britain and Ireland.\nSelection criteria\nProspective or retrospective diagnostic case-control or cross-sectional studies, irrespective of publication date, format, and language, which evaluated the diagnostic accuracy of total serum bile acids (TSBA) or components of serum bile acid profile for the diagnosis of intrahepatic cholestasis of pregnancy in pregnant women of any age or ethnicity, in any clinical setting, symptomatic for pruritus.\nData collection and analysis\nWe selected studies by reading titles, abstracts, or full texts, and assessing their fulfilment of our inclusion criteria. We emailed primary authors to request missing data or individual participant data. Having extracted data from each included study, we built the two-by-two tables for each primary study and for all the index tests considered. We estimated sensitivity and specificity with their 95% confidence intervals (CI). We presented data in coupled forest plots, showing sensitivities and specificities of each study, and we plotted the studies in the Receiver Operating Characteristic (ROC) space. We performed meta-analyses adopting the hierarchical summary ROC model (HSROC) or the bivariate model to meta-analyse the data. We made indirect comparisons of the considered index tests by adding the index tests as covariates to the bivariate or HSROC models. We performed heterogeneity analysis and sensitivity analysis on studies assessing TSBA accuracy. We used Review Manager 5 (RevMan 5) and SAS statistical software, release 9.4 (SAS Institute Inc., Cary, NC, USA), to perform all statistical analyses. We used QUADAS-2 domains to assess the risk of bias of the included studies.\nMain results\nOur search yielded 5073 references, but at the end of our selection process, only 16 studies fulfilled the review inclusion criteria. Nine of these provided individual participant data. We analysed only data concerning TSBA, cholic acid (CA), glycocholic acid (GCA), chenodeoxycholic acid (CDCA), and CA/CDCA because the remaining planned index tests were assessed in few studies. Only one study had low risk of bias in all four QUADAS-2 domains. The most biased domains were the patient sampling and the reference standard domains. When considering all studies with a cut-off of 10 μmol/L, TSBA overall sensitivity ranged from 0.72 to 0.98 and specificity ranged from 0.81 to 0.97. After a sensitivity analysis excluding case-control studies, TSBA sensitivity ranged from 0.48 to 0.66 and specificity from 0.52 to 0.99. After a sensitivity analysis excluding studies in which TSBA was part of the reference standard, TSBA sensitivity ranged from 0.49 to 0.65 and specificity from 0.53 to 0.99. We found the estimates of the overall accuracy for some serum bile acid components (CA, GCA, CDCA, and CA/CDCA) to be imprecise, with the CI for sensitivity and specificity very wide or impossible to calculate. Indirect comparisons between serum bile acid profile components and TSBA were not statistically significant. None of the heterogeneity analysis performed was statistically significant, except for the timing of assessment of TSBA (onset of symptoms, peak value among multiple assessments, delivery) but without clinically relevant results. We could not analyse the diagnostic accuracy of combinations of index tests because none of the included studies carried them out, and because of the small number of included studies.\nAuthors' conclusions\nThe overall high risk of bias, the existing concern regarding applicability of the results in clinical practice, and the great heterogeneity of the results in the included studies prevents us from making recommendations and reaching definitive conclusions at the present time. Thus, we do not find any compelling evidence to recommend or refute the routine use of any of these tests in clinical practice. So far, the diagnostic accuracy of TSBA for intrahepatic cholestasis of pregnancy might have been overestimated. There were too few studies to permit a precise estimate of the accuracy of serum bile acid profile components. Further primary clinical research is mandatory. We need both further phase II and phase III diagnostic studies.\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": "Only one of the 16 included studies was performed and reported well (low risk of bias). The remaining 15 studies had problems with study design or reporting (high risk of bias). Only five studies seemed to show low concern regarding applicability of the results in clinical practice."
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query-laysum | 2757 | [
{
"role": "user",
"content": "Abstract: Background\nDelirium is defined as a disturbance in attention, awareness and cognition with reduced ability to direct, focus, sustain and shift attention, and reduced orientation to the environment. Critically ill patients in the intensive care unit (ICU) frequently develop ICU delirium. It can profoundly affect both them and their families because it is associated with increased mortality, longer duration of mechanical ventilation, longer hospital and ICU stay and long-term cognitive impairment. It also results in increased costs for society.\nObjectives\nTo assess existing evidence for the effect of preventive interventions on ICU delirium, in-hospital mortality, the number of delirium- and coma-free days, ventilator-free days, length of stay in the ICU and cognitive impairment.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, BIOSIS, International Web of Science, Latin American Caribbean Health Sciences Literature, CINAHL from 1980 to 11 April 2018 without any language limits. We adapted the MEDLINE search for searching the other databases. Furthermore, we checked references, searched citations and contacted study authors to identify additional studies. We also checked the following trial registries: Current Controlled Trials; ClinicalTrials.gov; and CenterWatch.com (all on 24 April 2018).\nSelection criteria\nWe included randomized controlled trials (RCTs) of adult medical or surgical ICU patients receiving any intervention for preventing ICU delirium. The control could be standard ICU care, placebo or both. We assessed the quality of evidence with GRADE.\nData collection and analysis\nWe checked titles and abstracts to exclude obviously irrelevant studies and obtained full reports on potentially relevant ones. Two review authors independently extracted data. If possible we conducted meta-analyses, otherwise we synthesized data narratively.\nMain results\nThe electronic search yielded 8746 records. We included 12 RCTs (3885 participants) comparing usual care with the following interventions: commonly used drugs (four studies); sedation regimens (four studies); physical therapy or cognitive therapy, or both (one study); environmental interventions (two studies); and preventive nursing care (one study). We found 15 ongoing studies and five studies awaiting classification. The participants were 48 to 70 years old; 48% to 74% were male; the mean acute physiology and chronic health evaluation (APACHE II) score was 14 to 28 (range 0 to 71; higher scores correspond to more severe disease and a higher risk of death). With the exception of one study, all participants were mechanically ventilated in medical or surgical ICUs or mixed. The studies were overall at low risk of bias. Six studies were at high risk of detection bias due to lack of blinding of outcome assessors. We report results for the two most commonly explored approaches to delirium prevention: pharmacologic and a non-pharmacologic intervention.\nHaloperidol versus placebo (two RCTs, 1580 participants)\nThe event rate of ICU delirium was measured in one study including 1439 participants. No difference was identified between groups, (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.87 to 1.17) (moderate-quality evidence). Haloperidol versus placebo neither reduced or increased in-hospital mortality, (RR 0.98, 95% CI 0.80 to 1.22; 2 studies; 1580 participants (moderate-quality evidence)); the number of delirium- and coma-free days, (mean difference (MD) -0.60, 95% CI -1.37 to 0.17; 2 studies, 1580 participants (moderate-quality of evidence)); number of ventilator-free days (mean 23.8 (MD -0.30, 95% CI -0.93 to 0.33) 1 study; 1439 participants, (high-quality evidence)); length of ICU stay, (MD 0.18, 95% CI 0.60 to 0.97); 2 studies, 1580 participants; high-quality evidence). None of the studies measured cognitive impairment. In one study there were three serious adverse events in the intervention group and five in the placebo group; in the other there were five serious adverse events and three patients died, one in each group. None of the serious adverse events were judged to be related to interventions received (moderate-quality evidence).\nPhysical and cognitive therapy interventions (one study, 65 participants)\nThe study did not measure the event rate of ICU delirium. A physical and cognitive therapy intervention versus standard care neither reduced nor increased in-hospital mortality, (RR 0.94, 95% CI 0.40 to 2.20, I² = 0; 1 study, 65 participants; very low-quality evidence); the number of delirium- and coma-free days, (MD -2.8, 95% CI -10.1 to 4.6, I² = 0; 1 study, 65 participants; very low-quality evidence); the number of ventilator-free days (within the first 28/30 days) was median 27.4 (IQR 0 to 29.2) and 25 (IQR 0 to 28.9); 1 study, 65 participants; very low-quality evidence, length of ICU stay, (MD 1.23, 95% CI -0.68 to 3.14, I² = 0; 1 study, 65 participants; very low-quality evidence); cognitive impairment measured by the MMSE: Mini-Mental State Examination with higher scores indicating better function, (MD 0.97, 95% CI -0.19 to 2.13, I² = 0; 1 study, 30 participants; very low-quality evidence); or measured by the Dysexecutive questionnaire (DEX) with lower scores indicating better function (MD -8.76, 95% CI -19.06 to 1.54, I² = 0; 1 study, 30 participants; very low-quality evidence). One patient experienced acute back pain accompanied by hypotensive urgency during physical therapy.\nAuthors' conclusions\nThere is probably little or no difference between haloperidol and placebo for preventing ICU delirium but further studies are needed to increase our confidence in the findings. There is insufficient evidence to determine the effects of physical and cognitive intervention on delirium. The effects of other pharmacological interventions, sedation, environmental, and preventive nursing interventions are unclear and warrant further investigation in large multicentre studies. Five studies are awaiting classification and we identified 15 ongoing studies, evaluating pharmacological interventions, sedation regimens, physical and occupational therapy combined or separately, and environmental interventions, that may alter the conclusions of the review in future.\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": "Our aim was to assess the existing evidence on the effect of interventions for preventing ICU delirium, reducing in-hospital death, reducing length of coma/delirium, the need for mechanical ventilation to assist breathing, the length of stay in the ICU and mental problems"
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query-laysum | 2758 | [
{
"role": "user",
"content": "Abstract: Background\nAge-related cataract affects both eyes in most cases. Most people undergo cataract surgery in both eyes on separate days, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating on both eyes on the same day, but as two separate procedures, known as immediate sequential bilateral cataract surgery (ISBCS). Potential advantages of ISBCS include fewer hospital visits for the patient, faster visual recovery, and lower healthcare costs. Nevertheless, concerns exist about possible bilateral, postoperative, sight-threatening adverse effects with ISBCS. Therefore, there is a clear need for evaluating evidence regarding the safety, effectiveness, and cost-effectiveness of ISBCS versus DSBCS.\nObjectives\nTo assess the safety of ISBCS compared to DSBCS in people with bilateral age-related cataracts and to summarise current evidence for the incremental resource use, utilities, costs, and cost-effectiveness associated with the use of ISBCS compared to DSBCS in people with bilateral age-related cataracts (primary objectives). The secondary objective was to assess visual and patient-reported outcomes of ISBCS compared to DSBCS in people with bilateral age-related cataracts.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register; 2021, Issue 5); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov; the WHO ICTRP; and DARE and NHS EED on the CRD Database on 11 May 2021. There were no language restrictions. We limited the searches to a date range of 2007 onwards.\nSelection criteria\nWe included randomised controlled trials (RCTs) to assess complications, refractive outcomes, best-corrected distance visual acuity (BCDVA) and patient-reported outcome measures (PROMs) with ISBCS compared to DSBCS. We included non-randomised (NRSs), prospective, and retrospective cohort studies comparing ISBCS and DSBCS for safety assessment, because of the rare incidence of important adverse events. To assess cost-effectiveness of ISBCS compared to DSBCS, we included both full and partial economic evaluations, and both trial-based and model-based economic evaluations.\nData collection and analysis\nWe used standard Cochrane methodological procedures and assessed risk of bias for NRSs using the ROBINS-I tool. For cost-evaluations, we used the CHEC-list, the CHEERS-checklist, and the NICE-checklist to investigate risk of bias. We assessed the certainty of evidence with the GRADE tool. We reported results for economic evaluations narratively.\nMain results\nWe included 14 studies in the review; two RCTs, seven NRSs, and six economic evaluations (one study was both an NRS and economic evaluation). The studies reported on 276,260 participants (7384 for ISBCS and 268,876 for DSBCS) and were conducted in Canada, the Czech Republic, Finland, Iran, (South) Korea, Spain (Canary Islands), Sweden, the UK, and the USA. Overall, we considered the included RCTs to be at 'high to some concerns' risk of bias for complications, 'some concerns' risk of bias for refractive outcomes and visual acuity, and 'high' risk of bias for PROMs. The overall risk of bias for NRSs was graded 'serious' regarding complications and 'serious to critical' regarding refractive outcomes.\nWith regard to endophthalmitis, we found that relative effects were estimated imprecisely and with low certainty, so that relative estimates were not reliable. Nonetheless, we found a very low risk of endophthalmitis in both ISBCS (1/14,076 participants) and DSBCS (55/556,246 participants) groups. Based on descriptive evidence and partially weak statistical evidence we found no evidence of an increased risk of endophthalmitis with ISBCS. Regarding refractive outcomes, we found moderate-certainty (RCTs) and low-certainty (NRSs) evidence there was no difference in the percentage of eyes that did not achieve refraction within 1.0 dioptre of target one to three months after surgery (RCTs: risk ratio (RR) 0.84, 95% confidence interval (CI) 0.57 to 1.26; NRSs: RR 1.02, 95% CI 0.60 to 1.75). Similarly, postoperative complications did not differ between groups (RCTs: RR 1.33, 95% CI 0.52 to 3.40; NRSs: 1.04, 95% CI 0.47 to 2.29), although the certainty of this evidence was very low for both RCTs and NRSs. Furthermore, we found low-certainty (RCTs) to very low-certainty (NRSs) evidence that total costs per participant were lower for ISBCS compared to DSBCS, although results of individual studies could not be pooled. Only one study reported on cost-effectiveness. This study found that ISBCS is cost-effective compared to DSBCS, but did not measure quality-adjusted life years using preferred methods and calculated costs erroneously. Finally, regarding secondary outcomes, we found limited evidence on BCDVA (data of two RCTs could not be pooled, although both studies individually found no difference between groups (very low-certainty evidence)). Regarding PROMs, we found moderate-certainty evidence (RCTs only) that there was no difference between groups one to three months after surgery (standardised mean difference −0.08, 95% CI −0.19 to 0.03).\nAuthors' conclusions\nCurrent evidence supports there are probably no clinically important differences in outcomes between ISBCS and DSBCS, but with lower costs for ISBCS. However, the amount of evidence is limited, and the certainty of the evidence was graded moderate to very low. In addition, there is a need for well-designed cost-effectiveness studies.\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 looked at outcomes of ISBCS compared to DSBCS. We also searched for studies that looked at the balance between costs and outcomes for ISBCS compared to DSBCS (cost-effectiveness). We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes."
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query-laysum | 2759 | [
{
"role": "user",
"content": "Abstract: Background\nAbout one-third of women have urinary incontinence (UI) and up to one-tenth have faecal incontinence (FI) after childbirth. Pelvic floor muscle training (PFMT) is commonly recommended during pregnancy and after birth for both preventing and treating incontinence.\nThis is an update of a Cochrane Review previously published in 2017.\nObjectives\nTo assess the effects of PFMT for preventing or treating urinary and faecal incontinence in pregnant or postnatal women, and summarise the principal findings of relevant economic evaluations.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP, and handsearched journals and conference proceedings (searched 7 August 2019), and the reference lists of retrieved studies.\nSelection criteria\nWe included randomised or quasi-randomised trials in which one arm included PFMT. Another arm was no PFMT, usual antenatal or postnatal care, another control condition, or an alternative PFMT intervention.\nPopulations included women who, at randomisation, were continent (PFMT for prevention) or incontinent (PFMT for treatment), and a mixed population of women who were one or the other (PFMT for prevention or treatment).\nData collection and analysis\nWe independently assessed trials for inclusion and risk of bias. We extracted data and assessed the quality of evidence using GRADE.\nMain results\nWe included 46 trials involving 10,832 women from 21 countries. Overall, trials were small to moderately-sized. The PFMT programmes and control conditions varied considerably and were often poorly described. Many trials were at moderate to high risk of bias. Two participants in a study of 43 pregnant women performing PFMT for prevention of incontinence withdrew due to pelvic floor pain. No other trials reported any adverse effects of PFMT.\nPrevention of UI: compared with usual care, continent pregnant women performing antenatal PFMT probably have a lower risk of reporting UI in late pregnancy (62% less; risk ratio (RR) 0.38, 95% confidence interval (CI) 0.20 to 0.72; 6 trials, 624 women; moderate-quality evidence). Antenatal PFMT slightly decreased the risk of UI in the mid-postnatal period (more than three to six months' postpartum) (29% less; RR 0.71, 95% CI 0.54 to 0.95; 5 trials, 673 women; high-quality evidence). There was insufficient information available for the late postnatal period (more than six to 12 months) to determine effects at this time point (RR 1.20, 95% CI 0.65 to 2.21; 1 trial, 44 women; low-quality evidence).\nTreatment of UI: compared with usual care, there is no evidence that antenatal PFMT in incontinent women decreases incontinence in late pregnancy (very low-quality evidence), or in the mid-(RR 0.94, 95% CI 0.70 to 1.24; 1 trial, 187 women; low-quality evidence), or late postnatal periods (very low-quality evidence). Similarly, in postnatal women with persistent UI, there is no evidence that PFMT results in a difference in UI at more than six to 12 months postpartum (RR 0.55, 95% CI 0.29 to 1.07; 3 trials; 696 women; low-quality evidence).\nMixed prevention and treatment approach to UI: antenatal PFMT in women with or without UI probably decreases UI risk in late pregnancy (22% less; RR 0.78, 95% CI 0.64 to 0.94; 11 trials, 3307 women; moderate-quality evidence), and may reduce the risk slightly in the mid-postnatal period (RR 0.73, 95% CI 0.55 to 0.97; 5 trials, 1921 women; low-quality evidence). There was no evidence that antenatal PFMT reduces the risk of UI at late postpartum (RR 0.85, 95% CI 0.63 to 1.14; 2 trials, 244 women; moderate-quality evidence). For PFMT started after delivery, there was uncertainty about the effect on UI risk in the late postnatal period (RR 0.88, 95% CI 0.71 to 1.09; 3 trials, 826 women; moderate-quality evidence).\nFaecal incontinence: eight trials reported FI outcomes. In postnatal women with persistent FI, it was uncertain whether PFMT reduced incontinence in the late postnatal period compared to usual care (very low-quality evidence). In women with or without FI, there was no evidence that antenatal PFMT led to a difference in the prevalence of FI in late pregnancy (RR 0.64, 95% CI 0.36 to 1.14; 3 trials, 910 women; moderate-quality evidence). Similarly, for postnatal PFMT in a mixed population, there was no evidence that PFMT reduces the risk of FI in the late postnatal period (RR 0.73, 95% CI 0.13 to 4.21; 1 trial, 107 women, low-quality evidence).\nThere was little evidence about effects on UI or FI beyond 12 months' postpartum. There were few incontinence-specific quality of life data and little consensus on how to measure it.\nAuthors' conclusions\nThis review provides evidence that early, structured PFMT in early pregnancy for continent women may prevent the onset of UI in late pregnancy and postpartum. Population approaches (recruiting antenatal women regardless of continence status) may have a smaller effect on UI, although the reasons for this are unclear. A population-based approach for delivering postnatal PFMT is not likely to reduce UI. Uncertainty surrounds the effects of PFMT as a treatment for UI in antenatal and postnatal women, which contrasts with the more established effectiveness in mid-life women.\nIt is possible that the effects of PFMT might be greater with targeted rather than mixed prevention and treatment approaches, and in certain groups of women. Hypothetically, for instance, women with a high body mass index (BMI) are at risk of UI. Such uncertainties require further testing and data on duration of effect are also needed. The physiological and behavioural aspects of exercise programmes must be described for both PFMT and control groups, and how much PFMT women in both groups do, to increase understanding of what works and for whom.\nFew data exist on FI and it is important that this is included in any future trials. It is essential that future trials use valid measures of incontinence-specific quality of life for both urinary and faecal incontinence. In addition to further clinical studies, economic evaluations assessing the cost-effectiveness of different management strategies for FI and UI are needed.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Twenty-five studies were publicly funded, one of which received grants from both public and private sources. Three studies received no funding and 18 did not declare their funding sources."
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query-laysum | 2760 | [
{
"role": "user",
"content": "Abstract: Background\nAttention deficit hyperactivity disorder (ADHD) in children is associated with hyperactivity and impulsivity, attention problems, and difficulties with social interactions. Pharmacological treatment may alleviate the symptoms of ADHD but this rarely solves difficulties with social interactions. Children with ADHD may benefit from interventions designed to improve their social skills. We examined the benefits and harms of social skills training on social skills, emotional competencies, general behaviour, ADHD symptoms, performance in school of children with ADHD, and adverse events.\nObjectives\nTo assess the beneficial and harmful effects of social skills training in children and adolescents with ADHD.\nSearch methods\nIn July 2018, we searched CENTRAL, MEDLINE, Embase, PsycINFO, 4 other databases and two trials registers.We also searched online conference abstracts, and contacted experts in the field for information about unpublished or ongoing randomised clinical trials. We did not limit our searches by language, year of publication, or type or status of publication, and we sought translation of the relevant sections of non-English language articles.\nSelection criteria\nRandomised clinical trials investigating social skills training versus either no intervention or waiting-list control, with or without pharmacological treatment of both comparison groups of children and adolescents with ADHD.\nData collection and analysis\nWe conducted the review in accordance with the Cochrane Handbook for Systematic Reviews of Intervention. We performed the analyses using Review Manager 5 software and Trial Sequential Analysis. We assessed bias according to domains for systematic errors. We assessed the certainty of the evidence with the GRADE approach.\nMain results\nWe included 25 randomised clinical trials described in 45 reports. The trials included a total of 2690 participants aged between five and 17 years. In 17 trials, participants were also diagnosed with various comorbidities.\nThe social skills interventions were described as: 1) social skills training, 2) cognitive behavioural therapy, 3) multimodal behavioural/psychosocial therapy, 4) child life and attention skills treatment, 5) life skills training, 6) the \"challenging horizon programme\", 7) verbal self-instruction, 8) meta-cognitive training, 9) behavioural therapy, 10) behavioural and social skills treatment, and 11) psychosocial treatment. The control interventions were no intervention or waiting list.\nThe duration of the interventions ranged from five weeks to two years. We considered the content of the social skills interventions to be comparable and based on a cognitive-behavioural model. Most of the trials compared child social skills training or parent training combined with medication versus medication alone. Some of the experimental interventions also included teacher consultations.\nMore than half of the trials were at high risk of bias for generation of the allocation sequence and allocation concealment. No trial reported on blinding of participants and personnel. Most of the trials did not report on differences between groups in medication for comorbid disorders. We used all eligible trials in the meta-analyses, but downgraded the certainty of the evidence to low or very low.\nWe found no clinically relevant treatment effect of social skills interventions on the primary outcome measures: teacher-rated social skills at end of treatment (standardised mean difference (SMD) 0.11, 95% confidence interval (CI) 0.00 to 0.22; 11 trials, 1271 participants; I2 = 0%; P = 0.05); teacher-rated emotional competencies at end of treatment (SMD −0.02, 95% CI −0.72 to 0.68; two trials, 129 participants; I2 = 74%; P = 0.96); or on teacher-rated general behaviour (SMD −0.06 (negative value better), 95% CI −0.19 to 0.06; eight trials, 1002 participants; I2 = 0%; P = 0.33). The effect on the primary outcome, teacher-rated social skills at end of treatment, corresponds to a MD of 1.22 points on the social skills rating system (SSRS) scale (95% CI 0.09 to 2.36). The minimal clinical relevant difference (10%) on the SSRS is 10.0 points (range 0 to 102 points on SSRS).\nWe found evidence in favour of social skills training on teacher-rated core ADHD symptoms at end of treatment for all eligible trials (SMD −0.26, 95% CI −0.47 to −0.05; 14 trials, 1379 participants; I2= 69%; P = 0.02), but the finding is questionable due to lack of support from sensitivity analyses, high risk of bias, lack of clinical significance, high heterogeneity, and low certainty.\nThe studies did not report any serious or non-serious adverse events.\nAuthors' conclusions\nThe review suggests that there is little evidence to support or refute social skills training for children and adolescents with ADHD. We may need more trials that are at low risk of bias and a sufficient number of participants to determine the efficacy of social skills training versus no training for ADHD. The evidence base regarding adolescents is especially weak.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found no significant differences between social skills training versus controls on social skills, emotional competencies, and general behaviour as assessed by teachers. Compared with the children who had no social skills training, teachers rated those who had been in the social skills groups as having fewer ADHD symptoms at the end of treatment.. However, this finding was questionable because our other analyses did not support it. We found no indications of harmful effects.\nAll trials suffered from methodological problems such as overestimation of benefits and underestimation of harms. Many studies were also difficult to compare because they involved different interventions. The results from some trials were not very precise, which means it is difficult to be confident in the results. In seven trials, study authors were board members of pharmaceutical companies, had received funding from such companies, or had performed previous research on the topic."
}
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query-laysum | 2761 | [
{
"role": "user",
"content": "Abstract: Background\nAcceptable, effective and feasible support strategies (interventions) for parents experiencing complex post-traumatic stress disorder (CPTSD) symptoms or with a history of childhood maltreatment may offer an opportunity to support parental recovery, reduce the risk of intergenerational transmission of trauma and improve life-course trajectories for children and future generations. However, evidence relating to the effect of interventions has not been synthesised to provide a comprehensive review of available support strategies. This evidence synthesis is critical to inform further research, practice and policy approaches in this emerging area.\nObjectives\nTo assess the effects of interventions provided to support parents who were experiencing CPTSD symptoms or who had experienced childhood maltreatment (or both), on parenting capacity and parental psychological or socio-emotional wellbeing.\nSearch methods\nIn October 2021 we searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers, together with checking references and contacting experts to identify additional studies.\nSelection criteria\nAll variants of randomised controlled trials (RCTs) comparing any intervention delivered in the perinatal period designed to support parents experiencing CPTSD symptoms or with a history of childhood maltreatment (or both), to any active or inactive control. Primary outcomes were parental psychological or socio-emotional wellbeing and parenting capacity between pregnancy and up to two years postpartum.\nData collection and analysis\nTwo review authors independently assessed the eligibility of trials for inclusion, extracted data using a pre-designed data extraction form, and assessed risk of bias and certainty of evidence. We contacted study authors for additional information as required. We analysed continuous data using mean difference (MD) for outcomes using a single measure, and standardised mean difference (SMD) for outcomes using multiple measures, and risk ratios (RR) for dichotomous data. All data are presented with 95% confidence intervals (CIs). We undertook meta-analyses using random-effects models.\nMain results\nWe included evidence from 1925 participants in 15 RCTs that investigated the effect of 17 interventions. All included studies were published after 2005. Interventions included seven parenting interventions, eight psychological interventions and two service system approaches. The studies were funded by major research councils, government departments and philanthropic/charitable organisations. All evidence was of low or very low certainty.\nParenting interventions\nEvidence was very uncertain from a study (33 participants) assessing the effects of a parenting intervention compared to attention control on trauma-related symptoms, and psychological wellbeing symptoms (postpartum depression), in mothers who had experienced childhood maltreatment and were experiencing current parenting risk factors. Evidence suggested that parenting interventions may improve parent-child relationships slightly compared to usual service provision (SMD 0.45, 95% CI -0.06 to 0.96; I2 = 60%; 2 studies, 153 participants; low-certainty evidence). There may be little or no difference between parenting interventions and usual perinatal service in parenting skills including nurturance, supportive presence and reciprocity (SMD 0.25, 95% CI -0.07 to 0.58; I2 = 0%; 4 studies, 149 participants; low-certainty evidence). No studies assessed the effects of parenting interventions on parents' substance use, relationship quality or self-harm.\nPsychological interventions\nPsychological interventions may result in little or no difference in trauma-related symptoms compared to usual care (SMD -0.05, 95% CI -0.40 to 0.31; I2 = 39%; 4 studies, 247 participants; low-certainty evidence). Psychological interventions may make little or no difference compared to usual care to depression symptom severity (8 studies, 507 participants, low-certainty evidence, SMD -0.34, 95% CI -0.66 to -0.03; I2 = 63%). An interpersonally focused cognitive behavioural analysis system of psychotherapy may slightly increase the number of pregnant women who quit smoking compared to usual smoking cessation therapy and prenatal care (189 participants, low-certainty evidence). A psychological intervention may slightly improve parents' relationship quality compared to usual care (1 study, 67 participants, low-certainty evidence). Benefits for parent-child relationships were very uncertain (26 participants, very low-certainty evidence), while there may be a slight improvement in parenting skills compared to usual care (66 participants, low-certainty evidence). No studies assessed the effects of psychological interventions on parents' self-harm.\nService system approaches\nOne service system approach assessed the effect of a financial empowerment education programme, with and without trauma-informed peer support, compared to usual care for parents with low incomes. The interventions increased depression slightly (52 participants, low-certainty evidence). No studies assessed the effects of service system interventions on parents' trauma-related symptoms, substance use, relationship quality, self-harm, parent-child relationships or parenting skills.\nAuthors' conclusions\nThere is currently a lack of high-quality evidence regarding the effectiveness of interventions to improve parenting capacity or parental psychological or socio-emotional wellbeing in parents experiencing CPTSD symptoms or who have experienced childhood maltreatment (or both). This lack of methodological rigour and high risk of bias made it difficult to interpret the findings of this review. Overall, results suggest that parenting interventions may slightly improve parent-child relationships but have a small, unimportant effect on parenting skills. Psychological interventions may help some women stop smoking in pregnancy, and may have small benefits on parents' relationships and parenting skills. A financial empowerment programme may slightly worsen depression symptoms. While potential beneficial effects were small, the importance of a positive effect in a small number of parents must be considered when making treatment and care decisions. There is a need for further high-quality research into effective strategies for this population.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up-to-date to October 2021."
}
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query-laysum | 2762 | [
{
"role": "user",
"content": "Abstract: Background\nEssential tremor (ET) is one of the most common movement disorders. The treatment is primarily based on pharmacological agents. Although primidone and propranolol are well established treatments in clinical practice, they can be ineffective in 25% to 55% of patients, and can produce serious adverse events in a large percentage of them. For these reasons, it may be worthwhile evaluating the treatment alternatives for ET. Zonisamide has been suggested as a potentially useful agent for the treatment of ET but there is uncertainty about its efficacy and safety.\nObjectives\nTo assess the effect on functional abilities and the safety profile of zonisamide in adults with essential tremor (ET).\nSearch methods\nWe carried out a systematic search, without language restrictions to identify all relevant trials. We searched CENTRAL, MEDLINE, Embase, NICE, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) to January 2017. We searched BIOSIS Citation Index (2000 to January 2017) for conference proceedings. We handsearched grey literature and examined the reference lists of identified studies and reviews.\nSelection criteria\nWe included all randomised controlled trials (RCTs) of zonisamide versus placebo or any other treatment. We included studies in which the diagnosis of ET was made according to accepted and validated diagnostic criteria. We excluded studies conducted in patients presenting secondary forms of tremor or reporting only neurophysiological parameters to assess outcomes.\nData collection and analysis\nTwo review authors independently collected and extracted data using a data collection form. We assessed the risk of bias and the quality of evidence.We used inverse variance methods for continuous outcomes and measurement scales. We compared differences between treatment groups as mean differences. We combined results for dichotomous outcomes using Mantel-Haenszel methods and obtained risk differences to compare treatment groups. We used Review Manager 5 software for data management and analysis.\nMain results\nWe only considered one study eligible for this review (20 participants). Assessments of risk of bias for most domains were unclear or low. Adverse events were only reported in participants from the zonisamide group, making it possible that they were aware of treatment group assignment. We are uncertain as to the effects of zonisamide on motor tasks (mean difference (MD) -0.00, 95% confidence interval (CI) -1.51 to 1.51, very low-quality evidence) and functional disabilities (MD -0.30, 95% CI -1.23 to 0.63, very low-quality evidence) when compared with placebo. Three participants in the zonisamide group (30%) and two participants in the placebo group (20%) discontinued the treatment and withdrew from the study for any reason (very low-quality evidence), however the increased risk of withdrawal in the zonisamide group was statistically non-significant (risk difference (RD) 0.1, 95% CI -0.28 to 0.48). Six participants in the zonisamide group (60%) and none of the participants in the placebo group (0%) developed adverse events (AEs), with a RD of 0.60 (95% CI 0.28 to 0.92; very low quality evidence). The most common AEs, experienced with zonisamide treatment, were headache, nausea, fatigue, sleepiness, and diarrhoea. Quality of life was not assessed in the study included.\nAuthors' conclusions\nBased on currently available data, there is insufficient evidence to assess the efficacy and safety of zonisamide treatment for ET.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The single study we found was small and the possibility of study participants becoming aware of the treatment group means that we cannot be certain about the risk-benefit profile of this treatment."
}
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query-laysum | 2763 | [
{
"role": "user",
"content": "Abstract: Background\nMalignant gastric outlet obstruction is the clinical and pathological consequence of cancerous disease causing a mechanical obstruction to gastric emptying. It usually occurs when malignancy is at an advanced stage; therefore, people have a limited life expectancy. It is of paramount importance to restore oral intake to improve quality of life for the person in a manner that has a minimal risk of complications and a short recovery period.\nObjectives\nTo assess the benefits and harms of endoscopic stent placement versus surgical palliation for people with symptomatic malignant gastric outlet obstruction.\nSearch methods\nIn May 2018 we searched the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid Embase and Ovid CINAHL. We screened reference lists from included studies and review articles.\nSelection criteria\nWe included randomised controlled trials comparing stent placement with surgical palliation for people with gastric outlet obstruction secondary to malignant disease.\nData collection and analysis\nTwo review authors independently extracted study data. We calculated the risk ratio (RR) with 95% confidence intervals (CI) for binary outcomes, mean difference (MD) or standardised mean difference (SMD) with 95% CI for continuous outcomes and the hazard ratio (HR) for time-to-event outcomes. We performed meta-analyses where meaningful. We assessed the quality of evidence using GRADE criteria.\nMain results\nWe identified three randomised controlled trials with 84 participants. Forty-one participants underwent surgical palliation and 43 participants underwent duodenal stent placement. There may have been little or no difference in the technical success of the procedure (RR 0.98, 95% CI 0.88 to 1.09; low-quality evidence), or whether the time to resumption of oral intake was quicker for participants who had undergone duodenal stent placement (MD -3.07 days, 95% CI -4.76 to -1.39; low-quality evidence).\nDue to very low-quality evidence, we were uncertain whether surgical palliation improved all-cause mortality and median survival postintervention.\nThe time to recurrence of obstructive symptoms may have increased slightly following duodenal stenting (RR 5.08, 95% CI 0.96 to 26.74; moderate-quality evidence).\nDue to very low-quality evidence, we were uncertain whether surgical palliation improved serious and minor adverse events. The heterogeneity for adverse events was moderately high (serious adverse events: Chi² = 1.71; minor adverse events: Chi² = 3.08), reflecting the differences in definitions used and therefore, may have impacted the outcomes. The need for reintervention may have increased following duodenal stenting (RR 4.71, 95% CI 1.36 to 16.30; very low-quality evidence).\nThe length of hospital stay may have been shorter (by approximately 4 to 10 days) following stenting (MD -6.70 days, 95% CI -9.41 to -3.98; moderate-quality evidence).\nAuthors' conclusions\nThe use of duodenal stent placement in malignant gastric outlet obstruction has the benefits of a quicker resumption of oral intake and a reduced inpatient hospital stay; however, this is balanced by an increase in the recurrence of symptoms and the need for further intervention.\nIt is impossible to draw further conclusions on these and the other measured outcomes, primarily due to the low number of eligible studies and small number of participants which resulted in low-quality evidence. It was not possible to analyse the impact on quality of life each intervention had for these participants.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Is surgery or an endoscopic stent better for the treatment of blockage of the stomach (gastric) outlet that is caused by cancer?"
}
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query-laysum | 2764 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple sclerosis (MS) is a leading cause of neurological disability in young adults. The most widely accepted hypothesis regarding its pathogenesis is that it is an immune-mediated disease. It has been hypothesised that intraluminal defects, compression, or hypoplasia in the internal jugular or azygos veins may be important factors in the pathogenesis of MS. This condition has been named 'chronic cerebrospinal venous insufficiency' (CCSVI). It has been suggested that these intraluminal defects restrict the normal blood flow from the brain and spinal cord, causing the deposition of iron in the brain and the eventual triggering of an auto-immune response. The proposed treatment for CCSVI is venous percutaneous transluminal angioplasty (PTA), which is claimed to improve the blood flow in the brain thereby alleviating some of the symptoms of MS. This is an update of a review first published in 2012.\nObjectives\nTo assess the benefit and safety of venous PTA in people with MS and CCSVI.\nSearch methods\nWe searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group's Specialised Register up to 30 August 2018, CENTRAL (in the Cochrane Library 2018, issue 8), MEDLINE up to 30 August 2018, Embase up to 30 August 2018, metaRegister of Controlled Trials, ClinicalTrials.gov., the Australian New Zealand Clinical Trials Registry, and the World Health Organization (WHO) International Clinical Trials Registry platform. We examined the bibliographies of the included and excluded studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which PTA and sham interventions were compared in adults with MS and CCSVI.\nData collection and analysis\nTwo authors independently assessed study eligibility and risk of bias, and extracted data. We reported results as risk ratios (RR) with 95% confidence intervals (CI). We performed statistical analyses using the random-effects model; and we assessed the certainty of the evidence using GRADE.\nMain results\nWe included three RCTs (238 participants) in this update. One hundred and thirty-four participants were randomised to PTA and 104 to sham treatment. We attributed low risk of bias to two (67%) studies for sequence generation and two (67%) studies for performance bias. All studies were at a low risk of detection bias, attrition bias, reporting bias and other potential sources of bias.\nThere was moderate-quality evidence to suggest that venous PTA did not increase the proportion of patients who had operative or post-operative serious adverse events compared with the sham procedure (RR 3.33, 95% CI 0.36 to 30.44; 3 studies, 238 participants); nor did it increase the proportion of patients who improved on a functional composite measure including walking control, balance, manual dexterity, postvoid residual urine volume, and visual acuity over 12-month follow-up (RR 0.84, 95% CI 0.55 to 1.30; 1 study, 110 participants); nor did it reduce the proportion of patients who experienced new relapses at six- or 12-month follow-up (RR 0.87, 95% CI 0.51 to 1.49; 3 studies, 235 participants). There was no effect of venous PTA on disability worsening measured by the Expanded Disability Status Scale, which was reported at follow-up intervals of six months (one study), 11 months (one study) and 12 months (one study). Quality of life was reported in two studies with no difference between treatment groups. Moderate or severe pain during or post venography was reported in both PTA and sham-procedure participants in all included studies. Venous PTA was not effective in restoring blood flow assessed at one-month (one study) or 12-month follow-up (one study).\nAuthors' conclusions\nThis systematic review identified moderate-quality evidence that, compared with sham procedure, venous PTA intervention did not provide benefit on patient-centred outcomes (disability, physical or cognitive functions, relapses, quality of life) in people with MS. Venous PTA has proven to be a safe technique but in view of the available evidence of its ineffectiveness, this intervention cannot be recommended in people with MS. All ongoing trials were withdrawn or terminated and hence this updated review is conclusive. No further randomised clinical studies are needed.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Chronic cerebrospinal venous insufficiency (CCSVI) has been described as a vascular condition characterized by restricted venous outflow from the brain and spinal cord, mainly due to narrowing or blockage of the veins in the head and neck. It has been hypothesised that CCSVI may be an important factor in the development of MS and treatment of CCSVI by catheter venography and percutaneous transluminal angioplasty (PTA) to widen the veins might improve symptoms and quality of life in people with MS. There is uncertainty about whether PTA should be used in people with MS."
}
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query-laysum | 2765 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the original Cochrane Review published in Cochrane Library, Issue 10, 2012.\nHydatidiform mole (HM), also called a molar pregnancy, is characterised by an overgrowth of foetal chorionic tissue within the uterus. HMs may be partial (PM) or complete (CM) depending on their gross appearance, histopathology and karyotype. PMs usually have a triploid karyotype, derived from maternal and paternal origins, whereas CMs are diploid and have paternal origins only. Most women with HM can be cured by evacuation of retained products of conception (ERPC) and their fertility preserved. However, in some women the growth persists and develops into gestational trophoblastic neoplasia (GTN), a malignant form of the disease that requires treatment with chemotherapy. CMs have a higher rate of malignant transformation than PMs. It may be possible to reduce the risk of GTN in women with HM by administering prophylactic chemotherapy (P-Chem). However, P-Chem given before or after evacuation of HM to prevent malignant sequelae remains controversial, as the risks and benefits of this practice are unclear.\nObjectives\nTo evaluate the effectiveness and safety of P-Chem to prevent GTN in women with a molar pregnancy. To investigate whether any subgroup of women with HM may benefit more from P-Chem than others.\nSearch methods\nFor the original review we performed electronic searches in the Cochrane Gynaecological Cancer Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 2, 2012), MEDLINE (1946 to February week 4, 2012) and Embase (1980 to 2012, week 9). We developed the search strategy using free text and MeSH. For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 5, 2017), MEDLINE (February 2012 to June week 1, 2017) and Embase (February 2012 to 2017, week 23). We also handsearched reference lists of relevant literature to identify additional studies and searched trial registries.\nSelection criteria\nWe included randomised controlled trials (RCTs) of P-Chem for HM.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion in the review and extracted data using a specifically designed data collection form. Meta-analyses were performed by pooling data from individual trials using Review Manager 5 (RevMan 5) software in line with standard methodological procedures expected by Cochrane methodology.\nMain results\nThe searches identified 161 records; after de-duplication and title and abstract screening 90 full-text articles were retrieved. From these we included three RCTs with a combined total of 613 participants. One study compared prophylactic dactinomycin to no prophylaxis (60 participants); the other two studies compared prophylactic methotrexate to no prophylaxis (420 and 133 participants). All participants were diagnosed with CMs. We considered the latter two studies to be of poor methodological quality.\nP-Chem reduced the risk of GTN occurring in women following a CM (3 studies, 550 participants; risk ratio (RR) 0.37, 95% confidence interval (CI) 0.24 to 0.57; I² = 0%; P < 0.00001; low-quality evidence). However, owing to the poor quality (high risk of bias) of two of the included studies, we performed sensitivity analyses excluding these two studies. This left only one small study of high-risk women to contribute data for this primary outcome (59 participants; RR 0.28, 95% CI 0.10 to 0.73; P = 0.01); therefore we consider this evidence to be of low quality.\nThe time to diagnosis was longer in the P-Chem group than the control group (2 studies, 33 participants; mean difference (MD) 28.72, 95% CI 13.19 to 44.24; P = 0.0003; low-quality evidence); and the P-Chem group required more courses to cure subsequent GTN (1 poor-quality study, 14 participants; MD 1.10, 95% CI 0.52 to 1.68; P = 0.0002; very low quality evidence).\nThere were insufficient data to perform meta-analyses for toxicity, overall survival, drug resistance and reproductive outcomes.\nAuthors' conclusions\nP-Chem may reduce the risk of progression to GTN in women with CMs who are at a high risk of malignant transformation; however, current evidence in favour of P-Chem is limited by the poor methodological quality and small size of the included studies. As P-Chem may increase drug resistance, delays treatment of GTN and may expose women toxic side effects, this practice cannot currently be recommended.\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": "A molar pregnancy (hydatidiform mole) develops following an abnormal process of conception, whereby placental tissue overgrows inside the womb (uterus). Molar pregnancies are classified as complete (CM) or partial (PM) based on their appearance (gross and microscopic), and their chromosome pattern. When present, moles are usually suspected at the early pregnancy scan and women often present with bleeding, similar to a miscarriage. The molar tissue is removed by evacuation of retained products of conception (ERPC), also known as dilatation and curettage (D&C) and women generally make a full recovery. However, some women go on to develop a cancer in the womb (about 1 in every 5 women with a CM and 1 in 200 with a PM). Women are generally at a higher risk of getting this cancer, which is known as gestational trophoblastic neoplasia (GTN), if they are over 40 years old, have a large increase in the size of the womb, have large cysts in the ovaries or have high initial levels of β-human chorionic gonadotrophin (hCG) (the pregnancy hormone) in their blood. Although treatment of the cancer with chemotherapy (anti-cancer drugs) is almost always effective, it has been suggested that routinely giving women anti-cancer drugs (P-Chem) before or after the removal the molar tissue may reduce the risk of the cancerous tissue developing."
}
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query-laysum | 2766 | [
{
"role": "user",
"content": "Abstract: Background\nAdmission avoidance hospital at home provides active treatment by healthcare professionals in the patient's home for a condition that otherwise would require acute hospital inpatient care, and always for a limited time period. This is the third update of the original review.\nObjectives\nTo determine the effectiveness and cost of managing patients with admission avoidance hospital at home compared with inpatient hospital care.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, two other databases, and two trials registers on 2 March 2016. We checked the reference lists of eligible articles. We sought unpublished studies by contacting providers and researchers who were known to be involved in the field.\nSelection criteria\nRandomised controlled trials recruiting participants aged 18 years and over. Studies comparing admission avoidance hospital at home with acute hospital inpatient care.\nData collection and analysis\nWe followed the standard methodological procedures expected by Cochrane and the Effective Practice and Organisation of Care (EPOC) Group. We performed meta-analysis for trials that compared similar interventions and reported comparable outcomes with sufficient data, requested individual patient data from trialists, and relied on published data when this was not available. We used the GRADE approach to assess the certainty of the body of evidence for the most important outcomes.\nMain results\nWe included 16 randomised controlled trials with a total of 1814 participants; three trials recruited participants with chronic obstructive pulmonary disease, two trials recruited participants recovering from a stroke, six trials recruited participants with an acute medical condition who were mainly elderly, and the remaining trials recruited participants with a mix of conditions. We assessed the majority of the included studies as at low risk of selection, detection, and attrition bias, and unclear for selective reporting and performance bias. Admission avoidance hospital at home probably makes little or no difference on mortality at six months' follow-up (risk ratio (RR) 0.77, 95% confidence interval (CI) 0.60 to 0.99; P = 0.04; I2 = 0%; 912 participants; moderate-certainty evidence), little or no difference on the likelihood of being transferred (or readmitted) to hospital (RR 0.98, 95% CI 0.77 to 1.23; P = 0.84; I2 = 28%; 834 participants; moderate-certainty evidence), and may reduce the likelihood of living in residential care at six months' follow-up (RR 0.35, 95% CI 0.22 to 0.57; P < 0.0001; I2 = 78%; 727 participants; low-certainty evidence). Satisfaction with healthcare received may be improved with admission avoidance hospital at home (646 participants, low-certainty evidence); few studies reported the effect on caregivers. When the costs of informal care were excluded, admission avoidance hospital at home may be less expensive than admission to an acute hospital ward (287 participants, low-certainty evidence); there was variation in the reduction of hospital length of stay, estimates ranged from a mean difference of -8.09 days (95% CI -14.34 to -1.85) in a trial recruiting older people with varied health problems, to a mean increase of 15.90 days (95% CI 8.10 to 23.70) in a study that recruited patients recovering from a stroke.\nAuthors' conclusions\nAdmission avoidance hospital at home, with the option of transfer to hospital, may provide an effective alternative to inpatient care for a select group of elderly patients requiring hospital admission. However, the evidence is limited by the small randomised controlled trials included in the review, which adds a degree of imprecision to the results for the main 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": "Admission avoidance hospital at home probably makes little or no difference to patient health outcomes, may increase the chances of living at home at six months' follow-up, and may be slightly less expensive. However, the findings are not precise due to the small size of the studies included in the review."
}
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query-laysum | 2767 | [
{
"role": "user",
"content": "Abstract: Background\nFibromyalgia is characterized by chronic widespread pain that leads to reduced physical function. Exercise training is commonly recommended as a treatment for management of symptoms. We examined the literature on resistance training for individuals with fibromyalgia. Resistance training is exercise performed against a progressive resistance with the intention of improving muscle strength, muscle endurance, muscle power, or a combination of these.\nObjectives\nTo evaluate the benefits and harms of resistance exercise training in adults with fibromyalgia. We compared resistance training versus control and versus other types of exercise training.\nSearch methods\nWe searched nine electronic databases (The Cochrane Library, MEDLINE, EMBASE, CINAHL, PEDro, Dissertation Abstracts, Current Controlled Trials, World Health Organization (WHO) International Clinical Trials Registry Platform, AMED) and other sources for published full-text articles. The date of the last search was 5 March 2013. Two review authors independently screened 1856 citations, 766 abstracts and 156 full-text articles. We included five studies that met our inclusion criteria.\nSelection criteria\nSelection criteria included: a) randomized clinical trial, b) diagnosis of fibromyalgia based on published criteria, c) adult sample, d) full-text publication, and e) inclusion of between-group data comparing resistance training versus a control or other physical activity intervention.\nData collection and analysis\nPairs of review authors independently assessed risk of bias and extracted intervention and outcome data. We resolved disagreements between the two review authors and questions regarding interpretation of study methods by discussion within the pairs or when necessary the issue was taken to the full team of 11 members. We extracted 21 outcomes of which seven were designated as major outcomes: multidimensional function, self reported physical function, pain, tenderness, muscle strength, attrition rates, and adverse effects. We evaluated benefits and harms of the interventions using standardized mean differences (SMD) or mean differences (MD) or risk ratios or Peto odds ratios and 95% confidence intervals (CI). Where two or more studies provided data for an outcome, we carried out a meta-analysis.\nMain results\nThe literature search yielded 1865 citations with five studies meeting the selection criteria. One of the studies that had three arms contributed data for two comparisons. In the included studies, there were 219 women participants with fibromyalgia, 95 of whom were assigned to resistance training programs. Three randomized trials compared 16 to 21 weeks of moderate- to high-intensity resistance training versus a control group. Two studies compared eight weeks of progressive resistance training (intensity as tolerated) using free weights or body weight resistance exercise versus aerobic training (ie, progressive treadmill walking, indoor and outdoor walking), and one study compared 12 weeks of low-intensity resistance training using hand weights (1 to 3 lbs (0.45 to 1.36 kg)) and elastic tubing versus flexibility exercise (static stretches to major muscle groups).\nStatistically significant differences (MD; 95% CI) favoring the resistance training interventions over control group(s) were found in multidimensional function (Fibromyalgia Impact Questionnaire (FIQ) total decreased 16.75 units on a 100-point scale; 95% CI -23.31 to -10.19), self reported physical function (-6.29 units on a 100-point scale; 95% CI -10.45 to -2.13), pain (-3.3 cm on a 10-cm scale; 95% CI -6.35 to -0.26), tenderness (-1.84 out of 18 tender points; 95% CI -2.6 to -1.08), and muscle strength (27.32 kg force on bilateral concentric leg extension; 95% CI 18.28 to 36.36).\nDifferences between the resistance training group(s) and the aerobic training groups were not statistically significant for multidimensional function (5.48 on a 100-point scale; 95% CI -0.92 to 11.88), self reported physical function (-1.48 units on a 100-point scale; 95% CI -6.69 to 3.74) or tenderness (SMD -0.13; 95% CI -0.55 to 0.30). There was a statistically significant reduction in pain (0.99 cm on a 10-cm scale; 95% CI 0.31 to 1.67) favoring the aerobic groups.\nStatistically significant differences were found between a resistance training group and a flexibility group favoring the resistance training group for multidimensional function (-6.49 FIQ units on a 100-point scale; 95% CI -12.57 to -0.41) and pain (-0.88 cm on a 10-cm scale; 95% CI -1.57 to -0.19), but not for tenderness (-0.46 out of 18 tender points; 95% CI -1.56 to 0.64) or strength (4.77 foot pounds torque on concentric knee extension; 95% CI -2.40 to 11.94). This evidence was classified low quality due to the low number of studies and risk of bias assessment. There were no statistically significant differences in attrition rates between the interventions. In general, adverse effects were poorly recorded, but no serious adverse effects were reported. Assessment of risk of bias was hampered by poor written descriptions (eg, allocation concealment, blinding of outcome assessors). The lack of a priori protocols and lack of care provider blinding were also identified as methodologic concerns.\nAuthors' conclusions\nThe evidence (rated as low quality) suggested that moderate- and moderate- to high-intensity resistance training improves multidimensional function, pain, tenderness, and muscle strength in women with fibromyalgia. The evidence (rated as low quality) also suggested that eight weeks of aerobic exercise was superior to moderate-intensity resistance training for improving pain in women with fibromyalgia. There was low-quality evidence that 12 weeks of low-intensity resistance training was superior to flexibility exercise training in women with fibromyalgia for improvements in pain and multidimensional function. There was low-quality evidence that women with fibromyalgia can safely perform moderate- to high-resistance training.\n\nGiven the provided abstract, please respond to the following query: \"What is resistance training?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Resistance training is exercise that involves lifting weights, or using machines or elastic bands that provide resistance to movement.\n- This review only looked at resistance training programs supervised by a trained professional.\n- We compared resistance training to no exercise and to other types of exercise."
}
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query-laysum | 2768 | [
{
"role": "user",
"content": "Abstract: Background\nSmoking rates in people with alcohol and other drug dependencies are two to four times those of the general population. Concurrent treatment of tobacco dependence has been limited due to concern that these interventions are not successful in this population or that recovery from other addictions could be compromised if tobacco cessation was combined with other drug dependency treatment.\nObjectives\nTo evaluate whether interventions for tobacco cessation are associated with tobacco abstinence for people in concurrent treatment for or in recovery from alcohol and other drug dependence.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and clinicaltrials.gov databases, with the most recent search completed in August 2016. A grey literature search of conference abstracts from the Society on Nicotine Research and Treatment and the ProQuest database of digital dissertations yielded one additional study, which was excluded.\nSelection criteria\nWe included randomised controlled trials assessing tobacco cessation interventions among people in concurrent treatment for alcohol or other drug dependence or in outpatient recovery programmes.\nData collection and analysis\nTwo review authors independently assessed study risk of bias and extracted data. We resolved disagreements by consensus. The primary outcome was abstinence from tobacco use at the longest period of follow-up, and the secondary outcome was abstinence from alcohol or other drugs, or both. We reported the strictest definition of abstinence. We summarised effects as risk ratios and 95% confidence intervals (CI). Two clustered studies did not provide intraclass correlation coefficients, and were excluded from the sensitivity analysis. We used the I2 statistic to assess heterogeneity.\nMain results\nThirty-five randomised controlled trials, one ongoing, involving 5796 participants met the criteria for inclusion in this review. Included studies assessed the efficacy of tobacco cessation interventions, including counselling, and pharmacotherapy consisting of nicotine replacement therapy (NRT) or non-NRT, or the two combined, in both inpatient and outpatient settings for participants in treatment and in recovery. Most studies did not report information to assess the risk of allocation, selection, and attrition bias, and were classified as unclear.\nAnalyses considered the nature of the intervention, whether participants were in treatment or recovery and the type of dependency. Of the 34 studies included in the meta-analysis, 11 assessed counselling, 11 assessed pharmacotherapy, and 12 assessed counselling in combination with pharmacotherapy, compared to usual care or no intervention. Tobacco cessation interventions were significantly associated with tobacco abstinence for two types of interventions. Pharmacotherapy appeared to increase tobacco abstinence (RR 1.88, 95% CI 1.35 to 2.57, 11 studies, 1808 participants, low quality evidence), as did combined counselling and pharmacotherapy (RR 1.74, 95% CI 1.39 to 2.18, 12 studies, 2229 participants, low quality evidence) at the period of longest follow-up, which ranged from six weeks to 18 months. There was moderate evidence of heterogeneity (I2 = 56% with pharmacotherapy and 43% with counselling plus pharmacotherapy). Counselling interventions did not significantly increase tobacco abstinence (RR 1.33, 95% CI 0.90 to 1.95).\nInterventions were significantly associated with tobacco abstinence for both people in treatment (RR 1.99, 95% CI 1.59 to 2.50) and people in recovery (RR 1.33, 95% CI 1.06 to 1.67), and for people with alcohol dependence (RR 1.47, 95% CI 1.20 to 1.81) and people with other drug dependencies (RR 1.85, 95% CI 1.43 to 2.40).\nOffering tobacco cessation therapy to people in treatment or recovery for other drug dependence was not associated with a difference in abstinence rates from alcohol and other drugs (RR 0.97, 95% CI 0.91 to 1.03, 11 studies, 2231 participants, moderate evidence of heterogeneity (I2 = 66%)).\nData on adverse effect of the interventions were limited.\nAuthors' conclusions\nThe studies included in this review suggest that providing tobacco cessation interventions targeted to smokers in treatment and recovery for alcohol and other drug dependencies increases tobacco abstinence. There was no evidence that providing interventions for tobacco cessation affected abstinence from alcohol and other drugs. The association between tobacco cessation interventions and tobacco abstinence was consistent for both pharmacotherapy and combined counselling and pharmacotherapy, for participants both in treatment and in recovery, and for people with alcohol dependency or other drug dependency. The evidence for the interventions was low quality due primarily to incomplete reporting of the risks of bias and clinical heterogeneity in the nature of treatment. Certain results were sensitive to the length of follow-up or the type of pharmacotherapy, suggesting that further research is warranted regarding whether tobacco cessation interventions are associated with tobacco abstinence for people in recovery, and the outcomes associated with NRT versus non-NRT or combined pharmacotherapy. Overall, the results suggest that tobacco cessation interventions incorporating pharmacotherapy should be incorporated into clinical practice to reduce tobacco addiction among people in treatment for or recovery from alcohol and other drug dependence.\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 studies that enrolled adult smokers who were either in treatment or had completed treatment for substance abuse, in hospital, outpatient or community settings and randomised them to either a treatment to help them stop smoking or a control. We last searched for evidence in August 2016. We found 34 published studies. The types of smoking cessation treatment tested included: counselling (which might be a brief advice session or multiple sessions of behavioural support, either individually or in a group); medicine (called pharmacotherapy; including any type of nicotine replacement therapy, with or without other medicines that help smokers to stop smoking); or a combination of counselling and pharmacotherapy. We combined the results of trials separately for each of these types of treatment, although different trials used different treatments. People who were in the control groups received usual care, brief advice about quitting smoking, or were put on a waiting list to receive treatment later. Most trials assessed the number of people who had quit smoking at least six months after beginning treatment although we also included some studies with a shorter time."
}
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query-laysum | 2769 | [
{
"role": "user",
"content": "Abstract: Background\nThe central venous catheter (CVC) is essential in managing acutely ill patients in hospitals. Bloodstream infection is a major complication in patients with a CVC. Several infection control measures have been developed to reduce bloodstream infections, one of which is impregnation of CVCs with various forms of antimicrobials (either with an antiseptic or with antibiotics). This review was originally published in June 2013 and updated in 2016.\nObjectives\nOur main objective was to assess the effectiveness of antimicrobial impregnation, coating or bonding on CVCs in reducing clinically-diagnosed sepsis, catheter-related blood stream infection (CRBSI), all-cause mortality, catheter colonization and other catheter-related infections in adult participants who required central venous catheterization, along with their safety and cost effectiveness where data were available. We undertook the following comparisons: 1) catheters with antimicrobial modifications in the form of antimicrobial impregnation, coating or bonding, against catheters without antimicrobial modifications and 2) catheters with one type of antimicrobial impregnation against catheters with another type of antimicrobial impregnation. We planned to analyse the comparison of catheters with any type of antimicrobial impregnation against catheters with other antimicrobial modifications, e.g. antiseptic dressings, hubs, tunnelling, needleless connectors or antiseptic lock solutions, but did not find any relevant studies. Additionally, we planned to conduct subgroup analyses based on the length of catheter use, settings or levels of care (e.g. intensive care unit, standard ward and oncology unit), baseline risks, definition of sepsis, presence or absence of co-interventions and cost-effectiveness in different currencies.\nSearch methods\nWe used the standard search strategy of the Cochrane Anaesthesia, Critical and Emergency Care Review Group (ACE). In the updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 3), MEDLINE (OVID SP; 1950 to March 2015), EMBASE (1980 to March 2015), CINAHL (1982 to March 2015), and other Internet resources using a combination of keywords and MeSH headings. The original search was run in March 2012.\nSelection criteria\nWe included randomized controlled trials (RCTs) that assessed any type of impregnated catheter against either non-impregnated catheters or catheters with another type of impregnation in adult patients cared for in the hospital setting who required CVCs. We planned to include quasi-RCT and cluster-RCTs, but we identified none. We excluded cross-over studies.\nData collection and analysis\nWe extracted data using the standard methodological procedures expected by Cochrane. Two authors independently assessed the relevance and risk of bias of the retrieved records. We expressed our results using risk ratio (RR), absolute risk reduction (ARR) and number need to treat to benefit (NNTB) for categorical data and mean difference (MD) for continuous data, where appropriate, with their 95% confidence intervals (CIs).\nMain results\nWe included one new study (338 participants/catheters) in this update, which brought the total included to 57 studies with 16,784 catheters and 11 types of impregnations. The total number of participants enrolled was unclear, as some studies did not provide this information. Most studies enrolled participants from the age of 18, including patients in intensive care units (ICU), oncology units and patients receiving long-term total parenteral nutrition. There were low or unclear risks of bias in the included studies, except for blinding, which was impossible in most studies due to the catheters that were being assessed having different appearances. Overall, catheter impregnation significantly reduced catheter-related blood stream infection (CRBSI), with an ARR of 2% (95% CI 3% to 1%), RR of 0.62 (95% CI 0.52 to 0.74) and NNTB of 50 (high-quality evidence). Catheter impregnation also reduced catheter colonization, with an ARR of 9% (95% CI 12% to 7%), RR of 0.67 (95% CI 0.59 to 0.76) and NNTB of 11 (moderate-quality evidence, downgraded due to substantial heterogeneity). However, catheter impregnation made no significant difference to the rates of clinically diagnosed sepsis (RR 1.0, 95% CI 0.88 to 1.13; moderate-quality evidence, downgraded due to a suspicion of publication bias), all-cause mortality (RR 0.92, 95% CI 0.80 to 1.07; high-quality evidence) and catheter-related local infections (RR 0.84, 95% CI 0.66 to 1.07; 2688 catheters, moderate quality evidence, downgraded due to wide 95% CI).\nIn our subgroup analyses, we found that the magnitudes of benefits for impregnated CVCs varied between studies that enrolled different types of participants. For the outcome of catheter colonization, catheter impregnation conferred significant benefit in studies conducted in ICUs (RR 0.70;95% CI 0.61 to 0.80) but not in studies conducted in haematological and oncological units (RR 0.75; 95% CI 0.51 to 1.11) or studies that assessed predominantly patients who required CVCs for long-term total parenteral nutrition (RR 0.99; 95% CI 0.74 to 1.34). However, there was no such variation for the outcome of CRBSI. The magnitude of the effects was also not affected by the participants' baseline risks.\nThere were no significant differences between the impregnated and non-impregnated groups in the rates of adverse effects, including thrombosis/thrombophlebitis, bleeding, erythema and/or tenderness at the insertion site.\nAuthors' conclusions\nThis review confirms the effectiveness of antimicrobial CVCs in reducing rates of CRBSI and catheter colonization. However, the magnitude of benefits regarding catheter colonization varied according to setting, with significant benefits only in studies conducted in ICUs. A comparatively smaller body of evidence suggests that antimicrobial CVCs do not appear to reduce clinically diagnosed sepsis or mortality significantly. Our findings call for caution in routinely recommending the use of antimicrobial-impregnated CVCs across all settings. Further randomized controlled trials assessing antimicrobial CVCs should include important clinical outcomes like the overall rates of sepsis and mortality.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The amount of information in this review contributed to high-quality evidence for the major outcomes of CRBSI, all-cause mortality and adverse effects. However, for clinically-diagnosed sepsis we considered the quality of the evidence to be moderate, as we suspected that there had been selective non-publication of certain trials. We considered the quality of evidence to be moderate for catheter colonization too, due to major inconsistencies in the direction of the results amongst the included studies."
}
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query-laysum | 2770 | [
{
"role": "user",
"content": "Abstract: Background\nAmong people who have suffered a traumatic brain injury, increased intracranial pressure continues to be a major cause of early death; it is estimated that about 11 people per 100 with traumatic brain injury die.\nIndomethacin (also known as indometacin) is a powerful cerebral vasoconstrictor that can reduce intracranial pressure and, ultimately, restore cerebral perfusion and oxygenation. Thus, indomethacin may improve the recovery of a person with traumatic brain injury.\nObjectives\nTo assess the effects of indomethacin for adults with severe traumatic brain injury.\nSearch methods\nWe ran the searches from inception to 23 August 2019. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 8) in the Cochrane Library, Ovid MEDLINE, Ovid Embase, CINAHL Plus (EBSCO), four other databases, and clinical trials registries. We also screened reference lists and conference abstracts, and contacted experts in the field.\nSelection criteria\nOur search criteria included randomised controlled trials (RCTs) that compared indomethacin with any control in adults presenting with severe traumatic brain injury associated with elevated intracranial pressure, with no previous decompressive surgery.\nData collection and analysis\nTwo review authors independently decided on the selection of the studies. We followed standard Cochrane methods.\nMain results\nWe identified no eligible studies for this review, either completed or ongoing.\nAuthors' conclusions\nWe found no studies, either completed or ongoing, that assessed the effects of indomethacin in controlling intracranial hypertension secondary to severe traumatic brain injury. Thus, we cannot draw any conclusions about the effects of indomethacin on intracranial pressure, mortality rates, quality of life, disability or adverse effects.\nThis absence of evidence should not be interpreted as evidence of no effect for indomethacin in controlling intracranial hypertension secondary to severe traumatic brain injury. It means that we have not identified eligible research for this review.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is no evidence from randomised studies to guide healthcare professionals about the effects (benefits or harms) of using indomethacin to control the raised intracranial pressure that follows severe traumatic brain injury in adults. Therefore, it was not possible to assess the quality of the evidence."
}
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query-laysum | 2771 | [
{
"role": "user",
"content": "Abstract: Background\nChronic kidney disease (CKD) is an independent risk factor for atrial fibrillation (AF), which is more prevalent among CKD patients than the general population. AF causes stroke or systemic embolism, leading to increased mortality. The conventional antithrombotic prophylaxis agent warfarin is often prescribed for the prevention of stroke, but risk of bleeding necessitates regular therapeutic monitoring. Recently developed direct oral anticoagulants (DOAC) are expected to be useful as alternatives to warfarin.\nObjectives\nTo assess the efficacy and safety of DOAC including apixaban, dabigatran, edoxaban, and rivaroxaban versus warfarin among AF patients with CKD.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register (up to 1 August 2017) through contact with the Information Specialist using search terms relevant to this review. Studies in the Specialised Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.\nSelection criteria\nWe included all randomised controlled trials (RCTs) which directly compared the efficacy and safety of direct oral anticoagulants (direct thrombin inhibitors or factor Xa inhibitors) with dose-adjusted warfarin for preventing stroke and systemic embolic events in non-valvular AF patients with CKD, defined as creatinine clearance (CrCl) or eGFR between 15 and 60 mL/min (CKD stage G3 and G4).\nData collection and analysis\nTwo review authors independently selected studies, assessed quality, and extracted data. We calculated the risk ratio (RR) and 95% confidence intervals (95% CI) for the association between anticoagulant therapy and all strokes and systemic embolic events as the primary efficacy outcome and major bleeding events as the primary safety outcome. Confidence in the evidence was assessing using GRADE.\nMain results\nOur review included 12,545 AF participants with CKD from five studies. All participants were randomised to either DOAC (apixaban, dabigatran, edoxaban, and rivaroxaban) or dose-adjusted warfarin. Four studies used a central, interactive, automated response system for allocation concealment while the other did not specify concealment methods. Four studies were blinded while the other was partially open-label. However, given that all studies involved blinded evaluation of outcome events, we considered the risk of bias to be low. We were unable to create funnel plots due to the small number of studies, thwarting assessment of publication bias. Study duration ranged from 1.8 to 2.8 years. The large majority of participants included in this study were CKD stage G3 (12,155), and a small number were stage G4 (390). Of 12,545 participants from five studies, a total of 321 cases (2.56%) of the primary efficacy outcome occurred per year. Further, of 12,521 participants from five studies, a total of 617 cases (4.93%) of the primary safety outcome occurred per year. DOAC appeared to probably reduce the incidence of stroke and systemic embolism events (5 studies, 12,545 participants: RR 0.81, 95% CI 0.65 to 1.00; moderate certainty evidence) and to slightly reduce the incidence of major bleeding events (5 studies, 12,521 participants: RR 0.79, 95% CI 0.59 to 1.04; low certainty evidence) in comparison with warfarin.\nAuthors' conclusions\nOur findings indicate that DOAC are as likely as warfarin to prevent all strokes and systemic embolic events without increasing risk of major bleeding events among AF patients with kidney impairment. These findings should encourage physicians to prescribe DOAC in AF patients with CKD without fear of bleeding. The major limitation is that the results of this study chiefly reflect CKD stage G3. Application of the results to CKD stage G4 patients requires additional investigation. Furthermore, we could not assess CKD stage G5 patients. Future reviews should assess participants at more advanced CKD stages. Additionally, we could not conduct detailed analyses of subgroups and sensitivity analyses due to lack of data.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This review demonstrated that DOAC are as likely as warfarin to prevent all strokes and systemic embolic events without increasing major bleeding events among AF patients with CKD. According to GRADE, the quality of the evidence was moderate for the primary efficacy outcome because of concerns with imprecision and low for the primary safety outcome because of concerns with inconsistency and imprecision. The results of this study chiefly apply to CKD stage G3 patients, since we could not assess those with CKD stage G4 or G5."
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query-laysum | 2772 | [
{
"role": "user",
"content": "Abstract: Background\nSupplementary oxygen is routinely administered to low-risk pregnant women during an elective caesarean section under regional anaesthesia; however, maternal and foetal outcomes have not been well established. This is an update of a review first published in 2013.\nObjectives\nThe primary objective was to determine whether supplementary oxygen given to low-risk term pregnant women undergoing elective caesarean section under regional anaesthesia can prevent maternal and neonatal desaturation. The secondary objective was to compare the mean values of maternal and neonatal blood gas levels between mothers who received supplementary oxygen and those who did not (control group).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, issue 11), MEDLINE (1948 to November 2014) and EMBASE (1980 to November 2014). The original search was first performed in February 2012. We reran the search in CENTRAL, MEDLINE, EMBASE in February 2016. One potential new study of interest was added to the list of ‘Studies awaiting Classification' and will be incorporated into the formal review findings during the next review update.\nSelection criteria\nWe included randomized controlled trials (RCTs) of low-risk pregnant women undergoing an elective caesarean section under regional anaesthesia and compared outcomes with, and without, oxygen supplementation.\nData collection and analysis\nTwo review authors independently extracted data, assessed methodological quality and performed subgroup and sensitivity analyses.\nMain results\nWe found one new included study in this updated version. In total, our updated review includes 11 trials (with 753 participants). The low quality of evidence showed no significant differences in average Apgar scores at one minute (N = six trials, 519 participants; 95% confidence (CI) -0.16 to 0.31, P = 0.53) and at five minutes (N = six trials, 519 participants; 95% CI -0.06 to 0.06, P = 0.98). None of the 11 trials reported maternal desaturation. The very low quality of evidence showed that in comparison to room air, women in labour receiving supplementary oxygen had higher maternal oxygen saturation (N = three trials, 209 participants), maternal PaO2 (oxygen pressure in the blood; N = six trials, 241 participants), UaPO2 (foetal umbilical arterial blood; N = eight trials, 504 participants; 95% CI 1.8 to 4.9, P < 0.0001) and UvPO2 (foetal umbilical venous blood; N = 10 trials, 683 participants). There was high heterogeneity among these outcomes. A subgroup analysis showed no significant difference in UaPO2 between the two intervention groups in low-risk studies, whereas the high-risk studies showed a benefit for the neonatal oxygen group.\nAuthors' conclusions\nOverall, we found no convincing evidence that giving supplementary oxygen to healthy term pregnant women during elective caesarean section under regional anaesthesia is either beneficial or harmful for either the mother or the foetus' short-term clinical outcome as assessed by Apgar scores. Although, there were significant higher maternal and neonatal blood gas values and markers of free radicals when extra oxygen was given, the results should be interpreted with caution due to the low grade quality of the evidence.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Oxygen was routinely given to pregnant women to provide an extra supply for the foetus in order for the foetus to cope with any unplanned loss of oxygen during or after the birth. Previous studies have shown that giving extra oxygen provided better oxygenation for the mother and foetus in terms of oxygen saturation (a measure of how much oxygen the blood is carrying), PaO2 (oxygen pressure in the blood) and pH (a measure of acidity or alkalinity). However, clear evidence of foetal clinical outcomes have not been obtained."
}
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query-laysum | 2773 | [
{
"role": "user",
"content": "Abstract: Background\nSalvage systemic therapy has become the new standard of care in patients with advanced gastric and oesophago-gastric junction (OGJ) adenocarcinoma, following disease progression on first-line fluoropyrimidine and platinum-containing chemotherapy. Pharmacological agents proven to be effective in this setting include both chemotherapy and biological therapy, however, the consensus on the best salvage systemic therapy has not been reached.\nObjectives\nTo assess the effects of systemic chemotherapy and biological therapy, either alone or in combination, on overall survival (OS) and progression-free survival (PFS) in patients with advanced gastric and OGJ adenocarcinoma, whose disease has progressed on, or relapsed after first-line fluoropyrimidine and platinum-containing chemotherapy. Adverse events (AEs), tumour response rate (TRR) and quality of life (QoL) associated with systemic chemotherapy and/or biological therapy were additionally assessed.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, trial registries and proceedings of the major oncology conferences up to October 2020. We additionally handsearched the reference lists of studies. No language restriction was applied.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing salvage systemic therapy (chemotherapy and/or biological therapy) and either another type of salvage systemic therapy, placebo, best supportive care (BSC) or no treatment in patients with gastric and OGJ adenocarcinoma refractory to first-line fluoropyrimidine and platinum-containing chemotherapy.\nData collection and analysis\nTwo review authors independently performed selection of eligible studies and the primary author extracted study characteristics and outcome data from included studies. We assessed the quality and risk of bias of eligible studies according to the Cochrane Handbook for Systematic Reviews of Interventions. We expressed pooled estimates of effect using hazard ratio (HR) calculated using an inverse variance random-effects model for time-to-event data, and risk ratio (RR) calculated using Mantel-Haenszel random-effects model for binary data. The certainty of evidence was graded using GRADEpro.\nMain results\nWe identified 17 RCTs with 5110 participants for inclusion in this review. Tweenty-nine studies are ongoing and twenty studies are awaiting classification. No studies examined the following comparisons: chemotherapy combined with biological therapy versus placebo, BSC or no treatment, chemotherapy combined with biological therapy versus biological therapy, biological therapy versus biological therapy and chemotherapy combined with biological therapy versus chemotherapy combined with biological therapy.\nChemotherapy versus placebo, best supportive care or no treatment\nChemotherapy probably improves OS (HR = 0.66, 95% CI 0.52 to 0.83, moderate-certainty evidence) based on two studies involving 547 participants and improves PFS (HR = 0.57, 95% CI 0.47 to 0.69, high-certainty evidence) based on one study involving 507 participants over placebo and BSC. Chemotherapy probably increases serious AEs (SAEs) (RR = 1.38, 95% CI 1.20 to 1.59, moderate-certainty evidence) based on one study involving 503 participants.\nBiological therapy versus placebo, best supportive care or no treatment\nBiological therapy improves OS (HR = 0.55, 95% CI 0.41 to 0.73, high-certainty evidence) and probably improves PFS (HR = 0.33, 95% CI 0.19 to 0.57, moderate-certainty evidence) over placebo based on three studies involving 781 participants. There is currently insufficient evidence for increased SAEs from biological therapy (RR = 1.14, 95% CI 0.95 to 1.37, low-certainty evidence) based on two studies involving 638 participants.\nChemotherapy versus biological therapy\nThis comparison only considered immunotherapy. There is probably no evidence of a difference for OS (HR = 0.82, 95% CI 0.66 to 1.02, moderate-certainty evidence) between chemotherapy and immunotherapy, and immunotherapy probably reduces PFS (HR = 1.27, 95% CI 1.03 to 1.57, moderate-certainty evidence) based on one study involving 395 participants. SAEs may be less frequent with immunotherapy compared to chemotherapy (RR = 0.41, 95% CI 0.30 to 0.57, low-certainty evidence).\nChemotherapy combined with biological therapy versus chemotherapy\nAddition of biological therapy to chemotherapy probably does not improve OS (HR = 0.93, 95% CI 0.83 to 1.04, moderate-certainty evidence) and we are uncertain whether it improves PFS (HR = 0.87, 95% CI 0.74 to 1.02, very low-certainty evidence) based on seven studies involving 2743 participants. We are similarly uncertain whether combined chemotherapy and biological therapy increases SAEs (RR = 1.17, 95% CI 0.95 to 1.44, very low-certainty evidence) based on four studies involving 1618 participants.\nChemotherapy versus chemotherapy\nThere is no evidence of a difference for OS and PFS between irinotecan and paclitaxel (HR = 1.13, 95% CI 0.86 to 1.48, low-certainty evidence for OS; HR = 1.14, 95% CI 0.88 to 1.48, low-certainty evidence for PFS) based on one study involving 219 participants. Similarly, there is no evidence to indicate improved OS and PFS from addition of another chemotherapy to docetaxel (HR = 1.05, 95% CI 0.72 to 1.54, low-certainty evidence for OS; HR = 0.75, 95% CI 0.52 to 1.09, low-certainty evidence for PFS) based on two studies involving 121 participants. Grade ≥ 3 neutropenia occurred commonly with both mono- and poly-chemotherapy except for docetaxel-S1 and EOX chemotherapy.\nAuthors' conclusions\nSurvival outcome of patients with advanced gastric and OGJ adenocarcinoma whose disease progressed on first-line fluoropyrimidine and platinum-containing chemotherapy can be improved by chemotherapy and biological therapy. Biological therapy, in particular, achieves this without clear increase in SAEs or QoL impairment. Whether biological therapy is preferred over chemotherapy is still unclear and there is no evidence of a difference for OS outcome, although immunotherapy may be associated with less SAEs. Addition of biological therapy to chemotherapy and poly-chemotherapy are associated with frequent treatment-related toxicity without clear survival benefit.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are these results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are moderately confident that chemotherapy probably helps people to live longer than placebo treatment or best supportive care. We are confident that people live longer on biological therapy than placebo treatment. We think more evidence is unlikely to change this result.\nWe are less confident about the results for unwanted effects. Some studies had missing data or did not report these; and in some studies people and their doctors knew which treatment was given, which could have affected the study results. These results are likely to change when more evidence becomes available."
}
]
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query-laysum | 2774 | [
{
"role": "user",
"content": "Abstract: Background\nCarotid endarterectomy may significantly reduce the risk of stroke in people with recently symptomatic, severe carotid artery stenosis. However, there are significant perioperative risks that may be minimised by performing the operation under local rather than general anaesthetics. This is an update of a Cochrane Review first published in 1996, and previously updated in 2004, 2008, and 2013.\nObjectives\nTo determine whether carotid endarterectomy under local anaesthetic: 1) reduces the risk of perioperative stroke and death compared with general anaesthetic; 2) reduces the complication rate (other than stroke) following carotid endarterectomy; and 3) is acceptable to individuals and surgeons.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two trials registers (to February 2021). We also reviewed reference lists of articles identified.\nSelection criteria\nRandomised controlled trials (RCTs) comparing the use of local anaesthetics to general anaesthetics for people having carotid endarterectomy were eligible.\nData collection and analysis\nThree review authors independently extracted data, assessed risk of bias, and evaluated quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) tool. We calculated a pooled Peto odds ratio (OR) and corresponding 95% confidence interval (CI) for the following outcomes that occurred within 30 days of surgery: stroke, death, ipsilateral stroke, stroke or death, myocardial infarction, local haemorrhage, and arteries shunted.\nMain results\nWe included 16 RCTs involving 4839 participants, of which 3526 were obtained from the single largest trial (GALA). The main findings from our meta-analysis showed that, within 30 days of operation, neither incidence of stroke nor death were significantly different between local and general anaesthesia. Of these, the incidence of stroke in the local and general anaesthesia groups was 3.2% and 3.5%, respectively (Peto odds ratio (OR) 0.91, 95% confidence interval (CI) 0.66 to 1.26; P = 0.58; 13 studies, 4663 participants; low-quality evidence). The rate of ipsilateral stroke under both types of anaesthesia was 3.1% (Peto OR 1.03, 95% CI 0.71 to 1.48; P = 0.89; 2 studies, 3733 participants; low-quality evidence). The incidence of stroke or death in the local anaesthesia group was 3.5%, while stroke or death incidence was 4.1% in the general anaesthesia group (Peto OR 0.85, 95% CI 0.62 to 1.16; P = 0.31; 11 studies, 4391 participants; low-quality evidence). A lower rate of death was observed in the local anaesthetic group but evidence was of low quality (Peto OR 0.61, 95% CI 0.35 to 1.06; P = 0.08; 12 studies, 4421 participants).\nAuthors' conclusions\nThe incidence of stroke and death were not convincingly different between local and general anaesthesia for people undergoing carotid endarterectomy. The current evidence supports the choice of either approach. Further high-quality studies are still needed as the evidence is of limited reliability.\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": "- Current evidence does not show any clear difference between local anaesthesia (where the patient remains awake) and general anaesthesia for the risk of stroke, death, or other unwanted effects for people having surgery to widen a narrowed carotid artery (carotid endarterectomy).\n- Future studies should recruit more people, analyse and publish information from all of them, and make sure that the researchers assessing the outcomes do not know which type of anaesthetic people had."
}
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query-laysum | 2775 | [
{
"role": "user",
"content": "Abstract: Background\nCerebrolysin is a mixture of low-molecular-weight peptides and amino acids derived from porcine brain, which has potential neuroprotective properties. It is widely used in the treatment of acute ischaemic stroke in Russia, Eastern Europe, China, and other Asian and post-Soviet countries. This is an update of a review first published in 2010 and last updated in 2020.\nObjectives\nTo assess the benefits and harms of Cerebrolysin or Cerebrolysin-like agents for treating acute ischaemic stroke.\nSearch methods\nWe searched the Cochrane Stroke Trials Register, CENTRAL, MEDLINE, Embase, Web of Science Core Collection, with Science Citation Index, and LILACS in May 2022 and a number of Russian databases in June 2022. We also searched reference lists, ongoing trials registers, and conference proceedings.\nSelection criteria\nRandomised controlled trials (RCTs) comparing Cerebrolysin or Cerebrolysin-like agents started within 48 hours of stroke onset and continued for any length of time, with placebo or no treatment in people with acute ischaemic stroke.\nData collection and analysis\nThree review authors independently applied the inclusion criteria, assessed trial quality and risk of bias, extracted data, and applied GRADE criteria to the evidence.\nMain results\nSeven RCTs (1773 participants) met the inclusion criteria of the review. In this update we added one RCT of Cerebrolysin-like agent Cortexin, which contributed 272 participants.\nWe used the same approach for risk of bias assessment that was re-evaluated for the previous update: we added consideration of the public availability of study protocols and reported outcomes to the selective outcome reporting judgement, through identification, examination, and evaluation of study protocols.\nFor the Cerebrolysin studies, we judged the risk of bias for selective outcome reporting to be unclear across all studies; for blinding of participants and personnel to be low in three studies and unclear in the remaining four; and for blinding of outcome assessors to be low in three studies and unclear in four studies. We judged the risk of bias for generation of allocation sequence to be low in one study and unclear in the remaining six studies; for allocation concealment to be low in one study and unclear in six studies; and for incomplete outcome data to be low in three studies and high in the remaining four studies. The manufacturer of Cerebrolysin supported three multicentre studies, either totally, or by providing Cerebrolysin and placebo, randomisation codes, research grants, or statisticians. We judged two studies to be at high risk of other bias and the remaining five studies to be at unclear risk of other bias. We judged the study of Cortexin to be at low risk of bias for incomplete outcome data and at unclear risk of bias for all other domains.\nAll-cause death: Cerebrolysin or Cortexin probably result in little to no difference in all-cause death (risk ratio (RR) 0.96, 95% confidence interval (CI) 0.65 to 1.41; 6 trials, 1689 participants; moderate-certainty evidence).\nNone of the included studies reported on poor functional outcome, defined as death or dependence at the end of the follow-up period, early death (within two weeks of stroke onset), quality of life, or time to restoration of capacity for work.\nOnly one study clearly reported on the cause of death: cerebral infarct (four in the Cerebrolysin and two in the placebo group), heart failure (two in the Cerebrolysin and one in the placebo group), pulmonary embolism (two in the placebo group), and pneumonia (one in the placebo group).\nNon-death attrition (secondary outcome): Cerebrolysin or similar peptide mixtures may result in little to no difference in non-death attrition, but the evidence is very uncertain, with a considerable level of heterogeneity (RR 0.72, 95% CI 0.38 to 1.39; 6 trials, 1689 participants; very low-certainty evidence).\nSerious adverse events (SAEs): Cerebrolysin probably results in little to no difference in the total number of people with SAEs (RR 1.16, 95% CI 0.81 to 1.66; 3 trials, 1335 participants; moderate-certainty evidence). This comprised fatal SAEs (RR 0.90, 95% CI 0.59 to 1.38; 3 trials, 1335 participants; moderate-certainty evidence) and an increase in the total number of people with non-fatal SAEs (RR 2.39, 95% CI 1.10 to 5.23; 3 trials, 1335 participants; moderate-certainty evidence). In the subgroup of dosing schedule 30 mL for 10 days (cumulative dose 300 mL), the increase was more prominent (RR 2.87, 95% CI 1.24 to 6.69; 2 trials, 1189 participants).\nTotal number of people with adverse events: Cerebrolysin or similar peptide mixtures may result in little to no difference in the total number of people with adverse events (RR 1.03, 95% CI 0.92 to 1.14; 4 trials, 1607 participants; low-certainty evidence).\nAuthors' conclusions\nModerate-certainty evidence indicates that Cerebrolysin or Cerebrolysin-like peptide mixtures derived from cattle brain probably have no beneficial effect on preventing all-cause death in acute ischaemic stroke. Moderate-certainty evidence suggests that Cerebrolysin probably has no beneficial effect on the total number of people with serious adverse events. Moderate-certainty evidence also indicates a potential increase in non-fatal serious adverse events with Cerebrolysin use.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found seven studies in 1773 people who had had an acute ischaemic stroke. The studies looked at the effect of giving Cerebrolysin alongside medicines to prevent and dissolve blood clots (standard therapy) during the first 48 hours after a stroke. The studies compared this treatment with standard therapy alone or standard therapy plus a dummy treatment (placebo).\nThe studies were conducted in hospitals in Austria, Croatia, the Czech Republic, Hungary, Russia, Slovakia, Slovenia, China, Hong Kong, Iran, Myanmar, and South Korea, and lasted from 28 days to 90 days."
}
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query-laysum | 2776 | [
{
"role": "user",
"content": "Abstract: Background\nHumour-based interventions are defined as any intervention that promotes health and wellness by stimulating a playful discovery, expression, or appreciation of the absurdity or incongruity of life's situations. Humour-based interventions can be implemented in different settings, including hospitals, nursing homes and day care centres. They have been posed as an adjunct to usual care for people with schizophrenia, but a summary of the evidence is lacking.\nObjectives\nTo examine the effects of humour-based interventions as an add-on intervention to standard care for people with schizophrenia.\nSearch methods\nOn 31 July 2019 and 10 February 2021 we searched the Cochrane Schizophrenia Group's study-based register of trials, which is based on CENTRAL, CINAHL, ClinicalTrials.Gov, Embase, ISRCTN, MEDLINE, PsycINFO, PubMed, and WHO ICTRP.\nSelection criteria\nWe included all randomised controlled trials comparing humour-based interventions with active controls, other psychological interventions, or standard care for people with schizophrenia. We excluded studies fulfilling our prespecified selection criteria but without useable data from further quantitative synthesis.\nData collection and analysis\nTwo review authors independently inspected citations, selected studies, extracted data and appraised study quality, following the guidance from the Cochrane Handbook for Systematic Reviews of Interventions. For binary outcomes we calculated risk ratios (RRs) and their 95% confidence intervals (CIs). For continuous outcomes we calculated the mean differences (MDs) and their 95% CIs. We assessed risks of bias for included studies and created summary of findings tables using the GRADE approach.\nMain results\nWe included three studies in this review for qualitative synthesis, although one study did not report any relevant outcomes. We therefore include two studies (n = 96) in our quantitative synthesis. No data were available on the following prespecified primary outcomes: clinically-important change in general mental state, clinically-important change in negative symptoms, clinically-important change in overall quality of life, and adverse effects. As compared with active control, humour-based interventions may not improve the average endpoint score of a general mental state scale (Positive and Negative Syndrome Scale (PANSS) total score: MD −1.70, 95% CI −17.01 to 13.61; 1 study, 30 participants; very low certainty of evidence); positive symptoms (PANSS positive symptom score: MD 0.00, 95% CI −2.58 to 2.58; 1 study, 30 participants; low certainty of evidence), negative symptoms (PANSS negative symptom score: MD −0.70, 95% CI −4.22 to 2.82; 1 study, 30 participants; very low certainty of evidence) and anxiety (State-Trait Anxiety Inventory (STAI): MD −2.60, 95% CI −5.76 to 0.56; 1 study, 30 participants; low certainty of evidence). Due to the small sample size, we remain uncertain about the effect of humour-based interventions on leaving the study early as compared with active control (no event, 1 study, 30 participants; very low certainty of evidence). On the other hand, humour-based interventions may reduce depressive symptoms (Beck Depression Inventory (BDI): MD −6.20, 95% CI −12.08 to −0.32; 1 study, 30 participants; low certainty of evidence). Compared with standard care, humour-based interventions may not improve depressive symptoms (BDI second edition: MD 0.80, 95% CI −2.64 to 4.24; 1 study, 59 participants; low certainty of evidence). We are uncertain about the effect of humour-based interventions on leaving the study early for any reason compared with standard care (risk ratio 0.38, 95% CI 0.08 to 1.80; 1 study, 66 participants; very low certainty of evidence).\nAuthors' conclusions\nWe are currently uncertain whether the evidence supports the use of humour-based interventions in people with schizophrenia. Future research with rigorous and transparent methodology investigating clinically important outcomes is warranted.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is insufficient research evidence to support the use of humour-based interventions in people with schizophrenia."
}
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query-laysum | 2777 | [
{
"role": "user",
"content": "Abstract: Background\nPulmonary arteriovenous malformations are abnormal direct connections between the pulmonary artery and pulmonary vein which result in a right-to-left shunt. They are associated with substantial morbidity and mortality mainly from the effects of paradoxical emboli. Potential complications include stroke, cerebral abscess, pulmonary haemorrhage and hypoxaemia. Embolisation is an endovascular intervention based on the occlusion of the feeding arteries the pulmonary arteriovenous malformations thus eliminating the abnormal right-to-left-shunting. This is an update of a previously published review.\nObjectives\nTo determine the efficacy and safety of embolisation in patients with pulmonary arteriovenous malformations including a comparison with surgical resection and different embolisation devices.\nSearch methods\nWe searched the Cystic Fibrosis and Genetic Disorders Group's Trials Register; date of last search: 10 April 2017.\nWe also searched the following databases: the Australian New Zealand Clinical Trials Registry; ClinicalTrials.gov; International Standard Randomised Controlled Trial Number Register; International Clinical Trials Registry Platform Search Portal (last searched 27 August 2017). to be updated\nWe checked cross-references and searched references from review articles.\nSelection criteria\nTrials in which individuals with pulmonary arteriovenous malformations were randomly allocated to embolisation compared to no treatment, surgical resection or embolisation using a different embolisation device.\nData collection and analysis\nStudies identified for potential inclusion were independently assessed for eligibility by two authors, with excluded studies further checked by a third author. No trials were identified for inclusion in the review and hence no analysis was performed.\nMain results\nThere were no randomised controlled trials included in the review; one ongoing trial has been identified which may be eligible for inclusion in the future.\nAuthors' conclusions\nThere is no evidence from randomised controlled trials for embolisation of pulmonary arteriovenous malformations. However, randomised controlled trials are not always feasible on ethical grounds. Accumulated data from observational studies suggest that embolisation is a safe procedure which reduces morbidity and mortality. A standardised approach to reporting with long-term follow-up through registry studies can help to strengthen the evidence for embolisation in the absence of randomised controlled trials.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to: 10 April 2017."
}
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query-laysum | 2778 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoporosis is an abnormal reduction in bone mass and bone deterioration leading to increased fracture risk. Risedronate belongs to the bisphosphonate class of drugs which act to inhibit bone resorption by interfering with the activity of osteoclasts. This is an update of a Cochrane Review that was originally published in 2003.\nObjectives\nWe assessed the benefits and harms of risedronate in the primary and secondary prevention of osteoporotic fractures for postmenopausal women at lower and higher risk for fractures, respectively.\nSearch methods\nWith broader and updated strategies, we searched the Cochrane Central Register of Control Trials (CENTRAL), MEDLINE and Embase. A grey literature search, including the online databases ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), and drug approval agencies, as well as bibliography checks of relevant systematic reviews was also performed. Eligible trials published between 1966 to 24 March 2021 were identified.\nSelection criteria\nWe included randomised controlled trials that assessed the benefits and harms of risedronate in the prevention of fractures for postmenopausal women. Participants must have received at least one year of risedronate, placebo or other anti-osteoporotic drugs, with or without concurrent calcium/vitamin D. Major outcomes were clinical vertebral, non-vertebral, hip and wrist fractures, withdrawals due to adverse events, and serious adverse events. In the interest of clinical relevance and applicability, we classified a study as secondary prevention if its population fulfilled more than one of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, low bone mineral density (BMD)T score ≤ -2.5, and age ≥ 75 years old. If none of these criteria was met, the study was considered to be primary prevention.\nData collection and analysis\nWe used standard methodology expected by Cochrane. We pooled the relative risk (RR) of fractures using a fixed-effect model based on the expectation that the clinical and methodological characteristics of the respective primary and secondary prevention studies would be homogeneous, and the experience from the previous review suggesting that there would be a small number of studies. The base case included the data available for the longest treatment period in each placebo-controlled trial and a >15% relative change was considered clinically important. The main findings of the review were presented in summary of findings tables, using the GRADE approach.\nIn addition, we looked at benefit and harm comparisons between different dosage regimens for risedronate and between risedronate and other anti-osteoporotic drugs.\nMain results\nForty-three trials fulfilled the eligibility criteria, among which 33 studies (27,348 participants) reported data that could be extracted and quantitatively synthesized. We had concerns about particular domains of risk of bias in each trial. Selection bias was the most frequent concern, with only 24% of the studies describing appropriate methods for both sequence generation and allocation concealment. Fifty per cent and 39% of the studies reporting benefit and harm outcomes, respectively, were subject to high risk. None of the studies included in the quantitative syntheses were judged to be at low risk of bias in all seven domains. The results described below pertain to the comparisons for daily risedronate 5 mg versus placebo which reported major outcomes. Other comparisons are described in the full text.\nFor primary prevention, low- to very low-certainty evidence was collected from four studies (one to two years in length) including 989 postmenopausal women at lower risk of fractures. Risedronate 5 mg/day may make little or no difference to wrist fractures [RR 0.48 ( 95% CI 0.03 to 7.50; two studies, 243 participants); absolute risk reduction (ARR) 0.6% fewer (95% CI 1% fewer to 7% more)] and withdrawals due to adverse events [RR 0.67 (95% CI 0.38 to 1.18; three studies, 748 participants); ARR 2% fewer (95% CI 5% fewer to 1% more)], based on low-certainty evidence. However, its preventive effects on non-vertebral fractures and serious adverse events are not known due to the very low-certainty evidence. There were zero clinical vertebral and hip fractures reported therefore the effects of risedronate for these outcomes are not estimable.\nFor secondary prevention, nine studies (one to three years in length) including 14,354 postmenopausal women at higher risk of fractures provided evidence. Risedronate 5 mg/day probably prevents non-vertebral fractures [RR 0.80 (95% CI 0.72 to 0.90; six studies, 12,173 participants); RRR 20% (95% CI 10% to 28%) and ARR 2% fewer (95% CI 1% fewer to 3% fewer), moderate certainty], and may reduce hip fractures [RR 0.73 (95% CI 0.56 to 0.94); RRR 27% (95% CI 6% to 44%) and ARR 1% fewer (95% CI 0.2% fewer to 1% fewer), low certainty]. Both of these effects are probably clinically important. However, risedronate's effects are not known for wrist fractures [RR 0.64 (95% CI 0.33 to 1.24); three studies,1746 participants); ARR 1% fewer (95% CI 2% fewer to 1% more), very-low certainty] and not estimable for clinical vertebral fractures due to zero events reported (low certainty). Risedronate results in little to no difference in withdrawals due to adverse events [RR 0.98 (95% CI 0.90 to 1.07; eight studies, 9529 participants); ARR 0.3% fewer (95% CI 2% fewer to 1% more); 16.9% in risedronate versus 17.2% in control, high certainty] and probably results in little to no difference in serious adverse events [RR 1.00 (95% CI 0.94 to 1.07; six studies, 9435 participants); ARR 0% fewer (95% CI 2% fewer to 2% more; 29.2% in both groups, moderate certainty).\nAuthors' conclusions\nThis update recaps the key findings from our previous review that, for secondary prevention, risedronate 5 mg/day probably prevents non-vertebral fracture, and may reduce the risk of hip fractures. We are uncertain on whether risedronate 5mg/day reduces clinical vertebral and wrist fractures. Compared to placebo, risedronate probably does not increase the risk of serious adverse events.\nFor primary prevention, the benefit and harms of risedronate were supported by limited evidence with high uncertainty.\n\nGiven the provided abstract, please respond to the following query: \"What is osteoporosis and what is risedronate?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Bone is a living, growing part of your body. Throughout your lifetime, new bone cells grow and old bone cells break down to make room for the new, stronger bone. When you have osteoporosis, the old bone breaks down faster than the new bone can replace it. As this happens, the bones lose minerals (such as calcium). This makes bones weaker and more likely to break even after a minor injury, like a little bump or fall. Women who have gone through menopause are more likely to get osteoporosis than other people.\nRisedronate belongs to the class of drugs called bisphosphonates. It is a type of medication that slows down the cells that break down the old bone."
}
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query-laysum | 2779 | [
{
"role": "user",
"content": "Abstract: Background\nPatients treated with mechanical ventilation in intensive care units (ICUs) have a high risk of developing respiratory tract infections (RTIs). Ventilator-associated pneumonia (VAP) has been estimated to affect 5% to 40% of patients treated with mechanical ventilation for at least 48 hours. The attributable mortality rate of VAP has been estimated at about 9%. Selective digestive decontamination (SDD), which consists of the topical application of non-absorbable antimicrobial agents to the oropharynx and gastroenteric tract during the whole period of mechanical ventilation, is often used to reduce the risk of VAP. A related treatment is selective oropharyngeal decontamination (SOD), in which topical antibiotics are applied to the oropharynx only. This is an update of a review first published in 1997 and updated in 2002, 2004, and 2009.\nObjectives\nTo assess the effect of topical antibiotic regimens (SDD and SOD), given alone or in combination with systemic antibiotics, to prevent mortality and respiratory infections in patients receiving mechanical ventilation for at least 48 hours in ICUs.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Acute Respiratory Infections (ARI) Group's Specialised Register, PubMed, and Embase on 5 February 2020. We also searched the WHO ICTRP and ClinicalTrials.gov for ongoing and unpublished studies on 5 February 2020. All searches included non-English language literature. We handsearched references of topic-related systematic reviews and the included studies.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster-RCTs assessing the efficacy and safety of topical prophylactic antibiotic regimens in adults receiving intensive care and mechanical ventilation. The included studies compared topical plus systemic antibiotics versus placebo or no treatment; topical antibiotics versus no treatment; and topical plus systemic antibiotics versus systemic antibiotics.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included a total of 41 trials involving 11,004 participants (five new studies were added in this update). The minimum duration of mechanical ventilation ranged from 2 (19 studies) to 6 days (one study). Thirteen studies reported the mean length of ICU stay, ranging from 11 to 33 days. The percentage of immunocompromised patients ranged from 0% (10 studies) to 22% (1 study).\nThe reporting quality of the majority of included studies was very poor, so we judged more than 40% of the studies as at unclear risk of selection bias. We judged all studies to be at low risk of performance bias, though 47.6% were open-label, because hospitals usually have standardised infection control programmes, and possible subjective decisions on who should be tested for the presence or absence of RTIs are unlikely in an ICU setting. Regarding detection bias, we judged all included studies as at low risk for the outcome mortality. For the outcome RTIs, we judged all double-blind studies as at low risk of detection bias. We judged five open-label studies as at high risk of detection bias, as the diagnosis of RTI was not based on microbiological exams; we judged the remaining open-label studies as at low risk of detection bias, as a standardised set of diagnostic criteria, including results of microbiological exams, were used.\nTopical plus systemic antibiotic prophylaxis reduces overall mortality compared with placebo or no treatment (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.73 to 0.96; 18 studies; 5290 participants; high-certainty evidence). Based on an illustrative risk of 303 deaths in 1000 people this equates to 48 (95% CI 15 to 79) fewer deaths with topical plus systemic antibiotic prophylaxis. Topical plus systemic antibiotic prophylaxis probably reduces RTIs (RR 0.43, 95% CI 0.35 to 0.53; 17 studies; 2951 participants; moderate-certainty evidence). Based on an illustrative risk of 417 RTIs in 1000 people this equates to 238 (95% CI 196 to 271) fewer RTIs with topical plus systemic antibiotic prophylaxis.\nTopical antibiotic prophylaxis probably reduces overall mortality compared with no topical antibiotic prophylaxis (RR 0.96, 95% CI 0.87 to 1.05; 22 studies, 4213 participants; moderate-certainty evidence). Based on an illustrative risk of 290 deaths in 1000 people this equates to 19 (95% CI 37 fewer to 15 more) fewer deaths with topical antibiotic prophylaxis. Topical antibiotic prophylaxis may reduce RTIs (RR 0.57, 95% CI 0.44 to 0.74; 19 studies, 2698 participants; low-certainty evidence). Based on an illustrative risk of 318 RTIs in 1000 people this equates to 137 (95% CI 83 to 178) fewer RTIs with topical antibiotic prophylaxis.\nSixteen studies reported adverse events and dropouts due to adverse events, which were poorly reported with sparse data. The certainty of the evidence ranged from low to very low.\nAuthors' conclusions\nTreatments based on topical prophylaxis probably reduce respiratory infections, but not mortality, in adult patients receiving mechanical ventilation for at least 48 hours, whereas a combination of topical and systemic prophylactic antibiotics reduces both overall mortality and RTIs. However, we cannot rule out that the systemic component of the combined treatment provides a relevant contribution in the observed reduction of mortality. No conclusion can be drawn about adverse events as they were poorly reported with sparse data.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 41 trials involving a total of 11,004 patients mechanically ventilated in ICUs to find out whether giving topical antibiotics, alone or in combination with systemic antibiotics, prevents respiratory tract infections and reduces death. Antibiotics were administered either topically (e.g. antibiotics were applied directly to the oropharynx or to the stomach via a nasogastric tube) or systemically (e.g. intravenously (directly into the patient's vein))."
}
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query-laysum | 2780 | [
{
"role": "user",
"content": "Abstract: Background\nAlcohol use disorder (AUD) confers a prodigious burden of disease, disability, premature mortality, and high economic costs from lost productivity, accidents, violence, incarceration, and increased healthcare utilization. For over 80 years, Alcoholics Anonymous (AA) has been a widespread AUD recovery organization, with millions of members and treatment free at the point of access, but it is only recently that rigorous research on its effectiveness has been conducted.\nObjectives\nTo evaluate whether peer-led AA and professionally-delivered treatments that facilitate AA involvement (Twelve-Step Facilitation (TSF) interventions) achieve important outcomes, specifically: abstinence, reduced drinking intensity, reduced alcohol-related consequences, alcohol addiction severity, and healthcare cost offsets.\nSearch methods\nWe searched the Cochrane Drugs and Alcohol Group Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, CINAHL and PsycINFO from inception to 2 August 2019. We searched for ongoing and unpublished studies via ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 15 November 2018. All searches included non-English language literature. We handsearched references of topic-related systematic reviews and bibliographies of included studies.\nSelection criteria\nWe included randomized controlled trials (RCTs), quasi-RCTs and non-randomized studies that compared AA or TSF (AA/TSF) with other interventions, such as motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT), TSF treatment variants, or no treatment. We also included healthcare cost offset studies. Participants were non-coerced adults with AUD.\nData collection and analysis\nWe categorized studies by: study design (RCT/quasi-RCT; non-randomized; economic); degree of standardized manualization (all interventions manualized versus some/none); and comparison intervention type (i.e. whether AA/TSF was compared to an intervention with a different theoretical orientation or an AA/TSF intervention that varied in style or intensity). For analyses, we followed Cochrane methodology calculating the standard mean difference (SMD) for continuous variables (e.g. percent days abstinent (PDA)) or the relative risk (risk ratios (RRs)) for dichotomous variables. We conducted random-effects meta-analyses to pool effects wherever possible.\nMain results\nWe included 27 studies containing 10,565 participants (21 RCTs/quasi-RCTs, 5 non-randomized, and 1 purely economic study). The average age of participants within studies ranged from 34.2 to 51.0 years. AA/TSF was compared with psychological clinical interventions, such as MET and CBT, and other 12-step program variants.\nWe rated selection bias as being at high risk in 11 of the 27 included studies, unclear in three, and as low risk in 13. We rated risk of attrition bias as high risk in nine studies, unclear in 14, and low in four, due to moderate (> 20%) attrition rates in the study overall (8 studies), or in study treatment group (1 study). Risk of bias due to inadequate researcher blinding was high in one study, unclear in 22, and low in four. Risks of bias arising from the remaining domains were predominantly low or unclear.\nAA/TSF (manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi-randomized evidence)\nRCTs comparing manualized AA/TSF to other clinical interventions (e.g. CBT), showed AA/TSF improves rates of continuous abstinence at 12 months (risk ratio (RR) 1.21, 95% confidence interval (CI) 1.03 to 1.42; 2 studies, 1936 participants; high-certainty evidence). This effect remained consistent at both 24 and 36 months.\nFor percentage days abstinent (PDA), AA/TSF appears to perform as well as other clinical interventions at 12 months (mean difference (MD) 3.03, 95% CI -4.36 to 10.43; 4 studies, 1999 participants; very low-certainty evidence), and better at 24 months (MD 12.91, 95% CI 7.55 to 18.29; 2 studies, 302 participants; very low-certainty evidence) and 36 months (MD 6.64, 95% CI 1.54 to 11.75; 1 study, 806 participants; very low-certainty evidence).\nFor longest period of abstinence (LPA), AA/TSF may perform as well as comparison interventions at six months (MD 0.60, 95% CI -0.30 to 1.50; 2 studies, 136 participants; low-certainty evidence).\nFor drinking intensity, AA/TSF may perform as well as other clinical interventions at 12 months, as measured by drinks per drinking day (DDD) (MD -0.17, 95% CI -1.11 to 0.77; 1 study, 1516 participants; moderate-certainty evidence) and percentage days heavy drinking (PDHD) (MD -5.51, 95% CI -14.15 to 3.13; 1 study, 91 participants; low-certainty evidence).\nFor alcohol-related consequences, AA/TSF probably performs as well as other clinical interventions at 12 months (MD -2.88, 95% CI -6.81 to 1.04; 3 studies, 1762 participants; moderate-certainty evidence).\nFor alcohol addiction severity, one study found evidence of a difference in favor of AA/TSF at 12 months (P < 0.05; low-certainty evidence).\nAA/TSF (non-manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi-randomized evidence)\nFor the proportion of participants completely abstinent, non-manualized AA/TSF may perform as well as other clinical interventions at three to nine months follow-up (RR 1.71, 95% CI 0.70 to 4.18; 1 study, 93 participants; low-certainty evidence).\nNon-manualized AA/TSF may also perform slightly better than other clinical interventions for PDA (MD 3.00, 95% CI 0.31 to 5.69; 1 study, 93 participants; low-certainty evidence).\nFor drinking intensity, AA/TSF may perform as well as other clinical interventions at nine months, as measured by DDD (MD -1.76, 95% CI -2.23 to -1.29; 1 study, 93 participants; very low-certainty evidence) and PDHD (MD 2.09, 95% CI -1.24 to 5.42; 1 study, 286 participants; low-certainty evidence).\nNone of the RCTs comparing non-manualized AA/TSF to other clinical interventions assessed LPA, alcohol-related consequences, or alcohol addiction severity.\nCost-effectiveness studies\nIn three studies, AA/TSF had higher healthcare cost savings than outpatient treatment, CBT, and no AA/TSF treatment. The fourth study found that total medical care costs decreased for participants attending CBT, MET, and AA/TSF treatment, but that among participants with worse prognostic characteristics AA/TSF had higher potential cost savings than MET (moderate-certainty evidence).\nAuthors' conclusions\nThere is high quality evidence that manualized AA/TSF interventions are more effective than other established treatments, such as CBT, for increasing abstinence. Non-manualized AA/TSF may perform as well as these other established treatments. AA/TSF interventions, both manualized and non-manualized, may be at least as effective as other treatments for other alcohol-related outcomes. AA/TSF probably produces substantial healthcare cost savings among people with alcohol use disorder.\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 27 relevant studies that had included 10,565 participants. The studies varied in design; and whether treatments were delivered according to standardized procedures (i.e. manualized); and whether AA/TSF was compared to a treatment that had a different theoretical basis (e.g. cognitive behavioral therapy (CBT)), or to a different type of TSF (i.e. one that varied in style or intensity from the AA TSF)."
}
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query-laysum | 2781 | [
{
"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: \"What questions does this review aim to answer?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This review aims to answer the following questions for panic disorder in adults:\n1. Are azapirones more effective than placebo?\n2. Are azapirones more acceptable than placebo?\n3. What kind of adverse effects do azapirones have compared with placebo?"
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query-laysum | 2782 | [
{
"role": "user",
"content": "Abstract: Background\nAlpha-1 antitrypsin deficiency is an inherited disorder that can cause chronic obstructive pulmonary disease (COPD). People who smoke are more seriously affected and have a greater risk of dying from the disease. Therefore, the primary treatment is to help people give up smoking. There are now also preparations available that contain alpha-1 antitrypsin, but it is uncertain what their clinical effect is.\nObjectives\nTo review the benefits and harms of augmentation therapy with intravenous alpha-1 antitrypsin in patients with alpha-1 antitrypsin deficiency and lung disease.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed and ClinicalTrials.gov to 25 March 2016.\nSelection criteria\nWe included randomised trials of augmentation therapy with alpha-1 antitrypsin compared with placebo or no treatment.\nData collection and analysis\nThe two review authors independently selected trials, extracted outcome data and assessed the risk of bias.\nMain results\nWe included three trials (283 participants in the analyses) that ran for two to three years. All participants were ex- or never-smokers and had genetic variants that carried a high risk of developing COPD. Only one trial reported mortality data (one person of 93 died in the treatment group and three of 87 died in the placebo group). There was no information on harms in the oldest trial. Another trial reported serious adverse events in 10 participants in the treatment group and 18 participants in the placebo group. In the most recent trial, serious adverse events occurred in 28 participants in each group. None of the trials reported mean number of lung infections or hospital admissions. In the two trials that reported exacerbations, there were more exacerbations in the treatment group than in the placebo group, but the results of both trials included the possibility of no difference. Quality of life was similar in the two groups. Forced expiratory volume in one second (FEV1) deteriorated more in participants in the treatment group than in the placebo group but the confidence interval (CI) included no difference (standardised mean difference -0.19, 95% CI -0.42 to 0.05; P = 0.12). For carbon monoxide diffusion, the difference was -0.11 mmol/minute/kPa (95% CI -0.35 to 0.12; P = 0.34). Lung density measured by computer tomography (CT) scan deteriorated significantly less in the treatment group than in the placebo group (mean difference (MD) 0.86 g/L, 95% CI 0.31 to 1.42; P = 0.002). Several secondary outcomes were unreported in the largest and most recent trial whose authors had numerous financial conflicts of interest.\nAuthors' conclusions\nThis review update added one new study and 143 new participants, but the conclusions remain unchanged. Due to sparse data, we could not arrive at a conclusion about the impact of augmentation therapy on mortality, exacerbations, lung infections, hospital admission and quality of life, and there was uncertainty about possible harms. Therefore, it is our opinion that augmentation therapy with alpha-1 antitrypsin cannot be recommended.\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": "Due to a lack of information, we cannot be sure whether this treatment works or not. Therefore, it is our opinion that treatment with alpha-1 antitrypsin augmentation cannot be recommended."
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query-laysum | 2783 | [
{
"role": "user",
"content": "Abstract: Background\nAmbient air pollution is associated with a large burden of disease in both high-income countries (HICs) and low- and middle-income countries (LMICs). To date, no systematic review has assessed the effectiveness of interventions aiming to reduce ambient air pollution.\nObjectives\nTo assess the effectiveness of interventions to reduce ambient particulate matter air pollution in reducing pollutant concentrations and improving associated health outcomes.\nSearch methods\nWe searched a range of electronic databases with diverse focuses, including health and biomedical research (CENTRAL, Cochrane Public Health Group Specialised Register, MEDLINE, Embase, PsycINFO), multidisciplinary research (Scopus, Science Citation Index), social sciences (Social Science Citation Index), urban planning and environment (Greenfile), and LMICs (Global Health Library regional indexes, WHOLIS). Additionally, we searched grey literature databases, multiple online trial registries, references of included studies and the contents of relevant journals in an attempt to identify unpublished and ongoing studies, and studies not identified by our search strategy. The final search date for all databases was 31 August 2016.\nSelection criteria\nEligible for inclusion were randomized and cluster randomized controlled trials, as well as several non-randomized study designs, including controlled interrupted time-series studies (cITS-EPOC), interrupted time-series studies adhering to EPOC standards (ITS-EPOC), interrupted time-series studies not adhering to EPOC standards (ITS), controlled before-after studies adhering to EPOC standards (CBA-EPOC), and controlled before-after studies not adhering to EPOC standards (CBA); these were classified as main studies. Additionally, we included uncontrolled before-after studies (UBA) as supporting studies. We included studies that evaluated interventions to reduce ambient air pollution from industrial, residential, vehicular and multiple sources, with respect to their effect on mortality, morbidity and several air pollutant concentrations. We did not restrict studies based on the population, setting or comparison.\nData collection and analysis\nAfter a calibration exercise among the author team, two authors independently assessed studies for inclusion, extracted data and assessed risk of bias. We conducted data extraction, risk of bias assessment and evidence synthesis only for main studies; we mapped supporting studies with regard to the types of intervention and setting. To assess risk of bias, we used the Graphic Appraisal Tool for Epidemiological studies (GATE) for correlation studies, as modified and employed by the Centre for Public Health Excellence at the UK National Institute for Health and Care Excellence (NICE). For each intervention category, i.e. those targeting industrial, residential, vehicular and multiple sources, we synthesized evidence narratively, as well as graphically using harvest plots.\nMain results\nWe included 42 main studies assessing 38 unique interventions. These were heterogeneous with respect to setting; interventions were implemented in countries across the world, but most (79%) were implemented in HICs, with the remaining scattered across LMICs. Most interventions (76%) were implemented in urban or community settings.\nWe identified a heterogeneous mix of interventions, including those aiming to address industrial (n = 5), residential (n = 7), vehicular (n = 22), and multiple sources (n = 4). Some specific interventions, such as low emission zones and stove exchanges, were assessed by several studies, whereas others, such as a wood burning ban, were only assessed by a single study.\nMost studies assessing health and air quality outcomes used routine monitoring data. Studies assessing health outcomes mostly investigated effects in the general population, while few studies assessed specific subgroups such as infants, children and the elderly. No identified studies assessed unintended or adverse effects.\nThe judgements regarding the risk of bias of studies were mixed. Regarding health outcomes, we appraised eight studies (47%) as having no substantial risk of bias concerns, five studies (29%) as having some risk of bias concerns, and four studies (24%) as having serious risk of bias concerns. Regarding air quality outcomes, we judged 11 studies (31%) as having no substantial risk of bias concerns, 16 studies (46%) as having some risk of bias concerns, and eight studies (23%) as having serious risk of bias concerns.\nThe evidence base, comprising non-randomized studies only, was of low or very low certainty for all intervention categories and primary outcomes. The narrative and graphical synthesis showed that evidence for effectiveness was mixed across the four intervention categories. For interventions targeting industrial, residential and multiple sources, a similar pattern emerged for both health and air quality outcomes, with essentially all studies observing either no clear association in either direction or a significant association favouring the intervention. The evidence base for interventions targeting vehicular sources was more heterogeneous, as a small number of studies did observe a significant association favouring the control. Overall, however, the evidence suggests that the assessed interventions do not worsen air quality or health.\nAuthors' conclusions\nGiven the heterogeneity across interventions, outcomes, and methods, it was difficult to derive overall conclusions regarding the effectiveness of interventions in terms of improved air quality or health. Most included studies observed either no significant association in either direction or an association favouring the intervention, with little evidence that the assessed interventions might be harmful. The evidence base highlights the challenges related to establishing a causal relationship between specific air pollution interventions and outcomes. In light of these challenges, the results on effectiveness should be interpreted with caution; it is important to emphasize that lack of evidence of an association is not equivalent to evidence of no association.\nWe identified limited evidence for several world regions, notably Africa, the Middle East, Eastern Europe, Central Asia and Southeast Asia; decision-makers should prioritize the development and implementation of interventions in these settings. In the future, as new policies are introduced, decision-makers should consider a built-in evaluation component, which could facilitate more systematic and comprehensive evaluations. These could assess effectiveness, but also aspects of feasibility, fidelity and acceptability.\nThe production of higher quality and more uniform evidence would be helpful in informing decisions. Researchers should strive to sufficiently account for confounding, assess the impact of methodological decisions through the conduct and communication of sensitivity analyses, and improve the reporting of methods, and other aspects of the study, most importantly the description of the intervention and the context in which it is implemented.\n\nGiven the provided abstract, please respond to the following query: \"How do we interpret these results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Differences in the studies make it difficult to draw general conclusions about whether the measures worked. Detecting changes in population health and air pollution levels is challenging, and assessing whether changes that occur are due to a specific measure is complex. Air pollution levels are changing constantly and often unpredictably due to weather and other factors, and other changes happening at the same time could also impact population health and air pollution. When regulations to limit industrial pollution are introduced, one must keep in mind that several other changes may be occurring in the background: an increase in traffic and an upgrade of residential heating systems, for example, or an economic downturn that leads to reduced pollution. It can sometimes take a long time before improvements in health become apparent. In interpreting the review’s findings it is important to remember that just because a study did not detect an improvement does not mean that there really was no improvement.\nFurther evaluations of measures to reduce outdoor air pollution in different countries, in particular in low- and middle-income countries, are needed. Wherever possible, future evaluations should apply more reliable and standardized methods to analyze the data. This should help improve the quality of individual studies as well as our confidence in the findings across studies."
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query-laysum | 2784 | [
{
"role": "user",
"content": "Abstract: Background\nIn 2010, the World Health Organization recommended that all patients with suspected malaria are tested for malaria before treatment. In rural African settings light microscopy is often unavailable. Diagnosis has relied on detecting fever, and most people were given antimalarial drugs presumptively. Rapid diagnostic tests (RDTs) provide a point-of-care test that may improve management, particularly of people for whom the RDT excludes the diagnosis of malaria.\nObjectives\nTo evaluate whether introducing RDTs into algorithms for diagnosing and treating people with fever improves health outcomes, reduces antimalarial prescribing, and is safe, compared to algorithms using clinical diagnosis.\nSearch methods\nWe searched the Cochrane Infectious Disease Group Specialized Register; CENTRAL (The Cochrane Library); MEDLINE; EMBASE; CINAHL; LILACS; and the metaRegister of Controlled Trials for eligible trials up to 10 January 2014. We contacted researchers in the field and reviewed the reference lists of all included trials to identify any additional trials.\nSelection criteria\nIndividual or cluster randomized trials (RCTs) comparing RDT-supported algorithms and algorithms using clinical diagnosis alone for diagnosing and treating people with fever living in malaria-endemic settings.\nData collection and analysis\nTwo authors independently applied the inclusion criteria and extracted data. We combined data from individually and cluster RCTs using the generic inverse variance method. We presented all outcomes as risk ratios (RR) with 95% confidence intervals (CIs), and assessed the quality of evidence using the GRADE approach.\nMain results\nWe included seven trials, enrolling 17,505 people with fever or reported history of fever in this review; two individually randomized trials and five cluster randomized trials. All trials were conducted in rural African settings.\nIn most trials the health workers diagnosing and treating malaria were nurses or clinical officers with less than one week of training in RDT supported diagnosis. Health worker prescribing adherence to RDT results was highly variable: the number of participants with a negative RDT result who received antimalarials ranged from 0% to 81%.\nOverall, RDT supported diagnosis had little or no effect on the number of participants remaining unwell at four to seven days after treatment (6990 participants, five trials, low quality evidence); but using RDTs reduced prescribing of antimalarials by up to three-quarters (17,287 participants, seven trials, moderate quality evidence). As would be expected, the reduction in antimalarial prescriptions was highest where health workers adherence to the RDT result was high, and where the true prevalence of malaria was lower.\nUsing RDTs to support diagnosis did not have a consistent effect on the prescription of antibiotics, with some trials showing higher antibiotic prescribing and some showing lower prescribing in the RDT group (13,573 participants, five trials, very low quality evidence).\nOne trial reported malaria microscopy on all enrolled patients in an area of moderate endemicity, so we could compare the number of patients in the RDT and clinical diagnosis groups that actually had microscopy confirmed malaria infection but did not receive antimalarials. No difference was detected between the two diagnostic strategies (1280 participants, one trial, low quality evidence).\nAuthors' conclusions\nAlgorithms incorporating RDTs can substantially reduce antimalarial prescribing if health workers adhere to the test results. Introducing RDTs has not been shown to improve health outcomes for patients, but adherence to the test result does not seem to result in worse clinical outcomes than presumptive treatment.\nConcentrating on improving the care of RDT negative patients could improve health outcomes in febrile children.\n\nGiven the provided abstract, please respond to the following query: \"What the research says\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In these trials, diagnosis using RDTs had little or no effect on the number of people remaining unwell four to seven days after treatment (low quality evidence).\nHowever, using RDTs reduced the prescription of antimalarials by up to three-quarters (moderate quality evidence), and this reduction was highest where health workers only prescribed antimalarials following a positive test, and where malaria was less common.\nUsing RDTs to support diagnosis did not have a consistent effect on the prescription of antibiotics, with some trials showing an increase in antibiotic prescription and some showing a decrease (very low quality evidence).\nUse of RDTs did not result in more patients with malaria being incorrectly diagnosed as not having malaria and being sent home without treatment (low quality evidence)."
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query-laysum | 2785 | [
{
"role": "user",
"content": "Abstract: Background\nChronic pelvic pain (CPP) is a common gynaecological condition accounting for 20% of all gynaecological referrals. There are wide ranges of causes with overlapping symptomatology, therefore the management of the condition is a formidable challenge for clinicians. The aetiology of CPP is heterogeneous and in many cases, no clear diagnosis can be reached. It is in this scenario that the label of chronic pelvic pain syndrome (CPPS) can be applied. We defined women with CPPS as having a minimum duration of pain of at least 6 months, including with a diagnosis of pelvic congestion syndrome, but excluding pain caused by a condition such as endometriosis. Many surgical interventions have been tried in isolation or in conjunction with non-surgical interventions in the management with variable results. Surgical interventions are invasive and carry operative risks. Surgical interventions must be evaluated for their effectiveness prior to their prevalent use in the management of women with CPPS.\nObjectives\nTo review the effectiveness and safety of surgical interventions in the management of women with CPPS.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase and PsycINFO, on 23 April 2021 for any randomised controlled trials (RCT) for surgical interventions in women with CPPS. We also searched the citation lists of relevant publications, two trial registries, relevant journals, abstracts, conference proceedings and several key grey literature sources.\nSelection criteria\nRCTs with women who had CPPS. The review authors were prepared to consider studies of any surgical intervention used for the management of CPPS. Outcome measures were pain rating scales, adverse events, psychological outcomes, quality of life (QoL) measures and requirement for analgesia.\nData collection and analysis\nTwo review authors independently evaluated studies for inclusion and extracted data using the forms designed according to Cochrane guidelines. For each included trial, we collected information regarding the method of randomisation, allocation concealment, blinding, data reporting and analyses. We reported pooled results as mean difference (MDs) or odds ratios (OR) and 95% confidence interval (CI) by the Mantel-Haenszel method. If similar outcomes were reported on different scales, we calculated the standardised mean difference (SMD). We applied GRADE criteria to judge the overall certainty of the evidence.\nMain results\nFour studies met our inclusion criteria involving 216 women with CPP and no identifiable cause.\nAdhesiolysis compared to no surgery or diagnostic laparoscopy\nWe are uncertain of the effect of adhesiolysis on pelvic pain scores postoperatively at three months (MD −7.3, 95% CI −29.9 to 15.3; 1 study, 43 participants; low-certainty evidence), six months (MD −14.3, 95% CI −35.9 to 7.3; 1 study, 43 participants; low-certainty evidence) and 12 months postsurgery (MD 0.00, 95% CI −4.60 to 4.60; 1 study, 43 participants; very low-certainty evidence).\nAdhesiolysis may improve both the emotional wellbeing (MD 24.90, 95% CI 7.92 to 41.88; 1 study, 43 participants; low-certainty evidence) and social support (MD 23.90, 95% CI −1.77 to 49.57; 1 study, 43 participants; low-certainty evidence) components of the Endometriosis Health Profile-30, and both the emotional component (MD 32.30, 95% CI 13.16 to 51.44; 1 study, 43 participants; low-certainty evidence) and the physical component of the 12-item Short Form (MD 22.90, 95% CI 10.97 to 34.83; 1 study, 43 participants; low-certainty evidence) when compared to diagnostic laparoscopy.\nWe are uncertain of the safety of adhesiolysis compared to comparator groups due to low-certainty evidence and lack of structured adverse event reporting.\nNo studies reported on psychological outcomes or requirements for analgesia.\nLaparoscopic uterosacral ligament ablation or resection compared to diagnostic laparoscopy/other treatment\nWe are uncertain of the effect of laparoscopic uterosacral ligament/nerve ablation (LUNA) or resection compared to other treatments postoperatively at three months (OR 1.26, 95% CI 0.40 to 3.93; 1 study, 51 participants; low-certainty evidence) and six months (MD −2.10, 95% CI −4.38 to 0.18; 1 study, 74 participants; very low-certainty evidence). At 12 months post-surgery, we are uncertain of the effect of LUNA on the rate of successful treatment compared to diagnostic laparoscopy. One study of 56 participants found no difference in the effect of LUNA on non-cyclical pain (P = 0.854) or dyspareunia (P = 0.41); however, there was a difference favouring LUNA on dysmenorrhea (P = 0.045) and dyschezia (P = 0.05). We are also uncertain of the effect of LUNA compared to vaginal uterosacral ligament resection on pelvic pain at 12 months (MD 2.00, 95% CI 0.47 to 3.53; 1 study, 74 participants; very low-certainty evidence).\nWe are uncertain of the safety of LUNA or resection compared to comparator groups due to the lack of structured adverse event reporting.\nWomen undergoing LUNA may require more analgesia postoperatively than those undergoing other treatments (P < 0.001; 1 study, 74 participants).\nNo studies reported psychological outcomes or QoL.\nAuthors' conclusions\nWe are uncertain about the benefit of adhesiolysis or LUNA in management of pain in women with CPPS based on the current literature. There may be a QoL benefit to adhesiolysis in improving both emotional wellbeing and social support, as measured by the validated QoL tools. It was not possible to synthesis evidence on adverse events as these were only reported narratively in some studies, in which none were observed. With the inadequate objective assessment of adverse events, especially long-term adverse events, associated with adhesiolysis or LUNA for CPPS, there is currently little to support these interventions for CPPS.\n\nGiven the provided abstract, please respond to the following query: \"Why we did this Cochrane Review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We wanted to find out whether there are any effective and safe surgical treatments for women with chronic pelvic pain. We wanted to understand how effective these surgical treatments are compared to alternative treatments or no treatment at all."
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query-laysum | 2786 | [
{
"role": "user",
"content": "Abstract: Background\nIntestinal dysbiosis may contribute to the pathogenesis of necrotising enterocolitis (NEC) in very preterm or very low birth weight (VLBW) infants. Dietary supplementation with probiotics to modulate the intestinal microbiome has been proposed as a strategy to reduce the risk of NEC and associated mortality and morbidity in very preterm or VLBW infants.\nObjectives\nTo determine the effect of supplemental probiotics on the risk of NEC and associated mortality and morbidity in very preterm or very low birth weight infants.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, the Maternity and Infant Care database, and CINAHL from inception to July 2022. We searched clinical trials databases and conference proceedings, and examined the reference lists of retrieved articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing probiotics with placebo or no probiotics in very preterm infants (born before 32 weeks' gestation) and VLBW infants (weighing less than 1500 g at birth).\nData collection and analysis\nTwo review authors independently evaluated risk of bias of the trials, extracted data, and synthesised effect estimates using risk ratios (RRs), risk differences (RDs), and mean differences (MDs), with associated 95% confidence intervals (CIs). The primary outcomes were NEC and all-cause mortality; secondary outcome measures were late-onset invasive infection (more than 48 hours after birth), duration of hospitalisation from birth, and neurodevelopmental impairment. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included 60 trials with 11,156 infants. Most trials were small (median sample size 145 infants). The main potential sources of bias were unclear reporting of methods for concealing allocation and masking caregivers or investigators in about half of the trials. The formulation of the probiotics varied across trials. The most common preparations contained Bifidobacterium spp., Lactobacillus spp., Saccharomyces spp., andStreptococcus spp., alone or in combination.\nVery preterm or very low birth weight infants\nProbiotics may reduce the risk of NEC (RR 0.54, 95% CI 0.46 to 0.65; I² = 17%; 57 trials, 10,918 infants; low certainty). The number needed to treat for an additional beneficial outcome (NNTB) was 33 (95% CI 25 to 50). Probiotics probably reduce mortality slightly (RR 0.77, 95% CI 0.66 to 0.90; I² = 0%; 54 trials, 10,484 infants; moderate certainty); the NNTB was 50 (95% CI 50 to 100). Probiotics probably have little or no effect on the risk of late-onset invasive infection (RR 0.89, 95% CI 0.82 to 0.97; I² = 22%; 49 trials, 9876 infants; moderate certainty). Probiotics may have little or no effect on neurodevelopmental impairment (RR 1.03, 95% CI 0.84 to 1.26; I² = 0%; 5 trials, 1518 infants; low certainty).\nExtremely preterm or extremely low birth weight infants\nFew data were available for extremely preterm or extremely low birth weight (ELBW) infants. In this population, probiotics may have little or no effect on NEC (RR 0.92, 95% CI 0.69 to 1.22, I² = 0%; 10 trials, 1836 infants; low certainty), all-cause mortality (RR 0.92, 95% CI 0.72 to 1.18; I² = 0%; 7 trials, 1723 infants; low certainty), or late-onset invasive infection (RR 0.93, 95% CI 0.78 to 1.09; I² = 0%; 7 trials, 1533 infants; low certainty). No trials provided data for measures of neurodevelopmental impairment in extremely preterm or ELBW infants.\nAuthors' conclusions\nGiven the low to moderate certainty of evidence for the effects of probiotic supplements on the risk of NEC and associated morbidity and mortality for very preterm or VLBW infants, and particularly for extremely preterm or ELBW infants, there is a need for further large, high-quality trials to provide evidence of sufficient validity and applicability to inform policy and practice.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up to date to July 2022."
}
]
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query-laysum | 2787 | [
{
"role": "user",
"content": "Abstract: Background\nThere is strong evidence that our current consumption of salt is a major factor in the development of increased blood pressure (BP) and that a reduction in our salt intake lowers BP, whether BP levels are normal or raised initially. Effective control of BP in people with diabetes lowers the risk of strokes, heart attacks and heart failure and slows the progression of chronic kidney disease (CKD) in people with diabetes. This is an update of a review first published in 2010.\nObjectives\nTo evaluate the effect of altered salt intake on BP and markers of cardiovascular disease and of CKD in people with diabetes.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 31 March 2022 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\nWe included randomised controlled trials (RCTs) of altered salt intake in individuals with type 1 and type 2 diabetes. Studies were included when there was a difference between low and high sodium intakes of at least 34 mmol/day.\nData collection and analysis\nTwo authors independently assessed studies and resolved differences by discussion. We calculated mean effect sizes as mean difference (MD) and 95% confidence intervals (CI) using the random-effects model. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nThirteen RCTs (313 participants), including 21 comparisons (studies), met our inclusion criteria. One RCT (two studies) was added to this review update. Participants included 99 individuals with type 1 diabetes and 214 individuals with type 2 diabetes. Two RCTs (four studies) included some participants with reduced overall kidney function. The remaining studies either reported that participants with reduced glomerular filtration rate (GFR) were excluded from the study or only included participants with microalbuminuria and normal GFR. Five studies used a parallel study design, and 16 used a cross-over design. Studies were at high risk of bias for most criteria. Random sequence generation and allocation concealment were adequate in only three and two studies, respectively. One study was at low risk of bias for blinding of participants and outcome assessment, but no studies were at low risk for selective reporting. Twelve studies reported non-commercial funding sources, three reported conflicts of interest, and eight reported adequate washout between interventions in cross-over studies.\nThe median net reduction in 24-hour urine sodium excretion (24-hour UNa) in seven long-term studies (treatment duration four to 12 weeks) was 76 mmol (range 51 to 124 mmol), and in 10 short-term studies (treatment duration five to seven days) was 187 mmol (range 86 to 337 mmol). Data were only available graphically in four studies. In long-term studies, reduced sodium intake may lower systolic BP (SBP) by 6.15 mm Hg (7 studies: 95% CI -9.27 to -3.03; I² = 12%), diastolic BP (DBP) by 3.41 mm Hg (7 studies: 95% CI -5.56 to -1.27; I² = 41%) and mean arterial pressure (MAP) by 4.60 mm Hg (4 studies: 95% CI -7.26 to -1.94; I² = 28%). In short-term studies, low sodium intake may reduce SBP by 8.43 mm Hg (5 studies: 95% CI -14.37 to -2.48; I² = 88%), DBP by 2.95 mm Hg (5 studies: 95% CI -4.96 to -0.94; I² = 70%) and MAP by 2.37 mm Hg (9 studies: 95% CI -4.75 to -0.01; I² = 65%). There was considerable heterogeneity in most analyses but particularly among short-term studies. All analyses were considered to be of low certainty evidence.\nSBP, DBP and MAP reductions may not differ between hypertensive and normotensive participants or between individuals with type 1 or type 2 diabetes. In hypertensive participants, SBP, DBP and MAP may be reduced by 6.45, 3.15 and 4.88 mm Hg, respectively, while in normotensive participants, they may be reduced by 8.43, 2.95 and 2.15 mm Hg, respectively (all low certainty evidence). SBP, DBP and MAP may be reduced by 7.35, 3.04 and 4.30 mm Hg, respectively, in participants with type 2 diabetes and by 7.35, 3.20, and 0.08 mm Hg, respectively, in participants with type 1 diabetes (all low certainty evidence).\nEight studies provided measures of urinary protein excretion before and after salt restriction; four reported a reduction in urinary albumin excretion with salt restriction. Pooled analyses showed no changes in GFR (12 studies: MD -1.87 mL/min/1.73 m², 95% CI -5.05 to 1.31; I² = 32%) or HbA1c (6 studies: MD -0.62, 95% CI -1.49 to 0.26; I² = 95%) with salt restriction (low certainty evidence). Body weight was reduced in studies lasting one to two weeks but not in studies lasting for longer periods (low certainty evidence). Adverse effects were reported in only one study; 11% and 21% developed postural hypotension on the low-salt diet and the low-salt diet combined with hydrochlorothiazide, respectively.\nAuthors' conclusions\nThis systematic review shows an important reduction in SBP and DBP in people with diabetes with normal GFR during short periods of salt restriction, similar to that obtained with single drug therapy for hypertension. These data support the international recommendations that people with diabetes with or without hypertension or evidence of kidney disease should reduce salt intake to less than 5 g/day (2 g sodium).\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 13 studies, including 313 people with type 1 or 2 diabetes. We found that reducing salt intake by an average of 5 g/day lowered BP, with systolic BP reduced by 7 mm of mercury (Hg) and diastolic BP reduced by 3 mm Hg. We found that the amount of protein in the urine was reduced in four of the eight studies that reported this outcome. Only one study reported side effects with low BP when standing up with low salt diets reported in a quarter of the participants."
}
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query-laysum | 2788 | [
{
"role": "user",
"content": "Abstract: Background\nManaging hemophilia is challenging both in terms of medical treatment and its broad impact on many aspects of the individual's life, including self-perception. Several psychosocial issues are potentially relevant in the clinical management of hemophilia, including it being a chronic and incurable condition; e.g. people with hemophilia must adapt to optimally interact with peers and to practice sports - even choosing a sport represents an issue for perceived limitations, expectations and cultural influences on the individual and their family. People with hemophilia can react by denying their condition and its manifestations and not adhering to treatment. Due to the complexity of relationships surrounding genetic diseases, parents and relatives may have their own issues that contribute to making life easier or more difficult for the person with hemophilia. Anxiety, sadness and depression resulting in mental health disorders are reported in this population and may influence quality of life (QoL) depending on cultural background, religious beliefs, family support and other variables.\nObjectives\nPrimarily to assess the effectiveness of psychological therapies for improving the ability of people with hemophilia to cope with their chronic condition.\nSearch methods\nWe aimed to identify trials from the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, Embase and PsycINFO, CINAHL, MEDLINE and trial registries. We searched reference lists of included publications.\nMost recent search of the Group's register: 13 June 2019.\nSelection criteria\nRandomized controlled trials (RCTs) and quasi-RCTs in people with hemophilia of any age or gender, type A or B, any severity, with or without inhibitors, with or without HIV or hepatitis C virus. All psychological interventions for promoting emotional, intellectual and spiritual wellness. Individual, group or family group therapy interventions were eligible.\nData collection and analysis\nWe independently assessed trials, extracted data and assessed the risk of bias and assessed the quality of the evidence using GRADE.\nMain results\nSeven trials were included (362 participants randomized, data from 264 participants available for analysis); six of parallel design and one a partial cross-over design. One multicenter trial was conducted in Canada; the remaining six were single centre undertaken in the UK, USA, Iran and in the Netherlands.\nAll trials had a high risk of bias for participant blinding and use of patient-reported outcomes.\nEvidence was retrieved on four interventions: psycho-education (DVD plus information booklet versus information booklet alone; computerised learning versus no intervention); cognitive therapy (auto-hypnosis (self-hypnosis) versus control); and behavioural therapy (relaxation (progressive or self control) versus no treatment). We also aimed to assess psychodynamic therapy and systemic therapy, but no trials were identified.\nHeterogeneity of the outcome measures and measurements precluded meta-analyses. No trial reported the cost of the psychological intervention and family adjustment.\nDVD plus information booklet compared to information booklet alone\nOne trial (108 participants) showed coping strategies may lower pre-contemplation scores and negative thoughts, mean difference (MD) -0.24 (95%CI -0.48 - 0.00, low-certainty evidence), however, other measures of coping strategies in the same trial suggest little or no difference between groups, e.g. contemplation, MD (-0.09, 95%CI -0.32 – 0.14, low-certainty evidence). The same trial measured QoL and showed little or no difference between treatment groups for the physical domain, MD 0.59 (95% CI -3.66 to 4.84, low-certainty evidence), but may improve scores in the mental health domain for those receiving the booklet plus DVD compared to booklet alone, MD (4.70, 95% CI 0.33 to 9.07, low-certainty evidence). Mood or personal well-being were not reported.\nComputerised learning compared to no intervention\nTwo trials (57 participants) reported on interventions aimed at children and adolescents and their impact on promoting a sense of self-efficacy (primary outcome 'Mood and personal well-being'), but only one showed an increase, MD 7.46 (95%CI 3.21 to 11.71, 17 participants, very low-certainty evidence); the second did not report control group data. One trial (30 participants) showed the intervention did not improve self-efficacy in adults, but appropriate data could not be extracted. Two trials (47 participants) reported coping strategies; one only reported within-group differences from baseline, the second showed an increase from baseline in coping strategies in the Internet program group compared to the no intervention group (disease-specific knowledge, MD 2.45 (95% CI 0.89 to 4.01); self-management ability and transition readiness, MD 19.90 (95% CI 3.61 to 36.19; low-certainty evidence).\nOne trial reported QoL but with insufficient information to calculate changes from baseline; no difference in post-treatment scores was seen between groups, MD -8.65, 95% CI -18.30 to 1.00, very low-certainty evidence).\nAuto-hypnosis (self-hypnosis) compared to control\nThere were two older trials that reported on this intervention (50 participants) focusing mainly on the secondary outcome 'physical health'; only one trial reported the primary outcome ‘mood and personal well-being’ (only within-group differences in the treatment group). Coping strategies and QoL were not assessed in the trials.\nRelaxation (progressive or self control) compared to no treatment\nOnly one trial (seven participants) from 1985, was included which focused on 'physical health' and did not report on any of our primary outcomes.\nAuthors' conclusions\nNot all of the seven included trials analysed the effects of the interventions on our primary outcomes (mood and personal well-being, coping strategies and QoL).\nThree trials were conducted in the 1970s and 1980s using techniques of auto-hypnosis or relaxation and, in accordance with the needs and therapeutic possibilities of the time, they focused on secondary outcomes, e.g. frequency of bleeding (physical health) and adherence to the intervention.\nThe four newer trials assessed psycho-educational interventions all mediated by the use of technologies (DVD or computer) and often created according to age needs of the target group. In these cases, attention was shifted to our pre-defined primary outcomes.\nThis review has identified low- and very low-certainty evidence, prompting caution in its interpretation. The major problem we encountered was the heterogeneity of trial designs, of interventions and of outcome measures used across the trials. We strongly suggest that researchers consider developing a core outcome set to streamline future research; randomization was proven to be safe and acceptable, and blinding should be considered for those assessing patient-reported 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": "All treatments were safe, no major side effects were reported. Psycho-educational interventions in children and adolescents seemed to promote a sense of self-efficacy and better self-management skills, but the quality of the evidence suggests that more rigorous experimental design is required. One trial in adults did not show any effect. Self-hypnosis and relaxation techniques were not tested for the primary outcome but were useful in decreasing the number and severity of joint bleeds when drug treatment was not available. The effects of these interventions on quality of life vary. The major problem we encountered in this review is the difference in trial designs, interventions and outcome measures used across the trials. We strongly suggest that researchers in the field consider developing a core outcome set to streamline future research. Randomization was proven to be safe and acceptable in this research field, and blinding of outcome assessors should be considered in the presence of patient-reported outcomes."
}
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query-laysum | 2789 | [
{
"role": "user",
"content": "Abstract: Background\nNearsightedness (myopia) causes blurry vision when one is looking at distant objects. Interventions to slow the progression of myopia in children include multifocal spectacles, contact lenses, and pharmaceutical agents.\nObjectives\nTo assess the effects of interventions, including spectacles, contact lenses, and pharmaceutical agents in slowing myopia progression in children.\nSearch methods\nWe searched CENTRAL; Ovid MEDLINE; Embase.com; PubMed; the LILACS Database; and two trial registrations up to February 2018. A top up search was done in February 2019.\nSelection criteria\nWe included randomized controlled trials (RCTs). We excluded studies when most participants were older than 18 years at baseline. We also excluded studies when participants had less than -0.25 diopters (D) spherical equivalent myopia.\nData collection and analysis\nWe followed standard Cochrane methods.\nMain results\nWe included 41 studies (6772 participants). Twenty-one studies contributed data to at least one meta-analysis. Interventions included spectacles, contact lenses, pharmaceutical agents, and combination treatments. Most studies were conducted in Asia or in the United States. Except one, all studies included children 18 years or younger. Many studies were at high risk of performance and attrition bias.\nSpectacle lenses: undercorrection of myopia increased myopia progression slightly in two studies; children whose vision was undercorrected progressed on average -0.15 D (95% confidence interval [CI] -0.29 to 0.00; n = 142; low-certainty evidence) more than those wearing fully corrected single vision lenses (SVLs). In one study, axial length increased 0.05 mm (95% CI -0.01 to 0.11) more in the undercorrected group than in the fully corrected group (n = 94; low-certainty evidence). Multifocal lenses (bifocal spectacles or progressive addition lenses) yielded small effect in slowing myopia progression; children wearing multifocal lenses progressed on average 0.14 D (95% CI 0.08 to 0.21; n = 1463; moderate-certainty evidence) less than children wearing SVLs. In four studies, axial elongation was less for multifocal lens wearers than for SVL wearers (-0.06 mm, 95% CI -0.09 to -0.04; n = 896; moderate-certainty evidence). Three studies evaluating different peripheral plus spectacle lenses versus SVLs reported inconsistent results for refractive error and axial length outcomes (n = 597; low-certainty evidence).\nContact lenses: there may be little or no difference between vision of children wearing bifocal soft contact lenses (SCLs) and children wearing single vision SCLs (mean difference (MD) 0.20D, 95% CI -0.06 to 0.47; n = 300; low-certainty evidence). Axial elongation was less for bifocal SCL wearers than for single vision SCL wearers (MD -0.11 mm, 95% CI -0.14 to -0.08; n = 300; low-certainty evidence). Two studies investigating rigid gas permeable contact lenses (RGPCLs) showed inconsistent results in myopia progression; these two studies also found no evidence of difference in axial elongation (MD 0.02mm, 95% CI -0.05 to 0.10; n = 415; very low-certainty evidence). Orthokeratology contact lenses were more effective than SVLs in slowing axial elongation (MD -0.28 mm, 95% CI -0.38 to -0.19; n = 106; moderate-certainty evidence). Two studies comparing spherical aberration SCLs with single vision SCLs reported no difference in myopia progression nor in axial length (n = 209; low-certainty evidence).\nPharmaceutical agents: at one year, children receiving atropine eye drops (3 studies; n = 629), pirenzepine gel (2 studies; n = 326), or cyclopentolate eye drops (1 study; n = 64) showed significantly less myopic progression compared with children receiving placebo: MD 1.00 D (95% CI 0.93 to 1.07), 0.31 D (95% CI 0.17 to 0.44), and 0.34 (95% CI 0.08 to 0.60), respectively (moderate-certainty evidence). Axial elongation was less for children treated with atropine (MD -0.35 mm, 95% CI -0.38 to -0.31; n = 502) and pirenzepine (MD -0.13 mm, 95% CI -0.14 to -0.12; n = 326) than for those treated with placebo (moderate-certainty evidence) in two studies. Another study showed favorable results for three different doses of atropine eye drops compared with tropicamide eye drops (MD 0.78 D, 95% CI 0.49 to 1.07 for 0.1% atropine; MD 0.81 D, 95% CI 0.57 to 1.05 for 0.25% atropine; and MD 1.01 D, 95% CI 0.74 to 1.28 for 0.5% atropine; n = 196; low-certainty evidence) but did not report axial length. Systemic 7-methylxanthine had little to no effect on myopic progression (MD 0.07 D, 95% CI -0.09 to 0.24) nor on axial elongation (MD -0.03 mm, 95% CI -0.10 to 0.03) compared with placebo in one study (n = 77; moderate-certainty evidence). One study did not find slowed myopia progression when comparing timolol eye drops with no drops (MD -0.05 D, 95% CI -0.21 to 0.11; n = 95; low-certainty evidence).\nCombinations of interventions: two studies found that children treated with atropine plus multifocal spectacles progressed 0.78 D (95% CI 0.54 to 1.02) less than children treated with placebo plus SVLs (n = 191; moderate-certainty evidence). One study reported -0.37 mm (95% CI -0.47 to -0.27) axial elongation for atropine and multifocal spectacles when compared with placebo plus SVLs (n = 127; moderate-certainty evidence). Compared with children treated with cyclopentolate plus SVLs, those treated with atropine plus multifocal spectacles progressed 0.36 D less (95% CI 0.11 to 0.61; n = 64; moderate-certainty evidence). Bifocal spectacles showed small or negligible effect compared with SVLs plus timolol drops in one study (MD 0.19 D, 95% CI 0.06 to 0.32; n = 97; moderate-certainty evidence). One study comparing tropicamide plus bifocal spectacles versus SVLs reported no statistically significant differences between groups without quantitative results.\nNo serious adverse events were reported across all interventions. Participants receiving antimuscarinic topical medications were more likely to experience accommodation difficulties (Risk Ratio [RR] 9.05, 95% CI 4.09 to 20.01) and papillae and follicles (RR 3.22, 95% CI 2.11 to 4.90) than participants receiving placebo (n=387; moderate-certainty evidence).\nAuthors' conclusions\nAntimuscarinic topical medication is effective in slowing myopia progression in children. Multifocal lenses, either spectacles or contact lenses, may also confer a small benefit. Orthokeratology contact lenses, although not intended to modify refractive error, were more effective than SVLs in slowing axial elongation. We found only low or very low-certainty evidence to support RGPCLs and sperical aberration SCLs.\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 find out if there are treatments that can slow the progress of nearsightedness (myopia) in children. Myopia is a vision condition in which people can see close objects clearly, but objects farther away appear blurred."
}
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query-laysum | 2790 | [
{
"role": "user",
"content": "Abstract: Background\nAttention deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed and treated psychiatric disorders in childhood. Typically, children and adolescents with ADHD find it difficult to pay attention and they are hyperactive and impulsive. Methylphenidate is the psychostimulant most often prescribed, but the evidence on benefits and harms is uncertain. This is an update of our comprehensive systematic review on benefits and harms published in 2015.\nObjectives\nTo assess the beneficial and harmful effects of methylphenidate for children and adolescents with ADHD.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, three other databases and two trials registers up to March 2022. In addition, we checked reference lists and requested published and unpublished data from manufacturers of methylphenidate.\nSelection criteria\nWe included all randomised clinical trials (RCTs) comparing methylphenidate versus placebo or no intervention in children and adolescents aged 18 years and younger with a diagnosis of ADHD. The search was not limited by publication year or language, but trial inclusion required that 75% or more of participants had a normal intellectual quotient (IQ > 70). We assessed two primary outcomes, ADHD symptoms and serious adverse events, and three secondary outcomes, adverse events considered non-serious, general behaviour, and quality of life.\nData collection and analysis\nTwo review authors independently conducted data extraction and risk of bias assessment for each trial. Six review authors including two review authors from the original publication participated in the update in 2022. We used standard Cochrane methodological procedures. Data from parallel-group trials and first-period data from cross-over trials formed the basis of our primary analyses. We undertook separate analyses using end-of-last period data from cross-over trials. We used Trial Sequential Analyses (TSA) to control for type I (5%) and type II (20%) errors, and we assessed and downgraded evidence according to the GRADE approach.\nMain results\nWe included 212 trials (16,302 participants randomised); 55 parallel-group trials (8104 participants randomised), and 156 cross-over trials (8033 participants randomised) as well as one trial with a parallel phase (114 participants randomised) and a cross-over phase (165 participants randomised). The mean age of participants was 9.8 years ranging from 3 to 18 years (two trials from 3 to 21 years). The male-female ratio was 3:1. Most trials were carried out in high-income countries, and 86/212 included trials (41%) were funded or partly funded by the pharmaceutical industry. Methylphenidate treatment duration ranged from 1 to 425 days, with a mean duration of 28.8 days. Trials compared methylphenidate with placebo (200 trials) and with no intervention (12 trials). Only 165/212 trials included usable data on one or more outcomes from 14,271 participants.\nOf the 212 trials, we assessed 191 at high risk of bias and 21 at low risk of bias. If, however, deblinding of methylphenidate due to typical adverse events is considered, then all 212 trials were at high risk of bias.\nPrimary outcomes: methylphenidate versus placebo or no intervention may improve teacher-rated ADHD symptoms (standardised mean difference (SMD) −0.74, 95% confidence interval (CI) −0.88 to −0.61; I² = 38%; 21 trials; 1728 participants; very low-certainty evidence). This corresponds to a mean difference (MD) of −10.58 (95% CI −12.58 to −8.72) on the ADHD Rating Scale (ADHD-RS; range 0 to 72 points). The minimal clinically relevant difference is considered to be a change of 6.6 points on the ADHD-RS. Methylphenidate may not affect serious adverse events (risk ratio (RR) 0.80, 95% CI 0.39 to 1.67; I² = 0%; 26 trials, 3673 participants; very low-certainty evidence). The TSA-adjusted intervention effect was RR 0.91 (CI 0.31 to 2.68).\nSecondary outcomes: methylphenidate may cause more adverse events considered non-serious versus placebo or no intervention (RR 1.23, 95% CI 1.11 to 1.37; I² = 72%; 35 trials 5342 participants; very low-certainty evidence). The TSA-adjusted intervention effect was RR 1.22 (CI 1.08 to 1.43). Methylphenidate may improve teacher-rated general behaviour versus placebo (SMD −0.62, 95% CI −0.91 to −0.33; I² = 68%; 7 trials 792 participants; very low-certainty evidence), but may not affect quality of life (SMD 0.40, 95% CI −0.03 to 0.83; I² = 81%; 4 trials, 608 participants; very low-certainty evidence).\nAuthors' conclusions\nThe majority of our conclusions from the 2015 version of this review still apply. Our updated meta-analyses suggest that methylphenidate versus placebo or no-intervention may improve teacher-rated ADHD symptoms and general behaviour in children and adolescents with ADHD. There may be no effects on serious adverse events and quality of life. Methylphenidate may be associated with an increased risk of adverse events considered non-serious, such as sleep problems and decreased appetite. However, the certainty of the evidence for all outcomes is very low and therefore the true magnitude of effects remain unclear.\nDue to the frequency of non-serious adverse events associated with methylphenidate, the blinding of participants and outcome assessors is particularly challenging. To accommodate this challenge, an active placebo should be sought and utilised. It may be difficult to find such a drug, but identifying a substance that could mimic the easily recognised adverse effects of methylphenidate would avert the unblinding that detrimentally affects current randomised trials.\nFuture systematic reviews should investigate the subgroups of patients with ADHD that may benefit most and least from methylphenidate. This could be done with individual participant data to investigate predictors and modifiers like age, comorbidity, and ADHD subtypes.\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 212 studies with 16,302 children or adolescents with ADHD. Most of the trials compared methylphenidate with placebo. Most studies were small with around 70 children, with an average age of 10 years (ages ranged from 3 to 18 years). Most studies were short, lasting an average of around a month; the shortest study lasted just one day and the longest 425 days. Most studies were in the USA.\nBased on teachers' ratings, compared with placebo or no treatment, methylphenidate:\n- may improve ADHD symptoms (21 studies, 1728 children)\n- may make no difference to serious unwanted effects (26 studies, 3673 participants)\n- may cause more non-serious unwanted effects (35 studies, 5342 participants)\n- may improve general behaviour (7 trials 792 participants)\n- may not affect quality of life (4 trials, 608 participants)"
}
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query-laysum | 2791 | [
{
"role": "user",
"content": "Abstract: Background\nTrabeculectomy is performed as a treatment for many types of glaucoma in an attempt to lower the intraocular pressure. The surgery involves creating a channel through the sclera, through which intraocular fluid can leave the eye. If scar tissue blocks the exit of the surgically created channel, intraocular pressure rises and the operation fails. Antimetabolites such as 5-Fluorouracil (5-FU) are used to inhibit wound healing to prevent the conjunctiva scarring down on to the sclera. This is an update of a Cochrane review first published in 2000, and previously updated in 2009.\nObjectives\nTo assess the effects of both intraoperative application and postoperative injections of 5-FU in eyes of people undergoing surgery for glaucoma at one year.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2013), EMBASE (January 1980 to July 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the 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 25 July 2013. We also searched the reference lists of relevant articles and the Science Citation Index and contacted investigators and experts for details of additional relevant trials.\nSelection criteria\nWe included randomised trials of intraoperative application and postoperative 5-FU injections compared with placebo or no treatment in trabeculectomy for glaucoma.\nData collection and analysis\nTwo authors independently assessed trial quality and extracted data. We used standard methodological procedures expected by The Cochrane Collaboration. We contacted trial investigators for missing information. Data were summarised using risk ratio (RR), Peto odds ratio and mean difference, as appropriate.\nThe participants were divided into three separate subgroup populations (high risk of failure, combined surgery and primary trabeculectomy) and the interventions were divided into three subgroups of 5-FU injections (intraoperative, regular dose postoperative and low dose postoperative). The low dose was defined as a total dose less than 19 mg.\nMain results\nTwelve trials, which randomised 1319 participants, were included in the review. As far as can be determined from the trial reports, the methodological quality of the trials was not high, including a high risk of detection bias in many. Of note, only one study reported low-dose postoperative 5-FU and this paper was at high risk of reporting bias.\nNot all studies reported population characteristics, of those that did mean age ranged from 61 to 75 years. 83% of participants were white and 40% were male. All studies were a minimum of one year long.\nA significant reduction in surgical failure in the first year after trabeculectomy was detected in eyes at high risk of failure and those undergoing surgery for the first time receiving regular-dose 5-FU postoperative injections (RR 0.44, 95% confidence interval (CI) 0.29 to 0.68 and 0.21, 0.06 to 0.68, respectively). No surgical failures were detected in studies assessing combined surgery. No difference was detected in the low-dose postoperative 5-FU injection group in patients undergoing primary trabeculectomy (RR 0.93, 95% CI 0.70 to 1.24). Peroperative 5-FU in patients undergoing primary trabeculectomy significantly reduced risk of failure (RR 0.67, 95% CI 0.51 to 0.88). This translates to a number needed to treat for an additional beneficial outcome of 4.1 for the high risk of failure patients, and 5.0 for primary trabeculectomy patients receiving postoperative 5-FU.\nIntraocular pressure was also reduced in the primary trabeculectomy group receiving intraoperative 5-FU (mean difference (MD) -1.04, 95% CI -1.65 to -0.43) and regular-dose postoperative 5-FU (MD -4.67, 95% CI -6.60 to -2.73). No significant change occurred in the primary trabeculectomy group receiving low-dose postoperative 5-FU (MD -0.50, 95% CI -2.96 to 1.96). Intraocular pressure was particularly reduced in the high risk of failure population receiving regular-dose postoperative 5-FU (MD -16.30, 95% CI -18.63 to -13.97). No difference was detected in the combined surgery population receiving regular-dose postoperative 5-FU (MD -1.02, 95% CI -2.40 to 0.37).\nWhilst no evidence was found of an increased risk of serious sight-threatening complications, other complications are more common after 5-FU injections. None of the trials reported on the participants' perspective of care.\nThe quality of evidence varied between subgroups and outcomes, most notably the evidence for combined surgery and low-dose postoperative 5-FU was found to be very low using GRADE. The combined surgery postoperative 5-FU subgroup because no surgical failures have been reported and the sample size is small (n = 118), and the low-dose postoperative 5-FU group because of the small sample size (n = 76) and high risk of bias of the only contributing study.\nAuthors' conclusions\nPostoperative injections of 5-FU are now rarely used as part of routine packages of postoperative care but are increasingly used on an ad hoc basis. This presumably reflects an aspect of the treatment that is unacceptable to both patients and doctors. None of the trials reported on the participants' perspective of care, which constitutes a serious omission for an invasive treatment such as this.\nThe small but statistically significant reduction in surgical failures and intraocular pressure at one year in the primary trabeculectomy group and high-risk group must be weighed against the increased risk of complications and patient preference.\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": "Glaucoma involves a loss of vision that may be associated with raised pressure inside the eye. When glaucoma is diagnosed, it is common to try to reduce that pressure with medical, laser or surgical procedures (trabeculectomy). Surgery does not immediately restore vision, and may involve extra vision loss in the short term. Drugs can be used to modify wound healing to improve the likelihood of the success of surgery."
}
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query-laysum | 2792 | [
{
"role": "user",
"content": "Abstract: Background\nThis review adds to a series of reviews looking at primary medical management options for patients with chronic rhinosinusitis.\nChronic rhinosinusitis is common and characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Antifungals have been suggested as a treatment for chronic rhinosinusitis.\nObjectives\nTo assess the effects of systemic and topical antifungal agents in patients with chronic rhinosinusitis, including those with allergic fungal rhinosinusitis (AFRS) and, if possible, AFRS exclusively.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 17 November 2017.\nSelection criteria\nRandomised controlled trials (RCTs) with at least a two-week follow-up period comparing topical or systemic antifungals with (a) placebo, (b) no treatment, (c) other pharmacological interventions or (d) a different antifungal agent. We did not include post-surgical antifungal use.\nData collection and analysis\nWe used the standard Cochrane methodological procedures. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the significant adverse effects of hepatic toxicity (systemic antifungals). Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse effects of gastrointestinal disturbance (systemic antifungals) and epistaxis, headache or local discomfort (topical antifungals). We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included eight studies (490 adult participants). The presence of nasal polyps on examination was an inclusion criterion in three studies, an exclusion criterion in one study and the remaining studies included a mixed population. No studies specifically investigated the effect of antifungals in patients with AFRS.\nTopical antifungal treatment versus placebo or no intervention\nWe included seven studies (437 participants) that used amphotericin B (six studies; 383 participants) and one that used fluconazole (54 participants). Different delivery methods, volumes and concentrations were used.\nFour studies reported disease-specific health-related quality of life using a range of instruments. We did not meta-analyse the results due to differences in the instruments used, and measurement and reporting methods. At the end of treatment (one to six months) none of the studies reported statistically significant differences between the groups (low-quality evidence - we are uncertain about the result).\nTwo studies reported disease severity using patient-reported symptom scores. Meta-analysis was not possible. At the end of treatment (8 to 13 weeks) one study showed no difference and the second found that patients in the placebo group had less severe symptoms (very low-quality evidence - we are very uncertain about the result).\nIn terms of adverse effects , topical antifungals may lead to more local irritation compared with placebo (risk ratio (RR) 2.29, 95% confidence interval (CI) 0.61 to 8.62; 312 participants; 5 studies; low-quality evidence) but little or no difference in epistaxis (RR 0.97, 95% CI 0.14 to 6.63; 225 participants; 4 studies, low-quality evidence) or headache (RR 1.26, 95% CI 0.60 to 2.63; 195 participants; 3 studies; very low-quality evidence).\nNone of the studies found a difference in generic health-related quality of life (one study) or endoscopic score (five studies) between the treatment groups. Three studies investigated CT scan ; two found no difference between the groups and one found a significant decrease in the mean percentage of air space occluded, favouring the antifungal group.\nSystemic antifungal treatment versus placebo or no treatment\nOne study (53 participants) comparing terbinafine tablets against placebo reported that there may be little or no difference between the groups in disease-specific health-related quality of life or disease severity score (both low-quality evidence). Systemic antifungals may lead to more hepatic toxicity events (RR 3.35, 95% CI 0.14 to 78.60) but fewer gastrointestinal disturbances (RR 0.37, 95% CI 0.04 to 3.36), compared to placebo, although the evidence was of low quality.\nThis study did not find a difference in CT scan score between the groups. Generic health-related quality of life and endoscopic score were not measured.\nOther comparisons\nWe found no studies that compared antifungal agents against other treatments for chronic rhinosinusitis.\nAuthors' conclusions\nDue to the very low quality of the evidence, it is uncertain whether or not the use of topical or systemic antifungals has an impact on patient outcomes in adults with chronic rhinosinusitis compared with placebo or no treatment. Studies including specific subgroups (i.e. AFRS) are lacking.\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": "Chronic rhinosinusitis is a common condition characterised by inflammation of the nose and paranasal sinuses (a group of air-filled spaces behind the nose, eyes and cheeks). Patients with chronic rhinosinusitis have at least two of the following symptoms for at least 12 weeks: either a blocked nose and/or discharge from their nose (runny nose) and one of either pain/pressure in their face or a reduced sense of smell (hyposmia). Some people also have nasal polyps, which are grape-like swellings of the normal nasal lining inside the nasal passage and sinuses. Some people with chronic rhinosinusitis with nasal polyps are allergic to airborne fungus and this can cause a specific type of condition called allergic fungal rhinosinusitis (AFRS).\nFungal spores are commonly found in the nose as they are in the air we breathe. It is not clear if fungus plays a role in all cases of chronic rhinosinusitis but there is evidence that it may have a role in a subset of patients. Antifungal treatments work to kill fungal spores or to stop them growing. Antifungal treatments for chronic rhinosinusitis are used either topically (put into the nose) or taken systemically (by mouth)."
}
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query-laysum | 2793 | [
{
"role": "user",
"content": "Abstract: Background\nDelivery arrangements include changes in who receives care and when, who provides care, the working conditions of those who provide care, coordination of care amongst different providers, where care is provided, the use of information and communication technology to deliver care, and quality and safety systems. How services are delivered can have impacts on the effectiveness, efficiency and equity of health systems. This broad overview of the findings of systematic reviews can help policymakers and other stakeholders identify strategies for addressing problems and improve the delivery of services.\nObjectives\nTo provide an overview of the available evidence from up-to-date systematic reviews about the effects of delivery arrangements for health systems in low-income countries. Secondary objectives include identifying needs and priorities for future evaluations and systematic reviews on delivery arrangements and informing refinements of the framework for delivery arrangements outlined in the review.\nMethods\nWe searched Health Systems Evidence in November 2010 and PDQ-Evidence up to 17 December 2016 for systematic reviews. We did not apply any date, language or publication status limitations in the searches. We included well-conducted systematic reviews of studies that assessed the effects of delivery arrangements on patient outcomes (health and health behaviours), the quality or utilisation of healthcare services, resource use, healthcare provider outcomes (such as sick leave), or social outcomes (such as poverty or employment) and that were published after April 2005. We excluded reviews with limitations important enough to compromise the reliability of the findings. Two overview authors independently screened reviews, extracted data, and assessed the certainty of evidence using GRADE. We prepared SUPPORT Summaries for eligible reviews, including key messages, 'Summary of findings' tables (using GRADE to assess the certainty of the evidence), and assessments of the relevance of findings to low-income countries.\nMain results\nWe identified 7272 systematic reviews and included 51 of them in this overview. We judged 6 of the 51 reviews to have important methodological limitations and the other 45 to have only minor limitations. We grouped delivery arrangements into eight categories. Some reviews provided more than one comparison and were in more than one category. Across these categories, the following intervention were effective; that is, they have desirable effects on at least one outcome with moderate- or high-certainty evidence and no moderate- or high-certainty evidence of undesirable effects.\nWho receives care and when: queuing strategies and antenatal care to groups of mothers.\nWho provides care: lay health workers for caring for people with hypertension, lay health workers to deliver care for mothers and children or infectious diseases, lay health workers to deliver community-based neonatal care packages, midlevel health professionals for abortion care, social support to pregnant women at risk, midwife-led care for childbearing women, non-specialist providers in mental health and neurology, and physician-nurse substitution.\nCoordination of care: hospital clinical pathways, case management for people living with HIV and AIDS, interactive communication between primary care doctors and specialists, hospital discharge planning, adding a service to an existing service and integrating delivery models, referral from primary to secondary care, physician-led versus nurse-led triage in emergency departments, and team midwifery.\nWhere care is provided: high-volume institutions, home-based care (with or without multidisciplinary team) for people living with HIV and AIDS, home-based management of malaria, home care for children with acute physical conditions, community-based interventions for childhood diarrhoea and pneumonia, out-of-facility HIV and reproductive health services for youth, and decentralised HIV care.\nInformation and communication technology: mobile phone messaging for patients with long-term illnesses, mobile phone messaging reminders for attendance at healthcare appointments, mobile phone messaging to promote adherence to antiretroviral therapy, women carrying their own case notes in pregnancy, interventions to improve childhood vaccination.\nQuality and safety systems: decision support with clinical information systems for people living with HIV/AIDS.\nComplex interventions (cutting across delivery categories and other health system arrangements): emergency obstetric referral interventions.\nAuthors' conclusions\nA wide range of strategies have been evaluated for improving delivery arrangements in low-income countries, using sound systematic review methods in both Cochrane and non-Cochrane reviews. These reviews have assessed a range of outcomes. Most of the available evidence focuses on who provides care, where care is provided and coordination of care. For all the main categories of delivery arrangements, we identified gaps in primary research related to uncertainty about the applicability of the evidence to low-income countries, low- or very low-certainty evidence or a lack of studies.\n\nGiven the provided abstract, please respond to the following query: \"Where care is provided – site of service delivery\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- Clinics or hospitals that manage a high volume of people living with HIV and AIDS rather than smaller volumes\n- Intensive home-based care for people living with HIV and AIDS\n- Home-based management of malaria in children\n- Providing care closer to home for children with long-term health conditions\n- Community-based interventions using lay health workers for childhood diarrhoea and pneumonia\n- Youth HIV and reproductive health services provided outside of health facilities\n- Decentralising care for initiation and maintenance of HIV and AIDS medicine treatment to peripheral health centres or lower levels of healthcare"
}
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query-laysum | 2794 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with venous thromboembolism (VTE) generally are treated for five days with intravenous unfractionated heparin or subcutaneous low-molecular-weight heparin (LMWH), followed by three months of vitamin K antagonists (VKAs). Treatment with VKAs requires regular laboratory measurements and carries risk of bleeding; some patients have contraindications to such treatment. Treatment with LMWH has been proposed to minimise the risk of bleeding complications. This is the second update of a review first published in 2001.\nObjectives\nThe purpose of this review was to evaluate the efficacy and safety of long term treatment (three months) with LMWH versus long term treatment (three months) with VKAs for symptomatic VTE.\nSearch methods\nFor this update, the Cochrane Vascular Information Specialist searched the Specialised Register (last searched November 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 10), The Cochrane Vascular Information Specialistalso searched clinical trials registries for ongoing studies.\nSelection criteria\nRandomised controlled trials comparing LMWH versus VKA for long treatment (three months) of symptomatic VTE. Two review authors independently evaluated trials for inclusion and methodological quality.\nData collection and analysis\nReview authors independently extracted data and assessed risk of bias. We resolved disagreements by discussion and performed meta-analysis using fixed-effect models with Peto odds ratios (Peto ORs) and 95% confidence intervals (CIs). Outcomes of interest were recurrent VTE, major bleeding, and mortality. We used GRADE to assess the overall quality of evidence supporting these outcomes.\nMain results\nSixteen trials, with a combined total of 3299 participants fulfilled our inclusion criteria. According to GRADE, the quality of evidence was moderate for recurrent VTE, low for major bleeding, and moderate for mortality. We downgraded the quality of the evidence for imprecision (recurrent VTE, mortality) and for risk of bias and inconsistency (major bleeding).\nWe found no clear differences in recurrent VTE between LMWH and VKA (Peto OR 0.83, 95% confidence interval (CI) 0.60 to 1.15; P = 0.27; 3299 participants; 16 studies; moderate-quality evidence). We found less bleeding with LMWH than with VKA (Peto OR 0.51, 95% CI 0.32 to 0.80; P = 0.004; 3299 participants; 16 studies; low-quality evidence). However, when comparing only high-quality studies for bleeding, we observed no clear differences between LMWH and VKA (Peto OR 0.62, 95% CI 0.36 to 1.07; P = 0.08; 1872 participants; seven studies). We found no clear differences between LMWH and VKA in terms of mortality (Peto OR 1.08, 95% CI 0.75 to 1.56; P = 0.68; 3299 participants; 16 studies; moderate-quality evidence).\nAuthors' conclusions\nModerate-quality evidence shows no clear differences between LMWH and VKA in preventing symptomatic VTE and death after an episode of symptomatic DVT. Low-quality evidence suggests fewer cases of major bleeding with LMWH than with VKA. However, comparison of only high-quality studies for bleeding shows no clear differences between LMWH and VKA. LMWH may represent an alternative for some patients, for example, those residing in geographically inaccessible areas, those who are unable or reluctant to visit the thrombosis service regularly, and those with contraindications to VKA.\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 evidence for the outcomes recurrent blood clots and death was moderate. The quality of this evidence was downgraded because of the small number of events reported, leading to imprecision. For the outcome bleeding, the quality of evidence was low because of inconsistency between studies and risk of bias. Continued research into long term treatment of blood clots in the veins with LMWH and VKA is needed."
}
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query-laysum | 2795 | [
{
"role": "user",
"content": "Abstract: Background\nInfantile hypertrophic pyloric stenosis (IHPS) is a disorder of young children (aged one year or less) and can be treated by laparoscopic (LP) or open (OP) longitudinal myotomy of the pylorus. Since the first description in 1990, LP is being performed more often worldwide.\nObjectives\nTo compare the efficacy and safety of open versus laparoscopic pyloromyotomy for IHPS.\nSearch methods\nWe conducted a literature search on 04 February 2021 to identify all randomised controlled trials (RCTs), without any language restrictions. We searched the following electronic databases: MEDLINE (1990 to February 2021), Embase (1990 to February 2021), and the Cochrane Central Register of Controlled Trials (CENTRAL). We also searched the Internet using the Google Search engine (www.google.com) and Google Scholar (scholar.google.com) to identify grey literature not indexed in databases.\nSelection criteria\nWe included RCTs and quasi-randomised trials comparing LP with OP for hypertrophic pyloric stenosis.\nData collection and analysis\nTwo review authors independently screened references and extracted data from trial reports. Where outcomes or study details were not reported, we requested missing data from the corresponding authors of the primary RCTs. We used a random-effects model to calculate risk ratios (RRs) for binary outcomes, and mean differences (MDs) for continuous outcomes. Two review authors independently assessed risks of bias. We used GRADE to assess the certainty of the evidence for all outcomes.\nMain results\nThe electronic database search resulted in a total of 434 records. After de-duplication, we screened 410 independent publications, and ultimately included seven RCTs (reported in 8 reports) in quantitative analysis. The seven included RCTs enrolled 720 participants (357 with open pyloromyotomy and 363 with laparoscopic pyloromyotomy). One study was a multi-country trial, three were carried out in the USA, and one study each was carried out in France, Japan, and Bangladesh.\nThe evidence suggests that LP may result in a small increase in mucosal perforation compared with OP (RR 1.60, 95% CI 0.49 to 5.26; 7 studies, 720 participants; low-certainty evidence). LP may result in up to 5 extra instances of mucosal perforation per 1,000 participants; however, the confidence interval ranges from 4 fewer to 44 more per 1,000 participants.\nFour RCTs with 502 participants reported on incomplete pyloromyotomy. They indicate that LP may increase the risk of incomplete pyloromyotomy compared with OP, but the confidence interval crosses the line of no effect (RR 7.37, 95% CI 0.92 to 59.11; 4 studies, 502 participants; low-certainty evidence). In the LP groups, 6 cases of incomplete pyloromyotomy were reported in 247 participants while no cases of incomplete pyloromyotomy were reported in the OP groups (from 255 participants).\nAll included studies (720 participants) reported on postoperative wound infections or abscess formations. The evidence is very uncertain about the effect of LP on postoperative wound infection or abscess formation compared with OP (RR 0.59, 95% CI 0.24 to 1.45; 7 studies, 720 participants; very low-certainty evidence). The evidence is also very uncertain about the effect of LP on postoperative incisional hernia compared with OP (RR 1.01, 95% CI 0.11 to 9.53; 4 studies, 382 participants; very low-certainty evidence).\nLength of hospital stay was assessed by five RCTs, including 562 participants. The evidence is very uncertain about the effect of LP compared to OP (mean difference −3.01 hours, 95% CI −8.39 to 2.37 hours; very low-certainty evidence). Time to full feeds was assessed by six studies, including 622 participants. The evidence is very uncertain about the effect of LP on time to full feeds compared with OP (mean difference −5.86 hours, 95% CI −15.95 to 4.24 hours; very low-certainty evidence). The evidence is also very uncertain about the effect of LP on operating time compared with OP (mean difference 0.53 minutes, 95% CI −3.53 to 4.59 minutes; 6 studies, 622 participants; very low-certainty evidence).\nAuthors' conclusions\nLaparoscopic pyloromyotomy may result in a small increase in mucosal perforation when compared with open pyloromyotomy for IHPS. There may be an increased risk of incomplete pyloromyotomy following LP compared with OP, but the effect estimate is imprecise and includes the possibility of no difference. We do not know about the effect of LP compared with OP on the need for re-operation, postoperative wound infections or abscess formation, postoperative haematoma or seroma formation, incisional hernia occurrence, length of postoperative stay, time to full feeds, or operating time because the certainty of the evidence was very low for these outcomes. We downgraded the certainty of the evidence for most outcomes due to limitations in the study design (most outcomes were susceptible to detection bias) and imprecision. There is limited evidence available comparing LP with OP for IHPS. The included studies did not provide sufficient information to determine the effect of training, experience, or surgeon preferences on the outcomes assessed.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence is current to February 2021."
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query-laysum | 2796 | [
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"role": "user",
"content": "Abstract: Background\nAsthma is the most common chronic medical condition among children and is one of the most common causes of hospitalisation and medical visits. Poorly controlled asthma often leads to preventable exacerbations that require additional medications, hospital stays, or treatment in the emergency department.\nLong-acting beta2-agonists (LABA) are the preferred add-on treatment for children with asthma whose symptoms are not well controlled on inhaled corticosteroids (ICS). The US Food and Drug Administration has issued a 'black box' warning for LABA in asthma, and now recommends that they be used \"for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved\".\nObjectives\nTo compare the effect on asthma control and adverse effects of stepping down to inhaled corticosteroids (ICS)-only therapy versus continuing ICS plus LABA in children whose asthma is well controlled on combined ICS and LABA therapy.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register, and also searched www.ClinicalTrials.gov, www.who.int/ictrp/en/, reference lists of primary studies and existing reviews, and manufacturers' trial registries (GlaxoSmithKline and AstraZeneca). We searched all databases from their inception to the present, and imposed no restriction on language of publication. The most recent search was done in April 2015.\nSelection criteria\nWe looked for parallel randomised controlled trials of at least eight weeks' duration, available as published full text, abstract only, or unpublished data. We excluded studies including participants with other chronic respiratory comorbidities (for example bronchiectasis).\nWe looked for studies in which children (18 years or younger) whose asthma was well controlled on any dose of ICS and LABA combination therapy were randomised to: a) step-down therapy to ICS alone or b) continued use of ICS and LABA.\nWe included any dose of LABA (formoterol, salmeterol, vilanterol) and any dose of ICS (beclomethasone, budesonide, ciclesonide, mometasone, flunisolide, fluticasone propionate, fluticasone furoate, triamcinolone) delivered in a combination inhaler or in separate inhalers.\nData collection and analysis\nTwo review authors independently screened all records identified in the searches. We used a data extraction tool in Microsoft Excel to manage searches and document reasons for inclusion and exclusion, and to extract descriptive and numerical data from trials meeting the inclusion criteria.\nThe prespecified primary outcomes were exacerbations requiring oral steroids, asthma control, and all-cause serious adverse events.\nMain results\nDespite conducting extensive searches of electronic databases, trial registries and manufacturers' websites we identified no trials matching the inclusion criteria.\nAfter removing duplicates, we screened 1031 abstracts, and assessed 43 full-text articles for inclusion. We identified several adult studies, which will be summarised in a separate review (Ahmad 2014). The most common reasons for exclusion after viewing full texts were 'wrong comparison' (n = 22) and 'adult population' (n = 18).\nSome adult studies recruited adolescents from age 15, but none reported data separately for those under 18.\nAuthors' conclusions\nThere is currently no evidence from randomised trials to inform the discontinuation of LABAs in children once asthma control is achieved with ICS plus LABA. It is disappointing that such an important issue has not been studied, and a randomised double-blind trial recruiting children who are controlled on ICS plus LABA is warranted. The study should be large enough to assess children of different ages, and to measure the important safety and efficacy outcomes suggested in this review over at least six months.\nThe only randomised evidence for stopping LABA has been conducted in adults; it will be summarised in a separate review.\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": "Asthma is the most common long-term medical condition in children. Poorly controlled asthma often leads to flare-ups that require extra treatment, hospital stays, or treatment in the emergency department.\nLong-acting beta2-agonists (LABA) are an inhaled treatment that can be added to inhaled corticosteroids (ICS) for children with asthma whose symptoms are not well controlled on ICS alone. The US Food and Drug Administration issued a warning for the use of LABA in asthma after serious safety concerns emerged, and now recommends that they be used for the shortest time possible, and stopped when the child's asthma improves."
}
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query-laysum | 2797 | [
{
"role": "user",
"content": "Abstract: Background\nAcute necrotising pancreatitis carries significant mortality, morbidity, and resource use. There is considerable uncertainty as to how people with necrotising pancreatitis should be treated.\nObjectives\nTo assess the benefits and harms of different interventions in people with acute necrotising pancreatitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, 2015, Issue 4), MEDLINE, EMBASE, Science Citation Index Expanded, and trials registers to April 2015 to identify randomised controlled trials (RCT). We also searched the references of included trials to identify further trials.\nSelection criteria\nWe considered only RCTs performed in people with necrotising pancreatitis, irrespective of aetiology, presence of infection, language, blinding, or publication status for inclusion in the review.\nData collection and analysis\nTwo review authors independently identified trials and extracted data. We calculated the odds ratio (OR) and mean difference with 95% confidence intervals (CI) using Review Manager 5 based on an available-case analysis using fixed-effect and random-effects models. We planned a network meta-analysis using Bayesian methods, but due to sparse data and uncertainty about the transitivity assumption, performed only indirect comparisons and used Frequentist methods.\nMain results\nWe included eight RCTs with 311 participants in this review. After exclusion of five participants, we included 306 participants in one or more outcomes. Five trials (240 participants) investigated the three main treatments: open necrosectomy (121 participants), minimally invasive step-up approach (80 participants), and peritoneal lavage (39 participants) and were included in the network meta-analysis. Three trials (66 participants) investigated the variations in the main treatments: early open necrosectomy (25 participants), delayed open necrosectomy (11 participants), video-assisted minimally invasive step-up approach (12 participants), endoscopic minimally invasive step-up approach (10 participants), minimally invasive step-up approach (planned surgery) (four participants), and minimally invasive step-up approach (continued percutaneous drainage) (four participants). The trials included infected or sterile necrotising pancreatitis of varied aetiology.\nAll the trials were at unclear or high risk of bias and the overall quality of evidence was low or very low for all the outcomes. Overall, short-term mortality was 30% and serious adverse events rate was 139 serious adverse events per 100 participants. The differences in short-term mortality and proportion of people with serious adverse events were imprecise in all the comparisons. The number of serious adverse events and adverse events were fewer in the minimally invasive step-up approach compared to open necrosectomy (serious adverse events: rate ratio 0.41, 95% CI 0.25 to 0.68; 88 participants; 1 study; adverse events: rate ratio 0.41, 95% CI 0.25 to 0.68; 88 participants; 1 study). The proportion of people with organ failure and the mean costs were lower in the minimally invasive step-up approach compared to open necrosectomy (organ failure: OR 0.20, 95% CI 0.07 to 0.60; 88 participants; 1 study; mean difference in costs: USD -11,922; P value < 0.05; 88 participants; 1 studies). There were more adverse events with video-assisted minimally invasive step-up approach group compared to endoscopic-assisted minimally invasive step-up approach group (rate ratio 11.70, 95% CI 1.52 to 89.87; 22 participants; 1 study), but the number of interventions per participant was less with video-assisted minimally invasive step-up approach group compared to endoscopic minimally invasive step-up approach group (difference in medians: 2 procedures; P value < 0.05; 20 participants; 1 study). The differences in any of the other comparisons for number of serious adverse events, proportion of people with organ failure, number of adverse events, length of hospital stay, and intensive therapy unit stay were either imprecise or were not consistent. None of the trials reported long-term mortality, infected pancreatic necrosis (trials that included participants with sterile necrosis), health-related quality of life at any time frame, proportion of people with adverse events, requirement for additional invasive intervention, time to return to normal activity, and time to return to work.\nAuthors' conclusions\nLow to very low quality evidence suggested that the minimally invasive step-up approach resulted in fewer adverse events, serious adverse events, less organ failure, and lower costs compared to open necrosectomy. Very low quality evidence suggested that the endoscopic minimally invasive step-up approach resulted in fewer adverse events than the video-assisted minimally invasive step-up approach but increased the number of procedures required for treatment. There is currently no evidence to suggest that early open necrosectomy is superior or inferior to peritoneal lavage or delayed open necrosectomy. However, the CIs were wide and significant benefits or harms of different treatments cannot be ruled out. The TENSION trial currently underway in Netherlands is assessing the optimal way to perform the minimally invasive step-up approach (endoscopic drainage followed by endoscopic necrosectomy if necessary versus percutaneous drainage followed by video-assisted necrosectomy if necessary) and is assessing important clinical outcomes of interest for this review. Implications for further research on this topic will be determined after the results of this RCT are available.\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 evidence was low or very low for all the measurement because the trials were at high risk of bias (e.g. prejudice of people who conducted the trial and trial participants who prefer one treatment over another) and were small trials. As a result, further studies are required on this topic."
}
]
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query-laysum | 2798 | [
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers, also known as bedsores, decubitus ulcers and pressure injuries, are localised areas of injury to the skin or the underlying tissue, or both. Dressings are widely used to treat pressure ulcers and promote healing, and there are many options to choose from including alginate, hydrocolloid and protease-modulating dressings. Topical agents have also been used as alternatives to dressings in order to promote healing.\nA clear and current overview of all the evidence is required to facilitate decision-making regarding the use of dressings or topical agents for the treatment of pressure ulcers. Such a review would ideally help people with pressure ulcers and health professionals assess the best treatment options. This review is a network meta-analysis (NMA) which assesses the probability of complete ulcer healing associated with alternative dressings and topical agents.\nObjectives\nTo assess the effects of dressings and topical agents for healing pressure ulcers in any care setting. We aimed to examine this evidence base as a whole, determining probabilities that each treatment is the best, with full assessment of uncertainty and evidence quality.\nSearch methods\nIn July 2016 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses, guidelines and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nPublished or unpublished randomised controlled trials (RCTs) comparing the effects of at least one of the following interventions with any other intervention in the treatment of pressure ulcers (Stage 2 or above): any dressing, or any topical agent applied directly to an open pressure ulcer and left in situ. We excluded from this review dressings attached to external devices such as negative pressure wound therapies, skin grafts, growth factor treatments, platelet gels and larval therapy.\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias assessment and data extraction. We conducted network meta-analysis using frequentist mega-regression methods for the efficacy outcome, probability of complete healing. We modelled the relative effectiveness of any two treatments as a function of each treatment relative to the reference treatment (saline gauze). We assumed that treatment effects were similar within dressings classes (e.g. hydrocolloid, foam). We present estimates of effect with their 95% confidence intervals for individual treatments compared with every other, and we report ranking probabilities for each intervention (probability of being the best, second best, etc treatment). We assessed the certainty (quality) of the body of evidence using GRADE for each network comparison and for the network as whole.\nMain results\nWe included 51 studies (2947 participants) in this review and carried out NMA in a network of linked interventions for the sole outcome of probability of complete healing. The network included 21 different interventions (13 dressings, 6 topical agents and 2 supplementary linking interventions) and was informed by 39 studies in 2127 participants, of whom 783 had completely healed wounds.\nWe judged the network to be sparse: overall, there were relatively few participants, with few events, both for the number of interventions and the number of mixed treatment contrasts; most studies were small or very small. The consequence of this sparseness is high imprecision in the evidence, and this, coupled with the (mainly) high risk of bias in the studies informing the network, means that we judged the vast majority of the evidence to be of low or very low certainty. We have no confidence in the findings regarding the rank order of interventions in this review (very low-certainty evidence), but we report here a summary of results for some comparisons of interventions compared with saline gauze. We present here only the findings from evidence which we did not consider to be very low certainty, but these reported results should still be interpreted in the context of the very low certainty of the network as a whole.\nIt is not clear whether regimens involving protease-modulating dressings increase the probability of pressure ulcer healing compared with saline gauze (risk ratio (RR) 1.65, 95% confidence interval (CI) 0.92 to 2.94) (moderate-certainty evidence: low risk of bias, downgraded for imprecision). This risk ratio of 1.65 corresponds to an absolute difference of 102 more people healed with protease modulating dressings per 1000 people treated than with saline gauze alone (95% CI 13 fewer to 302 more). It is unclear whether the following interventions increase the probability of healing compared with saline gauze (low-certainty evidence): collagenase ointment (RR 2.12, 95% CI 1.06 to 4.22); foam dressings (RR 1.52, 95% CI 1.03 to 2.26); basic wound contact dressings (RR 1.30, 95% CI 0.65 to 2.58) and polyvinylpyrrolidone plus zinc oxide (RR 1.31, 95% CI 0.37 to 4.62); the latter two interventions both had confidence intervals consistent with both a clinically important benefit and a clinically important harm, and the former two interventions each had high risk of bias as well as imprecision.\nAuthors' conclusions\nA network meta-analysis (NMA) of data from 39 studies (evaluating 21 dressings and topical agents for pressure ulcers) is sparse and the evidence is of low or very low certainty (due mainly to risk of bias and imprecision). Consequently we are unable to determine which dressings or topical agents are the most likely to heal pressure ulcers, and it is generally unclear whether the treatments examined are more effective than saline gauze.\nMore research is needed to determine whether particular dressings or topical agents improve the probability of healing of pressure ulcers. The NMA is uninformative regarding which interventions might best be included in a large trial, and it may be that research is directed towards prevention, leaving clinicians to decide which treatment to use on the basis of wound symptoms, clinical experience, patient preference and cost.\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": "Pressure ulcers, also known as bedsores, decubitus ulcers and pressure injuries, are wounds involving the skin and sometimes the tissue that lies underneath. Pressure ulcers can be painful, may become infected and affect people's quality of life. People at risk of developing pressure ulcers include those with limited mobility - such as older people and people with short-term or long-term medical conditions - and people with spinal cord injuries. In 2004 the total yearly cost of treating pressure ulcers in the UK was estimated as being GBP 1.4 to 2.1 billion, which was equivalent to 4% of the total National Health Service expenditure.\nTopical agents such as ointments, creams or gels are applied to unhealed pressure ulcers and left in place to treat the wound; they may be covered with a dressing. Some of these treatments have been compared with each other in trials, usually comparing two treatments at a time. We used a method called 'network meta-analysis' to bring together all the trial results of different treatments in a reliable way. We hoped that this method, which compares all treatment options, would help us find out which was the best treatment for healing pressure ulcers."
}
]
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query-laysum | 2799 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with cancer with febrile neutropenia are at risk of severe infections and mortality and are thus treated empirically with broad-spectrum antibiotic therapy. However, the recommended duration of antibiotic therapy differs across guidelines.\nObjectives\nTo assess the safety of protocol-guided discontinuation of antibiotics regardless of neutrophil count, compared to continuation of antibiotics until neutropenia resolution in people with cancer with fever and neutropenia, in terms of mortality and morbidity. To assess the emergence of resistant bacteria in people with cancer treated with short courses of antibiotic therapy compared with people with cancer treated until resolution of neutropenia.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 10) in the Cochrane Library, MEDLINE, Embase, and LILACS up to 1 October 2018. We searched the metaRegister of Controlled Trials and the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov for ongoing and unpublished trials. We reviewed the references of all identified studies for additional trials and handsearched conference proceedings of international infectious diseases and oncology and haematology conferences.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared a short antibiotic therapy course in which discontinuation of antibiotics was guided by protocols regardless of the neutrophil count to a long course in which antibiotics were continued until neutropenia resolution in people with cancer with febrile neutropenia. The primary outcome was 30-day or end of follow-up all-cause mortality.\nData collection and analysis\nTwo review authors independently reviewed all studies for eligibility, extracted data, and assessed risk of bias for all included trials. We calculated risk ratios (RRs) with 95% confidence intervals (CIs) whenever possible. For dichotomous outcomes with zero events in both arms of the trials, we conducted meta-analysis of risk differences (RDs) as well. For continuous outcomes, we extracted means with standard deviations (SD) from the studies and computed mean difference (MD) and 95% CI. If no substantial clinical heterogeneity was found, trials were pooled using the Mantel–Haenszel fixed-effect model.\nMain results\nWe included eight RCTs comprising a total of 662 distinct febrile neutropenia episodes. The studies included adults and children, and had variable design and criteria for discontinuation of antibiotics in both study arms. All included studies but two were performed before the year 2000. All studies included people with cancer with fever of unknown origin and excluded people with microbiological documented infections.\nWe found no significant difference between the short-antibiotic therapy arm and the long-antibiotic therapy arm for all-cause mortality (RR 1.38, 95% CI 0.73 to 2.62; RD 0.02, 95% CI -0.02 to 0.05; low-certainty evidence). We downgraded the certainty of the evidence to low due to imprecision and high risk of selection bias. The number of fever days was significantly lower for people in the short-antibiotic treatment arm compared to the long-antibiotic treatment arm (mean difference -0.64, 95% CI -0.96 to -0.32; I² = 30%). In all studies, total antibiotic days were fewer in the intervention arm by three to seven days compared to the long antibiotic therapy. We found no significant differences in the rates of clinical failure (RR 1.23, 95% CI 0.85 to 1.77; very low-certainty evidence). We downgraded the certainty of the evidence for clinical failure due to variable and inconsistent definitions of clinical failure across studies, possible selection bias, and wide confidence intervals. There was no significant difference in the incidence of bacteraemia occurring after randomisation (RR 1.56, 95% CI 0.91 to 2.66; very low-certainty evidence), while the incidence of any documented infections was significantly higher in the short-antibiotic therapy arm (RR 1.67, 95% CI 1.08 to 2.57). There was no significant difference in the incidence of invasive fungal infections (RR 0.86, 95% CI 0.32 to 2.31) and development of antibiotic resistance (RR 1.49, 95% CI 0.62 to 3.61). The data on hospital stay were too sparse to permit any meaningful conclusions.\nAuthors' conclusions\nWe could make no strong conclusions on the safety of antibiotic discontinuation before neutropenia resolution among people with cancer with febrile neutropenia based on the existing evidence and its low certainty. Results of microbiological outcomes favouring long antibiotic therapy may be misleading due to lower culture positivity rates under antibiotic therapy and not true differences in infection rates. Well-designed, adequately powered RCTs are required that address this issue in the era of rising antibiotic resistance.\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": "Neutrophils are a type of white blood cell crucial to the defence of the immune system against many infective pathogens including bacteria. People with cancer receiving chemotherapy suffer from decreased production of neutrophils, which means that they are exposed to severe, life-threatening infections. When a cancer patient with neutropenia develops fever, it is crucial to start broad-range antibacterial treatment as soon as possible in order to lower the risk of death and serious complications. To date, the best duration of course of antibiotics to give is unclear. The continuation of antibiotics beyond the required duration might result in the development of side effects and resistant bacteria."
}
]
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query-laysum | 2800 | [
{
"role": "user",
"content": "Abstract: Background\nThere are two different international standards for the treatment of early unfavourable and advanced stage Hodgkin lymphoma (HL): chemotherapy with escalated BEACOPP (bleomycin/etoposide/doxorubicin/cyclophosphamide/vincristine/procarbazine/prednisone) regimen and chemotherapy with ABVD (doxorubicin/bleomycin/vinblastine/dacarbazine) regimen.\nObjectives\nTo determine the advantages and disadvantages of chemotherapy including escalated BEACOPP compared to chemotherapy including ABVD in the treatment of early unfavourable or advanced stage HL as first-line treatment.\nSearch methods\nWe searched for randomised controlled trials in MEDLINE, CENTRAL and conference proceedings (January 1985 to July 2013 and for the update to March 2017) and Embase (1985 to November 2008). Moreover we searched trial registries (March 2017; www.controlled-trials.com, www.clinicaltrialsregister.eu/ctr-search/search, clinicaltrials.gov, www.eortc.be, www.ghsg.org, www.ctc.usyd.edu.au, www.trialscentral.org/index.html)\nSelection criteria\nWe included randomised controlled trials examining chemotherapy including at least two cycles of escalated BEACOPP regimens compared with chemotherapy including at least four cycles of ABVD regimens as first-line treatment for patients with early unfavourable stage or advanced stage HL.\nData collection and analysis\nThe effect measures we used were hazard ratios (HRs) for overall survival (OS), progression-free survival (PFS) and freedom from first progression.\nWe used risk ratios (RRs) relative risks to analyse harms: treatment-related mortality, secondary malignancies (including myeloid dysplastic syndrome (MDS) or acute myeloid leukaemia (AML)), infertility and adverse events.\nQuality of life was not reported in any trial, therefore not analysed. Two review authors independently extracted data and assessed quality of trials.\nMain results\nWe screened 1796 records and identified five eligible trials in total i.e. one trial could be added on the previous review. These trials included only adults (16 to 65 years of age). We included all five trials with 3427 people in the meta-analyses: the HD9 and HD14 trials were co-ordinated in Germany, the HD2000 and GSM-HD trials were performed in Italy and the EORTC 20012 was conducted in Belgium. The overall risk of performance and detection bias was low for overall survival (OS), but was high for other outcomes, as therapy blinding was not feasible. The remaining 'Risk of bias' domains were low and unclear.\nAll trials reported results for OS and progression-free survival (PFS). In contrast to the our first published review (2011) the addition of results from the EORTC 20012 BEACOPP escalated increases OS (3142 participants; HR 0.74 (95% confidence interval (CI) 0.57 to 0.97; high-quality evidence). This means that only 90 (70 to 117) patients will die after five years in the BEACOPP escalated arm compared to 120 in the ABVD arm. This survival advantage is also reflected in an increased PFS with BEACOPP escalated (3142 participants; HR 0.54 (95% CI 0.45 to 0.64); moderate-quality evidence), meaning that after five years only 144 (121 to 168) patients will experience a progress, relapse or death in the BEACOPP escalated arm compared to 250 in the ABVD arm.\nThere is no evidence for a difference for treatment-related mortality (2700 participants, RR 2.15 (95% CI = 0.93 to 4.95), low-quality evidence).\nAlthough the occurrence of MDS or AML may increase with BEACOPP escalated (3332 participants, RR 3.90 (95% CI 1.36 to 11.21); low-quality evidence)), there is no evidence for a difference between both regimens for overall secondary malignancies (3332 participants, RR 1.00 (95% CI 0.68 to 1.48), low-quality evidence). However, the observation time of the studies included in the review is too short to be expected to demonstrate differences with respect to second solid tumours which would not be expected to show significance until around 15 years after treatment.\nWe are very uncertain how many female patients will be infertile due to chemotherapy and which arm might be favoured (106 participants, RR 1.37 (95% CI 0.83 to 2.26), very low-quality evidence). This is a very small sample, and the age of the patients was not detailed. No analysis of male fertility was provided.\nFive trials reported adverse events and the analysis shows that the escalated BEACOPP regimens probably causes more haematological toxicities WHO grade III or IV ((anaemia: 2425 participants, RR 10.67 (95% CI 7.14 to 15.93); neutropenia: 519 participants, RR 1.80 (95% CI 1.52 to 2.13); thrombocytopenia: 2425 participants, RR 18.12 (95% CI 11.77 to 27.92); infections: 2425 participants, RR 3.73 (95% CI 2.58 to 5.38), all low-quality evidence).\nOnly one trial (EORTC 20012) planned to assess quality of life, however, no results were reported.\nAuthors' conclusions\nThis meta-analysis provides moderate- to high-quality evidence that adult patients between 16 and 60 years of age with early unfavourable and advanced stage HL benefit regarding OS and PFS from first-line chemotherapy including escalated BEACOPP. The proven benefit in OS for patients with advanced HL is a new finding of this updated review due to the inclusion of the results from the EORTC 20012 trial. Furthermore, there is only low-quality evidence of a difference in the total number of secondary malignancies, as the follow-up period might be too short to detect meaningful differences. Low-quality evidence also suggests that people treated with escalated BEACOPP may have a higher risk to develop secondary AML or MDS. Due to the availability of only very low-quality evidence available, we are unable to come to a conclusion in terms of infertility. This review does for the first time suggest a survival benefit. However, it is clear from this review that BEACOPP escalated may be more toxic that ABVD, and very important long-term side effects of second malignancies and infertility have not been sufficiently analysed yet.\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 eligible trials by the date of this updated review (search date March 2017). These trials included 3427 patients adult patients (16 to 65 years of age)."
}
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query-laysum | 2801 | [
{
"role": "user",
"content": "Abstract: Background\nMany people with schizophrenia do not respond to an initially prescribed antipsychotic drug. In such cases, one treatment strategy could be to increase the antipsychotic dose; and another strategy could be to switch to a different antipsychotic drug.\nObjectives\nTo examine the efficacy of increasing the antipsychotic dose versus switching the antipsychotic drug in the treatment of non-responsive people with schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register (10 June 2014, 6 October 2015, and 30 March 2017). We examined references of all included studies for further trials.\nSelection criteria\nAll relevant randomised controlled trials (RCTs) comparing increasing the antipsychotic dose versus switching to a different antipsychotic drug for people with schizophrenia who have not responded to their initial antipsychotic treatment.\nData collection and analysis\nAt least two review authors independently extracted data. We analysed dichotomous data using relative risks (RR) and their 95% confidence intervals (CIs). We analysed continuous data using mean differences (MD) and their 95% CIs. We assessed risk of bias for included studies and used GRADE to create a 'Summary of findings' table.\nMain results\nWe include one RCT with relevant data on 29 participants in this review. The trial had a parallel design and was double-blind, but blinding procedures were not described. The trial included people who were non-responsive to fluphenazine 20 mg/day administered for 4 weeks. Participants were randomly assigned to continuing treatment with fluphenazine 20 mg/day, increasing the dose to fluphenazine 80 mg/day or switching to haloperidol 20 mg/day for four additional weeks. Data were reported only for 47 out of 58 initially randomised participants. The trial was published in 1993. The fact that only one RCT with a small sample size (N = 29) was included in the analysis limits the quality of the evidence. Overall, no clear difference was found between groups in terms of the three available outcomes: global state (number of participants with clinically relevant response (RR 1.63, 95% CI 0.17 to 15.99, very low quality evidence); general mental state (endpoint score, BPRS total) (MD 2.00, 95% CI −4.20 to 8.20, very low quality evidence); and negative symptoms (endpoint score, SANS) (MD 3.40, 95% CI −12.56 to 19.36). No data were reported for leaving the study early, adverse effects, time in hospital, quality of life, satisfaction with care and functioning.\nAuthors' conclusions\nThere is extremely limited evidence and no clear conclusions can be drawn. There is an urgent need for further trials in order to determine the optimal treatment strategy for people with schizophrenia who do not respond to their initial antipsychotic treatment.\n\nGiven the provided abstract, please respond to the following query: \"Evidence found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Only one trial met the review requirements and provided usable data. Data were reported for the number of participants who responded to treatment, the general mental state of participants at endpoint of the trial and the presence of negative symptoms at endpoint. There were no data available for any other outcome. No clear difference between increasing the dose of the antipsychotic drug and switching to a different antipsychotic was shown. The available evidence was extremely limited and of very low quality."
}
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query-laysum | 2802 | [
{
"role": "user",
"content": "Abstract: Background\nThe optimal treatment for end-stage kidney disease is kidney transplantation. During the operation, a catheter is introduced into the bladder and remains in place postoperatively to allow the bladder to drain. This decreases tension from the cysto-ureteric anastomosis and promotes healing. Unfortunately, urinary catheters can pose an infection risk to patients as they allow bacteria into the bladder, potentially resulting in a urinary tract infection (UTI). The longer the catheter remains in place, the greater the risk of developing a UTI. There is no consensus approach to the time a catheter should remain in place post-transplant. Furthermore, the different timings of catheter removal are thought to be associated with different incidences of UTI and postoperative complications, such as anastomotic breakdown.\nObjectives\nThis review aimed to compare patients who had their catheter removed < 5 days post-transplant surgery to those patients who had their catheter removed ≥ 5 days following their kidney transplant. Primary outcome measures between the two groups included: the incidence of symptomatic UTIs, the incidence of asymptomatic bacteriuria and the incidence of major urological complications requiring intervention and treatment.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 13 April 2023 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 Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials (RCTs) and quasi-RCTs comparing timing of catheter removal post-transplantation were eligible for inclusion. All donor types were included, and all recipients were included regardless of age, demographics or type of urinary catheter used.\nData collection and analysis\nResults from the literature search were screened by two authors to identify if they met our inclusion criteria. We designated removal of a urinary catheter before five days (120 hours) as an 'early removal' and anything later than this as a 'late removal.' The studies were assessed for quality using the risk of bias tool. The primary outcome of interest was the incidence of asymptomatic bacteriuria. Statistical analyses were performed using the random effects model, and results were expressed as relative risk (RR) with 95% confidence intervals (CI). Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nTwo studies (197 patients) were included in our analysis. One study comprised a full-text article, and the other was a conference abstract with very limited information. The risk of bias in the included studies was generally either high or unclear.\nIt is uncertain whether early versus late removal of the urinary catheter made any difference to the incidence of asymptomatic bacteriuria (RR 0.89, 95% Cl 0.17 to 4.57; participants = 197; I2 = 88%; very low certainty evidence). Data on other outcomes, such as the incidence of UTI and the incidence of major urological complications, were lacking. Furthermore, the follow-up of patients across the studies was short, with no patients being followed beyond one month.\nAuthors' conclusions\nA high-quality, well-designed RCT is required to compare the effectiveness of early catheter removal versus late catheter removal in patients following a kidney transplant. At the present time, there is insufficient evidence to suggest any difference between early and late catheter removal post-transplant, and the studies investigating this were generally of poor quality.\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": "This study was designed to review all the previously published research in this area to determine the answer to this question. Two studies, including 197 people who have received a kidney transplant, were identified."
}
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query-laysum | 2803 | [
{
"role": "user",
"content": "Abstract: Background\nEarly accurate detection of all skin cancer types is essential to guide appropriate management, reduce morbidity and improve survival. Basal cell carcinoma (BCC) is usually localised to the skin but has potential to infiltrate and damage surrounding tissue, while cutaneous squamous cell carcinoma (cSCC) and melanoma have a much higher potential to metastasise and ultimately lead to death. Exfoliative cytology is a non-invasive test that uses the Tzanck smear technique to identify disease by examining the structure of cells obtained from scraped samples. This simple procedure is a less invasive diagnostic test than a skin biopsy, and for BCC it has the potential to provide an immediate diagnosis that avoids an additional clinic visit to receive skin biopsy results. This may benefit patients scheduled for either Mohs micrographic surgery or non-surgical treatments such as radiotherapy. A cytology scrape can never give the same information as a skin biopsy, however, so it is important to better understand in which skin cancer situations it may be helpful.\nObjectives\nTo determine the diagnostic accuracy of exfoliative cytology for detecting basal cell carcinoma (BCC) in adults, and to compare its accuracy with that of standard diagnostic practice (visual inspection with or without dermoscopy). Secondary objectives were: to determine the diagnostic accuracy of exfoliative cytology for detecting cSCC, invasive melanoma and atypical intraepidermal melanocytic variants, and any other skin cancer; and for each of these secondary conditions to compare the accuracy of exfoliative cytology with visual inspection with or without dermoscopy in direct test comparisons; and to determine the effect of observer experience.\nSearch methods\nWe undertook a comprehensive search of the following databases from inception up to August 2016: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We also studied the reference lists of published systematic review articles.\nSelection criteria\nStudies evaluating exfoliative cytology in adults with lesions suspicious for BCC, cSCC or melanoma, compared with a reference standard of histological confirmation.\nData collection and analysis\nTwo review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). Where possible we estimated summary sensitivities and specificities using the bivariate hierarchical model.\nMain results\nWe synthesised the results of nine studies contributing a total of 1655 lesions to our analysis, including 1120 BCCs (14 datasets), 41 cSCCs (amongst 401 lesions in 2 datasets), and 10 melanomas (amongst 200 lesions in 1 dataset). Three of these datasets (one each for BCC, melanoma and any malignant condition) were derived from one study that also performed a direct comparison with dermoscopy. Studies were of moderate to poor quality, providing inadequate descriptions of participant selection, thresholds used to make cytological and histological diagnoses, and blinding. Reporting of participants' prior referral pathways was particularly poor, as were descriptions of the cytodiagnostic criteria used to make diagnoses. No studies evaluated the use of exfoliative cytology as a primary diagnostic test for detecting BCC or other skin cancers in lesions suspicious for skin cancer. Pooled data from seven studies using standard cytomorphological criteria (but various stain methods) to detect BCC in participants with a high clinical suspicion of BCC estimated the sensitivity and specificity of exfoliative cytology as 97.5% (95% CI 94.5% to 98.9%) and 90.1% (95% CI 81.1% to 95.1%). respectively. When applied to a hypothetical population of 1000 clinically suspected BCC lesions with a median observed BCC prevalence of 86%, exfoliative cytology would miss 21 BCCs and would lead to 14 false positive diagnoses of BCC. No false positive cases were histologically confirmed to be melanoma. Insufficient data are available to make summary statements regarding the accuracy of exfoliative cytology to detect melanoma or cSCC, or its accuracy compared to dermoscopy.\nAuthors' conclusions\nThe utility of exfoliative cytology for the primary diagnosis of skin cancer is unknown, as all included studies focused on the use of this technique for confirming strongly suspected clinical diagnoses. For the confirmation of BCC in lesions with a high clinical suspicion, there is evidence of high sensitivity and specificity. Since decisions to treat low-risk BCCs are unlikely in practice to require diagnostic confirmation given that clinical suspicion is already high, exfoliative cytology might be most useful for cases of BCC where the treatments being contemplated require a tissue diagnosis (e.g. radiotherapy). The small number of included studies, poor reporting and varying methodological quality prevent us from drawing strong conclusions to guide clinical practice. Despite insufficient data on the use of cytology for cSCC or melanoma, it is unlikely that cytology would be useful in these scenarios since preservation of the architecture of the whole lesion that would be available from a biopsy provides crucial diagnostic information. Given the paucity of good quality data, appropriately designed prospective comparative studies may be required to evaluate both the diagnostic value of exfoliative cytology by comparison to dermoscopy, and its confirmatory value in adequately reported populations with a high probability of BCC scheduled for further treatment requiring a tissue diagnosis.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The small number of studies included in this review, poor description of how patients were selected to be included in the study, and limited information on how the test results were used to make diagnoses, reduces the reliability of our results.\nThe studies did not explain how patients had been referred to have the exfoliative cytology test. Most important of all, the test was only used in people in whom doctors had already diagnosed a BCC just by looking at the skin lesion. In other words, the test was being used to confirm a doctor's diagnosis. Most studies did not include enough people with skin lesions that are similar in appearance to a BCC to be sure that this test correctly identifies a BCC. This may cause exfoliative cytology to appear more accurate than it would be in actual practice."
}
]
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query-laysum | 2804 | [
{
"role": "user",
"content": "Abstract: Background\nBronchiolitis is one of the most frequent causes of respiratory failure in infants; some infants will require intensive care and mechanical ventilation. There is lack of evidence regarding effective treatment for bronchiolitis other than supportive care. Abnormalities of surfactant quantity or quality (or both) have been observed in severe cases of bronchiolitis. Exogenous surfactant administration appears to favourably change the haemodynamics of the lungs and may be a potentially promising therapy for severe bronchiolitis. This is an update of a review published in Issue 9, 2012. We did not identify any new studies for inclusion, and our conclusions remain unchanged.\nObjectives\nTo evaluate the efficacy of exogenous surfactant administration (i.e. intratracheal administration of surfactant of any type (whether animal-derived or synthetic), at any dose and at any time after start of ventilation) compared to placebo, no intervention or standard care in reducing mortality and the duration of ventilation in infants and children with bronchiolitis requiring mechanical ventilation.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Studies (CENTRAL; 2015, Issue 5) which contains the Cochrane Acute Respiratory Infections Group's Specialised Register; MEDLINE (1948 to June week 3, 2015); EMBASE (1974 to June 2015); CINAHL (1982 to June 2015); LILACS (1985 to June 2015); and Web of Science (1985 to June 2015).\nSelection criteria\nWe considered prospective, randomised controlled trials (RCTs) and quasi-RCTs evaluating the effect of exogenous surfactant in infants and children with bronchiolitis requiring mechanical ventilation.\nData collection and analysis\nTwo review authors selected studies independently. We extracted the data using a predefined proforma, independently analysed the data, and performed meta-analyses.\nMain results\nWe included three small RCTs enrolling 79 participants. Two trials did not use a placebo in the control arms and the third trial used air placebo. Two included studies reported no mortality. We judged all three of the included studies to be at low risk or unclear risk across all risk of bias categories; we did not judge any of the studies to be at high risk of bias in any category. Our pooled analysis of the three trials revealed that duration of mechanical ventilation was not significantly different between the groups (mean difference (MD) -63.04, 95% confidence interval (CI) -130.43 to 4.35 hours) but duration of intensive care unit (ICU) stay was less in the surfactant group compared to the control group: MD -3.31, 95% CI -6.38 to -0.25 days. After excluding one trial which produced significant heterogeneity, the duration of mechanical ventilation and duration of ICU stay were significantly lower in the surfactant group compared to the control group: MD -28.99, 95% CI -40.10 to -17.87 hours; and MD -1.81, 95% CI -2.42 to -1.19 days, respectively. Use of surfactant had favourable effects on oxygenation and CO2 elimination. No adverse effects and no complications were observed in any of the three included studies. The level of evidence for duration of mechanical ventilation, duration of intensive care unit stay, oxygenation parameters, and carbon dioxide parameters was of moderate quality.\nAuthors' conclusions\nUse of surfactant had favourable effects on duration of mechanical ventilation, duration of ICU stay, oxygenation, and CO2 elimination. However, the studies are few and small (n = 79) so available evidence is insufficient to establish the effectiveness of surfactant therapy for bronchiolitis in critically ill infants who require mechanical ventilation. There is a need for larger trials with adequate power and a cost-effectiveness analysis to evaluate the effectiveness of exogenous surfactant therapy for infants with bronchiolitis who require intensive care management.\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": "Will use of exogenous surfactant (a material made of lipid and protein that is produced by the lungs) in infants and children with bronchiolitis, who require mechanical ventilation, decrease mortality and duration of mechanical ventilation?"
}
]
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query-laysum | 2805 | [
{
"role": "user",
"content": "Abstract: Background\nOrbital lymphangiomas are a subset of localized vascular and lymphatic malformations, which most commonly occur in the head and neck region. Orbital lymphangiomas typically present in the first decade of life with signs of ptosis, proptosis, restriction of ocular motility, compressive optic neuropathy, and disfigurement. Therefore, early and effective treatment is crucial to preserving vision. Due to proximity to vital structures, such as the globe, optic nerve, and extraocular muscles, treatment for these lesions is complicated and includes a large array of approaches including observation, sclerotherapy, systemic therapy, and surgical excision. Of these options, there is no clear gold standard of treatment.\nObjectives\nTo assess the evidence supporting medical and surgical interventions for the reduction/treatment of orbital lymphangiomas in children and young adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2018, Issue 5); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature Database (LILACS); ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 22 May 2018.\nSelection criteria\nWe planned to include randomized controlled trials (RCTs) comparing at least two of the following interventions with each other for the treatment of orbital lymphangiomas: observation; sildenafil therapy; sirolimus therapy; sclerotherapy; surgery (partial or complete resection). We planned to include trials that enrolled children and adults up to 32 years of age, based on a prior clinical trial protocol. There were no restrictions regarding location or demographic factors.\nData collection and analysis\nTwo review authors independently screened the titles, abstracts, and full articles to assess their suitability for inclusion in this review. No risk of bias or data extraction was performed because we did not find any trials for inclusion. If there had been RCTs, two authors would have assessed the risk of bias and abstracted data independently with discrepancies being settled by consensus or consultation with a third review author.\nMain results\nThere were no RCTs that compared any two of the mentioned interventions (medical or surgical) for treating orbital lymphangiomas in children and young adults.\nAuthors' conclusions\nCurrently, there are no published RCTs of orbital lymphangioma treatments. Without these types of studies, conclusions cannot be drawn regarding the effectiveness of the medical and surgical treatment options for patients with orbital lymphangiomas. The presence of only case reports and case series on orbital lymphangiomas makes it clear that RCTs are needed to address the differences between these options and help guide treatment plans. Such trials would ideally compare outcomes between individuals randomized to one of the following treatment options: observation, sclerotherapy, systemic sirolimus therapy, systemic sildenafil therapy, and surgical excision.\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": "Currently, there are no eligible randomized controlled trials (RCTs) comparing treatment options for orbital lymphangioma. Therefore, the effectiveness, recurrence rate, and side effects of the four major interventions used to treat orbital lymphangiomas remains uncertain."
}
]
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query-laysum | 2806 | [
{
"role": "user",
"content": "Abstract: Background\nIrritable bowel syndrome (IBS) is a prevalent condition that currently lacks highly effective therapies for its management. Biofeedback has been proposed as a therapy that may help individuals learn to exert conscious control over sympatho-vagal balance as an indirect method of symptom management.\nObjectives\nOur primary objective was to assess the efficacy and safety of biofeedback-based interventions for IBS in adults and children.\nSearch methods\nWe searched the Cochrane Inflammatory Bowel Disease (IBD) Group Specialized Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Allied and Complementary Medicine Database (AMED) from inception to 24 July 2019. We also searched reference lists from published trials, trial registries, device manufacturers, conference proceedings, theses, and dissertations.\nSelection criteria\nWe judged randomized controlled trials to be eligible for inclusion if they met the Association for Applied Psychophysiology and Biofeedback definition of biofeedback, and if they compared a biofeedback intervention to an active, sham, or no-treatment control for the management of IBS.\nData collection and analysis\nTwo authors independently screened trials for inclusion, extracted data, and assessed risk of bias. Primary outcomes were IBS global or clinical improvement scores and overall quality of life measures. Secondary outcome measures were adverse events, assessments of stool frequency and consistency, changes in abdominal pain, depression, and anxiety. For dichotomous outcomes, we calculated the risk ratio (RR) and 95% confidence interval (CI). For continuous outcomes, we calculated the mean difference (MD) and 95% CI. We used GRADE criteria to assess the overall certainty of the evidence.\nMain results\nWe identified eight randomized trials with a total of 300 adult participants for our analysis. We did not identify any trials in children. Four trials assessed thermal biofeedback. One trial assessed rectosigmoidal biofeedback. Two trials assessed heart rate variability biofeedback. Two trials assessed electrocutaneous biofeedback. Comparators were: no treatment (symptom monitoring group; three studies), attention control (pseudomeditation; two studies), relaxation control (one study), counseling (two studies), hypnotherapy (one study), standard therapy (one study), and sham biofeedback (one study). We judged all trials to have a high or unclear risk of bias.\nGlobal/Clinical improvement\nThe clinical benefit of biofeedback plus standard therapy compared to standard therapy alone was uncertain (RR 4.20, 95% CI 1.40 to 12.58; 1 study, 20 participants; very low-certainty evidence). The same study also compared biofeedback plus standard therapy to sham biofeedback plus standard therapy. The clinical benefit in the biofeedback group was uncertain (RR 2.33, 95% CI 1.13 to 4.80; 1 study, 20 participants; very low-certainty evidence).\nThe clinical benefit of heart rate biofeedback compared to hypnotherapy was uncertain when measured with the IBS severity scoring system (IBS-SSS) (MD -58.80, 95% CI -109.11 to -8.49; 1 study, 61 participants; low-certainty evidence). Compared to counseling, the effect of heart rate biofeedback was unclear when measured with a composite symptom reduction score (MD 7.03, 95% CI -51.07 to 65.13; 1 study, 29 participants; low-certainty evidence) and when evaluated for clinical response (50% improvement) (RR 1.09, 95% CI 0.48 to 2.45; 1 study, 29 participants; low-certainty evidence).\nThe clinical benefit of thermal biofeedback used in a multi-component psychological intervention (MCPI) compared to no treatment was uncertain when measured with a composite clinical symptom reduction score (MD 30.34, 95% CI 8.47 to 52.21; 3 studies, 101 participants; very low-certainty evidence), and when evaluated as clinical response (50% improvement) (RR 2.12, 95% CI 1.24 to 3.62; 3 studies, 101 participants; very low-certainty evidence). Compared to attention control, the effects of thermal biofeedback within an MCPI were unclear when measured with a composite clinical symptom reduction score (MD 4.02, 95% CI -21.41 to 29.45; 2 studies, 80 participants; very low-certainty evidence) and when evaluated as clinical response (50% improvement) (RR 1.10, 95% CI 0.72 to 1.69, 2 studies, 80 participants; very low-certainty evidence).\nQuality of life\nA single trial used overall quality of life as an outcome measure, and reported that both the biofeedback and cognitive therapy groups improved after treatment. The trial did not note any between-group differences, and did not report any outcome data.\nAdverse events\nOnly one of the eight trials explicitly reported adverse events. This study reported no adverse events in either the biofeedback or cognitive therapy groups (RD 0.00, 95% CI -0.12 to 0.12; 29 participants; low-certainty evidence).\nAuthors' conclusions\nThere is currently not enough evidence to assess whether biofeedback interventions are effective for controlling symptoms of IBS. Given the positive results reported in small trials to date, biofeedback deserves further study in people with IBS. Future research should include active control groups that use high provider-participant interaction, in an attempt to balance non-specific effects of interventions between groups, and report both commonly used outcome measures (e.g. IBS-SSS) and historical outcome measures (e.g. the composite primary symptom reduction (CPSR) score) to allow for meta-analysis with previous studies. Future studies should be explicit in their reporting of adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Authors' Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We conclude that the existing data on biofeedback for IBS are limited and leave us uncertain about its value in IBS symptom management. The studies currently available all have design limitations that make the results difficult to apply to clinical settings. We do, however, recommend further study in this area, as biofeedback could represent a unique approach for a difficult to manage condition."
}
]
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query-laysum | 2807 | [
{
"role": "user",
"content": "Abstract: Background\nStenotrophomonas maltophilia is one of the most common emerging multi-drug resistant organisms found in the lungs of people with cystic fibrosis and its prevalence is increasing. Chronic infection with Stenotrophomonas maltophilia has recently been shown to be an independent predictor of pulmonary exacerbation requiring hospitalization and antibiotics. However, the role of antibiotic treatment of Stenotrophomonas maltophilia infection in people with cystic fibrosis is still unclear. This is an update of a previously published review.\nObjectives\nThe objective of our review is to assess the effectiveness of antibiotic treatment for Stenotrophomonas maltophilia in people with cystic fibrosis. The primary objective is to assess this in relation to lung function and pulmonary exacerbations in the setting of acute pulmonary exacerbations. The secondary objective is to assess this in relation to the eradication of Stenotrophomonas maltophilia.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched a registry of ongoing trials and the reference lists of relevant articles and reviews.\nDate of latest search: 03 March 2020.\nSelection criteria\nRandomized controlled trials of Stenotrophomonas maltophilia mono-infection or Stenotrophomonas maltophilia co-infection with Pseudomonas aeruginosa in either the setting of an acute pulmonary exacerbation or a chronic infection treated with suppressive antibiotic therapy.\nData collection and analysis\nBoth authors independently assessed the trials identified by the search for potential inclusion in the review.\nMain results\nWe identified only one trial of antibiotic treatment of pulmonary exacerbations that included people with cystic fibrosis with Stenotrophomonas maltophilia. However, this trial had to be excluded because data was not available per pathogen.\nAuthors' conclusions\nThis review did not identify any evidence regarding the effectiveness of antibiotic treatment for Stenotrophomonas maltophilia in people with cystic fibrosis. Until such evidence becomes available, clinicians need to use their clinical judgement as to whether or not to treat Stenotrophomonas maltophilia infection in people with cystic fibrosis. Randomized clinical trials are needed to address these unanswered clinical questions.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to: 03 March 2020."
}
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query-laysum | 2808 | [
{
"role": "user",
"content": "Abstract: Background\nAbdominal aortic aneurysm (AAA) is an abnormal dilatation of the infradiaphragmatic aorta that is equal to or greater than 30 mm or a local dilatation of equal to or greater than 50% compared to the expected normal diameter of the artery. AAAs rarely occur in individuals under 50 years of age, but thereafter the prevalence dramatically increases with age, with men at a six-fold greater risk of developing an AAA than women. Prevalence of AAA has been reported to range from 1.3% in women aged 65 to 80 years to between 4% and 7.7% in men aged 65 to 80 years.\nThere is evidence that the risk of rupture increases as the aneurysm diameter increases from 50 mm to 60 mm. People with AAAs over 55 mm in diameter are therefore generally referred for consideration of repair, as the risk of rupture exceeds the risk of repair. The traditional treatment for AAA is open surgical repair (OSR) which involves a large abdominal incision and is associated with a significant risk of complications. Two less invasive procedures have recently become more widely used: endovascular aneurysm repair (EVAR) and laparoscopic repair. EVAR is carried out through sheaths inserted in the femoral artery in the groin: thereafter, a stent graft is placed within the aneurysm sac under radiological image guidance and anchored in place to form a new channel for blood flow. Laparoscopic repair involves the use of a laparoscope which is inserted through small cuts in the abdomen and the synthetic graft is sewn in place to replace the weakened area of the aorta. Laparoscopic AAA repair falls into two categories: hand-assisted laparoscopic surgery (HALS), where an incision is made to allow the surgeon's hand to assist in the repair; and total laparoscopic surgery (TLS). Both EVAR and laparoscopic repair are favourable over OSR as they are minimally invasive, less painful, associated with fewer complications and lower mortality rate and have a shorter duration of hospital stay.\nCurrent evidence suggests that elective laparoscopic AAA repair has a favourable safety profile comparable with that of EVAR, with low conversion rates as well as similar mortality and morbidity rates. As a result, it has been suggested that elective laparoscopic AAA repair may have a role in treating those patients for whom EVAR is unsuitable.\nObjectives\nTo assess the effects of laparoscopic surgery for elective abdominal aortic aneurysm repair.\nThe primary objective of this review was to assess the perioperative mortality and operative time of laparoscopic (total and hand-assisted) surgical repair of abdominal aortic aneurysms (AAA) compared to traditional open surgical repair or EVAR. The secondary objective was to assess complication rates, all-cause mortality (> 30 days), hospital and intensive care unit (ICU) length of stay, conversion and re-intervention rates, and quality of life associated with laparoscopic (total and hand-assisted) surgical repair compared to traditional open surgical repair or EVAR.\nSearch methods\nThe Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (last searched August 2016) and CENTRAL (2016, Issue 7). In addition the CIS searched trials registries for details of ongoing or unpublished studies. We searched the reference lists of relevant articles retrieved by electronic searches for additional citations.\nSelection criteria\nRandomised controlled trials and controlled clinical trials in which patients with an AAA underwent elective laparoscopic repair (total laparoscopic repair or hand-assisted laparoscopic repair) compared with either open surgical repair or EVAR.\nData collection and analysis\nStudies identified for potential inclusion were independently assessed for inclusion by at least two review authors.\nMain results\nOne randomised controlled trial with a total of 100 male participants was included in the review. The trial compared hand-assisted laparoscopic repair with EVAR and provided results for in-hospital mortality, operative time, length of hospital stay and lower limb ischaemia. The included study did not report on the other pre-planned outcomes of this review. No in-hospital deaths occurred in the study. Hand-associated laparoscopic repair was associated with a longer operative time (MD 53.00 minutes, 95% CI 36.49 to 69.51) than EVAR. The incidence of lower limb ischaemia was similar between the two treatment groups (risk ratio (RR) 0.50, 95% confidence interval (CI) 0.05 to 5.34). The mean length of hospital stay was 4.2 days and 3.4 days in the hand-assisted laparoscopic repair and EVAR groups respectively but standard deviations were not reported and therefore it was not possible to independently test the statistical significance of this result. The quality of evidence was downgraded for imprecision due to the inclusion of one small study; and wide confidence intervals and indirectness due to the study including male participants only. No study compared laparoscopic repair (total or hand-assisted) with open surgical repair or total laparoscopic surgical repair with EVAR.\nAuthors' conclusions\nThere is insufficient evidence to draw any conclusions about effectiveness and safety of laparoscopic (total and hand-assisted) surgical repair of AAA versus open surgical repair or EVAR, because only one small randomised trial was eligible for inclusion in this review. High-quality randomised controlled trials are needed.\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": "Further research is required before conclusions can be made."
}
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query-laysum | 2809 | [
{
"role": "user",
"content": "Abstract: Background\nLow health literacy affects 25% of people with chronic kidney disease (CKD) and is associated with increased morbidity and death. Improving health literacy is a recognised priority, but effective interventions are not clear.\nObjectives\nThis review looked the benefits and harms of interventions for improving health literacy in people with CKD.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 12 July 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. We also searched MEDLINE (OVID) and EMBASE (OVID) for non-randomised studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and non-randomised studies that assessed interventions aimed at improving health literacy in people with CKD.\nData collection and analysis\nTwo authors independently assessed studies for eligibility and performed risk of bias analysis. We classified studies as either interventions aimed at improving aspects of health literacy or interventions targeting a population of people with poor health literacy. The interventions were further sub-classified in terms of the type of intervention (educational, self-management training, or educational with self-management training). Results were expressed as mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) for continuous outcomes and risk ratios (RR) with 95% CI for dichotomous outcomes.\nMain results\nWe identified 120 studies (21,149 participants) which aimed to improve health literacy. There were 107 RCTs and 13 non-randomised studies. No studies targeted low literacy populations. For the RCTs, selection bias was low or unclear in 94% of studies, performance bias was high in 86% of studies, detection bias was high in 86% of studies reporting subjective outcomes and low in 93% of studies reporting objective outcomes. Attrition and other biases were low or unclear in 86% and 78% of studies, respectively.\nCompared to usual care, low certainty evidence showed educational interventions may increase kidney-related knowledge (14 RCTs, 2632 participants: SMD 0.99, 95% CI 0.69 to 1.32; I² = 94%). Data for self-care, self-efficacy, quality of life (QoL), death, estimated glomerular filtration rate (eGFR) and hospitalisations could not be pooled or was not reported.\nCompared to usual care, low-certainty evidence showed self-management interventions may improve self-efficacy (5 RCTs, 417 participants: SMD 0.58, 95% CI 0.13 to 1.03; I² = 74%) and QoL physical component score (3 RCTs, 131 participants: MD 4.02, 95% CI 1.09 to 6.94; I² = 0%). There was moderate-certainty evidence that self-management interventions probably did not slow the decline in eGFR after one year (3 RCTs, 855 participants: MD 1.53 mL/min/1.73 m², 95% CI -1.41 to 4.46; I² = 33%). Data for knowledge, self-care behaviour, death and hospitalisations could not be pooled or was not reported.\nCompared to usual care, low-certainty evidence showed educational with self-management interventions may increase knowledge (15 RCTs, 2185 participants: SMD 0.65, 95% CI 0.36 to 0.93; I² = 90%), improve self-care behaviour scores (4 RCTs, 913 participants: SMD 0.91, 95% CI 0.00 to 1.82; I² =97%), self-efficacy (8 RCTs, 687 participants: SMD 0.50, 95% CI 0.10 to 0.89; I² = 82%), improve QoL physical component score (3 RCTs, 2771 participants: MD 2.56, 95% CI 1.73 to 3.38; I² = 0%) and may make little or no difference to slowing the decline of eGFR (4 RCTs, 618 participants: MD 4.28 mL/min/1.73 m², 95% CI -0.03 to 8.85; I² = 43%). Moderate-certainty evidence shows educational with self-management interventions probably decreases the risk of death (any cause) (4 RCTs, 2801 participants: RR 0.73, 95% CI 0.53 to 1.02; I² = 0%). Data for hospitalisation could not be pooled.\nAuthors' conclusions\nInterventions to improve aspects of health literacy are a very broad category, including educational interventions, self-management interventions and educational with self-management interventions. Overall, this type of health literacy intervention is probably beneficial in this cohort however, due to methodological limitations and high heterogeneity in interventions and outcomes, the evidence is of low certainty.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the literature for any studies that included an intervention aimed at improving health literacy in people with CKD. The interventions were divided into educational interventions, self-management training interventions, and educational with self-management training interventions."
}
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query-laysum | 2810 | [
{
"role": "user",
"content": "Abstract: Background\nA Class II division 2 malocclusion is characterised by upper front teeth that are retroclined (tilted toward the roof of the mouth) and an increased overbite (deep overbite), which can cause oral problems and may affect appearance.\nThis problem can be corrected by the use of special dental braces (functional appliances) that move the upper front teeth forward and change the growth of the upper or lower jaws, or both. Most types of functional appliances are removable and this treatment approach does not usually require extraction of any permanent teeth. Additional treatment with fixed braces may be necessary to ensure the best result.\nAn alternative approach is to provide space for the correction of the front teeth by moving the molar teeth backwards. This is done by applying a force to the teeth from the back of the head using a head brace (headgear) and transmitting this force to part of a fixed or removable dental brace that is attached to the back teeth. The treatment may be carried out with or without extraction of permanent teeth.\nIf headgear use is not feasible, the back teeth may be held in place by bands connected to a fixed bar placed across the roof of the mouth or in contact with the front of the roof of the mouth. This treatment usually requires two permanent teeth to be taken out from the middle of the upper arch (one on each side).\nObjectives\nTo establish whether orthodontic treatment that does not involve extraction of permanent teeth produces a result that is any different from no orthodontic treatment or orthodontic treatment involving extraction of permanent teeth, in children with a Class II division 2 malocclusion.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following electronic databases: Cochrane Oral Health's Trials Register (to 13 November 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 10), MEDLINE Ovid (1946 to 13 November 2017), and Embase Ovid (1980 to 13 November 2017). To identify any unpublished or ongoing trials, the US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform (apps.who.int/trialsearch) were searched. We also contacted international researchers who were likely to be involved in any Class II division 2 clinical trials.\nSelection criteria\nRandomised controlled trials (RCTs) and controlled clinical trials (CCTs) of orthodontic treatments to correct deep bite and retroclined upper front teeth in children.\nData collection and analysis\nTwo review authors independently screened the search results to find eligible studies, and would have extracted data and assessed the risk of bias from any included trials. We had planned to use random-effects meta-analysis; to express effect estimates as mean differences for continuous outcomes and risk ratios for dichotomous outcomes, with 95% confidence intervals; and to investigate any clinical or methodological heterogeneity.\nMain results\nWe did not identify any RCTs or CCTs that assessed the treatment of Class II division 2 malocclusion in children.\nAuthors' conclusions\nThere is no evidence from clinical trials to recommend or discourage any type of orthodontic treatment to correct Class II division 2 malocclusion in children. This situation seems unlikely to change as trials to evaluate the best management of Class II division 2 malocclusion are challenging to design and conduct due to low prevalence, difficulties with recruitment and ethical issues with randomisation.\n\nGiven the provided abstract, please respond to the following query: \"Aim\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We carried out this Cochrane Review to find out if orthodontic treatment without the removal of permanent teeth had different effects than no orthodontic treatment or orthodontic treatment involving the removal of permanent teeth, in children with a Class II division 2 malocclusion."
}
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query-laysum | 2811 | [
{
"role": "user",
"content": "Abstract: Background\nSurgical site infection (SSI) rates vary from 1% to 5% in the month following surgery. Due to the large number of surgical procedures conducted annually, the costs of these SSIs can be considerable in financial and social terms. Many interventions are used with the aim of reducing the risk of SSI in people undergoing surgery. These interventions can be broadly delivered at three stages: preoperatively, intraoperatively and postoperatively. The intraoperative interventions are largely focused on decontamination of skin using soap and antiseptics; the use of barriers to prevent movement of micro-organisms into incisions; and optimising the patient's own bodily functions to promote best recovery. Both decontamination and barrier methods can be aimed at people undergoing surgery and operating staff. Other interventions focused on SSI prevention may be aimed at the surgical environment and include methods of theatre cleansing and approaches to managing theatre traffic.\nObjectives\nTo present an overview of Cochrane Reviews of the effectiveness and safety of interventions, delivered during the intraoperative period, aimed at preventing SSIs in all populations undergoing surgery in an operating theatre.\nMethods\nPublished Cochrane systematic reviews reporting the effectiveness of interventions delivered during the intraoperative period in terms of SSI prevention were eligible for inclusion in this overview. We also identified Cochrane protocols and title registrations for future inclusion into the overview. We searched the Cochrane Library on 01 July 2017. Two review authors independently screened search results and undertook data extraction and 'Risk of bias' and certainty assessment. We used the ROBIS (risk of bias in systematic reviews) tool to assess the quality of included reviews, and we used GRADE methods to assess the certainty of the evidence for each outcome. We summarised the characteristics of included reviews in the text and in additional tables.\nMain results\nWe included 32 Cochrane Reviews in this overview: we judged 30 reviews as being at low risk of bias and two at unclear risk of bias. Thirteen reviews had not been updated in the past three years. Two reviews had no relevant data to extract. We extracted data from 30 reviews with 349 included trials, totaling 73,053 participants. Interventions assessed included gloving, use of disposable face masks, patient oxygenation protocols, use of skin antiseptics for hand washing and patient skin preparation, vaginal preparation, microbial sealants, methods of surgical incision, antibiotic prophylaxis and methods of skin closure. Overall, the GRADE certainty of evidence for outcomes was low or very low. Of the 77 comparisons providing evidence for the outcome of SSI, seven provided high- or moderate-certainty evidence, 39 provided low-certainty evidence and 31 very low-certainty evidence. Of the nine comparisons that provided evidence for the outcome of mortality, five provided low-certainty evidence and four very low-certainty evidence.\nThere is high- or moderate-certainty evidence for the following outcomes for these intraoperative interventions. (1) Prophylactic intravenous antibiotics administered before caesarean incision reduce SSI risk compared with administration after cord clamping (10 trials, 5041 participants; risk ratio (RR) 0.59, 95% confidence interval (CI) 0.44 to 0.81; high-certainty evidence - assessed by review authors). (2) Preoperative antibiotics reduce SSI risk compared with placebo after breast cancer surgery (6 trials, 1708 participants; RR 0.74, 95% CI 0.56 to 0.98; high-certainty evidence - assessed by overview authors). (3) Antibiotic prophylaxis probably reduce SSI risk in caesarean sections compared with no antibiotics (82 relevant trials, 14,407 participants; RR 0.40, 95% CI 0.35 to 0.46; moderate-certainty evidence; downgraded once for risk of bias - assessed by review authors). (4) Antibiotic prophylaxis probably reduces SSI risk for hernia repair compared with placebo or no treatment (17 trials, 7843 participants; RR 0.67, 95% CI 0.54 to 0.84; moderate-certainty evidence; downgraded once for risk of bias - assessed by overview authors); (5) There is currently no clear difference in the risk of SSI between iodine-impregnated adhesive drapes compared with no adhesive drapes (2 trials, 1113 participants; RR 1.03, 95% CI 0.66 to 1.60; moderate-certainty evidence; downgraded once for imprecision - assessed by review authors); (6) There is currently no clear difference in SSI risk between short-term compared with long-term duration antibiotics in colorectal surgery (7 trials; 1484 participants; RR 1.05 95% CI 0.78 to 1.40; moderate-certainty evidence; downgraded once for imprecision - assessed by overview authors). There was only one comparison showing negative effects associated with the intervention: adhesive drapes increase the risk of SSI compared with no drapes (5 trials; 3082 participants; RR 1.23, 95% CI 1.02 to 1.48; high-certainty evidence - rated by review authors).\nAuthors' conclusions\nThis overview provides the most up-to-date evidence on use of intraoperative treatments for the prevention of SSIs from all currently published Cochrane Reviews. There is evidence that some interventions are useful in reducing SSI risk for people undergoing surgery, such as antibiotic prophylaxis for caesarean section and hernia repair, and also the timing of prophylactic intravenous antibiotics administered before caesarean incision. Also, there is evidence that adhesive drapes increase SSI risk. Evidence for the many other treatment choices is largely of low or very low certainty and no quality-of-life or cost-effectiveness data were reported. Future trials should elucidate the relative effects of some treatments. These studies should focus on increasing participant numbers, using robust methodology and being of sufficient duration to adequately assess SSI. Assessment of other outcomes such as mortality might also be investigated as part of non-experimental prospective follow-up of people with SSI of different severity, so the risk of death for different subgroups can be better understood.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this overview?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for reviews that had been published up to July 2017. Of the 32 reviews included in this overview, 13 reviews had not been updated in the past three years."
}
]
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query-laysum | 2812 | [
{
"role": "user",
"content": "Abstract: Background\nAcute otitis media (AOM) is one of the most common childhood illnesses. While many children experience sporadic AOM episodes, an important group suffer from recurrent AOM (rAOM), defined as three or more episodes in six months, or four or more in one year. In this subset of children AOM poses a true burden through frequent episodes of ear pain, general illness, sleepless nights and time lost from nursery or school. Grommets, also called ventilation or tympanostomy tubes, can be offered for rAOM.\nObjectives\nTo assess the benefits and harms of bilateral grommet insertion with or without concurrent adenoidectomy in children with rAOM.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; CENTRAL; MEDLINE; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 4 December 2017.\nSelection criteria\nRandomised controlled trials (RCTs) comparing bilateral grommet insertion with or without concurrent adenoidectomy and no ear surgery in children up to age 16 years with rAOM. We planned to apply two main scenarios: grommets as a single surgical intervention and grommets as concurrent treatment with adenoidectomy (i.e. children in both the intervention and comparator groups underwent adenoidectomy). The comparators included active monitoring, antibiotic prophylaxis and placebo medication.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Primary outcomes were: proportion of children who have no AOM recurrences at three to six months follow-up (intermediate-term) and persistent tympanic membrane perforation (significant adverse event). Secondary outcomes were: proportion of children who have no AOM recurrences at six to 12 months follow-up (long-term); total number of AOM recurrences, disease-specific and generic health-related quality of life, presence of middle ear effusion and other adverse events at short-term, intermediate-term and long-term follow-up. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nFive RCTs (805 children) with unclear or high risk of bias were included. All studies were conducted prior to the introduction of pneumococcal vaccination in the countries' national immunisation programmes. In none of the trials was adenoidectomy performed concurrently in both groups.\nGrommets versus active monitoring\nGrommets were more effective than active monitoring in terms of:\n- proportion of children who had no AOM recurrence at six months (one study, 95 children, 46% versus 5%; risk ratio (RR) 9.49, 95% confidence interval (CI) 2.38 to 37.80, number needed to treat to benefit (NNTB) 3; low-quality evidence);\n- proportion of children who had no AOM recurrence at 12 months (one study, 200 children, 48% versus 34%; RR 1.41, 95% CI 1.00 to 1.99, NNTB 8; low-quality evidence);\n- number of AOM recurrences at six months (one study, 95 children, mean number of AOM recurrences per child: 0.67 versus 2.17, mean difference (MD) -1.50, 95% CI -1.99 to -1.01; low-quality evidence);\n- number of AOM recurrences at 12 months (one study, 200 children, one-year AOM incidence rate: 1.15 versus 1.70, incidence rate difference -0.55, 95% -0.17 to -0.93; low-quality evidence).\nChildren receiving grommets did not have better disease-specific health-related quality of life (Otitis Media-6 questionnaire) at four (one study, 85 children) or 12 months (one study, 81 children) than those managed by active monitoring (low-quality evidence).\nOne study reported no persistent tympanic membrane perforations among 54 children receiving grommets (low-quality evidence).\nGrommets versus antibiotic prophylaxis\nIt is uncertain whether or not grommets are more effective than antibiotic prophylaxis in terms of:\n- proportion of children who had no AOM recurrence at six months (two studies, 96 children, 60% versus 35%; RR 1.68, 95% CI 1.07 to 2.65, I2 = 0%, fixed-effect model, NNTB 5; very low-quality evidence);\n- number of AOM recurrences at six months (one study, 43 children, mean number of AOM recurrences per child: 0.86 versus 1.38, MD -0.52, 95% CI -1.37 to 0.33; very low-quality evidence).\nGrommets versus placebo medication\nGrommets were more effective than placebo medication in terms of:\n- proportion of children who had no AOM recurrence at six months (one study, 42 children, 55% versus 15%; RR 3.64, 95% CI 1.20 to 11.04, NNTB 3; very low-quality evidence);\n- number of AOM recurrences at six months (one study, 42 children, mean number of AOM recurrences per child: 0.86 versus 2.0, MD -1.14, 95% CI -2.06 to -0.22; very low-quality evidence).\nOne study reported persistent tympanic membrane perforations in 3 of 76 children (4%) receiving grommets (low-quality evidence).\nSubgroup analysis\nThere were insufficient data to determine whether presence of middle ear effusion at randomisation, type of grommet or age modified the effectiveness of grommets.\nAuthors' conclusions\nCurrent evidence on the effectiveness of grommets in children with rAOM is limited to five RCTs with unclear or high risk of bias, which were conducted prior to the introduction of pneumococcal vaccination. Low to very low-quality evidence suggests that children receiving grommets are less likely to have AOM recurrences compared to those managed by active monitoring and placebo medication, but the magnitude of the effect is modest with around one fewer episode at six months and a less noticeable effect by 12 months. The low to very low quality of the evidence means that these numbers need to be interpreted with caution since the true effects may be substantially different. It is uncertain whether or not grommets are more effective than antibiotic prophylaxis. The risk of persistent tympanic membrane perforation after grommet insertion was low.\nWidespread use of pneumococcal vaccination has changed the bacteriology and epidemiology of AOM, and how this might impact the results of prior trials is unknown. New and high-quality RCTs of grommet insertion in children with rAOM are therefore needed. These trials should not only focus on the frequency of AOM recurrences, but also collect data on the severity of AOM episodes, antibiotic consumption and adverse effects of both surgery and antibiotics. This is particularly important since grommets may reduce the severity of AOM recurrences and allow for topical rather than oral antibiotic treatment.\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 quality of the evidence on the benefits and harms of placement of grommets in both ears for children with recurring acute middle ear infections to be low to very low due to study limitations (risk of bias) and the small to very small sample sizes of included studies (leading to imprecise effect estimates). This means that the findings of this review should be interpreted with caution since the true effects of grommets in this group of children may be different than the numbers presented."
}
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query-laysum | 2813 | [
{
"role": "user",
"content": "Abstract: Background\nFor people with physical, sensory and cognitive limitations due to stroke, the routine practice of oral health care (OHC) may become a challenge. Evidence-based supported oral care intervention is essential for this patient group.\nObjectives\nTo compare the effectiveness of OHC interventions with usual care or other treatment options for ensuring oral health in people after a stroke.\nSearch methods\nWe searched the Cochrane Stroke Group and Cochrane Oral Health Group trials registers, CENTRAL, MEDLINE, Embase, and six other databases in February 2019. We scanned reference lists from relevant papers and contacted authors and researchers in the field. We handsearched the reference lists of relevant articles and contacted other researchers. There were no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated one or more interventions designed to improve the cleanliness and health of the mouth, tongue and teeth in people with a stroke who received assisted OHC led by healthcare staff. We included trials with a mixed population provided we could extract the stroke-specific data. The primary outcomes were dental plaque or denture plaque. Secondary outcomes included presence of oral disease, presence of related infection and oral opportunistic pathogens related to OHC and pneumonia, stroke survivor and providers' knowledge and attitudes to OHC, and patient satisfaction and quality of life.\nData collection and analysis\nTwo review authors independently screened abstracts and full-text articles according to prespecified selection criteria, extracted data and assessed the methodological quality using the Cochrane 'Risk of bias' tool. We sought clarification from investigators when required. Where suitable statistical data were available, we combined the selected outcome data in pooled meta-analyses. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nFifteen RCTs (22 randomised comparisons) involving 3631 participants with data for 1546 people with stroke met the selection criteria.\nOHC interventions compared with usual care\nSeven trials (2865 participants, with data for 903 participants with stroke, 1028 healthcare providers, 94 informal carers) investigated OHC interventions compared with usual care.\nMulti-component OHC interventions showed no evidence of a difference in the mean score (DMS) of dental plaque one month after the intervention was delivered (DMS –0.66, 95% CI –1.40 to 0.09; 2 trials, 83 participants; I2 = 83%; P = 0.08; very low-quality evidence).\nStroke survivors had less plaque on their dentures when staff had access to the multi-component OHC intervention (DMS –1.31, 95% CI –1.96 to –0.66; 1 trial, 38 participants; P < 0.0001; low-quality evidence).\nThere was no evidence of a difference in gingivitis (DMS –0.60, 95% CI –1.66 to 0.45; 2 trials, 83 participants; I2 = 93%; P = 0.26: very low-quality evidence) or denture-induced stomatitis (DMS –0.33, 95% CI –0.92 to 0.26; 1 trial, 38 participants; P = 0.69; low-quality evidence) among participants receiving the multi-component OHC protocol compared with usual care one month after the intervention. There was no difference in the incidence of pneumonia in participants receiving a multi-component OHC intervention (99 participants; 5 incidents of pneumonia) compared with those receiving usual care (105 participants; 1 incident of pneumonia) (OR 4.17, CI 95% 0.82 to 21.11; 1 trial, 204 participants; P = 0.08; low-quality evidence).\nOHC training for stroke survivors and healthcare providers significantly improved their OHC knowledge at one month after training (SMD 0.70, 95% CI 0.06 to 1.35; 3 trials, 728 participants; I2 = 94%; P = 0.03; very low-quality evidence). Pooled data one month after training also showed evidence of a difference between stroke survivor and providers' oral health attitudes (SMD 0.28, 95% CI 0.01 to 0.54; 3 trials, 728 participants; I2 = 65%; P = 0.06; very low-quality evidence).\nOHC interventions compared with placebo\nThree trials (394 participants, with data for 271 participants with stroke) compared an OHC intervention with placebo. There were no data for primary outcomes. There was no evidence of a difference in the incidence of pneumonia in participants receiving an OHC intervention compared with placebo (OR 0.39, CI 95% 0.14 to 1.09; 2 trials, 242 participants; I2 = 42%; P = 0.07; low-quality evidence). However, decontamination gel reduced the incidence of pneumonia among the intervention group compared with placebo gel group (OR 0.20, 95% CI 0.05 to 0.84; 1 trial, 203 participants; P = 0.028). There was no difference in the incidence of pneumonia in participants treated with povidone-iodine compared with a placebo (OR 0.81, 95% CI 0.18 to 3.51; 1 trial, 39 participants; P = 0.77).\nOne OHC intervention compared with another OHC intervention\nTwelve trials (372 participants with stroke) compared one OHC intervention with another OHC intervention. There was no difference in dental plaque scores between those participants that received an enhanced multi-component OHC intervention compared with conventional OHC interventions at three months (MD –0.04, 95% CI –0.33 to 0.25; 1 trial, 61 participants; P = 0.78; low-quality evidence). There were no data for denture plaque.\nAuthors' conclusions\nWe found low- to very low-quality evidence suggesting that OHC interventions can improve the cleanliness of patient's dentures and stroke survivor and providers' knowledge and attitudes. There is limited low-quality evidence that selective decontamination gel may be more beneficial than placebo at reducing the incidence of pneumonia. Improvements in the cleanliness of a patient's own teeth was limited. We judged the quality of the evidence included within meta-analyses to be low or very low quality, and this limits our confidence in the results. We still lack high-quality evidence of the optimal approach to providing OHC to people after stroke.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found little evidence to inform how OHC is best delivered. There was low-quality evidence from trials that compared OHC with standard care showing that OHC reduced denture plaque. There was no difference for studies that measured dental plaque. We found very low-quality evidence to show that training nursing staff and family carers improved their knowledge and attitudes to OHC. There was low-quality evidence that demonstrated the beneficial impact of a decontamination gel (to reduce the number of bacteria in the mouth) on the incidence of pneumonia compared with placebo gel among patients in a stroke ward. However, there was no other information on how best to provide OHC and more studies are urgently needed."
}
]
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query-laysum | 2814 | [
{
"role": "user",
"content": "Abstract: Background\nLarval source management (LSM) may help reduce Plasmodium parasite transmission in malaria-endemic areas. LSM approaches include habitat modification (permanently or temporarily reducing mosquito breeding aquatic habitats); habitat manipulation (temporary or recurrent change to environment); or use of chemical (e.g. larviciding) or biological agents (e.g. natural predators) to breeding sites. We examined the effectiveness of habitat modification or manipulation (or both), with and without larviciding.\nThis is an update of a review published in 2013.\nObjectives\n1. To describe and summarize the interventions on mosquito aquatic habitat modification or mosquito aquatic habitat manipulation, or both, on malaria control.\n2. To evaluate the beneficial and harmful effects of mosquito aquatic habitat modification or mosquito aquatic habitat manipulation, or both, on malaria control.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was from January 2012 to 30 November 2021.\nSelection criteria\nRandomized controlled trials (RCT) and non-randomized intervention studies comparing mosquito aquatic habitat modification or manipulation (or both) to no treatment or another active intervention. We also included uncontrolled before-after (BA) studies, but only described and summarized the interventions from studies with these designs. Primary outcomes were clinical malaria incidence, malaria parasite prevalence, and malaria parasitaemia incidence.\nData collection and analysis\nWe used standard Cochrane methods. We assessed risk of bias using the Cochrane RoB 2 tool for RCTs and the ROBINS-I tool for non-randomized intervention studies. We used a narrative synthesis approach to systematically describe and summarize all the interventions included within the review, categorized by the type of intervention (habitat modification, habitat manipulation, combination of habitat modification and manipulation). Our primary outcomes were 1. clinical malaria incidence; 2. malaria parasite prevalence; and 3. malaria parasitaemia incidence. Our secondary outcomes were 1. incidence of severe malaria; 2. anaemia prevalence; 3. mean haemoglobin levels; 4. mortality rate due to malaria; 5. hospital admissions for malaria; 6. density of immature mosquitoes; 7. density of adult mosquitoes; 8. sporozoite rate; 9. entomological inoculation rate; and 10. harms. We used the GRADE approach to assess the certainty of the evidence for each type of intervention.\nMain results\nSixteen studies met the inclusion criteria. Six used an RCT design, six used a controlled before-after (CBA) study design, three used a non-randomized controlled design, and one used an uncontrolled BA study design. Eleven studies were conducted in Africa and five in Asia. Five studies reported epidemiological outcomes and 15 studies reported entomological outcomes. None of the included studies reported on the environmental impacts associated with the intervention. For risk of bias, all trials had some concerns and other designs ranging from moderate to critical.\nTen studies assessed habitat manipulation (temporary change to the environment). This included water management (spillways across streams; floodgates; intermittent flooding; different drawdown rates of water; different flooding and draining regimens), shading management (shading of drainage channels with different plants), other/combined management approaches (minimal tillage; disturbance of aquatic habitats with grass clearing and water replenishment), which showed mixed results for entomological outcomes. Spillways across streams, faster drawdown rates of water, shading drainage canals with Napier grass, and using minimal tillage may reduce the density of immature mosquitoes (range of effects from 95% reduction to 1.7 times increase; low-certainty evidence), and spillways across streams may reduce densities of adult mosquitoes compared to no intervention (low-certainty evidence). However, the effect of habitat manipulation on malaria parasite prevalence and clinical malaria incidence is uncertain (very low-certainty evidence).\nTwo studies assessed habitat manipulation with larviciding. This included reducing or removal of habitat sites; and drain cleaning, grass cutting, and minor repairs. It is uncertain whether drain cleaning, grass cutting, and minor repairs reduces malaria parasite prevalence compared to no intervention (odds ratio 0.59, 95% confidence interval (CI) 0.42 to 0.83; very low-certainty evidence).\nTwo studies assessed combination of habitat manipulation and permanent change (habitat modification). This included drainage canals, filling, and planting of papyrus and other reeds for shading near dams; and drainage of canals, removal of debris, land levelling, and filling ditches. Studies did not report on epidemiological outcomes, but entomological outcomes suggest that such activities may reduce the density of adult mosquitoes compared to no intervention (relative risk reduction 0.49, 95% CI 0.47 to 0.50; low-certainty evidence), and preventing water stagnating using drainage of canals, removal of debris, land levelling, and filling ditches may reduce the density of immature mosquitoes compared to no intervention (ranged from 10% to 55% reductions; low-certainty evidence).\nThree studies assessed combining manipulation and modification with larviciding. This included filling or drainage of water bodies; filling, draining, or elimination of rain pools and puddles at water supply points and stream bed pools; and shoreline work, improvement and maintenance to drainage, clearing vegetation and undergrowth, and filling pools. There were mixed effect sizes for the reduction of entomological outcomes (moderate-certainty evidence). However, filling or draining water bodies probably makes little or no difference to malaria parasite prevalence, haemoglobin levels, or entomological inoculation rate when delivered with larviciding compared to no intervention (moderate-certainty evidence).\nAuthors' conclusions\nHabitat modification and manipulation interventions for preventing malaria has some indication of benefit in both epidemiological and entomological outcomes. While the data are quite mixed and further studies could help improve the knowledge base, these varied approaches may be useful in some circumstances.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review included a wide range of different changes to the water environment of immature mosquitoes, with some combining them with water treatments (larviciding), which meant that very few studies looked at the same intervention. Many of the included studies had issues regarding how well they were conducted."
}
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query-laysum | 2815 | [
{
"role": "user",
"content": "Abstract: Background\nWomen who have undergone surgical treatment for epithelial ovarian cancer (EOC) may develop menopausal symptoms due to immediate loss of ovarian function following surgery and chemotherapy. Women may experience vasomotor symptoms, sleep disturbance, difficulty concentrating, sexual dysfunction, vaginal symptoms and accelerated osteoporosis. Although hormone replacement therapy (HRT) is the most effective treatment to relieve these symptoms, its safety has been questioned for women with EOC.\nObjectives\nTo assess the safety and efficacy of HRT for menopausal symptoms in women surgically treated for EOC.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 6), MEDLINE via Ovid (1946 to 12 June 2019) and Embase via Ovid (1980 to 2019, week 23). We also handsearched conference reports and trial registries. There was no language restriction.\nSelection criteria\nWe included randomized controlled trials (RCTs) with participants of any age and menopausal status who had undergone surgery for EOC and, after diagnosis and treatment, used any regimen and duration of HRT compared with placebo or no hormone therapy. We also included trials comparing different regimens or duration of administration of HRT.\nData collection and analysis\nTwo review authors independently identified studies that met the inclusion criteria. They used Covidence to extract study characteristics, outcome data and to assess methodological quality of the included studies.\nMain results\nOur search strategy identified 2617 titles, of which 2614 titles were excluded. Three studies, involving 350 women, met our inclusion criteria. Two of the studies included pre and postmenopausal women, and the third only included premenopausal women. The overall age range of those women included in the studies was 20 to 89.6 years old, with a median follow-up ranging from 31.4 months to 19.1 years. The geographical distribution of participants included Europe, South Africa and China. All stages and histological subtypes were included in two of the studies, but stage IV disease had been excluded in the third. The three included studies used a variety of HRT regimens (conjugated oestrogen with or without medroxyprogesterone and with or without nylestriol) and HRT administrations (oral, patch and implant), In all studies, the comparisons were made versus women who had not received HRT.\nThe studies were at low or unclear risk of selection and reporting bias, and at high risk of performance, detection and attrition bias. The certainty of the evidence was low for overall survival and progression-free survival, and very low for quality-of-life assessment, incidence of breast cancer, transient ischaemic attack (TIA), cerebrovascular accident (CVA) and myocardial infarction (MI).\nMeta-analysis of these studies showed that HRT may improve overall survival (hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.54 to 0.93; 350 participants, 3 studies; low-certainty evidence). Quality-of-life assessment by use of the EORTC-C30 questionnaire was performed only in one study. We are uncertain whether HRT improves or reduces quality of life as the certainty of the evidence was assessed as very low (mean difference (MD) 13.67 points higher, 95% CI 9.26 higher to 18.08 higher; 1 study; 75 participants; very low-certainty evidence). Likewise, HRT may make little or no difference to progression-free survival (HR 0.76, 95% CI 0.57 to 1.01; 275 participants, 2 studies; low-certainty evidence).\nWe are uncertain whether HRT improves or reduces the incidence of breast cancer (risk ratio (RR) 2.00, 95% CI 0.19 to 21.59; 225 participants, 2 studies; very low-certainty evidence); TIA (RR 5.00, 95% CI 0.24 to 102.42; 150 participants, 1 study; very low-certainty evidence); CVA (RR 0.67, 95% CI 0.11 to 3.88; 150 participants, 1 study; very low-certainty evidence); and MI (RR 0.20, 95% CI 0.01 to 4.10; 150 participants, 1 study; very low-certainty evidence). The incidence of gallstones was not reported in the included studies.\nAuthors' conclusions\nHormone replacement therapy may slightly improve overall survival in women who have undergone surgical treatment for EOC, but the certainty of the evidence is low. HRT may make little or no difference to quality of life, incidence of breast cancer, TIA, CVA and MI as the certainty of the evidence has been assessed as very low. There may be little or no effect of HRT use on progression-free survival. The evidence in this review is limited by imprecision and incompleteness of reported relevant outcomes and therefore the results should be interpreted with caution. Future well-designed RCTs are required as this is an important area to women experiencing menopausal symptoms following surgical treatment for ovarian cancer, especially as doctors are often reluctant to prescribe HRT in this scenario. The evidence in this review is too limited to support or refute that HRT is very harmful in this population.\n\nGiven the provided abstract, please respond to the following query: \"What were the conclusions?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Hormone replacement therapy may improve the overall survival in women who are experiencing surgically induced menopause after treatment for EOC, but it may make little or no difference to survival without the disease getting worse. The overall certainty of these findings is low to very low, mainly due to a lack of information. This is a very important area for further research, which has the potential to make a big impact on many women."
}
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query-laysum | 2816 | [
{
"role": "user",
"content": "Abstract: Background\nThere are several possible interventions for managing pressure ulcers (sometimes referred to as pressure injuries), ranging from pressure-relieving measures, such as repositioning, to reconstructive surgery. The surgical approach is usually reserved for recalcitrant wounds (where the healing process has stalled, or the wound is not responding to treatment) or wounds with full-thickness skin loss and exposure of deeper structures such as muscle fascia or bone. Reconstructive surgery commonly involves wound debridement followed by filling the wound with new tissue. Whilst this is an accepted means of ulcer management, the benefits and harms of different surgical approaches, compared with each other or with non-surgical treatments, are unclear. This is an update of a Cochrane Review published in 2016.\nObjectives\nTo assess the effects of different types of reconstructive surgery for treating pressure ulcers (category/stage II or above), compared with no surgery or alternative reconstructive surgical approaches, in any care setting.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was January 2022.\nSelection criteria\nPublished or unpublished randomised controlled trials (RCTs) that assessed reconstructive surgery in the treatment of pressure ulcers.\nData collection and analysis\nTwo review authors independently selected the studies, extracted study data, assessed the risk of bias and undertook GRADE assessments. We would have involved a third review author in case of disagreement.\nMain results\nWe identified one RCT conducted in a hospital setting in the USA. It enrolled 20 participants aged between 20 and 70 years with stage IV ischial or sacral pressure ulcers (involving full-thickness skin and tissue loss). The study compared two reconstructive techniques for stage IV pressure ulcers: conventional flap surgery and cone of pressure flap surgery, in which a large portion of the flap tip is de-epithelialised and deeply inset to obliterate dead space. There were no clear data for any of our outcomes, although we extracted some information on complete wound healing, wound dehiscence, pressure ulcer recurrence and wound infection. We graded the evidence for these outcomes as very low-certainty. The study provided no data for any other outcomes.\nAuthors' conclusions\nCurrently there is very little randomised evidence on the role of reconstructive surgery in pressure ulcer management, although it is considered a priority area. More rigorous and robust research is needed to explore this intervention.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This is an update of a previous review. The evidence is up to date to January 2022."
}
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query-laysum | 2817 | [
{
"role": "user",
"content": "Abstract: Background\nDrowning is responsible for an estimated 320,000 deaths a year, and over 90% of drowning mortality occurs in low- to middle-income countries (LMICs), with peak drowning rates among children aged 1 to 4 years. In this age group, mortality due to drowning is particularly common in rural settings and about 75% of drowning accidents happen in natural bodies of water close to the home. Providing adequate child supervision can protect children from drowning, and organized formal day care programs could offer a way to achieve this.\nObjectives\nPrimary objective\n• To assess the effects of day care programs for children under 6 years of age on drowning-related mortality or morbidity, or on total drowning accidents (fatal and non-fatal), in LMICs, compared to no day care programs or other drowning prevention interventions\nSecondary objectives\n• To assess the effects of day care programs in LMICs for children under 6 years of age on unsafe water exposure\n• To assess safety within these programs (e.g. transmission of infection within day care, physical or sexual abuse of children within day care)\n• To assess the incidence of unintentional injury within these programs\n• To describe the cost-effectiveness of such programs, in relation to averted drowning-related mortality or morbidity\nSearch methods\nOn November 23, 2019, and for an update on August 18, 2020, we searched MEDLINE (PubMed), Embase, CENTRAL, ERIC, and CINAHL, as well as two trial registries. On December 16, 2019, and for an update on February 9, 2021, we searched 12 other resources, including websites of organizations that develop programs targeted to children.\nSelection criteria\nWe included randomized, quasi-randomized, and non-randomized controlled studies (with explicitly listed specific study design features) that implemented formal day care programs as a single program or combined with additional out-of-day care components (such as educational activities aimed at preventing injury or drowning or early childhood development activities) for children of preschool age (below 6 years of age) in LMICs for comparison with no such programs or with other drowning prevention interventions. Studies had to report at least one outcome related to drowning or injury prevention for the children enrolled.\nData collection and analysis\nTwo review authors independently performed study selection and data extraction, as well as risk of bias and GRADE assessment.\nMain results\nTwo non-randomized observational studies, conducted in rural Bangladesh, involving a total of 252,631 participants, met the inclusion criteria for this review. One of these studies compared a formal day care program combined with parent education, playpens provided to parents, and community-based activities as additional out-of-day care components versus no such program. Overall we assessed this study to be at moderate risk of bias (moderate risk of bias due to confounding, low risk of bias for other domains). This study showed that implementation of a formal day care program combined with parent education, provision of playpens to parents, and community-based activities, in a rural area with a high drowning incidence, likely reduces the risk of death from drowning over the study period of 4 years and 8 months compared to no day care program (hazard ratio 0.18, 95% confidence interval [CI] 0.06 to 0.58; 1 study, 136,577 participants; moderate-certainty evidence). Drowning morbidity (non-fatal drowning resulting in complications), total drowning (fatal and non-fatal), unsafe water exposure, and program safety (e.g. transmission of infection within day care, physical or sexual abuse of children within day care) were not reported, nor was the incidence of other unintentional injuries. Cost-effectiveness was reported as 812 USD (95% CI 589 to 1777) per disability-adjusted life-year averted as a consequence of drowning (moderate-certainty evidence). The second study compared day care programs with or without playpens provided to parents as an additional component versus only playpens provided to parents as an alternative drowning prevention intervention. Overall we assessed the study to be at critical risk of bias because we judged bias due to confounding to be at critical risk. As the certainty of evidence was very low, we are uncertain about the effects on drowning mortality rate of implementing a day care program compared to providing playpens (rate ratio 0.25, 95% CI 0.15 to 0.41; 1 study; 76,575 participants; very low-certainty evidence). Likewise, we are uncertain about the effects of a day care program with playpens provided as an additional component versus playpens provided alone (rate ratio 0.06, 95% CI 0.02 to 0.12; 1 study, 45,460 participants; very low-certainty evidence). The other outcomes of interest - drowning morbidity, total drowning, unsafe water exposure, program safety, incidence of other unintentional injuries, and cost-effectiveness - were not reported.\nAuthors' conclusions\nThis review provides evidence suggesting that a day care program with additional out-of-day care components such as community-based education, parent education, and playpens provided to parents likely reduces the drowning mortality risk in regions with a high burden of drowning compared to no intervention.\n\nGiven the provided abstract, please respond to the following query: \"Why did we do this Cochrane Review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Children living in rural areas near open water are at risk of drowning, particularly if they are not attending school or are left unsupervised. Child supervision is recommended to prevent drowning accidents, and organized day care at a center outside the home could help.\nWe wanted to know if a day care program for children under 6 years of age in low- to middle-income countries might help to reduce the number of drowning accidents (fatal and non-fatal)."
}
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query-laysum | 2818 | [
{
"role": "user",
"content": "Abstract: Background\nThere has been renewal of interest in the use of prophylactic antibiotics to reduce the frequency of exacerbations and improve quality of life in chronic obstructive pulmonary disease (COPD).\nObjectives\nTo determine whether or not regular (continuous, intermittent or pulsed) treatment of COPD patients with prophylactic antibiotics reduces exacerbations or affects quality of life.\nSearch methods\nWe searched the Cochrane Airways Group Trials Register and bibliographies of relevant studies. The latest literature search was performed on 27 July 2018.\nSelection criteria\nRandomised controlled trials (RCTs) that compared prophylactic antibiotics with placebo in patients with COPD.\nData collection and analysis\nWe used the standard Cochrane methods. Two independent review authors selected studies for inclusion, extracted data, and assessed risk of bias. We resolved discrepancies by involving a third review author.\nMain results\nWe included 14 studies involving 3932 participants in this review. We identified two further studies meeting inclusion criteria but both were terminated early without providing results. All studies were published between 2001 and 2015. Nine studies were of continuous macrolide antibiotics, two studies were of intermittent antibiotic prophylaxis (three times per week) and two were of pulsed antibiotic regimens (e.g. five days every eight weeks). The final study included one continuous, one intermittent and one pulsed arm. The antibiotics investigated were azithromycin, erythromycin, clarithromycin, doxycyline, roxithromycin and moxifloxacin. The study duration varied from three months to 36 months and all used intention-to-treat analysis. Most of the pooled results were of moderate quality. The risk of bias of the included studies was generally low.\nThe studies recruited participants with a mean age between 65 and 72 years and mostly at least moderate-severity COPD. Five studies only included participants with frequent exacerbations and two studies recruited participants requiring systemic steroids or antibiotics or both, or who were at the end stage of their disease and required oxygen. One study recruited participants with pulmonary hypertension secondary to COPD and a further study was specifically designed to asses whether eradication of Chlamydia pneumoniae reduced exacerbation rates.\nThe co-primary outcomes for this review were the number of exacerbations and quality of life.\nWith use of prophylactic antibiotics, the number of participants experiencing one or more exacerbations was reduced (odds ratio (OR) 0.57, 95% CI 0.42 to 0.78; participants = 2716; studies = 8; moderate-quality evidence). This represented a reduction from 61% of participants in the control group compared to 47% in the treatment group (95% CI 39% to 55%). The number needed to treat for an additional beneficial outcome with prophylactic antibiotics given for three to 12 months to prevent one person from experiencing an exacerbation (NNTB) was 8 (95% CI 5 to 17). The test for subgroup difference suggested that continuous and intermittent antibiotics may be more effective than pulsed antibiotics (P = 0.02, I² = 73.3%).\nThe frequency of exacerbations per patient per year was also reduced with prophylactic antibiotic treatment (rate ratio 0.67; 95% CI 0.54 to 0.83; participants = 1384; studies = 5; moderate-quality evidence). Although we were unable to pool the result, six of the seven studies reporting time to first exacerbation identified an increase (i.e. benefit) with antibiotics, which was reported as statistically significant in four studies.\nThere was a statistically significant improvement in quality of life as measured by the St George's Respiratory Questionnaire (SGRQ) with prophylactic antibiotic treatment, but this was smaller than the four unit improvement that is regarded as being clinically significant (mean difference (MD) -1.94, 95% CI -3.13 to -0.75; participants = 2237; studies = 7, high-quality evidence).\nProphylactic antibiotics showed no significant effect on the secondary outcomes of frequency of hospital admissions, change in forced expiratory volume in one second (FEV1), serious adverse events or all-cause mortality (moderate-quality evidence). There was some evidence of benefit in exercise tolerance, but this was driven by a single study of lower methodological quality.\nThe adverse events that were recorded varied among the studies depending on the antibiotics used. Azithromycin was associated with significant hearing loss in the treatment group, which was in many cases reversible or partially reversible. The moxifloxacin pulsed study reported a significantly higher number of adverse events in the treatment arm due to the marked increase in gastrointestinal adverse events (P < 0.001). Some adverse events that led to drug discontinuation, such as development of long QTc or tinnitus, were not significantly more frequent in the treatment group than the placebo group but pose important considerations in clinical practice.\nThe development of antibiotic resistance in the community is of major concern. Six studies reported on this, but we were unable to combine results. One study found newly colonised participants to have higher rates of antibiotic resistance. Participants colonised with moxifloxacin-sensitive pseudomonas at initiation of therapy rapidly became resistant with the quinolone treatment. A further study with three active treatment arms found an increase in the degree of antibiotic resistance of isolates in all three arms after 13 weeks treatment.\nAuthors' conclusions\nUse of continuous and intermittent prophylactic antibiotics results in a clinically significant benefit in reducing exacerbations in COPD patients. All studies of continuous and intermittent antibiotics used macrolides, hence the noted benefit applies only to the use of macrolide antibiotics prescribed at least three times per week. The impact of pulsed antibiotics remains uncertain and requires further research.\nThe studies in this review included mostly participants who were frequent exacerbators with at least moderate-severity COPD. There were also older individuals with a mean age over 65 years. The results of these studies apply only to the group of participants who were studied in these studies and may not be generalisable to other groups.\nBecause of concerns about antibiotic resistance and specific adverse effects, consideration of prophylactic antibiotic use should be mindful of the balance between benefits to individual patients and the potential harms to society created by antibiotic overuse. Monitoring of significant side effects including hearing loss, tinnitus, and long QTc in the community in this elderly patient group may require extra health resources.\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 carried out the latest search for studies in July 2018. We found 14 randomised controlled trials (RCTs) involving 3932 participants. All studies were published between 2001 and 2015. Nine studies were of continuous antibiotics, two studies were of intermittent antibiotic prophylaxis and two were of pulsed antibiotics. The final study included one continuous, one intermittent, one pulsed and one placebo arm. The antibiotics investigated were azithromycin, erythromycin, clarithromycin, roxithromycin, doxycycline and moxifloxacin. On average, the people involved in the studies were 65 to 72 years old and had moderate or severe COPD. Three studies included participants with frequent exacerbations and two of the studies recruited participants requiring steroid tablets or antibiotics or both, or who were at the end stage of their disease and required oxygen. One study only included people with a particular complication of COPD, involving the heart and blood vessels in the lungs (known as pulmonary hypertension)."
}
]
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query-laysum | 2819 | [
{
"role": "user",
"content": "Abstract: Background\nMedications or mechanical dilators are often used to soften and dilate the cervix prior to surgical evacuation of the uterus for non-viable pregnancy, or miscarriage. The majority of miscarriages occur in the first trimester. The aim of cervical ripening is to reduce the possibility of injury to the uterus and cervix and improve the surgical ease of the procedure. Cervical ripening agents can have adverse effects and it is uncertain as to whether these risks outweigh the benefits of their use.\nObjectives\nTo systematically review the benefits and harms of using cervical ripening agents prior to surgical evacuation of non-viable pregnancy prior to 14 weeks' gestation.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2015) and reference lists of retrieved papers.\nSelection criteria\nRandomised controlled trials (published in full-text form, or as abstracts only), which assessed the use of pharmacological or mechanical agents to ripen the cervix in women undergoing dilation and curettage or vacuum aspiration for non-viable pregnancy at less than 14 weeks' gestation were eligible for inclusion. Cluster-randomised controlled trials and trials using a cross-over design were not eligible for inclusion.\nUnpublished randomised controlled trials and quasi-randomised trials would have been eligible for inclusion but none were identified.\nData collection and analysis\nTwo review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Data were checked for accuracy.\nMain results\nWe included nine trials with 469 women. A diverse set of medications and regimens were studied in these trials, making the comparisons available for meta-analysis limited. The comparisons draw data from six trials with 383 participants. All trials were relatively small and had several aspects of unclear risk of bias with few of this review's outcomes reported. Due to this, no data from three trials were able to be used despite them meeting inclusion criteria.\nWe carried out four comparisons: isosorbide mononitrate or dinitrate compared with misoprostol; misoprostol compared with placebo; chemical dilation (use of medications) compared with mechanical dilation; and any cervical preparation compared with placebo.\nNone of the included studies reported data on the review's primary outcome: cervical or uterine injury (perforation, laceration, creation of a false passage).\nNo clear difference was shown between isosorbide compounds and misoprostol for the outcome need for manual cervical dilation (average risk ratio (RR) 0.76, 95% confidence interval (CI) 0.10 to 5.64; three trials, 150 women; Tau² = 2.11; I² = 69%), however the data were heterogenous. In terms of adverse effects, misoprostol was associated with more vomiting (RR 0.11, 95% CI 0.01 to 0.85; two trials, 120 women), however there were no clear differences between isosorbide compounds and misoprostol in relation to other reported adverse effects (headache, nausea or hypotension). The dosing regimens differed in terms of dose, number of administrations and route of administration in the different trials. Mechanical (Dilapan-S hygroscopic) dilators performed similarly to chemical dilators in a single trial (65 women) that measured difficulty in cervical dilation, excessive bleeding and adverse effects.\nMisoprostol was shown to be more effective than placebo for cervical ripening (reduced need for manual cervical dilation) (RR 0.14, 95% CI 0.08 to 0.26; one trial, 120 women), and surgical time was reduced when misoprostol was used (mean difference (MD) -3.15, 95% CI -3.59 to -2.70; one trial, 120 women). However, compared to placebo, misoprostol, was associated with more abdominal pain (RR 29.00, 95% CI 1.77 to 475.35; one trial, 120 women), although no clear differences in the risk of other adverse effects (nausea, vomiting, headache or fever) were observed between groups.\nThere was no clear differences between chemical dilation and mechanical dilators for the outcomes: difficulty in cervical dilation, excessive bleeding or adverse effects.\nCompared with placebo, any cervical preparation reduced the need for manual cervical dilatation (average RR 0.25, 95% CI 0.07 to 0.89; two trials, 168 women; Tau² = 0.67; I² = 81%), and reduced surgical time (MD -2.55, 95% CI -3.67 to -1.43, two trials, 168 women; Tau² = 0.63; I² = 96%).\nNone of the included trials reported on the review's other secondary outcomes, including: injury to bladder or bowel, miscarriage/preterm birth in a subsequent pregnancy, analgesia use after administration of ripening agent but before surgery, or analgesia use after surgery.\nAuthors' conclusions\nThis review found no evidence to evaluate cervical ripening prior to first trimester surgical evacuation for miscarriage for reducing the rate of cervical or uterine injury, however, this may be because these outcomes are very rare. Cervical preparation was shown to reduce the need for manual cervical dilatation compared with placebo.\nMisoprostol and isosorbide mononitrate and dinitrate were similarly effective in ripening the cervix, however there was more vomiting with misoprostol. Mechanical (Dilapan-S hygroscopic) dilators performed similarly to chemical dilators.\nThe nine studies included in this review were small and the methodological quality of the trials was mixed, and for the most part, not well-described; thus any conclusions drawn from the data included in this review must be treated with caution. Consequently, large, high-quality trials are required to determine whether the benefits of this treatment outweigh the risks. Further research should be powered to assess the rate of cervical and uterine injury between interventions. Future research should also guide clinicians in deciding whether the benefits of reduced manual cervical dilatation outweigh the risks of adverse effects associated with these agents (nausea, vomiting, headache, fever, diarrhoea and pain). Women's satisfaction and outcomes of future pregnancies should also be assessed.\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 nine studies included in this review were small and the methodological quality of the trials was varied. For the most part, the study methods were not well-described; thus any conclusions drawn from the data included in this review must be treated with caution. Large, high-quality trials are required to understand whether easier dilation means there is less risk of injury to the woman's uterus or cervix during the surgery, or if there are any effects on future pregnancies."
}
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query-laysum | 2820 | [
{
"role": "user",
"content": "Abstract: Background\nSore throat is a common side-effect of general anaesthesia and is reported by between 30% and 70% of patients after tracheal intubation. The likelihood of a sore throat varies with the type, diameter, and cuff pressure of the endotracheal tube used. If intubation is essential, it may be helpful to give drugs prophylactically to alleviate postoperative sore throat. Local anaesthetics and steroids have been used for this purpose. This review was originally published in 2009 and was updated in 2015.\nObjectives\nThe objective of this review was to evaluate the efficacy and any harm caused by topical and systemic lidocaine used prophylactically to prevent postoperative sore throat in adults undergoing general anaesthesia with endotracheal intubation.\nSearch methods\nWe searched CENTRAL (The Cochrane Library 2013, Issue 9), MEDLINE (January 1966 to October 2013), and EMBASE (1980 to October 2013). We also contacted manufacturers and researchers in the field. The original search was undertaken in June 2007. We reran the search in February 2015 and found four studies of interest. We will deal with those studies when we next update the review.\nSelection criteria\nWe included randomized controlled trials (RCTs) of topical and systemic prophylactic lidocaine therapy versus control (using air or saline) that reported on the risk and severity of postoperative sore throat as an outcome.\nData collection and analysis\nTwo authors independently assessed trial quality and extracted data. We contacted study authors for additional information, such as the risk of any adverse effects.\nMain results\nWe included 19 studies involving 1940 participants in this updated review. Of those 1940 participants, 952 received topical or systemic lidocaine therapy and 795 were allocated to the control groups. Topical and systemic lidocaine therapy appeared to reduce the risk of postoperative sore throat (16 studies, 1774 participants, risk ratio (RR) was 0.64 (95% confidence interval (CI) 0.48 to 0.85), the quality of the evidence was low), although when only high-quality trials were included (eight studies, 814 participants) the effect was no longer significant (RR 0.71, 95% CI 0.47 to 1.09). Lidocaine given systemically in two studies (320 participants) did not reveal evidence of an effect (RR 0.44, 95% CI 0.19 to 1.05 ). The severity of sore throat as measured on a visual-analogue scale (VAS) was reduced by lidocaine therapy (six trials, 611 participants, (mean difference (MD) -10.80, 95% CI -14.63 to -6.98). The adverse effects of lidocaine were not reported in these studies, though toxicity is generally rare.\nAuthors' conclusions\nIn our revised systematic review, although the results of included studies show generally positive results, they should be interpreted carefully. The effect size of lidocaine appeared to be affected by study quality; drug concentration; route of administration; management of cuff pressure during anaesthesia; the included population; and the type of outcome measured.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The summarized results of the included studies showed positive results. However, the interpretation of the results should be judged carefully. Though the possible adverse effects of using lidocaine were not reported in the included studies, there are a few case reports about lidocaine toxicity, although this is very rare."
}
]
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query-laysum | 2821 | [
{
"role": "user",
"content": "Abstract: Background\nEplerenone is an aldosterone receptor blocker that is chemically derived from spironolactone. In Canada, it is indicated for use as adjunctive therapy to reduce mortality for heart failure patients with New York Heart Association (NYHA) class II systolic chronic heart failure and left ventricular systolic dysfunction. It is also used as adjunctive therapy for patients with heart failure following myocardial infarction. Additionally, it is indicated for the treatment of mild and moderate essential hypertension for patients who cannot be treated adequately with other agents. It is important to determine the clinical impact of all antihypertensive medications, including aldosterone antagonists, to support their continued use in essential hypertension. No previous systematic reviews have evaluated the effect of eplerenone on cardiovascular morbidity, mortality, and magnitude of blood pressure lowering in patients with hypertension.\nObjectives\nTo assess the effects of eplerenone monotherapy versus placebo for primary hypertension in adults. Outcomes of interest were all-cause mortality, cardiovascular events (fatal or non-fatal myocardial infarction), cerebrovascular events (fatal or non fatal strokes), adverse events or withdrawals due to adverse events, and systolic and diastolic blood pressure.\nSearch methods\nWe searched the Cochrane Hypertension Specialised Register, CENTRAL, MEDLINE, Embase, and two trials registers up to 3 March 2016. We handsearched references from retrieved studies to identify any studies missed in the initial search. We also searched for unpublished data by contacting the corresponding authors of the included studies and pharmaceutical companies involved in conducting studies on eplerenone monotherapy in primary hypertension. The search had no language restrictions.\nSelection criteria\nWe selected randomized placebo-controlled trials studying adult patients with primary hypertension. We excluded studies in people with secondary or gestational hypertension and studies where participants were receiving multiple antihypertensives.\nData collection and analysis\nThree review authors independently reviewed the search results for studies meeting our criteria. Three review authors independently extracted data and assessed trial quality using a standardized data extraction form. A fourth independent review author resolved discrepancies or disagreements. We performed data extraction and synthesis using a standardized format on Covidence. We conducted data analysis using Review Manager 5.\nMain results\nA total of 1437 adult patients participated in the five randomized parallel group studies, with treatment durations ranging from 8 to 16 weeks. The daily doses of eplerenone ranged from 25 mg to 400 mg daily. Meta-analysis of these studies showed a reduction in systolic blood pressure of 9.21 mmHg (95% CI −11.08 to −7.34; I2 = 58%) and a reduction of diastolic pressure of 4.18 mmHg (95% CI −5.03 to −3.33; I2 = 0%) (moderate quality evidence).\nThere may be a dose response effect for eplerenone in the reduction in systolic blood pressure at doses of 400 mg/day. However, this finding is uncertain, as it is based on a single included study with low quality evidence. Overall there does not appear to be a clinically important dose response in lowering systolic or diastolic blood pressure at eplerenone doses of 50 mg to 400 mg daily. There did not appear to be any differences in the number of patients who withdrew due to adverse events or the number of patients with at least one adverse event in the eplerenone group compared to placebo. However, only three of the five included studies reported adverse events. Most of the included studies were of moderate quality, as we judged multiple domains as being at unclear risk in the 'Risk of bias' assessment.\nAuthors' conclusions\nEplerenone 50 to 200 mg/day lowers blood pressure in people with primary hypertension by 9.21 mmHg systolic and 4.18 mmHg diastolic compared to placebo, with no difference of effect between doses of 50 mg/day to 200 mg/day. A dose of 25 mg/day did not produce a statistically significant reduction in systolic or diastolic blood pressure and there is insufficient evidence for doses above 200 mg/day. There is currently no available evidence to determine the effect of eplerenone on clinically meaningful outcomes such as mortality or morbidity in hypertensive patients. The evidence available on side effects is insufficient and of low quality, which makes it impossible to draw conclusions about potential harm associated with eplerenone treatment in hypertensive patients.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is currently no evidence that eplerenone has a beneficial effect on life expectancy or complications rleated to hypertension (e.g. heart attack, stroke). Evidence for risk of side effects with eplerenone is limited and of poor quality; it is difficult to tell the extent of possible harm with eplerenone versus placebo. This meta-analysis shows that eplerenone 50 to 200 mg/day reduces systolic blood pressure by approximately 9 mmHg and diastolic blood pressure by 4 mmHg compared to taking no medication."
}
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query-laysum | 2822 | [
{
"role": "user",
"content": "Abstract: Background\nIn people who have had a stroke, upper limb paresis affects many activities of daily life. Reducing disability is therefore a major aim of rehabilitative interventions. Despite preserving or recovering movement ability after stroke, sometimes people do not fully realise this ability in their everyday activities. Constraint-induced movement therapy (CIMT) is an approach to stroke rehabilitation that involves the forced use and massed practice of the affected arm by restraining the unaffected arm. This has been proposed as a useful tool for recovering abilities in everyday activities.\nObjectives\nTo assess the efficacy of CIMT, modified CIMT (mCIMT), or forced use (FU) for arm management in people with hemiparesis after stroke.\nSearch methods\nWe searched the Cochrane Stroke Group trials register (last searched June 2015), the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library Issue 1, 2015), MEDLINE (1966 to January 2015), EMBASE (1980 to January 2015), CINAHL (1982 to January 2015), and the Physiotherapy Evidence Database (PEDro; January 2015).\nSelection criteria\nRandomised control trials (RCTs) and quasi-RCTs comparing CIMT, mCIMT or FU with other rehabilitative techniques, or none.\nData collection and analysis\nOne author identified trials from the results of the electronic searches according to the inclusion and exclusion criteria, three review authors independently assessed methodological quality and risk of bias, and extracted data. The primary outcome was disability.\nMain results\nWe included 42 studies involving 1453 participants. The trials included participants who had some residual motor power of the paretic arm, the potential for further motor recovery and with limited pain or spasticity, but tended to use the limb little, if at all. The majority of studies were underpowered (median number of included participants was 29) and we cannot rule out small-trial bias. Eleven trials (344 participants) assessed disability immediately after the intervention, indicating a non-significant standard mean difference (SMD) 0.24 (95% confidence interval (CI) -0.05 to 0.52) favouring CIMT compared with conventional treatment. For the most frequently reported outcome, arm motor function (28 studies involving 858 participants), the SMD was 0.34 (95% CI 0.12 to 0.55) showing a significant effect (P value 0.004) in favour of CIMT. Three studies involving 125 participants explored disability after a few months of follow-up and found no significant difference, SMD -0.20 (95% CI -0.57 to 0.16) in favour of conventional treatment.\nAuthors' conclusions\nCIMT is a multi-faceted intervention where restriction of the less affected limb is accompanied by increased exercise tailored to the person’s capacity. We found that CIMT was associated with limited improvements in motor impairment and motor function, but that these benefits did not convincingly reduce disability. This differs from the result of our previous meta-analysis where there was a suggestion that CIMT might be superior to traditional rehabilitation. Information about the long-term effects of CIMT is scarce. Further trials studying the relationship between participant characteristics and improved outcomes are required.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to assess the effects of constraint-induced movement therapy (CIMT) on ability to manage daily activities and on the recovery of movement in paralysed arms after a stroke."
}
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query-laysum | 2823 | [
{
"role": "user",
"content": "Abstract: Background\nEarly accurate detection of all skin cancer types is essential to guide appropriate management, reduce morbidity and improve survival. Basal cell carcinoma (BCC) is usually localised to the skin but has potential to infiltrate and damage surrounding tissue, while cutaneous squamous cell carcinoma (cSCC) and melanoma have a much higher potential to metastasise and ultimately lead to death. Exfoliative cytology is a non-invasive test that uses the Tzanck smear technique to identify disease by examining the structure of cells obtained from scraped samples. This simple procedure is a less invasive diagnostic test than a skin biopsy, and for BCC it has the potential to provide an immediate diagnosis that avoids an additional clinic visit to receive skin biopsy results. This may benefit patients scheduled for either Mohs micrographic surgery or non-surgical treatments such as radiotherapy. A cytology scrape can never give the same information as a skin biopsy, however, so it is important to better understand in which skin cancer situations it may be helpful.\nObjectives\nTo determine the diagnostic accuracy of exfoliative cytology for detecting basal cell carcinoma (BCC) in adults, and to compare its accuracy with that of standard diagnostic practice (visual inspection with or without dermoscopy). Secondary objectives were: to determine the diagnostic accuracy of exfoliative cytology for detecting cSCC, invasive melanoma and atypical intraepidermal melanocytic variants, and any other skin cancer; and for each of these secondary conditions to compare the accuracy of exfoliative cytology with visual inspection with or without dermoscopy in direct test comparisons; and to determine the effect of observer experience.\nSearch methods\nWe undertook a comprehensive search of the following databases from inception up to August 2016: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We also studied the reference lists of published systematic review articles.\nSelection criteria\nStudies evaluating exfoliative cytology in adults with lesions suspicious for BCC, cSCC or melanoma, compared with a reference standard of histological confirmation.\nData collection and analysis\nTwo review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). Where possible we estimated summary sensitivities and specificities using the bivariate hierarchical model.\nMain results\nWe synthesised the results of nine studies contributing a total of 1655 lesions to our analysis, including 1120 BCCs (14 datasets), 41 cSCCs (amongst 401 lesions in 2 datasets), and 10 melanomas (amongst 200 lesions in 1 dataset). Three of these datasets (one each for BCC, melanoma and any malignant condition) were derived from one study that also performed a direct comparison with dermoscopy. Studies were of moderate to poor quality, providing inadequate descriptions of participant selection, thresholds used to make cytological and histological diagnoses, and blinding. Reporting of participants' prior referral pathways was particularly poor, as were descriptions of the cytodiagnostic criteria used to make diagnoses. No studies evaluated the use of exfoliative cytology as a primary diagnostic test for detecting BCC or other skin cancers in lesions suspicious for skin cancer. Pooled data from seven studies using standard cytomorphological criteria (but various stain methods) to detect BCC in participants with a high clinical suspicion of BCC estimated the sensitivity and specificity of exfoliative cytology as 97.5% (95% CI 94.5% to 98.9%) and 90.1% (95% CI 81.1% to 95.1%). respectively. When applied to a hypothetical population of 1000 clinically suspected BCC lesions with a median observed BCC prevalence of 86%, exfoliative cytology would miss 21 BCCs and would lead to 14 false positive diagnoses of BCC. No false positive cases were histologically confirmed to be melanoma. Insufficient data are available to make summary statements regarding the accuracy of exfoliative cytology to detect melanoma or cSCC, or its accuracy compared to dermoscopy.\nAuthors' conclusions\nThe utility of exfoliative cytology for the primary diagnosis of skin cancer is unknown, as all included studies focused on the use of this technique for confirming strongly suspected clinical diagnoses. For the confirmation of BCC in lesions with a high clinical suspicion, there is evidence of high sensitivity and specificity. Since decisions to treat low-risk BCCs are unlikely in practice to require diagnostic confirmation given that clinical suspicion is already high, exfoliative cytology might be most useful for cases of BCC where the treatments being contemplated require a tissue diagnosis (e.g. radiotherapy). The small number of included studies, poor reporting and varying methodological quality prevent us from drawing strong conclusions to guide clinical practice. Despite insufficient data on the use of cytology for cSCC or melanoma, it is unlikely that cytology would be useful in these scenarios since preservation of the architecture of the whole lesion that would be available from a biopsy provides crucial diagnostic information. Given the paucity of good quality data, appropriately designed prospective comparative studies may be required to evaluate both the diagnostic value of exfoliative cytology by comparison to dermoscopy, and its confirmatory value in adequately reported populations with a high probability of BCC scheduled for further treatment requiring a tissue diagnosis.\n\nGiven the provided abstract, please respond to the following query: \"Why is improving the diagnosis of skin cancer important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There are a number of different types of skin cancer. The most common is basal cell carcinoma (BCC). BCC is a localised cancer that can grow and destroy the skin around it. They rarely spread into the body like other cancers can. Very small or superficial low-risk BCCs can generally be treated with treatments such as creams rather than surgery, while it is better to surgically remove BCCs that are more likely to grow and spread. Radiotherapy (a treatment where radiation is used to kill cancer cells) can also be used if BCCs are very large or cannot be removed by surgery. Cutaneous squamous cell carcinoma (cSCC) is also usually a localised skin cancer. In a small proportion of cases it can spread to other parts of the body, so the best treatment is to remove it using surgery. Melanoma is one of the most dangerous forms of skin cancer as it has a higher potential to spread to other parts of the body, and so it is vital to recognise it and remove it early. If people with BCC do not receive the correct diagnosis (known as a false negative test result), their treatment can be delayed, making the surgical procedure more complicated. Diagnosing BCC when it is actually something else (a false positive result) may result in unnecessary treatment, surgery or other investigations and can cause the patient stress and anxiety. If BCC is incorrectly diagnosed in an individual who actually has an cSCC or melanoma, effective treatment can be delayed and this might lead to a greater chance that the cSCC or melanoma spreads to other organs in the body, which can be very serious."
}
]
|
query-laysum | 2824 | [
{
"role": "user",
"content": "Abstract: Background\nA stroke occurs when the blood supply to part of the brain is cut off. Activities of daily living (ADL) are daily home-based activities that people carry out to maintain health and well-being. ADLs include the ability to: eat and drink unassisted, move, go to the toilet, carry out personal hygiene tasks, dress unassisted, and groom. Stroke causes impairment-related functional limitations that may result in difficulties participating in ADLs independent of supervision, direction, or physical assistance.\nFor adults with stroke, the goal of occupational therapy is to improve their ability to carry out activities of daily living. Strategies used by occupational therapists include assessment, treatment, adaptive techniques, assistive technology, and environmental adaptations. This is an update of the Cochrane review first published in 2006.\nObjectives\nTo assess the effects of occupational therapy interventions on the functional ability of adults with stroke in the domain of activities of daily living, compared with no intervention or standard care/practice.\nSearch methods\nFor this update, we searched the Cochrane Stroke Group Trials Register (last searched 30 January 2017), the Cochrane Controlled Trials Register (The Cochrane Library, January 2017), MEDLINE (1946 to 5 January 2017), Embase (1974 to 5 January 2017), CINAHL (1937 to January 2017), PsycINFO (1806 to 2 November 2016), AMED (1985 to 1 November 2016), and Web of Science (1900 to 6 January 2017). We also searched grey literature and clinical trials registers.\nSelection criteria\nWe identified randomised controlled trials of an occupational therapy intervention (compared with no intervention or standard care/practice) where people with stroke practiced activities of daily living, or where performance in activities of daily living was the focus of the occupational therapy intervention.\nData collection and analysis\nTwo review authors independently selected trials, assessed risk of bias, and extracted data for prespecified outcomes. The primary outcomes were the proportion of participants who had deteriorated or were dependent in personal activities of daily living and performance in activities of daily living at the end of follow-up.\nMain results\nWe included nine studies with 994 participants in this update. Occupational therapy targeted towards activities of daily living after stroke increased performance scores (standardised mean difference (SMD) 0.17, 95% confidence interval (CI) 0.03 to 0.31, P = 0.02; 7 studies; 749 participants; low-quality evidence) and reduced the risk of poor outcome (death, deterioration or dependency in personal activities of daily living) (odds ratio (OR) 0.71, 95% CI 0.52 to 0.96; P = 0.03; 5 studies; 771 participants; low-quality evidence). We also found that those who received occupational therapy were more independent in extended activities of daily living (OR 0.22 (95% CI 0.07 to 0.37); P = 0.005; 5 studies; 665 participants; low-quality evidence). Occupational therapy did not influence mortality (OR: 1.02 (95% CI 0.65 to 1.61); P = 0.93; 8 studies; 950 participants), or reduce the combined odds of death and institutionalisation (OR 0.89 (95% CI 0.60 to 1.32); P = 0.55; 4 studies; 671 participants), or death and dependency (OR 0.89 (95% CI 0.64 to 1.23); P = 0.47; 4 trials; 659 participants). Occupational therapy did not improve mood or distress scores (SMD 0.08 (95% CI -0.09 to 0.26); P = 0.35; 4 studies; 519 participants; low-quality evidence). There were insufficient data to determine the effects of occupational therapy on health-related quality of life. We found no studies of consenting carers prior to study participation and therefore there were no carer-related outcomes in our review. There were insufficient data to determine participants' and carers' satisfaction with services.\nUsing GRADE, the quality of evidence was low. The major limitation was the number of studies at unclear risk of selection bias and an inevitable high risk of performance and detection bias, as both participants and occupational therapists could not be blinded to the intervention. In addition, there was a sparseness of data for our outcomes of interest and we downgraded the quality of our evidence for these reasons.\nAuthors' conclusions\nWe found low-quality evidence that occupational therapy targeted towards activities of daily living after stroke can improve performance in activities of daily living and reduce the risk of deterioration in these abilities. Because the included studies had methodological flaws, this research does not provide a reliable indication of the likely effect of occupational therapy for adults with 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": "What are the effects of occupational therapy for adults with stroke on activities of daily living?"
}
]
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query-laysum | 2825 | [
{
"role": "user",
"content": "Abstract: Background\nDiarrhoeal disease accounts for millions of child deaths every year. Although the role of flies as vectors of infectious diarrhoea has been established, fly control is not often mentioned as an approach to decrease childhood diarrhoea. Theoretically, fly control for decreasing diarrhoea incidence can be achieved by intervening at four different levels: reduction or elimination of fly breeding sites; reduction of sources that attract houseflies; prevention of contact between flies and disease-causing organisms; and protection of people, food, and food utensils from contact with flies.\nObjectives\nTo assess the impact of various housefly control measures on the incidence of diarrhoea and its related morbidity and mortality in children under five years of age.\nSearch methods\nWe searched electronic databases including the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, CINAHL, and LILACS, from database inception to 24 May 2018. We also searched trial registries for relevant grey literature and ongoing trials. We checked the references of the identified studies and reviews. We did not apply any filters for language, publication status (published, unpublished, in press, and ongoing), or publication date.\nSelection criteria\nWe planned to include randomized controlled trials (RCTs), quasi-RCTs, and controlled before-and-after studies that studied the effect of fly control on diarrhoea in children under five years of age.\nData collection and analysis\nTwo review authors extracted the data and independently assessed the risk of bias in the included study. We planned to contact study authors for additional information, where necessary. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included one cluster-RCT (491 participants) conducted in Pakistan that evaluated insecticide spraying in the first two years and baited fly traps in the third year. Insecticide spraying reduced the fly population (house index) in the intervention group during the four months of the year when both flies and cases of diarrhoea were more common, but not at other times. On average, this was associated with a reduction in the incidence of diarrhoea in the first year (illustrative mean episodes per child-year in the intervention group was 6.3 while in the control group was 7.1) and second year of the intervention (illustrative mean episodes per child‒year in the intervention group was 4.4 while in the control group was 6.5; rate ratio (RaR) 0.77, 95% confidence interval (CI) 0.67 to 0.89, low-certainty evidence). In the third year of the intervention, the baited fly traps did not demonstrate an effect on the fly population or on diarrhoea incidence (RaR 1.15, 95% CI 0.90 to 1.47, low-certainty evidence).\nAuthors' conclusions\nThe trial, conducted in a setting where there were clear seasonal peaks in fly numbers and associated diarrhoea, shows insecticide spraying may reduce diarrhoea in children. Further research on whether this finding is applicable to other setting is required, as well as work on other fly control methods, their effects, feasibility, costs, and acceptability.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Insecticide spraying almost eliminated the flies and there were 23% fewer cases of diarrhoea in children residing in the sprayed villages when compared to unsprayed villages. This was due to an effect on the incidence of diarrhoea during fly seasons but not in the non-fly season (low-certainty evidence). Baited fly traps may have been ineffective in controlling flies and diarrhoea compared to villages with no fly traps (low-certainty evidence)."
}
]
|
query-laysum | 2826 | [
{
"role": "user",
"content": "Abstract: Background\nDisease recurrence and progression remain major challenges in the treatment of non-muscle invasive bladder cancer (NMIBC). Blue light-enhanced transurethral resection of bladder cancer (TURBT) is an approach to improve staging and achieve a complete resection of NMIBC.\nObjectives\nTo assess the effects of blue light-enhanced TURBT compared to white light-based TURBT in the treatment of NMIBC.\nSearch methods\nWe searched several medical literature databases, including the Cochrane Library, MEDLINE, and Embase, as well as trial registers, including ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We performed a comprehensive search with no restrictions on language of publication or publication status until March 2021.\nSelection criteria\nWe included randomized controlled trials using blue light versus white light TURBT. Included participants had a high level of suspicion based on imaging or ‘visible diagnosis’ for primary urothelial carcinoma of the bladder or recurrent urothelial carcinoma of the bladder upon cytoscopy. We excluded studies in which blue light was used in a surveillance setting.\nData collection and analysis\nTwo review authors independently performed data extraction and risk of bias assessment. Our primary outcomes were time to disease recurrence, time to disease progression, and serious surgical complications. Secondary outcomes were time to death from bladder cancer, any adverse events, and non-serious complications. We rated the certainty of evidence using the GRADE approach.\nMain results\nWe included 16 randomized controlled trials involving a total of 4325 participants in the review. The studies compared blue light versus white light TURBT for treatment of NMIBC.\nPrimary outcomes\nBlue light TURBT may reduce the risk of disease recurrence over time (hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.54 to 0.81; low-certainty evidence) depending on baseline risk. For participants with low-, intermediate-, and high-risk NMIBC, this corresponded to 48 (66 fewer to 27 fewer), 109 (152 fewer to 59 fewer), and 147 (211 fewer to 76 fewer) fewer recurrences per 1000 participants when compared to white light TURBT, respectively.\nBlue light TURBT may also reduce the risk of disease progression over time (HR 0.65, 95% CI 0.50 to 0.84; low-certainty evidence) depending on baseline risk. For participants with low-, intermediate-, and high-risk NMIBC, this corresponded to 1 (1 fewer to 0 fewer), 17 (25 fewer to 8 fewer), and 56 (81 fewer to 25 fewer) fewer progressions per 1000 participants when compared to white light TURBT, respectively.\nBlue light TURBT may have little or no effect on serious surgical complications (risk ratio (RR) 0.54, 95% CI 0.14 to 2.14; low-certainty evidence). This corresponded to 10 fewer (19 fewer to 25 more) surgical complications per 1000 participants with blue light TURBT.\nSecondary outcomes\nBlue light TURBT may have little or no effect on the risk of death from bladder cancer over time (HR 0.55, 95% CI 0.19 to 1.61; low-certainty evidence). This corresponded to 22 deaths per 1000 participants with white light TURBT and 10 fewer (17 fewer to 13 more) deaths per 1000 participants with blue light TURBT.\nWe are very uncertain how blue light TURBT affects the outcome adverse events of any grade (RR 1.09, 95% CI 0.88 to 1.33; low-certainty evidence).\nNo analysis was possible for the outcome non-serious surgical complications, as it was not reported by any of the included studies.\nAuthors' conclusions\nBlue light-enhanced TURBT for the treatment of non-muscle invasive bladder cancer compared to white light-based TURBT may reduce the risk of disease recurrence and disease progression over time depending on baseline risk. There may be little or no effect on serious surgical complications. The certainty of evidence for our findings was low, meaning that future studies are likely change to the reported estimates of effect. Frequent issues that led to downgrading of the certainty of the evidence were study limitations, inconsistency, and imprecision.\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": "How does a resection (surgical removal) of bladder cancer supported with a special visualization method (blue light) compare to a standard resection with white light in people in whom a tumor of the inner bladder wall is suspected?"
}
]
|
query-laysum | 2827 | [
{
"role": "user",
"content": "Abstract: Background\nBronchial thermoplasty is a procedure that consists of the delivery of controlled radiofrequency-generated heat via a catheter inserted into the bronchial tree of the lungs through a flexible bronchoscope. It has been suggested that bronchial thermoplasty works by reducing airway smooth muscle, thereby reducing the ability of the smooth muscle to bronchoconstrict. This treatment could then reduce asthma symptoms and exacerbations, resulting in improved asthma control and quality of life.\nObjectives\nTo determine the efficacy and safety of bronchial thermoplasty in adults with bronchial asthma.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register of Trials (CAGR) up to January 2014.\nSelection criteria\nWe included randomised controlled clinical trials that compared bronchial thermoplasty versus any active control in adults with moderate or severe persistent asthma. Our primary outcomes were quality of life, asthma exacerbations and adverse events.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias.\nMain results\nWe included three trials (429 participants) with differences regarding their design (two trials compared bronchial thermoplasty vs medical management and the other compared bronchial thermoplasty vs a sham intervention) and participant characteristics; one of the studies included participants with more symptomatic asthma compared with the others.\nThe pooled analysis showed improvement in quality of life at 12 months in participants who received bronchial thermoplasty that did not reach the threshold for clinical significance (3 trials, 429 participants; mean difference (MD) in Asthma Quality of Life Questionnaire (AQLQ) scores 0.28, 95% confidence interval (CI) 0.07 to 0.50; moderate-quality evidence). Measures of symptom control showed no significant differences (3 trials, 429 participants; MD in Asthma Control Questionnaire (ACQ) scores -0.15, 95% CI -0.40 to 0.10; moderate-quality evidence). The risk of bias for these outcomes was high because two of the studies did not have a sham intervention for the control group.\nThe results from two trials showed a lower rate of exacerbation after 12 months of treatment for participants who underwent bronchial thermoplasty. The trial with sham intervention showed a significant reduction in the proportion of participants visiting the emergency department for respiratory symptoms, from 15.3% on sham treatment to 8.4% over 12 months following thermoplasty. The trials showed no significant improvement in pulmonary function parameters (with the exception of a greater increase in morning peak expiratory flow (PEF) in one trial). Treated participants who underwent bronchial thermoplasty had a greater risk of hospitalisation for respiratory adverse events during the treatment period (3 trials, 429 participants; risk ratio 3.50, 95% CI 1.26 to 9.68; high-quality evidence), which represents an absolute increase from 2% to 8% (95% CI 3% to 23%) over the treatment period. This means that six of 100 participants treated with thermoplasty (95% CI 1 to 21) would require an additional hospitalisation over the treatment period. No significant difference in the risk of hospitalisation was noted at the end of the treatment period.\nBronchial thermoplasty was associated with an increase in respiratory adverse events, mainly during the treatment period. Most of these events were mild or moderate, appeared in the 24-hour post-treatment period, and were resolved within a week.\nAuthors' conclusions\nBronchial thermoplasty for patients with moderate to severe asthma provides a modest clinical benefit in quality of life and lower rates of asthma exacerbation, but no significant difference in asthma control scores. The quality of life findings are at risk of bias, as the main benefits were seen in the two studies that did not include a sham treatment arm. This procedure increases the risk of adverse events during treatment but has a reasonable safety profile after completion of the bronchoscopies. The overall quality of evidence regarding this procedure is moderate. For clinical practice, it would be advisable to collect data from patients systematically in independent clinical registries. Further research should provide better understanding of the mechanisms of action of bronchial thermoplasty, as well as its effect in different asthma phenotypes or in patients with worse lung function.\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": "These studies showed moderate improvement only in quality of life of patients treated with bronchial thermoplasty and in the number of asthma attacks (exacerbations) that they experienced. In addition, patients treated with this procedure had more respiratory problems than patients who received the alternative intervention during the period when they were undergoing treatment, resulting in increased risk of hospitalisation due to a respiratory symptom during this phase, but not afterward."
}
]
|
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