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query-laysum	21527	[ { "role": "user", "content": "Abstract: Background\nHepatocellular carcinoma occurs mostly in people with chronic liver disease and ranks sixth in terms of global incidence of cancer, and fourth in terms of cancer deaths. In clinical practice, computed tomography (CT) is used as a second-line diagnostic imaging modality to confirm the presence of focal liver lesions suspected as hepatocellular carcinoma on prior diagnostic test such as abdominal ultrasound or alpha-foetoprotein, or both, either in surveillance programmes or in clinical settings. According to current guidelines, a single contrast-enhanced imaging study CT or magnetic resonance imaging (MRI) showing typical hallmarks of hepatocellular carcinoma in people with cirrhosis is valid to diagnose hepatocellular carcinoma. However, a significant number of hepatocellular carcinomas do not show typical hallmarks on imaging modalities, and hepatocellular carcinoma is, therefore, missed. There is no clear evidence of the benefit of surveillance programmes in terms of overall survival: the conflicting results can be a consequence of inaccurate detection, ineffective treatment, or both. Assessing the diagnostic accuracy of CT may clarify whether the absence of benefit could be related to underdiagnosis. Furthermore, an assessment of the accuracy of CT in people with chronic liver disease, who are not included in surveillance programmes is needed for either ruling out or diagnosing hepatocellular carcinoma.\nObjectives\nPrimary: to assess the diagnostic accuracy of multidetector, multiphasic contrast-enhanced CT for the diagnosis of hepatocellular carcinoma of any size and at any stage in adults with chronic liver disease, either in a surveillance programme or in a clinical setting.\nSecondary: to assess the diagnostic accuracy of CT for the diagnosis of resectable hepatocellular carcinoma in adults with chronic liver disease.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Trials Register, Cochrane Hepato-Biliary Diagnostic-Test-Accuracy Studies Register, the Cochrane Library, MEDLINE, Embase, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index – Science until 4 May 2021. We applied no language or document-type restrictions.\nSelection criteria\nStudies assessing the diagnostic accuracy of CT for the diagnosis of hepatocellular carcinoma in adults with chronic liver disease, with cross-sectional designs, using one of the acceptable reference standards, such as pathology of the explanted liver and histology of resected or biopsied focal liver lesion with at least a six-month follow-up.\nData collection and analysis\nAt least two review authors independently screened studies, extracted data, and assessed the risk of bias and applicability concerns, using the QUADAS-2 checklist. We presented the results of sensitivity and specificity, using paired forest plots, and tabulated the results. We used a hierarchical meta-analysis model where appropriate. We presented uncertainty of the accuracy estimates using 95% confidence intervals (CIs). We double-checked all data extractions and analyses.\nMain results\nWe included 21 studies, with a total of 3101 participants. We judged all studies to be at high risk of bias in at least one domain because most studies used different reference standards, often inappropriate to exclude the presence of the target condition, and the time-interval between the index test and the reference standard was rarely defined. Regarding applicability in the patient selection domain, we judged 14% (3/21) of studies to be at low concern and 86% (18/21) of studies to be at high concern owing to characteristics of the participants who were on waiting lists for orthotopic liver transplantation.\nCT for hepatocellular carcinoma of any size and stage: sensitivity 77.5% (95% CI 70.9% to 82.9%) and specificity 91.3% (95% CI 86.5% to 94.5%) (21 studies, 3101 participants; low-certainty evidence).\nCT for resectable hepatocellular carcinoma: sensitivity 71.4% (95% CI 60.3% to 80.4%) and specificity 92.0% (95% CI 86.3% to 95.5%) (10 studies, 1854 participants; low-certainty evidence).\nIn the three studies at low concern for applicability (861 participants), we found sensitivity 76.9% (95% CI 50.8% to 91.5%) and specificity 89.2% (95% CI 57.0% to 98.1%).\nThe observed heterogeneity in the results remains mostly unexplained. The sensitivity analyses, which included only studies with clearly prespecified positivity criteria and only studies in which the reference standard results were interpreted without knowledge of the results of the index test, showed no variation in the results.\nAuthors' conclusions\nIn the clinical pathway for the diagnosis of hepatocellular carcinoma in adults with chronic liver disease, CT has roles as a confirmatory test for hepatocellular carcinoma lesions, and for staging assessment. We found that using CT in detecting hepatocellular carcinoma of any size and stage, 22.5% of people with hepatocellular carcinoma would be missed, and 8.7% of people without hepatocellular carcinoma would be unnecessarily treated. For resectable hepatocellular carcinoma, we found that 28.6% of people with resectable hepatocellular carcinoma would improperly not be resected, while 8% of people without hepatocellular carcinoma would undergo inappropriate surgery. The uncertainty resulting from the high risk of bias in the included studies and concerns regarding their applicability limit our ability to confidently draw conclusions based on our results.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The evidence is up to date to 4 May 2021." } ]
query-laysum	21528	[ { "role": "user", "content": "Abstract: Background\nAcute myeloid leukaemia (AML) is a malignant cancer of hematopoietic stem cells. The treatment of AML consists of two treatment phases: the remission induction phase to achieve a rapid, complete remission (CR) and the consolidation phase to achieve a durable molecular remission. People in CR are at risk of AML relapse, and people with relapsed AML have poor survival prospects. Thus, there is a continuous need for treatments to further improve prognosis. Interleukin-2 (IL-2), an immune-stimulatory cytokine, is an alternative to standard treatment for people with AML to maintain the efficacy after consolidation therapy. Maintenance therapy is not an integral part of the standard treatment for AML. Studies have been conducted to evaluate the efficacy of IL-2 as maintenance therapy for people with AML in first CR, but the effect of IL-2 is not yet fully established.\nObjectives\nTo evaluate the efficacy and safety of IL-2 as maintenance therapy for children and adults with AML who have achieved first CR and have not relapsed.\nSearch methods\nWe systematically searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2015, Issue 8), MEDLINE (1950 to August 2015), EMBASE (1950 to August 2015), LILACS (1982 to August 2015), CBM (1978 to August 2015), relevant conference proceedings (2000 to 2015), and metaRegister of Controlled Trials (since inception to August 2015) of ongoing and unpublished trials. In addition, we screened the reference lists of relevant trials and reviews.\nSelection criteria\nEligible studies were randomised controlled trials (RCTs) comparing IL-2 with no treatment in people with AML who had achieved first CR and had not relapsed. We did not identify studies comparing IL-2 versus best supportive care or maintenance chemotherapy or studies comparing IL-2 plus maintenance chemotherapy versus maintenance chemotherapy alone.\nData collection and analysis\nTwo review authors independently screened studies, extracted data with a predefined extraction form, and assessed risk of bias of included studies. We extracted data on the following outcomes: disease-free survival, overall survival, event-free survival, treatment-related mortality, adverse events, and quality of life. We measured the treatment effect on time-to-event outcomes and dichotomous outcomes with hazard ratio (HR) and risk ratio, respectively. We used inverse-variance method to combine HRs with fixed-effect model unless there was significant between-study heterogeneity.\nMain results\nWe included nine RCTs with a total of 1665 participants, comparing IL-2 with no treatment. Six studies included adult participants, and three studies included both adults and children. However, the latter three studies did not report data for children, thus we were unable to conduct subgroup analysis of children. One Chinese study did not report any outcomes of interest for this review. We included six trials involving 1426 participants in the meta-analysis on disease-free survival, and included five trials involving 1355 participants in the meta-analysis on overall survival. There is no evidence for difference between IL-2 group and no-treatment group regarding disease-free survival (HR 0.95; 95% CI 0.86 to 1.06, P = 0.37; quality of evidence: low) or overall survival (HR 1.05; 95% CI 0.95 to 1.16, P = 0.35; quality of evidence: moderate). Based on one trial of 161 participants, IL-2 exerted no effect on event-free survival (HR 1.02; 95% CI 0.79 to 1.32, P = 0.88; quality of evidence: low). Adverse events (including thrombocytopenia, neutropenia, malaise/fatigue, and infection/fever) were more frequent in participants receiving IL-2, according to one trial of 308 participants. No mortality due to adverse events was reported. None of the included studies reported treatment-related mortality or quality of life.\nAuthors' conclusions\nThere is no evidence for a difference between IL-2 maintenance therapy and no treatment with respect to disease-free survival or overall survival of people with AML in first CR; however, the quality of the evidence is moderate or low, and further research is likely or very likely to have an important impact on the estimate or our confidence in the estimate. Adverse events seem to be more frequent in participants treated with IL-2, but the quality of the evidence is very low and our confidence in the estimates is very uncertain. Thus, further prospective randomised trials are needed before definitive conclusions can be drawn on these issues.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We searched all databases for relevant studies published between January 1950 and August 2015 and identified 679 citations. We included nine studies involving 1665 participants. These trials enrolled from 24 to 528 participants between 1991 and 2008, with a median follow-up period of 2.4 to 8.3 years. Participants were aged from 0 to more than 60 years old. Six studies included adult participants; the other three included both adults and children. However, the latter three studies did not report data for children, so we were unable to conduct subgroup analysis of children. One Chinese study did not report any outcomes of interest for this review. Funding sources of these trials were mainly national institutes or organisations. Participants in the treatment group received IL-2 maintenance therapy, and participants in the control group received no further treatment. We did not identify studies comparing IL-2 with maintenance chemotherapy or comparing IL-2 plus maintenance chemotherapy with maintenance chemotherapy alone. The evidence is current to August 2015." } ]
query-laysum	21530	[ { "role": "user", "content": "Abstract: Background\nWhen primary root canal therapy fails, periapical lesions can be retreated with or without surgery. Root canal retreatment is a non-surgical procedure that involves removal of root canal filling materials from the tooth, followed by cleaning, shaping and obturating of the canals. Root-end resection is a surgical procedure that involves exposure of the periapical lesion through an osteotomy, surgical removal of the lesion, removal of part of the root-end tip, disinfection and, commonly, retrograde sealing or filling of the apical portion of the remaining root canal. This review updates one published in 2008.\nObjectives\nTo assess effects of surgical and non-surgical therapy for retreatment of teeth with apical periodontitis.\nTo assess effects of surgical root-end resection under various conditions, for example, when different materials, devices or techniques are used.\nSearch methods\nWe searched the following electronic databases: the Cochrane Oral Health Trials Register (to 10 February 2016), the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1), MEDLINE Ovid (1946 to 10 February 2016) and Embase Ovid (1980 to 10 February 2016). We searched the US National Registry of Clinical Trials (ClinicalTrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform for ongoing trials (to 10 February 2016). We placed no restrictions regarding language and publication date. We handsearched the reference lists of the studies retrieved and key journals in the field of endodontics.\nSelection criteria\nWe included randomised controlled trials (RCTs) involving people with periapical pathosis. Studies could compare surgery versus non-surgical treatment or could compare different types of surgery. Outcome measures were healing of the periapical lesion assessed after one-year follow-up or longer; postoperative pain and discomfort; and adverse effects such as tooth loss, mobility, soft tissue recession, abscess, infection, neurological damage or loss of root sealing material evaluated through radiographs.\nData collection and analysis\nTwo review authors independently extracted data from included studies and assessed their risk of bias. We contacted study authors to obtain missing information. We combined results of trials assessing comparable outcomes using the fixed-effect model, with risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, and 95% confidence intervals (CIs). We used generic inverse variance for split-mouth studies.\nMain results\nWe included 20 RCTs. Two trials at high risk of bias assessed surgery versus a non-surgical approach: root-end resection with root-end filling versus root canal retreatment. The other 18 trials evaluated different surgical protocols: cone beam computed tomography (CBCT) versus periapical radiography for preoperative assessment (one study at high risk of bias); antibiotic prophylaxis versus placebo (one study at unclear risk); different magnification devices (loupes, surgical microscope, endoscope) (two studies at high risk); types of incision (papilla base incision, sulcular incision) (one study at high risk and one at unclear risk); ultrasonic devices versus handpiece burs (one study at high risk); types of root-end filling material (glass ionomer cement, amalgam, intermediate restorative material (IRM), mineral trioxide aggregate (MTA), gutta-percha (GP), super-ethoxy benzoic acid (EBA)) (five studies at high risk of bias, one at unclear risk and one at low risk); grafting versus no grafting (three studies at high risk and one at unclear risk); and low energy level laser therapy versus placebo (irradiation without laser activation) versus control (no use of the laser device) (one study at high risk).\nThere was no clear evidence of superiority of the surgical or non-surgical approach for healing at one-year follow-up (RR 1.15, 95% CI 0.97 to 1.35; two RCTs, 126 participants) or at four- or 10-year follow-up (one RCT, 82 to 95 participants), although the evidence is very low quality. More participants in the surgically treated group reported pain in the first week after treatment (RR 3.34, 95% CI 2.05 to 5.43; one RCT, 87 participants; low quality evidence).\nIn terms of surgical protocols, there was some inconclusive evidence that ultrasonic devices for root-end preparation may improve healing one year after retreatment, when compared with the traditional bur (RR 1.14, 95% CI 1.00 to 1.30; one RCT, 290 participants; low quality evidence).\nThere was evidence of better healing when root-ends were filled with MTA than when they were treated by smoothing of orthograde GP root filling, after one-year follow-up (RR 1.60, 95% CI 1.14 to 2.24; one RCT, 46 participants; low quality evidence).\nThere was no evidence that using CBCT rather than radiography for preoperative evaluation was advantageous for healing (RR 1.02, 95% CI 0.70 to 1.47; one RCT, 39 participants; very low quality evidence), nor that any magnification device affected healing more than any other (loupes versus endoscope at one year: RR 1.05, 95% CI 0.92 to 1.20; microscope versus endoscope at two years: RR 1.01, 95% CI 0.89 to 1.15; one RCT, 70 participants, low quality evidence).\nThere was no evidence that antibiotic prophylaxis reduced incidence of postoperative infection (RR 0.49, 95% CI 0.09 to 2.64; one RCT, 250 participants; low quality evidence).\nThere was some evidence that using a papilla base incision (PBI) may be beneficial for preservation of the interdental papilla compared with complete papilla mobilisation (one RCT (split-mouth), 12 participants/24 sites; very low quality evidence). There was no evidence of less pain in the PBI group at day 1 post surgery (one RCT, 38 participants; very low quality evidence).\nThere was evidence that adjunctive use of a gel of plasma rich in growth factors reduced postoperative pain compared with no grafting (measured on visual analogue scale: one day postoperative MD -51.60 mm, 95% CI -63.43 to -39.77; one RCT, 36 participants; low quality evidence).\nThere was no evidence that use of low energy level laser therapy (LLLT) prevented postoperative pain (very low quality evidence).\nAuthors' conclusions\nAvailable evidence does not provide clinicians with reliable guidelines for treating periapical lesions. Further research is necessary to understand the effects of surgical versus non-surgical approaches, and to determine which surgical procedures provide the best results for periapical lesion healing and postoperative quality of life. Future studies should use standardised techniques and success criteria, precisely defined outcomes and the participant as the unit of analysis.\n\nGiven the provided abstract, please respond to the following query: \"Author conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "It is difficult to draw conclusions, as the evidence currently available is of low to very low quality. More randomised controlled trials conducted to high standards are needed to find out the effects of the surgical versus non-surgical approach and, when surgery is used, which materials, devices or operative protocols are best for improving lesion healing and reducing patient discomfort." } ]
query-laysum	21531	[ { "role": "user", "content": "Abstract: Background\nInjuries to the recurrent inferior laryngeal nerve (RILN) remain one of the major post-operative complications after thyroid and parathyroid surgery. Damage to this nerve can result in a temporary or permanent palsy, which is associated with vocal cord paresis or paralysis. Visual identification of the RILN is a common procedure to prevent nerve injury during thyroid and parathyroid surgery. Recently, intraoperative neuromonitoring (IONM) has been introduced in order to facilitate the localisation of the nerves and to prevent their injury during surgery. IONM permits nerve identification using an electrode, where, in order to measure the nerve response, the electric field is converted to an acoustic signal.\nObjectives\nTo assess the effects of IONM versus visual nerve identification for the prevention of RILN injury in adults undergoing thyroid surgery.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, ICTRP Search Portal and ClinicalTrials.gov. The date of the last search of all databases was 21 August 2018. We did not apply any language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing IONM nerve identification plus visual nerve identification versus visual nerve identification alone for prevention of RILN injury in adults undergoing thyroid surgery\nData collection and analysis\nTwo review authors independently screened titles and abstracts for relevance. One review author carried out screening for inclusion, data extraction and 'Risk of bias' assessment and a second review author checked them. For dichotomous outcomes, we calculated risk ratios (RRs) with 95% confidence intervals (CIs). For continuous outcomes, we calculated mean differences (MDs) with 95% CIs. We assessed trials for certainty of the evidence using the GRADE instrument.\nMain results\nFive RCTs with 1558 participants (781 participants were randomly assigned to IONM and 777 to visual nerve identification only) met the inclusion criteria; two trials were performed in Poland and one trial each was performed in China, Korea and Turkey. Inclusion and exclusion criteria differed among trials: previous thyroid or parathyroid surgery was an exclusion criterion in three trials. In contrast, this was a specific inclusion criterion in another trial. Three trials had central neck compartment dissection or lateral neck dissection and Graves’ disease as exclusion criteria. The mean duration of follow-up ranged from 6 to 12 months. The mean age of participants ranged between 41.7 years and 51.9 years.\nThere was no firm evidence of an advantage or disadvantage comparing IONM with visual nerve identification only for permanent RILN palsy (RR 0.77, 95% CI 0.33 to 1.77; P = 0.54; 4 trials; 2895 nerves at risk; very low-certainty evidence) or transient RILN palsy (RR 0.62, 95% CI 0.35 to 1.08; P = 0.09; 4 trials; 2895 nerves at risk; very low-certainty evidence). None of the trials reported health-related quality of life. Transient hypoparathyroidism as an adverse event was not substantially different between intervention and comparator groups (RR 1.25; 95% CI 0.45 to 3.47; P = 0.66; 2 trials; 286 participants; very low-certainty evidence). Operative time was comparable between IONM and visual nerve monitoring alone (MD 5.5 minutes, 95% CI −0.7 to 11.8; P = 0.08; 3 trials; 1251 participants; very low-certainty evidence). Three of five included trials provided data on all-cause mortality: no deaths were reported. None of the trials reported socioeconomic effects. The evidence reported in this review was mostly of very low certainty, particularly because of risk of bias, a high degree of imprecision due to wide confidence intervals and substantial between-study heterogeneity.\nAuthors' conclusions\nResults from this systematic review and meta-analysis indicate that there is currently no conclusive evidence for the superiority or inferiority of IONM over visual nerve identification only on any of the outcomes measured. Well-designed, executed, analysed and reported RCTs with a larger number of participants and longer follow-up, employing the latest IONM technology and applying new surgical techniques are needed.\n\nGiven the provided abstract, please respond to the following query: \"Trial characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We searched for randomised controlled trials (trials where the participants are randomly allocated to one, two, or more treatment arms), comparing intraoperative neuromonitoring plus visual nerve identification with visual nerve identification alone. We included only trials that reported data on participants older than 18 years who underwent thyroid surgery. We excluded trials with participants with previous neck surgery or repeated laryngeal nerve paralysis. We included five trials with a total of 1558 participants; 781 participants were allocated to intraoperative neuromonitoring and 777 participants were allocated to visual nerve identification only. Two trials took place in Poland and one study each in Turkey, China and Korea. The average age of participants ranged between 41.7 years and 51.9 years.\nThis evidence is up to date as of 21 August 2018." } ]
query-laysum	21532	[ { "role": "user", "content": "Abstract: Background\nRelapse (the re-emergence of depressive symptoms after some level of improvement but preceding recovery) and recurrence (onset of a new depressive episode after recovery) are common in depression, lead to worse outcomes and quality of life for patients and exert a high economic cost on society. Outcomes can be predicted by using multivariable prognostic models, which use information about several predictors to produce an individualised risk estimate. The ability to accurately predict relapse or recurrence while patients are well (in remission) would allow the identification of high-risk individuals and may improve overall treatment outcomes for patients by enabling more efficient allocation of interventions to prevent relapse and recurrence.\nObjectives\nTo summarise the predictive performance of prognostic models developed to predict the risk of relapse, recurrence, sustained remission or recovery in adults with major depressive disorder who meet criteria for remission or recovery.\nSearch methods\nWe searched the Cochrane Library (current issue); Ovid MEDLINE (1946 onwards); Ovid Embase (1980 onwards); Ovid PsycINFO (1806 onwards); and Web of Science (1900 onwards) up to May 2020. We also searched sources of grey literature, screened the reference lists of included studies and performed a forward citation search. There were no restrictions applied to the searches by date, language or publication status .\nSelection criteria\nWe included development and external validation (testing model performance in data separate from the development data) studies of any multivariable prognostic models (including two or more predictors) to predict relapse, recurrence, sustained remission, or recovery in adults (aged 18 years and over) with remitted depression, in any clinical setting. We included all study designs and accepted all definitions of relapse, recurrence and other related outcomes. We did not specify a comparator prognostic model.\nData collection and analysis\nTwo review authors independently screened references; extracted data (using a template based on the CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies (CHARMS)); and assessed risks of bias of included studies (using the Prediction model Risk Of Bias ASsessment Tool (PROBAST)). We referred any disagreements to a third independent review author. Where we found sufficient (10 or more) external validation studies of an individual model, we planned to perform a meta-analysis of its predictive performance, specifically with respect to its calibration (how well the predicted probabilities match the observed proportions of individuals that experience the outcome) and discrimination (the ability of the model to differentiate between those with and without the outcome). Recommendations could not be qualified using the GRADE system, as guidance is not yet available for prognostic model reviews.\nMain results\nWe identified 11 eligible prognostic model studies (10 unique prognostic models). Seven were model development studies; three were model development and external validation studies; and one was an external validation-only study. Multiple estimates of performance measures were not available for any of the models and, meta-analysis was therefore not possible. Ten out of the 11 included studies were assessed as being at high overall risk of bias. Common weaknesses included insufficient sample size, inappropriate handling of missing data and lack of information about discrimination and calibration. One paper (Klein 2018) was at low overall risk of bias and presented a prognostic model including the following predictors: number of previous depressive episodes, residual depressive symptoms and severity of the last depressive episode. The external predictive performance of this model was poor (C-statistic 0.59; calibration slope 0.56; confidence intervals not reported). None of the identified studies examined the clinical utility (net benefit) of the developed model.\nAuthors' conclusions\nOf the 10 prognostic models identified (across 11 studies), only four underwent external validation. Most of the studies (n = 10) were assessed as being at high overall risk of bias, and the one study that was at low risk of bias presented a model with poor predictive performance. There is a need for improved prognostic research in this clinical area, with future studies conforming to current best practice recommendations for prognostic model development/validation and reporting findings in line with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The literature search for this review was completed in May 2020." } ]
query-laysum	21533	[ { "role": "user", "content": "Abstract: Background\nIn school dental screening, a dental health professional visually inspects children’s oral cavities in a school setting and provides information for parents on their child's current oral health status and treatment needs. Screening at school aims to identify potential problems before symptomatic disease presentation, hence prompting preventive and therapeutic oral health care for the children. This review evaluates the effectiveness of school dental screening for improving oral health status. It is the second update of a review originally published in December 2017 and first updated in August 2019.\nObjectives\nTo assess the effectiveness of school dental screening programmes on overall oral health status and use of dental services.\nSearch methods\nAn information specialist searched four bibliographic databases up to 15 October 2021 and used additional search methods to identify published, unpublished and ongoing studies.\nSelection criteria\nWe included randomised controlled trials (RCTs; cluster- or individually randomised) that evaluated school dental screening compared with no intervention, or that compared two different types of screening.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nThe previous version of this review included seven RCTs, and our updated search identified one additional trial. Therefore, this update included eight trials (six cluster-RCTs) with 21,290 children aged 4 to 15 years. Four trials were conducted in the UK, two in India, one in the USA and one in Saudi Arabia. We rated two trials at low risk of bias, three at high risk of bias and three at unclear risk of bias.\nNo trials had long-term follow-up to ascertain the lasting effects of school dental screening. The trials assessed outcomes at 3 to 11 months of follow-up.\nNo trials reported the proportion of children with treated or untreated oral diseases other than caries. Neither did they report on cost-effectiveness or adverse events.\nFour trials evaluated traditional screening versus no screening. We performed a meta-analysis for the outcome 'dental attendance' and found an inconclusive result with high heterogeneity. The heterogeneity was partly due to study design (three cluster-RCTs and one individually randomised trial). Due to this inconsistency, and unclear risk of bias, we downgraded the evidence to very low certainty, and we are unable to draw conclusions about this comparison.\nTwo cluster-RCTs (both four-arm trials) evaluated criteria-based screening versus no screening, suggesting a possible small benefit (pooled risk ratio (RR) 1.07, 95% confidence interval (CI) 0.99 to 1.16; low-certainty evidence). There was no evidence of a difference when comparing criteria-based screening to traditional screening (RR 1.01, 95% CI 0.94 to 1.08; very low-certainty evidence).\nOne trial compared a specific (personalised) referral letter to a non-specific letter. Results favoured the specific referral letter for increasing attendance at general dentist services (RR 1.39, 95% CI 1.09 to 1.77; very low-certainty evidence) and attendance at specialist orthodontist services (RR 1.90, 95% CI 1.18 to 3.06; very low-certainty evidence).\nOne trial compared screening supplemented with motivation to screening alone. Dental attendance was more likely after screening supplemented with motivation (RR 3.08, 95% CI 2.57 to 3.71; very low-certainty evidence).\nOne trial compared referral to a specific dental treatment facility with advice to attend a dentist. There was no evidence of a difference in dental attendance between these two referrals (RR 0.91, 95% CI 0.34 to 2.47; very low-certainty evidence).\nOnly one trial reported the proportion of children with treated dental caries. This trial evaluated a post-screening referral letter based on the common-sense model of self-regulation (a theoretical framework that explains how people understand and respond to threats to their health), with or without a dental information guide, compared to a standard referral letter. The findings were inconclusive. Due to high risk of bias, indirectness and imprecision, we assessed the evidence as very low certainty.\nAuthors' conclusions\nThe evidence is insufficient to draw conclusions about whether there is a role for school dental screening in improving dental attendance.\nWe are uncertain whether traditional screening is better than no screening (very low-certainty evidence). Criteria-based screening may improve dental attendance when compared to no screening (low-certainty evidence). However, when compared to traditional screening, there is no evidence of a difference in dental attendance (very low-certainty evidence).\nFor children requiring treatment, personalised or specific referral letters may improve dental attendance when compared to non-specific referral letters (very low-certainty evidence). Screening supplemented with motivation (oral health education and offer of free treatment) may improve dental attendance in comparison to screening alone (very low-certainty evidence). We are uncertain whether a referral letter based on the 'common-sense model of self-regulation' is better than a standard referral letter (very low-certainty evidence) or whether specific referral to a dental treatment facility is better than a generic advice letter to visit the dentist (very low-certainty evidence).\nThe trials included in this review evaluated effects of school dental screening in the short term. None of them evaluated its effectiveness for improving oral health or addressed possible adverse effects or costs.\n\nGiven the provided abstract, please respond to the following query: \"What were the main results of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Our updated search identified one new study to be included since the last version of the review was published. In total, the review includes eight studies that presented results for 21,290 children. Four studies took place in the UK, two in India, one in the USA and one in Saudi Arabia. The children were 4 to 15 years old. Studies looked at the oral health and dental attendance of children who were screened in school compared to children who did not have screening. Some studies also compared different ways of screening and different forms of follow-up (e.g. advice letter or referral).\nWe do not know whether traditional school dental screening improves dental attendance. Studies looking at screening based on specific criteria (e.g. targeted at children not registered with a dentist) suggested it may be slightly more effective than no screening for improving attendance at the dentist. There may be no difference between criteria-based screening and universal screening for improving dental attendance, but we are very unsure about the results.\nA personalised or specific referral letter to parents may improve dental attendance more than a non-specific letter, but we are very unsure about the results.\nScreening with added motivation (health education and offer of free treatment) may improve dental attendance compared to screening alone, but we are very unsure about the results.\nOne study comparing different referral letters (with more or less information about dental diseases) found that neither was better than the other for improving dental treatment in children.\nA specific referral letter did not encourage more parents to take their children to the dentist when compared to a letter with generic advice to visit the dentist.\nThe eight studies followed up children for 3 to 11 months after they received screening. Therefore, we do not know the effects of screening over a longer period of time.\nNone of the studies checked whether there were any negative effects of screening programmes or how much they cost." } ]
query-laysum	21535	[ { "role": "user", "content": "Abstract: Background\nNeonatal healthcare-associated infections (HAIs) result in increased morbidity and mortality, as well as increased healthcare costs. Patient isolation measures, i.e. single-room isolation or the cohorting of patients with similar infections, remain a recommended and commonly used practice for preventing horizontal spread of infections in the neonatal intensive care unit (NICU).\nObjectives\nOur primary objective was to assess the effect of single-room isolation or cohorting, or both for preventing transmission of HAIs or colonization with HAI-causing pathogens in newborn infants less than six months of age admitted to the neonatal intensive care unit (NICU).\nOur secondary objective was to assess the effect of single-room isolation or cohorting, or both on neonatal mortality and perceived or documented adverse effects in newborn infants admitted to the NICU.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, the WHO ICTRP and ClinicalTrials.gov trials registries. There were no restrictions to date, language or publication type. We also checked the reference lists of studies identified for full-text review.\nSelection criteria\nTypes of studies: cluster-randomized or quasi-randomized trials at the level of the cluster (where clusters may be defined by NICU, hospital, ward, or other subunits of the hospital). We also included cross-over trials with a washout period of more than four months (arbitrarily defined).\nTypes of participants: newborn infants less than six months of age in neonatal units that implemented patient isolation or cohorting as infection control measures to prevent HAIs.\nTypes of interventions: patient isolation measures (single-room isolation or cohorting, or both of infants with similar colonization or infections) compared to routine isolation measures.\nTypes of outcome measures: the primary outcome was the rate of transmission of HAIs as estimated by the infection and colonization rates in the NICU. Secondary outcomes included all-cause mortality during hospital stay at 28 days of age, length of hospital stay, as well as potential adverse effects of isolation or cohorting measures, or both.\nData collection and analysis\nThe standard methods of Cochrane Neonatal were used to identify studies and assess the methodological quality of eligible cluster-randomized trials. The certainty of the evidence was to be assessed by the GRADE method as evidence of high, moderate, low, or very low certainty. Infection and colonization rates were to be expressed as rate ratios for each trial and if appropriate for meta-analysis, the generic inverse variance method in RevMan was to be used.\nMain results\nWe did not identify any published or ongoing trials to include in the review.\nAuthors' conclusions\nThe review found no evidence from randomized trials to either support or refute the use of patient isolation measures (single-room isolation or cohorting) in neonates with HAIs. Risks secondary to infection control measures need to be balanced against the benefits of decreasing horizontal transmission in the neonatal unit for optimal neonatal outcomes. There is an urgent need to research the effectiveness of patient isolation measures for preventing the transmission of HAIs in neonatal units. Well-designed trials randomizing clusters of units or hospitals to a type of patient isolation method intervention are warranted.\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 assessed isolation and grouping of infants in addition to the routine methods of infection control (e.g. hand washing, use of gowns and gloves, etc.)." } ]
query-laysum	21536	[ { "role": "user", "content": "Abstract: Background\nDental pain can have a detrimental effect on quality of life. Symptomatic apical periodontitis and acute apical abscess are common causes of dental pain and arise from an inflamed or necrotic dental pulp, or infection of the pulpless root canal system. Clinical guidelines recommend that the first-line treatment for teeth with these conditions should be removal of the source of inflammation or infection by local, operative measures, and that systemic antibiotics are currently only recommended for situations where there is evidence of spreading infection (cellulitis, lymph node involvement, diffuse swelling) or systemic involvement (fever, malaise). Despite this, there is evidence that dentists frequently prescribe antibiotics in the absence of these signs. There is concern that this could contribute to the development of antibiotic-resistant bacterial colonies within both the individual and the community. This review is an update of the original version that was published in 2014.\nObjectives\nTo evaluate the effects of systemic antibiotics provided with or without surgical intervention (such as extraction, incision and drainage of a swelling, or endodontic treatment), with or without analgesics, for symptomatic apical periodontitis and acute apical abscess in adults.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 26 February 2018), the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1) in the Cochrane Library (searched 26 February 2018), MEDLINE Ovid (1946 to 26 February 2018), Embase Ovid (1980 to 26 February 2018), and CINAHL EBSCO (1937 to 26 February 2018). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. A grey literature search was conducted using OpenGrey (to 26 February 2018) and ZETOC Conference Proceedings (1993 to 26 February 2018). No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials of systemic antibiotics in adults with a clinical diagnosis of symptomatic apical periodontitis or acute apical abscess, with or without surgical intervention (considered in this situation to be extraction, incision and drainage or endodontic treatment) and with or without analgesics.\nData collection and analysis\nTwo authors screened the results of the searches against inclusion criteria, extracted data and assessed risk of bias independently and in duplicate. We calculated mean differences (MD) (standardised mean difference (SMD) when different scales were reported) and 95% confidence intervals (CI) for continuous data. A fixed-effect model was used in the meta-analysis as there were fewer than four studies. We contacted study authors to obtain missing information.\nMain results\nWe included two trials in this review, with 62 participants included in the analyses. Both trials were conducted in university dental schools in the USA and compared the effects of oral penicillin V potassium (penicillin VK) versus a matched placebo when provided in conjunction with a surgical intervention (total or partial pulpectomy) and analgesics to adults with acute apical abscess or symptomatic necrotic tooth. The patients included in these trials had no signs of spreading infection or systemic involvement (fever, malaise). We assessed one study as having a high risk of bias and the other study as having unclear risk of bias.\nThe primary outcome variables reported in both studies were participant-reported pain and swelling (one trial also reported participant-reported percussion pain). One study reported the type and number of analgesics taken by participants. One study recorded the incidence of postoperative endodontic flare-ups (people who returned with symptoms that necessitated further treatment). Adverse effects, as reported in one study, were diarrhoea (one participant, placebo group) and fatigue and reduced energy postoperatively (one participant, antibiotic group). Neither study reported quality of life measurements.\nObjective 1: systemic antibiotics versus placebo with surgical intervention and analgesics for symptomatic apical periodontitis or acute apical abscess\nTwo studies provided data for the comparison between systemic antibiotics (penicillin VK) and a matched placebo for adults with acute apical abscess or a symptomatic necrotic tooth when provided in conjunction with a surgical intervention. Participants in one study all underwent a total pulpectomy of the affected tooth, while participants in the other study had their tooth treated by either partial or total pulpectomy. Participants in both trials received oral analgesics. There were no statistically significant differences in participant-reported measures of pain or swelling at any of the time points assessed within the review. The MD for pain (short ordinal numerical scale 0 to 3) was -0.03 (95% CI -0.53 to 0.47) at 24 hours; 0.32 (95% CI -0.22 to 0.86) at 48 hours; and 0.08 (95% CI -0.38 to 0.54) at 72 hours. The SMD for swelling was 0.27 (95% CI -0.23 to 0.78) at 24 hours; 0.04 (95% CI -0.47 to 0.55) at 48 hours; and 0.02 (95% CI -0.49 to 0.52) at 72 hours. The body of evidence was assessed as at very low quality.\nObjective 2: systemic antibiotics without surgical intervention for adults with symptomatic apical periodontitis or acute apical abscess\nWe found no studies that compared the effects of systemic antibiotics with a matched placebo delivered without a surgical intervention for symptomatic apical periodontitis or acute apical abscess in adults.\nAuthors' conclusions\nThere is very low-quality evidence that is insufficient to determine the effects of systemic antibiotics on adults with symptomatic apical periodontitis or acute apical abscess.\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": "Dental pain is a common problem and can arise when the nerve within a tooth dies due to progressing decay or injury. Without treatment, bacteria can infect the dead tooth and cause a dental abscess, which can lead to swelling and spreading infection, which can occasionally be life threatening.\nThe recommended treatment for these forms of toothache is removal of the dead nerve and associated bacteria. This is usually done by extraction of the tooth or root canal treatment (a procedure where the nerve and pulp are removed and the inside of the tooth cleaned and sealed). Antibiotics are only recommended when there is severe infection that has spread from the tooth into the surrounding tissues. However, some dentists still routinely prescribe oral antibiotics to patients with acute dental conditions who have no signs of spreading infection, or without dental treatment to remove the infected material.\nUse of antibiotics contributes to the development of antibiotic-resistant bacteria. It is therefore important that antibiotics are only used when they are likely to result in benefit for the patient. Dentists prescribe approximately 8% to 10% of all primary care antibiotics in high-income countries, and therefore it is important to ensure that dentists have good information about when antibiotics are likely to be beneficial for patients." } ]
query-laysum	21537	[ { "role": "user", "content": "Abstract: Background\nAdolescent vaccination has received increased attention since the Global Vaccine Action Plan's call to extend the benefits of immunisation more equitably beyond childhood. In recent years, many programmes have been launched to increase the uptake of different vaccines in adolescent populations; however, vaccination coverage among adolescents remains suboptimal. Therefore, understanding and evaluating the various interventions that can be used to improve adolescent vaccination is crucial.\nObjectives\nTo evaluate the effects of interventions to improve vaccine uptake among adolescents.\nSearch methods\nIn October 2018, we searched the following databases: CENTRAL, MEDLINE Ovid, Embase Ovid, and eight other databases. In addition, we searched two clinical trials platforms, electronic databases of grey literature, and reference lists of relevant articles. For related systematic reviews, we searched four databases. Furthermore, in May 2019, we performed a citation search of five other websites.\nSelection criteria\nRandomised trials, non-randomised trials, controlled before-after studies, and interrupted time series studies of adolescents (girls or boys aged 10 to 19 years) eligible for World Health Organization-recommended vaccines and their parents or healthcare providers.\nData collection and analysis\nTwo review authors independently screened records, reviewed full-text articles to identify potentially eligible studies, extracted data, and assessed risk of bias, resolving discrepancies by consensus. For each included study, we calculated risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI) where appropriate. We pooled study results using random-effects meta-analyses and assessed the certainty of the evidence using GRADE.\nMain results\nWe included 16 studies (eight individually randomised trials, four cluster randomised trials, three non-randomised trials, and one controlled before-after study). Twelve studies were conducted in the USA, while there was one study each from: Australia, Sweden, Tanzania, and the UK. Ten studies had unclear or high risk of bias. We categorised interventions as recipient-oriented, provider-oriented, or health systems-oriented.\nThe interventions targeted adolescent boys or girls or both (seven studies), parents (four studies), and providers (two studies). Five studies had mixed participants that included adolescents and parents, adolescents and healthcare providers, and parents and healthcare providers. The outcomes included uptake of human papillomavirus (HPV) (11 studies); hepatitis B (three studies); and tetanus–diphtheria–acellular–pertussis (Tdap), meningococcal, HPV, and influenza (three studies) vaccines among adolescents.\nHealth education improves HPV vaccine uptake compared to usual practice (RR 1.43, 95% CI 1.16 to 1.76; I² = 0%; 3 studies, 1054 participants; high-certainty evidence). In addition, one large study provided evidence that a complex multi-component health education intervention probably results in little to no difference in hepatitis B vaccine uptake compared to simplified information leaflets on the vaccine (RR 0.98, 95% CI 0.97 to 0.99; 17,411 participants; moderate-certainty evidence).\nFinancial incentives may improve HPV vaccine uptake compared to usual practice (RR 1.45, 95% CI 1.05 to 1.99; 1 study, 500 participants; low-certainty evidence). However, we are uncertain whether combining health education and financial incentives has an effect on hepatitis B vaccine uptake, compared to usual practice (RR 1.38, 95% CI 0.96 to 2.00; 1 study, 104 participants; very low certainty evidence).\nMandatory vaccination probably leads to a large increase in hepatitis B vaccine uptake compared to usual practice (RR 3.92, 95% CI 3.65 to 4.20; 1 study, 6462 participants; moderate-certainty evidence).\nProvider prompts probably make little or no difference compared to usual practice, on completion of Tdap (OR 1.28, 95% CI 0.59 to 2.80; 2 studies, 3296 participants), meningococcal (OR 1.09, 95% CI 0.67 to 1.79; 2 studies, 3219 participants), HPV (OR 0.99, 95% CI 0.55 to 1.81; 2 studies, 859 participants), and influenza (OR 0.91, 95% CI 0.61 to 1.34; 2 studies, 1439 participants) vaccination schedules (moderate-certainty evidence).\nProvider education with performance feedback may increase the proportion of adolescents who are offered and accept HPV vaccination by clinicians, compared to usual practice. Compared to adolescents visiting non-participating clinicians (in the usual practice group), the adolescents visiting clinicians in the intervention group were more likely to receive the first dose of HPV during preventive visits (5.7 percentage points increase) and during acute visits (0.7 percentage points for the first and 5.6 percentage points for the second doses of HPV) (227 clinicians and more than 200,000 children; low-certainty evidence).\nA class-based school vaccination strategy probably leads to slightly higher HPV vaccine uptake than an age-based school vaccination strategy (RR 1.09, 95% CI 1.06 to 1.13; 1 study, 5537 participants; moderate-certainty evidence).\nA multi-component provider intervention (including an education session, repeated contacts, individualised feedback, and incentives) probably improves uptake of HPV vaccine compared to usual practice (moderate-certainty evidence).\nA multi-component intervention targeting providers and parents involving social marketing and health education may improve HPV vaccine uptake compared to usual practice (RR 1.41, 95% CI 1.25 to 1.59; 1 study, 25,869 participants; low-certainty evidence).\nAuthors' conclusions\nVarious strategies have been evaluated to improve adolescent vaccination including health education, financial incentives, mandatory vaccination, and class-based school vaccine delivery. However, most of the evidence is of low to moderate certainty. This implies that while this research provides some indication of the likely effect of these interventions, the likelihood that the effects will be substantially different is high. Therefore, additional research is needed to further enhance adolescent immunisation strategies, especially in low- and middle-income countries where there are limited adolescent vaccination programmes. In addition, it is critical to understand the factors that influence hesitancy, acceptance, and demand for adolescent vaccination in different settings. This is the topic of an ongoing Cochrane qualitative evidence synthesis, which may help to explain why and how some interventions were more effective than others in increasing adolescent HPV vaccination coverage.\n\nGiven the provided abstract, please respond to the following query: \"What were the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The review authors found 16 relevant studies. Twelve of the studies were from the USA. The other studies were one each from Australia, Sweden, Tanzania, and the UK. These studies showed the following.\nWhen adolescents (girl or boys, or both) and their parents were given vaccination information and education, more adolescents got HPV vaccines (high-certainty evidence).\nWhen adolescents were given gift vouchers, more adolescents may have got HPV vaccines (low-quality evidence). However, we were uncertain whether giving adolescents and their parents health education, cash, and gift packages led to more adolescents getting hepatitis B vaccines (very low certainty evidence).\nWhen laws were passed stating that adolescents must be vaccinated to go to school, substantially more adolescents probably got hepatitis B vaccines (moderate-certainty evidence).\nWhen healthcare providers were reminded to vaccinate adolescents when they opened their electronic medical charts, this probably had little or no effect on the number of adolescents who got tetanus–diphtheria–pertussis, meningococcal, HPV, or influenza vaccines (moderate-certainty evidence).\nWhen healthcare providers were given education with performance feedback, more adolescents may have got HPV vaccines (low-certainty evidence).\nWhen healthcare providers were given education, individualised feedback, frequent visits, and incentives, more adolescents probably got HPV vaccines (moderate-certainty evidence).\nWhen healthcare providers and parents were targeted in several ways, including through education, telephone calls, and radio messages, more adolescents may have got HPV vaccines (low-certainty evidence).\nThese studies compared the use of these approaches (health education, gifts and rewards, laws, or reminders) to using no approaches.\nIn addition, one study from Tanzania gave vaccination information to all girls that were in school class six but were not necessarily of the same age. They were compared to girls who were given vaccination information because they were all born in the same year, but were not necessarily in the same class. This study showed that the class-based approach probably led to slightly more girls getting HPV vaccines (moderate-certainty evidence)." } ]
query-laysum	21538	[ { "role": "user", "content": "Abstract: Background\nDuchenne muscular dystrophy (DMD) is an X-linked recessive disorder characterised by progressive muscle weakness beginning in early childhood. Respiratory failure and weak cough develop in all patients as a consequence of muscle weakness leading to a risk of atelectasis, pneumonia, or the need for ventilatory support. There is no curative treatment for DMD. Corticosteroids are the only pharmacological intervention proven to delay the onset and progression of muscle weakness and thus respiratory decline in DMD. Antioxidant treatment has been proposed to try to reduce muscle weakness in general, and respiratory decline in particular.\nObjectives\nTo assess the effects of antioxidant agents on preventing respiratory decline in people with Duchenne muscular dystrophy during the respiratory decline phase of the condition.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two trials registers to 23 March 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs that met our inclusion criteria. We included male patients with a diagnosis of DMD who had respiratory decline evidenced by a forced vital capacity (FVC%) less than 80% but greater than 30% of predicted values, receiving any antioxidant agent compared with other therapies for the management of DMD or placebo.\nData collection and analysis\nTwo review authors screened studies for eligibility, assessed risk of bias of studies, and extracted data. We used standard methods expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach. The primary outcomes were FVC and hospitalisation due to respiratory infections. Secondary outcomes were quality of life, adverse events, change in muscle function, forced expiratory volume in the first second (FEV1), and peak expiratory flow (PEF).\nMain results\nWe included one study with 66 participants who were not co-treated with corticosteroids, which was the only study to contribute data to our main analysis. We also included a study that enrolled 255 participants treated with corticosteroids, which was only available as a press release without numerical results. The studies were parallel-group RCTs that assessed the effect of idebenone on respiratory function compared to placebo. The trial that contributed numerical data included patients with a mean (standard deviation) age of 14.3 (2.7) years at the time of inclusion, with a documented diagnosis of DMD or severe dystrophinopathy with clinical features consistent with typical DMD. The overall risk of bias across most outcomes was similar and judged as 'low'.\nIdebenone may result in a slightly less of a decline in FVC from baseline to one year compared to placebo (mean difference (MD) 3.28%, 95% confidence interval (CI) −0.41 to 6.97; 64 participants; low-certainty evidence), and probably has little or no effect on change in quality of life (MD −3.80, 95% CI −10.09 to 2.49; 63 participants; moderate-certainty evidence) (Pediatric Quality of Life Inventory (PedsQL), range 0 to 100, 0 = worst, 100 = best quality of life). As a related but secondary outcome, idebenone may result in less of a decline from baseline in FEV1 (MD 8.28%, 95% CI 0.89 to 15.67; 53 participants) and PEF (MD 6.27%, 95% CI 0.61 to 11.93; 1 trial, 64 participants) compared to placebo.\nIdebenone was associated with fewer serious adverse events (RR 0.42, 95% CI 0.09 to 2.04; 66 participants; low-certainty evidence) and little to no difference in non-serious adverse events (RR 1.00, 95% CI 0.88 to 1.13; 66 participants; low-certainty evidence) compared to placebo. Idebenone may result in little to no difference in change in arm muscle function (MD −2.45 N, 95% CI −8.60 to 3.70 for elbow flexors and MD −1.06 N, 95% CI −6.77 to 4.65 for elbow extensors; both 52 participants) compared to placebo. We found no studies evaluating the outcome hospitalisation due to respiratory infection.\nThe second trial, involving 255 participants, for which data were available only as a press release without numerical data, was prematurely discontinued due to futility after an interim efficacy analysis based on FVC. There were no safety concerns.\nThe certainty of the evidence was low for most outcomes due to imprecision and publication bias (the lack of a full report of the larger trial, which was prematurely terminated).\nAuthors' conclusions\nIdebenone is the only antioxidant agent tested in RCTs for preventing respiratory decline in people with DMD for which evidence was available for assessment. Idebenone may result in slightly less of a decline in FVC and less of a decline in FEV1 and PEF, but probably has little to no measurable effect on change in quality of life. Idebenone is associated with fewer serious adverse events than placebo. Idebenone may result in little to no difference in change in muscle function.\nDiscontinuation due to the futility of the SIDEROS trial and its expanded access programmes may indicate that idebenone research in this condition is no longer needed, but we await the trial data. Further research is needed to establish the effect of different antioxidant agents on preventing respiratory decline in people with DMD during the respiratory decline phase of the condition.\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": "Idebenone may result in slightly less of a decline in forced vital capacity (a measure of lung capacity), but probably has little or no effect on quality of life in patients with worsening breathing. Idebenone may result in less of a decline in the ability to force air out of the lungs and airways (based on tests of forced expiratory volume in the first second and peak expiratory flow). Idebenone was associated with fewer serious side effects than the dummy drug and has little or no effect on non-serious side effects. Idebenone may have little or no effect on muscle function (arm strength). We found no studies that looked at hospitalisation due to respiratory infection." } ]
query-laysum	21539	[ { "role": "user", "content": "Abstract: Background\nPolycystic ovarian syndrome (PCOS) occurs in 4% to 7% of all women of reproductive age and 50% of women presenting with subfertility. Subfertility affects 15% to 20% of couples trying to conceive. A significant proportion of these women ultimately need assisted reproductive technology (ART). In vitro fertilisation (IVF) is one of the assisted reproduction techniques employed to raise the chances of achieving a pregnancy. For the standard IVF technique, stimulating follicle development and growth before oocyte retrieval is essential, for which a large number of different methods combining gonadotrophins with a gonadotrophin-releasing hormone (GnRH) agonist or antagonist are used. In women with PCOS, the supra-physiological doses of gonadotrophins used for controlled ovarian hyperstimulation (COH) often result in an exaggerated ovarian response, characterised by the development of a large cohort of follicles of uneven quality, retrieval of immature oocytes, and increased risk of ovarian hyperstimulation syndrome (OHSS). A potentially effective intervention for women with PCOS-related subfertility involves earlier retrieval of immature oocytes at the germinal-vesicle stage followed by in vitro maturation (IVM). So far, the only data available have derived from observational studies and non-randomised clinical trials.\nObjectives\nTo assess the effectiveness and safety of IVM followed by IVF or ICSI versus conventional IVF or ICSI among women with PCOS undergoing assisted reproduction.\nSearch methods\nThis is the second update of this review. We performed the search on 17 April 2018.\nThe search was designed with the help of the Cochrane Gynaecology and Fertility Group Information Specialist, for all published and unpublished randomised controlled trials (RCTs).\nWe searched the the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL via the Cochrane Central Register of Studies Online, MEDLINE, Embase, CINAHL, and the trial registers for ongoing and registered trials and the Open Grey database for grey literature from Europe. We made further searches in the National Institute for Health and Care Excellence (NICE) fertility assessment and treatment guidelines. We handsearched reference lists of relevant systematic reviews and RCTs, together with PubMed and Google for any recent trials that have not yet been indexed in the major databases.\nSelection criteria\nAll RCTs on the intention to perform IVM before IVF or ICSI compared with conventional IVF or ICSI for subfertile women with PCOS, irrespective of language and country of origin.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, extracted data from studies, and attempted to contact the authors of studies for which data were missing. Our primary outcomes were live birth per woman randomised and miscarriage. We performed statistical analysis using Review Manager 5. We assessed evidence quality using GRADE methods.\nMain results\nWe found two RCTs suitable for inclusion in the review and six ongoing trials that have not yet reported results. Both included studies were published as abstracts in international conferences.\nBoth studies were at unclear or high risk of bias for most of the seven domains assessed. Common problems were unclear reporting of study methods and lack of blinding. The main limitations in the overall quality of the evidence were high risk of bias and serious imprecision.\nThere were no data on the primary outcomes of this review, namely live birth per woman randomised and miscarriage.\nBoth studies reported clinical pregnancy rate: there was evidence of an effect between IVM and IVF, favouring the former (odds ratio 3.10, 95% confidence interval 1.06 to 9.00; 71 participants; 2 studies; I2 = 0%; very low-quality evidence). The incidence of OHSS was zero in both studies in both groups.\nThere were no data for the other outcomes specified in this review.\nAuthors' conclusions\nThough promising data on the in vitro maturation (IVM) technique have been published, unfortunately there is still no evidence from properly conducted randomised controlled trials upon which to base any practice recommendations regarding IVM before in vitro fertilisation (IVF) or intracytoplasmic sperm injection for women with polycystic ovarian syndrome. Regarding our secondary outcomes, very low-quality evidence showed that clinical pregnancy was higher with IVM when compared to IVF, whereas the incidence of ovarian hyperstimulation syndrome was zero in both studies in both groups. We are awaiting the results of six ongoing trials and eagerly anticipate further evidence from good-quality trials in the field.\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 in vitro maturation efficient compared to standard assisted reproduction techniques (ART) in subfertile women with polycystic ovarian syndrome (PCOS)?" } ]
query-laysum	21540	[ { "role": "user", "content": "Abstract: Background\nRadiation therapy (RT) is given to about half of all people with cancer. RT alone is used to treat various cancers at different stages. Although it is a local treatment, systemic symptoms may occur. Cancer- or treatment-related side effects can lead to a reduction in physical activity, physical performance, and quality of life (QoL). The literature suggests that physical exercise can reduce the risk of various side effects of cancer and cancer treatments, cancer-specific mortality, recurrence of cancer, and all-cause mortality.\nObjectives\nTo evaluate the benefits and harms of exercise plus standard care compared with standard care alone in adults with cancer receiving RT alone.\nSearch methods\nWe searched CENTRAL, MEDLINE (Ovid), Embase (Ovid), CINAHL, conference proceedings and trial registries up to 26 October 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that enrolled people who were receiving RT without adjuvant systemic treatment for any type or stage of cancer. We considered any type of exercise intervention, defined as a planned, structured, repetitive, objective-oriented physical activity programme in addition to standard care. We excluded exercise interventions that involved physiotherapy alone, relaxation programmes, and multimodal approaches that combined exercise with other non-standard interventions such as nutritional restriction.\nData collection and analysis\nWe used standard Cochrane methodology and the GRADE approach for assessing the certainty of the evidence. Our primary outcome was fatigue and the secondary outcomes were QoL, physical performance, psychosocial effects, overall survival, return to work, anthropometric measurements, and adverse events.\nMain results\nDatabase searching identified 5875 records, of which 430 were duplicates. We excluded 5324 records and the remaining 121 references were assessed for eligibility. We included three two-arm RCTs with 130 participants. Cancer types were breast and prostate cancer. Both treatment groups received the same standard care, but the exercise groups also participated in supervised exercise programmes several times per week while undergoing RT. Exercise interventions included warm-up, treadmill walking (in addition to cycling and stretching and strengthening exercises in one study), and cool-down.\nIn some analysed endpoints (fatigue, physical performance, QoL), there were baseline differences between exercise and control groups.\nWe were unable to pool the results of the different studies owing to substantial clinical heterogeneity.\nAll three studies measured fatigue. Our analyses, presented below, showed that exercise may reduce fatigue (positive SMD values signify less fatigue; low certainty).\n• Standardised mean difference (SMD) 0.96, 95% confidence interval (CI) 0.27 to 1.64; 37 participants (fatigue measured with Brief Fatigue Inventory (BFI))\n• SMD 2.42, 95% CI 1.71 to 3.13; 54 participants (fatigue measured with BFI)\n• SMD 1.44, 95% CI 0.46 to 2.42; 21 participants (fatigue measured with revised Piper Fatigue Scale)\nAll three studies measured QoL, although one provided insufficient data for analysis. Our analyses, presented below, showed that exercise may have little or no effect on QoL (positive SMD values signify better QoL; low certainty).\n• SMD 0.40, 95% CI −0.26 to 1.05; 37 participants (QoL measured with Functional Assessment of Cancer Therapy-Prostate)\n• SMD 0.47, 95% CI −0.40 to 1.34; 21 participants (QoL measured with World Health Organization QoL questionnaire (WHOQOL-BREF))\nAll three studies measured physical performance. Our analyses of two studies, presented below, showed that exercise may improve physical performance, but we are very unsure about the results (positive SMD values signify better physical performance; very low certainty)\n• SMD 1.25, 95% CI 0.54 to 1.97; 37 participants (shoulder mobility and pain measured on a visual analogue scale)\n• SMD⁠⁠⁠⁠⁠⁠ 3.13 (95% CI 2.32 to 3.95; 54 participants (physical performance measured with the six-minute walk test)\nOur analyses of data from the third study showed that exercise may have little or no effect on physical performance measured with the stand-and-sit test, but we are very unsure about the results (SMD 0.00, 95% CI −0.86 to 0.86, positive SMD values signify better physical performance; 21 participants; very low certainty).\nTwo studies measured psychosocial effects. Our analyses (presented below) showed that exercise may have little or no effect on psychosocial effects, but we are very unsure about the results (positive SMD values signify better psychosocial well-being; very low certainty).\n• SMD 0.48, 95% CI −0.18 to 1.13; 37 participants (psychosocial effects measured on the WHOQOL-BREF social subscale)\n• SMD 0.29, 95% CI −0.57 to 1.15; 21 participants (psychosocial effects measured with the Beck Depression Inventory)\nTwo studies recorded adverse events related to the exercise programmes and reported no events. We estimated the certainty of the evidence as very low. No studies reported adverse events unrelated to exercise.\nNo studies reported the other outcomes we intended to analyse (overall survival, anthropometric measurements, return to work).\nAuthors' conclusions\nThere is little evidence on the effects of exercise interventions in people with cancer who are receiving RT alone. While all included studies reported benefits for the exercise intervention groups in all assessed outcomes, our analyses did not consistently support this evidence. There was low-certainty evidence that exercise improved fatigue in all three studies. Regarding physical performance, our analysis showed very low-certainty evidence of a difference favouring exercise in two studies, and very low-certainty evidence of no difference in one study. We found very low-certainty evidence of little or no difference between the effects of exercise and no exercise on quality of life or psychosocial effects. We downgraded the certainty of the evidence for possible outcome reporting bias, imprecision due to small sample sizes in a small number of studies, and indirectness of outcomes.\nIn summary, exercise may have some beneficial outcomes in people with cancer who are receiving RT alone, but the evidence supporting this statement is of low certainty. There is a need for high-quality research on this topic.\n\nGiven the provided abstract, please respond to the following query: \"What is radiation therapy?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Radiation therapy (also called radiotherapy) is a treatment that delivers high doses of radiation to a specific part of the body to kill cancer cells. One in two people with cancer will undergo radiation therapy. Some people receive radiation therapy alone, while others receive radiation therapy combined with other cancer treatments that affect the whole body (chemotherapy, immunotherapy, or hormone therapy). The unwanted effects of radiation therapy usually affect the part of the body where the radiation is delivered, but there may also be symptoms that affect the whole body. These unwanted effects can lead to reduced physical activity, physical performance, and quality of life. There is evidence that people with cancer who perform exercise may be less likely to die from cancer or from other causes, may be less likely to have their cancer return, and may have fewer unwanted effects of cancer treatment." } ]
query-laysum	21541	[ { "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: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "A search of the current literature and research on this topic yielded 5258 journal articles but no RCTs comparing two types of orbital lymphangioma treatments were found. Therefore no conclusions can be drawn about the effectiveness of the four major interventions of interest in treating people with orbital lymphangioma. It is clear from this review that further studies are needed that randomize people into these various treatments. Of note: there is one ongoing study that may meet these criteria, which is expected to be completed in 2021." } ]
query-laysum	21542	[ { "role": "user", "content": "Abstract: Background\nGlobal high rates of unplanned pregnancy and abortion among young women demonstrate the need for increased access to modern contraceptive services. In sub-Saharan Africa, the birth rate for those aged 15 to 19 years is 121 per 1000. In the USA, 6% of teens aged 15 to 19 years became pregnant in 2010. Most pregnancies among young women to age 25 are unintended.\nObjectives\nThe aim was to identify brief educational interventions for improving contraceptive use among young people that are feasible for implementing in a clinic or similar setting with limited resources.\nSearch methods\nTo 7 March 2016, we searched for studies in CENTRAL, PubMed, POPLINE, Web of Science, ClinicalTrials.gov and ICTRP.\nSelection criteria\nWe considered randomized controlled trials (RCTs) that assigned individuals or clusters as well as non-randomized studies (NRS). We included young people to age 25.\nThe intervention had to be sufficiently brief for a clinic, i.e. one to three sessions of 15 to 60 minutes plus potential follow-up. The strategy had to emphasize one or more effective methods of contraception. Primary outcomes were pregnancy and contraceptive use.\nData collection and analysis\nWe assessed titles and abstracts identified during the searches. One author extracted and entered the data into Review Manager; a second author verified accuracy. We examined studies for methodological quality.\nFor dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). For continuous variables, we computed the mean difference (MD) with 95% CI. We used adjusted measures for cluster RCTs, typically ORs, that the investigators reported. For NRS, which need to control for confounding, we also used reported adjusted measures. We did not conduct meta-analysis due to varied interventions and outcome measures.\nMain results\nWe found 11 studies, published from 1983 to 2015, that included a total of 8338 participants. Ten were from the USA and one was from China. We focused here on intervention effects for our primary outcomes. Five studies showed some effect on contraceptive use. Of three RCTs that examined innovative counseling, one showed an intervention effect. At one year, adolescents with developmental counseling were more likely to use contraception effectively than those with standard counseling (OR 48.38, 95% CI 5.96 to 392.63).\nThree studies used an audiovisual tool plus counseling; two reported some effect on contraceptive use. An NRS with young men, aged 15 to 18, examined a slide-tape presentation plus reproductive health consultation. At one year, the intervention group was more likely than the standard-care group to report using an effective contraceptive and having a partner who used oral contraceptives (OCs), both at last intercourse (reported adjusted OR 1.51 and 1.66, respectively). Another study utilized a computer program for contraceptive decision-making plus standard counseling for women to age 20. At one year, fewer women in the intervention group at one site had not used OCs compared with the counseling-only group (3.4% versus 8.8%; reported P = 0.05).\nThree RCTs provided phone follow-up after counseling, one of which showed an effect on contraceptive use among women age 16 to 24. Women who received counseling plus phone calls to encourage contraceptive use were more likely than the counseling-only group to report consistent OC use at three months (OR 1.41, 95% CI 1.06 to 1.87) and six months (OR 1.39, 95% CI 1.03 to 1.87). Also at three months, they were more likely to report condom use at last sex (OR 1.45, 95% CI 1.03 to 2.03).\nTwo cluster randomized trials trained providers on contraceptive methods and counseling. One trial with an intervention effect tested comprehensive contraceptive services for women to age 25, postabortion. At six months, the comprehensive-service group was more likely than the standard-care group to use an effective contraceptive (reported adjusted OR 2.03, 95% CI 1.04 to 3.98) and to use condoms consistently and correctly (reported adjusted OR 5.68, 95% CI 3.39 to 9.53).\nAuthors' conclusions\nFew studies tested brief strategies for young people. We noted heterogeneity across studies in participants' ages and life situations. Of five studies with some effect, one provided moderate-quality evidence; four were older studies with low-quality evidence. More intensive strategies could be more effective, but would also be challenging for many clinics to implement.\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": "Few studies tested brief teaching methods for young people. About half of the studies had some effect, but they differed in methods and in ages and life situations of the young people. More intense strategies could work better, but would be difficult for many clinics to use. Overall, study quality was low." } ]
query-laysum	21543	[ { "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: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We found three trials comparing groups of adults treated with bronchial thermoplasty versus adults who received standard medical treatment or a \"sham\" (simulated) bronchial thermoplasty treatment." } ]
query-laysum	21544	[ { "role": "user", "content": "Abstract: Background\nAllergic rhinitis is a common condition affecting both adults and children. Patients experience symptoms of nasal obstruction, rhinorrhoea, sneezing and nasal itching, which may affect their quality of life.\nNasal irrigation with saline (salty water), also known as nasal douching, washing or lavage, is a procedure that rinses the nasal cavity with isotonic or hypertonic saline solutions. It can be performed with low positive pressure from a spray, pump or squirt bottle, with a nebuliser or with gravity-based pressure in which the person instils saline into one nostril and allows it to drain out of the other. Saline solutions are available over the counter and can be used alone or as an adjunct to other therapies.\nObjectives\nTo evaluate the effects of nasal saline irrigation in people with allergic rhinitis.\nSearch methods\nThe Cochrane ENT Information Specialist searched the ENT Trials Register; 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 23 November 2017.\nSelection criteria\nRandomised controlled trials (RCTs) comparing nasal saline irrigation, delivered by any means and with any volume, tonicity and alkalinity, with (a) no nasal saline irrigation or (b) other pharmacological treatments in adults and children with allergic rhinitis. We included studies comparing nasal saline versus no saline, where all participants also received pharmacological treatment (intranasal corticosteroids or oral antihistamines).\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Primary outcomes were patient-reported disease severity and a common adverse effect - epistaxis. Secondary outcomes were disease-specific health-related quality of life (HRQL), individual symptom scores, general HRQL, the adverse effects of local irritation or discomfort, ear symptoms (pain or pressure) and nasal endoscopy scores. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included 14 studies (747 participants). The studies included children (seven studies, 499 participants) and adults (seven studies, 248 participants). No studies reported outcomes beyond three months follow-up. Saline volumes ranged from 'very low' to 'high' volume. Where stated, studies used either hypertonic or isotonic saline solution.\nNasal saline versus no saline treatment\nAll seven studies (112 adults; 332 children) evaluating this comparison used different scoring systems for patient-reported disease severity, so we pooled the data using the standardised mean difference (SMD). Saline irrigation may improve patient-reported disease severity compared with no saline at up to four weeks (SMD -1.32, 95% confidence interval (CI) -1.84 to -0.81; 407 participants; 6 studies; low quality) and between four weeks and three months (SMD -1.44, 95% CI -2.39 to -0.48; 167 participants; 5 studies; low quality). Although the evidence was low quality the SMD values at both time points are considered large effect sizes. Subgroup analysis showed the improvement in both adults and children. Subgroup analyses for volume and tonicity were inconclusive due to heterogeneity.\nTwo studies reported methods for recording adverse effects and five studies mentioned them. Two studies (240 children) reported no adverse effects (epistaxis or local discomfort) in either group and three only reported no adverse effects in the saline group.\nOne study (48 children) reported disease-specific HRQL using a modified RCQ-36 scale. It was uncertain whether there was a difference between the groups at any of the specified time points (very low quality). No other secondary outcomes were reported.\nNasal saline versus no saline with adjuvant use of intranasal steroids or oral antihistamines\nThree studies (40 adults; 79 children) compared saline with intranasal steroids versus intranasal steroids alone; one study (14 adults) compared saline with oral antihistamines versus oral antihistamines alone. It is uncertain if there is a difference in patient-reported disease severity at up to four weeks (SMD -0.60, 95% CI -1.34 to 0.15; 32 participants; 2 studies; very low quality) or from four weeks to three months (SMD -0.32, 95% CI -0.85 to 0.21; 58 participants; 2 studies; very low quality). Although none of the studies reported methods for recording adverse effects, three mentioned them: one study (40 adults; adjuvant intranasal steroids) reported no adverse effects (epistaxis or local discomfort) in either group; the other two only reported no adverse effects in the saline group.\nIt is uncertain if saline irrigation in addition to pharmacological treatment improved disease-specific HRQL at four weeks to three months, compared with pharmacological treatment alone (SMD -1.26, 95% CI -2.47 to -0.05; 54 participants; 2 studies; very low quality). No other secondary outcomes were reported.\nNasal saline versus intranasal steroids\nIt is uncertain if there was a difference in patient-reported disease severity between nasal saline and intranasal steroids at up to four weeks (MD 1.06, 95% CI -1.65 to 3.77; 14 participants; 1 study), or between four weeks and three months (SMD 1.26, 95% CI -0.92 to 3.43; 97 participants; 3 studies), or indisease-specific HRQL between four weeks and three months (SMD 0.01, 95% CI -0.73 to 0.75; 83 participants; 2 studies). Only one study reported methods for recording adverse effects although three studies mentioned them. One (21 participants) reported two withdrawals due to adverse effects but did not describe these or state which group. Three studies reported no adverse effects (epistaxis or local discomfort) with saline, although one study reported that 27% of participants experienced local discomfort with steroid use. No other secondary outcomes were reported.\nAuthors' conclusions\nSaline irrigation may reduce patient-reported disease severity compared with no saline irrigation at up to three months in both adults and children with allergic rhinitis, with no reported adverse effects. No data were available for any outcomes beyond three months. The overall quality of evidence was low or very low. The included studies were generally small and used a range of different outcome measures to report disease severity scores, with unclear validation. This review did not include direct comparisons of saline types (e.g. different volume, tonicity).\nSince saline irrigation could provide a cheap, safe and acceptable alternative to intranasal steroids and antihistamines further high-quality, adequately powered research in this area is warranted.\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 up to date to November 2017." } ]
query-laysum	21545	[ { "role": "user", "content": "Abstract: Background\nTuberculosis is a leading cause of infectious disease-related death and is one of the top 10 causes of death worldwide. The World Health Organization (WHO) recommends the use of specific rapid molecular tests, including Xpert MTB/RIF or Xpert Ultra, as initial diagnostic tests for the detection of tuberculosis and rifampicin resistance in people with signs and symptoms of tuberculosis. However, the WHO estimates that nearly one-third of all active tuberculosis cases go undiagnosed and unreported. We were interested in whether a single test, Xpert MTB/RIF or Xpert Ultra, could be useful as a screening test to close this diagnostic gap and improve tuberculosis case detection.\nObjectives\nTo estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for screening for pulmonary tuberculosis in adults, irrespective of signs or symptoms of pulmonary tuberculosis in high-risk groups and in the general population. Screening \"irrespective of signs or symptoms\" refers to screening of people who have not been assessed for the presence of tuberculosis symptoms (e.g. cough).\nTo estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for detecting rifampicin resistance in adults screened for tuberculosis, irrespective of signs and symptoms of pulmonary tuberculosis in high-risk groups and in the general population.\nSearch methods\nWe searched 12 databases including the Cochrane Infectious Diseases Group Specialized Register, MEDLINE and Embase, on 19 March 2020 without language restrictions. We also reviewed reference lists of included articles and related Cochrane Reviews, and contacted researchers in the field to identify additional studies.\nSelection criteria\nCross-sectional and cohort studies in which adults (15 years and older) in high-risk groups (e.g. people living with HIV, household contacts of people with tuberculosis) or in the general population were screened for pulmonary tuberculosis using Xpert MTB/RIF or Xpert Ultra. For tuberculosis detection, the reference standard was culture. For rifampicin resistance detection, the reference standards were culture-based drug susceptibility testing and line probe assays.\nData collection and analysis\nTwo review authors independently extracted data using a standardized form and assessed risk of bias and applicability using QUADAS-2. We used a bivariate random-effects model to estimate pooled sensitivity and specificity with 95% credible intervals (CrIs) separately for tuberculosis detection and rifampicin resistance detection. We estimated all models using a Bayesian approach. For tuberculosis detection, we first estimated screening accuracy in distinct high-risk groups, including people living with HIV, household contacts, people residing in prisons, and miners, and then in several high-risk groups combined.\nMain results\nWe included a total of 21 studies: 18 studies (13,114 participants) evaluated Xpert MTB/RIF as a screening test for pulmonary tuberculosis and one study (571 participants) evaluated both Xpert MTB/RIF and Xpert Ultra. Three studies (159 participants) evaluated Xpert MTB/RIF for rifampicin resistance. Fifteen studies (75%) were conducted in high tuberculosis burden and 16 (80%) in high TB/HIV-burden countries. We judged most studies to have low risk of bias in all four QUADAS-2 domains and low concern for applicability.\nXpert MTB/RIF and Xpert Ultra as screening tests for pulmonary tuberculosis\nIn people living with HIV (12 studies), Xpert MTB/RIF pooled sensitivity and specificity (95% CrI) were 61.8% (53.6 to 69.9) (602 participants; moderate-certainty evidence) and 98.8% (98.0 to 99.4) (4173 participants; high-certainty evidence). Of 1000 people where 50 have tuberculosis on culture, 40 would be Xpert MTB/RIF-positive; of these, 9 (22%) would not have tuberculosis (false-positives); and 960 would be Xpert MTB/RIF-negative; of these, 19 (2%) would have tuberculosis (false-negatives).\nIn people living with HIV (1 study), Xpert Ultra sensitivity and specificity (95% CI) were 69% (57 to 80) (68 participants; very low-certainty evidence) and 98% (97 to 99) (503 participants; moderate-certainty evidence). Of 1000 people where 50 have tuberculosis on culture, 53 would be Xpert Ultra-positive; of these, 19 (36%) would not have tuberculosis (false-positives); and 947 would be Xpert Ultra-negative; of these, 16 (2%) would have tuberculosis (false-negatives).\nIn non-hospitalized people in high-risk groups (5 studies), Xpert MTB/RIF pooled sensitivity and specificity were 69.4% (47.7 to 86.2) (337 participants, low-certainty evidence) and 98.8% (97.2 to 99.5) (8619 participants, moderate-certainty evidence). Of 1000 people where 10 have tuberculosis on culture, 19 would be Xpert MTB/RIF-positive; of these, 12 (63%) would not have tuberculosis (false-positives); and 981 would be Xpert MTB/RIF-negative; of these, 3 (0%) would have tuberculosis (false-negatives).\nWe did not identify any studies using Xpert MTB/RIF or Xpert Ultra for screening in the general population.\nXpert MTB/RIF as a screening test for rifampicin resistance\nXpert MTB/RIF sensitivity was 81% and 100% (2 studies, 20 participants; very low-certainty evidence), and specificity was 94% to 100%, (3 studies, 139 participants; moderate-certainty evidence).\nAuthors' conclusions\nOf the high-risks groups evaluated, Xpert MTB/RIF applied as a screening test was accurate for tuberculosis in high tuberculosis burden settings. Sensitivity and specificity were similar in people living with HIV and non-hospitalized people in high-risk groups. In people living with HIV, Xpert Ultra sensitivity was slightly higher than that of Xpert MTB/RIF and specificity similar. As there was only one study of Xpert Ultra in this analysis, results should be interpreted with caution. There were no studies that evaluated the tests in people with diabetes mellitus and other groups considered at high-risk for tuberculosis, or in the general population.\n\nGiven the provided abstract, please respond to the following query: \"What are the implications of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "In PLHIV, Xpert MTB/RIF as a screening test was accurate for tuberculosis in high tuberculosis burden settings. In high-risk groups, Xpert MTB/RIF may assist in identifying tuberculosis, but the certainty of evidence is low. In PLHIV, Xpert Ultra sensitivity was slightly higher than that of Xpert MTB/RIF and specificity similar based on one study. There were few studies and few people tested for rifampicin resistance and no studies that evaluated the tests in people with diabetes or in the general population." } ]
query-laysum	21546	[ { "role": "user", "content": "Abstract: Background\nTraditionally, amalgam has been used for filling cavities in posterior teeth, and it continues to be the restorative material of choice in some low- and middle-income countries due to its effectiveness and relatively low cost. However, there are concerns over the use of amalgam restorations (fillings) with regard to mercury release in the body and the environmental impact of mercury disposal. Dental composite resin materials are an aesthetic alternative to amalgam, and their mechanical properties have developed sufficiently to make them suitable for restoring posterior teeth. Nevertheless, composite resin materials may have potential for toxicity to human health and the environment.\nThe United Nations Environment Programme has established the Minamata Convention on Mercury, which is an international treaty that aims \"to protect the [sic] human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds\". It entered into force in August 2017, and as of February 2021 had been ratified by 127 governments. Ratification involves committing to the adoption of at least two of nine proposed measures to phase down the use of mercury, including amalgam in dentistry. In light of this, we have updated a review originally published in 2014, expanding the scope of the review by undertaking an additional search for harms outcomes. Our review synthesises the results of studies that evaluate the long-term effectiveness and safety of amalgam versus composite resin restorations, and evaluates the level of certainty we can have in that evidence.\nObjectives\nTo examine the effects (i.e. efficacy and safety) of direct composite resin fillings versus amalgam fillings.\nSearch methods\nAn information specialist searched five bibliographic databases up to 16 February 2021 and used additional search methods to identify published, unpublished and ongoing studies\nSelection criteria\nTo assess efficacy, we included randomised controlled trials (RCTs) comparing dental composite resin with amalgam restorations in permanent posterior teeth that assessed restoration failure or survival at follow-up of at least three years.\nTo assess safety, we sought non-randomised studies in addition to RCTs that directly compared composite resin and amalgam restorative materials and measured toxicity, sensitivity, allergy, or injury.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included a total of eight studies in this updated review, all of which were RCTs. Two studies used a parallel-group design, and six used a split-mouth design. We judged all of the included studies to be at high risk of bias due to lack of blinding and issues related to unit of analysis. We identified one new trial since the previous version of this review (2014), as well as eight additional papers that assessed safety, all of which related to the two parallel-group studies that were already included in the review.\nFor our primary meta-analyses, we combined data from the two parallel-group trials, which involved 1645 composite restorations and 1365 amalgam restorations in 921 children. We found low-certainty evidence that composite resin restorations had almost double the risk of failure compared to amalgam restorations (risk ratio (RR) 1.89, 95% confidence interval (CI) 1.52 to 2.35; P < 0.001), and were at much higher risk of secondary caries (RR 2.14, 95% CI 1.67 to 2.74; P < 0.001). We found low-certainty evidence that composite resin restorations were not more likely to result in restoration fracture (RR 0.87, 95% CI 0.46 to 1.64; P = 0.66).\nSix trials used a split-mouth design. We considered these studies separately, as their reliability was compromised due to poor reporting, unit of analysis errors, and variability in methods and findings. Subgroup analysis showed that the findings were consistent with the results of the parallel-group studies.\nThree trials investigated possible harms of dental restorations. Higher urinary mercury levels were reported amongst children with amalgam restorations in two trials, but the levels were lower than what is known to be toxic. Some differences between amalgam and composite resin groups were observed on certain measures of renal, neuropsychological, and psychosocial function, physical development, and postoperative sensitivity; however, no consistent or clinically important harms were found. We considered that the vast number of comparisons made false-positive results likely. There was no evidence of differences between the amalgam and composite resin groups in neurological symptoms, immune function, and urinary porphyrin excretion. The evidence is of very low certainty, with most harms outcomes reported in only one trial.\nAuthors' conclusions\nLow-certainty evidence suggests that composite resin restorations may have almost double the failure rate of amalgam restorations. The risk of restoration fracture does not seem to be higher with composite resin restorations, but there is a much higher risk of developing secondary caries. Very low-certainty evidence suggests that there may be no clinically important differences in the safety profile of amalgam compared with composite resin dental restorations.\nThis review supports the utility of amalgam restorations, and the results may be particularly useful in parts of the world where amalgam is still the material of choice to restore posterior teeth with proximal caries. Of note, however, is that composite resin materials have undergone important improvements in the years since the trials informing the primary analyses for this review were conducted. The global phase-down of dental amalgam via the Minamata Convention on Mercury is an important consideration when deciding between amalgam and composite resin dental materials. The choice of which dental material to use will depend on shared decision-making between dental providers and patients in the clinic setting, and local directives and protocols.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "This review, carried out within Cochrane Oral Health, describes the effects of tooth-coloured (composite resin) fillings compared with amalgam fillings when placed directly into cavities (holes) in permanent teeth in the back of the mouth." } ]
query-laysum	21547	[ { "role": "user", "content": "Abstract: Background\nThalassaemia is a recessively-inherited blood disorder that leads to anaemia of varying severity. In those affected by the more severe forms, regular blood transfusions are required which may lead to iron overload. Accumulated iron from blood transfusions may be deposited in vital organs including the heart, liver and endocrine organs such as the pituitary glands which can affect growth hormone production. Growth hormone deficiency is one of the factors that can lead to short stature, a common complication in people with thalassaemia. Growth hormone replacement therapy has been used in children with thalassaemia who have short stature and growth hormone deficiency. This review on the role of growth hormone was originally published in September 2017 and updated in April 2020.\nObjectives\nTo assess the benefits and safety of growth hormone therapy in people with thalassaemia.\nSearch methods\nWe searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of latest search: 14 November 2019.\nWe also searched the reference lists of relevant articles, reviews and clinical trial registries. Date of latest search: 06 January 2020.\nSelection criteria\nRandomised and quasi-randomised controlled trials comparing the use of growth hormone therapy to placebo or standard care in people with thalassaemia of any type or severity.\nData collection and analysis\nTwo authors independently selected trials for inclusion. Data extraction and assessment of risk of bias were also conducted independently by two authors. The certainty of the evidence was assessed using GRADE criteria.\nMain results\nWe included one parallel trial conducted in Turkey. The trial recruited 20 children with homozygous beta thalassaemia who had short stature; 10 children received growth hormone therapy administered subcutaneously on a daily basis at a dose of 0.7 IU/kg per week and 10 children received standard care. The overall risk of bias in this trial was low except for the selection criteria and attrition bias which were unclear. The certainty of the evidence for all major outcomes was moderate, the main concern was imprecision of the estimates due to the small sample size leading to wide confidence intervals. Final height (cm) (the review's pre-specified primary outcome) and change in height were not assessed in the included trial. The trial reported no clear difference between groups in height standard deviation (SD) score after one year, mean difference (MD) -0.09 (95% confidence interval (CI) -0.33 to 0.15 (moderate-certainty evidence). However, modest improvements appeared to be observed in the following key outcomes in children receiving growth hormone therapy compared to control (moderate-certainty evidence): change between baseline and final visit in height SD score, MD 0.26 (95% CI 0.13 to 0.39); height velocity, MD 2.28 cm/year (95% CI 1.76 to 2.80); height velocity SD score, MD 3.31 (95% CI 2.43 to 4.19); and change in height velocity SD score between baseline and final visit, MD 3.41 (95% CI 2.45 to 4.37). No adverse effects of treatment were reported in either group; however, while there was no clear difference between groups in the oral glucose tolerance test at one year, fasting blood glucose was significantly higher in the growth hormone therapy group compared to control, although both results were still within the normal range, MD 6.67 mg/dL (95% CI 2.66 to 10.68). There were no data beyond the one-year trial period.\nAuthors' conclusions\nA small single trial contributed evidence of moderate certainty that the use of growth hormone for a year may improve height velocity of children with thalassaemia although height SD score in the treatment group was similar to the control group. There are no randomised controlled trials in adults or trials that address the use of growth hormone therapy over a longer period and assess its effect on final height and quality of life. The optimal dosage of growth hormone and the ideal time to start this therapy remain uncertain. Large well-designed randomised controlled trials over a longer period with sufficient duration of follow up are needed.\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": "In this update, we included evidence current to 14 November 2019." } ]
query-laysum	21548	[ { "role": "user", "content": "Abstract: Background\nMusic therapy is a therapeutic approach that uses musical interaction as a means of communication and expression. Within the area of serious mental disorders, the aim of the therapy is to help people improve their emotional and relational competencies, and address issues they may not be able to using words alone.\nObjectives\nTo review the effects of music therapy, or music therapy added to standard care, compared with placebo therapy, standard care or no treatment for people with serious mental disorders such as schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group’s Trials Study-Based Register (December 2010 and 15 January, 2015) and supplemented this by contacting relevant study authors, handsearching of music therapy journals and manual searches of reference lists.\nSelection criteria\nAll randomised controlled trials (RCTs) that compared music therapy with standard care, placebo therapy, or no treatment.\nData collection and analysis\nReview authors independently selected, quality assessed and data extracted studies. We excluded data where more than 30% of participants in any group were lost to follow-up. We synthesised non-skewed continuous endpoint data from valid scales using a standardised mean difference (SMD). We employed a fixed-effect model for all analyses. If statistical heterogeneity was found, we examined treatment dosage (i.e. number of therapy sessions) and treatment approach as possible sources of heterogeneity.\nMain results\nTen new studies have been added to this update; 18 studies with a total 1215 participants are now included. These examined effects of music therapy over the short, medium, and long-term, with treatment dosage varying from seven to 240 sessions. Overall, most information is from studies at low or unclear risk of bias\nA positive effect on global state was found for music therapy compared to standard care (medium term, 2 RCTs, n = 133, RR 0.38 95% confidence interval (CI) 0.24 to 0.59, low-quality evidence, number needed to treat for an additional beneficial outcome NNTB 2, 95% CI 2 to 4). No binary data were available for other outcomes. Medium-term continuous data identified good effects for music therapy on negative symptoms using the Scale for the Assessment of Negative Symptoms (3 RCTs, n = 177, SMD - 0.55 95% CI -0.87 to -0.24, low-quality evidence). General mental state endpoint scores on the Positive and Negative Symptoms Scale were better for music therapy (2 RCTs, n = 159, SMD -0.97 95% CI -1.31 to -0.63, low-quality evidence), as were average endpoint scores on the Brief Psychiatric Rating Scale (1 RCT, n = 70, SMD -1.25 95% CI -1.77 to -0.73, moderate-quality evidence). Medium-term average endpoint scores using the Global Assessment of Functioning showed no effect for music therapy on general functioning (2 RCTs, n = 118, SMD -0.19 CI -0.56 to 0.18, moderate-quality evidence). However, positive effects for music therapy were found for both social functioning (Social Disability Screening Schedule scores; 2 RCTs, n = 160, SMD -0.72 95% CI -1.04 to -0.40), and quality of life (General Well-Being Schedule scores: 1 RCT, n = 72, SMD 1.82 95% CI 1.27 to 2.38, moderate-quality evidence). There were no data available for adverse effects, service use, engagement with services, or cost.\nAuthors' conclusions\nModerate- to low-quality evidence suggests that music therapy as an addition to standard care improves the global state, mental state (including negative and general symptoms), social functioning, and quality of life of people with schizophrenia or schizophrenia-like disorders. However, effects were inconsistent across studies and depended on the number of music therapy sessions as well as the quality of the music therapy provided. Further research should especially address the long-term effects of music therapy, dose-response relationships, as well as the relevance of outcome measures in relation to music therapy.\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": "Characteristics of schizophrenia and schizophrenia-like disorders are disordered thoughts, feelings, beliefs and perceptions. People with schizophrenia often have two main types of symptoms: the acute symptoms of hearing voices or seeing things (hallucinations) and strange beliefs (delusions), and chronic symptoms such as low mood/depression, social withdrawal, and memory problems. Music therapy is a therapeutic approach that uses music experiences to help people with serious mental disorders improve their emotional and relational competencies and addresses issues that they may not be able to using words alone." } ]
query-laysum	21549	[ { "role": "user", "content": "Abstract: Background\nDespite widespread use, our 2012 Cochrane review did not confirm that use of imaging to guide glucocorticoid injection for people with shoulder pain improves its efficacy.\nObjectives\nTo update our review and assess the benefits and harms of image-guided glucocorticoid injection compared to non-image-guided injection for patients with shoulder pain.\nSearch methods\nWe updated the search of the Cochrane Central Register of Controlled Trials (CENTRAL, via Ovid), MEDLINE (Ovid), Embase (Ovid) and clinicaltrials.gov to 15 Feb 2021, and the World Health Organisation International Clinical Trials Registry Platform (http://www.who.int/trialsearch/Default.aspx) to 06 July 2020. We also screened reference lists of retrieved review articles and trials to identify potentially relevant studies.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials that compared image-guided glucocorticoid injection to injection without image guidance (either landmark-guided or intramuscular) in patients with shoulder pain (rotator cuff disease, adhesive capsulitis or mixed or undefined shoulder pain). Major outcomes were pain, function, proportion of participants with treatment success, quality of life, adverse events, serious adverse events and withdrawals due to adverse events. Minor outcomes were shoulder range of motion and proportion of participants requiring surgery or additional injections. There were no restrictions on language or date of publication.\nData collection and analysis\nWe used standard methodologic procedures expected by Cochrane.\nMain results\nNineteen trials were included (1035 participants). Fourteen trials included participants with rotator cuff disease, four with adhesive capsulitis, and one with mixed or undefined shoulder pain. Trial size varied from 28 to 256 participants, most participants were female, mean age ranged between 31 and 60 years, and mean symptom duration varied from 2 to 23 months.\nTwo trials were at low risk of bias for all criteria. The most notable sources of bias in the remaining trials included performance bias and detection bias.\nModerate-certainty evidence (downgraded for bias) indicates that ultrasound-guided injection probably provides little or no clinically important benefits compared with injection without guidance with respect to pain (15 trials) or function (14 trials) at three to six weeks follow-up. It may not improve quality of life (2 trials, low-certainty evidence, downgraded due to potential for bias and imprecision) and we are uncertain about the effect of ultrasound-guided injection on participant-rated treatment success due to very low-certainty evidence (downgraded for bias, inconsistency and imprecision).\nMean pain (scale range 0 to 10, higher scores indicate more pain) was 3.1 points with injection without image guidance and 0.5 points better (0.2 points better to 0.8 points better; 1003 participants, 15 trials) with an ultrasound-guided injection. This represents a slight difference for pain (0.5 to 1.0 points on a 0 to 10 scale). Mean function (scale range 0 to 100, higher scores indicate better function) was 68 points with injection without image guidance and 2.4 points better (0.2 points worse to 5.1 points better; 895 participants, 14 trials) with an ultrasound-guided injection. Mean quality of life (scale range 0 to 100, higher scores indicate better quality of life) was 65 with injection without image guidance and 2.8 points better (0.7 worse to 6.4 better; 220 participants, 2 trials) with an ultrasound-guided injection. In five trials (350 participants), 101/175 (or 606 per 1000) people in the ultrasound-guided group reported treatment success compared with 68/175 (or 389 per 1000) people in the group injected without image guidance (RR 1.56 (95% CI 0.89 to 2.75)), an absolute difference of 22% more reported success (4% fewer to 62% more).\nLow-certainty evidence (downgraded for bias and imprecision) indicates that ultrasound-guided injections may not reduce the risk of adverse events compared to injections without image guidance. In five trials (402 participants), 38/200 (or 181 per 1000) people in the ultrasound-guided group reported adverse events compared with 51/202 (or 252 per 1000) in the non-image-guided injection group (RR 0.72 (95% CI 0.4 to 1.28)), an absolute difference of 7% fewer adverse events (15% fewer to 7% more). Five trials reported that there were no serious adverse events. The remaining trials did not report serious adverse events. One trial reported that 1/53 (or 19 per 1000) in the injection without image guidance group and 0/53 in the ultrasound-guided group withdrew due to adverse events.\nSensitivity analyses indicate that the effects for pain and function may have been influenced by selection bias, and the effects for function may have been influenced by detection bias. The test for subgroup differences indicated there were unlikely to be differences in pain and function across different shoulder conditions.\nAuthors' conclusions\nOur updated review does not support use of image guidance for injections in the shoulder. Moderate-certainty evidence indicates that ultrasound-guided injection in the treatment of shoulder pain probably provides little or no benefit over injection without imaging in terms of pain or function and low-certainty evidence indicates there may be no difference in quality of life. We are uncertain if ultrasound-guided injection improves participant-rated treatment success, due to very low-certainty evidence. Low-certainty evidence also suggests ultrasound-guided injection may not reduce the risk of adverse events compared with non-image-guided injection. No serious adverse events were reported in any trial.\nThe lack of significant benefit of image guidance over injection without image guidance to improve patient-relevant outcomes or reduce harms, suggests that any added cost of image guidance appears unjustified.\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": "Shoulder pain is most often caused by rotator cuff disease, or adhesive capsulitis (‘frozen shoulder’). The rotator cuff is a group of tendons that holds the shoulder joint in place allowing people to lift their arm. Shoulder pain can be related to wear and tear or inflammation of the shoulder tendons, and pressure on the tendons by the overlying bone when lifting the arm up (impingement). Both conditions cause pain with movement and often pain during the night and sleeping on the affected side; adhesive capsulitis also causes shoulder stiffness.\nGlucocorticoids injections can relieve shoulder pain but their effect usually wears off after six to eight weeks. Traditionally, injections are given using anatomic landmarks around the shoulder. Sometimes imaging techniques, such as ultrasound, are used to more accurately guide the injections into the shoulder. It is not known if image-guided injection relieves shoulder pain more effectively than injections delivered without imaging." } ]
query-laysum	21550	[ { "role": "user", "content": "Abstract: Background\nFocal abnormalities most commonly acquired within the uterine cavity include endometrial polyps (arising from the endometrium) and submucous fibroids (arising from the myometrium). These benign abnormalities can cause several problems, including abnormal uterine bleeding (AUB) and subfertility. Two-dimensional saline infusion sonography (2D SIS) is a minimally invasive test that can be used to diagnose these pathologies, but it is less accurate than hysteroscopy, which is a more invasive procedure by which an endoscope allows direct visualisation of the uterine cavity. Three-dimensional (3D) SIS appears to enhance sonographic visualisation within the uterine cavity, thereby offering a potentially more accurate minimally invasive diagnostic test.\nObjectives\nPrimary objectives\n• To evaluate the diagnostic accuracy of 3D SIS (index test 1) compared with 2D SIS for the diagnosis of focally growing lesions (presence or not) in women with AUB or subfertility, with hysteroscopy performed as the reference test.\n• To evaluate the diagnostic accuracy of 2D+3D SIS (index test 2) compared with 2D SIS for the diagnosis of focally growing lesions (presence or not) in women with AUB or subfertility, with hysteroscopy performed as the reference test. In this case, any abnormality on either modality was regarded as a positive result (‘OR’ approach).\nSecondary objectives\n• To evaluate the diagnostic accuracy of 3D SIS (index test 1) compared with 2D SIS according to type of abnormality and discrimination between uterine polyps and submucous fibroids in women with AUB or subfertility, with hysteroscopy and histology used as the reference.\n• To evaluate the diagnostic accuracy of 2D+3D SIS (index test 2) compared with 2D SIS according to type of abnormality and discrimination between uterine polyps and submucous fibroids in women with AUB or subfertility, with hysteroscopy and histology used as the reference.\nSearch methods\nWe searched the following databases: Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, PubMed, Cochrane Gynaecology and Fertility Group (CGF) Specialised Register and CGFG Diagnostic Test Accuracy (DTA) Specialised Register, clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). Screening reference lists of appropriate studies was also performed. We screened for eligibility all studies identified from inception until March 2016. We performed searches with no date or language restrictions.\nSelection criteria\nThe population of interest consisted of premenopausal women with AUB or subfertility and postmenopausal women with AUB. Diagnostic test accuracy studies, randomised controlled trials (RCTs) and prospective cohort studies were eligible for inclusion if they evaluated the accuracy of both 2D SIS and 3D SIS for the diagnosis of acquired intracavitary abnormalities with hysteroscopy used as the reference standard. In light of the lack of data for 3D SIS, we also included studies that evaluated the accuracy of 3D SIS alone.\nData collection and analysis\nTwo review authors read all potentially eligible references after performing a first screening by title and abstract (LLN and FJRH). They independently extracted data to construct 2×2 tables from eligible studies and assessed studies for methodological quality using the QUADAS-2 tool (revised tool for quality assessment of diagnostic accuracy studies). To describe and visually present results, we produced in RevMan forest plots showing pairs of sensitivity and specificity together with 95% confidence intervals from each study, as well as raw receiver operating characteristic (ROC) plots. We displayed paired analyses in an ROC plot by linking sensitivity-specificity pairs from each study by using a dashed line. To compare 3D SIS versus 2D SIS, we restricted analyses to studies that provided 2×2 tables for both tests and used the bivariate meta-analysis of sensitivity and specificity.\nMain results\nThirteen studies (1053 women) reported the accuracy of 3D SIS for focal uterine abnormalities; 11 of these (846 women) were suitable for meta-analysis, and eight reported accuracy according to the type of focal abnormality. The design of the included studies seems applicable. The main problem involving the quality of included studies is insufficient reporting of study methods, resulting in unclear risk of bias for several of the quality domains assessed. Therefore, we considered the overall quality of the evidence as low. The summary estimate (11 studies reporting absence or presence of abnormality at 3D SIS) for sensitivity was 94.5% (95% confidence interval (CI) 90.6% to 96.9%) and for specificity 99.4% (95% CI 96.2% to 99.9%). Meta-analysis of the eight studies (N = 716) directly comparing 2D SIS versus 3D SIS showed summary sensitivity of 96.9% (95% CI 91.9% to 98.8%) and summary specificity of 99.5% (95% CI 96.1% to 100%) for 3D SIS. For 2D SIS, summary sensitivity was 90.9% (95% CI 81.2% to 95.8%) and summary specificity was 96.3% (95% CI 86.1% to 99.1%). The difference in accuracy between 2D SIS and 3D SIS was non-significant (P values of 0.07 for sensitivity and 0.10 for specificity).\nAuthors' conclusions\nLow-quality evidence suggests that 3D SIS may be very accurate in detecting intracavitary abnormalities. Meta-analysis revealed no statistically significant differences between 2D SIS and 3D SIS. Summary sensitivity and summary specificity are higher for 3D SIS, but margins of improvement are limited because 2D SIS is already very accurate. When the technology and appropriate expertise are available, 3D SIS offers an alternative to 2D SIS. Both 2D SIS and 3D SIS should be considered alternatives to diagnostic hysteroscopy when intracavitary pathology is suspected in subfertile women and in those with abnormal uterine bleeding.\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": "In all studies, researchers checked the results of 2D SIS and 3D SIS against results obtained when a camera was used to look inside the womb (hysteroscopy); this is expected to give the true picture but is also more painful for the patient. All studies were performed in the usual way. Some studies did not report several items that might have influenced the results. For example, not all studies made it clear that the person evaluating the ultrasound pictures was unaware of the hysteroscopy results, and vice versa. The main problem involving the quality of included studies is insufficient reporting of study methods, resulting in unclear risk of bias for several of the quality domains assessed. Therefore, review authors considered the overall quality of the evidence as low." } ]
query-laysum	21551	[ { "role": "user", "content": "Abstract: Background\nImpairment of vision is associated with a decrease in activities of daily living. Avoidance of physical activity in older adults with visual impairment can lead to functional decline and is an important risk factor for falls. The rate of falls and fractures is higher in older people with visual impairment than in age-matched visually normal older people. Possible interventions to reduce activity restriction and prevent falls include environmental and behavioral interventions.\nObjectives\nWe aimed to assess the effectiveness and safety of environmental and behavioral interventions in reducing physical activity limitation, preventing falls and improving quality of life amongst visually impaired older people.\nSearch methods\nWe searched CENTRAL (including the Cochrane Eyes and Vision Trials Register) (Issue 2, 2020), Ovid MEDLINE, Embase and eight other databases to 4 February 2020, with no language restrictions.\nSelection criteria\nEligible studies were randomized controlled trials (RCTs) and quasi-randomized controlled trials (Q-RCTs) that compared environmental interventions, behavioral interventions or both, versus control (usual care or no intervention); or that compared different types of environmental or behavioral interventions. Eligible study populations were older people (aged 60 and over) with irreversible visual impairment, living in their own homes or in residential settings. To be eligible for inclusion, studies must have included a measure of physical activity or falls, the two primary outcomes of interest. Secondary outcomes included fear of falling, and quality of life.\nData collection and analysis\nWe used standard Cochrane methods. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included six RCTs (686 participants) conducted in five countries (Australia, Hungary, New Zealand, UK, US) with follow-up periods ranging from two to 12 months. Participants in these trials included older adults (mean age 80 years) and were mostly female (69%), with visual impairments of varying severity and underlying causes. Participants mostly lived in their homes and were physically independent. We classified all trials as having high risk of bias for masking of participants, and three trials as having high or unclear risk of bias for all other domains. The included trials evaluated various intervention strategies (e.g. an exercise program versus home safety modifications). Heterogeneity of study characteristics, including interventions and outcomes, (e.g. different fall measures), precluded any meta-analysis.\nTwo trials compared the home safety modification by occupational therapists versus social/home visits. One trial (28 participants) reported physical activity at six months and showed no evidence of a difference in mean estimates between groups (step counts: mean difference (MD) = 321, 95% confidence interval (CI) -1981 to 2623; average walking time (minutes): MD 1.70, 95% CI -24.03 to 27.43; telephone questionnaire for self-reported physical activity: MD -3.68 scores, 95% CI -20.6 to 13.24; low-certainty of evidence for each outcome). Two trials reported the proportion of participants who fell at six months (risk ratio (RR) 0.76, 95% CI 0.38 to 1.51; 28 participants) and 12 months (RR 0.59, 95% CI 0.43 to 0.80, 196 participants) with low-certainty of evidence for each outcome. One trial (28 participants) reported fear of falling at six months, using the Short Falls Efficacy Scale-International, and found no evidence of a difference in mean estimates between groups (MD 2.55 scores, 95% CI -0.51 to 5.61; low-certainty of evidence). This trial also reported quality of life at six months using 12-Item Short Form Health Survey, and showed no evidence of a difference in mean estimates between groups (MD -3.14 scores, 95% CI -10.86 to 4.58; low-certainty of evidence).\nFive trials compared a behavioral intervention (exercise) versus usual activity or social/home visits. One trial (59 participants) assessed self-reported physical activity at six months and showed no evidence of a difference between groups (MD 9.10 scores, 95% CI -13.85 to 32.5; low-certainty of evidence). Three trials investigated different fall measures at six or 12 months, and found no evidence of a difference in effect estimates (RRs for proportion of fallers ranged from 0.54 (95% CI 0.29 to 1.01; 41 participants); to 0.93 (95% CI 0.61 to 1.39; 120 participants); low-certainty of evidence for each outcome). Three trials assessed the fear of falling using Short Falls Efficacy Scale-International or the Illinois Fear of Falling Measure from two to 12 months, and found no evidence of a difference in mean estimates between groups (the estimates ranged from -0.88 score (95% CI -2.72 to 0.96, 114 participants) to 1.00 score (95% CI -0.13 to 2.13; 59 participants); low-certainty of evidence). One trial (59 participants) assessed the European Quality of Life scale at six months (MD -0.15 score, 95% CI -0.29 to -0.01), and found no evidence of a clinical difference between groups (low-certainty of evidence).\nAuthors' conclusions\nThere is no evidence of effect for most of the environmental or behavioral interventions studied for reducing physical activity limitation and preventing falls in visually impaired older people. The certainty of evidence is generally low due to poor methodological quality and heterogeneous outcome measurements.\nResearchers should form a consensus to adopt standard ways of measuring physical activity and falls reliably in older people with visual impairments. Fall prevention trials should plan to use objectively measured or self-reported physical activity as outcome measures of reduced activity limitation. Future research should evaluate the acceptability and applicability of interventions, and use validated questionnaires to assess the adherence to rehabilitative strategies and performance during activities of daily living.\n\nGiven the provided abstract, please respond to the following query: \"How-up-to date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The evidence in this Cochrane Review is current to 4 February 2020." } ]
query-laysum	21552	[ { "role": "user", "content": "Abstract: Background\nPsychosis is an illness characterised by the presence of hallucinations and delusions that can cause distress or a marked change in an individual's behaviour (e.g. social withdrawal, flat or blunted affect). A first episode of psychosis (FEP) is the first time someone experiences these symptoms that can occur at any age, but the condition is most common in late adolescence and early adulthood. This review is concerned with FEP and the early stages of a psychosis, referred to throughout this review as 'recent-onset psychosis.'\nSpecialised early intervention (SEI) teams are community mental health teams that specifically treat people who are experiencing, or have experienced, a recent-onset psychosis. SEI teams provide a range of treatments including medication, psychotherapy, psychoeducation, educational and employment support, augmented by assertive contact with the service user and small caseloads. Treatment is time limited, usually offered for two to three years, after which service users are either discharged to primary care or transferred to a standard adult community mental health team. Evidence suggests that once SEI treatment ends, improvements may not be sustained, bringing uncertainty about the optimal duration of SEI to ensure the best long-term outcomes. Extending SEI has been proposed as a way of providing continued intensive treatment and continuity of care, of usually up to five years, in order to a) sustain the positive initial outcomes of SEI; and b) improve the long-term trajectory of the illness.\nObjectives\nTo compare extended SEI teams with treatment as usual (TAU) for people with recent-onset psychosis.\nTo compare extended SEI teams with standard SEI teams followed by TAU (standard SEI + TAU) for people with recent-onset psychosis.\nSearch methods\nOn 3 October 2018 and 22 October 2019, we searched Cochrane Schizophrenia's study-based register of trials, including registries of clinical trials.\nSelection criteria\nWe selected all randomised controlled trials (RCTs) comparing extended SEI with TAU for people with recent-onset psychosis and all RCTs comparing extended SEI with standard SEI + TAU for people with recent-onset psychosis. We entered trials meeting these criteria and reporting usable data as included studies.\nData collection and analysis\nWe independently inspected citations, selected studies, extracted data and appraised study quality. For binary outcomes we calculated the risk ratios (RRs) and their 95% confidence intervals (CIs). For continuous outcomes we calculated the mean difference (MD) and their 95% CIs, or if assessment measures differed for the same construct, we calculated the standardised mean difference (SMD) with 95% CIs. We assessed risk of bias for included studies and created a 'Summary of findings' table using the GRADE approach.\nMain results\nWe included three RCTs, with a total 780 participants, aged 16 to 35 years. All participants met the criteria for schizophrenia spectrum disorders or affective psychoses. No trials compared extended SEI with TAU. All three trials randomly allocated people approximately two years into standard SEI to either extended SEI or standard SEI + TAU.\nThe certainty of evidence for outcomes varied from low to very low. Our primary outcomes were recovery and disengagement from mental health services. No trials reported on recovery, and we used remission as a proxy.\nThree trials reported on remission, with the point estimate suggesting a 13% increase in remission in favour of extended SEI, but this included wide confidence intervals (CIs) and a very uncertain estimate of no benefit (RR 1.13, 95% CI 0.97 to 1.31; 3 trials, 780 participants; very low-certainty evidence).\nTwo trials provided data on disengagement from services with evidence that extended SEI care may result in fewer disengagements from mental health treatment (15%) in comparison to standard SEI + TAU (34%) (RR 0.45, 95% CI 0.27 to 0.75; 2 trials, 380 participants; low-certainty evidence).\nThere may be no evidence of a difference in rates of psychiatric hospital admission (RR 1.55, 95% CI 0.68 to 3.52; 1 trial, 160 participants; low-certainty evidence), or the number of days spent in a psychiatric hospital (MD -2.70, 95% CI -8.30 to 2.90; 1 trial, 400 participants; low-certainty evidence).\nOne trial found uncertain evidence regarding lower global psychotic symptoms in extended SEI in comparison to standard SEI + TAU (MD -1.90, 95% CI -3.28 to -0.52; 1 trial, 156 participants; very low-certainty evidence).\nIt was uncertain whether the use of extended SEI over standard SEI + TAU resulted in fewer deaths due to all-cause mortality, as so few deaths were recorded in trials (RR 0.38, 95% CI 0.09 to 1.64; 3 trials, 780 participants; low-certainty evidence).\nVery uncertain evidence suggests that using extended SEI instead of standard SEI + TAU may not improve global functioning (SMD 0.23, 95% CI -0.29 to 0.76; 2 trials, 560 participants; very low-certainty evidence).\nThere was low risk of bias in all three trials for random sequence generation, allocation concealment and other biases. All three trials had high risk of bias for blinding of participants and personnel due to the nature of the intervention. For the risk of bias for blinding of outcome assessments and incomplete outcome data there was at least one trial with high or unclear risk of bias.\nAuthors' conclusions\nThere may be preliminary evidence of benefit from extending SEI team care for treating people experiencing psychosis, with fewer people disengaging from mental health services. Evidence regarding other outcomes was uncertain. The certainty of evidence for the measured outcomes was low or very low.\nFurther, suitably powered studies that use a consistent approach to outcome selection are needed, but with only one further ongoing trial, there is unlikely to be any definitive conclusion for the effectiveness of extended SEI for at least the next few years.\n\nGiven the provided abstract, please respond to the following query: \"What are the results of our review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We found no difference between standard treatment and longer treatment by an early intervention team in the numbers of people who recovered (assessed by remission of symptoms; 3 studies; 780 people).\nFewer people may stop their treatment too soon during longer treatment than standard treatment (2 studies; 380 people).\nThere may be no difference between standard treatment and longer treatment for how many people are admitted to a psychiatric hospital (1 study; 160 people), or for how long they stay in hospital (1 study; 400 people).\nLonger treatment may reduce psychotic symptoms more than standard treatment (1 study; 156 people); but may not improve people's functioning (2 studies; 560 people).\nWe are uncertain about whether longer treatment reduces the number of people who died, compared with standard treatment, because so few deaths were reported in the studies (3 studies; 780 people)." } ]
query-laysum	21553	[ { "role": "user", "content": "Abstract: Background\nAlcohol dependence is a major public health problem that is characterised by recidivism and a host of medical and psychosocial complications. Besides psychosocial interventions, different pharmacological interventions have been or currently are under investigation through Cochrane systematic reviews.\nObjectives\nThe primary aim of the review is to assess the benefits/risks of anticonvulsants for the treatment of alcohol dependence.\nSearch methods\nWe searched the Cochrane Drugs and Alcohol Group Trials Register (October 2013), PubMed (1966 to October 2013), EMBASE (1974 to October 2013) and CINAHL (1982 to October 2013).\nSelection criteria\nRandomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing anticonvulsants alone or in association with other drugs and/or psychosocial interventions versus placebo, no treatment and other pharmacological or psychosocial interventions.\nData collection and analysis\nWe used standard methodological procedures as expected by The Cochrane Collaboration.\nMain results\nA total of 25 studies were included in the review (2641 participants). Most participants were male, with an average age of 44 years. Anticonvulsants were compared with placebo (17 studies), other medications (seven studies) and no medication (two studies). The mean duration of the trials was 17 weeks (range four to 52 weeks). The studies took place in the USA, Europe, South America, India and Thailand. Variation was reported in the characteristics of the studies, including their design and the rating instruments used. For many key outcomes, the risk of bias associated with unclear or unconcealed allocation and lack of blinding affected the quality of the evidence.\nAnticonvulsants versus placebo: For dropouts (16 studies, 1675 participants, risk ratio (RR) 0.94, 95% confidence interval (Cl) 0.74 to 1.19, moderate-quality evidence) and continuous abstinence (eight studies, 634 participants, RR 1.21, 95% Cl 95% 0.97 to 1.52, moderate-quality evidence), results showed no evidence of differences. Moderate-quality evidence suggested that anticonvulsants reduced drinks/drinking days (11 studies, 1126 participants, mean difference (MD) -1.49, 95% Cl -2.32 to -0.65) and heavy drinking (12 studies, 1129 participants, standardised mean difference (SMD) -0.35, 95% Cl -0.51 to -0.19). Moreover, withdrawal for medical reasons (12 studies, 1410 participants, RR 1.22, 95% Cl 0.58 to 2.56, moderate-quality evidence) showed no evidence of difference, but for specific adverse effects (nine studies, 1164 participants), two of 18 adverse event outcomes favoured placebo. The direction of results was confirmed by subgroup analyses for topiramate and partially for gabapentin and valproate.\nAnticonvulsants versus naltrexone: No evidence of difference was shown in dropout rates (five studies, 528 participants, RR 0.74, 95% CI 0.52 to 1.06), severe relapse rates (four studies, 427 participants, RR 0.69, 95% Cl 0.44 to 1.07) and continuous abstinence rates (five studies, 528 participants, RR 1.21, 95% Cl 0.99 to 1.49); anticonvulsants were associated with fewer heavy drinking days (three studies, 308 participants, MD -5.21, 95% Cl -8.58 to -1.83), more days to severe relapse (three studies, 244 participants, MD 11.88, 95% Cl 3.29 to 20.46) and lower withdrawal for medical reasons (three studies, 245 participants, RR 0.13, 95% Cl 0.03 to 0.58).\nAuthors' conclusions\nAt the current stage of research, randomised evidence supporting the clinical use of anticonvulsants to treat alcohol dependence is insufficient. Results are conditioned by heterogeneity and by the low number and quality of studies comparing anticonvulsants with other medications. The uncertainty associated with these results leaves to clinicians the need to balance possible benefits/risks of treatment with anticonvulsants versus other medications as supported by evidence of efficacy.\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": "Alcohol dependence is a major public health problem characterised by recidivism and a host of medical and psychosocial complications. Together with psychosocial interventions, different pharmacological interventions have been tested in trials and systematic reviews. In this review, we wanted to discover whether anticonvulsants are better than placebo or are better than other medications, psychosocial interventions or no intervention." } ]
query-laysum	21554	[ { "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: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We judged the five included trials to be of moderate quality, as authors did not extensively describe portions of their methodology." } ]
query-laysum	21555	[ { "role": "user", "content": "Abstract: Background\nBranch retinal vein occlusion (BRVO) is one of the most commonly occurring retinal vascular abnormalities. The most common cause of visual loss in people with BRVO is macular oedema (MO). Grid or focal laser photocoagulation has been shown to reduce the risk of visual loss. Limitations to this treatment exist, however, and newer modalities may have equal or improved efficacy. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) has recently been used successfully to treat MO resulting from a variety of causes.\nObjectives\nTo investigate the efficacy and gather evidence from randomised controlled trials (RCTs) on the potential harms of anti-vascular endothelial growth factor (VEGF) agents for the treatment of macular oedema (MO) secondary to branch retinal vein occlusion (BRVO).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 6); MEDLINE Ovid; Embase Ovid; the ISRCTN registry; ClinicalTrials.gov; and the WHO ICTRP. The date of the last search was 12 June 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) investigating BRVO. Eligible trials had to have at least six months' follow-up where anti-VEGF treatment was compared with another treatment, no treatment, or placebo. We excluded trials where combination treatments (anti-VEGF plus other treatments) were used; and trials that investigated the dose and duration of treatment without a comparison group (other treatment/no treatment/sham).\nData collection and analysis\nTwo review authors independently extracted the data using standard methodological procedures expected by Cochrane. The primary outcome was the proportion of participants with an improvement from baseline in best-corrected visual acuity of greater than or equal to 15 letters (3 lines) on the Early Treatment in Diabetic Retinopathy Study (ETDRS) Chart at six months and 12 months of follow-up. The secondary outcomes were the proportion of participants who lost greater than or equal to 15 ETDRS letters (3 lines) and the mean visual acuity (VA) change at six and 12 months, as well as the change in central retinal thickness (CRT) on optical coherence tomography from baseline at six and 12 months. We also collected data on adverse events and quality of life (QoL).\nMain results\nWe found eight RCTs of 1631 participants that met the inclusion criteria after independent and duplicate review of the search results. These studies took place in Europe, North America, Eastern Mediterranean region and East Asia. Included participants were adults aged 18 or over with VA of 20/40 or worse. Studies varied by duration of disease but permitted previously treated eyes as long as there was sufficient treatment-free interval. All anti-VEGF agents (bevacizumab, ranibizumab and aflibercept) and steroids (triamcinolone and dexamethasone) were included. Overall, we judged the studies to be at moderate or unclear risk of bias. Four of the eight studies did not mask participants or outcome assessors, or both.\nOne trial compared anti-VEGF to sham. At six months, eyes receiving anti-VEGF were significantly more likely to have a gain of 15 or more ETDRS letters (risk ratio (RR) 1.72, 95% confidence interval (CI) 1.19 to 2.49; 283 participants; moderate-certainty evidence). Mean VA was better in the anti-VEGF group at six months compared with control (mean difference (MD) 7.50 letters, 95% CI 5.29 to 9.71; 282 participants; moderate-certainty evidence). Anti-VEGF also proved more effective at reducing CRT at six months (MD −57.50 microns, 95% CI −108.63 to −6.37; 281 participants; lower CRT is better; moderate-certainty evidence). There was only very low-certainty evidence on adverse effects. There were no reports of endophthalmitis. Mean change in QoL (measured using the National Eye Institute Visual Functioning Questionnaire VFQ-25) was better in people treated with anti-VEGF compared with people treated with sham (MD 7.6 higher score, 95% CI 4.3 to 10.9; 281 participants; moderate-certainty evidence).\nThree RCTs compared anti-VEGF with macular laser (total participants = 473). The proportion of eyes gaining 15 or more letters was greater in the anti-VEGF group at six months (RR 2.09, 95% CI 1.44 to 3.05; 2 studies, 201 participants; moderate-certainty evidence). Mean VA in the anti-VEGF groups was better than the laser groups at six months (MD 9.63 letters, 95% CI 7.23 to 12.03; 3 studies, 473 participants; moderate-certainty evidence). There was a greater reduction in CRT in the anti-VEGF group compared with the laser group at six months (MD −147.47 microns, 95% CI −200.19 to −94.75; 2 studies, 201 participants; moderate-certainty evidence). There was only very low-certainty evidence on adverse events. There were no reports of endophthalmitis. QoL outcomes were not reported.\nFour studies compared anti-VEGF with intravitreal steroid (875 participants). The proportion of eyes gaining 15 or more ETDRS letters was greater in the anti-VEGF group at six months (RR 1.67, 95% CI 1.33 to 2.10; 2 studies, 330 participants; high-certainty evidence) and 12 months (RR 1.76, 95% CI 1.36 to 2.28; 1 study, 307 participants; high-certainty evidence). Mean VA was better in the anti-VEGF group at six months (MD 8.22 letters, 95% CI 5.69 to 10.76; 2 studies, 330 participants; high-certainty evidence) and 12 months (MD 9.15 letters, 95% CI 6.32 to 11.97; 2 studies, 343 participants; high-certainty evidence). Mean CRT also showed a greater reduction in the anti-VEGF arm at 12 months compared with intravitreal steroid (MD −26.92 microns, 95% CI −65.88 to 12.04; 2 studies, 343 participants; moderate-certainty evidence). People receiving anti-VEGF showed a greater improvement in QoL at 12 months compared to those receiving steroid (MD 3.10, 95% CI 0.22 to 5.98; 1 study, 307 participants; moderate-certainty evidence). Moderate-certainty evidence suggested increased risk of cataract and raised IOP with steroids. There was only very low-certainty evidence on APTC events. No cases of endophthalmitis were observed.\nAuthors' conclusions\nThe available RCT evidence suggests that treatment of MO secondary to BRVO with anti-VEGF improves visual and anatomical outcomes at six and 12 months.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Cochrane researchers searched for studies that had been published up to June 2019." } ]
query-laysum	21556	[ { "role": "user", "content": "Abstract: Background\nTesting for carcino-embryonic antigen (CEA) in the blood is a recommended part of follow-up to detect recurrence of colorectal cancer following primary curative treatment. There is substantial clinical variation in the cut-off level applied to trigger further investigation.\nObjectives\nTo determine the diagnostic performance of different blood CEA levels in identifying people with colorectal cancer recurrence in order to inform clinical practice.\nSearch methods\nWe conducted all searches to January 29 2014. We applied no language limits to the searches, and translated non-English manuscripts. We searched for relevant reviews in the MEDLINE, EMBASE, MEDION and DARE databases. We searched for primary studies (including conference abstracts) in the Cochrane Central Register of Controlled Trials (CENTRAL), in MEDLINE, EMBASE, and the Science Citation Index & Conference Proceedings Citation Index – Science. We identified ongoing studies by searching WHO ICTRP and the ASCO meeting library.\nSelection criteria\nWe included cross-sectional diagnostic test accuracy studies, cohort studies, and randomised controlled trials (RCTs) of post-resection colorectal cancer follow-up that compared CEA to a reference standard. We included studies only if we could extract 2 x 2 accuracy data. We excluded case-control studies, as the ratio of cases to controls is determined by the study design, making the data unsuitable for assessing test accuracy.\nData collection and analysis\nTwo review authors (BDN, IP) assessed the quality of all articles independently, discussing any disagreements. Where we could not reach consensus, a third author (BS) acted as moderator. We assessed methodological quality against QUADAS-2 criteria. We extracted binary diagnostic accuracy data from all included studies as 2 x 2 tables. We conducted a bivariate meta-analysis. We used the xtmelogit command in Stata to produce the pooled estimates of sensitivity and specificity and we also produced hierarchical summary ROC plots.\nMain results\nIn the 52 included studies, sensitivity ranged from 41% to 97% and specificity from 52% to 100%. In the seven studies reporting the impact of applying a threshold of 2.5 µg/L, pooled sensitivity was 82% (95% confidence interval (CI) 78% to 86%) and pooled specificity 80% (95% CI 59% to 92%). In the 23 studies reporting the impact of applying a threshold of 5 µg/L, pooled sensitivity was 71% (95% CI 64% to 76%) and pooled specificity 88% (95% CI 84% to 92%). In the seven studies reporting the impact of applying a threshold of 10 µg/L, pooled sensitivity was 68% (95% CI 53% to 79%) and pooled specificity 97% (95% CI 90% to 99%).\nAuthors' conclusions\nCEA is insufficiently sensitive to be used alone, even with a low threshold. It is therefore essential to augment CEA monitoring with another diagnostic modality in order to avoid missed cases. Trying to improve sensitivity by adopting a low threshold is a poor strategy because of the high numbers of false alarms generated. We therefore recommend monitoring for colorectal cancer recurrence with more than one diagnostic modality but applying the highest CEA cut-off assessed (10 µg/L).\n\nGiven the provided abstract, please respond to the following query: \"Key Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "This review shows that setting a low cut-off point will increase the number of genuine cases of colorectal cancer recurrence that are detected (true positives), but a low cut-off will also cause unnecessary alarm by incorrectly classifying too many cases that are not actually recurrences (false positives). In addition, this review shows that a rise in CEA does not occur in up to 20% of patients with a true recurrence (false negatives). The current evidence supports using the highest cut-off point assessed (10 µg/L), but that adding another diagnostic modality (e.g. a single scan of the chest, abdomen and pelvis at 12 to 18 months) is necessary in order to avoid the missed cases." } ]
query-laysum	21557	[ { "role": "user", "content": "Abstract: Background\nStroke is the second leading cause of death and a major cause of morbidity worldwide. Retrospective clinical and animal studies have demonstrated neuroprotective effects of iron chelators in people with haemorrhagic or ischaemic stroke. This is the first update of the original Cochrane Review published in 2012.\nObjectives\nTo evaluate the effectiveness and safety of iron-chelating drugs in people with acute stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (2 September 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2019, Issue 9; 2 September 2019), MEDLINE Ovid (2 September 2019), Embase Ovid (2 September 2019), and Science Citation Index (2 September 2019). We also searched ongoing trials registers.\nSelection criteria\nWe included randomised controlled trials (RCTs) of iron chelators versus no iron chelators or placebo for the treatment of acute stroke, including subarachnoid haemorrhage.\nData collection and analysis\nTwo review authors independently screened the search results. We obtained the full texts of potentially relevant studies and evaluated them for eligibility. We assessed risk of bias using the Cochrane 'Risk of bias' tool, and the certainty of evidence using the GRADE approach.\nMain results\nTwo RCTs (333 participants) were eligible for inclusion; both compared the iron-chelating agent deferoxamine against placebo. Both studies evaluated participants with spontaneous intracerebral haemorrhage. We assessed one study to have a low risk of bias; the other study had potential sources of bias.\nThe limited and heterogeneous data did not allow for meta-analysis of the outcome parameters. The evidence suggests that administration of deferoxamine may result in little to no difference in deaths (8% in placebo vs 8% in deferoxamine at 180 days; 1 RCT, 291 participants; low-certainty evidence). These RCTs suggest that there may be little to no difference in good functional outcome (modified Rankin Scale score 0 to 2) between groups at 30, 90 and 180 days (placebo vs deferoxamine: 67% vs 57% at 30 days and 36% vs 45% at 180 days; 2 RCTs, 333 participants; low-certainty evidence). One RCT suggests that administration of deferoxamine may not increase the number of serious adverse events or deaths (placebo vs deferoxamine: 33% vs 27% at 180 days; risk ratio 0.81, 95 % confidence interval 0.57 to 1.16; 1 RCT, 291 participants; low-certainty evidence). No data were available on any deaths within the treatment period. Deferoxamine may result in little to no difference in the evolution of National Institute of Health Stroke Scale scores from baseline to 90 days (placebo vs deferoxamine: 13 to 4 vs 13 to 3; P = 0.37; 2 RCTs, 333 participants; low-certainty evidence). Deferoxamine may slightly reduce relative oedema surrounding intracerebral haemorrhage at 15 days (placebo vs deferoxamine: 1.91 vs 10.26; P = 0.042; 2 RCTs, 333 participants; low-certainty evidence). Neither study reported quality of life.\nAuthors' conclusions\nWe identified two eligible RCTs for assessment. We could not demonstrate any benefit for the use of iron chelators in spontaneous intracerebral haemorrhage. The added value of iron-chelating therapy in people with ischaemic stroke or subarachnoid haemorrhage remains unknown.\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": "With the limitation that studies could not be pooled, the data did not show any difference in good neurological outcome between groups. Both studies reported that administration of deferoxamine was safe. Oedema formation around the haematoma was slightly reduced in the deferoxamine group in one study, but not in the other." } ]
query-laysum	21558	[ { "role": "user", "content": "Abstract: Background\nPersistent cough is a common clinical problem. Despite thorough investigation and empirical management, a considerable proportion of those people with subacute and chronic cough have unexplained cough, for which treatment options are limited. While current guidelines recommend inhaled corticosteroids (ICS), the research evidence for this intervention is conflicting.\nObjectives\nTo assess the effects of ICS for subacute and chronic cough in adults.\nSearch methods\nWe searched the Cochrane Airways Group Register of Trials, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and ClinicalTrials.gov in December 2012 and conducted handsearches.\nSelection criteria\nTwo authors independently assessed all potentially relevant trials. All published and unpublished randomised comparisons of ICS versus placebo in adults with subacute or chronic cough were included. Participants with known chronic respiratory disease and asthma were excluded. Studies of cough-variant asthma and eosinophilic bronchitis were eligible.\nData collection and analysis\nTwo authors independently extracted data pertaining to pre-defined outcomes. The primary outcome was the proportion of participants with clinical cure or significant improvement (over 70% reduction in cough severity measure) at follow up (clinical success). The secondary outcomes included proportion of participants with clinical cure or over 50% reduction in cough severity measure at follow up, mean change in cough severity measures, complications of cough, biomarkers of inflammation and adverse effects. We requested additional data from study authors.\nMain results\nEight primary studies, including 570 participants, were included. The overall methodological quality of studies was good. Significant clinical heterogeneity resulting from differences in participants and interventions, as well as variation in outcome measures, limited the validity of comparisons between studies for most outcomes. Data for the primary outcome of clinical cure or significant (> 70%) improvement were available for only three studies, which were too heterogeneous to pool. Similarly, heterogeneity in study characteristics limited the validity of meta-analysis for the secondary outcomes of proportion of participants with clinical cure or over 50% reduction in cough severity measure and clinical cure. One parallel group trial of chronic cough which identified a significant treatment effect contributed the majority of statistical heterogeneity for these outcomes. While ICS treatment resulted in a mean decrease in cough score of 0.34 standard deviations (SMD -0.34; 95% CI -0.56 to -0.13; 346 participants), the quality of evidence was low. Heterogeneity also prevented meta-analysis for the outcome of mean change in visual analogue scale score. Meta-analysis was not possible for the outcomes of pulmonary function, complications of cough or biomarkers of inflammation due to insufficient data. There was moderate quality evidence that treatment with ICS did not significantly increase the odds of experiencing an adverse event (OR 1.67; 95% CI 0.92 to 3.04).\nAuthors' conclusions\nThe studies were highly heterogeneous and results were inconsistent. Heterogeneity in study design needs to be addressed in future research in order to test the efficacy of this intervention. International cough guidelines recommend that a trial of ICS should only be considered in patients after thorough evaluation including chest X-ray and consideration of spirometry and other appropriate investigations.\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 eight studies on 570 people with cough lasting over three weeks. Studies included different types of participants in terms of age, duration of coughing and risk factors for cough. Studies also varied in types of ICS, doses, treatment lengths and types of inhaler used. Cough severity was measured using different scales." } ]
query-laysum	21559	[ { "role": "user", "content": "Abstract: Background\nA deficiency in vitamin K has been associated with increased calcium deposition and coronary artery calcification, which may lead to cardiovascular disease.\nObjectives\nTo determine the effectiveness of vitamin K supplementation as a single nutrient supplement for the primary prevention of cardiovascular disease.\nSearch methods\nWe searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 8 of 12, 2014); MEDLINE (Ovid, 1946 to September week 2 2014); EMBASE Classic + EMBASE (Ovid, 1947 to September 18 2014); Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index, Science (CPCI-S) (both 1990 to 17 September 2014) on Web of Science (Thomson Reuters); Database of Abstracts of Reviews of Effects (DARE); Health Technology Assessment Database and Health Economics Evaluations Database (Issue 3 of 4, 2014). We searched trial registers and reference lists of reviews for further studies. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials of vitamin K supplementation as a single nutrient supplement, lasting at least three months, and involving healthy adults or adults at high risk of cardiovascular disease. The comparison group was no intervention or placebo. The outcomes of interest were cardiovascular disease clinical events and cardiovascular disease risk factors.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, abstracted the data and assessed the risk of bias.\nMain results\nWe included only one small trial (60 participants randomised) which overall was judged to be at low risk of bias. The study examined two doses of menaquinone (vitamin K2) over 3 months in healthy participants aged 40 to 65 years. The primary focus of the trial was to examine the effects of menaquinone (subtype MK7) on different matrix Gla proteins (MGP - vitamin K dependent proteins in the vessel wall) at different doses, but the authors also reported blood pressure and lipid levels. The trial did not report on our primary outcomes (cardiovascular disease clinical events) as it was small, short term and conducted in healthy participants.\nIn terms of cardiovascular disease risk factors, no effects were seen for vitamin K2 on blood pressure or lipid levels, although the trial was small and findings are limited. The trial did not report any of our other secondary outcomes.\nAuthors' conclusions\nThe very limited results of this review highlight the lack of evidence currently available to determine the effectiveness of vitamin K supplementation for the primary prevention of cardiovascular disease, and demonstrate the need for further high quality trials in this area.\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": "Only one small trial met our inclusion criteria. It included 60 participants aged 40 to 65 years. This study looked at the effects of vitamin K2 supplements on CVD risk factors (blood pressure and lipid levels) over three months in healthy participants. No differences in these risk factors were seen between the comparison groups, but this was a small study and the findings are limited. The trial did not look at fatal and non-fatal cardiovascular endpoints as it was small and short term.\nThe evidence is currently extremely limited and further high-quality trials are needed so that the effectiveness of vitamin K supplementation for CVD prevention can be determined." } ]
query-laysum	21560	[ { "role": "user", "content": "Abstract: Background\nNeonatal hyperbilirubinaemia is a common problem which carries a risk of neurotoxicity. Certain infants who have hyperbilirubinaemia develop bilirubin encephalopathy and kernicterus which may lead to long-term disability. Phototherapy is currently the mainstay of treatment for neonatal hyperbilirubinaemia. Among the adjunctive measures to compliment the effects of phototherapy, fluid supplementation has been proposed to reduce serum bilirubin levels. The mechanism of action proposed includes direct dilutional effects of intravenous (IV) fluids, or enhancement of peristalsis to reduce enterohepatic circulation by oral fluid supplementation.\nObjectives\nTo assess the risks and benefits of fluid supplementation compared to standard fluid management in term and preterm newborn infants with unconjugated hyperbilirubinaemia who require phototherapy.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 5), MEDLINE via PubMed (1966 to 7 June 2017), Embase (1980 to 7 June 2017), and CINAHL (1982 to 7 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included randomised controlled trials that compared fluid supplementation against no fluid supplementation, or one form of fluid supplementation against another.\nData collection and analysis\nWe extracted data using the standard methods of the Cochrane Neonatal Review Group using the Covidence platform. Two review authors independently assessed the eligibility and risk of bias of the retrieved records. We expressed our results using mean difference (MD), risk difference (RD), and risk ratio (RR) with 95% confidence intervals (CIs).\nMain results\nOut of 1449 articles screened, seven studies were included. Three articles were awaiting classification, among them, two completed trials identified from the trial registry appeared to be unpublished so far.\nThere were two major comparisons: IV fluid supplementation versus no fluid supplementation (six studies) and IV fluid supplementation versus oral fluid supplementation (one study). A total of 494 term, healthy newborn infants with unconjugated hyperbilirubinaemia were evaluated. All studies were at high risk of bias for blinding of care personnel, five studies had unclear risk of bias for blinding of outcome assessors, and most studies had unclear risk of bias in allocation concealment. There was low- to moderate-quality evidence for all major outcomes.\nIn the comparison between IV fluid supplementation and no supplementation, no infant in either group developed bilirubin encephalopathy in the one study that reported this outcome. Serum bilirubin was lower at four hours postintervention for infants who received IV fluid supplementation (MD -34.00 μmol/L (-1.99 mg/dL), 95% CI -52.29 (3.06) to -15.71 (0.92); participants = 67, study = 1) (low quality of evidence, downgraded one level for indirectness and one level for suspected publication bias). Beyond eight hours postintervention, serum bilirubin was similar between the two groups. Duration of phototherapy was significantly shorter for fluid-supplemented infants, but the estimate was affected by heterogeneity which was not clearly explained (MD -10.70 hours, 95% CI -15.55 to -5.85; participants = 218; studies = 3; I² = 67%). Fluid-supplemented infants were less likely to require exchange transfusion (RR 0.39, 95% CI 0.21 to 0.71; RD -0.01, 95% CI -0.04 to 0.02; participants = 462; studies = 6; I² = 72%) (low quality of evidence, downgraded one level due to inconsistency, and another level due to suspected publication bias), and the estimate was similarly affected by unexplained heterogeneity. The frequencies of breastfeeding were similar between the fluid-supplemented and non-supplemented infants in days one to three based on one study (estimate on day three: MD 0.90 feeds, 95% CI -0.40 to 2.20; participants = 60) (moderate quality of evidence, downgraded one level for imprecision).\nOne study contributed to all outcome data in the comparison of IV versus oral fluid supplementation. In this comparison, no infant in either group developed abnormal neurological signs. Serum bilirubin, as well as the rate of change of serum bilirubin, were similar between the two groups at four hours after phototherapy (serum bilirubin: MD 11.00 μmol/L (0.64 mg/dL), 95% CI -21.58 (-1.26) to 43.58 (2.55); rate of change of serum bilirubin: MD 0.80 μmol/L/hour (0.05 mg/dL/hour), 95% CI -2.55 (-0.15) to 4.15 (0.24); participants = 54 in both outcomes) (moderate quality of evidence for both outcomes, downgraded one level for indirectness). The number of infants who required exchange transfusion was similar between the two groups (RR 1.60, 95% CI 0.60 to 4.27; RD 0.11, 95% CI -0.12 to 0.34; participants = 54). No infant in either group developed adverse effects including vomiting or abdominal distension.\nAuthors' conclusions\nThere is no evidence that IV fluid supplementation affects important clinical outcomes such as bilirubin encephalopathy, kernicterus, or cerebral palsy in healthy, term newborn infants with unconjugated hyperbilirubinaemia requiring phototherapy. In this review, no infant developed these bilirubin-associated clinical complications. Low- to moderate-quality evidence shows that there are differences in total serum bilirubin levels between fluid-supplemented and control groups at some time points but not at others, the clinical significance of which is uncertain. There is no evidence of a difference between the effectiveness of IV and oral fluid supplementations in reducing serum bilirubin. Similarly, no infant developed adverse events or complications from fluid supplementation such as vomiting or abdominal distension. This suggests a need for future research to focus on different population groups with possibly higher baseline risks of bilirubin-related neurological complications, such as preterm or low birthweight infants, infants with haemolytic hyperbilirubinaemia, as well as infants with dehydration for comparison of different fluid supplementation regimen.\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 no evidence that intravenous fluid supplementation affected major clinical outcomes such as acute- or long-term brain problems associated with excessive bilirubin in healthy, full-term newborn infants, mainly because the baseline risk of developing such problems was very low in this group of infants. Intravenous fluid supplementation may reduce serum bilirubin at certain time points but it is unclear whether this translates into important clinical benefits. Future research should focus on higher-risk populations such as preterm infants or infants with haemolysis (increased red blood cell breakdown which causes a rapid rise in bilirubin)." } ]
query-laysum	21561	[ { "role": "user", "content": "Abstract: Background\nTobacco smoking remains one of the few preventable factors associated with complications in pregnancy, and has serious long-term implications for women and babies. Smoking in pregnancy is decreasing in high-income countries, but is strongly associated with poverty and is increasing in low- to middle-income countries.\nObjectives\nTo assess the effects of smoking cessation interventions during pregnancy on smoking behaviour and perinatal health outcomes.\nSearch methods\nIn this sixth update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register (13 November 2015), checked reference lists of retrieved studies and contacted trial authors.\nSelection criteria\nRandomised controlled trials, cluster-randomised trials, and quasi-randomised controlled trials of psychosocial smoking cessation interventions during pregnancy.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and trial quality, and extracted data. Direct comparisons were conducted in RevMan, with meta-regression conducted in STATA 14.\nMain results\nThe overall quality of evidence was moderate to high, with reductions in confidence due to imprecision and heterogeneity for some outcomes. One hundred and two trials with 120 intervention arms (studies) were included, with 88 trials (involving over 28,000 women) providing data on smoking abstinence in late pregnancy. Interventions were categorised as counselling, health education, feedback, incentives, social support, exercise and dissemination.\nIn separate comparisons, there is high-quality evidence that counselling increased smoking cessation in late pregnancy compared with usual care (30 studies; average risk ratio (RR) 1.44, 95% confidence interval (CI) 1.19 to 1.73) and less intensive interventions (18 studies; average RR 1.25, 95% CI 1.07 to 1.47). There was uncertainty whether counselling increased the chance of smoking cessation when provided as one component of a broader maternal health intervention or comparing one type of counselling with another. In studies comparing counselling and usual care (largest comparison), it was unclear whether interventions prevented smoking relapse among women who had stopped smoking spontaneously in early pregnancy. However, a clear effect was seen in smoking abstinence at zero to five months postpartum (11 studies; average RR 1.59, 95% CI 1.26 to 2.01) and 12 to 17 months (two studies, average RR 2.20, 95% CI 1.23 to 3.96), with a borderline effect at six to 11 months (six studies; average RR 1.33, 95% CI 1.00 to 1.77). In other comparisons, the effect was unclear for most secondary outcomes, but sample sizes were small.\nEvidence suggests a borderline effect of health education compared with usual care (five studies; average RR 1.59, 95% CI 0.99 to 2.55), but the quality was downgraded to moderate as the effect was unclear when compared with less intensive interventions (four studies; average RR 1.20, 95% CI 0.85 to 1.70), alternative interventions (one study; RR 1.88, 95% CI 0.19 to 18.60), or when smoking cessation health education was provided as one component of a broader maternal health intervention.\nThere was evidence feedback increased smoking cessation when compared with usual care and provided in conjunction with other strategies, such as counselling (average RR 4.39, 95% CI 1.89 to 10.21), but the confidence in the quality of evidence was downgraded to moderate as this was based on only two studies and the effect was uncertain when feedback was compared to less intensive interventions (three studies; average RR 1.29, 95% CI 0.75 to 2.20).\nHigh-quality evidence suggests incentive-based interventions are effective when compared with an alternative (non-contingent incentive) intervention (four studies; RR 2.36, 95% CI 1.36 to 4.09). However pooled effects were not calculable for comparisons with usual care or less intensive interventions (substantial heterogeneity, I2 = 93%).\nHigh-quality evidence suggests the effect is unclear in social support interventions provided by peers (six studies; average RR 1.42, 95% CI 0.98 to 2.07), in a single trial of support provided by partners, or when social support for smoking cessation was provided as part of a broader intervention to improve maternal health.\nThe effect was unclear in single interventions of exercise compared to usual care (RR 1.20, 95% CI 0.72 to 2.01) and dissemination of counselling (RR 1.63, 95% CI 0.62 to 4.32).\nImportantly, high-quality evidence from pooled results demonstrated that women who received psychosocial interventions had a 17% reduction in infants born with low birthweight, a significantly higher mean birthweight (mean difference (MD) 55.60 g, 95% CI 29.82 to 81.38 g higher) and a 22% reduction in neonatal intensive care admissions. However the difference in preterm births and stillbirths was unclear. There did not appear to be adverse psychological effects from the interventions.\nThe intensity of support women received in both the intervention and comparison groups has increased over time, with higher-intensity interventions more likely to have higher-intensity comparisons, potentially explaining why no clear differences were seen with increasing intervention intensity in meta-regression analyses. Among meta-regression analyses: studies classified as having 'unclear' implementation and unequal baseline characteristics were less effective than other studies. There was no clear difference between trials implemented by researchers (efficacy studies), and those implemented by routine pregnancy staff (effectiveness studies), however there was uncertainty in the effectiveness of counselling in four dissemination trials where the focus on the intervention was at an organisational level. The pooled effects were similar in interventions provided for women classified as having predominantly low socio-economic status, compared to other women. The effect was significant in interventions among women from ethnic minority groups; however not among indigenous women. There were similar effect sizes in trials with biochemically validated smoking abstinence and those with self-reported abstinence. It was unclear whether incorporating use of self-help manuals or telephone support increased the effectiveness of interventions.\nAuthors' conclusions\nPsychosocial interventions to support women to stop smoking in pregnancy can increase the proportion of women who stop smoking in late pregnancy and the proportion of infants born low birthweight. Counselling, feedback and incentives appear to be effective, however the characteristics and context of the interventions should be carefully considered. The effect of health education and social support is less clear. New trials have been published during the preparation of this review and will be included in the next update.\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": "Tobacco smoking during pregnancy increases the risk of the mother having complications during pregnancy and the baby being born low birthweight. Nicotine and other contents of cigarettes can have harmful effects on the baby’s growth and development." } ]
query-laysum	21562	[ { "role": "user", "content": "Abstract: Background\nTopical corticosteroids are the most frequently prescribed dermatological treatment and are often used by pregnant women with skin conditions. However, little is known about their safety in pregnancy.\nObjectives\nTo assess the effects of topical corticosteroids on pregnancy outcomes in pregnant women.\nSearch methods\nThis is an update of a review previously published in 2009. We updated our searches of the following databases to July 2015: the Cochrane Skin Group Specialised Register, the Cochrane Pregnancy and Childbirth Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 6), MEDLINE, EMBASE, and LILACS. We also searched five trials registers and checked the reference lists of included studies, published reviews, articles that had cited the included studies, and one author's literature collection, for further references to relevant RCTs.\nSelection criteria\nRandomised controlled trials and cohort studies of topical corticosteroids in pregnant women, as well as case-control studies comparing maternal exposure to topical corticosteroids between cases and controls when studies reported pre-specified outcomes. The primary outcomes included mode of delivery, major congenital abnormality, birth weight, and preterm delivery (delivery before 37 completed weeks gestation); the secondary outcomes included foetal death, minor congenital abnormality, and low Apgar score (less than seven at 5 min).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two authors independently applied selection criteria, extracted data, and assessed the quality of the included studies. A third author was available for resolving differences of opinion. A further author independently extracted data from included studies that were conducted by authors of this systematic review.\nMain results\nWe included 7 new observational studies in this update, bringing the total number to 14, including 5 cohort and 9 case-control studies, with 1,601,515 study subjects.\nMost studies found no causal associations between maternal exposure to topical corticosteroids of any potency and pregnancy outcomes when compared with no exposure. These outcomes included: mode of delivery (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.95 to 1.15, 1 cohort study, n = 9904, low quality evidence); congenital abnormalities, including orofacial cleft or cleft palate and hypospadias (where the urethral opening is on the underside of the penis) (RR 0.82, 95% CI 0.34 to 1.96, 2 cohort studies, n = 9512, low quality evidence; and odds ratio (OR) 1.07, 95% CI 0.71 to 1.60, 1 case-control study, n = 56,557); low birth weight (RR 1.08, 95% CI 0.86 to 1.36; n = 59,419, 4 cohort studies; very low quality evidence); preterm delivery (RR 0.93, 95% CI 0.81 to 1.08, 4 cohort studies, n = 59,419, low quality evidence); foetal death (RR 1.02, 95% CI 0.60 to 1.73, 4 cohort studies, n = 63,885, very low quality evidence); and low Apgar score (RR 0.84, 95% CI 0.54 to 1.31, 1 cohort study, n = 9220, low quality evidence).\nWe conducted stratified analyses of mild or moderate potency, and potent or very potent topical corticosteroids, but we found no causal associations between maternal exposure to topical corticosteroid of any potency and congenital abnormality, orofacial clefts, preterm delivery, or low Apgar score. For low birth weight, although the meta-analysis based on study-level data was not significant for either mild to moderate corticosteroids (pooled RR 0.90, 95% CI 0.74 to 1.09, 3 cohort studies, n > 55,713) or potent to very potent corticosteroids (pooled RR 1.58, 95% CI 0.96 to 2.58, 4 cohort studies, n > 47,651), there were significant differences between the two subgroups (P = 0.04). The results from three of the individual studies in the meta-analysis indicated an increased risk of low birth weight in women who received potent to very potent topical corticosteroids. Maternal use of mild to moderate potency topical steroids was associated with a decreased risk of foetal death (pooled RR 0.70, 95% CI 0.64 to 0.77, 2 studies, n = 48,749; low quality evidence), but we did not observe this effect when potent to very potent topical corticosteroids were given during pregnancy (pooled RR 1.14, 95% CI 0.69 to 1.88, 3 studies, n = 37,086, low quality evidence).\nWe used the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group approach to rate the overall quality of the evidence. Data from observational studies started at low quality. We further downgraded the evidence because of imprecision in low birth weight and inconsistency in foetal death. Lower quality evidence resulted in lower confidence in the estimate of effect for those outcomes.\nAuthors' conclusions\nThis update adds more evidence showing no causal associations between maternal exposure to topical corticosteroids of all potencies and pregnancy outcomes including mode of delivery, congenital abnormalities, preterm delivery, foetal death, and low Apgar score, which is consistent with the previous version of this review. This update provides stratified analyses based on steroid potency; we found no association between maternal use of topical corticosteroids of any potency and an increase in adverse pregnancy outcomes, including mode of delivery, congenital abnormality, preterm delivery, foetal death, and low Apgar score. Similar to the previous version of the review, this update identified a probable association between low birth weight and maternal use of potent to very potent topical corticosteroids, especially when the cumulative dosage of topical corticosteroids throughout the pregnancy is very large, which warrants further investigation. The finding of a possible protective effect of mild to moderate topical corticosteroids on foetal death could also be examined.\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 associations between mothers' use of topical steroids of any potency and type of delivery, birth defects, premature births, or low Apgar score.\nThere is some evidence indicating a relation between low birth weight and maternal use of potent or very potent topical steroids, especially when high doses are used in pregnancy, and this may warrant more research. On the other hand, maternal use of mild or moderate topical corticosteroids is not related to low birth weight. We even found that mild or moderately potent topical steroids protect against death of the baby, but this was not seen when the mothers used potent or very potent topical steroids. This finding needs further examination." } ]
query-laysum	21563	[ { "role": "user", "content": "Abstract: Background\nSeasonal affective disorder (SAD) is a seasonal pattern of recurrent major depressive episodes that most commonly starts in autumn or winter and remits in spring. The prevalence of SAD depends on latitude and ranges from 1.5% to 9%. The predictable seasonal aspect of SAD provides a promising opportunity for prevention in people who have a history of SAD. This is one of four reviews on the efficacy and safety of interventions to prevent SAD; we focus on agomelatine and melatonin as preventive interventions.\nObjectives\nTo assess the efficacy and safety of agomelatine and melatonin (in comparison with each other, placebo, second-generation antidepressants, light therapy, psychological therapy or lifestyle interventions) in preventing SAD and improving person-centred outcomes among adults with a history of SAD.\nSearch methods\nWe searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 19 June 2018. An earlier search of these databases was conducted via the Cochrane Common Mental Disorders Controlled Trial Register (CCMD-CTR) (all years to 11 August 2015). Furthermore, we searched the Cumulative Index to Nursing and Allied Health Literature, Web of Science, the Cochrane Library, the Allied and Complementary Medicine Database and international trial registers (to 19 June 2018). We also conducted a grey literature search and handsearched the reference lists of included studies and pertinent review articles.\nSelection criteria\nTo examine efficacy, we included randomised controlled trials (RCTs) on adults with a history of winter-type SAD who were free of symptoms at the beginning of the study. For adverse events, we intended also to include non-randomised studies. We planned to include studies that compared agomelatine versus melatonin, or agomelatine or melatonin versus placebo, any second-generation antidepressant, light therapy, psychological therapies or lifestyle changes. We also intended to compare melatonin or agomelatine in combination with any of the comparator interventions mentioned above versus the same comparator intervention as monotherapy.\nData collection and analysis\nTwo review authors screened abstracts and full-text publications, abstracted data and assessed risk of bias of included studies independently. We intended to pool data in a meta-analysis using a random-effects model, but included only one study.\nMain results\nWe identified 3745 citations through electronic searches and reviews of reference lists after deduplication of search results. We excluded 3619 records during title and abstract review and assessed 126 full-text papers for inclusion in the review. Only one study, providing data of 225 participants, met our eligibility criteria and compared agomelatine (25 mg/day) with placebo. We rated it as having high risk of attrition bias because nearly half of the participants left the study before completion. We rated the certainty of the evidence as very low for all outcomes, because of high risk of bias, indirectness, and imprecision.\nThe main analysis based on data of 199 participants rendered an indeterminate result with wide confidence intervals (CIs) that may encompass both a relevant reduction as well as a relevant increase of SAD incidence by agomelatine (risk ratio (RR) 0.83, 95% CI 0.51 to 1.34; 199 participants; very low-certainty evidence). Also the severity of SAD may be similar in both groups at the end of the study with a mean SIGH-SAD (Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorders) score of 8.3 (standard deviation (SD) 9.4) in the agomelatine group and 10.1 (SD 10.6) in the placebo group (mean difference (MD) -1.80, 95% CI -4.58 to 0.98; 199 participants; very low-certainty evidence). The incidence of adverse events and serious adverse events may be similar in both groups. In the agomelatine group, 64 out of 112 participants experienced at least one adverse event, while 61 out of 113 did in the placebo group (RR 1.06, 95% CI 0.84 to 1.34; 225 participants; very low-certainty evidence). Three out of 112 patients experienced serious adverse events in the agomelatine group, compared to 4 out of 113 in the placebo group (RR 0.76, 95% CI 0.17 to 3.30; 225 participants; very low-certainty evidence).\nNo data on quality of life or interpersonal functioning were reported. We did not identify any studies on melatonin.\nAuthors' conclusions\nGiven the uncertain evidence on agomelatine and the absence of studies on melatonin, no conclusion about efficacy and safety of agomelatine and melatonin for prevention of SAD can currently be drawn. The decision for or against initiating preventive treatment of SAD and the treatment selected should consider patient preferences and reflect on the evidence base of all available treatment options.\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" }, { "role": "assistant", "content": "Because of the seasonal pattern and high recurrence of SAD, melatonin or agomelatine could be used to prevent the onset of depressed mood. The goal of this report is to examine whether benefits outweigh harms of melatonin or agomelatine when used to prevent onset of a new depressive episode in people with a history of SAD who were free of symptoms when the preventive intervention started. To date, this question has not been examined in a systematic way. This is one of four reviews on the efficacy and potential harms of interventions to prevent SAD." } ]
query-laysum	21564	[ { "role": "user", "content": "Abstract: Background\nMotion sickness is a syndrome that occurs as a result of passive body movement in response to actual motion, or the illusion of motion when exposed to virtual and moving visual environments. The most common symptoms are nausea and vomiting. Antihistamines have been used in the management of motion sickness for decades, however studies have shown conflicting results regarding their efficacy.\nObjectives\nTo assess the effectiveness of antihistamines in the prevention and treatment of motion sickness in adults and children.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials; Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 7 December 2021.\nSelection criteria\nRandomised controlled trials (RCTs) in susceptible adults and children in whom motion sickness was induced under natural conditions such as air, sea and land transportation. We also included studies in which motion sickness was induced under experimental conditions (analysed separately). Antihistamines were included regardless of class, route or dosage and compared to no treatment, placebo or any other pharmacological or non-pharmacological interventions.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1) the proportion of susceptible participants who did not experience any motion sickness symptoms; 2) the proportion of susceptible participants who experienced a reduction or resolution of existing symptoms. Secondary outcomes were 1) physiological measures (heart rate, core temperature and gastric tachyarrhythmia (electrogastrography)) and 2) adverse effects (sedation, impaired cognition, blurred vision). We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included nine RCTs (658 participants). Studies were conducted across seven countries, with an overall age range of 16 to 55 years. Motion sickness was induced naturally in six studies and experimentally in four studies (rotating chair). All the naturally induced studies only evaluated first-generation antihistamines (cinnarizine and dimenhydrinate). Risk of bias across the studies varied, with mostly low risk for random sequence generation and allocation concealment, and mostly high risk for selective reporting. Only the experimentally induced studies measured physiological parameters and only the naturally induced studies evaluated adverse effects. There were no studies that clearly assessed the paediatric population.\nAntihistamines versus placebo or no treatment\nAntihistamines are probably more effective than placebo at preventing motion sickness symptoms under natural conditions (symptoms prevented: 25% placebo; 40% antihistamines) (risk ratio (RR) 1.81, 95% confidence interval (CI) 1.23 to 2.66; 3 studies; 240 participants) (moderate-certainty). The evidence is very uncertain about the effect of antihistamines on preventing motion sickness under experimental conditions (standardised mean difference (SMD) 0.32, 95% CI -0.18 to 0.83; 2 studies; 62 participants) (very low-certainty). No studies reported results on the resolution of existing motion sickness symptoms.\nAntihistamines may result in little or no difference in gastric tachyarrhythmia under experimental conditions (mean difference (MD) -2.2, 95% CI -11.71 to 7.31; 1 study; 42 participants) (low-certainty). No studies reported results for any other physiological measures. When compared to placebo, antihistamines may be more likely to cause sedation (sedation: 44% placebo; 66% antihistamines) (RR 1.51, 95% CI 1.12 to 2.02; 2 studies; 190 participants) (low-certainty); they may result in little or no difference in blurred vision (blurred vision: 12.5% placebo; 14% antihistamines) (RR 1.14, 95% CI 0.53 to 2.48; 2 studies; 190 participants) (low-certainty); and they may result in little or no difference in terms of impaired cognition (impaired cognition: 33% placebo; 29% antihistamines) (RR 0.89, 95% CI 0.58 to 1.38; 2 studies; 190 participants) (low-certainty).\nAntihistamines versus scopolamine\nThe evidence is very uncertain about the effect of antihistamines on preventing motion sickness under natural conditions when compared to scopolamine (symptoms prevented: 81% scopolamine; 71% antihistamines) (RR 0.89, 95% CI 0.68 to 1.16; 2 studies; 71 participants) (very low-certainty). No studies were performed under experimental conditions. No studies reported results on the resolution of existing motion sickness symptoms.\nThe evidence is very uncertain about the effect of antihistamines on heart rate under natural conditions (narrative report, 1 study; 20 participants; \"No difference in pulse frequency\"; very low-certainty). No studies reported results for any other physiological measures. When compared to scopolamine, the evidence is very uncertain about the effect of antihistamines on sedation (sedation: 21% scopolamine; 30% antihistamines) (RR 0.82, 95% CI 0.07 to 9.25; 2 studies; 90 participants) (very low-certainty) and on blurred vision (narrative report: not a significant difference; 1 study; 51 participants; very low-certainty). No studies evaluated impaired cognition.\nAntihistamines versus antiemetics\nAntihistamines may result in little or no difference in the prevention of motion sickness under experimental conditions (MD -0.20, 95% CI -10.91 to 10.51; 1 study; 42 participants) (low-certainty). The evidence is of low certainty due to imprecision as the sample size is small and the confidence interval crosses the line of no effect. No studies assessed the effects of antihistamines versus antiemetics under natural conditions. No studies reported results on the resolution of existing motion sickness symptoms.\nAntihistamines may result in little or no difference in gastric tachyarrhythmia (MD 4.56, 95% CI -3.49 to 12.61; 1 study; 42 participants) (low-certainty). No studies reported results for any other physiological measures. No studies evaluated sedation, impaired cognition or blurred vision.\nOne study reported physiological data for this outcome, evaluating gastric tachyarrhythmia specifically. Antihistamines may result in little or no difference in gastric tachyarrhythmia (MD 4.56, 95% CI -3.49 to 12.61; 1 study; 42 participants; low-certainty evidence). This evidence is of low certainty due to imprecision as the sample size is small and the confidence interval crosses the line of no effect.\nAntihistamines versus acupuncture\nThe evidence is very uncertain about the effects of antihistamines on the prevention of motion sickness under experimental conditions when compared to acupuncture (RR 1.32, 95% CI 1.12 to 1.57; 1 study; 100 participants) (very low-certainty). This study did not assess the prevention of motion sickness under natural conditions, nor the resolution of existing motion sickness symptoms. There was no study performed under natural conditions.\nPhysiological measures and adverse effects were not reported.\nAuthors' conclusions\nThere is probably a reduction in the risk of developing motion sickness symptoms under naturally occurring conditions of motion when using first-generation antihistamines, in motion sickness-susceptible adults, compared to placebo. Antihistamines may be more likely to cause sedation when compared to placebo. No studies evaluated the treatment of existing motion sickness, and there are few data on the effect of antihistamines in children. The evidence for all other outcomes and comparisons (versus scopolamine, antiemetics and acupuncture) was of low or very low certainty and we are therefore uncertain about these effects of antihistamines.\n\nGiven the provided abstract, please respond to the following query: \"Antihistamines versus acupuncture\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "There is uncertainty about the effectiveness of antihistamines in preventing motion sickness compared to acupuncture under laboratory conditions." } ]
query-laysum	21565	[ { "role": "user", "content": "Abstract: Background\nWork-related upper limb and neck musculoskeletal disorders (MSDs) are one of the most common occupational disorders worldwide. Studies have shown that the percentage of office workers that suffer from MSDs ranges from 20 to 60 per cent. The direct and indirect costs of work-related upper limb MSDs have been reported to be high in Europe, Australia, and the United States. Although ergonomic interventions are likely to reduce the risk of office workers developing work-related upper limb and neck MSDs, the evidence is unclear. This is an update of a Cochrane Review which was last published in 2012.\nObjectives\nTo assess the effects of physical, cognitive and organisational ergonomic interventions, or combinations of those interventions for the prevention of work-related upper limb and neck MSDs among office workers.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, Web of Science (Science Citation Index), SPORTDiscus, Embase, the US Centers for Disease Control and Prevention, the National Institute for Occupational Safety and Health database, and the World Health Organization's International Clinical Trials Registry Platform, to 10 October 2018.\nSelection criteria\nWe included randomised controlled trials (RCTs) of ergonomic interventions for preventing work-related upper limb or neck MSDs (or both) among office workers. We only included studies where the baseline prevalence of MSDs of the upper limb or neck, or both, was less than 25%.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias. We included studies with relevant data that we judged to be sufficiently homogeneous regarding the interventions and outcomes in the meta-analysis. We assessed the overall quality of the evidence for each comparison using the GRADE approach.\nMain results\nWe included 15 RCTs (2165 workers). We judged one study to have a low risk of bias and the remaining 14 studies to have a high risk of bias due to small numbers of participants and the potential for selection bias.\nPhysical ergonomic interventions\nThere is inconsistent evidence for arm supports and alternative computer mouse designs. There is moderate-quality evidence that an arm support with an alternative computer mouse (two studies) reduced the incidence of neck or shoulder MSDs (risk ratio (RR) 0.52; 95% confidence interval (CI) 0.27 to 0.99), but not the incidence of right upper limb MSDs (RR 0.73; 95% CI 0.32 to 1.66); and low-quality evidence that this intervention reduced neck or shoulder discomfort (standardised mean difference (SMD) −0.41; 95% CI −0.69 to −0.12) and right upper limb discomfort (SMD −0.34; 95% CI −0.63 to −0.06).\nThere is moderate-quality evidence that the incidence of neck or shoulder and right upper limb disorders were not considerably reduced when comparing an alternative computer mouse and a conventional mouse (two studies; neck or shoulder: RR 0.62; 95% CI 0.19 to 2.00; right upper limb: RR 0.91; 95% CI 0.48 to 1.72), and also when comparing an arm support with a conventional mouse and a conventional mouse alone (two studies) (neck or shoulder: RR 0.91; 95% CI 0.12 to 6.98; right upper limb: RR 1.07; 95% CI 0.58 to 1.96).\nWorkstation adjustment (one study) and sit-stand desks (one study) did not have an effect on upper limb pain or discomfort, compared to no intervention.\nOrganisational ergonomic interventions\nThere is very low-quality evidence that supplementary breaks (two studies) reduce discomfort of the neck (MD −0.25; 95% CI −0.40 to −0.11), right shoulder or upper arm (MD −0.33; 95% CI −0.46 to −0.19), and right forearm or wrist or hand (MD -0.18; 95% CI -0.29 to -0.08) among data entry workers.\nTraining in ergonomic interventions\nThere is low to very low-quality evidence in five studies that participatory and active training interventions may or may not prevent work-related MSDs of the upper limb or neck or both.\nMultifaceted ergonomic interventions\nFor multifaceted interventions there is one study (very low-quality evidence) that showed no effect on any of the six upper limb pain outcomes measured in that study.\nAuthors' conclusions\nWe found inconsistent evidence that the use of an arm support or an alternative mouse may or may not reduce the incidence of neck or shoulder MSDs. For other physical ergonomic interventions there is no evidence of an effect. For organisational interventions, in the form of supplementary breaks, there is very low-quality evidence of an effect on upper limb discomfort. For training and multifaceted interventions there is no evidence of an effect on upper limb pain or discomfort. Further high-quality studies are needed to determine the effectiveness of these interventions among office workers.\n\nGiven the provided abstract, please respond to the following query: \"Physical ergonomic interventions\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We found that the use of an arm support or a mouse based on neutral posture may or may not prevent work-related MSDs of the neck and shoulder. Workstation adjustment, and sit-stand desks do not have an effect on upper limb pain compared to no intervention." } ]
query-laysum	21566	[ { "role": "user", "content": "Abstract: Background\nPine bark (Pinus spp.) extract is rich in bioflavonoids, predominantly proanthocyanidins, which are antioxidants. Commercially-available extract supplements are marketed for preventing or treating various chronic conditions associated with oxidative stress. This is an update of a previously published review.\nObjectives\nTo assess the efficacy and safety of pine bark extract supplements for treating chronic disorders.\nSearch methods\nWe searched three databases and three trial registries; latest search: 30 September 2019.\nWe contacted the manufacturers of pine bark extracts to identify additional studies and hand-searched bibliographies of included studies.\nSelection criteria\nRandomised controlled trials (RCTs) evaluating pine bark extract supplements in adults or children with any chronic disorder.\nData collection and analysis\nTwo authors independently assessed trial eligibility, extracted data and assessed risk of bias. Where possible, we pooled data in meta-analyses. We used GRADE to evaluate the certainty of evidence.\nPrimary outcomes were participant- and investigator-reported clinical outcomes directly related to each disorder and all-cause mortality. We also assessed adverse events and biomarkers of oxidative stress.\nMain results\nThis review included 27 RCTs (22 parallel and five cross-over designs; 1641 participants) evaluating pine bark extract supplements across 10 chronic disorders: asthma (two studies; 86 participants); attention deficit hyperactivity disorder (ADHD) (one study; 61 participants), cardiovascular disease (CVD) and risk factors (seven studies; 338 participants), chronic venous insufficiency (CVI) (two studies; 60 participants), diabetes mellitus (DM) (six studies; 339 participants), erectile dysfunction (three studies; 277 participants), female sexual dysfunction (one study; 83 participants), osteoarthritis (three studies; 293 participants), osteopenia (one study; 44 participants) and traumatic brain injury (one study; 60 participants).\nTwo studies exclusively recruited children; the remainder recruited adults. Trials lasted between four weeks and six months. Placebo was the control in 24 studies. Overall risk of bias was low for four, high for one and unclear for 22 studies.\nIn adults with asthma, we do not know whether pine bark extract increases change in forced expiratory volume in one second (FEV1) % predicted/forced vital capacity (FVC) (mean difference (MD) 7.70, 95% confidence interval (CI) 3.19 to 12.21; one study; 44 participants; very low-certainty evidence), increases change in FEV1 % predicted (MD 7.00, 95% CI 0.10 to 13.90; one study; 44 participants; very low-certainty evidence), improves asthma symptoms (risk ratio (RR) 1.85, 95% CI 1.32 to 2.58; one study; 60 participants; very low-certainty evidence) or increases the number of people able to stop using albuterol inhalers (RR 6.00, 95% CI 1.97 to 18.25; one study; 60 participants; very low-certainty evidence).\nIn children with ADHD, we do not know whether pine bark extract decreases inattention and hyperactivity assessed by parent- and teacher-rating scales (narrative synthesis; one study; 57 participants; very low-certainty evidence) or increases the change in visual-motoric coordination and concentration (MD 3.37, 95% CI 2.41 to 4.33; one study; 57 participants; very low-certainty evidence).\nIn participants with CVD, we do not know whether pine bark extract decreases diastolic blood pressure (MD -3.00 mm Hg, 95% CI -4.51 to -1.49; one study; 61 participants; very low-certainty evidence); increases HDL cholesterol (MD 0.05 mmol/L, 95% CI -0.01 to 0.11; one study; 61 participants; very low-certainty evidence) or decreases LDL cholesterol (MD -0.03 mmol/L, 95% CI -0.05 to 0.00; one study; 61 participants; very low-certainty evidence).\nIn participants with CVI, we do not know whether pine bark extract decreases pain scores (MD -0.59, 95% CI -1.02 to -0.16; one study; 40 participants; very low-certainty evidence), increases the disappearance of pain (RR 25.0, 95% CI 1.58 to 395.48; one study; 40 participants; very low-certainty evidence) or increases physician-judged treatment efficacy (RR 4.75, 95% CI 1.97 to 11.48; 1 study; 40 participants; very low-certainty evidence).\nIn type 2 DM, we do not know whether pine bark extract leads to a greater reduction in fasting blood glucose (MD 1.0 mmol/L, 95% CI 0.91 to 1.09; one study; 48 participants;very low-certainty evidence) or decreases HbA1c (MD -0.90 %, 95% CI -1.78 to -0.02; 1 study; 48 participants; very low-certainty evidence). In a mixed group of participants with type 1 and type 2 DM we do not know whether pine bark extract decreases HbA1c (MD -0.20 %, 95% CI -1.83 to 1.43; one study; 67 participants; very low-certainty evidence).\nIn men with erectile dysfunction, we do not know whether pine bark extract supplements increase International Index of Erectile Function-5 scores (not pooled; two studies; 147 participants; very low-certainty evidence). In women with sexual dysfunction, we do not know whether pine bark extract increases satisfaction as measured by the Female Sexual Function Index (MD 5.10, 95% CI 3.49 to 6.71; one study; 75 participants; very low-certainty evidence) or leads to a greater reduction of pain scores (MD 4.30, 95% CI 2.69 to 5.91; one study; 75 participants; very low-certainty evidence).\nIn adults with osteoarthritis of the knee, we do not know whether pine bark extract decreases composite Western Ontario and McMaster Universities Osteoarthritis Index scores (MD -730.00, 95% CI -1011.95 to -448.05; one study; 37 participants; very low-certainty evidence) or the use of non-steroidal anti-inflammatory medication (MD -18.30, 95% CI -25.14 to -11.46; one study; 35 participants; very low-certainty evidence). We do not know whether pine bark extract increases bone alkaline phosphatase in post-menopausal women with osteopenia (MD 1.16 ug/L, 95% CI -2.37 to 4.69; one study; 40 participants; very low-certainty evidence).\nIn individuals with traumatic brain injury, we do not know whether pine bark extract decreases cognitive failure scores (MD -2.24, 95% CI -11.17 to 6.69; one study; 56 participants; very low-certainty evidence) or post-concussion symptoms (MD -0.76, 95% CI -5.39 to 3.87; one study; 56 participants; very low-certainty evidence).\nFor most comparisons, studies did not report outcomes of hospital admissions or serious adverse events.\nAuthors' conclusions\nSmall sample sizes, limited numbers of RCTs per condition, variation in outcome measures, and poor reporting of the included RCTs mean no definitive conclusions regarding the efficacy or safety of pine bark extract supplements are possible.\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": "Can pine bark antioxidant supplements help to treat chronic diseases?" } ]
query-laysum	21567	[ { "role": "user", "content": "Abstract: Background\nCystic fibrosis is an autosomal recessive inherited defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene resulting in abnormal regulation of salt and water movement across the membranes. In the liver this leads to focal biliary fibrosis resulting in progressive portal hypertension and end-stage liver disease in some individuals. This can be asymptomatic, but may lead to splenomegaly and hypersplenism, development of varices and variceal bleeding, and ascites; it has negative impact on overall nutritional status and respiratory function in this population. Prognosis is poor once significant portal hypertension is established. The role and outcome of various interventions for managing advanced liver disease (non-malignant end stage disease) in people with cystic fibrosis is currently unidentified. This is an updated version of a previously published review.\nObjectives\nTo review and assess the efficacy of currently available treatment options for preventing and managing advanced liver disease in children and adults with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books.\nDate of last search: 19 November 2019.\nWe also searched the reference lists of relevant articles and reviews and online trials registries.\nDate of last search: 01 January 2020.\nSelection criteria\nAny published and unpublished randomised controlled trials and quasi-randomised controlled trials of advanced liver disease in cystic fibrosis with cirrhosis or liver failure, portal hypertension or variceal bleeding (or both).\nData collection and analysis\nAuthors independently examined titles and abstracts to identify potentially relevant trials, but none were eligible for inclusion in this review.\nMain results\nA comprehensive search of the literature did not identify any published eligible randomised controlled trials.\nAuthors' conclusions\nIn order to develop the best source of evidence, there is a need to undertake randomised controlled trials of interventions for preventing and managing advanced liver disease in adults and children with cystic fibrosis.\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": "Since we did not find any trials for this review, it is not possible to make any specific recommendations or to develop best-practice guidelines at this stage. Our review highlighted a clear need for randomised controlled trials of treatments for the prevention and management of advanced liver disease in adults and children with cystic fibrosis." } ]
query-laysum	21568	[ { "role": "user", "content": "Abstract: Background\nPneumonia is a lung infection that causes more deaths in children aged under five years than any other single cause. Chest physiotherapy is widely used as adjuvant treatment for pneumonia. Physiotherapy is thought to help remove inflammatory exudates, tracheobronchial secretions, and airway obstructions, and reduce airway resistance to improve breathing and enhance gas exchange. This is an update of a review published in 2013.\nObjectives\nTo assess the effectiveness of chest physiotherapy with regard to time until clinical resolution in children (from birth to 18 years) of either gender with any type of pneumonia.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1), which includes the Cochrane Acute Respiratory Infections Group Specialised Register, MEDLINE (22 February 2018), Embase (22 February 2018), CINAHL (22 February 2018), LILACS (22 February 2018), Web of Science (22 February 2018), and PEDro (22 February 2018). We also searched clinical trials registers (ClinicalTrials.gov and WHO ICTRP) to identify planned, ongoing, and unpublished trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared any type of chest physiotherapy with no chest physiotherapy for children with pneumonia.\nData collection and analysis\nWe used standard Cochrane methodological procedures. The primary outcomes of interest were mortality, duration of hospital stay, and time to clinical resolution. We used Review Manager 5 software to analyse data and GRADE to assess the quality of the evidence for each outcome.\nMain results\nWe included three new RCTs for this update, for a total of six included RCTs involving 559 children aged from 29 days to 12 years with pneumonia who were treated as inpatients. Pneumonia severity was described as moderate in one trial, severe in two trials, and was not stated in three trials. The studies assessed five different interventions: effects of conventional chest physiotherapy (3 studies, 211 children), positive expiratory pressure (1 study, 72 children), continuous positive airway pressure (CPAP) (1 study, 94 children), bubble CPAP (bCPAP) (1 study, 225 children), and assisted autogenic drainage (1 studies, 29 children). The included studies were conducted in Bangladesh, Brazil, China, Egypt, and South Africa. The studies were overall at low risk of bias. Blinding of participants was not possible in most studies, but we considered that the outcomes were unlikely to be influenced by the lack of blinding.\nOne study of bCPAP reported that three deaths occurred in children in the physiotherapy group (N = 79), and 20 deaths in the control group (N = 146) (risk ratio (RR) 0.28, 95% confidence interval (CI) 0.08 to 0.90; 225 children; low-quality evidence). One study of assisted autogenic drainage (N = 29), and one study of conventional chest physiotherapy (N = 72) reported no deaths occurred. It is uncertain whether chest physiotherapy techniques (bCPAP, assisted autogenic drainage, and conventional chest physiotherapy) reduced hospital stay duration (days) (mean difference (MD) 0.10, 95% CI -0.56 to 0.76; 4 studies; low-quality evidence).\nThere was variation among clinical parameters used to define clinical resolution. Two small studies found no difference in resolution of fever between children in the physiotherapy (conventional chest physiotherapy and assisted autogenic drainage) and control groups. Of five studies that considered peripheral oxygen saturation levels, only two reported that use of chest physiotherapy (CPAP and conventional chest physiotherapy) showed a greater improvement in peripheral oxygen saturation levels. However, it was unclear whether respiratory rate (breaths/min) improved after conventional chest physiotherapy (MD -2.25, 95% CI -5.17 to 0.68; 2 studies, 122 children; low-quality evidence). Two studies assessed adverse events (number of events), but only one study reported any events (RR 1.28, 95% CI 0.98 to 1.67; 2 studies, 254 children; low-quality evidence).\nAuthors' conclusions\nWe could draw no reliable conclusions concerning the use of chest physiotherapy for children with pneumonia due to the small number of included trials with differing study characteristics and statistical presentation of data. Future studies should consider the following key points: appropriate sample size with adequate power to detect expected differences, standardisation of chest physiotherapy techniques, appropriate outcomes (such as duration of leukocytosis, and airway clearance), and adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We assessed the overall quality of the evidence as low due to inadequate study methods and design, differing results among studies, and few data." } ]
query-laysum	21569	[ { "role": "user", "content": "Abstract: Background\nTuberculosis is the primary cause of hospital admission in people living with HIV, and the likelihood of death in the hospital is unacceptably high. The Alere Determine TB LAM Ag test (AlereLAM) is a point-of-care test and the only lateral flow lipoarabinomannan assay (LF-LAM) assay currently commercially available and recommended by the World Health Organization (WHO). A 2019 Cochrane Review summarised the diagnostic accuracy of LF-LAM for tuberculosis in people living with HIV. This systematic review assesses the impact of the use of LF-LAM (AlereLAM) on mortality and other patient-important outcomes.\nObjectives\nTo assess the impact of the use of LF-LAM (AlereLAM) on mortality in adults living with HIV in inpatient and outpatient settings.\nTo assess the impact of the use of LF-LAM (AlereLAM) on other patient-important outcomes in adults living with HIV, including time to diagnosis of tuberculosis, and time to initiation of tuberculosis treatment.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (PubMed); Embase (Ovid); Science Citation Index Expanded (Web of Science), BIOSIS Previews, Scopus, LILACS; ProQuest Dissertations and Theses; ClinicalTrials.gov; and the WHO ICTRP up to 12 March 2021.\nSelection criteria\nRandomized controlled trials that compared a diagnostic intervention including LF-LAM with diagnostic strategies that used smear microscopy, mycobacterial culture, a nucleic acid amplification test such as Xpert MTB/RIF, or a combination of these tests. We included adults (≥ 15 years) living with HIV.\nData collection and analysis\nTwo review authors independently assessed trials for eligibility, extracted data, and analysed risk of bias using the Cochrane tool for assessing risk of bias in randomized studies. We contacted study authors for clarification as needed. We used risk ratio (RR) with 95% confidence intervals (CI). We used a fixed-effect model except in the presence of clinical or statistical heterogeneity, in which case we used a random-effects model. We assessed the certainty of the evidence using GRADE.\nMain results\nWe included three trials, two in inpatient settings and one in outpatient settings. All trials were conducted in sub-Saharan Africa and assessed the impact of diagnostic strategies that included LF-LAM on mortality when the test was used in conjunction with other tuberculosis diagnostic tests or clinical assessment for clinical decision-making in adults living with HIV.\nInpatient settings\nIn inpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy likely reduces mortality in people living with HIV at eight weeks compared to routine tuberculosis diagnostic testing without LF-LAM (pooled RR 0.85, 95% CI 0.76 to 0.94; 5102 participants, 2 trials; moderate-certainty evidence). That is, people living with HIV who received LF-LAM had 15% lower risk of mortality. The absolute effect was 34 fewer deaths per 1000 (from 14 fewer to 55 fewer).\nIn inpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy probably results in a slight increase in the proportion of people living with HIV who were started on tuberculosis treatment compared to routine tuberculosis diagnostic testing without LF-LAM (pooled RR 1.26, 95% CI 0.94 to 1.69; 5102 participants, 2 trials; moderate-certainty evidence).\nOutpatient settings\nIn outpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy may reduce mortality in people living with HIV at six months compared to routine tuberculosis diagnostic testing without LF-LAM (RR 0.89, 95% CI 0.71 to 1.11; 2972 participants, 1 trial; low-certainty evidence). Although this trial did not detect a difference in mortality, the direction of effect was towards a mortality reduction, and the effect size was similar to that in inpatient settings.\nIn outpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy may result in a large increase in the proportion of people living with HIV who were started on tuberculosis treatment compared to routine tuberculosis diagnostic testing without LF-LAM (RR 5.44, 95% CI 4.70 to 6.29, 3022 participants, 1 trial; low-certainty evidence).\nOther patient-important outcomes\nAssessment of other patient-important and implementation outcomes in the trials varied. The included trials demonstrated that a higher proportion of people living with HIV were able to produce urine compared to sputum for tuberculosis diagnostic testing; a higher proportion of people living with HIV were diagnosed with tuberculosis in the group that received LF-LAM; and the incremental diagnostic yield was higher for LF-LAM than for urine or sputum Xpert MTB/RIF.\nAuthors' conclusions\nIn inpatient settings, the use of LF-LAM as part of a tuberculosis diagnostic testing strategy likely reduces mortality and probably results in a slight increase in tuberculosis treatment initiation in people living with HIV. The reduction in mortality may be due to earlier diagnosis, which facilitates prompt treatment initiation. In outpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy may reduce mortality and may result in a large increase in tuberculosis treatment initiation in people living with HIV. Our results support the implementation of LF-LAM to be used in conjunction with other WHO-recommended tuberculosis diagnostic tests to assist in the rapid diagnosis of tuberculosis in people living with HIV.\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": "In inpatient settings, the use of LF-LAM as part of a tuberculosis diagnostic testing strategy likely reduces deaths and probably results in a slight increase in tuberculosis treatment initiation in people living with HIV.\nIn outpatient settings, the use of LF-LAM testing as part of a tuberculosis diagnostic strategy may reduce deaths and may result in a large increase in tuberculosis treatment initiation in people living with HIV." } ]
query-laysum	21570	[ { "role": "user", "content": "Abstract: Background\nCurrently, there are five major approaches to hysterectomy for benign gynaecological disease: abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH), robotic-assisted hysterectomy (RH) and vaginal natural orifice hysterectomy (V-NOTES). Within the LH category we further differentiate the laparoscopic-assisted vaginal hysterectomy (LAVH) from the total laparoscopic hysterectomy (TLH) and single-port laparoscopic hysterectomy (SP-LH).\nObjectives\nTo assess the effectiveness and safety of different surgical approaches to hysterectomy for women with benign gynaecological conditions.\nSearch methods\nWe searched the following databases (from their inception to December 2022): the Cochrane Gynaecology and Fertility Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO. We also searched the trial registries and relevant reference lists, and communicated with experts in the field for any additional trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which clinical outcomes were compared between one surgical approach to hysterectomy and another.\nData collection and analysis\nAt least two review authors independently selected trials, assessed risk of bias and performed data extraction. Our primary outcomes were return to normal activities, satisfaction and quality of life, intraoperative visceral injury and major long-term complications (i.e. fistula, pelvic-abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition and sexual dysfunction).\nMain results\nWe included 63 studies with 6811 women. The evidence for most comparisons was of low or moderate certainty. The main limitations were poor reporting and imprecision.\nVaginal hysterectomy (VH) versus abdominal hysterectomy (AH) (12 RCTs, 1046 women)\nReturn to normal activities was probably faster in the VH group (mean difference (MD) -10.91 days, 95% confidence interval (CI) -17.95 to -3.87; 4 RCTs, 274 women; I2 = 67%; moderate-certainty evidence). This suggests that if the return to normal activities after AH is assumed to be 42 days, then after VH it would be between 24 and 38 days. We are uncertain whether there is a difference between the groups for the other primary outcomes.\nLaparoscopic hysterectomy (LH) versus AH (28 RCTs, 3431 women)\nReturn to normal activities may be sooner in the LH group (MD -13.01 days, 95% CI -16.47 to -9.56; 7 RCTs, 618 women; I2 = 68%, low-certainty evidence), but there may be more urinary tract injuries in the LH group (odds ratio (OR) 2.16, 95% CI 1.19 to 3.93; 18 RCTs, 2594 women; I2 = 0%; moderate-certainty evidence). This suggests that if the return to normal activities after abdominal hysterectomy is assumed to be 37 days, then after laparoscopic hysterectomy it would be between 22 and 25 days. It also suggests that if the rate of ureter injury during abdominal hysterectomy is assumed to be 0.2%, then during laparoscopic hysterectomy it would be between 0.2% and 2%. We are uncertain whether there is a difference between the groups for the other primary outcomes.\nLH versus VH (22 RCTs, 2135 women)\nWe are uncertain whether there is a difference between the groups for any of our primary outcomes. Both short- and long-term complications were rare in both groups.\nRobotic-assisted hysterectomy (RH) versus LH (three RCTs, 296 women)\nNone of the studies reported satisfaction rates or quality of life. We are uncertain whether there is a difference between the groups for our other primary outcomes.\nSingle-port laparoscopic hysterectomy (SP-LH) versus LH (seven RCTs, 621 women)\nNone of the studies reported satisfaction rates, quality of life or major long-term complications. We are uncertain whether there is a difference between the groups for rates of intraoperative visceral injury.\nTotal laparoscopic hysterectomy (TLH) versus laparoscopic-assisted vaginal hysterectomy (LAVH) (three RCTs, 233 women)\nNone of the studies reported satisfaction rates or quality of life. We are uncertain whether there is a difference between the groups for rates of intraoperative visceral injury or major long-term complications.\nTransvaginal natural orifice transluminal endoscopic surgery (V-NOTES) versus LH (two RCTs, 96 women)\nWe are uncertain whether there is a difference between the groups for rates of bladder injury. Our other primary outcomes were not reported.\nOverall, adverse events were rare in the included studies.\nAuthors' conclusions\nAmong women undergoing hysterectomy for benign disease, VH appears to be superior to AH. When technically feasible, VH should be performed in preference to AH because it is associated with faster return to normal activities, fewer wound/abdominal wall infections and shorter hospital stay. Where VH is not possible, LH has advantages over AH including faster return to normal activities, shorter hospital stay, and decreased risk of wound/abdominal wall infection, febrile episodes or unspecified infection, and transfusion. These advantages must be balanced against the increased risk of ureteric injury and longer operative time. When compared to LH, VH was associated with no difference in time to return to normal activities but shorter operative time and shorter hospital stay. RH and V-NOTES require further evaluation since there is a lack of evidence of any patient benefit over conventional LH. Overall, the evidence in this review has to be interpreted with caution as adverse event rates were low, resulting in low power for these comparisons. The surgical approach to hysterectomy should be discussed with the patient and decided in the light of the relative benefits and hazards. Surgical expertise is difficult to quantify and poorly reported in the available studies and this may influence outcomes in ways that cannot be accounted for in this review. In conclusion, when VH is not feasible, LH has multiple advantages over AH, but at the cost of more ureteric injuries. Evidence is limited for RH and V-NOTES.\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 analysed 63 randomised controlled trials (RCTs). An RCT is a type of study in which the people being studied are randomly allocated one or other of the different treatments being investigated. This type of study is usually the best way to evaluate whether a treatment is truly effective, i.e. truly helps the patient. A systematic review systematically summarises the available RCTs on a subject.\nA total of 6811 women participated in the studies. The studies compared vaginal versus abdominal hysterectomy (12 trials, 1046 women), laparoscopic versus abdominal hysterectomy (28 trials, 3431 women), laparoscopic versus vaginal hysterectomy (22 trials, 2135 women), laparoscopic versus robot-assisted hysterectomy (three trials, 296 women) and laparoscopic versus transvaginal natural orifice transluminal endoscopic surgery (two trials, 96 women). There were also studies included in which different types of laparoscopic hysterectomies were compared, including single-port versus multi-port (seven trials, 613 women) and total laparoscopic hysterectomy versus laparoscopic-assisted vaginal hysterectomy (three trials, 233 women). The main outcomes were return to normal activities, satisfaction, quality of life and surgical complications." } ]
query-laysum	21571	[ { "role": "user", "content": "Abstract: Background\nShared care has been used in the management of many chronic conditions with the assumption that it delivers better care than primary or specialty care alone; however, little is known about the effectiveness of shared care.\nObjectives\nTo determine the effectiveness of shared care health service interventions designed to improve the management of chronic disease across the primary/specialty care interface. This is an update of a previously published review.\nSecondary questions include the following:\n1. Which shared care interventions or portions of shared care interventions are most effective?\n2. What do the most effective systems have in common?\nSearch methods\nWe searched MEDLINE, Embase and the Cochrane Library to 12 October 2015.\nSelection criteria\nOne review author performed the initial abstract screen; then two review authors independently screened and selected studies for inclusion. We considered randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after studies (CBAs) and interrupted time series analyses (ITS) evaluating the effectiveness of shared care interventions for people with chronic conditions in primary care and community settings. The intervention was compared with usual care in that setting.\nData collection and analysis\nTwo review authors independently extracted data from the included studies, evaluated study quality and judged the certainty of the evidence using the GRADE approach. We conducted a meta-analysis of results when possible and carried out a narrative synthesis of the remainder of the results. We presented the results in a 'Summary of findings' table, using a tabular format to show effect sizes for all outcome types.\nMain results\nWe identified 42 studies of shared care interventions for chronic disease management (N = 18,859), 39 of which were RCTs, two CBAs and one an NRCT. Of these 42 studies, 41 examined complex multi-faceted interventions and lasted from six to 24 months. Overall, our confidence in results regarding the effectiveness of interventions ranged from moderate to high certainty. Results showed probably few or no differences in clinical outcomes overall with a tendency towards improved blood pressure management in the small number of studies on shared care for hypertension, chronic kidney disease and stroke (mean difference (MD) 3.47, 95% confidence interval (CI) 1.68 to 5.25)(based on moderate-certainty evidence). Mental health outcomes improved, particularly in response to depression treatment (risk ratio (RR) 1.40, 95% confidence interval (CI) 1.22 to 1.62; six studies, N = 1708) and recovery from depression (RR 2.59, 95% CI 1.57 to 4.26; 10 studies, N = 4482) in studies examining the 'stepped care' design of shared care interventions (based on high-certainty evidence). Investigators noted modest effects on mean depression scores (standardised mean difference (SMD) -0.29, 95% CI -0.37 to -0.20; six studies, N = 3250). Differences in patient-reported outcome measures (PROMs), processes of care and participation and default rates in shared care services were probably limited (based on moderate-certainty evidence). Studies probably showed little or no difference in hospital admissions, service utilisation and patient health behaviours (with evidence of moderate certainty).\nAuthors' conclusions\nThis review suggests that shared care improves depression outcomes and probably has mixed or limited effects on other outcomes. Methodological shortcomings, particularly inadequate length of follow-up, may account in part for these limited effects. Review findings support the growing evidence base for shared care in the management of depression, particularly stepped care models of shared care. Shared care interventions for other conditions should be developed within research settings, with account taken of the complexity of such interventions and awareness of the need to carry out longer studies to test effectiveness and sustainability over time.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Review authors searched for studies that had been published up to October 2015." } ]
query-laysum	21572	[ { "role": "user", "content": "Abstract: Background\nPanic disorder (PD) is a common type of anxiety disorder, characterized by unexpected and repeated panic attacks or fear of future panic attacks, or both. Individuals with PD are often resistant to pharmacological or psychological treatments and this can lead to the disorder becoming a chronic and disabling illness. Repetitive transcranial magnetic stimulation (rTMS) can deliver sustained and spatially selective current to suppress or induce cortical excitability, and its therapeutic effect on pathological neuronal activity in people with PD has already been examined in case studies and clinical trials. However, a systematic review is necessary to assess the efficacy and safety of rTMS for PD.\nObjectives\nTo assess the effects of repetitive transcranial magnetic stimulation (rTMS) for panic disorder (PD) in adults aged 18 to 65 years, either as a monotherapy or as an augmentation strategy.\nSearch methods\nAn electronic search of the Cochrane Depression, Anxiety and Neurosis Review Group Controlled Trials Register (CCDANCTR) was conducted to 19 February 2014. The CCDANCTR includes reports of relevant randomised controlled trials (RCTs) from MEDLINE (1950 to date), EMBASE (1974 to date), PsycINFO (1967 to date) and the Cochrane Central Register of Controlled Trials (CENTRAL) (all years). Additional searches were conducted in Psyndex and the main Chinese medical databases.\nSelection criteria\nRCTs or quasi-randomised trials evaluating rTMS for PD in people aged between 18 and 65 years, either as a monotherapy or as an augmentation strategy.\nData collection and analysis\nTwo review authors independently selected studies and extracted data and verified the data by cross-checking. Disagreements were resolved by discussion. For binary data, we calculated fixed-effect model risk ratio (RR) and its 95% confidence interval (CI). For continuous data, we calculated fixed-effect model standardized mean difference (SMD) and its 95% CI.\nMain results\nTwo RCTs (n = 40) were included in this review. The included trials compared rTMS with sham rTMS; no trials comparing rTMS with active treatments (electroconvulsive therapy (ECT), pharmacotherapy, psychotherapy) met our inclusion criteria. Both included studies used 1 Hz rTMS over the right dorso-lateral prefrontal cortex (DLPFC) for two or four weeks as an augmentation treatment for PD. However, in both studies the data for the primary outcome, panic symptoms as measured by the Panic Disorder Severity Scale (PDSS), were skewed and could not be pooled for a quantitative analysis. For this primary outcome one trial with 25 participants reported a superior effect of rTMS in reducing panic symptoms compared with sham rTMS (t = 3.04, df = 16.57, P = 0.007), but this trial had a 16% dropout rate and so was deemed as having a high risk of attrition bias. The other trial found that all 15 participants exhibited a reduction in panic symptoms but there was no significant difference between rTMS and sham rTMS (Mann Whitney U test, P > 0.05). Regarding the acceptability of rTMS, no significant difference was found between rTMS and sham rTMS in dropout rates or in reports of side effects. The quality of evidence contributing to this review was assessed as very low. Assessments of the risk of bias for the two studies were hampered by the lack of information provided in the reports, especially on methods of sequence generation and whether allocation concealment had been applied. Of the remaining sources of bias, we considered one of the studies to have been at risk of attrition bias.\nAuthors' conclusions\nOnly two RCTs of rTMS were available and their sample sizes were small. The available data were insufficient for us to draw any conclusions about the efficacy of rTMS for PD. Further trials with large sample sizes and adequate methodology are needed to confirm the effectiveness of rTMS for PD.\n\nGiven the provided abstract, please respond to the following query: \"What does the evidence from the review tell us?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "One study found that all patients improved during the study period, but the treatment effect did not differ between the group who received rTMS and the group who received sham rTMS. The other study administered more sessions and reported higher levels of improvement of panic symptoms in those people who received rTMS compared to those who received sham rTMS.\nAlthough neither trial reported any serious side effects, they provided only very low quality evidence for adverse event outcomes. On the basis of the limited quality of the evidence available we were unable to determine how safe rTMS is.\nThe limited information available from these two studies is insufficient to conclude whether rTMS is effective in reducing the severity of panic disorder symptoms. The main limitation of this review was that the number of people with panic disorder who were involved was too small." } ]
query-laysum	21573	[ { "role": "user", "content": "Abstract: Background\nHypertension (high blood pressure) in pregnancy carries a high risk of maternal morbidity and mortality. Although antihypertensive drugs are commonly used, they have adverse effects on mothers and fetuses. Guided imagery is a non-pharmacological technique that has the potential to lower blood pressure among pregnant women with hypertension. Guided imagery is a mind-body therapy that involves the visualisation of various mental images to facilitate relaxation and reduction in blood pressure.\nObjectives\nTo determine the effect of guided imagery as a non-pharmacological treatment of hypertension in pregnancy and its influence on perinatal outcomes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register, and two trials registers (October 2018). We also searched relevant conference proceedings and journals, and scanned the reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials (RCTs). We would have included RCTs using a cluster-randomised design, but none were identified. We excluded quasi-RCTs and cross-over trials.\nWe sought intervention studies of various guided imagery techniques performed during pregnancy in comparison with no intervention or other non-pharmacological treatments for hypertension (e.g. quiet rest, music therapy, aromatherapy, relaxation therapy, acupuncture, acupressure, massage, device-guided slow breathing, hypnosis, physical exercise, and yoga).\nData collection and analysis\nThree review authors independently assessed the trials for inclusion, extracted data, and assessed risk of bias for the included studies. We checked extracted data for accuracy, and resolved differences in assessments by discussion. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included two small trials (involving a total of 99 pregnant women) that compared guided imagery with quiet rest. The trials were conducted in Canada and the USA. We assessed both trials as at high risk of performance bias, and low risk of attrition bias; one trial was at low risk for selection, detection, and reporting bias, while the other was at unclear risk for the same domains.\nWe could not perform a meta-analysis because the two included studies reported different outcomes, and the frequency of the intervention was slightly different between the two studies. One study performed guided imagery for 15 minutes at least twice daily for four weeks, or until the baby was born (whichever came first). In the other study, the intervention included guided imagery, self-monitoring of blood pressure, and thermal biofeedback-assisted relaxation training for four total hours; the participants were instructed to practice the procedures twice daily and complete at least three relief relaxation breaks each day. The control groups were similar - one was quiet rest, and the other was quiet rest as bed rest.\nNone of our primary outcomes were reported in the included trials: severe hypertension (either systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher); severe pre-eclampsia, or perinatal death (stillbirths plus deaths in the first week of life). Only one of the secondary outcomes was measured.\nLow-certainty evidence from one trial (69 women) suggests that guided imagery may make little or no difference in the use of antihypertensive drugs (risk ratio 1.27, 95% confidence interval 0.72 to 2.22).\nAuthors' conclusions\nThere is insufficient evidence to inform practice about the use of guided imagery for hypertension in pregnancy.\nThe available evidence for this review topic is sparse, and the effect of guided imagery for treating hypertension during pregnancy (compared with quiet rest) remains unclear. There was low-certainty evidence that guided imagery made little or no difference to the use of antihypertensive drugs, downgraded because of imprecision.\nThe two included trials did not report on any of the primary outcomes of this review. We did not identify any trials comparing guided imagery with no intervention, or with another non-pharmacological method for hypertension.\nLarge and well-designed RCTs are needed to identify the effects of guided imagery on hypertension during pregnancy and on other relevant outcomes associated with short-term and long-term maternal and neonatal health. Trials could also consider utilisation and costs of health service.\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 searched for evidence (October 2018) and found two trials (involving 99 women) conducted in Canada and the USA. Both trials compared guided imagery with quiet rest. There were no trials comparing guided imagery with no intervention, or other with another non-pharmacological method for hypertension.\nThe two included studies reported different outcomes and the Intervention frequency was slightly different between the two studies. One study performed guided imagery for 15 minutes at least twice daily for four weeks or until the baby was born (whichever came first). The other study involved guided imagery, self-monitoring of blood pressure, and thermal biofeedback-assisted relaxation training for a total of four hours; the women were instructed to practice the procedures twice daily and complete at least three relaxation breaks each day. The control groups between the two studies were similar - one used quiet rest and the other used quiet rest as bed rest.\nNeither trial reported data for our main outcomes of interest: severe hypertension, severe pre-eclampsia, or death of the baby during birth or within the first week of life. The trials provided data for only one of our secondary outcomes of interest.\nLow-certainty evidence from the one trial (69 women) suggests that, compared with quiet rest, guided imagery may make little or no difference in the use of antihypertensive drugs." } ]
query-laysum	21575	[ { "role": "user", "content": "Abstract: Background\nThe projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether metformin can prevent or delay T2DM and its complications in people with increased risk of developing T2DM is unknown.\nObjectives\nTo assess the effects of metformin for the prevention or delay of T2DM and its associated complications in persons at increased risk for the T2DM.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, Scopus, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform and the reference lists of systematic reviews, articles and health technology assessment reports. We asked investigators of the included trials for information about additional trials. The date of the last search of all databases was March 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) with a duration of one year or more comparing metformin with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or standard care in people with impaired glucose tolerance, impaired fasting glucose, moderately elevated glycosylated haemoglobin A1c (HbA1c) or combinations of these.\nData collection and analysis\nTwo review authors read all abstracts and full-text articles and records, assessed risk of bias and extracted outcome data independently. We used a random-effects model to perform meta-analysis and calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the certainty of the evidence using GRADE.\nMain results\nWe included 20 RCTs randomising 6774 participants. One trial contributed 48% of all participants. The duration of intervention in the trials varied from one to five years. We judged none of the trials to be at low risk of bias in all 'Risk of bias' domains.\nOur main outcome measures were all-cause mortality, incidence of T2DM, serious adverse events (SAEs), cardiovascular mortality, non-fatal myocardial infarction or stroke, health-related quality of life and socioeconomic effects.The following comparisons mostly reported only a fraction of our main outcome set.\nFifteen RCTs compared metformin with diet and exercise with or without placebo: all-cause mortality was 7/1353 versus 7/1480 (RR 1.11, 95% CI 0.41 to 3.01; P = 0.83; 2833 participants, 5 trials; very low-quality evidence); incidence of T2DM was 324/1751 versus 529/1881 participants (RR 0.50, 95% CI 0.38 to 0.65; P < 0.001; 3632 participants, 12 trials; moderate-quality evidence); the reporting of SAEs was insufficient and diverse and meta-analysis could not be performed (reported numbers were 4/118 versus 2/191; 309 participants; 4 trials; very low-quality evidence); cardiovascular mortality was 1/1073 versus 4/1082 (2416 participants; 2 trials; very low-quality evidence). One trial reported no clear difference in health-related quality of life after 3.2 years of follow-up (very low-quality evidence). Two trials estimated the direct medical costs (DMC) per participant for metformin varying from $220 to $1177 versus $61 to $184 in the comparator group (2416 participants; 2 trials; low-quality evidence).\nEight RCTs compared metformin with intensive diet and exercise: all-cause mortality was 7/1278 versus 4/1272 (RR 1.61, 95% CI 0.50 to 5.23; P = 0.43; 2550 participants, 4 trials; very low-quality evidence); incidence of T2DM was 304/1455 versus 251/1505 (RR 0.80, 95% CI 0.47 to 1.37; P = 0.42; 2960 participants, 7 trials; moderate-quality evidence); the reporting of SAEs was sparse and meta-analysis could not be performed (one trial reported 1/44 in the metformin group versus 0/36 in the intensive exercise and diet group with SAEs). One trial reported that 1/1073 participants in the metformin group compared with 2/1079 participants in the comparator group died from cardiovascular causes. One trial reported that no participant died due to cardiovascular causes (very low-quality evidence). Two trials estimated the DMC per participant for metformin varying from $220 to $1177 versus $225 to $3628 in the comparator group (2400 participants; 2 trials; very low-quality evidence).\nThree RCTs compared metformin with acarbose: all-cause mortality was 1/44 versus 0/45 (89 participants; 1 trial; very low-quality evidence); incidence of T2DM was 12/147 versus 7/148 (RR 1.72, 95% CI 0.72 to 4.14; P = 0.22; 295 participants; 3 trials; low-quality evidence); SAEs were 1/51 versus 2/50 (101 participants; 1 trial; very low-quality evidence).\nThree RCTs compared metformin with thiazolidinediones: incidence of T2DM was 9/161 versus 9/159 (RR 0.99, 95% CI 0.41 to 2.40; P = 0.98; 320 participants; 3 trials; low-quality evidence). SAEs were 3/45 versus 0/41 (86 participants; 1 trial; very low-quality evidence).\nThree RCTs compared metformin plus intensive diet and exercise with identical intensive diet and exercise: all-cause mortality was 1/121 versus 1/120 participants (450 participants; 2 trials; very low-quality evidence); incidence of T2DM was 48/166 versus 53/166 (RR 0.55, 95% CI 0.10 to 2.92; P = 0.49; 332 participants; 2 trials; very low-quality evidence). One trial estimated the DMC of metformin plus intensive diet and exercise to be $270 per participant compared with $225 in the comparator group (94 participants; 1 trial; very-low quality evidence).\nOne trial in 45 participants compared metformin with a sulphonylurea. The trial reported no patient-important outcomes.\nFor all comparisons there were no data on non-fatal myocardial infarction, non-fatal stroke or microvascular complications.\nWe identified 11 ongoing trials which potentially could provide data of interest for this review. These trials will add a total of 17,853 participants in future updates of this review.\nAuthors' conclusions\nMetformin compared with placebo or diet and exercise reduced or delayed the risk of T2DM in people at increased risk for the development of T2DM (moderate-quality evidence). However, metformin compared to intensive diet and exercise did not reduce or delay the risk of T2DM (moderate-quality evidence). Likewise, the combination of metformin and intensive diet and exercise compared to intensive diet and exercise only neither showed an advantage or disadvantage regarding the development of T2DM (very low-quality evidence). Data on patient-important outcomes such as mortality, macrovascular and microvascular diabetic complications and health-related quality of life were sparse or missing.\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": "All included studies had problems in the way they were conduced or reported." } ]
query-laysum	21576	[ { "role": "user", "content": "Abstract: Background\nBronchopulmonary dysplasia (BPD) remains a major complication of prematurity and currently lacks efficient treatments. Mesenchymal stem/stromal cells (MSCs) have been extensively explored as a potential therapy in several preclinical and clinical settings. Human and animal MSCs have been shown to prevent and treat lung injury in various preclinical models of lung diseases, including experimental BPD.\nObjectives\nTo determine if MSCs, administered intravenously or endotracheally, are safe and effective in preventing or treating BPD, or both, in preterm infants.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 10), MEDLINE via PubMed (1966 to 6 November 2016), Embase (1980 to 6 November 2016), and CINAHL (1982 to 6 November 2016). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs.\nSelection criteria\nWe considered RCTs and quasi-RCTs investigating prevention or treatment of BPD, or both, in preterm infants.\nData collection and analysis\nTwo review authors independently assessed trial quality according to prespecified criteria.\nMain results\nWe found no RCTs or quasi-RCTs addressing the use of MSCs for prevention or treatment of BPD in premature infants. Two RCTs are currently registered and ongoing.\nAuthors' conclusions\nThere is insufficient evidence to determine the safety and efficacy of MSCs in the treatment or prevention of BPD in premature infants. The results of the ongoing trials addressing this issue are expected in the near future.\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": "Bronchopulmonary dysplasia (BPD) is a chronic lung disease that often complicates the course of babies who are born too early. Bronchopulmonary dysplasia can lead to serious health issues during childhood and later in life. There is currently no effective and safe treatment for BPD. Mesenchymal stem cells (MSCs), cells that can multiply and turn into a different type of cell, can protect the damage to newborn lungs in experimental models of BPD. Mesenchymal stem cells may bring new hope for untreatable health issues in babies born too early, including BPD, and thus improve their survival and quality of life." } ]
query-laysum	21577	[ { "role": "user", "content": "Abstract: Background\nPelvic floor muscle training (PFMT) is the most commonly used physical therapy treatment for women with stress urinary incontinence (SUI). It is sometimes also recommended for mixed urinary incontinence (MUI) and, less commonly, urgency urinary incontinence (UUI).\nThis is an update of a Cochrane Review first published in 2001 and last updated in 2014.\nObjectives\nTo assess the effects of PFMT for women with urinary incontinence (UI) in comparison to no treatment, placebo or sham treatments, or other inactive control treatments; and summarise the findings of relevant economic evaluations.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register (searched 12 February 2018), which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP, handsearching of journals and conference proceedings, and the reference lists of relevant articles.\nSelection criteria\nRandomised or quasi-randomised controlled trials in women with SUI, UUI or MUI (based on symptoms, signs or urodynamics). One arm of the trial included PFMT. Another arm was a no treatment, placebo, sham or other inactive control treatment arm.\nData collection and analysis\nAt least two review authors independently assessed trials for eligibility and risk of bias. We extracted and cross-checked data. A third review author resolved disagreements. We processed data as described in the Cochrane Handbook for Systematic Reviews of Interventions. We subgrouped trials by diagnosis of UI. We undertook formal meta-analysis when appropriate.\nMain results\nThe review included 31 trials (10 of which were new for this update) involving 1817 women from 14 countries. Overall, trials were of small-to-moderate size, with follow-ups generally less than 12 months and many were at moderate risk of bias. There was considerable variation in the intervention's content and duration, study populations and outcome measures. There was only one study of women with MUI and only one study with UUI alone, with no data on cure, cure or improvement, or number of episodes of UI for these subgroups.\nSymptomatic cure of UI at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT groups were eight times more likely to report cure (56% versus 6%; risk ratio (RR) 8.38, 95% confidence interval (CI) 3.68 to 19.07; 4 trials, 165 women; high-quality evidence). For women with any type of UI, PFMT groups were five times more likely to report cure (35% versus 6%; RR 5.34, 95% CI 2.78 to 10.26; 3 trials, 290 women; moderate-quality evidence).\nSymptomatic cure or improvement of UI at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT groups were six times more likely to report cure or improvement (74% versus 11%; RR 6.33, 95% CI 3.88 to 10.33; 3 trials, 242 women; moderate-quality evidence). For women with any type of UI, PFMT groups were two times more likely to report cure or improvement than women in the control groups (67% versus 29%; RR 2.39, 95% CI 1.64 to 3.47; 2 trials, 166 women; moderate-quality evidence).\nUI-specific symptoms and quality of life (QoL) at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT group were more likely to report significant improvement in UI symptoms (7 trials, 376 women; moderate-quality evidence), and to report significant improvement in UI QoL (6 trials, 348 women; low-quality evidence). For any type of UI, women in the PFMT group were more likely to report significant improvement in UI symptoms (1 trial, 121 women; moderate-quality evidence) and to report significant improvement in UI QoL (4 trials, 258 women; moderate-quality evidence). Finally, for women with mixed UI treated with PFMT, there was one small trial (12 women) reporting better QoL.\nLeakage episodes in 24 hours at the end of treatment: PFMT reduced leakage episodes by one in women with SUI (mean difference (MD) 1.23 lower, 95% CI 1.78 lower to 0.68 lower; 7 trials, 432 women; moderate-quality evidence) and in women with all types of UI (MD 1.00 lower, 95% CI 1.37 lower to 0.64 lower; 4 trials, 349 women; moderate-quality evidence).\nLeakage on short clinic-based pad tests at the end of treatment: women with SUI in the PFMT groups lost significantly less urine in short (up to one hour) pad tests. The comparison showed considerable heterogeneity but the findings still favoured PFMT when using a random-effects model (MD 9.71 g lower, 95% CI 18.92 lower to 0.50 lower; 4 trials, 185 women; moderate-quality evidence). For women with all types of UI, PFMT groups also reported less urine loss on short pad tests than controls (MD 3.72 g lower, 95% CI 5.46 lower to 1.98 lower; 2 trials, 146 women; moderate-quality evidence).\nWomen in the PFMT group were also more satisfied with treatment and their sexual outcomes were better. Adverse events were rare and, in the two trials that did report any, they were minor. The findings of the review were largely supported by the 'Summary of findings' tables, but most of the evidence was downgraded to moderate on methodological grounds. The exception was 'participant-perceived cure' in women with SUI, which was rated as high quality.\nAuthors' conclusions\nBased on the data available, we can be confident that PFMT can cure or improve symptoms of SUI and all other types of UI. It may reduce the number of leakage episodes, the quantity of leakage on the short pad tests in the clinic and symptoms on UI-specific symptom questionnaires. The authors of the one economic evaluation identified for the Brief Economic Commentary reported that the cost-effectiveness of PFMT looks promising. The findings of the review suggest that PFMT could be included in first-line conservative management programmes for women with UI. The long-term effectiveness and cost-effectiveness of PFMT needs to be further researched.\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": "The quality of the evidence we looked at was mostly moderate, which means we can have some confidence in the results.\nCure of urinary incontinence after PFMT: women with stress urinary incontinence in the PFMT group were, on average, eight times more likely to report being cured. Women with any type of urinary incontinence in the PFMT group were, on average, five times more likely to report being cured.\nCure or improvement of urinary incontinence after PFMT: women with stress urinary incontinence in PFMT groups were, on average, six times more likely to report they were cured or improved. Women with all type of urinary incontinence in the PFMT group were roughly twice as likely to report they were cured or improved.\nLeakage episodes after PFMT: women with stress urinary incontinence and women with all types of urinary incontinence in the PFMT group had one fewer leakage episode in 24 hours. PFMT appeared to reduce leakage episodes in women with urgency urinary incontinence alone.\nFor women with stress and all types of urinary incontinence, their incontinence symptoms and QoL were improved in the PFMT groups. Women were more satisfied with the PFMT treatment, while those in the control groups were more likely to seek further treatment.\nNegative side effects of performing PFMT were rare and, in the two trials that did report them, the side effects were minor.\nThe authors of the one economic evaluation identified for the Brief Economic Commentary reported that the cost-effectiveness of PFMT looks promising." } ]
query-laysum	21578	[ { "role": "user", "content": "Abstract: Background\nIdentification of the causes of stillbirth is critical to the primary prevention of stillbirth and to the provision of optimal care in subsequent pregnancies. A wide variety of investigations are available, but there is currently no consensus on the optimal approach. Given their cost and potential to add further emotional burden to parents, there is a need to systematically assess the effect of these interventions on outcomes for parents, including psychosocial outcomes, economic costs, and on rates of diagnosis of the causes of stillbirth.\nObjectives\nTo assess the effect of different tests, protocols or guidelines for investigating and identifying the causes of stillbirth on outcomes for parents, including psychosocial outcomes, economic costs, and rates of diagnosis of the causes of stillbirth.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 May 2017).\nSelection criteria\nWe planned to include randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs. We planned to include studies published as abstract only, provided there was sufficient information to allow us to assess study eligibility. We planned to exclude cross-over trials.\nParticipants included parents (including mothers, fathers, and partners) who had experienced a stillbirth of 20 weeks' gestation or greater.\nThis review focused on interventions for investigating and identifying the causes of stillbirth. Such interventions are likely to be diverse, but could include:\n* review of maternal and family history, and current pregnancy and birth history;\n* clinical history of present illness;\n* maternal investigations (such as ultrasound, amniocentesis, antibody screening, etc.);\n* examination of the stillborn baby (including full autopsy, partial autopsy or noninvasive components, such as magnetic resonance imaging (MRI), computerised tomography (CT) scanning, and radiography);\n* umbilical cord examination;\n* placental examination including histopathology (microscopic examination of placental tissue); and\n* verbal autopsy (interviews with care providers and support people to ascertain causes, without examination of the baby).\nWe planned to include trials assessing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth, compared with the absence of a test, protocol or guideline, or usual care (further details are presented in the Background, see Description of the intervention).\nWe also planned to include trials comparing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth with another, for example, the use of a limited investigation protocol compared with a comprehensive investigation protocol.\nData collection and analysis\nTwo review authors assessed trial eligibility independently.\nMain results\nWe excluded five studies that were not RCTs. There were no eligible trials for inclusion in this review.\nAuthors' conclusions\nThere is currently a lack of RCT evidence regarding the effectiveness of interventions for investigating and identifying the causes of stillbirth. Seeking to determine the causes of stillbirth is an essential component of quality maternity care, but it remains unclear what impact these interventions have on the psychosocial outcomes of parents and families, the rates of diagnosis of the causes of stillbirth, and the care and management of subsequent pregnancies following stillbirth. Due to the absence of trials, this review is unable to inform clinical practice regarding the investigation of stillbirths, and the specific investigations that would determine the causes.\nFuture RCTs addressing this research question would be beneficial, but the settings in which the trials take place, and their design, need to be given careful consideration. Trials need to be conducted with the utmost care and consideration for the needs, concerns, and values of parents and families. Assessment of longer-term psychosocial variables, economic costs to health services, and effects on subsequent pregnancy care and outcomes should also be considered in any future trials.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Searching for causes of stillbirth can be difficult emotionally for families, and financially costly to health services and sometimes to parents. Some tests and investigations may be more helpful than others in identifying the causes of stillbirth. There is a need to assess systematically which approaches are most helpful in finding causes of stillbirth, how cost-effective the different approaches are, what the emotional and social effects on parents are, what impact the investigations have on future pregnancies, and the end result of future pregnancies." } ]
query-laysum	21579	[ { "role": "user", "content": "Abstract: Background\nAsthma is characterised by chronic inflammation of the airways and recurrent exacerbations with wheezing, chest tightness, and cough. Treatment with inhaled steroids and bronchodilators can result in good control of symptoms, prevention of further morbidity, and improved quality of life. However, an increase in serious adverse events with the use of both regular formoterol and regular salmeterol (long-acting beta₂-agonists) compared with placebo for chronic asthma has been demonstrated in previous Cochrane Reviews. This increase was statistically significant in trials that did not randomise participants to an inhaled corticosteroid, but not when formoterol or salmeterol was combined with an inhaled corticosteroid. The confidence intervals were found to be too wide to ensure that the addition of an inhaled corticosteroid renders regular long-acting beta₂-agonists completely safe; few participants and insufficient serious adverse events in these trials precluded a definitive decision about the safety of combination treatments.\nObjectives\nTo assess risks of mortality and non-fatal serious adverse events in trials that have randomised patients with chronic asthma to regular formoterol and an inhaled corticosteroid versus regular salmeterol and an inhaled corticosteroid.\nSearch methods\nWe searched the Cochrane Airways Register of Trials, CENTRAL, MEDLINE, Embase, and two trial registries to identify reports of randomised trials for inclusion. We checked manufacturers' websites and clinical trial registers for unpublished trial data, as well as Food and Drug Administration (FDA) submissions in relation to formoterol and salmeterol. The date of the most recent search was 24 February 2021.\nSelection criteria\nWe included controlled clinical trials with a parallel design, recruiting patients of any age and severity of asthma, if they randomised patients to treatment with regular formoterol versus regular salmeterol (each with a randomised inhaled corticosteroid) and were of at least 12 weeks' duration.\nData collection and analysis\nTwo review authors independently selected trials for inclusion in the review, extracted outcome data from published papers and trial registries, and applied GRADE rating for the results. We sought unpublished data on mortality and serious adverse events from study sponsors and authors. The primary outcomes were all cause mortality and non-fatal serious adverse events. We chose not to calculate an average result from all the formulations of formoterol and inhaled steroid, as the doses and delivery devices are too diverse to assume a single class effect.\nMain results\nTwenty-one studies in 11,572 adults and adolescents and two studies in 723 children met the eligibility criteria of the review. No data were available for two studies; therefore these were not included in the analysis. Among adult and adolescent studies, seven compared formoterol and budesonide to salmeterol and fluticasone (N = 7764), six compared formoterol and beclomethasone to salmeterol and fluticasone (N = 1923), two compared formoterol and mometasone to salmeterol and fluticasone (N = 1126), two compared formoterol and fluticasone to salmeterol and fluticasone (N = 790), and one compared formoterol and budesonide to salmeterol and budesonide (N = 229).\nIn total, five deaths were reported among adults, none of which was thought to be related to asthma. The certainty of evidence for all-cause mortality was low, as there were not enough deaths to permit any precise conclusions regarding the risk of mortality on combination formoterol versus combination salmeterol.\nIn all, 201 adults reported non-fatal serious adverse events. In studies comparing formoterol and budesonide to salmeterol and fluticasone, there were 77 in the formoterol arm and 68 in the salmeterol arm (Peto odds ratio (OR) 1.14, 95% confidence interval (CI) 0.82 to 1.59; 5935 participants, 7 studies; moderate-certainty evidence). In the formoterol and beclomethasone studies, there were 12 adults in the formoterol arm and 13 in the salmeterol arm with events (Peto OR 0.94, 95% CI 0.43 to 2.08; 1941 participants, 6 studies; moderate-certainty evidence). In the formoterol and mometasone studies, there were 18 in the formoterol arm and 11 in the salmeterol arm (Peto OR 1.02, 95% CI 0.47 to 2.20; 1126 participants, 2 studies; moderate-certainty evidence). One adult in the formoterol and fluticasone studies in the salmeterol arm experienced an event (Peto OR 0.05, 95% CI 0.00 to 3.10; 293 participants, 2 studies; low-certainty evidence). Another adult in the formoterol and budesonide compared to salmeterol and budesonide study in the formoterol arm had an event (Peto OR 7.45, 95% CI 0.15 to 375.68; 229 participants, 1 study; low-certainty evidence).\nOnly 46 adults were reported to have experienced asthma-related serious adverse events. The certainty of the evidence was low to very low due to the small number of events and the absence of independent assessment of causation.\nThe two studies in children compared formoterol and fluticasone to salmeterol and fluticasone. No deaths and no asthma-related serious adverse events were reported in these studies. Four all-cause serious adverse events were reported: three in the formoterol arm, and one in the salmeterol arm (Peto OR 2.72, 95% CI 0.38 to 19.46; 548 participants, 2 studies; low-certainty evidence).\nAuthors' conclusions\nOverall, for both adults and children, evidence is insufficient to show whether regular formoterol in combination with budesonide, beclomethasone, fluticasone, or mometasone has a different safety profile from salmeterol in combination with fluticasone or budesonide. Five deaths of any cause were reported across all studies and no deaths from asthma; this information is insufficient to permit any firm conclusions about the relative risks of mortality on combination formoterol in comparison to combination salmeterol inhalers. Evidence on all-cause non-fatal serious adverse events indicates that there is probably little to no difference between formoterol/budesonide and salmeterol/fluticasone inhalers. However events for the other formoterol combination inhalers were too few to allow conclusions. Only 46 non-fatal serious adverse events were thought to be asthma related; this small number in addition to the absence of independent outcome assessment means that we have very low confidence for this outcome.\nWe found no evidence of safety issues that would affect the choice between salmeterol and formoterol combination inhalers used for regular maintenance therapy by adults and children with asthma.\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": "We found no safety issues that would affect the choice between salmeterol and formoterol combination inhalers used for regular maintenance therapy in adults and children with asthma." } ]
query-laysum	21580	[ { "role": "user", "content": "Abstract: Background\nPhysicians often prescribe opioids for pain in the acute care setting. Nausea and vomiting are well-described adverse events, occurring in over one-third of patients. Prophylactic antiemetics may be one option to reduce opioid-associated nausea and vomiting. However, these medications also have their own adverse effects, so it is important to understand their efficacy and safety prior to routine use. This is a review of randomized controlled trials comparing prophylactic antiemetics versus placebo or standard care for preventing opioid-associated nausea and vomiting.\nObjectives\nTo assess the effects of prophylactic antiemetics for nausea and vomiting in adults (aged 16 years or older) receiving intravenous opioids in the acute care setting.\nSearch methods\nWe searched CENTRAL (the Cochrane Library), MEDLINE (OVID), Embase (OVID) from inception to January 2022, and Google Scholar (17 January 2022). We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and screened reference lists.\nSelection criteria\nWe included randomized controlled trials of prophylactic antiemetics versus placebo or standard care in adults prior to receiving an intravenous opioid.\nData collection and analysis\nTwo review authors (MG, JNC) independently determined the eligibility of each study according to the inclusion criteria. Two review authors (MG, GDP) then independently extracted data, assessed risk of bias, and determined the certainty of evidence using GRADE. Our primary outcomes were the occurrence of nausea, vomiting, and adverse events. Secondary outcomes included nausea severity, number of vomiting episodes, and number of participants requiring antiemetic rescue therapy. We presented outcomes as risk ratios (RR) for dichotomous data (e.g. presence of vomiting, presence of nausea, number of participants requiring rescue medication, adverse events) and mean difference (MD) or standardized mean difference for continuous data (e.g. number of vomiting episodes, nausea severity) with 95% confidence intervals (CI).\nMain results\nWe included three studies involving 527 participants (187 women and 340 men) with a mean age of 42 years. All studies used intravenous metoclopramide (10 mg) as the intervention and a placebo for the comparator. No studies assessed any other antiemetic or compared the intervention to standard care.\nCompared to placebo, metoclopramide did not reduce vomiting (RR 1.18, 95% CI 0.26 to 5.32; low-certainty evidence) or nausea (RR 0.55; 95% CI 0.15 to 2.03; low-certainty evidence) and there was no difference in adverse events (RR 2.34, 95% CI 0.47 to 11.61; low-certainty evidence). No data were available regarding the number of vomiting episodes. Metoclopramide did reduce the severity of nausea compared with placebo (MD −0.49, 95% CI −0.75 to −0.23; low-certainty evidence) but did not reduce the need for rescue medication (RR 1.86, 95% CI 0.17 to 20.16; low-certainty evidence).\nTwo studies were at unclear risk of bias for random sequence generation, one for blinding of outcome assessors, one for incomplete outcome data, and two for selective reporting. The studies were at low risk of bias for all remaining components.\nAuthors' conclusions\nThere was no evidence that prophylactic metoclopramide affected the risk of vomiting, nausea, or the need for rescue medication when provided prior to intravenous opioids in the acute care setting. There was a clinically insignificant difference in nausea severity when comparing prophylactic metoclopramide with placebo. Overall, the evidence was of low certainty. Future research could better delineate the effects of prophylactic antiemetics on specific populations, and new studies are needed to evaluate the use of other prophylactic antiemetic agents, for which there were no data.\n\nGiven the provided abstract, please respond to the following query: \"What is opioid-induced emesis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Physicians often give patients opioids for pain in emergency departments, but over a third experience the side effects of nausea and vomiting (emesis). Some experts have suggested that taking antiemetics before receiving the opioid (that is, as a prophylactic) could prevent these symptoms from occurring. However, these medications have their own side effects, so it is important to understand whether they are effective and safe before routinely using them." } ]
query-laysum	21581	[ { "role": "user", "content": "Abstract: Background\nLeg cramps are a common problem in pregnancy. Various interventions have been used to treat them, including drug, electrolyte and vitamin therapies, and non-drug therapies. This Cochrane Review is an update of a review first published in 2015.\nObjectives\nTo assess the effectiveness and safety of different interventions for treating leg cramps in pregnancy.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (25 September 2019), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) of any intervention for the treatment of leg cramps in pregnancy compared with placebo, no treatment or other treatments. Quinine was excluded for its known adverse effects. Cluster-RCTS were eligible for inclusion. Quasi-RCTs and cross-over studies were excluded.\nData collection and analysis\nThree review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. The certainty of the evidence was assessed using the GRADE approach.\nMain results\nWe included eight small studies (576 women). Frequency of leg cramps was our primary outcome and secondary outcomes included intensity and duration of leg cramps, adverse outcomes for mother and baby and health-related quality of life. Overall, the studies were at low or unclear risk of bias. Outcomes were reported in different ways, precluding the use of meta-analysis and thus data were limited to single trials. Certainty of evidence was assessed as either low or very-low due to serious limitations in study design and imprecision.\nOral magnesium versus placebo/no treatment\nThe results for frequency of leg cramps were inconsistent. In one study, results indicated that women may be more likely to report never having any leg cramps after treatment (risk ratio (RR) 5.66, 95% confidence interval (CI) 1.35 to 23.68, 1 trial, 69 women, low-certainty evidence); whilst fewer women may report having twice-weekly leg cramps (RR 0.29, 95% CI 0.11 to 0.80, 1 trial, 69 women); and more women may report a 50% reduction in number of leg cramps after treatment (RR 1.42, 95% CI 1.09 to 1.86, 1 trial, 86 women, low-certainty evidence). However, other findings indicated that magnesium may make little to no difference in the frequency of leg cramps during differing periods of treatment.\nFor pain intensity, again results were inconsistent. Findings indicated that magnesium may make little or no difference: mean total pain score (MD 1.80, 95% CI -3.10 to 6.70, 1 trial, 38 women, low-certainty evidence). In another study the evidence was very uncertain about the effects of magnesium on pain intensity as measured in terms of a 50% reduction in pain. Findings from another study indicated that magnesium may reduce pain intensity according to a visual analogue scale (MD -17.50, 95% CI -34.68 to -0.32,1 trial, 69 women, low-certainty evidence). For all other outcomes examined there may be little or no difference: duration of leg cramps (low to very-low certainty); composite outcome - symptoms of leg cramps (very-low certainty); and for any side effects, including nausea and diarrhoea (low certainty).\nOral calcium versus placebo/no treatment\nThe evidence is unclear about the effect of calcium supplements on frequency of leg cramps because the certainty was found to be very low: no leg cramps after treatment (RR 8.59, 95% CI 1.19 to 62.07, 1 study, 43 women, very low-certainty evidence). In another small study, the findings indicated that the mean frequency of leg cramps may be slightly lower with oral calcium (MD -0.53, 95% CI -0.72 to -0.34; 1 study, 60 women; low certainty).\nOral vitamin B versus no treatment\nOne small trial, did not report on frequency of leg cramps individually, but showed that oral vitamin B supplements may reduce the frequency and intensity (composite outcome) of leg cramps (RR 0.29, 95% CI 0.11 to 0.73; 1 study, 42 women). There were no data on side effects.\nOral calcium versus oral vitamin C\nThe evidence is very uncertain about the effect of calcium on frequency of leg cramps after treatment compared with vitamin C (RR 1.33, 95% CI 0.53 to 3.38, 1 study, 60 women, very low-certainty evidence).\nOral vitamin D versus placebo\nOne trial (84 women) found vitamin D may make little or no difference to frequency of leg cramps compared with placebo at three weeks (MD 2.06, 95% CI 0.58 to 3.54); or six weeks after treatment (MD 1.53, 95% CI 0.12 to 2.94).\nOral calcium-vitamin D versus placebo\nOne trial (84 women) found oral calcium-vitamin D may make little or no difference to frequency of leg cramps compared with placebo after treatment at three weeks (MD -0.30, 95% CI -1.55 to 0.95); and six weeks (MD 0.03, 95% CI -1.3 to 1.36).\nOral calcium-vitamin D versus vitamin D\nOne trial (84 women) found oral calcium-vitamin D may make little or no difference to frequency of leg cramps compared with vitamin D after treatment at three weeks (MD -1.35, 95% CI -2.84 to 0.14); and six weeks after treatment (MD -1.10, 95% CI -2.69 to 0.49).\nAuthors' conclusions\nIt is unclear from the evidence reviewed whether any of the interventions provide an effective treatment for leg cramps. This is primarily due to outcomes being measured and reported in different, incomparable ways so that data could not be pooled. The certainty of evidence was found to be low or very-low due to design limitations and trials being too small to address the question satisfactorily.\nAdverse outcomes were not reported, other than side effects for magnesium versus placebo/no treatment. It is therefore not possible to assess the safety of these interventions.\nThe inconsistency in the measurement and reporting of outcomes meant that meta-analyses could not be carried out. The development of a core outcome set for measuring the frequency, intensity and duration of leg cramps would address these inconsistencies and mean these outcomes could be investigated effectively in the future.\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 level of evidence was found to be of low or very low quality. This was mainly due to the small sample size of studies and poor study design. Four studies were well-conducted and reported. The other four had design limitations: women were not allocated to different treatment groups in the best way in several studies, and in two studies women knew whether they were receiving treatment or not. Adverse effects such as any effect of the treatment on pregnancy complications, labour and the baby were not reported. Several of the studies focused mainly on serum calcium and magnesium levels. The frequency and intensity of cramps and the duration of pain were not reported in a consistent way and often information was lacking on how they were measured, either during treatment, at the end of treatment or after treatment had stopped.\nIt is not clear from the evidence reviewed whether any of the oral interventions (magnesium, calcium, calcium-vitamin D, vitamin B vitamin D or vitamin C) provide an effective and safe treatment for leg cramps in pregnancy. Supplements may have different effects depending on women's usual intake of these substances. No trials considered therapies such as muscle stretching, massage, relaxation or heat therapy." } ]
query-laysum	21582	[ { "role": "user", "content": "Abstract: Background\nEndophthalmitis is a sight-threatening emergency that requires prompt diagnosis and treatment. The condition is characterised by purulent inflammation of the intraocular fluids caused by an infective agent. In exogenous endophthalmitis, the infective agent is foreign and typically introduced into the eye through intraocular surgery or open globe trauma.\nObjectives\nTo assess the potential role of combined pars plana vitrectomy and intravitreal antibiotics in the acute management of exogenous endophthalmitis, versus the standard of care, defined as vitreous tap and intravitreal antibiotics.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 5); Ovid MEDLINE; Ovid Embase; the International Standard Randomised Controlled Trial Number registry; ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. There were no restrictions to language or year of publication. The date of the search was 5 May 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared pars plana vitrectomy and intravitreal injection of antibiotics versus intravitreal injection of antibiotics alone, for the immediate management of exogenous endophthalmitis.\nData collection and analysis\nWe used standard methods expected by Cochrane. Two review authors independently screened search results and extracted data. We considered the following outcomes: visual acuity improvement and change in visual acuity at three and six months; additional surgical procedures, including vitrectomy and cataract surgery, at any time during follow-up; quality of life and adverse effects. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe identified a single RCT that met our inclusion criteria. The included RCT enrolled a total of 420 participants with clinical evidence of endophthalmitis, within six weeks of cataract surgery or secondary intraocular lens implantation. Participants were randomly assigned according to a 2 x 2 factorial design to either treatment with vitrectomy (VIT) or vitreous tap biopsy (TAP) and to treatment with or without systemic antibiotics. Twenty-four participants did not have a final follow-up: 12 died, five withdrew consent to be followed up, and seven were not willing to return for the visit.\nThe study did not report visual acuity according to the review's predefined outcomes. At three months, 41% of all participants achieved 20/40 or better visual acuity and 69% had 20/100 or better acuity. The study authors reported that there was no statistically significant difference in visual acuity between treatment groups (very low-certainty evidence). There was low-certainty evidence of a similar requirement for additional surgical procedures (risk ratio RR 0.90, 95% confidence interval 0.66 to 1.21). Adverse effects included: VIT group: dislocated intraocular lens (n = 2), macular infarction (n = 1). TAP group: expulsive haemorrhage (n = 1). Quality of life and mean change in visual acuity were not reported.\nAuthors' conclusions\nWe identified a single RCT (published 27 years ago) for the role of early vitrectomy in exogenous endophthalmitis, which suggests that there may be no difference between groups (VIT vs TAP) for visual acuity at three or nine months' follow-up.\nWe are of the opinion that there is a clear need for more randomised studies comparing the role of primary vitrectomy in exogenous endophthalmitis. Moreover, since the original RCT study, there have been incremental changes in the surgical techniques with which vitrectomy is performed. Such advances are likely to influence the outcome of early vitrectomy in exogenous endophthalmitis.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The aim of this Cochrane Review was to assess the role of vitrectomy in the treatment of endophthalmitis." } ]
query-laysum	21583	[ { "role": "user", "content": "Abstract: Background\nExercise-based cardiac rehabilitation may benefit adults with atrial fibrillation or those who had been treated for atrial fibrillation. Atrial fibrillation is caused by multiple micro re-entry circuits within the atrial tissue, which result in chaotic rapid activity in the atria.\nObjectives\nTo assess the benefits and harms of exercise-based rehabilitation programmes, alone or with another intervention, compared with no-exercise training controls in adults who currently have AF, or have been treated for AF.\nSearch methods\nWe searched the following electronic databases; CENTRAL and the Database of Abstracts of Reviews of Effectiveness (DARE) in the Cochrane Library, MEDLINE Ovid, Embase Ovid, PsycINFO Ovid, Web of Science Core Collection Thomson Reuters, CINAHL EBSCO, LILACS Bireme, and three clinical trial registers on 14 July 2016. We also checked the bibliographies of relevant systematic reviews identified by the searches. We imposed no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCT) that investigated exercise-based interventions compared with any type of no-exercise control. We included trials that included adults aged 18 years or older with atrial fibrillation, or post-treatment for atrial fibrillation.\nData collection and analysis\nTwo authors independently extracted data. We assessed the risk of bias using the domains outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed clinical and statistical heterogeneity by visual inspection of the forest plots, and by using standard Chi² and I² statistics. We performed meta-analyses using fixed-effect and random-effects models; we used standardised mean differences where different scales were used for the same outcome. We assessed the risk of random errors with trial sequential analysis (TSA) and used the GRADE methodology to rate the quality of evidence, reporting it in the 'Summary of findings' table.\nMain results\nWe included six RCTs with a total of 421 patients with various types of atrial fibrillation. All trials were conducted between 2006 and 2016, and had short follow-up (eight weeks to six months). Risks of bias ranged from high risk to low risk.The exercise-based programmes in four trials consisted of both aerobic exercise and resistance training, in one trial consisted of Qi-gong (slow and graceful movements), and in another trial, consisted of inspiratory muscle training.\nFor mortality, very low-quality evidence from six trials suggested no clear difference in deaths between the exercise and no-exercise groups (relative risk (RR) 1.00, 95% confidence interval (CI) 0.06 to 15.78; participants = 421; I² = 0%; deaths = 2). Very low-quality evidence from five trials suggested no clear difference between groups for serious adverse events (RR 1.01, 95% CI 0.98 to 1.05; participants = 381; I² = 0%; events = 8). Low-quality evidence from two trials suggested no clear difference in health-related quality of life for the Short Form-36 (SF-36) physical component summary measure (mean difference (MD) 1.96, 95% CI -2.50 to 6.42; participants = 224; I² = 69%), or the SF-36 mental component summary measure (MD 1.99, 95% CI -0.48 to 4.46; participants = 224; I² = 0%). Exercise capacity was assessed by cumulated work, or maximal power (Watt), obtained by cycle ergometer, or by six minute walking test, or ergospirometry testing measuring VO2 peak. We found moderate-quality evidence from two studies that exercise-based rehabilitation increased exercise capacity, measured by VO2 peak, more than no exercise (MD 3.76, 95% CI 1.37 to 6.15; participants = 208; I² = 0%); and very low-quality evidence from four studies that exercise-based rehabilitation increased exercise capacity more than no exercise, measured by the six-minute walking test (MD 75.76, 95% CI 14.00 to 137.53; participants = 272; I² = 85%). When we combined the different assessment tools for exercise capacity, we found very low-quality evidence from six trials that exercise-based rehabilitation increased exercise capacity more than no exercise (standardised mean difference (SMD) 0.86, 95% CI 0.46 to 1.26; participants = 359; I² = 65%). Overall, the quality of the evidence for the outcomes ranged from moderate to very-low.\nAuthors' conclusions\nDue to few randomised patients and outcomes, we could not evaluate the real impact of exercise-based cardiac rehabilitation on mortality or serious adverse events. The evidence showed no clinically relevant effect on health-related quality of life. Pooled data showed a positive effect on the surrogate outcome of physical exercise capacity, but due to the low number of patients and the moderate to very low-quality of the underpinning evidence, we could not be certain of the magnitude of the effect. Future high-quality randomised trials are needed to assess the benefits and harms of exercise-based cardiac rehabilitation for adults with atrial fibrillation on patient-relevant outcomes.\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 randomised clinical trials that are conducted with low risks of bias and low risks of the play of chance, in a broader population of patients with AF, are needed to assess the impact of exercise-based interventions." } ]
query-laysum	21584	[ { "role": "user", "content": "Abstract: Background\nVery preterm infants often require respiratory support and are therefore exposed to an increased risk of bronchopulmonary dysplasia (chronic lung disease) and later neurodevelopmental disability. Caffeine is widely used to prevent and treat apnea (temporal cessation of breathing) associated with prematurity and facilitate extubation. Though widely recognized dosage regimes have been used for decades, higher doses have been suggested to further improve neonatal outcomes. However, observational studies suggest that higher doses may be associated with harm.\nObjectives\nTo determine the effects of higher versus standard doses of caffeine on mortality and major neurodevelopmental disability in preterm infants with (or at risk of) apnea, or peri-extubation.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and clinicaltrials.gov in May 2022. The reference lists of relevant articles were also checked to identify additional studies.\nSelection criteria\nWe included randomized (RCTs), quasi-RCTs and cluster-RCTs, comparing high-dose to standard-dose strategies in preterm infants. High-dose strategies were defined as a high-loading dose (more than 20 mg of caffeine citrate/kg) or a high-maintenance dose (more than 10 mg of caffeine citrate/kg/day). Standard-dose strategies were defined as a standard-loading dose (20 mg or less of caffeine citrate/kg) or a standard-maintenance dose (10 mg or less of caffeine citrate/kg/day). We specified three additional comparisons according to the indication for commencing caffeine: 1) prevention trials, i.e. preterm infants born at less than 34 weeks' gestation, who are at risk for apnea; 2) treatment trials, i.e. preterm infants born at less than 37 weeks' gestation, with signs of apnea; 3) extubation trials: preterm infants born at less than 34 weeks' gestation, prior to planned extubation.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We evaluated treatment effects using a fixed-effect model with risk ratio (RR) for categorical data and mean, standard deviation (SD), and mean difference (MD) for continuous data.\nMain results\nWe included seven trials enrolling 894 very preterm infants (reported in Comparison 1, i.e. any indication).\nTwo studies included infants for apnea prevention (Comparison 2), four studies for apnea treatment (Comparison 3) and two for extubation management (Comparison 4); in one study, indication for caffeine administration was both apnea treatment and extubation management (reported in Comparison 1, Comparison 3 and Comparison 4).\nIn the high-dose groups, loading and maintenance caffeine doses ranged from 30 mg/kg to 80 mg/kg, and 12 mg/kg to 30 mg/kg, respectively; in the standard-dose groups, loading and maintenance caffeine doses ranged from 6 mg/kg to 25 mg/kg, and 3 mg/kg to 10 mg/kg, respectively.\nTwo studies had three study groups: infants were randomized in three different doses (two of them matched our definition of high dose and one matched our definition of standard dose); high-dose caffeine and standard-dose caffeine were compared to theophylline administration (the latter is included in a separate review).\nSix of the seven included studies compared high-loading and high-maintenance dose to standard-loading and standard-maintenance dose, whereas in one study standard-loading dose and high-maintenance dose was compared to standard-loading dose and standard-maintenance dose.\nHigh-dose caffeine strategies (administration for any indication) may have little or no effect on mortality prior to hospital discharge (risk ratio (RR) 0.86, 95% confidence of interval (CI) 0.53 to 1.38; risk difference (RD) -0.01, 95% CI -0.05 to 0.03; I² for RR and RD = 0%; 5 studies, 723 participants; low-certainty evidence). Only one study enrolling 74 infants reported major neurodevelopmental disability in children aged three to five years (RR 0.79, 95% CI 0.51 to 1.24; RD -0.15, 95% CI -0.42 to 0.13; 46 participants; very low-certainty evidence). No studies reported the outcome mortality or major neurodevelopmental disability in children aged 18 to 24 months and 3 to 5 years. Five studies reported bronchopulmonary dysplasia at 36 weeks' postmenstrual age (RR 0.75, 95% CI 0.60 to 0.94; RD -0.08, 95% CI -0.15 to -0.02; number needed to benefit (NNTB) = 13; I² for RR and RD = 0%; 723 participants; moderate-certainty evidence). High-dose caffeine strategies may have little or no effect on side effects (RR 1.66, 95% CI 0.86 to 3.23; RD 0.03, 95% CI -0.01 to 0.07; I² for RR and RD = 0%; 5 studies, 593 participants; low-certainty evidence). The evidence is very uncertain for duration of hospital stay (data reported in three studies could not be pooled in meta-analysis because outcomes were expressed as medians and interquartile ranges) and seizures (RR 1.42, 95% CI 0.79 to 2.53; RD 0.14, 95% CI -0.09 to 0.36; 1 study, 74 participants; very low-certainty evidence).\nWe identified three ongoing trials conducted in China, Egypt, and New Zealand.\nAuthors' conclusions\nHigh-dose caffeine strategies in preterm infants may have little or no effect on reducing mortality prior to hospital discharge or side effects. We are very uncertain whether high-dose caffeine strategies improves major neurodevelopmental disability, duration of hospital stay or seizures. No studies reported the outcome mortality or major neurodevelopmental disability in children aged 18 to 24 months and 3 to 5 years. High-dose caffeine strategies probably reduce the rate of bronchopulmonary dysplasia.\nRecently completed and future trials should report long-term neurodevelopmental outcome of children exposed to different caffeine dosing strategies in the neonatal period. Data from extremely preterm infants are needed, as this population is exposed to the highest risk for mortality and morbidity. However, caution is required when administering high doses in the first hours of life, when the risk for intracranial bleeding is highest. Observational studies might provide useful information regarding potential harms of the highest doses.\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": "• Although caffeine is commonly given to babies born too early, its most effective dose is unclear.\n• Higher doses of caffeine might improve breathing and long-term development, but it potentially has unwanted effects." } ]
query-laysum	21585	[ { "role": "user", "content": "Abstract: Background\nInsecticide-treated nets (ITNs) and indoor residual spraying (IRS) are used to prevent malaria transmission. Both interventions use insecticides to kill mosquitoes that bite and rest indoors. Adding IRS to ITNs may improve malaria control simply because two interventions can be better than one. Furthermore, IRS may improve malaria control where ITNs are failing due to insecticide resistance. Pyrethroid insecticides are the predominant class of insecticide used for ITNs, as they are more safe than other insecticide classes when in prolonged contact with human skin. While many mosquito populations have developed some resistance to pyrethroid insecticides, a wider range of insecticides can be used for IRS. This review is an update of the previous Cochrane 2019 edition.\nObjectives\nTo summarize the effect on malaria of additionally implementing IRS, using non-pyrethroid-like or pyrethroid-like insecticides, in communities currently using ITNs.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register; CENTRAL; MEDLINE; and five other databases for records from 1 January 2000 to 8 November 2021, on the basis that ITN programmes did not begin to be implemented as policy before the year 2000.\nSelection criteria\nWe included cluster-randomized controlled trials (cRCTs), interrupted time series (ITS), or controlled before-after studies (CBAs) comparing IRS plus ITNs with ITNs alone. We included studies with at least 50% ITN ownership (defined as the proportion of households owning one or more ITN) in both study arms.\nData collection and analysis\nTwo review authors independently assessed studies for eligibility, analyzed risk of bias, and extracted data. We used risk ratio (RR) and 95% confidence intervals (CI). We stratified by type of insecticide, 'pyrethroid-like' and 'non-pyrethroid-like'; the latter could improve malaria control better than adding IRS insecticides that have the same way of working as the insecticide on ITNs ('pyrethroid-like'). We used subgroup analysis of ITN usage in the studies to explore heterogeneity. We assessed the certainty of evidence using the GRADE approach.\nMain results\nEight cRCTs (10 comparisons), one CBA, and one ITS study, all conducted since 2008 in sub-Saharan Africa, met our inclusion criteria. The primary vectors in all sites were mosquitoes belonging to the Anopheles gambiae s.l. complex species; five studies in Benin, Mozambique, Ghana, Sudan, and Tanzania also reported the vector Anopheles funestus. Five cRCTs and both quasi-experimental design studies used insecticides with targets different to pyrethroids (two used bendiocarb, three used pirimiphos-methyl, and one used propoxur. Each of these studies were conducted in areas where the vectors were described as resistant or highly resistant to pyrethroids. Two cRCTs used dichloro-diphenyl-trichlorethane (DDT), an insecticide with the same target as pyrethroids. The remaining cRCT used both types of insecticide (pyrethroid deltamethrin in the first year, switching to bendiocarb for the second year).\nIndoor residual spraying using 'non-pyrethroid-like' insecticides\nSix studies were included (four cRCTs, one CBA, and one ITS). Our main analysis for prevalence excluded a study at high risk of bias due to repeated sampling of the same population. This risk did not apply to other outcomes. Overall, the addition of IRS reduced malaria parasite prevalence (RR 0.61, 95% CI 0.42 to 0.88; 4 cRCTs, 16,394 participants; high-certainty evidence). IRS may also reduce malaria incidence on average (rate ratio 0.86, 95% CI 0.61 to 1.23; 4 cRCTs, 323,631 child-years; low-certainty evidence) but the effect was absent in two studies. Subgroup analyses did not explain the qualitative heterogeneity between studies. One cRCT reported no effect on malaria incidence or parasite prevalence in the first year, when a pyrethroid-like insecticide was used for IRS, but showed an effect on both outcomes in the second year, when a non-pyrethroid-like IRS was used.\nThe addition of IRS may also reduce anaemia prevalence (RR 0.71, 95% CI 0.38 to 1.31; 3 cRCTs, 4288 participants; low-certainty evidence). Four cRCTs reported the impact of IRS on entomological inoculation rate (EIR), with variable results; overall, we do not know if IRS had any effect on the EIR in communities using ITNs (very low-certainty evidence). Studies also reported the adult mosquito density and the sporozoite rate, but we could not summarize or pool these entomological outcomes due to differences in the reported data. Three studies measured the prevalence of pyrethroid resistance before and after IRS being introduced: there was no difference detected, but these data are limited.\nIndoor residual spraying using 'pyrethroid-like' insecticides\nAdding IRS using a pyrethroid-like insecticide did not appear to markedly alter malaria incidence (rate ratio 1.07, 95% CI 0.80 to 1.43; 2 cRCTs, 15,717 child-years; moderate-certainty evidence), parasite prevalence (RR 1.11, 95% CI 0.86 to 1.44; 3 cRCTs, 10,820 participants; moderate-certainty evidence), or anaemia prevalence (RR 1.12, 95% CI 0.89 to 1.40; 1 cRCT, 4186 participants; low-certainty evidence). Data on EIR were limited so no conclusion was made (very low-certainty evidence).\nAuthors' conclusions\nin communities using ITNs, the addition of IRS with 'non-pyrethroid-like' insecticides was associated with reduced malaria prevalence. Malaria incidence may also be reduced on average, but there was unexplained qualitative heterogeneity, and the effect may therefore not be observed in all settings.\nWhen using 'pyrethroid-like' insecticides, there was no detectable additional benefit of IRS in communities using ITNs.\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": "Indoor residual spraying (IRS) is the regular application of chemical insecticides to household walls. The insecticide lasts for several months, killing mosquitoes that land on them. Insecticide-treated nets (ITNs) are bed nets treated with insecticides, preventing mosquitoes from biting people and reducing the mosquito population. Both interventions help to control malaria by reducing the number of people being bitten by mosquitoes infected with malaria. Implementing IRS in communities that are using ITNs may be better for malaria control than using ITNs alone simply because two interventions may be better than one; but also because it may improve malaria control where mosquitoes have become resistant to the pyrethroid insecticides used in ITNs. Pyrethroids were the only class of insecticides approved for use in ITNs until 2018, but growing resistance of mosquitoes to pyrethroids impairs their effectiveness. The addition of IRS could counteract this reduction in ITN effectiveness and may help to slow the emergence of pyrethroid resistance. We could expect that IRS insecticides that have a different way of working to pyrethroids ('non-pyrethroid-like') could restore effectiveness better than those that have the same way of working ('pyrethroid-like'). The aim of this review was to summarize the impact of pyrethroid-like or non-pyrethroid-like IRS on malaria, when implemented in communities that are using ITNs." } ]
query-laysum	21586	[ { "role": "user", "content": "Abstract: Background\nPelvic adhesions can form secondary to inflammation, endometriosis, or surgical trauma. Strategies to reduce pelvic adhesion formation include placing barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene, and fibrin or collagen sheets between pelvic structures.\nObjectives\nTo evaluate the effects of barrier agents used during pelvic surgery on rates of pain, live birth, and postoperative adhesions in women of reproductive age.\nSearch methods\nWe searched the following databases in August 2019: the Cochrane Gynaecology and Fertility (CGF) Specialised Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the Cochrane Central Register of Controlled Trials (CENTRAL), Epistemonikos, and trial registries. We searched reference lists of relevant papers, conference proceedings, and grey literature sources. We contacted pharmaceutical companies for information and handsearched relevant journals and conference abstracts.\nSelection criteria\nRandomised controlled trials (RCTs) on the use of barrier agents compared with other barrier agents, placebo, or no treatment for prevention of adhesions in women undergoing gynaecological surgery.\nData collection and analysis\nThree review authors independently assessed trials for eligibility and risk of bias and extracted data. We calculated odds ratios (ORs) or mean differences (MDs) with 95% confidence intervals (CIs) using a fixed-effect model. We assessed the overall quality of the evidence using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods.\nMain results\nWe included 19 RCTs (1316 women). Seven RCTs randomised women; the remainder randomised pelvic organs. Laparoscopy (eight RCTs) and laparotomy (11 RCTs) were the primary surgical techniques. Indications for surgery included myomectomy (seven RCTs), ovarian surgery (five RCTs), pelvic adhesions (five RCTs), endometriosis (one RCT), and mixed gynaecological surgery (one RCT). The sole indication for surgery in three of the RCTs was infertility. Thirteen RCTs reported commercial funding; the rest did not state their source of funding.\nNo studies reported our primary outcomes of pelvic pain and live birth rate.\nOxidised regenerated cellulose versus no treatment at laparoscopy or laparotomy (13 RCTs)\nAt second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose at laparoscopy reduced the incidence of de novo adhesions (OR 0.50, 95% CI 0.30 to 0.83, 3 RCTs, 360 participants; I² = 75%; very low-quality evidence) or of re-formed adhesions (OR 0.17, 95% CI 0.07 to 0.41, 3 RCTs, 100 participants; I² = 36%; very low-quality evidence).\nAt second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose affected the incidence of de novo adhesions after laparotomy (OR 0.72, 95% CI 0.42 to 1.25, 1 RCT, 271 participants; very low-quality evidence). However, the incidence of re-formed adhesions may have been reduced in the intervention group (OR 0.38, 95% CI 0.27 to 0.55, 6 RCTs, 554 participants; I² = 41%; low-quality evidence).\nNo studies reported results on pelvic pain, live birth rate, adhesion score, or clinical pregnancy rate.\nExpanded polytetrafluoroethylene versus oxidised regenerated cellulose at gynaecological surgery (two RCTs)\nWe are uncertain whether expanded polytetrafluoroethylene reduced the incidence of de novo adhesions at second-look laparoscopy (OR 0.93, 95% CI 0.26 to 3.41, 38 participants; very low-quality evidence). We are also uncertain whether expanded polytetrafluoroethylene resulted in a lower adhesion score (out of 11) (MD -3.79, 95% CI -5.12 to -2.46, 62 participants; very low-quality evidence) or a lower risk of re-formed adhesions (OR 0.13, 95% CI 0.02 to 0.80, 23 participants; very low-quality evidence) when compared with oxidised regenerated cellulose.\nNo studies reported results regarding pelvic pain, live birth rate, or clinical pregnancy rate.\nCollagen membrane with polyethylene glycol and glycerol versus no treatment at gynaecological surgery (one RCT)\nEvidence suggests that collagen membrane with polyethylene glycol and glycerol may reduce the incidence of adhesions at second-look laparoscopy (OR 0.04, 95% CI 0.00 to 0.77, 47 participants; low-quality evidence). We are uncertain whether collagen membrane with polyethylene glycol and glycerol improved clinical pregnancy rate (OR 5.69, 95% CI 1.38 to 23.48, 39 participants; very low-quality evidence).\nOne study reported adhesion scores but reported them as median scores rather than mean scores (median score 0.8 in the treatment group vs median score 1.2 in the control group) and therefore could not be included in the meta-analysis. The reported P value was 0.230, and no evidence suggests a difference between treatment and control groups.\nNo studies reported results regarding pelvic pain or live birth rate.\nIn total, 15 of the 19 RCTs included in this review reported adverse events. No events directly attributed to adhesion agents were reported.\nAuthors' conclusions\nWe found no evidence on the effects of barrier agents used during pelvic surgery on pelvic pain or live birth rate in women of reproductive age because no trial reported these outcomes.\nIt is difficult to draw credible conclusions due to lack of evidence and the low quality of included studies. Given this caveat, low-quality evidence suggests that collagen membrane with polyethylene glycol plus glycerol may be more effective than no treatment in reducing the incidence of adhesion formation following pelvic surgery. Low-quality evidence also shows that oxidised regenerated cellulose may reduce the incidence of re-formation of adhesions when compared with no treatment at laparotomy. It is not possible to draw conclusions on the relative effectiveness of these interventions due to lack of evidence.\nNo adverse events directly attributed to the adhesion agents were reported. The quality of the evidence ranged from very low to moderate. Common limitations were imprecision and poor reporting of study methods. Most studies were commercially funded, and publication bias could not be ruled out.\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 most common limitations were imprecision (few participants and wide confidence intervals) and poor reporting of study methods. Most studies were commercially funded, and publication bias could not be ruled out." } ]
query-laysum	21587	[ { "role": "user", "content": "Abstract: Background\nPaediatric flat feet are a common presentation in primary care; reported prevalence approximates 15%. A minority of flat feet can hurt and limit gait. There is no optimal strategy, nor consensus, for using foot orthoses (FOs) to treat paediatric flat feet.\nObjectives\nTo assess the benefits and harms of foot orthoses for treating paediatric flat feet.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase to 01 September 2021, and two clinical trials registers on 07 August 2020.\nSelection criteria\nWe identified all randomised controlled trials (RCTs) of FOs as an intervention for paediatric flat feet. The outcomes included in this review were pain, function, quality of life, treatment success, and adverse events. Intended comparisons were: any FOs versus sham, any FOs versus shoes, customised FOs (CFOs) versus prefabricated FOs (PFOs).\nData collection and analysis\nWe followed standard methods recommended by Cochrane.\nMain results\nWe included 16 trials with 1058 children, aged 11 months to 19 years, with flexible flat feet. Distinct flat foot presentations included asymptomatic, juvenile idiopathic arthritis (JIA), symptomatic and developmental co-ordination disorder (DCD). The trial interventions were FOs, footwear, foot and rehabilitative exercises, and neuromuscular electrical stimulation (NMES). Due to heterogeneity, we did not pool the data. Most trials had potential for selection, performance, detection, and selective reporting bias. No trial blinded participants. We present the results separately for asymptomatic (healthy children) and symptomatic (children with JIA) flat feet.\nThe certainty of evidence was very low to low, downgraded for bias, imprecision, and indirectness.\nThree comparisons were evaluated across trials: CFO versus shoes; PFO versus shoes; CFO versus PFO.\nAsymptomatic flat feet\n1. CFOs versus shoes (1 trial, 106 participants): low-quality evidence showed that CFOs result in little or no difference in the proportion without pain (10-point visual analogue scale (VAS)) at one year (risk ratio (RR) 0.85, 95% confidence interval (CI) 0.67 to 1.07); absolute decrease (11.8%, 95% CI 4.7% fewer to 15.8% more); or on withdrawals due to adverse events (RR 1.05, 95% CI 0.94 to 1.19); absolute effect (3.4% more, 95% CI 4.1% fewer to 13.1% more).\n2. PFOs versus shoes (1 trial, 106 participants): low to very-low quality evidence showed that PFOs result in little or no difference in the proportion without pain (10-point VAS) at one year (RR 0.94, 95% CI 0.76 to 1.16); absolute effect (4.7% fewer, 95% CI 18.9% fewer to 12.6% more); or on withdrawals due to adverse events (RR 0.99, 95% CI 0.79 to 1.23).\n3. CFOs versus PFOs (1 trial, 108 participants): low-quality evidence found no difference in the proportion without pain at one year (RR 0.93, 95% CI 0.73 to 1.18); absolute effect (7.4% fewer, 95% CI 22.2% fewer to 11.1% more); or on withdrawal due to adverse events (RR 1.00, 95% CI 0.90 to 1.12).\nFunction and quality of life (QoL) were not assessed.\nSymptomatic (JIA) flat feet\n1. CFOs versus shoes (1 trial, 28 participants, 3-month follow-up): very low-quality evidence showed little or no difference in pain (0 to 10 scale, 0 no pain) between groups (MD -1.5, 95% CI -2.78 to -0.22). Low-quality evidence showed improvements in function with CFOs (Foot Function Index - FFI disability, 0 to 100, 0 best function; MD -18.55, 95% CI -34.42 to -2.68), child-rated QoL (PedsQL, 0 to 100, 100 best quality; MD 12.1, 95% CI -1.6 to 25.8) and parent-rated QoL (PedsQL MD 9, 95% CI -4.1 to 22.1) and little or no difference between groups in treatment success (timed walking; MD -1.33 seconds, 95% CI -2.77 to 0.11), or withdrawals due to adverse events (RR 0.58, 95% CI 0.11 to 2.94); absolute difference (9.7% fewer, 20.5 % fewer to 44.8% more).\n2. PFOs versus shoes (1 trial, 25 participants, 3-month follow-up): very low-quality evidence showed little or no difference in pain between groups (MD 0.02, 95% CI -1.94 to 1.98). Low-quality evidence showed no difference between groups in function (FFI-disability MD -4.17, 95% CI -24.4 to 16.06), child-rated QoL (PedsQL MD -3.84, 95% CI -19 to 11.33), or parent-rated QoL (PedsQL MD -0.64, 95% CI -13.22 to 11.94).\n3. CFOs versus PFOs (2 trials, 87 participants): low-quality evidence showed little or no difference between groups in pain (0 to 10 scale, 0 no pain) at 3 months (MD -1.48, 95% CI -3.23 to 0.26), function (FFI-disability MD -7.28, 95% CI -15.47 to 0.92), child-rated QoL (PedsQL MD 8.6, 95% CI -3.9 to 21.2), or parent-rated QoL (PedsQL MD 2.9, 95% CI -11 to 16.8).\nAuthors' conclusions\nLow to very low-certainty evidence shows that the effect of CFOs (high cost) or PFOs (low cost) versus shoes, and CFOs versus PFOs on pain, function and HRQoL is uncertain. This is pertinent for clinical practice, given the economic disparity between CFOs and PFOs. FOs may improve pain and function, versus shoes in children with JIA, with minimal delineation between costly CFOs and generic PFOs.\nThis review updates that from 2010, confirming that in the absence of pain, the use of high-cost CFOs for healthy children with flexible flat feet has no supporting evidence, and draws very limited conclusions about FOs for treating paediatric flat feet.\nThe availability of normative and prospective foot development data, dismisses most flat foot concerns, and negates continued attention to this topic. Attention should be re-directed to relevant paediatric foot conditions, which cause pain, limit function, or reduce quality of life. The agenda for researching asymptomatic flat feet in healthy children must be relegated to history, and replaced by a targeted research rationale, addressing children with indisputable foot pathology from discrete diagnoses, namely JIA, cerebral palsy, congenital talipes equino varus, trisomy 21 and Charcot Marie Tooth. Whether research resources should continue to be wasted on studying flat feet in healthy children that do not hurt, is questionable. Future updates of this review will address only relevant paediatric foot conditions.\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": "This Cochrane Review is current to September 2021. There are 16 studies (1058 children, aged 11 months to 19 years) including three groups - healthy children with painless flat feet; children with arthritis and painful flat feet; others (developmental coordination disorder; painful flat feet). The studies were conducted across the USA, Australia, India, Iran, Turkey, UK, and Republic of Korea. We found information about footwear, exercises, and different types of foot orthoses." } ]
query-laysum	21588	[ { "role": "user", "content": "Abstract: Background\nDown's syndrome occurs when a person has three, rather than two copies of chromosome 21; or the specific area of chromosome 21 implicated in causing Down's syndrome. It is the commonest congenital cause of mental disability and also leads to numerous metabolic and structural problems. It can be life-threatening, or lead to considerable ill health, although some individuals have only mild problems and can lead relatively normal lives. Having a baby with Down’s syndrome is likely to have a significant impact on family life.\nNoninvasive screening based on biochemical analysis of maternal serum or urine, or fetal ultrasound measurements, allows estimates of the risk of a pregnancy being affected and provides information to guide decisions about definitive testing. However, no test can predict the severity of problems a person with Down’s syndrome will have.\nObjectives\nThe aim of this review was to estimate and compare the accuracy of first trimester serum markers for the detection of Down’s syndrome in the antenatal period, both as individual markers and as combinations of markers. Accuracy is described by the proportion of fetuses with Down’s syndrome detected by screening before birth (sensitivity or detection rate) and the proportion of women with a low risk (normal) screening test result who subsequently had a baby unaffected by Down's syndrome (specificity).\nSearch methods\nWe conducted a sensitive and comprehensive literature search of MEDLINE (1980 to 25 August 2011), Embase (1980 to 25 August 2011), BIOSIS via EDINA (1985 to 25 August 2011), CINAHL via OVID (1982 to 25 August 2011), The Database of Abstracts of Reviews of Effectiveness (The Cochrane Library 25 August 2011), MEDION (25 August 2011), The Database of Systematic Reviews and Meta-Analyses in Laboratory Medicine (25 August 2011), The National Research Register (Archived 2007), Health Services Research Projects in Progress database (25 August 2011). We did forward citation searching ISI citation indices, Google Scholar and PubMed ‘related articles’. We did not apply a diagnostic test search filter. We also searched reference lists and published review articles.\nSelection criteria\nWe included studies in which all women from a given population had one or more index test(s) compared to a reference standard (either chromosomal verification or macroscopic postnatal inspection). Both consecutive series and diagnostic case-control study designs were included. Randomised trials where individuals were randomised to different screening strategies and all verified using a reference standard were also eligible for inclusion. Studies in which test strategies were compared head-to-head either in the same women, or between randomised groups were identified for inclusion in separate comparisons of test strategies. We excluded studies if they included less than five Down's syndrome cases, or more than 20% of participants were not followed up.\nData collection and analysis\nWe extracted data as test positive or test negative results for Down's and non-Down's pregnancies allowing estimation of detection rates (sensitivity) and false positive rates (1-specificity). We performed quality assessment according to QUADAS (Quality Assessment of Diagnostic Accuracy Studies) criteria. We used hierarchical summary ROC meta-analytical methods or random-effects logistic regression methods to analyse test performance and compare test accuracy as appropriate. Analyses of studies allowing direct and indirect comparisons between tests were undertaken.\nMain results\nWe included 56 studies (reported in 68 publications) involving 204,759 pregnancies (including 2113 with Down's syndrome). Studies were generally of good quality, although differential verification was common with invasive testing of only high-risk pregnancies. We evaluated 78 test combinations formed from combinations of 18 different tests, with or without maternal age; ADAM12 (a disintegrin and metalloprotease), AFP (alpha-fetoprotein), inhibin, PAPP-A (pregnancy-associated plasma protein A, ITA (invasive trophoblast antigen), free βhCG (beta human chorionic gonadotrophin), PlGF (placental growth factor), SP1 (Schwangerschafts protein 1), total hCG, progesterone, uE3 (unconjugated oestriol), GHBP (growth hormone binding protein), PGH (placental growth hormone), hyperglycosylated hCG, ProMBP (proform of eosinophil major basic protein), hPL (human placental lactogen), (free αhCG, and free ßhCG to AFP ratio. Direct comparisons between two or more tests were made in 27 studies.\nMeta-analysis of the nine best performing or frequently evaluated test combinations showed that a test strategy involving maternal age and a double marker combination of PAPP-A and free ßhCG significantly outperformed the individual markers (with or without maternal age) detecting about seven out of every 10 Down's syndrome pregnancies at a 5% false positive rate (FPR). Limited evidence suggested that marker combinations involving PAPP-A may be more sensitive than those without PAPP-A.\nAuthors' conclusions\nTests involving two markers in combination with maternal age, specifically PAPP-A, free βhCG and maternal age are significantly better than those involving single markers with and without age. They detect seven out of 10 Down's affected pregnancies for a fixed 5% FPR. The addition of further markers (triple tests) has not been shown to be statistically superior; the studies included are small with limited power to detect a difference.\nThe screening blood tests themselves have no adverse effects for the woman, over and above the risks of a routine blood test. However some women who have a ‘high risk’ screening test result, and are given amniocentesis or chorionic villus sampling (CVS) have a risk of miscarrying a baby unaffected by Down’s. Parents will need to weigh up this risk when deciding whether or not to have an amniocentesis or CVS following a ‘high risk’ screening test result.\n\nGiven the provided abstract, please respond to the following query: \"What we did\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The aim of this review was to find out which of the blood screening tests done during the first three months of pregnancy are the most accurate at predicting the risk of a pregnancy being affected by Down's. We looked at 18 different blood markers that can be used alone or in combination, taken before 14 weeks gestation, thus creating 78 screening tests fro Down’s. We found 56 studies, involving 204,759 pregnancies of which 2113 had pregnancies affected by Down's." } ]
query-laysum	21589	[ { "role": "user", "content": "Abstract: Background\nMany palliative care patients have a reduced oral intake during their illness. The management of this can include the provision of medically assisted nutrition with the aim of prolonging the length of life of a patient, improving their quality of life, or both. This is an updated version of the original Cochrane review published in Issue 4, 2008.\nObjectives\nTo determine the effect of medically assisted nutrition on the quality and length of life of palliative care patients.\nSearch methods\nWe identified studies from searching Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, CANCERLIT, Caresearch, Dissertation abstracts, SCIENCE CITATION INDEX and the reference lists of all eligible trials, key textbooks and previous systematic reviews. The date of the latest search was 26 March 2014.\nSelection criteria\nAll relevant randomised controlled trials (RCTs) or prospective controlled trials (if no RCTs were found).\nData collection and analysis\nWe found no RCTs or prospectively controlled trials that met the inclusion criteria.\nMain results\nThe original review identified four prospective non-controlled trials and the updated search in 2014 identified one more (plus an updated version of a Cochrane review on enteral feeding in motor neuron disease). There were five prospective non-controlled trials (including one qualitative study) that studied medically assisted nutrition in palliative care participants, and one Cochrane systematic review (on motor neuron disease that found no RCTs), but no RCTs or prospective controlled studies.\nAuthors' conclusions\nSince the last version of this review, we found no new studies. There are insufficient good-quality trials to make any recommendations for practice with regards to the use of medically assisted nutrition in palliative care patients.\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": "It is common for palliative care patients to have reduced oral intake during their illness. Management of this condition includes discussion with the patient, family and staff involved, and may include giving nutrition with medical assistance. This can be done either via a plastic tube inserted directly into a vein or into the stomach or other parts of the gastrointestinal tract. It is unknown whether this treatment helps people to feel better or live longer." } ]
query-laysum	21590	[ { "role": "user", "content": "Abstract: Background\nTotal hip arthroplasty (THA) is one of the most common orthopaedic operations performed worldwide. Painful osteoarthritis of the hip is the primary indication for THA. Following THA, people have conventionally been provided with equipment, such as raised toilet seats and chairs, and educated to avoid activities that could cause the hip joint to be in a position of flexion over 90 degrees, or adduction or rotation past the midline. These aspects of occupational therapy have been advocated to reduce the risks of prosthesis dislocation. However, the appropriateness of these recommendations has been questioned.\nObjectives\nTo assess the effects of provision of assistive devices, education on hip precautions, environmental modifications and training in activities of daily living (ADL) and extended ADL (EADL) for people undergoing THA.\nSearch methods\nWe searched MEDLINE (1946 to April 2016), EMBASE (1947 to April 2016), the Cochrane Library including CENTRAL (Issue 4 of 12, 2016), Database of Reviews of Effects (DARE), Health Technology Assessment (HTA), Economic Evaluations Database (EED), CINAHL, PEDro and CIRRIE from inception to April 2016. In addition we checked Controlled Clinical Trials, Clinicaltrials.gov, the National Institutes of Health Trial Registry, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and the OpenGrey database from inception to April 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs and cluster-RCTs that evaluated the effectiveness of the provision of assistive devices, education on hip precautions, environmental modifications, or training in ADL and EADL for people undergoing THA. The main outcomes of interest were pain, function, health-related quality of life (HRQOL), global assessment of treatment success, reoperation rate, hip dislocation and adverse events.\nData collection and analysis\nWe used standard methodological procedures recognised by Cochrane. We conducted a systematic literature search using several databases and contacted corresponding authors, appraised the evidence using the Cochrane risk of bias tool, analysed the data using a narrative analysis approach (as it was not possible to conduct a meta-analysis due to heterogeneity in interventions), and interpreted all outcomes using the GRADE approach.\nMain results\nWe included three trials with a total of 492 participants who had received 530 THA. The evidence presented with a high risk of performance, detection and reporting bias.\nOne study (81 participants) compared outcomes for participants randomised to the provision of hip precautions, equipment and functional restrictions versus no provision of hip precautions, equipment or functional restrictions. Due to the quality of evidence being very low, we are uncertain if the provision of hip precautions, equipment and functional restrictions improved function measured using the Harris Hip Score at 12 month follow-up, or health-related quality of life (HRQOL) measured by the Short Form-12 at four week follow-up, compared to not providing this. There were no incidences of hip dislocation or adverse events in either group during the initial 12 postoperative months. The study did not measure pain score, global assessment of treatment success or total adverse events.\nOne study (265 participants; 303 THAs) evaluated the provision of hip precautions with versus without the prescription of postoperative equipment and restrictions to functional activities. Due to the quality of evidence being very low, we are uncertain if perceived satisfaction in the rate of recovery differed in people who were not prescribed postoperative equipment and restrictions (135/151 satisfied) compared to those prescribed equipment and restrictions (113/152) (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.75 to 0.93; 265 participants, one trial; number needed to treat for an additional beneficial outcome (NNTB) = 7). Due to the low quality evidence, we are uncertain if the incidence of hip dislocation differed between participants provided with hip precautions with (1/152) compared to without providing equipment or restrictions post-THA (0/151) (RR 2.98, 95% CI 0.12 to 72.59). The study did not measure pain, function, HRQOL, re-operation rates or total adverse events.\nOne study (146 participants) investigated the provision of an enhanced postoperative education and rehabilitation service on hospital discharge to promote functional ADL versus a conventional rehabilitation intervention in the community. This study was of very low quality evidence. We were uncertain if the provision of enhanced postoperative education and rehabilitation improved function at six months follow-up, when assessed using the Objective and Subjective Functional Capability Index (146 participants, one trial; P > 0.05; no numerical results provided) compared to conventional rehabilitation. The study did not measure pain score, HRQOL, global assessment of treatment success, hip dislocation, re-operation rate or total adverse events.\nAuthors' conclusions\nVery low quality evidence is available from single trials, thus we are uncertain if hip precautions with or without the addition of equipment and functional restrictions are effective in preventing dislocation and improving outcomes after THA. There is also insufficient evidence to support or refute the adoption of a postoperative community rehabilitation programme consisting of functional reintegration and education compared to conventional rehabilitation strategies based on functional outcomes.\nFurther high-quality trials are warranted to assess the outcomes of different occupational therapy interventions both in the short and longer-term for those who undergo THA. An assessment of the impact of such interventions on pain and restriction on personal ADL, EADL and instrumental ADL is needed, and also of functional integration-type interventions rather than just hip precautions, equipment and restrictions.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the quality of the evidence. Due to issues relating to the small number of participants, size of studies and study conduct, including poorly blinding assessors to group allocation, we rated the quality of the evidence as 'very low'. Further research is highly likely to change the conclusions drawn from these results. We are uncertain whether the interventions improved outcomes." } ]
query-laysum	21591	[ { "role": "user", "content": "Abstract: Background\nOpen-angle glaucoma (OAG) is an important cause of blindness worldwide. Laser trabeculoplasty, a treatment modality, still does not have a clear position in the treatment sequence.\nObjectives\nTo assess the effects of laser trabeculoplasty for treating OAG and ocular hypertension (OHT) when compared to medication, glaucoma surgery or no intervention. We also wished to compare the effectiveness of different laser trabeculoplasty technologies for treating OAG and OHT.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2021, Issue 10); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; LILACS, ClinicalTrials.gov and the WHO ICTRP. The date of the search was 28 October 2021. We also contacted researchers in the field.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing laser trabeculoplasty with no intervention, with medical treatment, or with surgery in people with OAG or OHT. We also included trials comparing different types of laser trabeculoplasty technologies.\nData collection and analysis\nWe used standard methods expected by Cochrane. Two authors screened search results and extracted data independently. We considered the following outcomes at 24 months: failure to control intraocular pressure (IOP), failure to stabilise visual field progression, failure to stabilise optic neuropathy progression, adverse effects, quality of life, and costs. We graded the 'certainty' of the evidence using GRADE.\nMain results\nWe included 40 studies (5613 eyes of 4028 people) in this review. The majority of the studies were conducted in Europe and in the USA. Most of the studies were at risk of performance and/or detection bias as they were unmasked. None of the studies were judged as having low risk of bias for all domains. We did not identify any studies of laser trabeculoplasty alone versus no intervention.\nLaser trabeculoplasty versus medication\nFourteen studies compared laser trabeculoplasty with medication in either people with primary OAG (7 studies) or primary or secondary OAG (7 studies); five of the 14 studies also included participants with OHT. Six studies used argon laser trabeculoplasty and eight studies used selective laser trabeculoplasty. There was considerable clinical and methodological diversity in these studies leading to statistical heterogeneity in results for the primary outcome \"failure to control IOP\" at 24 months. Risk ratios (RRs) ranged from 0.43 in favour of laser trabeculoplasty to 1.87 in favour of medication (5 studies, I2 = 89%). Studies of argon laser compared with medication were more likely to show a beneficial effect compared with studies of selective laser (test for interaction P = 0.0001) but the argon laser studies were older and the medication comparator group in those studies may have been less effective. We considered this to be low-certainty evidence because the trials were at risk of bias (they were not masked) and there was unexplained heterogeneity. There was evidence from two studies (624 eyes) that argon laser treatment was associated with less failure to stabilise visual field progression compared with medication (7% versus 11%, RR 0.70, 95% CI 0.42 to 1.16) at 24 months and one further large recent study of selective laser also reported a reduced risk of failure at 48 months (17% versus 26%) RR 0.65, 95% CI 0.52 to 0.81, 1178 eyes). We judged this outcome as moderate-certainty evidence, downgrading for risk of bias. There was only very low-certainty evidence on optic neuropathy progression. Adverse effects were more commonly seen in the laser trabeculoplasty group including peripheral anterior synechiae (PAS) associated with argon laser (32% versus 26%, RR 11.74, 95% CI 5.94 to 23.22; 624 eyes; 2 RCTs; low-certainty evidence); 5% of participants treated with laser in three studies of selective laser group had early IOP spikes (moderate-certainty evidence). One UK-based study provided moderate-certainty evidence that laser trabeculoplasty was more cost-effective.\nLaser trabeculoplasty versus trabeculectomy\nThree studies compared laser trabeculoplasty with trabeculectomy. All three studies enrolled participants with OAG (primary or secondary) and used argon laser. People receiving laser trabeculoplasty may have a higher risk of uncontrolled IOP at 24 months compared with people receiving trabeculectomy (16% versus 8%, RR 2.12, 95% CI 1.44 to 3.11; 901 eyes; 2 RCTs). We judged this to be low-certainty evidence because of risk of bias (trials were not masked) and there was inconsistency between the two trials (I2 = 68%). There was limited evidence on visual field progression suggesting a higher risk of failure with laser trabeculoplasty. There was no information on optic neuropathy progression, quality of life or costs. PAS formation and IOP spikes were not reported but in one study trabeculectomy was associated with an increased risk of cataract (RR 1.78, 95% CI 1.46 to 2.16) (very low-certainty evidence).\nAuthors' conclusions\nLaser trabeculoplasty may work better than topical medication in slowing down the progression of open-angle glaucoma (rate of visual field loss) and may be similar to modern eye drops in controlling eye pressure at a lower cost. It is not associated with serious unwanted effects, particularly for the newer types of trabeculoplasty, such as selective laser trabeculoplasty.\n\nGiven the provided abstract, please respond to the following query: \"What is open-angle glaucoma?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Glaucoma is an eye disease where the nerve that connects the eye to the brain (optic nerve) is damaged. Usually, this happens because the pressure inside the eye (intraocular pressure) is too high, probably because the drainage channels in the eye have become blocked." } ]
query-laysum	21592	[ { "role": "user", "content": "Abstract: Background\nPeriodontal disease and dental caries are highly prevalent oral diseases that can lead to pain and discomfort, oral hygiene and aesthetic problems, and eventually tooth loss, all of which can be costly to treat and are a burden to healthcare systems. Triclosan is an antibacterial agent with low toxicity, which, along with a copolymer for aiding retention, can be added to toothpastes to reduce plaque and gingivitis (inflammation of the gums). It is important that these additional ingredients do not interfere with the anticaries effect of the fluoride present in toothpastes, and that they are safe.\nObjectives\nTo assess the effects of triclosan/copolymer containing fluoride toothpastes, compared with fluoride toothpastes, for the long-term control of caries, plaque and gingivitis in children and adults.\nSearch methods\nWe searched the Cochrane Oral Health's Trials Register (to 19 August 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 7), MEDLINE via OVID (1946 to 19 August 2013), Embase via OVID (1980 to 19 August 2013), and the US National Institutes of Health Trials Register (clinicaltrials.gov) (to 19 August 2013). We applied no restrictions regarding language or date of publication in the searches of the electronic databases.\nSelection criteria\nWe included randomised controlled trials (RCTs) assessing the effects triclosan/copolymer containing toothpastes on oral health.\nData collection and analysis\nTwo review authors independently assessed the search results against the inclusion criteria for this review, extracted data and carried out risk of bias assessments. We attempted to contact study authors for missing information or clarification when feasible. We combined sufficiently similar studies in meta-analyses using random-effects models when there were at least four studies (fixed-effect models when fewer than four studies), reporting mean differences (MD) for continuous data and risk ratios (RR) for dichotomous data.\nMain results\nWe included 30 studies, analysing 14,835 participants, in this review. We assessed 10 studies (33%) as at low risk of bias, nine (30%) as at high risk of bias and 11 (37%) as unclear.\nPlaque\nCompared with control, after six to seven months of use, triclosan/copolymer toothpaste reduced plaque by 0.47 on a 0 to 5 scale (MD -0.47, 95% confidence interval (CI) -0.60 to -0.34, 20 studies, 2675 participants, moderate-quality evidence). The control group mean was 2.17, representing a 22% reduction in plaque. After six to seven months of use, it also reduced the proportion of sites scoring 3 to 5 on a 0 to 5 scale by 0.15 (MD -0.15, 95% CI -0.20 to -0.10, 13 studies, 1850 participants, moderate-quality evidence). The control group mean was 0.37, representing a 41% reduction in plaque severity.\nGingivitis\nAfter six to nine months of use, triclosan/copolymer toothpaste reduced inflammation by 0.27 on a 0 to 3 scale (MD -0.27, 95% CI -0.33 to -0.21, 20 studies, 2743 participants, moderate-quality evidence). The control group mean was 1.22, representing a 22% reduction in inflammation. After six to seven months of use, it reduced the proportion of bleeding sites (i.e. scoring 2 or 3 on the 0 to 3 scale) by 0.13 (MD -0.13, 95% CI -0.17 to -0.08, 15 studies, 1998 participants, moderate-quality evidence). The control group mean was 0.27, representing a 48% reduction in bleeding.\nPeriodontitis\nAfter 36 months of use, there was no evidence of a difference between triclosan/copolymer toothpaste and control in the development of periodontitis (attachment loss) (RR 0.92, 95% CI 0.67 to 1.27, one study, 480 participants, low-quality evidence).\nCaries\nAfter 24 to 36 months of use, triclosan/copolymer toothpaste slightly reduced coronal caries when using the decayed and filled surfaces (DFS) index (MD -0.16, 95% CI -0.31 to -0.02, four studies, 9692 participants, high-quality evidence). The control group mean was 3.44, representing a 5% reduction in coronal caries. After 36 months of use, triclosan/copolymer toothpaste probably reduced root caries (MD -0.31, 95% CI -0.39 to -0.23, one study, 1357 participants, moderate-quality evidence).\nCalculus\nAfter six months of use, triclosan/copolymer toothpaste may have reduced the mean total calculus per participant by 2.12 mm (MD -2.12 mm, 95% CI -3.39 to -0.84, two studies, 415 participants, low-quality evidence). The control group mean was 14.61 mm, representing a 15% reduction in calculus.\nAdverse effects\nThere were no data available for meta-analysis regarding adverse effects, but 22 studies (73%) reported that there were no adverse effects caused by either the experimental or control toothpaste.\nThere was considerable heterogeneity present in the meta-analyses for plaque, gingivitis and calculus. Plaque and gingivitis showed such consistent results that it did not affect our conclusions, but the reader may wish to interpret the results with more caution.\nAuthors' conclusions\nThere was moderate-quality evidence showing that toothpastes containing triclosan/copolymer, in addition to fluoride, reduced plaque, gingival inflammation and gingival bleeding when compared with fluoride toothpastes without triclosan/copolymer. These reductions may or may not be clinically important, and are evident regardless of initial plaque and gingivitis levels, or whether a baseline oral prophylaxis had taken place or not. High-quality evidence showed that triclosan/copolymer toothpastes lead to a small reduction in coronal caries. There was weaker evidence to show that triclosan/copolymer toothpastes may have reduced root caries and calculus, but insufficient evidence to show whether or not they prevented periodontitis. There do not appear to be any serious safety concerns regarding the use of triclosan/copolymer toothpastes in studies up to three years in duration.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Authors from the Cochrane Oral Health Group carried out this review of existing studies and the evidence is current up to 19 August 2013. It includes 30 studies published from 1990 to 2012 in which 14,835 participants were randomised to receive a triclosan/copolymer containing fluoride toothpaste or a fluoride toothpaste that did not include triclosan/copolymer. The toothpaste that was used in most of the studies is sold by the manufacturer Colgate." } ]
query-laysum	21593	[ { "role": "user", "content": "Abstract: Background\nSmoking bans or restrictions can assist in eliminating nonsmokers' exposure to the dangers of secondhand smoke and can reduce tobacco consumption amongst smokers themselves. Evidence exists identifying the impact of tobacco control regulations and interventions implemented in general workplaces and at an individual level. However, it is important that we also review the evidence for smoking bans at a meso- or organisational level, to identify their impact on reducing the burden of exposure to tobacco smoke. Our review assesses evidence for meso- or organisational-level tobacco control bans or policies in a number of specialist settings, including public healthcare facilities, higher education and correctional facilities.\nObjectives\nTo assess the extent to which institutional smoking bans may reduce passive smoke exposure and active smoking, and affect other health-related outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE, EMBASE, and the reference lists of identified studies. We contacted authors to identify completed or ongoing studies eligible for inclusion in this review. We also checked websites of state agencies and organisations, such as trial registries. Date of latest searches was 22nd June 2015.\nSelection criteria\nWe considered studies that reported the effects of tobacco bans or policies, whether complete or partial, on reducing secondhand smoke exposure, tobacco consumption, smoking prevalence and other health outcomes, in public healthcare, higher educational and correctional facilities, from 2005 onwards.\nThe minimum standard for inclusion was having a settings-level policy or ban implemented in the study, and a minimum of six months follow-up for measures of smoking behaviour. We included quasi-experimental studies (i.e. controlled before-and-after studies), interrupted time series as defined by the Cochrane Effective Practice and Organization of Care Group, and uncontrolled pre- and post-ban data.\nData collection and analysis\nTwo or more review authors independently assessed studies for inclusion in the review. Due to variation in the measurement of outcomes we did not conduct a meta-analysis for all of the studies included in this review, but carried out a Mantel-Haenszel fixed-effect meta-analysis, pooling 11 of the included studies. We evaluated all studies using a qualitative narrative synthesis.\nMain results\nWe included 17 observational studies in this review. We found no randomized controlled trials. Twelve studies are based in hospitals, three in prisons and two in universities. Three studies used a controlled before-and-after design, with another site used for comparison. The remaining 14 studies used an uncontrolled before-and-after study design. Five studies reported evidence from two participant groups, including staff and either patients or prisoners (depending on specialist setting), with the 12 remaining studies investigating only one participant group.\nThe four studies (two in prisons, two in hospitals) providing health outcomes data reported an effect of reduced secondhand smoke exposure and reduced mortality associated with smoking-related illnesses. No studies included in the review measured cotinine levels to validate secondhand smoke exposure. Eleven studies reporting active smoking rates with 12,485 participants available for pooling, but with substantial evidence of statistical heterogeneity (I² = 72%). Heterogeneity was lower in subgroups defined by setting, and provided evidence for an effect of tobacco bans on reducing active smoking rates. An analysis exploring heterogeneity within hospital settings showed evidence of an effect on reducing active smoking rates in both staff (risk ratio (RR) 0.71, 95% confidence interval ( CI) 0.64 to 0.78) and patients (RR 0.86, 95% CI 0.76 to 0.98), but heterogeneity remained in the staff subgroup (I² = 76%). In prisons, despite evidence of reduced mortality associated with smoking-related illnesses in two studies, there was no evidence of effect on active smoking rates (1 study, RR 0.99, 95% CI 0.84 to 1.16).\nWe judged the quality of the evidence to be low, using the GRADE approach, as the included studies are all observational.\nAuthors' conclusions\nWe found evidence of an effect of settings-based smoking policies on reducing smoking rates in hospitals and universities. In prisons, reduced mortality rates and reduced exposure to secondhand smoke were reported. However, we rated the evidence base as low quality. We therefore need more robust studies assessing the evidence for smoking bans and policies in these important specialist settings.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We grouped together 11 of the included studies, involving 12,485 people, and found that banning smoking in hospitals and universities increased the number of smoking quit attempts and reduced the number of people smoking. In prisons, there was a reduction in the number of people who died from diseases related to smoking and a reduction in exposure to secondhand smoke after policies and bans were introduced, but there was no evidence of reduced smoking rates." } ]
query-laysum	21595	[ { "role": "user", "content": "Abstract: Background\nPneumonia is the most common hospital-acquired infection affecting patients in the intensive care unit (ICU). However, current national guidelines for the treatment of hospital-acquired pneumonia (HAP) are several years old and the diagnosis of pneumonia in mechanically ventilated patients (VAP) has been subject to considerable recent attention. The optimal duration of antibiotic therapy for HAP in the critically ill is uncertain.\nObjectives\nTo assess the effectiveness of short versus prolonged-course antibiotics for HAP in critically ill adults, including patients with VAP.\nSearch methods\nWe searched CENTRAL (2015, Issue 5), MEDLINE (1946 to June 2015), MEDLINE in-process and other non-indexed citations (5 June 2015), EMBASE (2010 to June 2015), LILACS (1982 to June 2015) and Web of Science (1955 to June 2015).\nSelection criteria\nWe considered all randomised controlled trials (RCTs) comparing a fixed 'short' duration of antibiotic therapy with a 'prolonged' course for HAP (including patients with VAP) in critically ill adults.\nData collection and analysis\nTwo review authors conducted data extraction and assessment of risk of bias. We contacted trial authors for additional information.\nMain results\nWe identified six relevant studies involving 1088 participants. This included two new studies published after the date of our previous review (2011). There was substantial variation in participants, in the diagnostic criteria used to define an episode of pneumonia, in the interventions and in the reported outcomes. We found no evidence relating to patients with a high probability of HAP who were not mechanically ventilated. For patients with VAP, overall a short seven- or eight-day course of antibiotics compared with a prolonged 10- to 15-day course increased 28-day antibiotic-free days (two studies; N = 431; mean difference (MD) 4.02 days; 95% confidence interval (CI) 2.26 to 5.78) and reduced recurrence of VAP due to multi-resistant organisms (one study; N = 110; odds ratio (OR) 0.44; 95% CI 0.21 to 0.95), without adversely affecting mortality and other recurrence outcomes. However, for cases of VAP specifically due to non-fermenting Gram-negative bacilli (NF-GNB), recurrence was greater after short-course therapy (two studies, N = 176; OR 2.18; 95% CI 1.14 to 4.16), though mortality outcomes were not significantly different. One study found that a three-day course of antibiotic therapy for patients with suspected HAP but a low Clinical Pulmonary Infection Score (CPIS) was associated with a significantly lower risk of superinfection or emergence of antimicrobial resistance, compared with standard (prolonged) course therapy.\nAuthors' conclusions\nOn the basis of a small number of studies and appreciating the lack of uniform definition of pneumonia, we conclude that for patients with VAP not due to NF-GNB a short, fixed course (seven or eight days) of antibiotic therapy appears not to increase the risk of adverse clinical outcomes, and may reduce the emergence of resistant organisms, compared with a prolonged course (10 to 15 days). However, for patients with VAP due to NF-GNB, there appears to be a higher risk of recurrence following short-course therapy. These findings do not differ from those of our previous review and are broadly consistent with current guidelines. There are few data from RCTs comparing durations of therapy in non-ventilated patients with HAP, but on the basis of a single study, short-course (three-day) therapy for HAP appears not to be associated with worse clinical outcome, and may reduce the risk of subsequent infection or the emergence of resistant organisms when there is low probability of pneumonia according to the CPIS.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "For patients with VAP, our main finding was that a course of seven or eight days of antibiotics was associated with an overall decrease in antibiotic administration and reduced the recurrence of pneumonia due to resistant organisms when compared with a 10- to 15-day course. Furthermore, this was achieved without any significant effect on mortality. Nevertheless, in cases when VAP was due to a particular type of organism ('non-fermenting Gram-negative bacillus'), which can be difficult to eradicate with antibiotics, the risk of pneumonia recurring appeared higher after a short course of treatment.\nOne study found that for patients with possible (but low probability) HAP a short (three-day) course of therapy seemed to be associated with a lower chance of acquiring resistant organisms or of subsequent infections being due to a resistant organism." } ]
query-laysum	21596	[ { "role": "user", "content": "Abstract: Background\nPhysical conditioning as part of a return to work strategy aims to improve work status for workers on sick leave due to back pain. This is the second update of a Cochrane Review (originally titled 'Work conditioning, work hardening and functional restoration for workers with back and neck pain') first published in 2003, updated in 2010, and updated again in 2013.\nObjectives\nTo assess the effectiveness of physical conditioning as part of a return to work strategy in reducing time lost from work and improving work status for workers with back pain. Further, to assess which aspects of physical conditioning are related to a faster return to work for workers with back pain.\nSearch methods\nWe searched the following databases to March 2012: CENTRAL, MEDLINE (from 1966), EMBASE (from 1980), CINAHL (from 1982), PsycINFO (from 1967), and PEDro.\nSelection criteria\nRandomized controlled trials (RCTs) and cluster RCTs that studied workers with work disability related to back pain and who were included in physical conditioning programmes.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias. We used standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included 41 articles reporting on 25 RCTs with 4404 participants. Risk of bias was low in 16 studies.\nThree studies involved workers with acute back pain, eight studies workers with subacute back pain, and 14 studies workers with chronic back pain.\nIn 14 studies, physical conditioning as part of a return to work strategy was compared to usual care. The physical conditioning mostly consisted of graded activity with work-related exercises aimed at increasing back strength and flexibility, together with a set date for return to work. The programmes were divided into a light version with a maximum of five sessions, or an intense version with more than five sessions up to full time or as inpatient treatment.\nFor acute back pain, there was low quality evidence that both light and intense physical conditioning programmes made little or no difference in sickness absence duration compared with care as usual at three to 12 months follow-up (3 studies with 340 workers).\nFor subacute back pain, the evidence on the effectiveness of intense physical conditioning combined with care as usual compared to usual care alone was conflicting (four studies with 395 workers). However, subgroup analysis showed low quality evidence that if the intervention was executed at the workplace, or included a workplace visit, it may have reduced sickness absence duration at 12 months follow-up (3 studies with 283 workers; SMD -0.42, 95% CI -0.65 to -0.18).\nFor chronic back pain, there was low quality evidence that physical conditioning as part of integrated care management in addition to usual care may have reduced sickness absence days compared to usual care at 12 months follow-up (1 study, 134 workers; SMD -4.42, 95% CI -5.06 to -3.79). What part of the integrated care management was most effective remained unclear. There was moderate quality evidence that intense physical conditioning probably reduced sickness absence duration only slightly compared with usual care at 12 months follow-up (5 studies, 1093 workers; SMD -0.23, 95% CI -0.42 to -0.03).\nPhysical conditioning compared to exercise therapy showed conflicting results for workers with subacute and chronic back pain. Cognitive behavioural therapy was probably not superior to physical conditioning as an alternative or in addition to physical conditioning.\nAuthors' conclusions\nThe effectiveness of physical conditioning as part of a return to work strategy in reducing sick leave for workers with back pain, compared to usual care or exercise therapy, remains uncertain. For workers with acute back pain, physical conditioning may have no effect on sickness absence duration. There is conflicting evidence regarding the reduction of sickness absence duration with intense physical conditioning versus usual care for workers with subacute back pain. It may be that including workplace visits or execution of the intervention at the workplace is the component that renders a physical conditioning programme effective. For workers with chronic back pain physical conditioning has a small effect on reducing sick leave compared to care as usual after 12 months follow-up. To what extent physical conditioning as part of integrated care management may alter the effect on sick leave for workers with chronic back pain needs further research.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The main goal of physical conditioning as part of a return to work strategy, sometimes called work conditioning, work hardening or functional restoration and exercise programmes, is to return injured or disabled workers to work or improve the work status for workers performing modified duties. Such programmes may also simulate or duplicate work or functional tasks, or both, using exercises in a safe, supervised environment. These exercises or tasks are structured and progressively graded to increase psychological, physical and emotional tolerance and to improve endurance and work feasibility. In such environments, injured workers improve their general physical condition through an exercise programme aimed at increasing strength, endurance, flexibility and cardiovascular fitness. We wanted to discover whether physical conditioning was more or less effective than usual care and other types of interventions like exercise therapy." } ]
query-laysum	21597	[ { "role": "user", "content": "Abstract: Background\nImproving mobility outcomes after hip fracture is key to recovery. Possible strategies include gait training, exercise and muscle stimulation. This is an update of a Cochrane Review last published in 2011.\nObjectives\nTo evaluate the effects (benefits and harms) of interventions aimed at improving mobility and physical functioning after hip fracture surgery in adults.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, trial registers and reference lists, to March 2021.\nSelection criteria\nAll randomised or quasi-randomised trials assessing mobility strategies after hip fracture surgery. Eligible strategies aimed to improve mobility and included care programmes, exercise (gait, balance and functional training, resistance/strength training, endurance, flexibility, three-dimensional (3D) exercise and general physical activity) or muscle stimulation. Intervention was compared with usual care (in-hospital) or with usual care, no intervention, sham exercise or social visit (post-hospital).\nData collection and analysis\nMembers of the review author team independently selected trials for inclusion, assessed risk of bias and extracted data. We used standard methodological procedures expected by Cochrane. We used the assessment time point closest to four months for in-hospital studies, and the time point closest to the end of the intervention for post-hospital studies. Critical outcomes were mobility, walking speed, functioning, health-related quality of life, mortality, adverse effects and return to living at pre-fracture residence.\nMain results\nWe included 40 randomised controlled trials (RCTs) with 4059 participants from 17 countries. On average, participants were 80 years old and 80% were women. The median number of study participants was 81 and all trials had unclear or high risk of bias for one or more domains. Most trials excluded people with cognitive impairment (70%), immobility and/or medical conditions affecting mobility (72%).\nIn-hospital setting, mobility strategy versus control\nEighteen trials (1433 participants) compared mobility strategies with control (usual care) in hospitals. Overall, such strategies may lead to a moderate, clinically-meaningful increase in mobility (standardised mean difference (SMD) 0.53, 95% confidence interval (CI) 0.10 to 0.96; 7 studies, 507 participants; low-certainty evidence) and a small, clinically meaningful improvement in walking speed (CI crosses zero so does not rule out a lack of effect (SMD 0.16, 95% CI -0.05 to 0.37; 6 studies, 360 participants; moderate-certainty evidence). Mobility strategies may make little or no difference to short-term (risk ratio (RR) 1.06, 95% CI 0.48 to 2.30; 6 studies, 489 participants; low-certainty evidence) or long-term mortality (RR 1.22, 95% CI 0.48 to 3.12; 2 studies, 133 participants; low-certainty evidence), adverse events measured by hospital re-admission (RR 0.70, 95% CI 0.44 to 1.11; 4 studies, 322 participants; low-certainty evidence), or return to pre-fracture residence (RR 1.07, 95% CI 0.73 to 1.56; 2 studies, 240 participants; low-certainty evidence). We are uncertain whether mobility strategies improve functioning or health-related quality of life as the certainty of evidence was very low.\nGait, balance and functional training probably causes a moderate improvement in mobility (SMD 0.57, 95% CI 0.07 to 1.06; 6 studies, 463 participants; moderate-certainty evidence). There was little or no difference in effects on mobility for resistance training. No studies of other types of exercise or electrical stimulation reported mobility outcomes.\nPost-hospital setting, mobility strategy versus control\nTwenty-two trials (2626 participants) compared mobility strategies with control (usual care, no intervention, sham exercise or social visit) in the post-hospital setting. Mobility strategies lead to a small, clinically meaningful increase in mobility (SMD 0.32, 95% CI 0.11 to 0.54; 7 studies, 761 participants; high-certainty evidence) and a small, clinically meaningful improvement in walking speed compared to control (SMD 0.16, 95% CI 0.04 to 0.29; 14 studies, 1067 participants; high-certainty evidence). Mobility strategies lead to a small, non-clinically meaningful increase in functioning (SMD 0.23, 95% CI 0.10 to 0.36; 9 studies, 936 participants; high-certainty evidence), and probably lead to a slight increase in quality of life that may not be clinically meaningful (SMD 0.14, 95% CI -0.00 to 0.29; 10 studies, 785 participants; moderate-certainty evidence). Mobility strategies probably make little or no difference to short-term mortality (RR 1.01, 95% CI 0.49 to 2.06; 8 studies, 737 participants; moderate-certainty evidence). Mobility strategies may make little or no difference to long-term mortality (RR 0.73, 95% CI 0.39 to 1.37; 4 studies, 588 participants; low-certainty evidence) or adverse events measured by hospital re-admission (95% CI includes a large reduction and large increase, RR 0.86, 95% CI 0.52 to 1.42; 2 studies, 206 participants; low-certainty evidence).\nTraining involving gait, balance and functional exercise leads to a small, clinically meaningful increase in mobility (SMD 0.20, 95% CI 0.05 to 0.36; 5 studies, 621 participants; high-certainty evidence), while training classified as being primarily resistance or strength exercise may lead to a clinically meaningful increase in mobility measured using distance walked in six minutes (mean difference (MD) 55.65, 95% CI 28.58 to 82.72; 3 studies, 198 participants; low-certainty evidence). Training involving multiple intervention components probably leads to a substantial, clinically meaningful increase in mobility (SMD 0.94, 95% CI 0.53 to 1.34; 2 studies, 104 participants; moderate-certainty evidence). We are uncertain of the effect of aerobic training on mobility (very low-certainty evidence). No studies of other types of exercise or electrical stimulation reported mobility outcomes.\nAuthors' conclusions\nInterventions targeting improvement in mobility after hip fracture may cause clinically meaningful improvement in mobility and walking speed in hospital and post-hospital settings, compared with conventional care. Interventions that include training of gait, balance and functional tasks are particularly effective. There was little or no between-group difference in the number of adverse events reported. Future trials should include long-term follow-up and economic outcomes, determine the relative impact of different types of exercise and establish effectiveness in emerging economies.\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": "Mobility is the ability to move about, including standing up and walking. Mobility strategies are treatments that aim to help people move better.\nMobility treatment undertaken in hospital may moderately improve people's mobility four months after their hip was fractured. The effect of mobility treatment on other main outcomes was unclear. Mobility treatment undertaken after discharge from hospital after a fractured hip improves mobility, probably increases walking speed, improves functioning slightly and reduces falls.\nFuture studies should focus on which types of treatments work best and whether the treatments work in poorer countries." } ]
query-laysum	21598	[ { "role": "user", "content": "Abstract: Background\nElective colorectal surgery can involve formation of bowel anastomoses, which may be complicated by postoperative anastomotic leaks. Routine intra-operative drain placement aims to help clinicians diagnose and treat postoperative leaks. There is little agreement on the prophylactic use of drains for elective colorectal anastomoses. Once anastomotic leakage has occurred, it is generally agreed that drains should be used for therapeutic purposes. However, on prophylactic use no such agreement exists.\nObjectives\nTo assess the effectiveness and safety of a prophylactic drain after elective colorectal anastomosis.\nSearch methods\nWe searched the Cochrane Colorectal Cancer Group's Specialized Register (February 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 2), Ovid MEDLINE (1950 to February 2015) and Ovid EMBASE (1974 to February 2015). We also searched trial registers for ongoing and registered trials, Clinicaltrials.gov and the World Health Organization (WHO) search platform International Clinical Trials Registry Platform.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing drainage with non-drainage regimens after anastomoses in elective colorectal surgery.\nData collection and analysis\nTwo review authors independently performed selection of studies, assessment of trial quality and extraction of relevant data; a third review author resolved disagreements. We used GRADE methods to evaluate the quality of evidence.\nMain results\nOf the 908 participants enrolled (three RCTs), 454 were allocated for drainage and 454 for no drainage. We found no new RCTs for this review update. Two trials reported the primary outcome measure of anastomotic dehiscence. There was no statistically significant difference in anastomotic dehiscence in participants treated with intra-abdominal drainage routinely compared to no treatment (risk ratio (RR) 1.40, 95% confidence intervals (CI) 0.45 to 4.40; I2 = 0%; 2 RCTs; 809 participants). There was no statistically significant difference in mortality (RR 0.77, 95% CI 0.41 to 1.45; I2 = 0%; 3 RCTs; 908 participants); surgical re-intervention (RR 1.11, 95% CI 0.67 to 1.82; I2 = 29%; 3 RCTs; 908 participants); radiological dehiscence (RR 0.85, 95% CI 0.39 to 1.83; I2 = 0%; 2 RCTs; 809 participants) and wound infection (RR 0.82, 95% CI 0.45 to 1.51; I2 = 0%; 3 RCTs; 908 participants) in participants treated with routine prophylactic drainage compared to no treatment undergoing elective colorectal surgery. The quality of evidence was low according to GRADE method assessment.\nAuthors' conclusions\nThere was insufficient evidence for the use of prophylactic drains after elective colorectal anastomoses. The conclusions of this review were limited due to the nature of the available clinical data; The three included RCTs performed different interventions with relatively small sample sizes of eligible participants.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The quality of the evidence was low, making it impossible to draw firm conclusions about the use of routine prophylactic drains after elective colorectal anastomosis. Additional studies are needed to strengthen the conclusion drawn by this systematic review and to provide further analysis using modern colorectal surgery. We found no new evidence since the previous version of our systematic review of 2004." } ]
query-laysum	21599	[ { "role": "user", "content": "Abstract: Background\nDental caries is a multifactorial disease in which the fermentation of food sugars by bacteria from the biofilm (dental plaque) leads to localised demineralisation of tooth surfaces, which may ultimately result in cavity formation. Resin composites are widely used in dentistry to restore teeth. These restorations can fail for a number of reasons, such as secondary caries, and restorative material fracture and other minor reasons. From these, secondary caries, which are caries lesions developed adjacent to restorations, is the main cause for restorations replacement. The presence of antibacterials in both the filling material and the bonding systems would theoretically be able to affect the initiation and progression of caries adjacent to restorations. This is an update of the Cochrane review published in 2009.\nObjectives\nTo assess the effects of antibacterial agents incorporated into composite restorations for the prevention of dental caries.\nSearch methods\nWe searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 23 July 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 6), MEDLINE via OVID (1946 to 23 July 2013) and EMBASE via OVID (1980 to 23 July 2013). We searched the US National Institutes of Health Trials Register (http://clinicaltrials.gov), the metaRegister of Controlled Trials (www.controlled-trials.com) and the World Health Organization International Clinical Trials Registry platform (www.who.int/trialsearch) for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials comparing resin composite restorations containing antibacterial agents with composite restorations not containing antibacterial agents.\nData collection and analysis\nTwo review authors conducted screening of studies in duplicate and independently, and although no eligible trials were identified, the two authors had planned to extract data independently and assess trial quality using standard Cochrane Collaboration methodologies.\nMain results\nWe retrieved 308 references to studies, none of which matched the inclusion criteria for this review and all of which were excluded.\nAuthors' conclusions\nWe were unable to identify any randomised controlled trials on the effects of antibacterial agents incorporated into composite restorations for the prevention of dental caries. The absence of high level evidence for the effectiveness of this intervention emphasises the need for well designed, adequately powered, randomised controlled clinical trials. Thus, conclusions remain the same as the previously published review, with no included clinical trials.\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": "When tooth decay (caries) has caused a cavity in a tooth a range of materials can be used as fillings. These include resin composite, glass ionomer cement, amalgam and compomers. Tooth decay that may develop next to or underneath, a filling at a later stage is a common concern in dental practice and may reduce the life span of these fillings. It is thought that including a substance that kills and prevents the growth of bacterial (also known as an antibacterial agent) in some dental fillings, for example resin composites, could help prevent the development of this secondary caries." } ]
query-laysum	21600	[ { "role": "user", "content": "Abstract: Background\nAcute soft tissue injuries are common and costly. The best drug treatment for such injuries is not certain, although non-steroidal anti-inflammatory drugs (NSAIDs) are often recommended. There is concern about the use of oral opioids for acute pain leading to dependence. This is an update of a Cochrane Review published in 2015.\nObjectives\nTo assess the benefits or harms of NSAIDs compared with other oral analgesics for treating acute soft tissue injuries.\nSearch methods\nWe searched the CENTRAL, 2020 Issue 1, MEDLINE (from 1946), and Embase (from 1980) to January 2020; other databases were searched to February 2019.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials involving people with acute soft tissue injury (sprain, strain, or contusion of a joint, ligament, tendon, or muscle occurring within 48 hours of inclusion in the study), and comparing oral NSAIDs versus paracetamol (acetaminophen), opioid, paracetamol plus opioid, or complementary and alternative medicine. The outcomes were pain, swelling, function, adverse effects, and early re-injury.\nData collection and analysis\nTwo review authors independently assessed studies for eligibility, extracted data, and assessed risk of bias. We assessed the quality of the evidence using GRADE methodology.\nMain results\nWe included 20 studies, with 3305 participants. Three studies included children only. The others included predominantly young adults; approximately 60% were male. Seven studies recruited people with ankle sprains only. Most studies were at low or unclear risk of bias; however, two were at high risk of selection bias, three were at high risk of bias from lack of blinding, and five were at high risk of selective outcome reporting bias. Some evidence relating to pain relief was high certainty. Other evidence was either moderate, low or very low certainty, reflecting study limitations, indirectness, imprecision, or combinations of these. Thus, we are certain or moderately certain about some of the estimates, and uncertain or very uncertain of others.\nEleven studies, involving 1853 participants compared NSAIDs with paracetamol. There were no differences between the two groups in pain at one to two hours (1178 participants, 6 studies; high-certainty evidence), at days one to three (1232 participants, 6 studies; high-certainty evidence), and at day seven or later (467 participants, 4 studies; low-certainty evidence). There was little difference between the groups in numbers of participants with minimal swelling at day seven or later (77 participants, 1 study; low-certainty evidence). Very low-certainty evidence from three studies (386 participants) means we are uncertain of the finding of little difference between the two groups in return to function at day seven or later. There was low-certainty evidence from 10 studies (1504 participants) that NSAIDs may slightly increase the risk of gastrointestinal adverse events compared with paracetamol. There was low-certainty evidence from nine studies (1679 participants) of little difference in neurological adverse events between the NSAID and paracetamol groups.\nSix studies, involving 1212 participants compared NSAIDs with opioids. There was moderate-certainty evidence of no difference between the groups in pain at one hour (1058 participants, 4 studies), and low-certainty evidence for no difference in pain at days four or seven (706 participants, 1 study). There was very low-certainty evidence of no important difference between the groups in swelling (84 participants, 1 study). Participants in the NSAIDs group were more likely to return to function in 7 to 10 days (542 participants, 2 studies; low-certainty evidence). There was moderate-certainty evidence (1143 participants, 5 studies) that NSAIDs were less likely to result in gastrointestinal or neurological adverse events compared with opioids.\nFour studies, involving 240 participants, compared NSAIDs with the combination of paracetamol and an opioid. The applicability of findings from these studies is in question because the dextropropoxyphene combination analgesic agents used are no longer in general use. Very low-certainty evidence means we are uncertain of the findings of no differences between the two interventions in the numbers with little or no pain at day one (51 participants, 1 study), day three (149 participants, 2 studies), or day seven (138 participants, 2 studies); swelling (230 participants, 3 studies); return to function at day seven (89 participants, 1 study); and the risk of gastrointestinal or neurological adverse events (141 participants, 3 studies).\nNo studies reported re-injury rates.\nNo studies compared NSAIDs with oral complementary and alternative medicines,\nAuthors' conclusions\nCompared with paracetamol, NSAIDs make no difference to pain at one to two hours and at two to three days, and may make no difference at day seven or beyond. NSAIDs may result in a small increase in gastrointestinal adverse events and may make no difference in neurological adverse events compared with paracetamol.\nCompared with opioids, NSAIDs probably make no difference to pain at one hour, and may make no difference at days four or seven. NSAIDs probably result in fewer gastrointestinal and neurological adverse effects compared with opioids.\nThe very low-certainly evidence for all outcomes for the NSAIDs versus paracetamol with opioid combination analgesics means we are uncertain of the findings of no differences in pain or adverse effects.\nThe current evidence should not be extrapolated to adults older than 65 years, as this group was not well represented in the studies\n\nGiven the provided abstract, please respond to the following query: \"Results of our search and description of studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We included 20 studies, with 3305 participants. Seven studies included people with ankle sprain only. Three studies included children only. Most of the participants of the other studies were young adults, and there were slightly more men than women. Few participants were aged over 65 years. Eleven studies compared NSAIDs with paracetamol, six studies compared NSAIDs with opioids, and four studies compared NSAIDs with paracetamol combined with an opioid. Studies reported outcomes at times varying from one hour after taking the medication, up to 10 to 14 days." } ]
query-laysum	21601	[ { "role": "user", "content": "Abstract: Background\nMinistries of health, donors, and other decision-makers are exploring how they can use mobile technologies to acquire accurate and timely statistics on births and deaths. These stakeholders have called for evidence-based guidance on this topic. This review was carried out to support World Health Organization (WHO) recommendations on digital interventions for health system strengthening.\nObjectives\nPrimary objective: To assess the effects of birth notification and death notification via a mobile device, compared to standard practice.\nSecondary objectives: To describe the range of strategies used to implement birth and death notification via mobile devices and identify factors influencing the implementation of birth and death notification via mobile devices.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, the Global Health Library, and POPLINE (August 2, 2019). We searched two trial registries (August 2, 2019). We also searched Epistemonikos for related systematic reviews and potentially eligible primary studies (August 27, 2019). We conducted a grey literature search using mHealthevidence.org (August 15, 2017) and issued a call for papers through popular digital health communities of practice. Finally, we conducted citation searches of included studies in Web of Science and Google Scholar (May 15, 2020). We searched for studies published after 2000 in any language.\nSelection criteria\nFor the primary objective, we included individual and cluster-randomised trials; cross-over and stepped-wedge study designs; controlled before-after studies, provided they have at least two intervention sites and two control sites; and interrupted time series studies. For the secondary objectives, we included any study design, either quantitative, qualitative, or descriptive, that aimed to describe current strategies for birth and death notification via mobile devices; or to explore factors that influence the implementation of these strategies, including studies of acceptability or feasibility.\nFor the primary objective, we included studies that compared birth and death notification via mobile devices with standard practice. For the secondary objectives, we included studies of birth and death notification via mobile device as long as we could extract data relevant to our secondary objectives.\nWe included studies of all cadres of healthcare providers, including lay health workers; administrative, managerial, and supervisory staff; focal individuals at the village or community level; children whose births were being notified and their parents/caregivers; and individuals whose deaths were being notified and their relatives/caregivers.\nData collection and analysis\nFor the primary objective, two authors independently screened all records, extracted data from the included studies and assessed risk of bias. For the analyses of the primary objective, we reported means and proportions, where appropriate. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence and we prepared a 'Summary of Findings' table.\nFor the secondary objectives, two authors screened all records, one author extracted data from the included studies and assessed methodological limitations using the WEIRD tool and a second author checked the data and assessments. We carried out a framework analysis using the Supporting the Use of Research Evidence (SURE) framework to identify themes in the data. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in the evidence and we prepared a 'Summary of Qualitative Findings' table.\nMain results\nFor the primary objective, we included one study, which used a controlled before-after study design. The study was conducted in Lao People’s Democratic Republic and assessed the effect of using mobile devices for birth notification on outcomes related to coverage and timeliness of Hepatitis B vaccination. However, we are uncertain of the effect of this approach on these outcomes because the certainty of this evidence was assessed as very low. The included study did not assess resource use or unintended consequences. For the primary objective, we did not identify any studies using mobile devices for death notification.\nFor the secondary objective, we included 21 studies. All studies were conducted in low- or middle-income settings. They focussed on identification of births and deaths in rural, remote, or marginalised populations who are typically under-represented in civil registration processes or traditionally seen as having poor access to health services.\nThe review identified several factors that could influence the implementation of birth-death notification via mobile device. These factors were tied to the health system, the person responsible for notifying, the community and families; and include:\n- Geographic barriers that could prevent people’s access to birth-death notification and post-notification services\n- Access to health workers and other notifiers with enough training, supervision, support, and incentives\n- Monitoring systems that ensure the quality and timeliness of the birth and death data\n- Legal frameworks that allow births and deaths to be notified by mobile device and by different types of notifiers\n- Community awareness of the need to register births and deaths\n- Socio-cultural norms around birth and death\n- Government commitment\n- Cost to the system, to health workers and to families\n- Access to electricity and network connectivity, and compatibility with existing systems\n- Systems that protect data confidentiality\nWe have low to moderate confidence in these findings. This was mainly because of concerns about methodological limitations and data adequacy.\nAuthors' conclusions\nWe need more, well-designed studies of the effect of birth and death notification via mobile devices and on factors that may influence its implementation.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "By registering notified births and deaths, governments can track the health of their population, identify needs and problems, and design better services. In many countries, births and deaths are not properly registered. Sometimes this is because government systems are poorly designed to facilitate registration, government workers do not have proper training, people live far from government services, or are not aware of the need to register births or deaths. In many cases, registration is affected by delays in or lack of birth or death notification.\nGovernments are starting to use mobile devices such as mobile phones to reduce problems with birth or death notification. In some settings, members of the public, healthcare workers and others use mobile phones to notify a birth or death to the health system or to a central registration system.\nThe main aim of our review was to assess what happens when people use mobile devices to notify births and deaths, compared to other systems or no systems at all. For instance, do they register more birth and deaths, and do they do this at the right time? And does this lead more babies and children to use or receive health services, such as immunisation? We also wanted to find out how people are using these mobile systems in practice and what influences their use." } ]
query-laysum	21602	[ { "role": "user", "content": "Abstract: Background\nThis is an update of a previous Cochrane review published in Issue 1, 2010 and updated in Issue 9, 2015. The role of lymphadenectomy in surgical management of endometrial cancer remains controversial. Lymph node metastases can be found in approximately 10% of women who before surgery are thought to have cancer confined to the womb. Removal of all pelvic and para-aortic lymph nodes (lymphadenectomy) at initial surgery has been widely advocated, and pelvic and para-aortic lymphadenectomy remains part of the FIGO (International Federation of Gynaecology and Obstetrics) staging system for endometrial cancer. This recommendation is based on data from studies that suggested improvement in survival following pelvic and para-aortic lymphadenectomy. However, these studies were not randomised controlled trials (RCTs), and treatment of pelvic lymph nodes may not confer a direct therapeutic benefit, other than allocating women to poorer prognosis groups. Furthermore, the Cochrane review and meta-analysis of RCTs of routine adjuvant radiotherapy to treat possible lymph node metastases in women with early-stage endometrial cancer found no survival advantage. Surgical removal of pelvic and para-aortic lymph nodes has serious potential short-term and long-term sequelae. Therefore, it is important to investigate the clinical value of this treatment.\nObjectives\nTo evaluate the effectiveness and safety of lymphadenectomy for the management of endometrial cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase to June 2009 for the original review, updated the search to June 2015 for the last updated version and further extended the search to March 2017 for this version of the review. We also searched registers of clinical trials, abstracts of scientific meetings, and reference lists of included studies, and we contacted experts in the field.\nSelection criteria\nRCTs and quasi-RCTs that compared lymphadenectomy versus no lymphadenectomy in adult women diagnosed with endometrial cancer.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias. Hazard ratios (HRs) for overall and progression-free survival and risk ratios (RRs) comparing adverse events in women who received lymphadenectomy versus those with no lymphadenectomy were pooled in random-effects meta-analyses. We assessed the quality of the evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.\nMain results\n978 unique references were identified via the search strategy. All but 50 were excluded by title and abstract screening. Three RCTs met the inclusion criteria; for one small RCT, data were insufficient for inclusion in the meta-analysis. The two RCTs included in the analysis randomly assigned 1945 women, reported HRs for survival adjusted for prognostic factors and based on 1851 women and had an overall low risk of bias, as they satisfied four of the assessment criteria. The third study had an overall unclear risk of bias, as information provided was not adequate concerning random sequence generation, allocation concealment, blinding, or completeness of outcome reporting.\nResults of the meta-analysis remained unchanged from the previous versions of this review and indicated no differences in overall and recurrence-free survival between women who underwent lymphadenectomy and those who did not undergo lymphadenectomy (pooled hazard ratio (HR) 1.07, 95% confidence interval (CI) 0.81 to 1.43; HR 1.23, 95% CI 0.96 to 1.58 for overall and recurrence-free survival, respectively) (1851 participants, two studies; moderate-quality evidence).\nWe found no difference in risk of direct surgical morbidity between women who underwent lymphadenectomy and those who did not undergo lymphadenectomy. However, women who underwent lymphadenectomy had a significantly higher risk of surgery-related systemic morbidity and lymphoedema/lymphocyst formation than those who did not undergo lymphadenectomy (RR 3.72, 95% CI 1.04 to 13.27; RR 8.39, 95% CI 4.06 to 17.33 for risk of surgery-related systemic morbidity and lymphoedema/lymphocyst formation, respectively) (1922 participants, two studies; high-quality evidence).\nAuthors' conclusions\nThis review found no evidence that lymphadenectomy decreases risk of death or disease recurrence compared with no lymphadenectomy in women with presumed stage I disease. Evidence on serious adverse events suggests that women who undergo lymphadenectomy are more likely to experience surgery-related systemic morbidity or lymphoedema/lymphocyst formation. Currently, no RCT evidence shows the impact of lymphadenectomy in women with higher-stage disease and in those at high risk of disease recurrence.\n\nGiven the provided abstract, please respond to the following query: \"What are the main findings?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We found only three trials that compared lymphadenectomy with no lymphadenectomy among women with endometrial cancer. One of these trials could not be included in the meta-analysis of this review, as it provided insufficient information about outcomes for women. When we combined findings from the two remaining trials, which included 1945 women, we found no evidence that women who received lymphadenectomy were less likely to die or have a relapse of their cancer. In addition, severe adverse events experienced as a consequence of lymphadenectomy outnumbered those reported when no lymphadenectomy was performed." } ]
query-laysum	21603	[ { "role": "user", "content": "Abstract: Background\nOcular infection caused by Toxoplasma gondii, a parasite, may result in inflammation in the retina, choroid, and uvea, and consequently lead to complications such as glaucoma, cataract, and posterior synechiae.\nObjectives\nThe objective of this systematic review was to assess the effects of adjunctive use of corticosteroids to anti-parasitic therapy versus anti-parasitic therapy alone for ocular toxoplasmosis.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register (2016; Issue 11)), MEDLINE Ovid, Epub Ahead of Print, In-Process & Other Non-Indexed Citations, MEDLINE Ovid Daily (January 1946 to December 2016), Embase (January 1980 to December 2016), Latin American and Caribbean Literature on Health Sciences (LILACS (January 1982 to December 2016)), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP; www.who.int/ictrp/search/en). We used no date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 7 December 2016.\nSelection criteria\nWe had planned to include randomized and quasi-randomized controlled trials. Eligible trials would have enrolled participants of any age who were immunocompetent and were diagnosed with acute ocular toxoplasmosis. Included trials would have compared anti-parasitic therapy plus corticosteroids versus anti-parasitic therapy alone, different doses or times of initiation of corticosteroids.\nData collection and analysis\nTwo authors independently screened titles and abstracts retrieved through the electronic searches. We retrieved full-text reports of studies categorized as 'unsure' or 'include' after we reviewed the abstracts. Two authors independently reviewed each full-text report for eligibility. Discrepancies were resolved through discussion.\nMain results\nWe identified no completed or ongoing trial that was eligible for this Cochrane review.\nAuthors' conclusions\nAlthough research has identified a wide variation in practice regarding the use of corticosteroids, our review did not identify any evidence from randomized controlled trials for or against the role of corticosteroids in the management of ocular toxoplasmosis. Several questions remain unanswered by well-conducted randomized trials in this context, including whether the use of corticosteroids as an adjunctive agent is more effective than the use of anti-parasitic therapy alone; if so, when corticosteroids should be initiated in the treatment regimen (early versus late course of treatment), and what would be the best dose and duration of steroid use.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Toxoplasmosis is an infection caused by a parasite calledToxoplasma gondii. People can get toxoplasmosis by eating meat that has not been cooked properly, or by eating food or drinking water contaminated with pooh (feces), in particular, cat feces. Toxoplasmosis can affect different parts of the body, including the eye. Not everyone infected by toxoplasma will get symptoms in the eye. However, some people can be affected badly, and can have severe vision loss.\nPeople with toxoplasma infection usually take either anti-parasite medications or antibiotics that kill the parasite. They may also use corticosteroids to reduce the swelling in the eye (inflammation). Using corticosteroids may lead to quicker symptom relief and better vision." } ]
query-laysum	21604	[ { "role": "user", "content": "Abstract: Background\nOsteoporosis is characterized by low bone mass and micro-architectural deterioration of bone tissue leading to increased bone fragility. In people with beta-thalassaemia, osteoporosis represents an important cause of morbidity and is due to a number of factors. First, ineffective erythropoiesis causes bone marrow expansion, leading to reduced trabecular bone tissue with cortical thinning. Second, excessive iron loading causes endocrine dysfunction, leading to increased bone turnover. Lastly, disease complications can result in physical inactivity, with a subsequent reduction in optimal bone mineralization.\nTreatments for osteoporosis in people with beta-thalassaemia include bisphosphonates (e.g. clodronate, pamidronate, alendronate; with or without hormone replacement therapy (HRT)), calcitonin, calcium, zinc supplementation, hydroxyurea, and HRT alone (for preventing hypogonadism). Denosumab, a fully human monoclonal antibody, inhibits bone resorption and increases bone mineral density (BMD). Finally, strontium ranelate simultaneously promotes bone formation and inhibits bone resorption, thus contributing to a net gain in BMD, increased bone strength, and reduced fracture risk.\nThis is an update of a previously published Cochrane Review.\nObjectives\nTo review the evidence on the efficacy and safety of treatment for osteoporosis in people with beta-thalassaemia.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group’s Haemoglobinopathies Trials Register, which includes references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched online trial registries.\nDate of most recent search: 4 August 2022.\nSelection criteria\nRandomized controlled trials (RCTs) in people with beta-thalassaemia with: a BMD Z score below −2 standard deviations (SDs) for children aged under 15 years, adult males (aged 15 to 50 years) and premenopausal females aged over 15 years; or a BMD T score below −2.5 SDs for postmenopausal females and males aged over 50 years.\nData collection and analysis\nTwo review authors assessed the eligibility and risk of bias of the included RCTs, and extracted and analysed data. We assessed the certainty of the evidence using GRADE.\nMain results\nWe included six RCTs (298 participants). Active interventions included bisphosphonates (3 trials, 169 participants), zinc supplementation (1 trial, 42 participants), denosumab (1 trial, 63 participants), and strontium ranelate (1 trial, 24 participants). The certainty of the evidence ranged from moderate to very low and was downgraded mainly due to concerns surrounding imprecision (low participant numbers), but also risk of bias issues related to randomization, allocation concealment, and blinding.\nBisphosphonates versus placebo or no treatment\nTwo RCTs compared bisphosphonates to placebo or no treatment. After two years, one trial (25 participants) found that alendronate and clodronate may increase BMD Z score compared to placebo at the femoral neck (mean difference (MD) 0.40, 95% confidence interval (CI) 0.22 to 0.58) and the lumbar spine (MD 0.14, 95% CI 0.05 to 0.23). One trial (118 participants) reported that neridronate compared to no treatment may increase BMD at the lumbar spine and total hip at six and 12 months; for the femoral neck, the study found increased BMD in the neridronate group at 12 months only. All results were of very low-certainty.\nThere were no major adverse effects of treatment. Participants in the neridronate group reported less back pain; we considered this representative of improved quality of life (QoL), though the certainty of the evidence was very low. One participant in the neridronate trial (116 participants) sustained multiple fractures as a result of a traffic accident. No trials reported BMD at the wrist or mobility.\nDifferent doses of bisphosphonate compared\nOne 12-month trial (26 participants) assessed different doses of pamidronate (60 mg versus 30 mg) and found a difference in BMD Z score favouring the 60 mg dose at the lumbar spine (MD 0.43, 95% CI 0.10 to 0.76) and forearm (MD 0.87, 95% CI 0.23 to 1.51), but no difference at the femoral neck (very low-certainty evidence). This trial did not report fracture incidence, mobility, QoL, or adverse effects of treatment.\nZinc versus placebo\nOne trial (42 participants) showed zinc supplementation probably increased BMD Z score compared to placebo at the lumbar spine after 12 months (MD 0.15, 95% CI 0.10 to 0.20; 37 participants) and 18 months (MD 0.34, 95% CI 0.28 to 0.40; 32 participants); the same was true for BMD at the hip after 12 months (MD 0.15, 95% CI 0.11 to 0.19; 37 participants) and 18 months (MD 0.26, 95% CI 0.21 to 0.31; 32 participants). The evidence for these results was of moderate certainty. The trial did not report BMD at the wrist, fracture incidence, mobility, QoL, or adverse effects of treatment.\nDenosumab versus placebo\nBased on one trial (63 participants), we are unsure about the effect of denosumab on BMD Z score at the lumbar spine, femoral neck, and wrist joint after 12 months compared to placebo (low-certainty evidence). This trial did not report fracture incidence, mobility, QoL, or adverse effects of treatment, but the investigators reported a reduction in bone pain measured on a visual analogue scale in the denosumab group after 12 months of treatment compared to placebo (MD −2.40 cm, 95% CI −3.80 to −1.00).\nStrontium ranelate\nOne trial (24 participants) only narratively reported an increase in BMD Z score at the lumbar spine in the intervention group and no corresponding change in the control group (very low-certainty evidence). This trial also found a reduction in back pain measured on a visual analogue scale after 24 months in the strontium ranelate group compared to the placebo group (MD −0.70 cm (95% CI −1.30 to −0.10); we considered this measure representative of improved quality of life.\nAuthors' conclusions\nBisphosphonates may increase BMD at the femoral neck, lumbar spine, and forearm compared to placebo after two years' therapy. Zinc supplementation probably increases BMD at the lumbar spine and hip after 12 months. Denosumab may make little or no difference to BMD, and we are uncertain about the effect of strontium on BMD.\nWe recommend further long-term RCTs on different bisphosphonates and zinc supplementation therapies in people with beta-thalassaemia-associated osteoporosis.\n\nGiven the provided abstract, please respond to the following query: \"Zinc versus placebo\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "One trial, which enrolled 42 people, showed that zinc supplementation compared to placebo probably increases BMD at the lower back and hip after 12 months and after 18 months. This trial did not report BMD at the wrist, fractures, mobility, quality of life or unwanted effects of treatment." } ]
query-laysum	21605	[ { "role": "user", "content": "Abstract: Background\nNocturia is the bothersome symptom of awakening one or more times per night to void. Desmopressin is a commonly used medication for treating nocturia.\nObjectives\nTo assess the effects of desmopressin as compared to other interventions in the treatment of nocturia in men.\nSearch methods\nWe performed a comprehensive search of the medical literature with no restrictions on the language of publication or publication status. The date of the latest search of all databases was August 2017.\nSelection criteria\nWe included randomised or quasi-randomised trials. Inclusion criteria were men with nocturia defined as one or more voids per night. We excluded trials of children or adults with primary or secondary enuresis or underlying distinct disorders.\nData collection and analysis\nTwo review authors independently classified studies and abstracted data from the included studies. We performed statistical analyses using a random-effects model and interpreted data according to the Cochrane Handbook for Systematic Reviews of Interventions. We compared desmopressin with placebo, behavioural modification, alpha-blockers, in combination with alpha-blockers against alpha-blockers alone, and in combination with alpha-blocker against alpha-blocker plus anticholinergic. Our outcomes were mean number of voids, quality of life, adverse events, and sleep disturbance.\nMain results\nWe included 14 studies with 2966 randomised men across five comparisons. The studies recruited from urology outpatients clinics and defined nocturia as two or more voids per night. The average age of study participants ranged between 57 and 74 years.\nDesmopressin versus placebo: based on short-term follow-up (up to three months), desmopressin may result in a small, possibly unimportant effect on the number of nocturnal voids (mean difference (MD) -0.61, 95% confidence interval (CI) -0.96 to -0.27; low-quality evidence). We are uncertain about the effect of desmopressin on major adverse events at short-term follow-up (risk ratio (RR) 0.97, 95% CI 0.10 to 9.03; very low-quality evidence). For intermediate-term follow-up (three to 12 months), desmopressin may reduce the number of nocturnal voids in an appreciable number of men (MD -0.85, 95% CI -1.17 to -0.53; low-quality evidence). There was one major adverse event in the desmopressin group at intermediate-term follow-up in one trial of 115 men (RR 3.05, 95% CI 0.13 to 73.39 for both outcomes; low-quality evidence). We found no evidence on quality of life. Subgroup analyses suggest a larger effect on nocturnal voiding with oral, higher-dose formulations of desmopressin and in men with documented nocturnal polyuria.\nDesmopressin versus behaviour modification: there were no data regarding the effect on the number of nocturnal voids, quality of life, or major adverse events.\nDesmopressin versus alpha-blocker: based on short-term follow-up in one small trial, desmopressin likely has a similar effect on the number of nocturnal voids (MD 0.30, 95% CI -0.20 to 0.80; moderate-quality evidence) and quality of life measured on the International Prostate Symptom Score (IPSS) scale (MD 0.00, 95% CI -0.35 to 0.35; moderate-quality evidence). There were no major adverse events in either group.\nDesmopressin plus alpha-blocker versus alpha-blocker alone: based on short-term follow-up, combination therapy likely results in a small, unimportant effect on the number of nocturnal voids (MD -0.47, 95% CI -0.73 to -0.21; moderate-quality evidence) and quality of life (MD -0.29, 95% CI -0.51 to -0.07; moderate-quality evidence). The risk of major adverse events may be similar (0.5% versus 0.3%; RR 0.30, 95% CI 0.01 to 7.32; low-quality evidence).\nDesmopressin plus alpha-blocker versus alpha-blocker plus an anticholinergic: based on short-term follow-up, combination therapy likely results in little or no difference in the number of nocturnal voids (MD -0.43, 95% CI -0.97 to 0.11; moderate-quality evidence). We found no evidence on quality of life or sleep duration. There were no major adverse events in either study group.\nAuthors' conclusions\nDesmopressin may reduce the number of nocturnal voids by a small amount compared to placebo in intermediate-term (three to 12 months) follow-up without increasing major adverse events. We found insufficient evidence to determine the effects of desmopressin when compared with behaviour modification. The effect on the number of nocturnal voids in the short term is likely to be similar to that of alpha-blockers, with very infrequent major adverse events. There appears to be little added benefit in the combined use of desmopressin with an alpha-blocker. The findings of this review were limited by short-term follow-up, study limitations, and imprecision.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Nocturia is the bothersome symptom of waking one or more times per night to pass urine. It is common in older men. More than half of men older than 70 years of age have nocturia, and there are many reasons for this. Desmopressin is a drug that regulates urine volume and concentration in the body. It is also used to treat nocturia." } ]
query-laysum	21606	[ { "role": "user", "content": "Abstract: Background\nDecreased concentration of nitric oxide has been proposed as one of the possible cellular mechanisms of necrotising enterocolitis (NEC). Arginine can act as a substrate for production of nitric oxide in the tissues, and arginine supplementation may help to prevent NEC.\nObjectives\nTo examine the effect of arginine supplementation (administered by any route) on the incidence of NEC in preterm neonates. To conduct subgroup analyses based on the dose of arginine and the gestational age of participants (≤ 32 weeks, > 32 weeks).\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 4), MEDLINE via PubMed (from 1966 to 12 May 2016), Embase (from 1980 to 12 May 2016) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; from 1982 to 12 May 2016). We also searched clinical trials databases, conference proceedings and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised and quasi-randomised controlled trials of arginine supplementation (administered orally or parenterally for at least seven days, in addition to what an infant may be receiving from an enteral or parenteral source) compared with placebo or no treatment.\nData collection and analysis\nWe assessed the methodological quality of trials by using information obtained from study reports and through personal communication with study authors. We extracted data on relevant outcomes and estimated and reported the effect size as risk ratio (RR), risk difference (RD) and mean difference (MD), as appropriate. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the quality of evidence.\nMain results\nWe identified three eligible studies that included a total of 285 neonates (140 received arginine) from three countries. We assessed the overall methodological quality of the included studies as good. We noted a statistically significant reduction in risk of development of NEC (any stage) among preterm neonates in the arginine group compared with the placebo group (RR 0.38, 95% confidence interval (CI) 0.23 to 0.64; I2 = 27%) (RD -0.19, 95% CI -0.28 to -0.10; I2 = 0%) and rated the quality of evidence as moderate. The number needed to treat for an additional beneficial outcome (NNTB) as required to prevent the development of NEC (any stage) was 6 (95% CI 4 to 10). Study results showed a statistically significant reduction in risk of development of NEC stage 1 (RR 0.37, 95% CI 0.15 to 0.90; I2 = 52%) (RD -0.07, 95% CI -0.14 to -0.01; I2 = 0%) and NEC stage 3 (RR 0.13, 95% CI 0.02 to 1.03; I2 = 0%) (RD -0.05, 95% CI -0.09 to -0.01; I2 = 89%) in the arginine group compared with the control group; the quality of evidence was moderate.\nArginine supplementation was associated with a significant reduction in death related to NEC (RR 0.18, 95% CI 0.03 to 1.00; I2 = 0%) (RD -0.05, 95% CI -0.09 to -0.01; I2 = 87%). Results showed clinical heterogeneity in mortality rates. Mortality due to any cause was not significantly different between arginine and control or no treatment groups (RR 0.77, 95% CI 0.41 to 1.45; I2 = 42%) (RD -0.03, 95% CI -0.10 to 0.04; I2 = 79%). Investigators noted no significant side effects directly attributable to arginine, including hypotension or alterations in glucose homeostasis. Follow-up data from one trial revealed no statistically significant differences in adverse outcomes (cerebral palsy, cognitive delay, bilateral blindness or hearing loss requiring hearing aids) at 36 months. Limitations of the present findings include a relatively small overall sample size.\nAuthors' conclusions\nAdministration of arginine to preterm infants may prevent development of NEC. Because information was provided by three small trials that included 285 participants, the data are insufficient at present to support a practice recommendation. A multi-centre randomised controlled study that is focused on the incidence of NEC, particularly at more severe stages (2 and 3), is needed.\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": "Review authors searched the literature for controlled studies evaluating the efficacy and safety of arginine supplementation. Adding extra arginine to a preterm infant's feed reduced the risk of NEC in three good quality studies that included 285 infants born at less than 34 weeks' gestation. Six infants had to be treated, for one to benefit from treatment. Researchers reported no significant side effects directly attributable to too much arginine in the first 28 days, and one study reported no long-term (36 months) developmental delays. Possible effects of supplementing arginine include lower blood pressure and changes in blood glucose control." } ]
query-laysum	21607	[ { "role": "user", "content": "Abstract: Background\nDifferent therapeutic strategies are available for the treatment of people with relapsing-remitting multiple sclerosis (RRMS), including immunomodulators, immunosuppressants and biologics. Although there is consensus that these therapies reduce the frequency of relapses, their relative benefit in delaying new relapses or disability worsening remains unclear due to the limited number of direct comparison trials.\nObjectives\nTo compare the benefit and acceptability of interferon beta-1b, interferon beta-1a (Avonex, Rebif), glatiramer acetate, natalizumab, mitoxantrone, fingolimod, teriflunomide, dimethyl fumarate, alemtuzumab, pegylated interferon beta-1a, daclizumab, laquinimod, azathioprine and immunoglobulins for the treatment of people with RRMS and to provide a ranking of these treatments according to their benefit and acceptability, defined as the proportion of participants who withdrew due to any adverse event.\nSearch methods\nWe searched the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group Trials Register, which contains trials from CENTRAL (2014, Issue 9), MEDLINE (1966 to 2014), EMBASE (1974 to 2014), CINAHL (1981 to 2014), LILACS (1982 to 2014), clinicaltrials.gov and the WHO trials registry, and US Food and Drug Administration (FDA) reports. We ran the most recent search in September 2014.\nSelection criteria\nRandomised controlled trials (RCTs) that studied one or more of the 15 treatments as monotherapy, compared to placebo or to another active agent, for use in adults with RRMS.\nData collection and analysis\nTwo authors independently identified studies from the search results and performed data extraction. We performed data synthesis by pairwise meta-analysis and network meta-analysis. We assessed the quality of the body of evidence for outcomes within the network meta-analysis according to GRADE, as very low, low, moderate or high.\nMain results\nWe included 39 studies in this review, in which 25,113 participants were randomised. The majority of the included trials were short-term studies, with a median duration of 24 months. Twenty-four (60%) were placebo-controlled and 15 (40%) were head-to-head studies.\nNetwork meta-analysis showed that, in terms of a protective effect against the recurrence of relapses in RRMS during the first 24 months of treatment, alemtuzumab, mitoxantrone, natalizumab, and fingolimod outperformed other drugs. The most effective drug was alemtuzumab (risk ratio (RR) versus placebo 0.46, 95% confidence interval (CI) 0.38 to 0.55; surface under the cumulative ranking curve (SUCRA) 96%; moderate quality evidence), followed by mitoxantrone (RR 0.47, 95% CI 0.27 to 0.81; SUCRA 92%; very low quality evidence), natalizumab (RR 0.56, 95% CI 0.47 to 0.66; SUCRA 88%; high quality evidence), and fingolimod (RR 0.72, 95% CI 0.64 to 0.81; SUCRA 71%; moderate quality evidence).\nDisability worsening was based on a surrogate marker, defined as irreversible worsening confirmed at three-month follow-up, measured during the first 24 months in the majority of included studies. Both direct and indirect comparisons revealed that the most effective treatments were mitoxantrone (RR versus placebo 0.20, 95% CI 0.05 to 0.84; SUCRA 96%; low quality evidence), alemtuzumab (RR 0.35, 95% CI 0.26 to 0.48; SUCRA 94%; low quality evidence), and natalizumab (RR 0.64, 95% CI 0.49 to 0.85; SUCRA 74%; moderate quality evidence).\nAlmost all of the agents included in this review were associated with a higher proportion of participants who withdrew due to any adverse event compared to placebo. Based on the network meta-analysis methodology, the corresponding RR estimates versus placebo over the first 24 months of follow-up were: mitoxantrone 9.92 (95% CI 0.54 to 168.84), fingolimod 1.69 (95% CI 1.32 to 2.17), natalizumab 1.53 (95% CI 0.93 to 2.53), and alemtuzumab 0.72 (95% CI 0.32 to 1.61).\nInformation on serious adverse events (SAEs) was scanty, characterised by heterogeneous results and based on a very low number of events observed during the short-term duration of the trials included in this review.\nAuthors' conclusions\nConservative interpretation of these results is warranted, since most of the included treatments have been evaluated in few trials. The GRADE approach recommends providing implications for practice based on moderate to high quality evidence. Our review shows that alemtuzumab, natalizumab, and fingolimod are the best choices for preventing clinical relapses in people with RRMS, but this evidence is limited to the first 24 months of follow-up. For the prevention of disability worsening in the short term (24 months), only natalizumab shows a beneficial effect on the basis of moderate quality evidence (all of the other estimates were based on low to very low quality evidence). Currently, therefore, insufficient evidence is available to evaluate treatments for the prevention of irreversible disability worsening.\nThere are two additional major concerns that have to be considered. First, the benefit of all of these treatments beyond two years is uncertain and this is a relevant issue for a disease with a duration of 30 to 40 years. Second, short-term trials provide scanty and poorly reported safety data and do not provide useful evidence in order to obtain a reliable risk profile of treatments. In order to provide long-term information on the safety of the treatments included in this review, it will be necessary also to evaluate non-randomised studies and post-marketing reports released from the regulatory agencies. Finally, more than 70% of the studies included in this review were sponsored by pharmaceutical companies and this may have influenced the results.\nThere are three needs that the research agenda should address. First, randomised trials of direct comparisons between active agents would be useful, avoiding further placebo-controlled studies. Second, follow-up of the original trial cohorts should be mandatory. Third, more studies are needed to assess the medium and long-term benefit and safety of immunotherapies and the comparative safety of different agents.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "For preventing relapses, alemtuzumab, natalizumab, and fingolimod are more effective than the other drugs, based on moderate to high quality evidence.\nFor preventing irreversible disability worsening, insufficient evidence is currently available.\nAlmost all of the agents included in this review were associated with a higher proportion of participants who withdrew due to any adverse event compared to placebo.\nIt is worth noting the following:\n- The benefit of all of these treatments beyond two years is uncertain and this is a very relevant issue for people with a lifelong disease such as multiple sclerosis, who will possibly need long-term treatments.\n- Safety data from these short-term studies are scanty, poorly reported and cannot provide enough evidence for us to obtain a reliable risk profile of the treatments included in this review.\n- Most of the included studies were sponsored by pharmaceutical companies and this is a known potential source of bias." } ]
query-laysum	21608	[ { "role": "user", "content": "Abstract: Background\nPersistent pulmonary hypertension in the neonate (PPHN) is associated with high mortality. Currently, the therapeutic mainstay for PPHN consists of assisted ventilation and administration of inhaled nitric oxide (iNO). However, nitric oxide is costly, and its use may not be appropriate in resource-poor settings. Approximately 30% of patients fail to respond to iNO. High concentrations of phosphodiesterases in the pulmonary vasculature have led to the use of phosphodiesterase inhibitors such as sildenafil or milrinone.\nObjectives\nTo assess the efficacy and safety of sildenafil for treatment of pulmonary hypertension in neonates.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 3), MEDLINE via PubMed (1966 to 18 April 2017), Embase (1980 to 18 April 2017), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 18 April 2017). We searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials of sildenafil compared with placebo or other pulmonary vasodilators, irrespective of dose, route, and duration of administration, in neonates with pulmonary hypertension, if investigators reported any of the prespecified outcomes.\nData collection and analysis\nWe assessed the methodological quality of trials regarding how bias was minimised at study entry, during study intervention, and at outcomes measurement. We extracted data on relevant outcomes; we estimated the effect size and reported it as risk ratio (RR), risk difference (RD), or mean difference (MD), as appropriate. We applied the I2 test of heterogeneity and used GRADE to assess the quality of evidence.\nMain results\nFor this update, we identified two additional studies, for a total of five eligible trials that enrolled 166 infants. The methodological quality of these studies ranged from low to high risk of bias. Three studies were performed in resource-limited settings, where iNO and high-frequency ventilation were not available at the time of the study. One study compared sildenafil versus active controls, and another study evaluated sildenafil as adjuvant therapy to iNO. When comparing sildenafil with placebo, investigators noted significant reduction in mortality in the sildenafil alone group (three studies, 77 participants; typical RR 0.20, 95% confidence interval (CI) 0.07 to 0.56; I2 = 0% - none; typical RR -0.36, 95% CI -0.53 to -0.18; number needed to treat for an additional beneficial outcome 3, 95% CI 2 to 6; I2 = 39% - low). Trials reported no significant differences in mortality upon comparison of the sildenafil group versus the active control group (one study, 65 participants; typical RR 0.55, 95% CI 0.05 to 5.75), or when iNO was administered to both groups (one study, 24 participants; typical RR 1.27, 95% CI 0.26 to 6.28). Physiological parameters of oxygenation (oxygenation index, partial pressure of oxygen in arterial blood (PaO2)) suggested steady improvement after the first dose of sildenafil. None of the included trials identified any clinically important side effects. We rated the quality of evidence as low to very low owing to imprecision related to small sample size and unclear methodological features.\nAuthors' conclusions\nSildenafil used for treatment of pulmonary hypertension has potential for reducing mortality and improving oxygenation in neonates, especially in resource-limited settings where iNO is not available. However, large-scale randomised trials comparing sildenafil versus active controls (other pulmonary vasodilators) and providing follow-up for survivors are needed to assess the comparative effectiveness and long-term safety of sildenafil versus other pulmonary vasodilators.\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 for reducing mortality or improving respiratory parameters was low owing to the small number of included studies and the small number of babies evaluated. Some of the included studies have methodological issues, resulting in low to very low quality of evidence." } ]
query-laysum	21609	[ { "role": "user", "content": "Abstract: Background\nPeriodontal disease has been linked with a number of conditions, such as cardiovascular disease, stroke, diabetes and adverse pregnancy outcomes, all likely through systemic inflammatory pathways. It is common in women of reproductive age and gum conditions tend to worsen during pregnancy. Some evidence from observational studies suggests that periodontal intervention may reduce adverse pregnancy outcomes. There is need for a comprehensive Cochrane review of randomised trials to assess the effect of periodontal treatment on perinatal and maternal health.\nObjectives\nTo assess the effects of treating periodontal disease in pregnant women in order to prevent or reduce perinatal and maternal morbidity and mortality.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 6 October 2016), Cochrane Pregnancy and Childbirth's Trials Register (to 7 October 2016), the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 9) in the Cochrane Library, MEDLINE Ovid (1946 to 6 October 2016), Embase Ovid (1980 to 6 October 2016), and LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database; 1982 to 6 October 2016). ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials on 6 October 2016. We placed no restrictions on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included all randomised controlled trials (RCTs) investigating the effects of periodontal treatment in preventing or reducing perinatal and maternal morbidity and mortality. We excluded studies where obstetric outcomes were not reported.\nData collection and analysis\nTwo review authors independently screened titles and abstracts and extracted data using a prepiloted data extraction form. Missing data were obtained by contacting authors and risk of bias was assessed using Cochrane's 'Risk of bias' tool. Where appropriate, results of comparable trials were pooled and expressed as risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI) . The random-effects model was used for pooling except where there was an insufficient number of studies. We assessed the quality of the evidence using GRADE.\nMain results\nThere were 15 RCTs (n = 7161 participants) meeting our inclusion criteria. All the included studies were at high risk of bias mostly due to lack of blinding and imbalance in baseline characteristics of participants. The studies recruited pregnant women from prenatal care facilities who had periodontitis (14 studies) or gingivitis (1 study).The two main comparisons were: periodontal treatment versus no treatment during pregnancy and periodontal treatment versus alternative periodontal treatment. The head-to-head comparison between periodontal treatments assessed a more intensive treatment versus a less intensive one.\nEleven studies compared periodontal treatment with no treatment during pregnancy. The meta-analysis shows no clear difference in preterm birth < 37 weeks (RR 0.87, 95% CI 0.70 to 1.10; 5671 participants; 11 studies; low-quality evidence) between periodontal treatment and no treatment. There is low-quality evidence that periodontal treatment may reduce low birth weight < 2500 g (9.70% with periodontal treatment versus 12.60% without treatment; RR 0.67, 95% CI 0.48 to 0.95; 3470 participants; 7 studies).\nIt is unclear whether periodontal treatment leads to a difference in preterm birth < 35 weeks (RR 1.19, 95% CI 0.81 to 1.76; 2557 participants; 2 studies; ) and < 32 weeks (RR 1.35, 95% CI 0.78 to 2.32; 2755 participants; 3 studies), low birth weight < 1500 g (RR 0.80, 95% CI 0.38 to 1.70; 2550 participants; 2 studies), perinatal mortality (including fetal and neonatal deaths up to the first 28 days after birth) (RR 0.85, 95% CI 0.51 to 1.43; 5320 participants; 7 studies; very low-quality evidence), and pre-eclampsia (RR 1.10, 95% CI 0.74 to 1.62; 2946 participants; 3 studies; very low-quality evidence). There is no evidence of a difference in small for gestational age (RR 0.97, 95% CI 0.81 to 1.16; 3610 participants; 3 studies; low-quality evidence) when periodontal treatment is compared with no treatment.\nFour studies compared periodontal treatment with alternative periodontal treatment. Data pooling was not possible due to clinical heterogeneity. The outcomes reported were preterm birth < 37 weeks, preterm birth < 35 weeks, birth weight < 2500 g, birth weight < 1500 g and perinatal mortality (very low-quality evidence). It is unclear whether there is a difference in < 37 weeks, preterm birth < 35 weeks, birth weight < 2500 g, birth weight < 1500 g and perinatal mortality when different periodontal treatments are compared because the quality of evidence is very low.\nMaternal mortality and adverse effects of the intervention did not occur in any of the studies that reported on either of the outcomes.\nAuthors' conclusions\nIt is not clear if periodontal treatment during pregnancy has an impact on preterm birth (low-quality evidence). There is low-quality evidence that periodontal treatment may reduce low birth weight (< 2500 g), however, our confidence in the effect estimate is limited. There is insufficient evidence to determine which periodontal treatment is better in preventing adverse obstetric outcomes. Future research should aim to report periodontal outcomes alongside obstetric outcomes.\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": "The review authors found 15 relevant studies. Five were from North America, four from South America, three from Europe, two from Asia and one from Austalia. Eleven studies compared either scaling and root planing or scale and polish with no treatment while the other four studies compared scaling and root planing with alternative mechanical treatments.\nWhen pregnant women with gum disease who receive periodontal treatment are compared with those who receive no treatment:\n- there is no clear difference in the number of babies born before 37 weeks (low-quality evidence);\n- there may be fewer babies born weighing less than 2500 g (low-quality evidence).\nIt is unclear if one periodontal treatment is better than alternative periodontal treatments in preventing adverse birth outcomes." } ]
query-laysum	21610	[ { "role": "user", "content": "Abstract: Background\nAcute respiratory distress syndrome (ARDS) is a critical condition that is associated with high mortality and morbidity. Aerosolized prostacyclin has been used to improve oxygenation despite the limited evidence available so far.\nThis review was originally published in 2010 and updated in 2017.\nObjectives\nTo assess the benefits and harms of aerosolized prostacyclin in adults and children with ARDS.\nSearch methods\nIn this update, we searched CENTRAL (2017, Issue 4); MEDLINE (OvidSP), Embase (OvidSP), ISI BIOSIS Previews, ISI Web of Science, LILACS, CINAHL (EBSCOhost), and three trials registers. We handsearched the reference lists of the latest reviews, randomized and non-randomized trials, and editorials, and cross-checked them with our search of MEDLINE. We contacted the main authors of included studies to request any missed, unreported or ongoing studies. The search was run from inception to 5 May 2017.\nSelection criteria\nWe included all randomized controlled trials (RCTs), irrespective of publication status, date of publication, blinding status, outcomes published or language. We contacted trial investigators and study authors to retrieve relevant and missing data.\nData collection and analysis\nThree authors independently abstracted data and resolved any disagreements by discussion. Our primary outcome measure was all-cause mortality. We planned to perform subgroup and sensitivity analyses to assess the effect of aerosolized prostacyclin in adults and children, and on various clinical and physiological outcomes. We assessed the risk of bias through assessment of methodological trial components and the risk of random error through trial sequential analysis.\nMain results\nWe included two RCTs with 81 participants.\nOne RCT involved 14 critically ill children with ARDS (very low quality of evidence), and one RCT involved 67 critically ill adults (very low quality evidence).\nOnly one RCT (paediatric trial) provided data on mortality and found no difference between intervention and control. However, this trial was eligible for meta-analysis due to a cross-over design.\nWe assessed the benefits and harms of aerosolized prostacyclin. One RCT found no difference in improvement of partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio (mean difference (MD) -25.35, 95% confidence interval (CI) -60.48 to 9.78; P = 0.16; 67 participants, very low quality evidence).\nThere were no adverse events such as bleeding or organ dysfunction in any of the included trials. Due to the limited number of RCTs, we were unable to perform the prespecified subgroup and sensitivity analyses or trial sequential analysis.\nAuthors' conclusions\nWe are unable to tell from our results whether the intervention has an important effect on mortality because the results were too imprecise to rule out a small or no effect. Therefore, no current evidence supports or refutes the routine use of aerosolized prostacyclin for people with ARDS. There is an urgent need for more RCTs.\n\nGiven the provided abstract, please respond to the following query: \"Study funding source\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "None of the included trials reported receiving money from drug companies." } ]
query-laysum	21611	[ { "role": "user", "content": "Abstract: Background\nAsthma is a common respiratory condition in children that is characterised by symptoms including wheeze, shortness of breath, chest tightness, and cough. Children with asthma may be able to manage their condition more effectively by improving inhaler technique, and by recognising and responding to symptoms. Schools offer a potentially supportive environment for delivering interventions aimed at improving self-management skills among children. The educational ethos aligns with skill and knowledge acquisition and makes it easier to reach children with asthma who do not regularly engage with primary care. Given the multi-faceted nature of self-management interventions, there is a need to understand the combination of intervention features that are associated with successful delivery of asthma self-management programmes.\nObjectives\nThis review has two primary objectives.\n• To identify the intervention features that are aligned with successful intervention implementation.\n• To assess effectiveness of school-based interventions provided to improve asthma self-management among children.\nWe addressed the first objective by performing qualitative comparative analysis (QCA), a synthesis method described in depth later, of process evaluation studies to identify the combination of intervention components and processes that are aligned with successful intervention implementation.\nWe pursued the second objective by undertaking meta-analyses of outcomes reported by outcome evaluation studies. We explored the link between how well an intervention is implemented and its effectiveness by using separate models, as well as by undertaking additional subgroup analyses.\nSearch methods\nWe searched the Cochrane Airways Trials Register for randomised studies. To identify eligible process evaluation studies, we searched MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the Cochrane Database of Systematic Reviews (CDSR), Web of Knowledge, the Database of Promoting Health Effectiveness Reviews (DoPHER), the Database of Abstracts of Reviews of Effects (DARE), the International Biography of Social Science (IBSS), Bibliomap, Health Technology Assessment (HTA), Applied Social Sciences Index and Abstracts (ASSIA), and Sociological Abstracts (SocAbs). We conducted the latest search on 28 August 2017.\nSelection criteria\nParticipants were school-aged children with asthma who received the intervention in school. Interventions were eligible if their purpose was to help children improve management of their asthma by increasing knowledge, enhancing skills, or changing behaviour. Studies relevant to our first objective could be based on an experimental or quasi-experimental design and could use qualitative or quantitative methods of data collection. For the second objective we included randomised controlled trials (RCTs) where children were allocated individually or in clusters (e.g. classrooms or schools) to self-management interventions or no intervention control.\nData collection and analysis\nWe used qualitative comparative analysis (QCA) to identify intervention features that lead to successful implementation of asthma self-management interventions. We measured implementation success by reviewing reports of attrition, intervention dosage, and treatment adherence, irrespective of effects of the interventions.\nTo measure the effects of interventions, we combined data from eligible studies for our primary outcomes: admission to hospital, emergency department (ED) visits, absence from school, and days of restricted activity due to asthma symptoms. Secondary outcomes included unplanned visits to healthcare providers, daytime and night-time symptoms, use of reliever therapies, and health-related quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ).\nMain results\nWe included 55 studies in the review. Thirty-three studies in 14,174 children provided information for the QCA, and 33 RCTs in 12,623 children measured the effects of interventions. Eleven studies contributed to both the QCA and the analysis of effectiveness. Most studies were conducted in North America in socially disadvantaged populations. High school students were better represented among studies contributing to the QCA than in studies contributing to effectiveness evaluations, which more commonly included younger elementary and junior high school students. The interventions all attempted to improve knowledge of asthma, its triggers, and stressed the importance of regular practitioner review, although there was variation in how they were delivered.\nQCA results highlighted the importance of an intervention being theory driven, along with the importance of factors such as parent involvement, child satisfaction, and running the intervention outside the child's own time as drivers of successful implementation.\nCompared with no intervention, school-based self-management interventions probably reduce mean hospitalisations by an average of about 0.16 admissions per child over 12 months (SMD –0.19, 95% CI -0.35 to -0.04; 1873 participants; 6 studies, moderate certainty evidence). They may reduce the number of children who visit EDs from 7.5% to 5.4% over 12 months (OR 0.70, 95% CI 0.53 to 0.92; 3883 participants; 13 studies, low certainty evidence), and probably reduce unplanned visits to hospitals or primary care from 26% to 21% at 6 to 9 months (OR 0.74, 95% CI 0.60 to 0.90; 3490 participants; 5 studies, moderate certainty evidence). Self-management interventions probably reduce the number of days of restricted activity by just under half a day over a two-week period (MD 0.38 days 95% CI -0.41 to -0.18; 1852 participants; 3 studies, moderate certainty evidence). Effects of interventions on school absence are uncertain due to the variation between the results of the studies (MD 0.4 fewer school days missed per year with self-management (-1.25 to 0.45; 4609 participants; 10 studies, low certainty evidence). Evidence is insufficient to show whether the requirement for reliever medications is affected by these interventions (OR 0.52, 95% CI 0.15 to 1.81; 437 participants; 2 studies; very low-certainty evidence). Self-management interventions probably improve children's asthma-related quality of life by a small amount (MD 0.36 units higher on the Paediatric AQLQ(95% CI 0.06 to 0.64; 2587 participants; 7 studies, moderate certainty evidence).\nAuthors' conclusions\nSchool-based asthma self-management interventions probably reduce hospital admission and may slightly reduce ED attendance, although their impact on school attendance could not be measured reliably. They may also reduce the number of days where children experience asthma symptoms, and probably lead to small improvements in asthma-related quality of life. Many of the studies tested the intervention in younger children from socially disadvantaged populations. Interventions that had a theoretical framework, engaged parents and were run outside of children's free time were associated with successful implementation.\n\nGiven the provided abstract, please respond to the following query: \"Take-home message\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Evidence suggests that school-based self-management interventions can help children with asthma and can reduce hospital admissions and trips to the emergency department. Study findings suggest that interventions that were based on a theory about how an intervention can be planned and delivered could prove useful in improving children's outcomes, reaching large numbers of children, and keeping dropout rates low, and indicate that those designing interventions should consider factors such as including parents.\nThis review is current to August 2017." } ]
query-laysum	21612	[ { "role": "user", "content": "Abstract: Background\nVenous leg ulcers (VLUs) are open skin wounds on the lower leg that occur because of poor blood flow in the veins of the leg; leg ulcers can last from weeks to years, and are both painful and costly. Prevalence in the UK is about 2.9 cases per 10,000 people. First-line treatment for VLUs is compression therapy, but around 60% of people have unhealed ulcers after 12 weeks' treatment and about 40% after 24 weeks; therefore, there is scope for further improvement. Limited evidence suggests non-healing leg ulcers may have persisting elevated levels of proteases, which is thought to deter the later stages of healing; thus, timely protease-modulating matrix (PMM) treatments may improve healing by physically removing proteases from the wound fluid.\nObjectives\nTo determine the effects of protease-modulating matrix (PMM) treatments on the healing of venous leg ulcers, in people managed in any care setting.\nSearch methods\nIn September 2016 we searched: the Cochrane Wounds Specialised Register; 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 and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe searched for published or unpublished randomised controlled trials (RCTs) that evaluated PMM treatments for VLUs. We defined PMM treatments as those with a purposeful intent of reducing proteases. Wound healing was the primary endpoint.\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias assessment and data extraction.\nMain results\nWe included 12 studies (784 participants) in this review; sample sizes ranged from 10 to 187 participants (median 56.5). One study had three arms that were all relevant to this review and all the other studies had two arms. One study was a within-participant comparison. All studies were industry funded. Two studies provided unpublished data for healing.\nNine of the included studies compared PMM treatments with other treatments and reported results for the primary outcomes. All treatments were dressings. All studies also gave the participants compression bandaging. Seven of these studies were in participants described as having 'non-responsive' or 'hard-to-heal' ulcers. Results, reported at short, medium and long durations and as time-to-event data, are summarised for the comparison of any dressing regimen incorporating PMM versus any other dressing regimen. The majority of the evidence was of low or very low certainty, and was mainly downgraded for risk of bias and imprecision.\nIt is uncertain whether PMM dressing regimens heal VLUs quicker than non-PMM dressing regimens (low-certainty evidence from 1 trial with 100 participants) (HR 1.21, 95% CI 0.74 to 1.97).\nIn the short term (four to eight weeks) it is unclear whether there is a difference between PMM dressing regimens and non-PMM dressing regimens in the probability of healing (very low-certainty evidence, 2 trials involving 207 participants).\nIn the medium term (12 weeks), it is unclear whether PMM dressing regimens increase the probability of healing compared with non-PMM dressing regimens (low-certainty evidence from 4 trials with 192 participants) (RR 1.28, 95% CI 0.95 to 1.71). Over the longer term (6 months), it is also unclear whether there is a difference between PMM dressing regimens and non-PMM dressing regimens in the probability of healing (low certainty evidence, 1 trial, 100 participants) (RR 1.06, 95% CI 0.80 to 1.41).\nIt is uncertain whether there is a difference in adverse events between PMM dressing regimens and non-PMM dressing regimens (low-certainty evidence from 5 trials, 363 participants) (RR 1.03, 95% CI 0.75 to 1.42). It is also unclear whether resource use is lower for PMM dressing regimens (low-certainty evidence, 1 trial involving 73 participants), or whether mean total costs in a German healthcare setting are different (low-certainty evidence, 1 trial in 187 participants). One cost-effectiveness analysis was not included because effectiveness was not based on complete healing.\nAuthors' conclusions\nThe evidence is generally of low certainty, particularly because of risk of bias and imprecision of effects. Within these limitations, we are unclear whether PMM dressing regimens influence venous ulcer healing relative to dressing regimens without PMM activity. It is also unclear whether there is a difference in rates of adverse events between PMM and non-PMM treatments. It is uncertain whether either resource use (products and staff time) or total costs associated with PMM dressing regimens are different from those for non-PMM dressing regimens. More research is needed to clarify the impact of PMM treatments on venous ulcer healing.\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": "Venous leg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Leg ulcers can be painful, may become infected, and may affect mobility and quality of life. In 2012 in the UK, it cost about GBP 1700 per year to treat each person with an open venous leg ulcer.\nThe usual treatment for venous leg ulcers is compression therapy (for example, compression bandages), but even this does not work for everyone (about a third of people still have wounds that have not healed after six months). Therefore, we need to try additional treatments, and various dressings have been used alongside compression therapy. One of these is a 'protease-modulating matrix' (PMM) type of dressing. Research suggests that wounds are slow to heal when there are high levels of a substance called 'protease'. The PMM dressing is designed to remove these proteases from wound fluid, and this is expected to help the wound heal.\nIn this study, we investigated whether there is any evidence that PMM dressings heal leg ulcers more quickly than other types of dressings." } ]
query-laysum	21613	[ { "role": "user", "content": "Abstract: Background\nMeticillin-resistant Staphylococcus aureus (MRSA; also known as methicillin-resistant S aureus) is a common hospital-acquired pathogen that increases morbidity, mortality, and healthcare costs. Its control continues to be an unresolved issue in many hospitals worldwide. The evidence base for the effects of the use of gloves, gowns or masks as control measures for MRSA is unclear.\nObjectives\nTo assess the effectiveness of wearing gloves, a gown or a mask when contact is anticipated with a hospitalised patient colonised or infected with MRSA, or with the patient's immediate environment.\nSearch methods\nWe searched the Specialised Registers of three Cochrane Groups (Wounds Group on 5 June 2015; Effective Practice and Organisation of Care (EPOC) Group on 9 July 2013; and Infectious Diseases Group on 5 January 2009); CENTRAL (The Cochrane Library 2015, Issue 6); DARE, HTA, NHS EED, and the Methodology Register (The Cochrane Library 2015, Issue 6); MEDLINE and MEDLINE In-Process & Other Non-Indexed Citations (1946 to June week 1 2015); EMBASE (1974 to 4 June 2015); Web of Science (WOS) Core Collection (from inception to 7 June 2015); CINAHL (1982 to 5 June 2015); British Nursing Index (1985 to 6 July 2010); and ProQuest Dissertations & Theses Database (1639 to 11 June 2015). We also searched three trials registers (on 6 June 2015), references list of articles, and conference proceedings. We finally contacted relevant individuals for additional studies.\nSelection criteria\nStudies assessing the effects on MRSA transmission of the use of gloves, gowns or masks by any person in the hospital setting when contact is anticipated with a hospitalised patient colonised or infected with MRSA, or with the patient's immediate environment. We did not assess adverse effects or economic issues associated with these interventions.\nWe considered any comparator to be eligible. With regard to study design, only randomised controlled trials (clustered or not) and the following non-randomised experimental studies were eligible: quasi-randomised controlled trials (clustered or not), non-randomised controlled trials (clustered or not), controlled before-and-after studies, controlled cohort before-after studies, interrupted time series studies (controlled or not), and repeated measures studies. We did not exclude any study on the basis of language or date of publication.\nData collection and analysis\nTwo review authors independently decided on eligibility of the studies. Had any study having been included, two review authors would have extracted data (at least for outcome data) and assessed the risk of bias independently. We would have followed the standard methodological procedures suggested by Cochrane and the Cochrane EPOC Group for assessing risk of bias and analysing the data.\nMain results\nWe identified no eligible studies for this review, either completed or ongoing.\nAuthors' conclusions\nWe found no studies assessing the effects of wearing gloves, gowns or masks for contact with MRSA hospitalised patients, or with their immediate environment, on the transmission of MRSA to patients, hospital staff, patients' caregivers or visitors. This absence of evidence should not be interpreted as evidence of no effect for these interventions. The effects of gloves, gowns and masks in these circumstances have yet to be determined by rigorous experimental studies, such as cluster-randomised trials involving multiple wards or hospitals, or interrupted time series studies.\n\nGiven the provided abstract, please respond to the following query: \"The aim of this research and what the researchers found\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The researchers aimed to find out whether the use of gloves, a gown or a mask by any person in the hospital (for example, a doctor) getting close to a patient found to have MRSA prevents the transmission of MRSA from this patient to other people in the hospital.\nThe researchers made a wide search of the medical literature, up to June 2015, but did not find any rigorous studies that addressed this topic.\nAt present there is no scientific evidence that the wearing of gloves, a gown, or a mask by people getting close to patients with MRSA reduces the transmission of MRSA to other people in the hospital. However, this should not be interpreted as demonstrating that gloves, gowns or masks are not effective; it means that the research that would be required to measure an effect - if there is one - has not been done yet." } ]
query-laysum	21614	[ { "role": "user", "content": "Abstract: Background\nYoga is an ancient spiritual practice that originated in India and is currently accepted in the Western world as a form of relaxation and exercise. It has been of interest for people with schizophrenia to determine its efficacy as an adjunct to standard-care treatment.\nObjectives\nTo examine the effects of yoga versus standard care for people with schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register (November 2012 and January 29, 2015), which is based on regular searches of MEDLINE, PubMed, EMBASE, CINAHL, BIOSIS, AMED, PsycINFO, and registries of clinical trials. We searched the references of all included studies. There were no language, date, document type, or publication status limitations for inclusion of records in the register.\nSelection criteria\nAll randomised controlled trials (RCTs) including people with schizophrenia comparing yoga to standard-care control.\nData collection and analysis\nThe review team independently selected studies, quality rated these, and extracted data. 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 mixed-effect and fixed-effect models for analyses. We examined data for heterogeneity (I2 technique), assessed risk of bias for included studies, and created 'Summary of findings' tables using GRADE (Grading of Recommendations Assessment, Development and Evaluation).\nMain results\nWe included eight studies in the review. All outcomes were short term (less than six months). There were clear differences in a number of outcomes in favour of the yoga group, although these were based on one study each, with the exception of leaving the study early. These included mental state (improvement in Positive and Negative Syndrome Scale, 1 RCT, n = 83, RR 0.70 CI 0.55 to 0.88, medium-quality evidence), social functioning (improvement in Social Occupational Functioning Scale, 1 RCT, n = 83, RR 0.88 CI 0.77 to 1, medium-quality evidence), quality of life (average change 36-Item Short Form Survey (SF-36) quality-of-life subscale, 1 RCT, n = 60, MD 15.50, 95% CI 4.27 to 26.73, low-quality evidence), and leaving the study early (8 RCTs, n = 457, RR 0.91 CI 0.6 to 1.37, medium-quality evidence). For the outcome of physical health, there was not a clear difference between groups (average change SF-36 physical-health subscale, 1 RCT, n = 60, MD 6.60, 95% CI -2.44 to 15.64, low-quality evidence). Only one study reported adverse effects, finding no incidence of adverse events in either treatment group. This review was subject to a considerable number of missing outcomes, which included global state, change in cognition, costs of care, effect on standard care, service intervention, disability, and activities of daily living.\nAuthors' conclusions\nEven though we found some positive evidence in favour of yoga over standard-care control, this should be interpreted cautiously in view of outcomes largely based each on one study with limited sample sizes and short-term follow-up. Overall, many outcomes were not reported and evidence presented in this review is of low to moderate quality - -too weak to indicate that yoga is superior to standard-care control for the management of schizophrenia.\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": "Some results suggest that yoga may be beneficial for people with schizophrenia. Yoga may be beneficial to mental state, social functioning and quality of life but the available evidence is weak and needs to be treated with a good degree of caution. No adverse effects were found by the one trial that reported this outcome. Several other important outcomes were not addressed by the studies, including changes in cognition, economic considerations, and daily living activities. There was not enough good-quality evidence in this review to claim that yoga should be prescribed as an add-on to standard care for schizophrenia." } ]
query-laysum	21615	[ { "role": "user", "content": "Abstract: Background\nChronic pulmonary infection in cystic fibrosis results in progressive lung damage. Once colonisation of the lungs with Pseudomonas aeruginosa occurs, it is almost impossible to eradicate. Vaccines, aimed at reducing infection with Pseudomonas aeruginosa, have been developed. This is an update of a previously published review.\nObjectives\nTo assess the effectiveness of vaccination against Pseudomonas aeruginosa in cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register using the terms vaccines AND pseudomonas (last search 30 March 2015). We previously searched PubMed using the terms vaccin* AND cystic fibrosis (last search 30 May 2013).\nSelection criteria\nRandomised trials (published or unpublished) comparing Pseudomonas aeruginosa vaccines (oral, parenteral or intranasal) with control vaccines or no intervention in cystic fibrosis.\nData collection and analysis\nThe authors independently selected trials, assessed them and extracted data.\nMain results\nSix trials were identified. Two trials were excluded since they were not randomised and one old, small trial because it was not possible to assess whether is was randomised. The three included trials comprised 483, 476 and 37 patients, respectively. No data have been published from one of the large trials, but the company stated in a press release that the trial failed to confirm the results from an earlier study and that further clinical development was suspended. In the other large trial, relative risk for chronic infection was 0.91 (95% confidence interval 0.55 to 1.49), and in the small trial, the risk was also close to one. In the large trial, one patient was reported to have died in the observation period. In that trial, 227 adverse events (4 severe) were registered in the vaccine group and 91 (1 severe) in the control group. In this large trial of a vaccine developed against flagella antigens, antibody titres against the epitopes contained in the vaccine were higher in the vaccine group compared to the placebo group (P < 0.0001).\nAuthors' conclusions\nVaccines against Pseudomonas aeruginosa cannot 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": "Cystic fibrosis is a hereditary disease where thick mucus is produced in the lungs. This can stop the lungs clearing bacteria such as Pseudomonas aeruginosa and other bacteria. This causes long-lasting lung infections in approximately 80% of adult patients; these infections result in permanent lung damage.\nVaccines have been developed which aim to reduce infection with Pseudomonas aeruginosa and it is important to know whether using these vaccines can prevent lung infection." } ]
query-laysum	21616	[ { "role": "user", "content": "Abstract: Background\nChronic anticoagulation with vitamin K antagonists (VKAs) prevents ischaemic stroke and systemic embolism in people with non-valvular atrial fibrillation (AF) but dose adjustment, coagulation monitoring and bleeding limits its use. Direct thrombin inhibitors (DTIs) are under investigation as potential alternatives.\nObjectives\nTo assess (1) the comparative efficacy of long-term anticoagulation using DTIs versus VKAs on vascular deaths and ischaemic events in people with non-valvular AF, and (2) the comparative safety of chronic anticoagulation using DTIs versus VKAs on (a) fatal and non-fatal major bleeding events including haemorrhagic strokes, (b) adverse events other than bleeding and ischaemic events that lead to treatment discontinuation and (c) all-cause mortality in people with non-valvular AF.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (July 2013), the Cochrane Central Register of Controlled Trials (CENTRAL), (The Cochrane Library, May 2013), MEDLINE (1950 to July 2013), EMBASE (1980 to October 2013), LILACS (1982 to October 2013) and trials registers (September 2013). We also searched the websites of clinical trials and pharmaceutical companies and handsearched the reference lists of articles and conference proceedings.\nSelection criteria\nRandomised controlled trials (RCTs) comparing DTIs versus VKAs for prevention of stroke and systemic embolism in people with non-valvular AF.\nData collection and analysis\nAll three review authors independently performed data extraction and assessment of risk of bias. Primary analyses compared all DTIs combined versus warfarin. We performed post hoc analyses excluding ximelagatran because this drug was withdrawn from the market owing to safety concerns.\nMain results\nWe included eight studies involving a total of 27,557 participants with non-valvular AF and one or more risk factors for stroke; 26,601 of them were assigned to standard doses groups and included in the primary analysis. The DTIs: dabigatran 110 mg twice daily and 150 mg twice daily (three studies, 12,355 participants), AZD0837 300 mg once per day (two studies, 233 participants) and ximelagatran 36 mg twice per day (three studies, 3726 participants) were compared with the VKA warfarin (10,287 participants). Overall risk of bias and statistical heterogeneity of the studies included were low.\nThe odds of vascular death and ischaemic events were not significantly different between all DTIs and warfarin (odds ratio (OR) 0.94, 95% confidence interval (CI) 0.85 to 1.05). Sensitivity analysis by dose of dabigatran on reduction in ischaemic events and vascular mortality indicated that dabigatran 150 mg twice daily was superior to warfarin although the effect estimate was of borderline statistical significance (OR 0.86, 95% CI 0.75 to 0.99). Sensitivity analyses by other factors did not alter the results. Fatal and non-fatal major bleeding events, including haemorrhagic strokes, were less frequent with the DTIs (OR 0.87, 95% CI 0.78 to 0.97). Adverse events that led to discontinuation of treatment were significantly more frequent with the DTIs (OR 2.18, 95% CI 1.82 to 2.61). All-cause mortality was similar between DTIs and warfarin (OR 0.91, 95% CI 0.83 to 1.01).\nAuthors' conclusions\nDTIs were as efficacious as VKAs for the composite outcome of vascular death and ischaemic events and only the dose of dabigatran 150 mg twice daily was found to be superior to warfarin. DTIs were associated with fewer major haemorrhagic events, including haemorrhagic strokes. Adverse events that led to discontinuation of treatment occurred more frequently with the DTIs. We detected no difference in death from all causes.\n\nGiven the provided abstract, please respond to the following query: \"Question\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We wanted to compare the effectiveness and safety of direct thrombin inhibitors (DTIs) with vitamin K antagonists in people with atrial fibrillation (AF) to prevent stroke." } ]
query-laysum	21617	[ { "role": "user", "content": "Abstract: Background\nChronic pain is a major health and socioeconomic burden, which is prevalent in children and adolescents. Among the most widely used interventions in children and adolescents are physical activity (including exercises) and education about physical activity.\nObjectives\nTo evaluate the effectiveness of physical activity, education about physical activity, or both, compared with usual care (including waiting-list, and minimal interventions, such as advice, relaxation classes, or social group meetings) or active medical care in children and adolescents with chronic musculoskeletal pain.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, PEDro, and LILACS from the date of their inception to October 2022. We also searched the reference lists of eligible papers, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared physical activity or education about physical activity, or both, with usual care (including waiting-list and minimal interventions) or active medical care, in children and adolescents with chronic musculoskeletal pain.\nData collection and analysis\nTwo review authors independently determined the eligibility of the included studies. Our primary outcomes were pain intensity, disability, and adverse events. Our secondary outcomes were depression, anxiety, fear avoidance, quality of life, physical activity level, and caregiver distress. We extracted data at postintervention assessment, and long-term follow-up. Two review authors independently assessed risk of bias for each study, using the RoB 1. We assessed the overall certainty of the evidence using the GRADE approach. We reported continuous outcomes as mean differences, and determined clinically important differences from the literature, or 10% of the scale.\nMain results\nWe included four studies (243 participants with juvenile idiopathic arthritis). We judged all included studies to be at unclear risk of selection bias, performance bias, and detection bias, and at high risk of attrition bias. We downgraded the certainty of the evidence for each outcome to very low due to serious or very serious study limitations, inconsistency, and imprecision.\nPhysical activity compared with usual care\nPhysical activity may slightly reduce pain intensity (0 to 100 scale; 0 = no pain) compared with usual care at postintervention (standardised mean difference (SMD) -0.45, 95% confidence interval (CI) -0.82 to -0.08; 2 studies, 118 participants; recalculated as a mean difference (MD) -12.19, 95% CI -21.99 to -2.38; I² = 0%; very low-certainty evidence). Physical activity may slightly improve disability (0 to 3 scale; 0 = no disability) compared with usual care at postintervention assessment (MD -0.37, 95% CI -0.56 to -0.19; I² = 0%; 3 studies, 170 participants; very low-certainty evidence). We found no clear evidence of a difference in quality of life (QoL; 0 to 100 scale; lower scores = better QoL) between physical activity and usual care at postintervention assessment (SMD -0.46, 95% CI -1.27 to 0.35; 4 studies, 201 participants; very low-certainty evidence; recalculated as MD -6.30, 95% CI -18.23 to 5.64; I² = 91%).\nNone of the included studies measured adverse events, depression, or anxiety for this comparison.\nPhysical activity compared with active medical care\nWe found no studies that could be analysed in this comparison.\nEducation about physical activity compared with usual care or active medical care\nWe found no studies that could be analysed in this comparison.\nPhysical activity and education about physical activity compared with usual care or active medical care\nWe found no studies that could be analysed in this comparison.\nAuthors' conclusions\nWe are unable to confidently state whether interventions based on physical activity and education about physical activity are more effective than usual care for children and adolescents with chronic musculoskeletal pain.\nWe found very low-certainty evidence that physical activity may reduce pain intensity and improve disability postintervention compared with usual care, for children and adolescents with juvenile idiopathic arthritis.\nWe did not find any studies reporting educational interventions; it remains unknown how these interventions influence the outcomes in children and adolescents with chronic musculoskeletal pain.\nTreatment decisions should consider the current best evidence, the professional's experience, and the young person's preferences.\nFurther randomised controlled trials in other common chronic musculoskeletal pain conditions, with high methodological quality, large sample size, and long-term follow-up are urgently needed.\n\nGiven the provided abstract, please respond to the following query: \"What is chronic musculoskeletal pain in children and adolescents?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Chronic pain is pain that lasts longer than three months. Chronic musculoskeletal pain (e.g. pain in muscles and bones) is common in children and adolescents, and has a negative impact on their lives. The most common chronic musculoskeletal pain in children and adolescents is pain in their back, neck, and arms, and pain resulting from sports injuries." } ]
query-laysum	21618	[ { "role": "user", "content": "Abstract: Background\nThe clinical presentation of acute chest syndrome is similar whether due to infectious or non-infectious causes, thus antibiotics are usually prescribed to treat all episodes. Many different pathogens, including bacteria, have been implicated as causative agents of acute chest syndrome. There is no standardized approach to antibiotic therapy and treatment is likely to vary from country to country. Thus, there is a need to identify the efficacy and safety of different antibiotic treatment approaches for people with sickle cell disease suffering from acute chest syndrome. This is an update of a Cochrane Review first published in 2007, and most recently updated in 2015.\nObjectives\nTo determine whether an empirical antibiotic treatment approach (used alone or in combination):\n1. is effective for acute chest syndrome compared to placebo or standard treatment;\n2. is safe for acute chest syndrome compared to placebo or standard treatment;\nFurther objectives are to determine whether there are important variations in efficacy and safety:\n3. for different treatment regimens,\n4. by participant age, or geographical location of the clinical trials.\nSearch methods\nWe searched The Group's Haemoglobinopathies Trials Register, which comprises references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. We also searched the LILACS database (1982 to 23 October 2017), African Index Medicus (1982 to 23 October 2017) and trial registries (23 October 2017).\nDate of most recent search of the Haemoglobinopathies Trials Register: 10 July 2019.\nSelection criteria\nWe searched for published or unpublished randomised controlled trials.\nData collection and analysis\nEach author intended to independently extract data and assess trial quality by standard Cochrane methodologies, but no eligible randomised controlled trials were identified.\nMain results\nFor this update, we were unable to find any randomised controlled trials on antibiotic treatment approaches for acute chest syndrome in people with sickle cell disease.\nAuthors' conclusions\nThis update was unable to identify randomised controlled trials on efficacy and safety of the antibiotic treatment approaches for people with sickle cell disease suffering from acute chest syndrome. While randomised controlled trials are needed to establish the optimum antibiotic treatment for this condition, we do not envisage further trials of this intervention will be conducted, and hence the review will no longer be regularly updated.\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": "While we conclude that a randomised controlled trial should attempt to answer these questions, we do not envisage further trials of this intervention will be conducted, and hence the review will no longer be regularly updated. Until there is firm evidence, clinicians should treat acute chest syndrome on a case by case basis and according to the diagnosis and the treatment available." } ]
query-laysum	21619	[ { "role": "user", "content": "Abstract: Background\nAntibiotic therapy for acute pulmonary exacerbations in people with cystic fibrosis is usually chosen based on the results of antimicrobial susceptibility testing of individual drugs. Combination antimicrobial susceptibility testing assesses the efficacy of drug combinations including two or three antibiotics in vitro and can often demonstrate antimicrobial efficacy against bacterial isolates even when individual antibiotics have little or no effect. Therefore, choosing antibiotics based on combination antimicrobial susceptibility testing could potentially improve response to treatment in people with cystic fibrosis with acute exacerbations. This is an updated version of a previously published review.\nObjectives\nTo compare antibiotic therapy based on conventional antimicrobial susceptibility testing to antibiotic therapy based on combination antimicrobial susceptibility testing in the treatment of acute pulmonary exacerbations in people with cystic fibrosis and chronic infection with Pseudomonas aeruginosa.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Cystic Fibrosis Trials Register which comprises of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of latest search: 19 March 2020.\nWe also searched ongoing trials registries. Date of latest search: 07 April 2020.\nSelection criteria\nRandomised and quasi-randomised controlled studies of antibiotic therapy based on conventional antimicrobial susceptibility testing compared to antibiotic therapy based on combination antimicrobial susceptibility testing in the treatment of acute pulmonary exacerbations in cystic fibrosis due to chronic infection with Pseudomonas aeruginosa.\nData collection and analysis\nBoth authors independently selected studies, assessed their quality and extracted data from eligible studies. Additionally, the authors contacted the study investigators to obtain further information.\nMain results\nThe search identified one multicentre study eligible for inclusion in the review. This study prospectively assessed whether the use of multiple combination bactericidal antibiotic testing improved clinical outcomes in participants with acute pulmonary exacerbations of cystic fibrosis who were infected with multiresistant bacteria. A total of 132 participants were randomised in the study. The study investigators provided data specific to the 82 participants who were only infected with Pseudomonas aeruginosa for their primary outcome of time until next pulmonary exacerbation. For participants specifically infected with only Pseudomonas aeruginosa, the hazard ratio of a subsequent exacerbation was 0.82, favouring the control group (95% confidence interval 0.44 to 1.51) (P = 0.52). No further data for any of this review's outcomes specific to participants infected with Pseudomonas aeruginosa were available. The risk of bias for the included study was deemed to be low. The quality of the evidence was moderate for the only outcome providing data solely for individuals with infection due to Pseudomonas aeruginosa. For other outcomes, we were unable to judge the quality of the evidence as no data were available for the relevant subset of participants.\nAuthors' conclusions\nThe current evidence, limited to one study, shows that there is insufficient evidence to determine effect of choosing antibiotics based on combination antimicrobial susceptibility testing compared to choosing antibiotics based on conventional antimicrobial susceptibility testing in the treatment of acute pulmonary exacerbations in people with cystic fibrosis with chronic Pseudomonas aeruginosa infection. A large international and multicentre study is needed to further investigate this issue.\nThe only study included in the review was published in 2005, and we have not identified any further relevant studies up to March 2017. We therefore do not plan to update this review until new studies are published.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The search identified one study that tried to answer this question and was eligible for inclusion in the review. The study enrolled 132 people with cystic fibrosis, most of whom (82 people) had acute lung infections with Pseudomonas aeruginosa, and randomly put them into two treatment groups. In the first group two antibiotics were selected following the testing of combinations of antibiotics and in the second group the two antibiotics were chosen after testing individual antibiotics to see how effective the drugs were against the bacterium. The study was run across several centres and assessed the clinical outcomes in the participants after a 14-day course of treatment." } ]
query-laysum	21620	[ { "role": "user", "content": "Abstract: Background\nThere are controversies about the amount of calories and the type of nutritional support that should be given to critically-ill people. Several authors advocate the potential benefits of hypocaloric nutrition support, but the evidence is inconclusive.\nObjectives\nTo assess the effects of prescribed hypocaloric nutrition support in comparison with standard nutrition support for critically-ill adults\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, Cochrane Library), MEDLINE, Embase and LILACS (from inception to 20 June 2017) with a specific strategy for each database. We also assessed three websites, conference proceedings and reference lists, and contacted leaders in the field and the pharmaceutical industry for undetected/unpublished studies. There was no restriction by date, language or publication status.\nSelection criteria\nWe included randomized and quasi-randomized controlled trials comparing hypocaloric nutrition support to normo- or hypercaloric nutrition support or no nutrition support (e.g. fasting) in adults hospitalized in intensive care units (ICUs).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We meta-analysed data for comparisons in which clinical heterogeneity was low. We conducted prespecified subgroup and sensitivity analyses, and post hoc analyses, including meta-regression. Our primary outcomes were: mortality (death occurred during the ICU and hospital stay, or 28- to 30-day all-cause mortality); length of stay (days stayed in the ICU and in the hospital); and Infectious complications. Secondary outcomes included: length of mechanical ventilation. We assessed the quality of evidence with GRADE.\nMain results\nWe identified 15 trials, with a total of 3129 ICU participants from university-associated hospitals in the USA, Colombia, Saudi Arabia, Canada, Greece, Germany and Iran. There are two ongoing studies. Participants suffered from medical and surgical conditions, with a variety of inclusion criteria. Four studies used parenteral nutrition and nine studies used only enteral nutrition; it was unclear whether the remaining two used parenteral nutrition. Most of them could not achieve the proposed caloric targets, resulting in small differences in the administered calories between intervention and control groups. Most studies were funded by the US government or non-governmental associations, but three studies received funding from industry. Five studies did not specify their funding sources.\nThe included studies suffered from important clinical and statistical heterogeneity. This heterogeneity did not allow us to report pooled estimates of the primary and secondary outcomes, so we have described them narratively.\nWhen comparing hypocaloric nutrition support with a control nutrition support, for hospital mortality (9 studies, 1775 participants), the risk ratios ranged from 0.23 to 5.54; for ICU mortality (4 studies, 1291 participants) the risk ratios ranged from 0.81 to 5.54, and for mortality at 30 days (7 studies, 2611 participants) the risk ratios ranged from 0.79 to 3.00. Most of these estimates included the null value. The quality of the evidence was very low due to unclear or high risk of bias, inconsistency and imprecision.\nParticipants who received hypocaloric nutrition support compared to control nutrition support had a range of mean hospital lengths of stay of 15.70 days lower to 10.70 days higher (10 studies, 1677 participants), a range of mean ICU lengths of stay 11.00 days lower to 5.40 days higher (11 studies, 2942 participants) and a range of mean lengths of mechanical ventilation of 13.20 days lower to 8.36 days higher (12 studies, 3000 participants). The quality of the evidence for this outcome was very low due to unclear or high risk of bias in most studies, inconsistency and imprecision.\nThe risk ratios for infectious complications (10 studies, 2804 participants) of each individual study ranged from 0.54 to 2.54. The quality of the evidence for this outcome was very low due to unclear or high risk of bias, inconsistency and imprecision\nWe were not able to explain the causes of the observed heterogeneity using subgroup and sensitivity analyses or meta-regression.\nAuthors' conclusions\nThe included studies had substantial clinical heterogeneity. We found very low-quality evidence about the effects of prescribed hypocaloric nutrition support on mortality in hospital, in the ICU and at 30 days, as well as in length of hospital and ICU stay, infectious complications and the length of mechanical ventilation. For these outcomes there is uncertainty about the effects of prescribed hypocaloric nutrition, since the range of estimates includes both appreciable benefits and harms.\nGiven these limitations, results must be interpreted with caution in the clinical field, considering the unclear balance of the risks and harms of this intervention. Future research addressing the clinical heterogeneity of participants and interventions, study limitations and sample size could clarify the effects of this intervention.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The differences in the type of nutrition and type of participants across studies did not allow us to combine study results, so we describe the range of results across the individual studies.\nThe number of deaths at the hospital, in the ICU and at 30 days in those who received low-calorie nutrition was similar to those in the control group. The length of hospital and ICU stay and the length of mechanical ventilation varied across studies, sometimes shorter and sometimes longer when compared to the control group. The number of infections also varied across studies. We tried to analyse subgroups of participants in order to clarify this variation, but the results were not consistent." } ]
query-laysum	21621	[ { "role": "user", "content": "Abstract: Background\nHealth care-associated infection is a major cause of morbidity and mortality. Hand hygiene is regarded as an effective preventive measure. This is an update of a previously published review.\nObjectives\nTo assess the short- and long-term success of strategies to improve compliance to recommendations for hand hygiene, and to determine whether an increase in hand hygiene compliance can reduce rates of health care-associated infection.\nSearch methods\nWe conducted electronic searches of the Cochrane Register of Controlled Trials, PubMed, Embase, and CINAHL. We conducted the searches from November 2009 to October 2016.\nSelection criteria\nWe included randomised trials, non-randomised trials, controlled before-after studies, and interrupted time series analyses (ITS) that evaluated any intervention to improve compliance with hand hygiene using soap and water or alcohol-based hand rub (ABHR), or both.\nData collection and analysis\nTwo review authors independently screened citations for inclusion, extracted data, and assessed risks of bias for each included study. Meta-analysis was not possible, as there was substantial heterogeneity across studies. We assessed the certainty of evidence using the GRADE approach and present the results narratively in a 'Summary of findings' table.\nMain results\nThis review includes 26 studies: 14 randomised trials, two non-randomised trials and 10 ITS studies. Most studies were conducted in hospitals or long-term care facilities in different countries, and collected data from a variety of healthcare workers. Fourteen studies assessed the success of different combinations of strategies recommended by the World Health Organization (WHO) to improve hand hygiene compliance. Strategies consisted of the following: increasing the availability of ABHR, different types of education for staff, reminders (written and verbal), different types of performance feedback, administrative support, and staff involvement. Six studies assessed different types of performance feedback, two studies evaluated education, three studies evaluated cues such as signs or scent, and one study assessed placement of ABHR. Observed hand hygiene compliance was measured in all but three studies which reported product usage. Eight studies also reported either infection or colonisation rates. All studies had two or more sources of high or unclear risks of bias, most often associated with blinding or independence of the intervention.\nMultimodal interventions that include some but not all strategies recommended in the WHO guidelines may slightly improve hand hygiene compliance (five studies; 56 centres) and may slightly reduce infection rates (three studies; 34 centres), low certainty of evidence for both outcomes.\nMultimodal interventions that include all strategies recommended in the WHO guidelines may slightly reduce colonisation rates (one study; 167 centres; low certainty of evidence). It is unclear whether the intervention improves hand hygiene compliance (five studies; 184 centres) or reduces infection (two studies; 16 centres) because the certainty of this evidence is very low.\nMultimodal interventions that contain all strategies recommended in the WHO guidelines plus additional strategies may slightly improve hand hygiene compliance (six studies; 15 centres; low certainty of evidence). It is unclear whether this intervention reduces infection rates (one study; one centre; very low certainty of evidence).\nPerformance feedback may improve hand hygiene compliance (six studies; 21 centres; low certainty of evidence). This intervention probably slightly reduces infection (one study; one centre) and colonisation rates (one study; one centre) based on moderate certainty of evidence.\nEducation may improve hand hygiene compliance (two studies; two centres), low certainty of evidence.\nCues such as signs or scent may slightly improve hand hygiene compliance (three studies; three centres), low certainty of evidence.\nPlacement of ABHR close to point of use probably slightly improves hand hygiene compliance (one study; one centre), moderate certainty of evidence.\nAuthors' conclusions\nWith the identified variability in certainty of evidence, interventions, and methods, there remains an urgent need to undertake methodologically robust research to explore the effectiveness of multimodal versus simpler interventions to increase hand hygiene compliance, and to identify which components of multimodal interventions or combinations of strategies are most effective in a particular context.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "The review authors searched for studies that had been published up to October 2016." } ]
query-laysum	21622	[ { "role": "user", "content": "Abstract: Background\nPreparing healthcare providers to manage relatively rare life-threatening emergency situations effectively is a challenge. Training sessions enable staff to rehearse for these events and are recommended by several reports and guidelines. In this review we have focused on interactive training, this includes any element where the training is not solely didactic but provides opportunity for discussions, rehearsals, or interaction with faculty or technology. It is important to understand the effective methods and essential elements for successful emergency training so that resources can be appropriately targeted to improve outcomes.\nObjectives\nTo assess the effects of interactive training of healthcare providers on the management of life-threatening emergencies in hospital on patient outcomes, clinical care practices, or organisational practices, and to identify essential components of effective interactive emergency training programmes.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL and ERIC and two trials registers up to 11 March 2019. We searched references of included studies, conference proceedings, and contacted study authors.\nSelection criteria\nWe included randomised trials and cluster-randomised trials comparing interactive training for emergency situations with standard/no training. We defined emergency situations as those in which immediate lifesaving action is required, for example cardiac arrests and major haemorrhage. We included all studies where healthcare workers involved in providing direct clinical care were participants. We excluded studies outside of a hospital setting or where the intervention was not targeted at practicing healthcare workers. We included trials irrespective of publication status, date, and language.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and Cochrane Effective Practice and Organisation of Care (EPOC) Group. Two review authors independently extracted data and assessed the risk of bias of each included trial. Due to the small number of studies and the heterogeneity in outcome measures, we were unable to perform the planned meta-analysis. We provide a structured synthesis for the following outcomes: survival to hospital discharge, morbidity rate, protocol or guideline adherence, patient outcomes, clinical practice outcomes, and organisation-of-care outcomes. We used the GRADE approach to rate the certainty of the evidence and the strength of recommendations for each outcome.\nMain results\nWe included 11 studies that reported on 2000 healthcare providers and over 300,000 patients; one study did not report the number of participants. Seven were cluster randomised trials and four were single centre studies. Four studies focused on obstetric training, three on obstetric and neonatal care, two on neonatal training, one on trauma and one on general resuscitations. The studies were spread across high-, middle- and low-income settings.\nInteractive training may make little or no difference in survival to hospital discharge for patients requiring resuscitation (1 study; 30 participants; 98 events; low-certainty evidence). We are uncertain if emergency training changes morbidity rate, as the certainty of the evidence is very low (3 studies; 1778 participants; 57,193 patients, when reported). We are uncertain if training alters healthcare providers' adherence to clinical protocols or guidelines, as the certainty of the evidence is very low (3 studies; 156 participants; 558 patients). We are uncertain if there were improvements in patient outcomes following interactive training for emergency situations, as we assessed the evidence as very low-certainty (5 studies, 951 participants; 314,055 patients). We are uncertain if training for emergency situations improves clinical practice outcomes as the certainty of the evidence is very low (4 studies; 1417 participants; 28,676 patients, when reported). Two studies reported organisation-of-care outcomes, we are uncertain if interactive emergency training has any effect on this outcome as the certainty of the evidence is very low (634 participants; 179,400 patient population).\nWe examined prespecified subgroups and found no clear commonalities in effect of multidisciplinary training, location of training, duration of the course, or duration of follow-up. We also examined areas arising from the studies including focus of training, proportion of staff trained, leadership of intervention, and incentive/trigger to participate, and again identified no clear mediating factors. The sources of funding for the studies were governmental, local organisations, or philanthropic donors.\nAuthors' conclusions\nWe are uncertain if there are any benefits of interactive training of healthcare providers on the management of life-threatening emergencies in hospital as the certainty of the evidence is very low. We were unable to identify any factors that may have allowed us to identify an essential element of these interactive training courses.\nWe found a lack of consistent reporting, which contributed to the inability to meta-analyse across specialities. More trials are required to build the evidence base for the optimum way to prepare healthcare providers for rare life-threatening emergency events. These trials need to be conducted with attention to outcomes important to patients, healthcare providers, and policymakers. It is vitally important to develop high-quality studies adequately powered and with attention to minimising the risk of bias.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We looked at all of the studies examining this area up until March 2019." } ]
query-laysum	21623	[ { "role": "user", "content": "Abstract: Background\nNitric oxide (NO) is a major endogenous regulator of vascular tone. Inhaled nitric oxide (iNO) gas has been investigated as treatment for persistent pulmonary hypertension of the newborn.\nObjectives\nTo determine whether treatment of hypoxaemic term and near-term newborn infants with iNO improves oxygenation and reduces rate of death and use of extracorporeal membrane oxygenation (ECMO), or affects long-term neurodevelopmental outcomes.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1), MEDLINE via PubMed (1966 to January 2016), Embase (1980 to January 2016) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to January 2016). We searched clinical trials databases, conference proceedings and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We contacted the principal investigators of studies published as abstracts to ascertain the necessary information.\nSelection criteria\nRandomised studies of iNO in term and near-term infants with hypoxic respiratory failure, with clinically relevant outcomes, including death, use of ECMO and oxygenation.\nData collection and analysis\nWe analysed trial reports to assess methodological quality using the criteria of the Cochrane Neonatal Review Group. We tabulated mortality, oxygenation, short-term clinical outcomes (particularly use of ECMO) and long-term developmental outcomes.\nStatistics: For categorical outcomes, we calculated typical estimates for risk ratios and risk differences. For continuous variables, we calculated typical estimates for weighted mean differences. We used 95% confidence intervals and assumed a fixed-effect model for meta-analysis.\nMain results\nWe found 17 eligible randomised controlled studies that included term and near-term infants with hypoxia.\nTen trials compared iNO versus control (placebo or standard care without iNO) in infants with moderate or severe severity of illness scores (Ninos 1996; Roberts 1996; Wessel 1996; Davidson 1997; Ninos 1997; Mercier 1998; Christou 2000; Clark 2000; INNOVO 2007; Liu 2008). Mercier 1998 compared iNO versus control but allowed back-up treatment with iNO for infants who continued to satisfy the same criteria for severity of illness after two hours. This trial enrolled both preterm and term infants but reported most results separately for the two groups. Ninos 1997 studied only infants with congenital diaphragmatic hernia.\nOne trial compared iNO versus high-frequency ventilation (Kinsella 1997).\nSix trials enrolled infants with moderate severity of illness scores (oxygenation index (OI) or alveolar-arterial oxygen difference (A-aDO2)) and randomised them to immediate iNO treatment or iNO treatment only after deterioration to more severe criteria (Barefield 1996; Day 1996; Sadiq 1998; Cornfield 1999; Konduri 2004; Gonzalez 2010).\nInhaled nitric oxide appears to have improved outcomes in hypoxaemic term and near-term infants by reducing the incidence of the combined endpoint of death or use of ECMO (high-quality evidence). This reduction was due to a reduction in use of ECMO (with number needed to treat for an additional beneficial outcome (NNTB) of 5.3); mortality was not affected. Oxygenation was improved in approximately 50% of infants receiving iNO. The OI was decreased by a (weighted) mean of 15.1 within 30 to 60 minutes after the start of therapy, and partial pressure of arterial oxygen (PaO2) was increased by a mean of 53 mmHg. Whether infants had clear echocardiographic evidence of persistent pulmonary hypertension of the newborn (PPHN) did not appear to affect response to iNO. Outcomes of infants with diaphragmatic hernia were not improved; outcomes were slightly, but not significantly, worse with iNO (moderate-quality evidence).\nInfants who received iNO at less severe criteria did not have better clinical outcomes than those who were enrolled but received treatment only if their condition deteriorated. Fewer of the babies who received iNO early satisfied late treatment criteria, showing that earlier iNO reduced progression of the disease but did not further decrease mortality nor the need for ECMO (moderate-quality evidence). Incidence of disability, incidence of deafness and infant development scores were all similar between tested survivors who received iNO and those who did not.\nAuthors' conclusions\nInhaled nitric oxide is effective at an initial concentration of 20 ppm for term and near-term infants with hypoxic respiratory failure who do not have a diaphragmatic hernia.\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 inhaled nitric oxide gas, in addition to standard therapy, beneficial for babies born at full term who have lung disease leading to low levels of oxygen in the blood? Specifically, does it reduce the death rate or the number of babies who require highly invasive ECMO treatment?" } ]
query-laysum	21624	[ { "role": "user", "content": "Abstract: Background\nThis is the third update of the original Cochrane Review published in July 2005 and updated previously in 2012 and 2016.\nCancer is a significant global health issue. Radiotherapy is a treatment modality for many malignancies, and about 50% of people having radiotherapy will be long-term survivors. Some will experience late radiation tissue injury (LRTI), developing months or years following radiotherapy. Hyperbaric oxygen therapy (HBOT) has been suggested as a treatment for LRTI based on the ability to improve the blood supply to these tissues. It is postulated that HBOT may result in both healing of tissues and the prevention of complications following surgery and radiotherapy.\nObjectives\nTo evaluate the benefits and harms of hyperbaric oxygen therapy (HBOT) for treating or preventing late radiation tissue injury (LRTI) compared to regimens that excluded HBOT.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 24 January 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing the effect of HBOT versus no HBOT on LRTI prevention or healing.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. survival from time of randomisation to death from any cause; 2. complete or substantial resolution of clinical problem; 3. site-specific outcomes; and 4. adverse events. Our secondary outcomes were 5. resolution of pain; 6. improvement in quality of life, function, or both; and 7. site-specific outcomes. We used GRADE to assess certainty of evidence.\nMain results\nEighteen studies contributed to this review (1071 participants) with publications ranging from 1985 to 2022. We added four new studies to this updated review and evidence for the treatment of radiation proctitis, radiation cystitis, and the prevention and treatment of osteoradionecrosis (ORN).\nHBOT may not prevent death at one year (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.47 to 1.83; I2 = 0%; 3 RCTs, 166 participants; low-certainty evidence). There is some evidence that HBOT may result in complete resolution or provide significant improvement of LRTI (RR 1.39, 95% CI 1.02 to 1.89; I2 = 64%; 5 RCTs, 468 participants; low-certainty evidence) and HBOT may result in a large reduction in wound dehiscence following head and neck soft tissue surgery (RR 0.24, 95% CI 0.06 to 0.94; I2 = 70%; 2 RCTs, 264 participants; low-certainty evidence). In addition, pain scores in ORN improve slightly after HBOT at 12 months (mean difference (MD) −10.72, 95% CI −18.97 to −2.47; I2 = 40%; 2 RCTs, 157 participants; moderate-certainty evidence).\nRegarding adverse events, HBOT results in a higher risk of a reduction in visual acuity (RR 4.03, 95% CI 1.65 to 9.84; 5 RCTs, 438 participants; high-certainty evidence). There was a risk of ear barotrauma in people receiving HBOT when no sham pressurisation was used for the control group (RR 9.08, 95% CI 2.21 to 37.26; I2 = 0%; 4 RCTs, 357 participants; high-certainty evidence), but no such increase when a sham pressurisation was employed (RR 1.07, 95% CI 0.52 to 2.21; I2 = 74%; 2 RCTs, 158 participants; high-certainty evidence).\nAuthors' conclusions\nThese small studies suggest that for people with LRTI affecting tissues of the head, neck, bladder and rectum, HBOT may be associated with improved outcomes (low- to moderate-certainty evidence). HBOT may also result in a reduced risk of wound dehiscence and a modest reduction in pain following head and neck irradiation. However, HBOT is unlikely to influence the risk of death in the short term. HBOT also carries a risk of adverse events, including an increased risk of a reduction in visual acuity (usually temporary) and of ear barotrauma on compression. Hence, the application of HBOT to selected participants may be justified.\nThe small number of studies and participants, and the methodological and reporting inadequacies of some of the primary studies included in this review demand a cautious interpretation. More information is required on the subset of disease severity and tissue type affected that is most likely to benefit from this therapy, the time for which we can expect any benefits to persist and the most appropriate oxygen dose. Further research is required to establish the optimum participant selection and timing of any therapy. An economic evaluation should also be undertaken.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "We searched medical databases for clinical studies reporting the evidence for or against the ability of HBOT to improve these complications compared to either no treatment or alternative treatments." } ]
query-laysum	21625	[ { "role": "user", "content": "Abstract: Background\nPostoperative delirium (POD) and postoperative cognitive dysfunction (POCD) may complicate a patient's postoperative recovery in several ways. Monitoring of processed electroencephalogram (EEG) or evoked potential (EP) indices may prevent or minimize POD and POCD, probably through optimization of anaesthetic doses.\nObjectives\nTo assess whether the use of processed EEG or auditory evoked potential (AEP) indices (bispectral index (BIS), narcotrend index, cerebral state index, state entropy and response entropy, patient state index, index of consciousness, A-line autoregressive index, and auditory evoked potentials (AEP index)) as guides to anaesthetic delivery can reduce the risk of POD and POCD in non-cardiac surgical or non-neurosurgical adult patients undergoing general anaesthesia compared with standard practice where only clinical signs are used.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and clinical trial registry databases up to 28 March 2017. We updated this search in February 2018, but these results have not been incorporated in the review.\nSelection criteria\nWe included randomized or quasi-randomized controlled trials comparing any method of processed EEG or evoked potential techniques (entropy, BIS, AEP etc.) against a control group where clinical signs were used to guide doses of anaesthetics in adults aged 18 years or over undergoing general anaesthesia for non-cardiac or non-neurosurgical elective operations.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were: occurrence of POD; and occurrence of POCD. Secondary outcomes included: all-cause mortality; any postoperative complications; and postoperative length of stay. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nWe included six randomized controlled trials (RCTs) with 2929 participants comparing processed EEG or EP indices-guided anaesthesia with clinical signs-guided anaesthesia. There are five ongoing studies and one study awaiting classification.\nAnaesthesia administration guided by the indices from a processed EEG (bispectral index) probably reduces the risk of POD within seven days after surgery with risk ratio (RR) of 0.71 (95% CI 0.59 to 0.85; number needed to treat for an additional beneficial outcome (NNTB) of 17, 95% CI 11 to 34; 2197 participants; 3 RCTs; moderate quality of evidence). Three trials also showed the lower rate of POCD at 12 weeks after surgery (RR 0.71, 95% CI 0.53 to 0.96; NNTB 38, 95% CI 21 to 289; 2051 participants; moderate-quality evidence), but it is uncertain whether processed EEG indices reduce POCD at one week (RR 0.84, 95% CI 0.69 to 1.02; 3 trials; 1989 participants; moderate-quality evidence), and at 52 weeks (RR 0.30, 95% CI 0.05 to 1.80; 1 trial; 59 participants; very low quality of evidence). There may be little or no effect on all-cause mortality (RR 1.01, 95% CI 0.62 to 1.64; 1 trial; 1155 participants; low-quality evidence). One trial suggested a lower risk of any postoperative complications with processed EEG (RR 0.51, 95% CI 0.37 to 0.71; 902 participants, moderate-quality evidence). There may be little or no effect on reduced postoperative length of stay (mean difference −0.2 days, 95% CI −2.02 to 1.62; 1155 participants; low-quality evidence).\nAuthors' conclusions\nThere is moderate-quality evidence that optimized anaesthesia guided by processed EEG indices could reduce the risk of postoperative delirium in patients aged 60 years or over undergoing non-cardiac surgical and non-neurosurgical procedures. We found moderate-quality evidence that postoperative cognitive dysfunction at three months could be reduced in these patients. The effect on POCD at one week and over one year after surgery is uncertain. There are no data available for patients under 60 years. Further blinded randomized controlled trials are needed to elucidate strategies for the amelioration of postoperative delirium and postoperative cognitive dysfunction, and their consequences such as dementia (including Alzheimer's disease (AD)) in both non-elderly (below 60 years) and elderly (60 years or over) adult patients. The one study awaiting classification and five ongoing studies may alter the conclusions of the review once 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" }, { "role": "assistant", "content": "The evidence is current to March 2017. We found six completed studies, five ongoing studies, and one awaiting classification." } ]
query-laysum	21626	[ { "role": "user", "content": "Abstract: Background\nFocal segmental glomerulosclerosis (FSGS) can be separated into primary, genetic or secondary causes. Primary disease results in nephrotic syndrome while genetic and secondary forms may be associated with asymptomatic proteinuria or with nephrotic syndrome. Overall only about 20% of patients with FSGS experience a partial or complete remission of nephrotic syndrome with treatment. FSGS progresses to kidney failure in about half of the cases. This is an update of a review first published in 2008.\nObjectives\nTo assess the benefits and harms of immunosuppressive and non-immunosuppressive treatment regimens in adults with FSGS.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies to 21 June 2021 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs of any intervention for FSGS in adults were included. Studies comparing different types, routes, frequencies, and duration of immunosuppressive agents and non-immunosuppressive agents were assessed.\nData collection and analysis\nAt least two authors independently assessed study quality and extracted data. Statistical analyses were performed using the random-effects model and results were expressed as a risk ratio (RR) for dichotomous outcomes, or mean difference (MD) for continuous data with 95% confidence intervals (CI). Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nFifteen studies (560 participants) were included. No studies specifically evaluating corticosteroids compared with placebo or supportive therapy were identified. Studies evaluated participants with steroid-resistant FSGS. Five studies (240 participants) compared cyclosporin with or without prednisone with different comparators (no specific treatment, prednisone, methylprednisolone, mycophenolate mofetil (MMF), dexamethasone). Three small studies compared monoclonal antibodies (adalimumab, fresolimumab) with other agents or placebo. Six single small studies compared rituximab with tacrolimus, cyclosporin plus valsartan with cyclosporin alone, MMF with prednisone, chlorambucil plus methylprednisolone and prednisone with no specific treatment, different regimens of dexamethasone and CCX140-B (an antagonist of the chemokine receptor CCR2) with placebo. The final study (109 participants) compared sparsentan, a dual inhibitor of endothelin Type A receptor and of the angiotensin II Type 1 receptor, with irbesartan. In the risk of bias assessment, seven and five studies were at low risk of bias for sequence generation and allocation concealment, respectively. Four studies were at low risk of performance bias and 14 studies were at low risk of detection bias. Thirteen, six and five studies were at low risk of attrition bias, reporting bias and other bias, respectively.\nOf five studies evaluating cyclosporin, four could be included in our meta-analyses (231 participants). Cyclosporin with or without prednisone compared with different comparators may increase the likelihood of complete remission (RR 2.31, 95% CI 1.13 to 4.73; I² = 1%; low certainty evidence) and of complete or partial remission (RR 1.64, 95% CI 1.10 to 2.44; I² = 19%) but not of partial remission (RR 1.36, 95% CI 0.78 to 2.39, I² = 22%). In Individual studies, cyclosporin with prednisone versus prednisone may increase the likelihood of partial (49 participants: RR 7.96, 95% CI 1.09 to 58.15) or complete or partial remission (49 participants: RR 8.85, 95% CI 1.22 to 63.92) but not of complete remission. The remaining individual comparisons may make little or no difference to the likelihood of complete remission, partial remission or complete or partial remission compared with no treatment, methylprednisolone, MMF, or dexamethasone. Individual study data and combined data showed that cyclosporin may make little or no difference to the outcomes of chronic kidney disease or kidney failure. It is uncertain whether cyclosporin compared with these comparators in individual or combined analyses makes any difference to the outcomes of hypertension or infection.\nMMF compared with prednisone may make little or no difference to the likelihood of complete remission (33 participants: RR 1.05, 95% CI 0.58 to 1.88; low certainty evidence), partial remission, complete or partial remission, glomerular filtration rate, or infection. It is uncertain whether other interventions make any difference to outcomes as the certainty of the evidence is very low. It is uncertain whether sparsentan reduces proteinuria to a greater extent than irbesartan.\nAuthors' conclusions\nNo RCTs, which evaluated corticosteroids, were identified although the KDIGO guidelines recommend corticosteroids as the first treatment for adults with FSGS. The studies identified included participants with steroid-resistant FSGS. Treatment with cyclosporin for at least six months was more likely to achieve complete remission of proteinuria compared with other treatments but there was considerable imprecision due to few studies and small participant numbers. In future studies of existing or new interventions, the investigators must clearly define the populations included in the study to provide appropriate recommendations for patients with primary, genetic or secondary FSGS.\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 15 studies involving 553 participants. In five studies cyclosporin was compared with different treatments. Combining four studies (231 participants) showed that cyclosporin was more effective than these other treatments in achieving complete remission of nephrotic syndrome. The studies were too small and lasted for too short a time to determine if cyclosporin reduced the risk of kidney failure. Nine small studies examined different medicines that suppress the body's immune system. None of these treatments reduced the amount of protein in the urine." } ]
query-laysum	21627	[ { "role": "user", "content": "Abstract: Background\nAllogeneic haematopoietic stem cell transplantation (allo-HSCT) is an established treatment option for many malignant and non-malignant disorders. In the past two decades, peripheral blood stem cells replaced bone marrow as stem cell source due to faster engraftment and practicability. Previous meta-analyses analysed patients treated from 1990 to 2002 and demonstrated no impact of the stem cell source on overall survival, but a greater risk for graft-versus-host disease (GvHD) in peripheral blood transplants. As transplant indications and conditioning regimens continue to change, whether the choice of the stem cell source has an impact on transplant outcomes remains to be determined.\nObjectives\nTo assess the effect of bone marrow versus peripheral blood stem cell transplantation in adult patients with haematological malignancies with regard to overall survival, incidence of relapse and non-relapse mortality, disease-free survival, transplant-related mortality, incidence of GvHD and time to engraftment.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 1), MEDLINE (from 1948 to February 2014), trial registries and conference proceedings. The search was conducted in October 2011 and was last updated in February 2014. We did not apply any language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing bone marrow and peripheral blood allogeneic stem cell transplantation in adults with haematological malignancies.\nData collection and analysis\nTwo review authors screened abstracts and extracted and analysed data independently. We contacted study authors for additional information. We used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included nine RCTs that met the pre-defined selection criteria, involving a total of 1521 participants. Quality of data reporting was heterogeneous among the studies. Overall, the risk of bias in the included studies was low.\nFor the primary outcome overall survival, our analysis demonstrated comparable results between bone marrow transplantation (BMT) and peripheral blood stem cell transplantation (PBSCT) (six studies, 1330 participants; hazard ratio (HR) 1.07; 95% CI 0.91 to 1.25; P value = 0.43; high-quality evidence).\nDisease-free survival (six studies, 1225 participants; HR 1.04; 95% CI 0.89 to 1.21; P value = 0.6; moderate-quality of evidence) and non-relapse or transplant-related mortality (three studies, 758 participants; HR 0.98; 95% CI 0.76 to 1.28; P = 0.91; high-quality evidence) were also comparable between transplantation arms.\nIn the related-donor setting, data from two of eight studies with 211 participants (21%) indicated a higher relapse incidence in participants transplanted with bone marrow stem cells rather than peripheral blood stem cells (HR 2.73; 95% CI 1.47 to 5.08; P value = 0.001). There was no clear evidence of a difference in relapse incidence between transplantation groups in unrelated donors (HR 1.07; 95% CI 0.78 to 1.47; P value = 0.66). The difference between the donor-related and -unrelated subgroups (P-value = 0.008) was considered to be statistically significant.\nBMT was associated with lower rates of overall and extensive chronic GvHD than PBSCT (overall chronic GvHD: four studies, 1121 participants; HR 0.72; 95% CI 0.61 to 0.85; P value = 0.0001, extensive chronic GvHD: four studies, 765 participants; HR 0.69; 95% CI 0.54 to 0.9; P value = 0.006; moderate-quality evidence for both outcomes). The incidence of acute GvHD grades II to IV was not lower (six studies, 1330 participants; HR 1.03; 95% CI 0.89 to 1.21; P value = 0.67; moderate-quality evidence), but there was a trend for a lower incidence of grades III and IV acute GvHD with BMT than with PBSCT (three studies, 925 participants; HR 0.75; 95% CI 0.55 to 1.02; P value = 0.07; moderate-quality evidence).\nTimes to neutrophil and platelet engraftment were longer with BMT than with PBSCT (neutrophil: five studies, 662 participants; HR 1.96; 95% CI 1.64 to 2.35; P value < 0.00001; platelet: four studies, 333 participants; HR 2.17; 95% CI 1.69 to 2.78; P value < 0.00001).\nAuthors' conclusions\nThis systematic review found high-quality evidence that overall survival following allo-HSCT using the current clinical standard stem cell source - peripheral blood stem cells - was similar to that following allo-HSCT using bone marrow stem cells in adults with haematological malignancies. We found moderate-quality evidence that PBSCT was associated with faster engraftment of neutrophils and platelets, but a higher risk of GvHD (in terms of more overall and extensive chronic GvHD). There was an imprecise effect on relapse and on severe (grades III to IV) acute GvHD. Quality of life, which is severely affected by GvHD, was not evaluated.\nAgainst the background of transplantation practices that have clearly changed over the past 10 to 15 years, our aim was to provide current data on the best stem cell source for allo-HSCT, by including the results of recently conducted trials. Our review includes participants recruited up to 2009, a proportion of whom were older, had received reduced-intensity conditioning regimens or had been transplanted with stem cells from unrelated donors. However, only one, large, study included relatively recently treated participants. Nevertheless, our findings are comparable to those of previous meta-analyses suggesting that our results hold true for today's practice.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n" }, { "role": "assistant", "content": "Against the background of altering clinical strategies these results confirm that the current practice of using peripheral blood rather than bone marrow as a source of stem cells for stem cell transplantation in adults with haematological malignancies is not deleterious with respect to overall survival." } ]
query-laysum	21628	[ { "role": "user", "content": "Abstract: Background\nMacrolide antibiotics (macrolides) are among the most commonly prescribed antibiotics worldwide and are used for a wide range of infections. However, macrolides also expose people to the risk of adverse events. The current understanding of adverse events is mostly derived from observational studies, which are subject to bias because it is hard to distinguish events caused by antibiotics from events caused by the diseases being treated. Because adverse events are treatment-specific, rather than disease-specific, it is possible to increase the number of adverse events available for analysis by combining randomised controlled trials (RCTs) of the same treatment across different diseases.\nObjectives\nTo quantify the incidences of reported adverse events in people taking macrolide antibiotics compared to placebo for any indication.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), which includes the Cochrane Acute Respiratory Infections Group Specialised Register (2018, Issue 4); MEDLINE (Ovid, from 1946 to 8 May 2018); Embase (from 2010 to 8 May 2018); CINAHL (from 1981 to 8 May 2018); LILACS (from 1982 to 8 May 2018); and Web of Science (from 1955 to 8 May 2018). We searched clinical trial registries for current and completed trials (9 May 2018) and checked the reference lists of included studies and of previous Cochrane Reviews on macrolides.\nSelection criteria\nWe included RCTs that compared a macrolide antibiotic to placebo for any indication. We included trials using any of the four most commonly used macrolide antibiotics: azithromycin, clarithromycin, erythromycin, or roxithromycin. Macrolides could be administered by any route. Concomitant medications were permitted provided they were equally available to both treatment and comparison groups.\nData collection and analysis\nTwo review authors independently extracted and collected data. We assessed the risk of bias of all included studies and the quality of evidence for each outcome of interest. We analysed specific adverse events, deaths, and subsequent carriage of macrolide-resistant bacteria separately. The study participant was the unit of analysis for each adverse event. Any specific adverse events that occurred in 5% or more of any group were reported. We undertook a meta-analysis when three or more included studies reported a specific adverse event.\nMain results\nWe included 183 studies with a total of 252,886 participants (range 40 to 190,238). The indications for macrolide antibiotics varied greatly, with most studies using macrolides for the treatment or prevention of either acute respiratory tract infections, cardiovascular diseases, chronic respiratory diseases, gastrointestinal conditions, or urogynaecological problems. Most trials were conducted in secondary care settings. Azithromycin and erythromycin were more commonly studied than clarithromycin and roxithromycin.\nMost studies (89%) reported some adverse events or at least stated that no adverse events were observed.\nGastrointestinal adverse events were the most commonly reported type of adverse event. Compared to placebo, macrolides caused more diarrhoea (odds ratio (OR) 1.70, 95% confidence interval (CI) 1.34 to 2.16; low-quality evidence); more abdominal pain (OR 1.66, 95% CI 1.22 to 2.26; low-quality evidence); and more nausea (OR 1.61, 95% CI 1.37 to 1.90; moderate-quality evidence). Vomiting (OR 1.27, 95% CI 1.04 to 1.56; moderate-quality evidence) and gastrointestinal disorders not otherwise specified (NOS) (OR 2.16, 95% CI 1.56 to 3.00; moderate-quality evidence) were also reported more often in participants taking macrolides compared to placebo.\nThe number of additional people (absolute difference in risk) who experienced adverse events from macrolides was: gastrointestinal disorders NOS 85/1000; diarrhoea 72/1000; abdominal pain 62/1000; nausea 47/1000; and vomiting 23/1000.\nThe number needed to treat for an additional harmful outcome (NNTH) ranged from 12 (95% CI 8 to 23) for gastrointestinal disorders NOS to 17 (9 to 47) for abdominal pain; 19 (12 to 33) for diarrhoea; 19 (13 to 30) for nausea; and 45 (22 to 295) for vomiting.\nThere was no clear consistent difference in gastrointestinal adverse events between different types of macrolides or route of administration.\nTaste disturbances were reported more often by participants taking macrolide antibiotics, although there were wide confidence intervals and moderate heterogeneity (OR 4.95, 95% CI 1.64 to 14.93; I² = 46%; low-quality evidence).\nCompared with participants taking placebo, those taking macrolides experienced hearing loss more often, however only four studies reported this outcome (OR 1.30, 95% CI 1.00 to 1.70; I² = 0%; low-quality evidence).\nWe did not find any evidence that macrolides caused more cardiac disorders (OR 0.87, 95% CI 0.54 to 1.40; very low-quality evidence); hepatobiliary disorders (OR 1.04, 95% CI 0.27 to 4.09; very low-quality evidence); or changes in liver enzymes (OR 1.56, 95% CI 0.73 to 3.37; very low-quality evidence) compared to placebo.\nWe did not find any evidence that appetite loss, dizziness, headache, respiratory symptoms, blood infections, skin and soft tissue infections, itching, or rashes were reported more often by participants treated with macrolides compared to placebo.\nMacrolides caused less cough (OR 0.57, 95% CI 0.40 to 0.80; moderate-quality evidence) and fewer respiratory tract infections (OR 0.70, 95% CI 0.62 to 0.80; moderate-quality evidence) compared to placebo, probably because these are not adverse events, but rather characteristics of the indications for the antibiotics. Less fever (OR 0.73, 95% 0.54 to 1.00; moderate-quality evidence) was also reported by participants taking macrolides compared to placebo, although these findings were non-significant.\nThere was no increase in mortality in participants taking macrolides compared with placebo (OR 0.96, 95% 0.87 to 1.06; I² = 11%; low-quality evidence).\nOnly 24 studies (13%) provided useful data on macrolide-resistant bacteria. Macrolide-resistant bacteria were more commonly identified among participants immediately after exposure to the antibiotic. However, differences in resistance thereafter were inconsistent.\nPharmaceutical companies supplied the trial medication or funding, or both, for 91 trials.\nAuthors' conclusions\nThe macrolides as a group clearly increased rates of gastrointestinal adverse events. Most trials made at least some statement about adverse events, such as \"none were observed\". However, few trials clearly listed adverse events as outcomes, reported on the methods used for eliciting adverse events, or even detailed the numbers of people who experienced adverse events in both the intervention and placebo group. This was especially true for the adverse event of bacterial resistance.\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 183 studies with a total of 252,886 participants. Most studies were conducted in the hospital setting. Azithromycin and erythromycin were more commonly studied than clarithromycin and roxithromycin. Most studies (89%) reported some adverse events, or at least stated that no adverse events were observed." } ]
query-laysum	21629	[ { "role": "user", "content": "Abstract: Background\nLevels of physical activity and physical fitness are low after stroke. Interventions to increase physical fitness could reduce mortality and reduce disability through increased function.\nObjectives\nThe primary objectives of this updated review were to determine whether fitness training after stroke reduces death, death or dependence, and disability. The secondary objectives were to determine the effects of training on adverse events, risk factors, physical fitness, mobility, physical function, health status and quality of life, mood, and cognitive function.\nSearch methods\nIn July 2018 we searched the Cochrane Stroke Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, SPORTDiscus, PsycINFO, and four additional databases. We also searched ongoing trials registers and conference proceedings, screened reference lists, and contacted experts in the field.\nSelection criteria\nRandomised trials comparing either cardiorespiratory training or resistance training, or both (mixed training), with usual care, no intervention, or a non-exercise intervention in stroke survivors.\nData collection and analysis\nTwo review authors independently selected studies, assessed quality and risk of bias, and extracted data. We analysed data using random-effects meta-analyses and assessed the quality of the evidence using the GRADE approach. Diverse outcome measures limited the intended analyses.\nMain results\nWe included 75 studies, involving 3017 mostly ambulatory participants, which comprised cardiorespiratory (32 studies, 1631 participants), resistance (20 studies, 779 participants), and mixed training interventions (23 studies, 1207 participants).\nDeath was not influenced by any intervention; risk differences were all 0.00 (low-certainty evidence). There were few deaths overall (19/3017 at end of intervention and 19/1469 at end of follow-up). None of the studies assessed death or dependence as a composite outcome. Disability scores were improved at end of intervention by cardiorespiratory training (standardised mean difference (SMD) 0.52, 95% CI 0.19 to 0.84; 8 studies, 462 participants; P = 0.002; moderate-certainty evidence) and mixed training (SMD 0.23, 95% CI 0.03 to 0.42; 9 studies, 604 participants; P = 0.02; low-certainty evidence). There were too few data to assess the effects of resistance training on disability.\nSecondary outcomes showed multiple benefits for physical fitness (VO2 peak and strength), mobility (walking speed) and physical function (balance). These physical effects tended to be intervention-specific with the evidence mostly low or moderate certainty. Risk factor data were limited or showed no effects apart from cardiorespiratory fitness (VO2 peak), which increased after cardiorespiratory training (mean difference (MD) 3.40 mL/kg/min, 95% CI 2.98 to 3.83; 9 studies, 438 participants; moderate-certainty evidence). There was no evidence of any serious adverse events. Lack of data prevents conclusions about effects of training on mood, quality of life, and cognition. Lack of data also meant benefits at follow-up (i.e. after training had stopped) were unclear but some mobility benefits did persist. Risk of bias varied across studies but imbalanced amounts of exposure in control and intervention groups was a common issue affecting many comparisons.\nAuthors' conclusions\nFew deaths overall suggest exercise is a safe intervention but means we cannot determine whether exercise reduces mortality or the chance of death or dependency. Cardiorespiratory training and, to a lesser extent mixed training, reduce disability during or after usual stroke care; this could be mediated by improved mobility and balance. There is sufficient evidence to incorporate cardiorespiratory and mixed training, involving walking, within post-stroke rehabilitation programmes to improve fitness, balance and the speed and capacity of walking. The magnitude of VO2 peak increase after cardiorespiratory training has been suggested to reduce risk of stroke hospitalisation by ˜7%. Cognitive function is under-investigated despite being a key outcome of interest for patients. Further well-designed randomised trials are needed to determine the optimal exercise prescription, the range of benefits and any long-term benefits.\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": "In July 2018 we identified 75 studies for inclusion in the review. The studies involved a total of 3617 participants at all stages of care including being in hospital or back living at home. Most of the people who took part were able to walk on their own. The studies tested different forms of fitness training; these included cardiorespiratory or 'endurance' training, resistance or 'strength' training, or mixed training, which is a combination of cardiorespiratory plus resistance training." } ]
query-laysum	21630	[ { "role": "user", "content": "Abstract: Background\nCystic fibrosis is a life-limiting genetic condition in which thick mucus builds up in the lungs, leading to infections, inflammation, and eventually, deterioration in lung function. To clear their lungs of mucus, people with cystic fibrosis perform airway clearance techniques daily. There are various airway clearance techniques, which differ in terms of the need for assistance or equipment, and cost.\nObjectives\nTo summarise the evidence from Cochrane Reviews on the effectiveness and safety of various airway clearance techniques in people with cystic fibrosis.\nMethods\nFor this overview, we included Cochrane Reviews of randomised or quasi-randomised controlled trials (including cross-over trials) that evaluated an airway clearance technique (conventional chest physiotherapy, positive expiratory pressure (PEP) therapy, high-pressure PEP therapy, active cycle of breathing techniques, autogenic drainage, airway oscillating devices, external high frequency chest compression devices and exercise) in people with cystic fibrosis.\nWe searched the Cochrane Database of Systematic Reviews on 29 November 2018.\nTwo review authors independently evaluated reviews for eligibility. One review author extracted data from included reviews and a second author checked the data for accuracy. Two review authors independently graded the quality of reviews using the ROBIS tool. We used the GRADE approach for assessing the overall strength of the evidence for each primary outcome (forced expiratory volume in one second (FEV1), individual preference and quality of life).\nMain results\nWe included six Cochrane Reviews, one of which compared any type of chest physiotherapy with no chest physiotherapy or coughing alone and the remaining five reviews included head-to-head comparisons of different airway clearance techniques. All the reviews were considered to have a low risk of bias. However, the individual trials included in the reviews often did not report sufficient information to adequately assess risk of bias. Many trials did not sufficiently report on outcome measures and had a high risk of reporting bias.\nWe are unable to draw definitive conclusions for comparisons of airway clearance techniques in terms of FEV1, except for reporting no difference between PEP therapy and oscillating devices after six months of treatment, mean difference -1.43% predicted (95% confidence interval -5.72 to 2.87); the quality of the body of evidence was graded as moderate. The quality of the body of evidence comparing different airway clearance techniques for other outcomes was either low or very low.\nAuthors' conclusions\nThere is little evidence to support the use of one airway clearance technique over another. People with cystic fibrosis should choose the airway clearance technique that best meets their needs, after considering comfort, convenience, flexibility, practicality, cost, or some other factor. More long-term, high-quality randomised controlled trials comparing airway clearance techniques among people with cystic fibrosis are needed.\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": "All of the reviews were considered to be well-conducted. However, the individual trials included in the reviews often did not report enough detailed information to allow us to properly determine trial quality. Many trials did not report enough information on outcome measures; it is unclear how this missing information would influence the results. We graded the evidence for lung function when PEP was compared to vibrating (oscillating) devices as moderate, but the evidence comparing different airway clearance techniques for other outcomes, such as individual preference and quality of life was of low or very low quality. More long-term, high-quality trials (where participants are put into groups at random) which compare different airway clearance techniques among people with CF are needed." } ]

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