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This systematic review aimed to evaluate the effects of therapeutic exercise on physical and psychosocial outcomes in community-dwelling adults aged 80 years or older. Databases were searched from inception to July 8, 2020. Randomized controlled trials (RCTs) were screened by two reviewers who extracted data and assessed study quality. Sixteen RCTs (1,660 participants) were included. Compared to nonexercise controls there was no evidence of an effect of exercise on performance based (standardized mean differences: 0.58, 95% confidence interval: [−0.19, 1.36]; I2: 89%; six RCTs; 290 participants; very low-quality evidence) or self-reported physical function (standardized mean differences: 1.35, 95% confidence interval: [−0.78, 3.48]; I2: 96%; three RCTs; 280 participants; very low-quality evidence) at short-medium term follow-up. Four RCTs reporting psychosocial outcomes could not be combined in meta-analysis and reported varying results. Exercise appeared to reduce the risk of mortality during follow-up (risk ratio: 0.47, 95% confidence interval: [0.32, 0.70]; I2: 0.0%; six RCTs; 1,222 participants; low-quality evidence). [ABSTRACT FROM AUTHOR]

Objective: To assess the longer term effects of multifactorial interventions for preventing falls in older people living in the community, and to explore whether prespecific trial-level characteristics are associated with greater fall prevention effects.Design: Systematic review with meta-analysis and meta-regression.Data Sources: MEDLINE, EMBASE, CINHAL, CENTRAL and trial registries were searched up to 25 July 2018.Study Selection: We included randomised controlled trials (≥12 months' follow-up) evaluating the effects of multifactorial interventions on falls in older people aged 65 years and over, living in the community, compared with either usual care or usual care plus advice.Review Methods: Two authors independently verified studies for inclusion, assessed risk of bias and extracted data. Rate ratios (RaR) with 95% CIs were calculated for rate of falls, risk ratios (RR) for dichotomous outcomes and standardised mean difference for continuous outcomes. Data were pooled using a random effects model. The Grading of Recommendations, Assessment, Development and Evaluation was used to assess the quality of the evidence.Results: We included 41 trials totalling 19 369 participants; mean age 72-85 years. Exercise was the most common prespecified component of the multifactorial interventions (85%; n=35/41). Most trials were judged at unclear or high risk of bias in ≥1 domain. Twenty trials provided data on rate of falls and showed multifactorial interventions may reduce the rate at which people fall compared with the comparator (RaR 0.79, 95% CI 0.70 to 0.88; 20 trials; 10 116 participants; I2=90%; low-quality evidence). Multifactorial interventions may also slightly lower the risk of people sustaining one or more falls (RR 0.95, 95% CI 0.90 to 1.00; 30 trials; 13 817 participants; I2=56%; moderate-quality evidence) and recurrent falls (RR 0.88, 95% CI 0.78 to 1.00; 15 trials; 7277 participants; I2=46%; moderate-quality evidence). However, there may be little or no difference in other fall-related outcomes, such as fall-related fractures, falls requiring hospital admission or medical attention and health-related quality of life. Very few trials (n=3) reported on adverse events related to the intervention. Prespecified subgroup analyses showed that the effect on rate of falls may be smaller when compared with usual care plus advice as opposed to usual care only. Overall, heterogeneity remained high and was not explained by the prespecified characteristics included in the meta-regression.Conclusion: Multifactorial interventions (most of which include exercise prescription) may reduce the rate of falls and slightly reduce risk of older people sustaining one or more falls and recurrent falls (defined as two or more falls within a specified time period).Trial Registration Number: CRD42018102549. [ABSTRACT FROM AUTHOR]

Aim: To determine the reported outcome domains and measures used to assess lower limb orthopaedic surgery of ambulant children and young people with cerebral palsy (CP) and map these outcomes to the International Classification of Functioning, Disability and Health - Children and Youth (ICF-CY) framework.Method: This updated scoping review included studies published between January 2016 and July 2019 in five databases: MEDLINE, PubMed, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials. Studies were included if participants were ambulant individuals with CP aged between 0 and 20 years who had undergone lower limb orthopaedic surgery. Health outcome domains and measures were identified and classified using the ICF-CY framework.Results: Forty-four eligible studies were identified with a total of 40 different outcome domains recorded. Among eligible studies, 44 (100%) measured body function and structural impairment and seven (16%) measured activity limitation and participation restriction. The most frequently reported outcome was gait pattern (n=37, 84%). Few studies reported adverse effects of surgery (n=13, 30%). Twenty-nine different outcome measures were identified. Patient-reported outcomes measures were used in 10 studies (23%).Interpretation: The review highlights a heterogeneity in the reported outcome domains and measures used in CP studies. The majority of the reported outcomes focus on the ICF-CY domain of body function and structure. The review also highlights a notable shift towards patient-reported outcomes in recent years. Development of a core outcome set for lower limb orthopaedic surgery would guide researchers to use more consistent and complete measurement sets. [ABSTRACT FROM AUTHOR]

Objectives: To assess the effects of exercise interventions for preventing falls in older people living in the community.Selection Criteria: We included randomised controlled trials evaluating the effects of any form of exercise as a single intervention on falls in people aged 60+years living in the community.Results: Exercise reduces the rate of falls by 23% (rate ratio (RaR) 0.77, 95% CI 0.71 to 0.83; 12 981 participants, 59 studies; high-certainty evidence). Subgroup analyses showed no evidence of a difference in effect on falls on the basis of risk of falling as a trial inclusion criterion, participant age 75 years+ or group versus individual exercise but revealed a larger effect of exercise in trials where interventions were delivered by a health professional (usually a physiotherapist). Different forms of exercise had different impacts on falls. Compared with control, balance and functional exercises reduce the rate of falls by 24% (RaR 0.76, 95% CI 0.70 to 0.81; 7920 participants, 39 studies; high-certainty evidence). Multiple types of exercise (commonly balance and functional exercises plus resistance exercises) probably reduce the rate of falls by 34% (RaR 0.66, 95% CI 0.50 to 0.88; 1374 participants, 11 studies; moderate-certainty evidence). Tai Chi may reduce the rate of falls by 19% (RaR 0.81, 95% CI 0.67 to 0.99; 2655 participants, 7 studies; low-certainty evidence). We are uncertain of the effects of programmes that primarily involve resistance training, dance or walking.Conclusions and Implications: Given the certainty of evidence, effective programmes should now be implemented. [ABSTRACT FROM AUTHOR]

Importance: The quality of reporting of randomized clinical trials is suboptimal. In an era in which the need for greater research transparency is paramount, inadequate reporting hinders assessment of the reliability and validity of trial findings. The Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement was developed to improve the reporting of randomized clinical trials, but the primary focus was on parallel-group trials with 2 groups. Multi-arm trials that use a parallel-group design (comparing treatments by concurrently randomizing participants to one of the treatment groups, usually with equal probability) but have 3 or more groups are relatively common. The quality of reporting of multi-arm trials varies substantially, making judgments and interpretation difficult. While the majority of the elements of the CONSORT 2010 Statement apply equally to multi-arm trials, some elements need adaptation, and, in some cases, additional issues need to be clarified.Objective: To present an extension to the CONSORT 2010 Statement for reporting multi-arm trials to facilitate the reporting of such trials.Design: A guideline writing group, which included all authors, formed following the CONSORT group meeting in 2014. The authors met in person and by teleconference bimonthly between 2014 and 2018 to develop and revise the checklist and the accompanying text, with additional discussions by email. A draft manuscript was circulated to the wider CONSORT group of 36 individuals, plus 5 other selected individuals known for their specialist knowledge in clinical trials, for review. Extensive feedback was received from 14 individuals and, after detailed consideration of their comments, a final revised version of the extension was prepared.Findings: This CONSORT extension for multi-arm trials expands on 10 items of the CONSORT 2010 checklist and provides examples of good reporting and a rationale for the importance of each extension item. Key recommendations are that multi-arm trials should be identified as such and require clear objectives and hypotheses referring to all of the treatment groups. Primary treatment comparisons should be identified and authors should report the planned and unplanned comparisons resulting from multiple groups completely and transparently. If statistical adjustments for multiplicity are applied, the rationale and method used should be described.Conclusions and Relevance: This extension of the CONSORT 2010 Statement provides specific guidance for the reporting of multi-arm parallel-group randomized clinical trials and should help provide greater transparency and accuracy in the reporting of such trials. [ABSTRACT FROM AUTHOR]

Background: Arthroscopic surgery of the knee is one of the most frequently performed orthopaedic procedures. One-third of these procedures are performed for meniscal injuries. It is essential that this commonly performed surgery be supported by robust evidence. Purpose: To compare the effectiveness of arthroscopic surgery for meniscal injuries in all populations. Study Design: Systematic review. Methods: An online search was conducted for randomized controlled trials (RCTs) and systematic reviews (SRs) that compared treatment options for meniscal injury. The following databases (inception to April 2015) were included in the search: CENTRAL; MEDLINE; EMBASE; NHS Evidence; National Guideline Clearing House, Database of Abstracts of Reviews of Effects, Health Technology Assessment; ISRCTN; Clinicaltrials.gov; WHO trials platform. Only studies whose participants were selected on the basis of meniscal injury were included; no restrictions were placed on patient demographics. Two independent reviewers applied AMSTAR (A Measurement Tool to Assess Systematic Reviews) criteria for SRs and the Cochrane Collaboration risk-of-bias tool for RCTs. Results: Nine RCTs and 8 SRs were included in the review. No difference was found between arthroscopic meniscal debridement compared with nonoperative management as a first-line treatment strategy for patients with knee pain and a degenerative meniscal tear (mean difference: Knee injury and Osteoarthritis Outcome Score, 1.6 [95% CI, −2.2 to 5.2], pain visual analog scale, −0.06 [95% CI, −0.28 to 0.15]). Some evidence was found to indicate that patients with resistant mechanical symptoms who initially fail nonoperative management may benefit from meniscal debridement No studies compared meniscal repair with meniscectomy or nonoperative management. Initial evidence suggested that meniscal transplant might be favorable in certain patient groups. Conclusion: Further evidence is required to determine which patient groups have good outcomes from each intervention. Given the current widespread use of arthroscopic meniscal surgeries, more research is urgently needed to support evidence-based practice in meniscal surgery in order to reduce the numbers of ineffective interventions and support potentially beneficial surgery. [ABSTRACT FROM AUTHOR]

Background: It is important that planned randomised trials are justified and placed in the context of the available evidence. The SPIRIT guidelines for reporting clinical trial protocols recommend that a recent and relevant systematic review should be included. The aim of this study was to assess the use of the existing evidence in order to justify trial conduct. Methods: Protocols of randomised trials published over a 1-month period (December 2015) indexed in PubMed were obtained. Data on trial characteristics relating to location, design, funding, conflict of interest and type of evidence included for trial justification was extracted in duplicate and independently by two investigators. The frequency of citation of previous research including relevant systematic reviews and randomised trials was assessed. Results: Overall, 101 protocols for RCTs were identified. Most proposed trials were parallel-group (n = 74; 73.3%). Reference to an earlier systematic review with additional randomised trials was found in 9.9% (n = 10) of protocols and without additional trials in 30.7% (n = 31), while reference was made to randomised trials in isolation in 21.8% (n = 22). Explicit justification for the proposed randomised trial on the basis of being the first to address the research question was made in 17.8% (n = 18) of protocols. A randomised controlled trial was not cited in 10.9% (95% CI: 5.6, 18.7) (n = 11), while in 8.9% (95% CI: 4.2, 16.2) (n = 9) of the protocols a systematic review was cited but did not inform trial design. Conclusions: A relatively high percentage of protocols of randomised trials involves prior citation of randomised trials, systematic reviews or both. However, improvements are required to ensure that it is explicit that clinical trials are justified and shaped by contemporary best evidence. [ABSTRACT FROM AUTHOR]

Background: Anterior open reduction is commonly used to treat hip subluxation or dislocation in developmental dysplasia of the hip (DDH) in walking-age children. Pelvic and/or femoral osteotomy may be used in addition, but it is unclear how this affects avascular necrosis (AVN) risk and radiological and clinical results.Questions/purposes: The purpose of this study was to review studies of walking-age patients treated either with an open reduction alone or combined with pelvic and/or femoral osteotomies and determine whether there is a difference between groups in the proportion of patients: (1) developing clinically relevant femoral head AVN (Kalamchi & MacEwen Types II to IV or equivalent); (2) achieving a satisfactory radiological result (Severin Grade I/II or equivalent); (3) achieving a satisfactory clinical result (McKay excellent or good rating or equivalent); and (4) requiring further nonsalvage surgery.Methods: MEDLINE, Embase, the Cochrane Centre Register of Controlled Trials, and ClinicalTrials.gov were searched for studies of anterior open reduction for DDH in children aged 12 months to 6 years old. We assessed AVN, clinical and radiological results, and requirement for further procedures. The effect of failed conservative management, traction, age at operation, and followup duration was also assessed. Eighteen studies met the review eligibility criteria.Results: Open reduction alone had a lower risk of AVN than open reduction combined with pelvic and femoral osteotomy (4% versus 24%), but there was no significant difference compared with open reduction with either pelvic (17%) or femoral osteotomy (18%). More hips treated with open reduction alone had satisfactory radiological results than open reduction combined with pelvic and femoral osteotomy (97% versus 83%) and satisfactory clinical results than all other interventions. More hips treated with open reduction alone required further surgical management (56%) compared with open reduction and pelvic osteotomy (11%) and combined pelvic and femoral osteotomies (8%).Conclusions: Open reduction with concomitant pelvic osteotomy is the most appropriate option to provide durable results with the lowest risk of AVN and best radiological and clinical results. There is no evidence that addition of a femoral osteotomy provides any additional benefit to the patient, although it may be necessary to achieve reduction.Level Of Evidence: Level III, therapeutic study. [ABSTRACT FROM AUTHOR]

We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms ‘pilot’ and ‘feasibility’ in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms ‘feasibility’ or ‘pilot’ as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term ‘feasibility’ in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention. [ABSTRACT FROM AUTHOR]

Background: Many researchers and professional bodies are seeking consensus for core outcomes for clinical trials. The Prevention of Falls Network Europe (ProFaNE) developed a common outcome data set for fall injury prevention trials 10 years ago. This study assesses the impact of these recommendations.Methods: A systematic search (up to 16 January 2015) was performed using Web of Science, Scopus and PubMed for articles citing the ProFaNE recommendations. Randomised trials on fall prevention in older people were selected for further analysis. Data were extracted on study characteristics and adherence to the key domains recommended by the ProFaNE consensus: falls, fall injury, physical activity, psychological consequences and health-related quality of life. Details of non-recommended outcome measures used were also recorded.Results: The ProFaNE recommendations were cited in a total of 464 published articles, of which 34 were randomised trials on fall prevention in older people. Only one study (3 %) reported on all core domains. Most of the trials reported on falls (n = 32/34, 94 %) as a core outcome measure. Most of the recommendations within the falls domain were well-followed. Around half of the trials reported on fall-related injury (n = 16/34, 47 %). However, none reported the number of radiologically confirmed peripheral fracture events, which is the recommended outcome measure for injury. The other key domains (quality of life, physical activity and psychological consequences) were less frequently reported on, with a lack of consistency in the outcome measures used.Conclusions: The ProFaNE recommendations had a limited effect on standardising the reporting of outcomes in randomised trials on fall injury prevention in older people during the search period. Authors of consensus guidelines should consider maximising buy-in by including a diversity of geographic areas and academic disciplines at the development stage and using a solid dissemination strategy. [ABSTRACT FROM AUTHOR]

Background To allow an accurate evaluation of abstracts of systematic reviews, the PRISMA Statement recommends that the limitations of the evidence (e.g., risk of bias, publication bias, inconsistency, imprecision) should be described in the abstract. We aimed to evaluate the impact of adding such limitations sections on reader's interpretation. Method We performed a two-arm parallel group randomized controlled trial (RCT) using a sample of 30 abstracts of systematic reviews evaluating the effects of healthcare intervention with conclusions favoring the beneficial effect of the experimental treatments. Two formats of these abstracts were derived: one reported without and one with a standardized limitations section written according to the PRISMA statement for abstracts. The primary outcome was readers' confidence in the results of the systematic review as stated in the abstract assessed by a Likert scale from 0, not at all confident, to 10, very confident. In total, 300 participants (corresponding authors of RCT reports indexed in PubMed) were randomized by a web-based randomization procedure to interpret one abstract with a limitations section (n = 150) or without a limitations section (n = 150). Participants were blinded to the study hypothesis. Results Adding a limitations section did not modify readers' interpretation of findings in terms of confidence in the results (mean difference [95% confidence interval] 0.19 [-0.37-0.74], p = 0.50), confidence in the validity of the conclusions (0.07 [-0.49-0.62], p = 0.80), or benefit of the experimental intervention (0.12 [-0.42-0.44], p = 0.65). This study is limited because the participants were expert-readers and are not representative of all systematic review readers. Conclusion Adding a limitations section to abstracts of systematic reviews did not affect readers' interpretation of the abstract results. Other studies are needed to confirm the results and explore the impact of a limitations section on a less expert panel of participants. [ABSTRACT FROM AUTHOR]

Background: Determining the effectiveness of social and psychological interventions is important for improving individual and population health. Such interventions are complex and, where possible, are best evaluated by randomised controlled trials (RCTs). The use of research findings in policy and practice decision making is hindered by poor reporting of RCTs. Poor reporting limits the ability to replicate interventions, synthesise evidence in systematic reviews, and utilise findings for evidence-based policy and practice. The lack of guidance for reporting the specific methodological features of complex intervention RCTs contributes to poor reporting. We aim to develop an extension of the Consolidated Standards of Reporting Trials Statement for Social and Psychological Interventions (CONSORT-SPI). Methods/design: This research project will be conducted in five phases. The first phase was the project launch, which consisted of the establishment of a Project Executive and International Advisory Group, and recruitment of journal editors and the CONSORT Group. The second phase involves a Delphi process that will generate a list of possible items to include in the CONSORT Extension. Next, there will be a formal consensus meeting to select the reporting items to add to, or modify for, the CONSORT-SPI Extension. Fourth, guideline documents will be written, including an explanation and elaboration (E&E) document that will provide detailed advice for each item and examples of good reporting. The final phase will comprise guideline dissemination, with simultaneous publication and endorsement of the guideline in multiple journals, endorsement by funding agencies, presentations at conferences and other meetings, and a dedicated website that will facilitate feedback about the guideline. Conclusion: As demonstrated by previous CONSORT guidelines, the development of an evidence-based reporting guideline for social and psychological intervention RCTs should improve the accuracy, comprehensiveness, and transparency of study reports. This, in turn, promises to improve the critical appraisal of research and its use in policy and practice decision making. We invite readers to participate in the project by visiting our website (http://tinyurl.com/CONSORT-study). [ABSTRACT FROM AUTHOR]

BACKGROUND: The clinical use of frozen plasma (FP) continues to increase, both in prophylactic and in therapeutic settings. In 2004, a systematic review of all published randomized controlled trials (RCTs) revealed a lack of evidence that supported the efficacy of FP use. This is an update that includes all new RCTs published since the original review. STUDY DESIGN AND METHODS: Trials involving transfusion of FP up to July 2011 were identified from searches of MEDLINE, EMBASE, CINAHL, The Cochrane Library, and the UKBTS/SRI Transfusion Evidence Library. Methodologic quality was assessed. The primary outcome measure was the effect of FP on survival. RESULTS: Twenty-one new trials were eligible for inclusion. These covered prophylactic and therapeutic FP use in liver disease, in cardiac surgery, for warfarin anticoagulation reversal, for thrombotic thrombocytopenic purpura treatment, for plasmapheresis, and in other settings, including burns, shock, and head injury. The largest number of recent RCTs were conducted in cardiac surgery; meta-analysis showed no significant difference for FP use for the outcome of 24-hours postoperative blood loss (weighted mean difference, −35.24 mL; 95% confidence interval, −84.16 to 13.68 mL). Overall, there was no significant benefit for FP use across all the clinical conditions. Only two of the 21 trials fulfilled all the criteria for quality assessment. CONCLUSION: Combined with the 2004 review, 80 RCTs have investigated FP with no consistent evidence of significant benefit for prophylactic and therapeutic use across a range of indications evaluated. There has been little improvement in the overall methodologic quality of RCTs conducted in the past few years. [ABSTRACT FROM AUTHOR]

Premature neonates commonly receive red blood cell ( RBC) transfusions. This study systematically identified and appraised randomized controlled trials ( RCTs) where the intervention was 'transfusion of red blood cells' from searches of multiple databases. Primary review outcomes were mortality, neurodevelopmental and respiratory endpoints. Two reviewers extracted data and assigned overall quality. Twenty-seven RCTs were identified and grouped into four predefined categories: trials comparing RBC transfusion versus no transfusion/placebo ( n = 3); different thresholds for transfusion ( n = 6); differing doses or administration schedule ( n = 4), or different types or products of RBC ( n = 14). In the threshold group of trials, enrolling 679 neonates, no significant differences in mortality (relative risk 1·22, 95% confidence interval 0·84-1·75) or chronic lung disease were found. Only two trials assessed neurodevelopment outcomes, both within the threshold group, but with differing results. The largest subgroup of RCTs by number evaluated different media for storage of red cells ( n = 7), enrolling 221 neonates. The methodological quality of many RCTs was poor. The design of future RCTs can be informed by the lessons from this review. Many trials failed to report on outcomes that would be considered of primary importance to clinicians. Consistent reporting of adverse events is required, and endpoints need to include neurodevelopmental outcomes. [ABSTRACT FROM AUTHOR]

Background: There is no specific guidance for the reporting of Cochrane systematic reviews that do not have studies eligible for inclusion. As a result, the reporting of these so-called ''empty reviews'' may vary across reviews. This research explores the incidence of empty systematic reviews in The Cochrane Database of Systematic Reviews (The CDSR) and describes their current characteristics. Methodology/Principal Findings: Empty reviews within The CDSR as of 15 August 2010 were identified, extracted, and coded for analysis. Review group, original publication year, and time since last update, as well as number of studies listed as excluded, awaiting assessment, or on-going within empty reviews were examined. 376 (8.7%) active reviews in The CDSR reported no included studies. At the time of data collection, 45 (84.9%) of the Cochrane Collaboration's 53 Review Groups sustained at least one empty review, with the number of empty reviews for each of these 45 groups ranging from 1 to 35 (2.2-26.9%). Time since original publication of empty reviews ranged from 0 to 15 years with a mean of 4.2 years (SD = 3.4). Time since last assessed as up-to-date ranged from 0 to 12 years with a mean of 2.8 years (SD = 2.2). The number of excluded studies reported in these reviews ranged from 0 to 124, with an average of 9.6 per review (SD = 14.5). Eighty-eight (23.4%) empty reviews reported no excluded studies, studies awaiting assessment, or on-going studies. Conclusions: There is a substantial number of empty reviews in The CDSR, and there is some variation in the reporting and updating of empty reviews across Cochrane Review Groups. This variation warrants further analysis, and may indicate a need to develop guidance for the reporting of empty systematic reviews in The CDSR. [ABSTRACT FROM AUTHOR]

Abstract: Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document—intended to enhance the use, understanding, and dissemination of the CONSORT statement—has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials. [Copyright &y& Elsevier]

Abstract: Objective: To assess how information about adverse events is included in systematic reviews. Study Design and Setting: We included all new Cochrane reviews published in the Cochrane Database of Systematic Reviews (CDSRs) and all new reviews (2003–2004) in the Database of Abstracts of Reviews of Effects (DAREs) in Issue 1 2005 of The Cochrane Library. Results: More than half of Cochrane (44/78) and DARE (46/79) reviews assessed drug interventions. The rest assessed surgery (Cochrane [12]; DARE [10]), psychosocial, educational, or physiotherapy interventions (22; 23). Seventy-six percent (59/78) of Cochrane reviews mentioned adverse events as an outcome compared with 48% (38/79) of DARE reviews. Most reviews mentioning adverse events were of drug interventions (Cochrane [41/59]; DARE reviews [29/38]). Considering reviews that mentioned adverse events, 95% (56/59) of Cochrane reviews included only randomized trials and 73% (43/59) included an analysis of adverse events. For 10 Cochrane reviews, adverse events had not been reported by the included trials. In contrast, 58% (22/38) of DARE reviews mentioning adverse events included only randomized trials, the rest included both randomized and nonrandomized studies. Conclusions: Most Cochrane reviews of drug interventions considered adverse events. This was not the case for DARE reviews and for Cochrane reviews of nondrug interventions. This could be improved. [Copyright &y& Elsevier]

Abstract: Objectives: To assess how trial information reported in conference abstracts differs to their subsequent full publication. Methods: Randomized trials reported at the American Society of Clinical Oncology conference (1992) were identified. CENTRAL and PubMed (December 2002) were searched to identify corresponding full publications. A checklist (based on CONSORT) was used to compare abstracts for 37 trials with their full publication. Results: Some aspects were well reported. Ninety-five percent of study objectives, 92% of participant eligibility, 100% of trial interventions, and 84% of primary outcomes were the same in both abstract and full publication. Other areas were more discrepant. Forty-six percent reported the same number of participants randomized in the abstract and full publication; only 22% reported the same number analyzed (median number analyzed per trial was 96 for abstracts and 117 for full publications). Eighty-two percent of trials were closed to follow-up in the full publication compared to 19% of abstracts. Lack of information was a major problem in assessing trial quality: no abstracts reported on allocation concealment, 16% reported on blinding and 14% reported intention to treat analysis. These figures were 49, 19, and 46%, respectively, for full publications. Conclusion: The information given for trials in conference proceedings can be unstable, especially for trials presenting early or preliminary results, and needs to be improved. [Copyright &y& Elsevier]

Context: Publication of research protocols minimizes bias by explicitly stating a priori hypotheses and methods without prior knowledge of results. Methods: We conducted a retrospective comparative study to assess the extent to which the content of published Cochrane reviews had changed compared with their previously published protocols and to assess any potential impact these changes may have had in introducing bias to the study. We identified previously published protocols for new Cochrane reviews appearing in The Cochrane Library; 2000, issue 3. The texts of published protocols and completed reviews were compared. Two raters independently identified changes to the different sections of the protocol and classified the changes as none, minor, or major. Results: Of the 66 new Cochrane reviews, we identified a previously published protocol for 47 reviews. Of these, 43 reviews had at least 1 section that had undergone a major change compared with the most recently published protocol. The greatest variation between protocols and reviews was in the methods section, in which 68% of reviews (n = 32) had undergone a major change. Changes made in other sections that may have resulted in the introduction of bias included narrowing of objectives, addition of comparisons or new outcome measures, broadening of criteria for the types of study design included, and narrowing of types of participants included. Conclusions: Research protocols, even if published, are likely to remain, at least to some extent, iterative documents. We found that a large number of changes were made to Cochrane reviews, some of which could be prone to influence by prior knowledge of results. Even if many of the changes between protocol and review improve the overall study, the reasons for making these should be clearly identified and documented within the final review. [ABSTRACT FROM AUTHOR]

Background: The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the CONSORT 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioural and social scientists report these studies transparently.Methods: Following a systematic review of existing reporting guidelines, we conducted an online Delphi process to prioritise the list of potential items for the CONSORT-SPI 2018 checklist identified from the systematic review. Of 384 international participants, 321 (84%) participated in both rating rounds. We then held a consensus meeting of 31 scientists, journal editors, and research funders (March 2014) to finalise the content of the CONSORT-SPI 2018 checklist and flow diagram.Results: CONSORT-SPI 2018 extends 9 items (14 including sub-items) from the CONSORT 2010 checklist, adds a new item (with 3 sub-items) related to stakeholder involvement in trials, and modifies the CONSORT 2010 flow diagram. This Explanation and Elaboration (E&E) document is a user manual to enhance understanding of CONSORT-SPI 2018. It discusses the meaning and rationale for each checklist item and provides examples of complete and transparent reporting.Conclusions: The CONSORT-SPI 2018 Extension, this E&E document, and the CONSORT website ( www.consort-statement.org ) are helpful resources for improving the reporting of social and psychological intervention RCTs. [ABSTRACT FROM AUTHOR]

Background: Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018.Methods: We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010.Results: The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention.Conclusions: Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions. [ABSTRACT FROM AUTHOR]

The article analyzes a sample of systematic review abstracts to examine the nature and degree of any deficiencies in reporting. Results reveal that 77 of 182 abstracts failed to describe the direction of intervention effect in words, and just 22 described the size in words. In 34 of the abstracts, the direction of effect could only be determined by interpreting numerical results. In 43 of the abstracts, the direction of effect was not reliably determined.

A letter emphasizing the need for clinical trials to start and end with systematic reviews of relevant previous research in order for it to be scientifically and ethically justifiable is presented. It discusses meta-analyses of randomized trials, showing the importance of systematic reviews to trials. The authors also argue that despite the known value of systemic reviews to trials, most researchers still do not consider them when designing trials.

The article offers a systematic review of randomized clinical trials on the use of placebo controls in the evaluation of surgery. Topics covered include the selection criteria for studies, the results of the assessment on the improvement in each arm and the superiority of surgery and the events that were in related to the intervention or were associated with the severity of the investigated condition. Bias and other reasons for caution are also presented.

Introduction: Worldwide, trauma is a leading cause of death and disability. Haemorrhage is responsible for up to 40% of trauma deaths. Recent strategies to improve mortality rates have focused on optimal methods of early hemorrhage control and correction of coagulopathy. We undertook a systematic review of randomized controlled trials (RCT) which evaluated trauma patients with hemorrhagic shock within the first 24 hours of injury and appraised how the interventions affected three outcomes: bleeding and/or transfusion requirements; correction of trauma induced coagulopathy and mortality.Methods: Comprehensive searches were performed of MEDLINE, EMBASE, CENTRAL (The Cochrane Library Issue 7, 2010), Current Controlled Trials, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP) and the National Health Service Blood and Transplant Systematic Review Initiative (NHSBT SRI) RCT Handsearch Database.Results: A total of 35 RCTs were identified which evaluated a wide range of clinical interventions in trauma hemorrhage. Many of the included studies were of low methodological quality and participant numbers were small. Bleeding outcomes were reported in 32 studies; 7 reported significantly reduced transfusion use following a variety of clinical interventions, but this was not accompanied by improved survival. Minimal information was found on traumatic coagulopathy across the identified RCTs. Overall survival was improved in only three RCTs: two small studies and a large study evaluating the use of tranexamic acid.Conclusions: Despite 35 RCTs there has been little improvement in outcomes over the last few decades. No clear correlation has been demonstrated between transfusion requirements and mortality. The global trauma community should consider a coordinated and strategic approach to conduct well designed studies with pragmatic endpoints. [ABSTRACT FROM AUTHOR]

Abstract: Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document—intended to enhance the use, understanding, and dissemination of the CONSORT statement—has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials. [Copyright &y& Elsevier]

Abstract: Objective: Many reviews specifically aimed to assess the quality of randomized controlled trials (RCTs). We evaluated the quality of reporting in such reviews. Study Design and Setting: PubMed and the Cochrane library were searched for all reviews assessing the quality of RCTs between 1987 and 2007, and experts in the field were also contacted. Results: We found 177 reviews published from 1987 to 2007, 58% of which were published after 2002. Of these, 131 (74%) focused on the quality of RCTs, 44 (25%) on quality of reporting, and 2 (1%) assessed both. The search strategy was well reported (92%). The criteria for assessment were reported in 97% of the reviews but were defined in only 38%. Seventy-four different items and 26 different scales were identified. Allocation sequence generation and concealment were reported in 41% and 40%, respectively, but their adequacy was assessed in 20% and 29%, respectively; scales were used in 40% and Consolidated Standards of Reporting Trials (CONSORT) checklist in 12%. Conclusion: The number of methodological reviews has dramatically increased in recent years. Despite an improved reporting of the methodology, how quality is assessed still raises important issues. Heterogeneity of criteria used and lack of definition may limit the relevance of these reviews. [Copyright &y& Elsevier]