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Background: Multivariate meta-analysis (MVMA) jointly synthesizes effects for multiple correlated outcomes. The MVMA model is potentially more difficult and time-consuming to apply than univariate models, so if its use makes little difference to parameter estimates, it could be argued that it is redundant. Methods: We assessed the applicability and impact of MVMA in Cochrane Pregnancy and Childbirth (CPCB) systematic reviews. We applied MVMA to CPCB reviews published between 2011 and 2013 with two or more binary outcomes with at least three studies and compared findings with results of univariate meta-analyses. Univariate random effects meta-analysis models were fitted using restricted maximum likelihood estimation (REML). Results: Eighty CPCB reviews were published. MVMA could not be applied in 70 of these reviews. MVMA was not feasible in three of the remaining 10 reviews because the appropriate models failed to converge. Estimates from MVMA agreed with those of univariate analyses in most of the other seven reviews. Statistical significance changed in two reviews: In one, this was due to a very small change in P value; in the other, the MVMA result for one outcome suggested that previous univariate results may be vulnerable to small-study effects and that the certainty of clinical conclusions needs consideration. Conclusions: MVMA methods can be applied only in a minority of reviews of interventions in pregnancy and childbirth and can be difficult to apply because of missing correlations or lack of convergence. Nevertheless, clinical and/or statistical conclusions from MVMA may occasionally differ from those from univariate analyses.

Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for studies evaluating the effectiveness of treatments for neonatal sepsis. Since a systematic review of key outcomes from randomised trials of therapeutic interventions in neonatal sepsis was published recently, we will complement this with a qualitative systematic review of the key outcomes of neonatal sepsis identified by parents, other family members, parent representatives, healthcare providers, policymakers, and researchers. We will interpret the outcomes of both studies using a previously established framework. Stakeholders across three different groups i.e., (1) researchers, (2) healthcare providers, and (3) patients' parents/family members and parent representatives will rate the importance of the outcomes in an online Real-Time Delphi Survey. Afterwards, consensus meetings will be held to agree on the final COS through online discussions with key stakeholders. This COS is expected to minimize outcome heterogeneity in measurements and publications, improve comparability and synthesis, and decrease research waste. [ABSTRACT FROM AUTHOR]

Background: There is substantial heterogeneity between trial outcomes in pressure ulcer prevention research. The development of core outcome sets is one strategy to improve comparability between trial results and thus increase the quality of evidence. Objectives: To identify core outcomes for pressure ulcer prevention trials. Methods: A workshop was held with service users to discuss their views and understanding of the outcomes identified by a scoping review and to identify any missing outcomes. In a next step, a Delphi survey comprising three rounds was conducted to evaluate a compiled list of outcomes by their importance. Afterwards the preselection from the Delphi survey was discussed in a virtual consensus meeting with the aim of agreeing on a final set of core outcomes. Individuals who had completed all three rounds of the Delphi survey were eligible to participate in this meeting. Participants included practitioners, service users, researchers and industry representatives. The OUTPUTs project is registered in the COMET database and is part of the Cochrane Skin Core Outcome Set Initiative. Results: The workshop did not reveal any missing outcomes, but highlighted the need for further efforts to make lay people understand what an outcome is in a study setting. The Delphi survey took place between December 2020 and June 2021. After the three rounds, 18 out of 37 presented outcomes were rated to be critically important. In the following consensus meeting, six outcomes were prioritized to be included in the core outcome set for pressure ulcer prevention trials: (i) pressure ulcer occurrence; (ii) pressure ulcer precursor signs and symptoms; (iii) mobility; (iv) acceptability and comfort of intervention; (v) adherence/compliance; and (vi) adverse events/safety. Conclusions: Based on a comprehensive list of outcomes in pressure ulcer prevention research, there was clear agreement on the six identified core outcomes in three international Delphi rounds and in the consensus meeting. Although outcome measurement instruments need to be identified next, the six identified core outcomes should already be considered in future trials, as service users, practitioners, researchers and industry representatives have agreed that they are critically important. What is already known about this topic?There are numerous trials on pressure ulcer prevention, but evidence on the effectiveness of preventive measures is limited due to heterogeneity between trial outcomes.The development of a core outcome set is one strategy to improve comparability between trial results. What does this study add?A service user workshop, a three‐round Delphi survey and an online consensus meeting with practitioners, service users, researchers and industry representatives were conducted to identify core outcomes for pressure ulcer prevention trials.Six core outcomes were defined: (i) pressure ulcer occurrence, (ii) pressure ulcer precursor signs and symptoms, (iii) mobility, (iv) acceptability and comfort of intervention, (v) adherence/compliance and (vi) adverse events/safety. What are the clinical implications of this work?Better evidence of interventions for pressure ulcer prevention will help health professionals and service users to decide which interventions are most appropriate and effective.Better evidence may contribute to better pressure ulcer prevention. [ABSTRACT FROM AUTHOR]

Background The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR]). Methods and findings An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1-9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process. Conclusions The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using reasonable methods., Author(s): Jamie J. Kirkham 1, Katherine Davis 1, Douglas G. Altman 2, Jane M. Blazeby 3, Mike Clarke 4, Sean Tunis 5, Paula R. Williamson 1,* Introduction The selection of [...]

Background Core outcome sets (COS) can enhance the relevance of research by ensuring that outcomes of importance to health service users and other people making choices about health care in a particular topic area are measured routinely. Over 200 COS to date have been developed, but the clarity of these reports is suboptimal. COS studies will not achieve their goal if reports of COS are not complete and transparent. Methods and Findings In recognition of these issues, an international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set-STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies. The developmental process consisted of an initial reporting item generation stage and a two-round Delphi survey involving nearly 200 participants representing key stakeholder groups, followed by a consensus meeting. The COS-STAR Statement consists of a checklist of 18 items considered essential for transparent and complete reporting in all COS studies. The checklist items focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. A limitation of the COS-STAR Statement is that it was developed without representative views of low- and middle-income countries. COS have equal relevance to studies conducted in these areas, and, subsequently, this guideline may need to evolve over time to encompass any additional challenges from developing COS in these areas. Conclusions With many ongoing COS studies underway, the COS-STAR Statement should be a helpful resource to improve the reporting of COS studies for the benefit of all COS users., Author(s): Jamie J. Kirkham 1, Sarah Gorst 1, Douglas G. Altman 2, Jane M. Blazeby 3, Mike Clarke 4, Declan Devane 5, Elizabeth Gargon 1, David Moher 6, Jochen Schmitt [...]

Objective Design Setting Population Methods Main Outcome Measures Results Conclusions To identify current practices in the management of selective fetal growth restriction (sFGR) in monochorionic diamniotic (MCDA) twin pregnancies.Cross‐sectional survey.International.Clinicians involved in the management of MCDA twin pregnancies with sFGR.A structured, self‐administered survey.Clinical practices and attitudes to diagnostic criteria and management strategies.Overall, 62.8% (113/180) of clinicians completed the survey; of which, 66.4% (75/113) of the respondents reported that they would use an estimated fetal weight (EFW) of <10th centile for the smaller twin and an inter‐twin EFW discordance of >25% for the diagnosis of sFGR. For early‐onset type I sFGR, 79.8% (75/94) of respondents expressed that expectant management would be their routine practice. On the other hand, for early‐onset type II and type III sFGR, 19.3% (17/88) and 35.7% (30/84) of respondents would manage these pregnancies expectantly, whereas 71.6% (63/88) and 57.1% (48/84) would refer these pregnancies to a fetal intervention centre or would offer fetal intervention for type II and type III cases, respectively. Moreover, 39.0% (16/41) of the respondents would consider fetoscopic laser surgery (FLS) for early‐onset type I sFGR, whereas 41.5% (17/41) would offer either FLS or selective feticide, and 12.2% (5/41) would exclusively offer selective feticide. For early‐onset type II and type III sFGR cases, 25.9% (21/81) and 31.4% (22/70) would exclusively offer FLS, respectively, whereas 33.3% (27/81) and 32.9% (23/70) would exclusively offer selective feticide.There is significant variation in clinician practices and attitudes towards the management of early‐onset sFGR in MCDA twin pregnancies, especially for type II and type III cases, highlighting the need for high‐level evidence to guide management. [ABSTRACT FROM AUTHOR]

Abstract Background Missing outcome data or the inconsistent reporting of outcome data in clinical research can affect the quality of evidence within a systematic review. A potential solution is an agreed standardized set of outcomes known as a core outcome set (COS) to be measured in all studies for a specific condition. We investigated the amount of missing patient data for primary outcomes in Cochrane systematic reviews, and surveyed the Co-ordinating Editors of Cochrane Review Groups (CRGs) on issues related to the standardization of outcomes in their CRG’s reviews. These groups are responsible for the more than 7,000 protocols and full versions of Cochrane Reviews that are currently available, and the several hundred new reviews published each year, presenting the world’s largest collection of standardized systematic reviews in health care. Methods Using an unselected cohort of Cochrane Reviews, we calculated and presented the percentage of missing patient data for the primary outcome measure chosen for each review published by each CRG. We also surveyed the CRG Co-ordinating Editors to see what their policies are with regards to outcome selection and outcomes to include in the Summary of Finding (SoF) tables in their Cochrane Reviews. They were also asked to list the main advantages and challenges of standardizing outcomes across all reviews within their CRG. Results In one fifth of the 283 reviews in the sample, more than 50% of the patient data for the primary outcome was missing. Responses to the survey were received from 90% of Co-ordinating Editors. Thirty-six percent of CRGs have a centralized policy regarding which outcomes to include in the SoF table and 73% of Co-ordinating Editors thought that a COS for effectiveness trials should be used routinely for a SoF table. Conclusions The reliability of systematic reviews, in particular meta-analyses they contain, can be improved if more attention is paid to missing outcome data. The availability of COSs for specific health conditions might help with this and the concept has support from the majority of Co-ordinating Editors in CRGs.

Background: The B-MaP-C study aimed to determine alterations to breast cancer (BC) management during the peak transmission period of the UK COVID-19 pandemic and the potential impact of these treatment decisions.Methods: This was a national cohort study of patients with early BC undergoing multidisciplinary team (MDT)-guided treatment recommendations during the pandemic, designated 'standard' or 'COVID-altered', in the preoperative, operative and post-operative setting.Findings: Of 3776 patients (from 64 UK units) in the study, 2246 (59%) had 'COVID-altered' management. 'Bridging' endocrine therapy was used (n = 951) where theatre capacity was reduced. There was increasing access to COVID-19 low-risk theatres during the study period (59%). In line with national guidance, immediate breast reconstruction was avoided (n = 299). Where adjuvant chemotherapy was omitted (n = 81), the median benefit was only 3% (IQR 2-9%) using 'NHS Predict'. There was the rapid adoption of new evidence-based hypofractionated radiotherapy (n = 781, from 46 units). Only 14 patients (1%) tested positive for SARS-CoV-2 during their treatment journey.Conclusions: The majority of 'COVID-altered' management decisions were largely in line with pre-COVID evidence-based guidelines, implying that breast cancer survival outcomes are unlikely to be negatively impacted by the pandemic. However, in this study, the potential impact of delays to BC presentation or diagnosis remains unknown. [ABSTRACT FROM AUTHOR]

Background: Most publications about selective reporting in clinical trials have focussed on outcomes. However, selective reporting of analyses for a given outcome may also affect the validity of findings. If analyses are selected on the basis of the results, reporting bias may occur. The aims of this study were to review and summarise the evidence from empirical cohort studies that assessed discrepant or selective reporting of analyses in randomised controlled trials (RCTs). Methods and Findings: A systematic review was conducted and included cohort studies that assessed any aspect of the reporting of analyses of RCTs by comparing different trial documents, e.g., protocol compared to trial report, or different sections within a trial publication. The Cochrane Methodology Register, Medline (Ovid), PsycInfo (Ovid), and PubMed were searched on 5 February 2014. Two authors independently selected studies, performed data extraction, and assessed the methodological quality of the eligible studies. Twenty-two studies (containing 3,140 RCTs) published between 2000 and 2013 were included. Twenty-two studies reported on discrepancies between information given in different sources. Discrepancies were found in statistical analyses (eight studies), composite outcomes (one study), the handling of missing data (three studies), unadjusted versus adjusted analyses (three studies), handling of continuous data (three studies), and subgroup analyses (12 studies). Discrepancy rates varied, ranging from 7% (3/42) to 88% (7/8) in statistical analyses, 46% (36/79) to 82% (23/28) in adjusted versus unadjusted analyses, and 61% (11/18) to 100% (25/25) in subgroup analyses. This review is limited in that none of the included studies investigated the evidence for bias resulting from selective reporting of analyses. It was not possible to combine studies to provide overall summary estimates, and so the results of studies are discussed narratively. Conclusions: Discrepancies in analyses between publications and other study documentation were common, but reasons for these discrepancies were not discussed in the trial reports. To ensure transparency, protocols and statistical analysis plans need to be published, and investigators should adhere to these or explain discrepancies. Please see later in the article for the Editors' Summary., Introduction Selective reporting in clinical trial reports has been described mainly with respect to the reporting of a subset of the originally recorded outcome variables in the final trial report. [...]

Background: Large sample sizes are often required to detect statistically significant associations between pharmacogenetic markers and treatment response. Meta-analysis may be performed to synthesize data from several studies, increasing sample size and, consequently, power to detect significant genetic effects. However, performing robust synthesis of data from pharmacogenetic studies is often challenging because of poor reporting of key data in study reports. There is currently no guideline for the reporting of pharmacogenetic studies that has been developed using a widely accepted robust methodology. The objective of this project was to develop the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline.Methods and Findings: We established a preliminary checklist of reporting items to be considered for inclusion in the guideline. We invited representatives of key stakeholder groups to participate in a 2-round Delphi survey. A total of 52 individuals participated in both rounds of the survey, scoring items with regards to their importance for inclusion in the STROPS guideline. We then held a consensus meeting, at which 8 individuals considered the results of the Delphi survey and voted on whether each item ought to be included in the final guideline. The STROPS guideline consists of 54 items and is accompanied by an explanation and elaboration document. The guideline contains items that are particularly important in the field of pharmacogenetics, such as the drug regimen of interest and whether adherence to treatment was accounted for in the conducted analyses. The guideline also requires that outcomes be clearly defined and justified, because in pharmacogenetic studies, there may be a greater number of possible outcomes than in other types of study (for example, disease-gene association studies). A limitation of this project is that our consensus meeting involved a small number of individuals, the majority of whom are based in the United Kingdom.Conclusions: Our aim is for the STROPS guideline to improve the transparency of reporting of pharmacogenetic studies and also to facilitate the conduct of high-quality systematic reviews and meta-analyses. We encourage authors to adhere to the STROPS guideline when publishing pharmacogenetic studies. [ABSTRACT FROM AUTHOR]

Objective To evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials. Design Randomised controlled trial (RCT). Setting BMJ Open’s quality improvement programme. Participants 24 manuscripts describing RCTs. Interventions We used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review. Outcomes The primary outcome is the number of adequately reported items (0–8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention. Results Manuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min. Conclusions We demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability. [ABSTRACT FROM AUTHOR]

Background: Core outcome sets (COS) have the potential to reduce waste in research by improving the consistency of outcomes measured in trials of the same health condition. However, this reduction in waste will only be realised through the uptake of COS by clinical trialists. Without uptake, the continued development of COS that are not implemented may add to waste in research. Funders of clinical trials have the potential to have an impact on COS uptake by recommending their use to those applying for funding. The aim of our study was to assess the extent to which applicants followed the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme’s recommendation to search for a COS to include in their clinical trial. Methods and findings: We examined the outcomes section and detailed project descriptions of all 95 researcher-led primary research applications submitted to the NIHR HTA between January 2012, when the recommendation to search for a COS was included in the guidance for applicants, and December 2015 for evidence that a search for a COS had taken place and rationale for outcome choice in the absence of COS. A survey of applicants was conducted to further explore their use of COS and choice of outcomes with a response rate of 49%. Nine out of 95 applicants (10%) stated in their application that they had searched the COMET (Core Outcome Measures for Effectiveness Trials) Initiative database for a COS and another nine referred to searching for a COS using another method, e.g. a review of the literature. Of the 77 (81%) applicants that did not mention COMET or COS in their application, eight stated in the survey that they had searched the COMET database and ten carried out a search using another method. Some applicants who did not search for a COS gave reasons for their choice of outcomes including taking advice from patients and the public and choosing outcomes used in previous trials. Conclusion: A funding body can have an impact on COS uptake by encouraging trialists to search for a COS. Funders could take further steps by putting processes in place to prompt applicants to be explicit about searching for COS in their application and notifying the funding board if a search has not taken place. The sources of information used by trialists to make decisions about outcomes in the absence of COS may suggest methods of dissemination for COS. [ABSTRACT FROM AUTHOR]

Background: Multivariate meta‐analysis (MVMA) jointly synthesizes effects for multiple correlated outcomes. The MVMA model is potentially more difficult and time‐consuming to apply than univariate models, so if its use makes little difference to parameter estimates, it could be argued that it is redundant. Methods: We assessed the applicability and impact of MVMA in Cochrane Pregnancy and Childbirth (CPCB) systematic reviews. We applied MVMA to CPCB reviews published between 2011 and 2013 with two or more binary outcomes with at least three studies and compared findings with results of univariate meta‐analyses. Univariate random effects meta‐analysis models were fitted using restricted maximum likelihood estimation (REML). Results: Eighty CPCB reviews were published. MVMA could not be applied in 70 of these reviews. MVMA was not feasible in three of the remaining 10 reviews because the appropriate models failed to converge. Estimates from MVMA agreed with those of univariate analyses in most of the other seven reviews. Statistical significance changed in two reviews: In one, this was due to a very small change in P value; in the other, the MVMA result for one outcome suggested that previous univariate results may be vulnerable to small‐study effects and that the certainty of clinical conclusions needs consideration. Conclusions: MVMA methods can be applied only in a minority of reviews of interventions in pregnancy and childbirth and can be difficult to apply because of missing correlations or lack of convergence. Nevertheless, clinical and/or statistical conclusions from MVMA may occasionally differ from those from univariate analyses. [ABSTRACT FROM AUTHOR]

Introduction Large sample sizes are often required to detect statistically significant associations between pharmacogenetic markers and treatment response. Metaanalysis may be performed to synthesise data from several studies, increasing sample size and consequently power to detect significant genetic effects. However, performing robust synthesis of data from pharmacogenetic studies is often challenging due to poor reporting of key data in study reports. There is currently no guideline for the reporting of pharmacogenetic studies. The aim of this project is to develop the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline. The STROPS guideline will facilitate the conduct of high-quality metaanalyses and thus improve the power to detect genetic associations. Methods and analysis We will establish a preliminary checklist of reporting items to be considered for inclusion in the guideline. We will then conduct a Delphi survey of key stakeholder groups to gain consensus opinion on which reporting items to include in the final guideline. The Delphi survey will consist of two rounds: the first round will invite participants to score items from the preliminary checklist and to suggest additional relevant items; the second round will provide feedback from the previous round and invite participants to re-score the items. Following the second round, we will summarise the distribution of scores for each item, stratified by stakeholder group. The Steering Committee for the project and representatives from the key stakeholder groups will meet to consider the results of the Delphi survey and to finalise the list of reporting items. We will then draft, pilot-test and publish the STROPS reporting guideline and accompanying explanatory document. Ethics and dissemination The University of Liverpool Ethics Committee has confirmed ethical approval for this study (reference: 3586). Dissemination activities will include presenting the reporting guideline at conferences relevant to pharmacogenetic research. [ABSTRACT FROM AUTHOR]

Objectives The goal of this study is to identify, analyse and classify interventions to improve adherence to reporting guidelines in order to obtain a wide picture of how the problem of enhancing the completeness of reporting of biomedical literature has been tackled so far. Design Scoping review. Search strategy We searched the MEDLINE, EMBASE and Cochrane Library databases and conducted a grey literature search for (1) studies evaluating interventions to improve adherence to reporting guidelines in health research and (2) other types of references describing interventions that have been performed or suggested but never evaluated. The characteristics and effect of the evaluated interventions were analysed. Moreover, we explored the rationale of the interventions identified and determined the existing gaps in research on the evaluation of interventions to improve adherence to reporting guidelines. Results 109 references containing 31 interventions (11 evaluated) were included. These were grouped into five categories: (1) training on the use of reporting guidelines, (2) improving understanding, (3) encouraging adherence, (4) checking adherence and providing feedback, and (5) involvement of experts. Additionally, we identified lack of evaluated interventions (1) on training on the use of reporting guidelines and improving their understanding, (2) at early stages of research and (3) after the final acceptance of the manuscript. Conclusions This scoping review identified a wide range of strategies to improve adherence to reporting guidelines that can be taken by different stakeholders. Additional research is needed to assess the effectiveness of many of these interventions. [ABSTRACT FROM AUTHOR]

Summary: Background: The suitability of disease activity indices has been challenged, with growing interest in objective measures of inflammation. Aim: To undertake a systematic review of efficacy and safety outcomes in placebo‐controlled randomised controlled trials (RCTs) of patients with Crohn's disease. Methods: MEDLINE, EMBASE, CINAHL and Cochrane Library were searched until November 2015, for RCTs of adult Crohn's disease patients treated with medical or surgical therapies. Data on efficacy and safety outcomes, end‐point definitions, and measurement instruments were extracted and stratified by publication date (pre‐2009 and 2009 onwards). Results: One hundred and eighty‐one RCTs (110 induction and 71 maintenance) were identified, including 23 850 patients. About 92.3% reported clinical efficacy endpoints. The Crohn's Disease Activity Index (CDAI) dominated, defining clinical response or remission in 63.5% of trials (35 definitions of response or remission). CDAI < 150 was the commonest endpoint, but reporting reduced between periods (46.4%‐41.1%), whilst use of CDAI100 increased (16.8%‐30.4%). Fistula studies most commonly reported fistula closure (9, 90.0%). Reporting of biomarker, endoscopy and histology endpoints increased overall (33.3%‐40.6%, 14.4%‐30.4% and 3.2%‐12.5%, respectively), but were heterogeneous and rarely reported in fistula trials. Patient‐reported outcome measures were reported in 41.4% of trials and safety endpoints in 35.4%. Many of the common adverse events relate to disease exacerbation or treatment failure. Conclusions: Trial endpoints vary across studies, over time and are distinct in fistula studies. Despite growth in reporting of objective measures of inflammation and in patient‐reported outcome measures, there is a lack of standardisation. This confirms the need for a core outcome set for comparative effectiveness research in Crohn's disease. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to develop consensus on an internationally agreed dataset for juvenile dermatomyositis (JDM), designed for clinical use, to enhance collaborative research and allow integration of data between centres.Methods: A prototype dataset was developed through a formal process that included analysing items within existing databases of patients with idiopathic inflammatory myopathies. This template was used to aid a structured multistage consensus process. Exploiting Delphi methodology, two web-based questionnaires were distributed to healthcare professionals caring for patients with JDM identified through email distribution lists of international paediatric rheumatology and myositis research groups. A separate questionnaire was sent to parents of children with JDM and patients with JDM, identified through established research networks and patient support groups. The results of these parallel processes informed a face-to-face nominal group consensus meeting of international myositis experts, tasked with defining the content of the dataset. This developed dataset was tested in routine clinical practice before review and finalisation.Results: A dataset containing 123 items was formulated with an accompanying glossary. Demographic and diagnostic data are contained within form A collected at baseline visit only, disease activity measures are included within form B collected at every visit and disease damage items within form C collected at baseline and annual visits thereafter.Conclusions: Through a robust international process, a consensus dataset for JDM has been formulated that can capture disease activity and damage over time. This dataset can be incorporated into national and international collaborative efforts, including existing clinical research databases. [ABSTRACT FROM AUTHOR]

Introduction There is evidence that the use of some reporting guidelines, such as the Consolidated Standards for Reporting Trials, is associated with improved completeness of reporting in health research. However, the current levels of adherence to reporting guidelines are suboptimal. Over the last few years, several actions aiming to improve compliance with reporting guidelines have been taken and proposed. We will conduct a scoping review of interventions to improve adherence to reporting guidelines in health research that have been evaluated or suggested, in order to inform future interventions. Methods and analysis Our review will follow the Joanna Briggs Institute scoping review methods manual. We will search for relevant studies in MEDLINE, EMBASE and Cochrane Library databases. Moreover, we will carry out lateral searches from the reference lists of the included studies, as well as from the lists of articles citing the included ones. One reviewer will screen the full list, which will be randomly split into two halves and independently screened by the other two reviewers. Two reviewers will perform data extraction independently. Discrepancies will be solved through discussion. In addition, this search strategy will be supplemented by a grey literature search. The interventions found will be classified as assessed or suggested, as well as according to different criteria, in relation to their target (journal policies, journal editors, authors, reviewers, funders, ethical boards or others) or the research stage at which they are performed (design, conducting, reporting or peer review). Descriptive statistical analysis will be performed. Ethics and dissemination A paper summarising the findings from this review will be published in a peerreviewed journal. This scoping review will contribute to a better understanding and a broader perspective on how the problem of adhering better to reporting guidelines has been tackled so far. This could be a major first step towards developing future strategies to improve compliance with reporting guidelines in health research. [ABSTRACT FROM AUTHOR]

The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area.Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified. [ABSTRACT FROM AUTHOR]