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Primary outcome reporting in adolescent depression clinical trials needs standardization.

ABSTRACT: BACKGROUND:Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. METHODS:RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as "fully reported", "partially reported", or "not reported" for each checklist item, as applicable. RESULTS:Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6 to 17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time. CONCLUSIONS:Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed.

SUBMITTER: Monsour A

PROVIDER: S-EPMC7247139 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Primary outcome reporting in adolescent depression clinical trials needs standardization.

Monsour Andrea A Mew Emma J EJ Patel Sagar S Chee-A-Tow Alyssandra A Saeed Leena L Santos Lucia L Courtney Darren B DB Watson Priya N PN Monga Suneeta S Szatmari Peter P Offringa Martin M Butcher Nancy J NJ

BMC medical research methodology 20200525 1

<h4>Background</h4>Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the report ...[more]

PMID: 32450810

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Project description:Inadequate planning, selective reporting, and incomplete reporting of outcomes in randomized controlled trials (RCTs) contribute to the problem of waste of research. We aimed to describe such a waste and to examine to what extent this waste could be avoided.This research-on-research study was based on RCTs included in Cochrane reviews with a summary of findings (SoF) table. We considered the outcomes reported in the SoF tables as surrogates for important outcomes for patients and other decision makers. We used a three-step approach. (1) First, in each review, we identified, for each important outcome, RCTs that were excluded from the corresponding meta-analysis. (2) Then, for these RCTs, we systematically searched for registrations and protocols to distinguish between inadequate planning (an important outcome was not reported in registries or protocols), selective reporting (an important outcome was reported in registries or protocols but not in publications), and incomplete reporting (an important outcome was incompletely reported in publications). (3) Finally, we assessed, with the consensus of five experts, the feasibility and cost of measuring the important outcomes that were not planned. We considered inadequately planned or selectively or incompletely reported important outcomes as avoidable waste if the outcome could have been easily measured at no additional cost based on expert evaluation.Of the 2711 RCTs included in the main comparison of 290 reviews, 2115 (78%) were excluded from at least one meta-analysis of important outcomes. Every trial contributed to 55%, on average, of the meta-analyses of important outcomes. Of the 310 RCTs published in 2010 or later, 156 were registered. Inadequate planning affected 79% of these RCTs, whereas incomplete and selective reporting affected 41% and 15%, respectively. For 63% of RCTs, we found at least one missing important outcome for which the waste was avoidable and for 30%, the waste was avoidable for all important outcomes.Most of the RCTs included in our sample did not contribute to all the important outcomes in meta-analyses, mostly because of inadequate planning or incomplete reporting. A large part of this waste of research seemed to be avoidable.

Project description:PurposeTo evaluate the completeness of patient-reported outcomes (PROs) reporting using Consolidated Standards of Reporting Trials Patient-Reported Outcome (CONSORT-PRO) in randomized controlled trials (RCTs) involving rotator cuff injuries.MethodsWe performed a comprehensive search of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on rotator cuff injuries that included at least one PRO measure. We included RCTs published from 2006 to 2020. Investigators extracted data from RCTs using the CONSORT-PRO and evaluated each RCT using the Cochrane Risk of Bias 2.0 tool. Our primary objective was to evaluate the mean completion percentage of CONSORT-PRO. Our secondary objective used bivariate regression analyses to explore the relationship between trial characteristics and completeness of reporting.ResultsThe initial search returned 467 results, with 33 published RCTs meeting the prespecified inclusion criteria. The mean CONSORT-PRO completeness across all included RCTs was 49.7% (standard deviation 15.43). An increase in sample size was associated with an increase in mean completeness of reporting (t = 2.31; P = .028). The Risk of Bias assessment found 29 (of 33, 87.88%) RCTs had "some concerns" for bias. We did not find any additional significant associations between completeness of reporting and trial characteristics.ConclusionsRandomized controlled trials involving rotator cuff injuries frequently use PRO measures as primary outcomes. Reporting of these PRO measures is suboptimal and may benefit from rigorous standardization.Clinical relevancePRO measures are increasingly incorporated as primary or secondary outcomes of RCTs. Appropriate reporting and use of state-of-the-art PRO measures may improve the dissemination of clinical knowledge from RCTs to guide treatment and determine intervention effectiveness. With increased adoption of Patient-Reported Outcome Measure Information System and adherence to CONSORT-PRO, orthopaedic literature may improve PRO reporting to optimize the interpretability of PROs and facilitate patient-centered care.

Project description:IntroductionSystematic reviews collate trial data to provide evidence to support clinical decision-making. For effective synthesis, there must be consistency in outcome reporting. There is no agreed set of outcomes for reporting the effect of burn care interventions. Issues with outcome reporting have been identified, although not systematically investigated. This study gathers empirical evidence on any variation in outcome reporting and assesses the need for a core outcome set for burn care research.MethodsElectronic searches of four search engines were undertaken from January 2012 to December 2016 for randomised controlled trials (RCTs), using medical subject headings and free text terms including 'burn', 'scald' 'thermal injury' and 'RCT'. Two authors independently screened papers, extracted outcomes verbatim and recorded the timing of outcome measurement. Duplicate outcomes (exact wording ± different?spelling), similar outcomes (albumin in blood, serum albumin) and identical outcomes measured at different times were removed. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included trials. Outcomes were classified into domains. Bias was reduced using five researchers and a patient working independently and together.Results147 trials were included, of which 127 (86.4%) were RCTs, 13 (8.8%) pilot studies and 7 (4.8%) RCT protocols. 1494 verbatim clinical outcomes were reported; 955 were unique. 76.8% of outcomes were measured within 6?months of injury. Commonly reported outcomes were defined differently. Numbers of unique outcomes per trial varied from one to 37 (median 9; IQR 5,13). No single outcome was reported across all studies demonstrating inconsistency of reporting. Outcomes were classified into 54 domains. Numbers of outcomes per domain ranged from 1 to 166 (median 11; IQR 3,24).ConclusionsThis review has demonstrated heterogeneity in outcome reporting in burn care research which will hinder amalgamation of study data. We recommend the development of a Core Outcome Set.Prospero registration numberCRD42017060908.

Project description:BackgroundInadequate and poor quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize, and build upon study findings and impacts evidence-based decision-making by patients, clinicians, and policy-makers. To facilitate harmonized and transparent reporting of outcomes in trial protocols and published reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is being developed. The final product will provide unique InsPECT extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines.MethodsThe InsPECT SPIRIT and CONSORT extensions will be developed in accordance with the methodological framework created by the EQUATOR (Enhancing the Quality and Transparency of Health Research Quality) Network for reporting guideline development. Development will consist of (1) the creation of an initial list of candidate outcome reporting items synthesized from expert consultations and a scoping review of existing guidance for reporting outcomes in trial protocols and reports; (2) a three-round international Delphi study to identify additional candidate items and assess candidate item importance on a 9-point Likert scale, completed by stakeholders such as trial report and protocol authors, systematic review authors, biostatisticians and epidemiologists, reporting guideline developers, clinicians, journal editors, and research ethics board representatives; and (3) an in-person expert consensus meeting to finalize the set of essential outcome reporting items for trial protocols and reports, respectively. The consensus meeting discussions will be independently facilitated and informed by the empirical evidence identified in the primary literature and through the opinions (aggregate rankings and comments) collected via the Delphi study. An integrated knowledge translation approach will be used throughout InsPECT development to facilitate implementation and dissemination, in addition to standard post-development activities.DiscussionInsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes.

Project description:IntroductionThe aim of this study is to explore outcomes currently reported in physiotherapy trials for bronchiectasis and investigate the level of consistency in outcome reporting. This mapping of outcomes will be used to inform the development of a core outcome set (COS) for physiotherapy research in bronchiectasis. Outcomes reported in randomised clinical trials (RCTs) and RCT protocols were reviewed and evaluated. We included trials with physiotherapy as the main intervention, including pulmonary rehabilitation, exercise prescription, airway clearance, positive expiratory pressure devices, breathing training, self-management plans, and home exercise program. Medline, CINAHL, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and the physiotherapy evidence database (PEDro) were searched from inception using a prespecified search strategy. Records including adult patients with bronchiectasis were included. Outcomes were listed verbatim and categorised into domains based on a pre-specified system, frequency of reporting and sources of variation were inspected.ResultsOf 2158 abstracts screened, 37 trials (1202 participants) and 17 trial protocols were identified. Eighteen different physiotherapy techniques were investigated. A total of 331 outcomes were reported. No single outcome was reported by all trials. The most reported outcomes were lung function (27 trials, 50%), health related quality of life (26 trials, 48.1%), and dyspnoea (18 trials, 33.3%). A list of 104 unique outcomes covering 23 domains was created. Trials focus on physiological outcomes, mainly those related to respiratory system functions. Outcomes related to functioning and life impact are often neglected.ConclusionOutcome reporting in physiotherapy research for bronchiectasis was found to be inconsistent in terms of choosing and defining outcomes. Developing a core outcome set in this area of research is needed to facilitate aggregation of future trial results in systematic reviews that will in turn inform the strength of evidence for the effectiveness of physiotherapy. Outcome choice should include all stakeholders, including patients.Trial registrationThis study is registered in the PROSPERO registry under the number CRD42021266247.

Project description:BACKGROUND:Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials. METHODS:Each month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process. Our main outcomes were to assess: (1) the nature and extent of changes as part of the peer review process, in relation to reporting of the primary outcome(s) and/or primary statistical analysis; (2) how often authors followed these requests; and (3) whether this was related to specific journal or trial characteristics. RESULTS:Of 893 corresponding authors who were invited to take part in the online survey 258 (29%) responded. The majority of trials were multicentre (n?=?191; 74%); median sample size 325 (IQR 138 to 1010). The primary outcome was clearly defined in 92% (n?=?238), of which the direction of treatment effect was statistically significant in 49%. The majority responded (1-10 Likert scale) they were satisfied with the overall handling (mean 8.6, SD 1.5) and quality of peer review (mean 8.5, SD 1.5) of their manuscript. Only 3% (n?=?8) said that the editor or peer reviewers had asked them to change or clarify the trial's primary outcome. However, 27% (n?=?69) reported they were asked to change or clarify the statistical analysis of the primary outcome; most had fulfilled the request, the main motivation being to improve the statistical methods (n?=?38; 55%) or avoid rejection (n?=?30; 44%). Overall, there was little association between authors being asked to make this change and the type of journal, intervention, significance of the primary outcome, or funding source. Thirty-six percent (n?=?94) of authors had been asked to include additional analyses that had not been included in the original manuscript; in 77% (n?=?72) these were not pre-specified in the protocol. Twenty-three percent (n?=?60) had been asked to modify their overall conclusion, usually (n?=?53; 88%) to provide a more cautious conclusion. CONCLUSION:Overall, most changes, as a result of the peer review process, resulted in improvements to the published manuscript; there was little evidence of a negative impact in terms of post hoc changes of the primary outcome. However, some suggested changes might be considered inappropriate, such as unplanned additional analyses, and should be discouraged.

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Primary outcome reporting in adolescent depression clinical trials needs standardization.

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Primary outcome reporting in adolescent depression clinical trials needs standardization.

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