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Selective reporting of outcomes in randomised controlled trials in systematic reviews of cystic fibrosis.

ABSTRACT: Outcome reporting bias (ORB) in randomised trials has been identified as a threat to the validity of systematic reviews. Previous work highlighting this problem is limited to considering a single primary review outcome. The aim of this study was to assess ORB across all efficacy outcomes in the Cochrane systematic reviews of cystic fibrosis.Systematic reviews of interventions for cystic fibrosis published on the Cochrane Library by the Cochrane Cystic Fibrosis and Genetic Disorders Group before 2010 were assessed for discrepancies in outcomes between review protocol and full review. ORB in eligible trials was also assessed for all efficacy review outcomes. Two authors independently classified each outcome using a nine-point classification system developed by the Outcome Reporting Bias In Trials study. These classifications were used to inform the assessment of the risk of bias for selective outcome reporting for each trial.-46 Cochrane cystic fibrosis systematic reviews were included. The median number of primary outcomes, number of trials and participants per trial in the reviews were 3 (IQR 2, 3), 4 (IQR 2, 8) and 21 (IQR 14, 41), respectively. 18 reviews (39%, 18/46) had a discrepancy in outcomes between protocol and full review. 37 reviews were eligible to be included in the ORB assessment. When considering review primary outcomes and all review outcomes, ORB was suspected in at least one trial in 86% and 100%, respectively.Assessment of ORB within a systematic review of a single primary outcome underestimates the risk of ORB in comparison to the assessment of multiple primary and secondary outcomes. ORB in trials is highly prevalent within systematic reviews of cystic fibrosis when assessed across all outcomes. This could be reduced by the development of a core outcome set for trials and systematic reviews in cystic fibrosis.

SUBMITTER: Dwan K

PROVIDER: S-EPMC3669728 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Selective reporting of outcomes in randomised controlled trials in systematic reviews of cystic fibrosis.

Dwan Kerry K Kirkham Jamie J JJ Williamson Paula R PR Gamble Carrol C

BMJ open 20130620 6

<h4>Background</h4>Outcome reporting bias (ORB) in randomised trials has been identified as a threat to the validity of systematic reviews. Previous work highlighting this problem is limited to considering a single primary review outcome. The aim of this study was to assess ORB across all efficacy outcomes in the Cochrane systematic reviews of cystic fibrosis.<h4>Methods</h4>Systematic reviews of interventions for cystic fibrosis published on the Cochrane Library by the Cochrane Cystic Fibrosis ...[more]

PMID: 23794538

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Project description:ObjectivesTo determine the incidence and characteristics of randomised controlled trials that report using the modified intention to treat approach, and how the approach is described.DesignSystematic review.Data sourcesPubMed, Embase, Cochrane central register of controlled trials, ISI Web of Knowledge, Ovid, HighWire Press, Science-Direct, Ingenta, Medscape, BioMed Central, Springer, and Wiley, from inception to December 2006.Main outcome measuresIncidence of trials in which use of modified intention to treat was reported, and how the approach was described (classified according to the type and number of deviations from the intention to treat approach).Results475 randomised controlled trials reported use of a modified intention to treat analysis. Of these, 76 (16%) were published in five highly cited general medical journals. The incidence of all trials that reported use of modified intention to treat published in journals indexed in Medline increased from 0.006% in 1982-6 to 0.5% in 2002-6 (P<0.001 for linear trend). When the description of the modified intention to treat was examined in each trial, 192 (40%) reported one type of deviation from the intention to treat approach, 261 (55%) reported two or more types, and 22 (5%) did not describe any type. In 266 (56%) of the trials the deviation was related to the treatment received, in 196 (41%) to a post baseline assessment, in 118 (25%) to a baseline assessment, in 108 (23%) to a target condition, and in 23 (5%) to follow-up. Post-randomisation exclusions occurred in 380 (80%) trials. The results reported by 270 of the 352 (77%) superiority trials favoured the drug under investigation. All of the 123 trials using equivalence or non-inferiority methods to investigate interventions reported results that favoured their assumptions.ConclusionsRandomised controlled trials that report using a modified intention to treat are increasingly being published in the medical literature. The descriptions of such an approach were ambiguous, and may cover any type of descriptions for exclusion, such as missing data and deviation from protocol. Explicit statements about post-randomisation exclusions should replace the ambiguous terminology of modified intention to treat.

Project description:ObjectiveSystematic reviews can include cluster-randomised controlled trials (C-RCTs), which require different analysis compared with standard individual-randomised controlled trials. However, it is not known whether review authors follow the methodological and reporting guidance when including these trials. The aim of this study was to assess the methodological and reporting practice of Cochrane reviews that included C-RCTs against criteria developed from existing guidance.MethodsCriteria were developed, based on methodological literature and personal experience supervising review production and quality. Criteria were grouped into four themes: identifying, reporting, assessing risk of bias, and analysing C-RCTs. The Cochrane Database of Systematic Reviews was searched (2nd December 2013), and the 50 most recent reviews that included C-RCTs were retrieved. Each review was then assessed using the criteria.ResultsThe 50 reviews we identified were published by 26 Cochrane Review Groups between June 2013 and November 2013. For identifying C-RCTs, only 56% identified that C-RCTs were eligible for inclusion in the review in the eligibility criteria. For reporting C-RCTs, only eight (24%) of the 33 reviews reported the method of cluster adjustment for their included C-RCTs. For assessing risk of bias, only one review assessed all five C-RCT-specific risk-of-bias criteria. For analysing C-RCTs, of the 27 reviews that presented unadjusted data, only nine (33%) provided a warning that confidence intervals may be artificially narrow. Of the 34 reviews that reported data from unadjusted C-RCTs, only 13 (38%) excluded the unadjusted results from the meta-analyses.ConclusionsThe methodological and reporting practices in Cochrane reviews incorporating C-RCTs could be greatly improved, particularly with regard to analyses. Criteria developed as part of the current study could be used by review authors or editors to identify errors and improve the quality of published systematic reviews incorporating C-RCTs.

Project description:IntroductionIn people with cystic fibrosis (CF), exacerbations have been shown to have profound and prolonged negative effects such as reducing physical activity and health-related quality of life, increasing the rate of decline of lung function and healthcare costs, and ultimately increasing the risk of mortality. Delayed initiation of treatment following the signs of an exacerbation has been shown to be associated with failure to recover to baseline. Therefore, the late identification and treatment of an exacerbation due to delayed presentation will potentially worsen short-term and long-term outcomes. We have developed a smartphone application, containing questions which require yes or no responses relating to symptoms suggestive of a respiratory exacerbation. Its use is intended to facilitate the early identification of symptoms suggestive of a respiratory exacerbation, and allow the CF team to initiate treatment sooner, thereby potentially reducing the risk of severe exacerbations which require intravenous antibiotics (IVAB) and often a hospital admission.MethodsWe will undertake a randomised controlled trial. 60 adults with CF will be recruited and randomised to either the intervention or control group. The intervention group will use the smartphone application weekly for 12 months, or earlier than the next weekly reporting time if they feel their symptoms have worsened. The control group will continue to receive usual care, involving regular (approximately 3 monthly) CF outpatient clinic appointments. The primary outcome measure will be courses and days of IVAB.Ethics and disseminationApproval was obtained from the Sir Charles Gairdner Group Human Research Ethics Committee for WA Health (2015-030) and Curtin University Human Research Ethics Committee (HR212/2015), and has been registered with the Australian and New Zealand Clinical Trials Registry. Results of this study will be presented at international conferences and published in peer-reviewed journals in accordance with the Consolidated Standards of Reporting Trials statement.Trial registration numberACTRN12615000599572.

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.

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Selective reporting of outcomes in randomised controlled trials in systematic reviews of cystic fibrosis.

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Selective reporting of outcomes in randomised controlled trials in systematic reviews of cystic fibrosis.

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