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Management of confounding in controlled orthopaedic trials: a cross-sectional study.

ABSTRACT: Confounding occurs when the effect of an exposure on an outcome is distorted by a confounding factor and will lead to spurious effect estimates in clinical studies. Although confounding can be minimized at the design stage, residual confounding may remain. An argument therefore can be made for controlling for confounding during data analysis in all studies. We asked whether confounding is considered in controlled trials in orthopaedic research and hypothesized the likelihood of doing so is affected by participation of a scientifically trained individual and associated with the magnitude of the impact factor. We performed a cross-sectional study of all controlled trials published in 2006 in eight orthopaedic journals with a high impact factor. In 126 controlled studies, 20 (15.9%; 95% confidence interval, 9.5%-22.3%) studies discussed confounding without adjusting in the analysis. Thirty-eight (30.2%; 95% confidence interval, 22.2%-38.2%) controlled for confounding, although we suspect the true proportion might be somewhat higher. Participation of a methodologically trained researcher was associated with (odds ratio, 3.85) controlling for confounding, although there was no association between impact factor and controlling for confounding. The question remains to what extent the validity of published findings is affected by failure to control for confounding.

SUBMITTER: Vavken P

PROVIDER: S-EPMC2504668 | biostudies-other | 2008 Apr

REPOSITORIES: biostudies-other

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Project description:Background:Accurate reporting on sex and gender in health research is integral to ensuring that health interventions are safe and effective. In Canada and internationally, governments, research organizations, journal editors, and health agencies have called for more inclusive research, provision of sex-disaggregated data, and the integration of sex and gender analysis throughout the research process. Sex and gender analysis is generally defined as an approach for considering how and why different subpopulations (e.g., of diverse genders, ages, and social locations) may experience health conditions and interventions in different or similar ways.The objective of this study was to assess the extent and nature of reporting about sex and/or gender, including whether sex and gender analysis (SGA) was carried out in a sample of Canadian randomized controlled trials (RCTs) with human participants. Methods:We searched MEDLINE from 01 January 2013 to 23 July 2014 using a validated filter for identification of RCTs, combined with terms related to Canada. Two reviewers screened the search results to identify the first 100 RCTs that were either identified in the trial publication as funded by a Canadian organization or which had a first or last author based in Canada. Data were independently extracted by two people from 10% of the RCTs during an initial training period; once agreement was reached on this sample, the remainder of the data extraction was completed by one person and verified by a second. Results:The search yielded 1433 records. We screened 256 records to identify 100 RCTs which met our eligibility criteria. The median sample size of the RCTs was 107 participants (range 12-6085). While 98% of studies described the demographic composition of their participants by sex, only 6% conducted a subgroup analysis across sex and 4% reported sex-disaggregated data. No article defined "sex" and/or "gender." No publication carried out a comprehensive sex and gender analysis. Conclusions:Findings highlight poor uptake of sex and gender considerations in the Canadian RCT context and underscore the need for better articulated guidance on sex and gender analysis to improve reporting of evidence, inform policy development, and guide future research.

Project description:BackgroundAssessment of patient-reported outcomes (PROs) provides valuable information to inform patient-centered care, but may also reveal 'PRO alerts': psychological distress or physical symptoms that may require an immediate response. Ad-hoc management of PRO alerts in clinical trials may result in suboptimal patient care or potentially bias trial results. To gain greater understanding of current practice in PRO alert management we conducted a national survey of personnel involved in clinical trials with a PRO endpoint.Methods and findingsWe conducted a national cross-sectional survey of 767 UK-based research nurses, data managers/coordinators, trial managers and chief/principal investigators involved in clinical trials using PROs. Respondents were self-selected volunteers from a non-randomised sample of eligible individuals recruited via 55 UK Clinical Research Collaboration Registered Clinical Trials Units and 19 Comprehensive Local Research Networks. Questions centred on the proportion of trial personnel encountering alerts, how staff responded to PRO alerts and whether current guidance was deemed sufficient to support research personnel. We undertook descriptive analyses of the quantitative data and directed thematic analysis of free-text comments. 20% of research nurses did not view completed PRO questionnaires and were not in a position to discover alerts, 39-50% of the remaining respondent group participants reported encountering PRO alerts. Of these, 83% of research nurses and 54% of data managers/trial coordinators reported taking action to assist the trial participant, but less than half were able to record the intervention in the trial documentation. Research personnel reported current PRO alert guidance/training was insufficient.ConclusionsResearch personnel are intermittently exposed to PRO alerts. Some intervene to help trial participants, but are not able to record this intervention in the trial documentation, risking co-intervention bias. Other staff do not check PRO information during the trial, meaning alerts may remain undiscovered, or do not respond to alerts if they are inadvertently encountered; both of which may impact on patient safety. Guidance is needed to support PRO alert management that protects the interests of trial participants whilst avoiding potential bias.

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Management of confounding in controlled orthopaedic trials: a cross-sectional study.

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