Improving the relevance and consistency of outcomes in comparative effectiveness research

Tunis, Sean; Clarke, Mike; Gorst, Sarah L.; Gargon, Elizabeth; Blazeby, Jane M; Altman, Douglas G.; Williamson, Paula

doi:10.2217/cer-2015-0007

Cited by 76 publications

(70 citation statements)

References 43 publications

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“…The other outcome in the 2001 core outcome set was “prevalence of breastfeeding”, an outcome that was reported in 18% of trials and none of the reviews in our sample, hence not among the most frequent outcomes we identified. We agree with various other authors regarding the pressing need for core outcome sets for high-burden conditions, such as HIV/AIDS [2,3,18,21]. …”

Section: Discussionsupporting

confidence: 90%

“…When a trial included in a review has not measured or reported a certain outcome, it cannot be included in the meta-analysis for that outcome. For this reason, the overall usefulness of trials and reviews is compromised when trials and reviews report data on different outcomes, or report data on the same outcomes measured or analyzed differently or at different time-points [2–5]. This ultimately hinders the applicability of review evidence for healthcare decision-making [3,6].…”

Section: Introductionmentioning

confidence: 99%

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Clinical trials and systematic reviews addressing similar interventions for the same condition do not consider similar outcomes to be important: a case study in HIV/AIDS

Saldanha

Yang

et al. 2017

Journal of Clinical Epidemiology

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BACKGROUND The usefulness of clinical trials and systematic reviews is compromised when they report different outcomes. We compared outcomes in reviews of HIV/AIDS and the trials included in the reviews. STUDY DESIGN AND SETTING We examined all Cochrane reviews of HIV/AIDS (as of June 2013) that included ≥ 1 trial, and the trials that the reviews included. We compared outcomes within subgroups defined by type of intervention: clinical management, biomedical prevention, behavioral prevention, and health services. RESULTS We included 84 reviews that encompassed 524 trials. Although the median number of outcomes per trial (8) and per review (7.5) was similar, the trials reported a considerably greater number of unique outcomes than the reviews (779 vs. 218), ranging from 2.3 times greater (clinical management) to 5.4 times greater (behavioral prevention). High proportions of trial outcomes were not in any review: 68% (clinical management) to 83% (behavioral prevention). Lower proportions of review outcomes were not in any trial: 11% (clinical management) to 39% (health services). CONCLUSION Outcomes in trials and reviews are not well aligned for appropriate inclusion of trial results in reviews and meta-analyses. Differences in perspectives, goals, and constraints between trialists and reviewers may explain differences in outcomes they consider important.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Clinical trials and systematic reviews addressing similar interventions for the same condition do not consider similar outcomes to be important: a case study in HIV/AIDS

Saldanha

Yang

et al. 2017

Journal of Clinical Epidemiology

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“…Unless research funders and journal editors require the use of COS, clinical researchers may not fully embrace them. Thus, to be successful, a COS must address outcomes that clinical researchers and their funders believe are important and that assist patients, their families, and clinicians in clinical decision-making (39). We chose to include representatives from each of these stakeholder groups in our expert panel.…”

Section: Discussionmentioning

confidence: 99%

Core Domains for Clinical Research in Acute Respiratory Failure Survivors: An International Modified Delphi Consensus Study

Turnbull¹,

Sepúlveda

Dinglas

et al. 2017

Critical Care Medicine

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Objectives To identify the core “domains” (i.e., patient outcomes, health-related conditions, or aspects of health) that relevant stakeholders agree are essential to assess in all clinical research studies evaluating the outcomes of acute respiratory failure survivors after hospital discharge. Design A two-round consensus process, using a modified Delphi methodology, with participants from 16 countries, including patient and caregiver representatives. Prior to voting, participants were asked to review: 1) results from surveys of clinical researchers, acute respiratory failure survivors, and caregivers, that rated the importance of 19 preliminary outcome domains, and 2) results from a qualitative study of acute respiratory failure survivors’ outcomes after hospital discharge, as related to the 19 preliminary outcome domains. Participants also were asked to suggest any additional potential domains for evaluation in the first Delphi survey. Setting Web-based surveys of participants representing 4 stakeholder groups relevant to clinical research evaluating post-discharge outcomes of acute respiratory failure survivors: clinical researchers, clinicians, patients and caregivers, and US federal research funding organizations. Interventions None. Measurements and Main Results Survey response rates were 97% and 99% in Round 1 and Round 2 respectively. There were 7 domains that met the a priori consensus criteria to be designated as core domains: physical function, cognition, mental health, survival, pulmonary function, pain, and muscle and/or nerve function. Conclusion This study generated a consensus-based list of core domains that should be assessed in all clinical research studies evaluating acute respiratory failure survivors after hospital discharge. Identifying appropriate measurement instruments to assess these core domains is an important next step toward developing a set of core outcome measures for this field of research.

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“…This emphasises the importance of keeping the database current. There is also a need to identify health areas that are in particular need of a COS [6]. If COS were available and utilized for the most prevalent health conditions, this should accelerate the impact of research and result in improvements in global health.…”

Section: Introductionmentioning

confidence: 99%

Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and Identification of Gaps

et al. 2016

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BackgroundThe COMET (Core Outcome Measures in Effectiveness Trials) Initiative promotes the development and application of core outcome sets (COS), including relevant studies in an online database. In order to keep the database current, an annual search of the literature is undertaken. This study aimed to update a previous systematic review, in order to identify any further studies where a COS has been developed. Furthermore, no prioritization for COS development has previously been undertaken, therefore this study also aimed to identify COS relevant to the world’s most prevalent health conditions.MethodsThe methods used in this updated review followed the same approach used in the original review and the previous update. A survey was also sent to the corresponding authors of COS identified for inclusion in this review, to ascertain what lessons they had learnt from developing their COS. Additionally, the COMET database was searched to identify COS that might be relevant to the conditions with the highest global prevalence.ResultsTwenty-five reports relating to 22 new studies were eligible for inclusion in the review. Further improvements were identified in relation to the description of the scope of the COS, use of the Delphi technique, and the inclusion of patient participants within the development process. Additionally, 33 published and ongoing COS were identified for 13 of the world’s most prevalent conditions.ConclusionThe development of a reporting guideline and minimum standards should contribute towards future improvements in development and reporting of COS. This study has also described a first approach to identifying gaps in existing COS, and to priority setting in this area. Important gaps have been identified, on the basis of global burden of disease, and the development and application of COS in these areas should be considered a priority.

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Improving the relevance and consistency of outcomes in comparative effectiveness research

Cited by 76 publications

References 43 publications

Clinical trials and systematic reviews addressing similar interventions for the same condition do not consider similar outcomes to be important: a case study in HIV/AIDS

Clinical trials and systematic reviews addressing similar interventions for the same condition do not consider similar outcomes to be important: a case study in HIV/AIDS

Core Domains for Clinical Research in Acute Respiratory Failure Survivors: An International Modified Delphi Consensus Study

Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and Identification of Gaps

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