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Randomized Controlled Trial
. 2018 Jun 11;16(1):87.
doi: 10.1186/s12916-018-1083-x.

Avoidable waste of research related to outcome planning and reporting in clinical trials

Youri Yordanov  1   2   3   4 , Agnes Dechartres  5   6   7   8 , Ignacio Atal  5   6 , Viet-Thi Tran  5   6 , Isabelle Boutron  5   6   7   8 , Perrine Crequit  5   6 , Philippe Ravaud  5   6   7   8   9
Affiliations
Randomized Controlled Trial

Avoidable waste of research related to outcome planning and reporting in clinical trials

Youri Yordanov et al. BMC Med. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Core outcome set; Outcome; Randomized controlled trial; Selective reporting; Waste of research.

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Conflict of interest statement

Ethics approval and consent to participate

Ethics approval was not applicable. This was a research-on-research study of pre-existing published research; therefore, there was no patient recruitment.

Competing interests

The authors declare that they have no competing interests. All authors have completed the International Committee of Medical Journal Editors uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that they received no support from any organization for the submitted work, they have no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years, and they have no other relationships or activities that could appear to have influenced the submitted work.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the selection process. This figure summarizes the selection process for Cochrane reviews, RCTs, and outcomes. The analyzed sample involved 290 Cochrane reviews, which included 2711 RCTs in the SoF table of the main comparison. The SoF tables reported 1414 important outcomes. RCT randomized controlled trial, SoF summary of findings
Fig. 2
Fig. 2
Avoidable waste of research related to missing outcomes in RCTs published in 2010 or later and not contributing to all meta-analyses of important outcomes (n = 291). This figure summarizes the evolution of the outcomes status of SoF tables (O1 to O12 because SoF tables included from 1 to 12 outcomes per review) for each RCT at the different steps of our study: step I (i.e., information as it was extracted), step II (i.e., after evaluating the reason for the missing outcome) and after considering if there was no selective reporting or incomplete reporting, and finally step III (i.e., evaluation of waste of research) and after accounting for inadequate planning and selective reporting or incomplete reporting (i.e., adequate planning and no selective reporting or incomplete reporting). On the y-axis, each line represents one of the 291 RCTs published in 2010 or later and not contributing to all meta-analyses of the outcomes reported in the SoF table. The x-axis represents the outcomes reported in the SoF table. Each brick represents a single outcome of the SoF table. The color is a visual representation of the presence or absence of the outcome in the RCT. Light blue means that the outcome was present in the corresponding RCT and dark blue that the outcome was absent in the RCT. RCT randomized controlled trial, SoF summary of findings
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