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  3. Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials
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Research

Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f3755 (Published 10 September 2013) Cite this as: BMJ 2013;347:f3755
  1. Tammy C Hoffmann, associate professor of clinical epidemiology1,
  2. Chrissy Erueti, assistant professor1,
  3. Paul P Glasziou, professor of evidence-based medicine1
  1. 1Centre for Research in Evidence-Based Practice, Faculty of Health Sciences and Medicine, Bond University, Qld, Australia, 4229
  1. Correspondence to: T Hoffmann thoffmann{at}bond.edu.au
  • Accepted 29 May 2013

Abstract

Objectives To evaluate the completeness of descriptions of non-pharmacological interventions in randomised trials, identify which elements are most frequently missing, and assess whether authors can provide missing details.

Design Analysis of consecutive sample of randomised trials of non-pharmacological interventions.

Data sources and study selection All reports of randomised trials of non-pharmacological interventions published in 2009 in six leading general medical journals; 133 trial reports, with 137 interventions, met the inclusion criteria.

Data collection Using an eight item checklist, two raters assessed the primary full trial report, plus any reference materials, appendices, or websites. Questions about missing details were emailed to corresponding authors, and relevant items were then reassessed.

Results Of 137 interventions, only 53 (39%) were adequately described; this was increased to 81 (59%) by using 63 responses from 88 contacted authors. The most frequently missing item was the “intervention materials” (47% complete), but it also improved the most after author response (92% complete). Whereas some authors (27/70) provided materials or further information, other authors (21/70) could not; their reasons included copyright or intellectual property concerns, not having the materials or intervention details, or being unaware of their importance. Although 46 (34%) trial interventions had further information or materials readily available on a website, many were not mentioned in the report, were not freely accessible, or the URL was no longer functioning.

Conclusions Missing essential information about interventions is a frequent, yet remediable, contributor to the worldwide waste in research funding. If trial reports do not have a sufficient description of interventions, other researchers cannot build on the findings, and clinicians and patients cannot reliably implement useful interventions. Improvement will require action by funders, researchers, and publishers, aided by long term repositories of materials linked to publications.

Footnotes

  • We thank Iain Chalmers (editor, James Lind Library, Oxford, UK) and Susan Michie (professor of health psychology, University College London, UK) for reviewing the manuscript and providing helpful comments. We also thank the authors of included reports who responded to our questions.

  • Contributors: TCH and PPG were primarily responsible for study conception and design and for data analysis and interpretation. All authors had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. CE assisted with acquisition of the data and administrative support. TCH led the writing of the first draft of the manuscript, and all authors contributed to drafting and revising the manuscript. TCH and PPG are the guarantors.

  • Funding: TCH is supported by a National Health and Medical Research Council of Australia (NHMRC)/Primary Health Care Research Evaluation and Development Career Development Fellowship (number: 1033038), with funding provided by the Australian Department of Health and Ageing. PPG is supported by a NHMRC Australia Fellowship (number: 527500). The funders had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: TCH is supported by a NHMRC/Primary Health Care Research Evaluation and Development Career Development Fellowship, and PPG is supported by a NHMRC Australia Fellowship; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: Not required.

  • Data sharing: Data on the included trials and their ratings are available on request from the corresponding author at Tammy_Hoffmann{at}bond.edu.au.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.

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