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

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.

Fig 1 Percentage of interventions rated as adequately described, in primary report and after author reply, for each checklist item

Fig 2 Illustration of process of obtaining complete description of an intervention (from: Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial8)

Fig 3 Access to and source of websites that contained additional intervention information