Factors associated with reporting of the Prevention of Falls Network Europe (ProFaNE) core outcome set domains in randomized trials on falls in older people: a citation analysis and correlational study

Abstract

Background: Core outcome sets are advocated as a means to standardize outcome reporting across randomized controlled trials (RCTs) and reduce selective outcome reporting. In 2005, the Prevention of Falls Network Europe (ProFaNE) published a core outcome set identifying five domains that should be measured and reported, at a minimum, in RCTs or meta-analysis on falls in older people. As reporting of all five domains of the ProFaNE core outcome set has been minimal, we set out to investigate factors associated with reporting of the ProFaNE core outcome set domains in a purposeful sample of RCTs on falls in older people.

Methods: We conducted a systematic citation analysis to identify all reports of RCTs focused on falls in older people that cited the ProFaNE core outcome set between October 2005 and July 2021. We abstracted author-level, study-level, and manuscript-level data and whether each domain of the ProFaNE core outcome set was reported. We used penalized LASSO regression to identify factors associated with the mean percentage of ProFaNE core outcome set domains reported.

Results: We identified 85 eligible reports of RCTs. Articles were published between 2007 and 2021, described 75 unique RCTs, and were authored by 76 unique corresponding authors. The percentage of ProFaNE core outcome set domains reported ranged from 0 to 100%, with a median of 40% and mean (standard deviation, SD) of 52.2% (25.1). RCTs funded by a non-industry source reported a higher mean percentage of domains than RCTs without a non-industry funding source (estimated mean difference = 17.5%; 95% confidence interval (CI) 1.8-33.2). RCTs examining exercise (15.4%; 95% CI 1.9-28.9) or multi-component/factorial (17.4%; 95% CI 4.7-30.1) interventions each reported a higher mean percentage of domains than RCTs examining other intervention types.

Conclusions: We found that RCTs funded by at least one non-industry source, examining exercise or multi-component/factorial interventions, reported the highest percentages of ProFaNE core outcome set domains. Findings may help inform strategies to increase the impact of the ProFaNE core outcome set. Ultimately, this may lead to enhanced knowledge of the effectiveness and safety of interventions to prevent and/or manage falls in older people.

Keywords: Accidental falls; Adherence; Core outcome set; Fall injuries; Implementation fidelity; Older people; Physical activity; Psychological consequences of falls; Quality of life.