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. 2016 Mar 10;17(1):131.
doi: 10.1186/s13063-016-1259-7.

Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention

Bethan Copsey  1 , Sally Hopewell  2 , Clemens Becker  3 , Ian D Cameron  4 , Sarah E Lamb  2
Affiliations

Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention

Bethan Copsey et al. Trials. .

Abstract

Background: Many researchers and professional bodies are seeking consensus for core outcomes for clinical trials. The Prevention of Falls Network Europe (ProFaNE) developed a common outcome data set for fall injury prevention trials 10 years ago. This study assesses the impact of these recommendations.

Methods: A systematic search (up to 16 January 2015) was performed using Web of Science, Scopus and PubMed for articles citing the ProFaNE recommendations. Randomised trials on fall prevention in older people were selected for further analysis. Data were extracted on study characteristics and adherence to the key domains recommended by the ProFaNE consensus: falls, fall injury, physical activity, psychological consequences and health-related quality of life. Details of non-recommended outcome measures used were also recorded.

Results: The ProFaNE recommendations were cited in a total of 464 published articles, of which 34 were randomised trials on fall prevention in older people. Only one study (3 %) reported on all core domains. Most of the trials reported on falls (n = 32/34, 94 %) as a core outcome measure. Most of the recommendations within the falls domain were well-followed. Around half of the trials reported on fall-related injury (n = 16/34, 47 %). However, none reported the number of radiologically confirmed peripheral fracture events, which is the recommended outcome measure for injury. The other key domains (quality of life, physical activity and psychological consequences) were less frequently reported on, with a lack of consistency in the outcome measures used.

Conclusions: The ProFaNE recommendations had a limited effect on standardising the reporting of outcomes in randomised trials on fall injury prevention in older people during the search period. Authors of consensus guidelines should consider maximising buy-in by including a diversity of geographic areas and academic disciplines at the development stage and using a solid dissemination strategy.

Keywords: Core outcome set; Falls; Older adults.

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Figures

Fig. 1
Fig. 1
Identification of reports of randomised trials in the area of fall prevention among an elderly population
Fig. 2
Fig. 2
Number of publications citing the Prevention of Falls Network Europe (ProFaNE) recommendations by year and study type
Fig. 3
Fig. 3
Level of adherence to the Prevention of Falls Network Europe (ProFaNE) recommendations
See this image and copyright information in PMC

References

    1. The COMET Initiative. 2015. http://www.comet-initiative.org. Accessed 12 October 2015.
    1. Williamson PR, Altman DG, Blazeby JM, Clarke M, Gargon E. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy. 2012;17(1):1–2. doi: 10.1258/jhsrp.2011.011131. - DOI - PubMed
    1. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132. doi: 10.1186/1745-6215-13-132. - DOI - PMC - PubMed
    1. Lamb SE, Jørstad‐Stein EC, Hauer K, Becker C. Development of a common outcome data set for fall injury prevention trials: the Prevention of Falls Network Europe consensus. J Am Geriatr Soc. 2005;53(9):1618–22. doi: 10.1111/j.1532-5415.2005.53455.x. - DOI - PubMed
    1. Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, et al. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009;2 - PMC - PubMed

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