Feasibility of embedding orthopaedic clinical trials into national registries: a pilot quality improvement study for the UK Non-Arthroplasty Hip Registry (UK-NAHR)
M. Sohatee, Callum McBryde, Tony Andrade, Paul Gaston, Jonathan Hutt, V. Khanduja, A. Malviya
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引用次数: 0
Abstract
The integration of ‘Registry-based Randomised Control Trials’ (RRCT) into national registries has the potential to catalyse prospective research, enhancing the evidence base for practice. The aim of this study was to assess the feasibility of embedding a trial within the UK Non-Arthroplasty Hip Registry. This was a national observational, multi-centre study. Six pilot sites within the UK were provided with additional support for data collection. We compared the ability of these pilot sites to collect data with the ability of centres where no additional support was provided. We collected information on patient compliance, efficacy and adverse events of drugs routinely used after hip preserving surgery. The primary outcome measure was compliance with data collection in these centres at 30 and 90 days after surgery. Our intention was to assess the feasibility of, and factors influencing, the capturing data for interventional registry trials in the future. Two hundred and twenty-eight patients were enrolled in the Non-Arthroplasty Hip Registry during the study period (114 within pilot centres and 114 in non-pilot centres). Pilot centres had a mean follow-up compliance of 79% (30 days) and 69.4% (90 days) in contrast to 55% (30 days) and 47% (90 days) in the non-pilot centres (P = 0.009/P = 0.0058). The study revealed that supplementary administrative support resulted in improved compliance. However, deficient administration systems negatively impacted follow-up, and surgeon motivation emerged as a crucial determinant in ensuring robust follow-up. The lessons learned from this feasibility trial could be useful for any national registry embedding prospective, registry-based trials.
期刊介绍:
Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance.
Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.