Feasibility of embedding orthopaedic clinical trials into national registries: a pilot quality improvement study for the UK Non-Arthroplasty Hip Registry (UK-NAHR).

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.