Access to routinely collected health data for clinical trials - review of successful data requests to UK registries.

BACKGROUND: Clinical trials generally each collect their own data despite routinely collected health data (RCHD) increasing in quality and breadth. Our aim is to quantify UK-based randomised controlled trials (RCTs) accessing RCHD for participant data, characterise how these data are used and thereby recommend how more trials could use RCHD. METHODS: We conducted a systematic review of RCTs accessing RCHD from at least one registry in the UK between 2013 and 2018 for the purposes of informing or supplementing participant data. A list of all registries holding RCHD in the UK was compiled. In cases where registries published release registers, these were searched for RCTs accessing RCHD. Where no release register was available, registries were contacted to request a list of RCTs. For each identified RCT, information was collected from all publicly available sources (release registers, websites, protocol etc.). The search and data extraction were undertaken between January and May 2019. RESULTS: We identified 160 RCTs accessing RCHD between 2013 and 2018 from a total of 22 registries; this corresponds to only a very small proportion of all UK RCTs (about 3%). RCTs accessing RCHD were generally large (median sample size 1590), commonly evaluating treatments for cancer or cardiovascular disease. Most of the included RCTs accessed RCHD from NHS Digital (68%), and the most frequently accessed datasets were mortality (76%) and hospital visits (55%). RCHD was used to inform the primary trial (82%) and long-term follow-up (57%). There was substantial variation in how RCTs used RCHD to inform participant outcome measures. A limitation was the lack of information and transparency from registries and RCTs with respect to which datasets have been accessed and for what purposes. CONCLUSIONS: In the last five years, only a small minority of UK-based RCTs have accessed RCHD to inform participant data. We ask for improved accessibility, confirmed data quality and joined-up thinking between the registries and the regulatory authorities. TRIAL REGISTRATION: PROSPERO CRD42019123088.

A Randomized Crossover Trial of Conventional vs Virtual Chromoendoscopy for Colitis Surveillance: Dysplasia Detection, Feasibility, and Patient Acceptability (CONVINCE).

BACKGROUND: Chromoendoscopy (CE) is the recommended surveillance technique for colitis, but uptake has been limited and the literature provides scant information on patient experience (PE); imperative to adherence to surveillance programmes. Virtual CE (VCE) by Fujinon Intelligent Colour Enhancement digitally reconstructs mucosal images in real time, without the technical challenges of CE. We performed a multifaceted randomized crossover trial (RCT) to evaluate study feasibility and obtain preliminary comparative procedural and PE data. METHODS: Patients were randomized to undergo either CE with indigo carmine or VCE as the first procedure. After 3-8 weeks, participants underwent colonoscopy with the second technique. Patient recruitment/retention, missed dysplasia, prediction of dysplasia, and contamination (memory/sampling of the first procedure) were recorded. PE was assessed by validated questionnaires, and pain was assessed using a visual analog scale (mm). RESULTS: Sixty patients were recruited, and 48 patients (first procedure: 23 VCE, 25 CE) completed the trial (retention 80%) with no episodes of contamination. Eleven dysplastic lesions were detected in n = 7/48 (14.5%). VCE missed 1 lesion, and CE missed 2 lesions in n = 2 (data of VCE vs CE, respectively, for dysplasia diagnostic accuracy: 93.94% [85.2%-98.32%] vs 76.9% [66.9%-98.2%]; examination time [minutes]: 14 +/- 4 vs 20 +/- 7 (95% confidence interval, 3.5 to 8; P < 0.001); pain (mm): 27.4 +/- 17.5 vs 34.7 +/- 18; patient preference: 67% [n = 31] vs 33% [n = 15] in n = 46; P < 0.001). CONCLUSIONS: This is the first RCT to include validated PE in a colitis surveillance program. VCE is safe, technically easier, quicker, and more comfortable test, with dysplasia detection at least as good as that of CE, overcoming many barriers to the wider adoption of CE. This trial may serve as a successful foundation for a a multicenter trial to confirm the value of VCE for colitis surveillance.