SHARE: The Scottish Health Research Register
Although randomised controlled trials remain the gold standard for interventional medical research recruiting to them is difficult. In a study by Sully et al. 55% of trials recruited their originally specified target sample size. For most studies identification of potential participants relies on clinicians searching clinical records and contacting the patients on behalf of researchers. Clinicians perceive too busy to take part in research and moreover often use their knowledge of the patient to decide not to offer participation in a trial. Participants then have to respond and often a screening investigation is required to confirm eligibility. Increasingly a genetic profile is required. Each stage is a challenge to recruitment. This has led to the proposal to use NHS linked data sets to identify people who might be suitable for studies. Care.Data assumed consent unless patients actively opted out of sharing data. This led to protests and the project was therefore suspended.
SHARE adopts an approach which seeks individual consent from the outset and guarantees data will never leave the NHS without consent. Participants allow their information held in NHS datasets to be used to identify research studies for which they may be suitable, facilitated through the use of the Community Health Index number (a unique patient identifier used for NHS interactions in Scotland. Contact details are rupdated through regular downloads from their primary care practices and removed if they die or leave Scotland. Participants choose how they wish to be told about studies for which they may be suitable (telephone, email or letter) and how often they wish to be contacted yearly. In addition SHARE participants have the option to give consent for blood remaining after routine tests have been performed to be stored and subsequently used for medical research. This makes use of an automated system, running within NHS laboratories, which identifies and automatically collates and stores, residual samples. These can be used for research linked to de-identified data from the participant’s medical history.
SHARE has now recruited more than 100,000 volunteers with a goal of 250,000 by the end of 2017 and a million by 2025. A wide range of recruitment methods have been employed. Face-to-face recruitment in clinics and practices is most successful and cost-effective, followed by direct emails from employers. New participants are asked to share on social media. Early indications of recruitment to projects suggest a much higher rate of engagement by SHARE volunteers than is normally expected, largely facilitated by the registrants’ provision of telephone and email details.
The SHARE approach has great promise in increasing recruitment to trials and indeed, as participant numbers rise, and smartphone ownership increases, for real-time epidemiological research and trial follow-up.