The GP as an investigator

Andrew McGregor,^* a 71-year-old man with a past history of hypertension and myocardial infarction, has recently been discharged from hospital after having an intracerebral haemorrhage (ICH). He wonders if he should restart aspirin, and asks for your advice.

Patient-centred care and shared decision making underpinned by rigorous evidence-based medicine provide an ideal combination to answer areas of clinical equipoise such as the question asked by Mr McGregor. Research within primary care is able to help tailor treatment for patients, given the many daily consultations that GPs have with their patients, and whose multiple conditions require an integrated approach.¹ Primary care research can also help to improve the application of health policy and its implementation, an increasingly bigger task that is likely to become more common in the future workload of all doctors.²

Considering the time constraints that GPs have, with an increasing clinical and paper workload, financial pressures, and keeping up to date, it is understandable that many GPs may wonder what the purpose of research within primary care is and why should they participate? A report by Graham Watt defined its purpose: ‘... to inform the design and development of new approaches to clinical practice, health service organisation and health policy, through developments in research methods, modeling and exploratory studies.’³

Without some of the fundamental research that has been conducted in primary care by predominately clinically-oriented GPs, we would not know about the value of delayed antibiotic prescribing in upper respiratory tract infections.⁴

Given the above, and the uniquely autonomous position that GPs have in deciding on the important research questions affecting their patients, how would you respond to Mr McGregor’s dilemma?

Spontaneous ICH affects 10 000 adults in the UK each year and at least one-third of adults with spontaneous ICH have previously taken antithrombotic drugs because of a past history of cardiovascular or cerebrovascular vaso-occlusive disease. So this will be a live question in most practices in most years.⁵ This dilemma is likely to confront GPs more often in the future because the proportion of adults taking antithrombotic drugs at the time of ICH is increasing.⁶,⁷

Unfortunately, the most effective course of action is unknown, but an ongoing randomised controlled trial seeks to resolve this problem (www.RESTARTtrial.org; ISRCTN71907627). The REstart or STop Antithrombotics Randomised Trial (RESTART) is a prospective randomised open trial of 720 survivors of ICH across the UK who were taking antithrombotic drugs at the time of ICH. The trial ultimately aims to detect whether starting antiplatelet drugs results in a net reduction in all serious vascular events. Initially, RESTART is investigating whether restarting antiplatelet drugs doubles the risk of recurrent ICH over 2 years (based on 90% power and 5% significance level), which would outweigh the expected reduction in vaso-occlusive events. The trial has randomised 55 participants at 77 hospital sites to date.

Since the initial treatment decision will usually confront patients and their doctors close to hospital discharge, recruitment to RESTART will begin in hospital. However, most participants in the trial will be managed in primary care thereafter, which will be the primary source of information about the effects of these drugs. The detection of serious vascular events will require longitudinal follow-up as well as detailed clinical information to detect and distinguish haemorrhagic and ischaemic events. GP clinical records will once again prove invaluable for the detection of these events but this requires practices, who are the data controllers, to allow access to their data.⁸

‘Medicine will make but halting progress, while whole fields essential to the progress of medicine will remain unexplored, until the general practitioner takes his place as an investigator. The reason for this is that he has opportunities which no other worker possesses.’⁹

We hope that practices will agree to allow access to their records to ensure that patients will have treatment based on the best possible evidence and think that Sir James Mackenzie would approve of Mr McGregor’s GP participating in answering this important question, which depends on the information that only his GP can provide.

• © British Journal of General Practice 2014