Primary care research
Point-of-care research effective, but hampered by red tape, study finds
Costly clinical trials could be revamped if GPs recruit patients during consultations.
Source: Wiki Commons / Dreamstime.com
“Point-of-care” randomised trials may reveal the best use of existing treatments, with much less expense and inconvenience than traditional clinical trials, a study has found.
The approach, in which patients would be recruited during GP consultations and endpoint data are obtained from the electronic health records (EHRs), was evaluated in a report in Health Technology Assessment (11 July). It was developed by Tjeerd-Pieter van Staa, previously a member of the Clinical Practice Research Datalink (CPRD) and now at the University of Manchester’s Health eResearch Centre, and colleagues, and piloted in English and Scottish general practises that routinely contribute their patient records to the CPRD research database.
Of 459 practices that were invited to join the pilot, 270 expressed interest but just 23 took part. The low participation rate, van Staa said, was mainly due to the lengthy and complex governance process. The schemes took more than two years to be approved at both national and local level and entailed many changes to the protocol and informed consent forms, as well as protocol training for all GPs involved.
“The concept technically works,” van Staa said. “You can use the EHR to identify eligible patients and GPs and patients are willing to participate, but paperwork is the biggest stumbling block.”
At participating practices, computer software was installed on GPs’ desktop computers that automatically alerted a GP to a patient’s eligibility to participate in a trial and allowed them to sign patients up during regular consultations. The software was linked with the EHR in order to match treatment allocation with clinical outcomes.
Source: Tjeerd-Pieter van Staa / NIHR Journals Library
The first pilot, called Retropro, compared simvastatin with atorvastatin in 301 patients with hypercholesterolaemia and high cardiovascular risk. The second trial, eLung, compared immediate with delayed antibiotic treatment for mild-to-moderate exacerbations of lung disease. eLung aimed to recruit 150 patients but managed just 31.
In both trials, treatment allocation was randomised and open-label but endpoint assessment was blinded. Clinical data is now being analysed and will be published in due course.
Qualitative interviews with participants suggested that GPs were generally positive about the principle of computerised trial recruitment and use of EHRs to collect outcome data; however, many were concerned about a lack of time to recruit patients during routine consultations. All patients who were interviewed for the study said they considered the process to be acceptable.
The project was funded by the NIHR Health Technology Assessment programme and the Wellcome Trust.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065896
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