Pragmatic randomised trials using routine electronic health records: putting them to the test

Staa, Tjeerd van; Goldacre, Ben; Gulliford, Martin; Cassell, Jackie A; Pirmohamed, Munir; Taweel, Adel; Delaney, Brendan; Smeeth, Liam

doi:10.1136/bmj.e55

Cited by 143 publications

(100 citation statements)

References 17 publications

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“…The conduct of trials using electronic health records as a means for increasing the speed and efficiency with which trials can be completed is a topic of growing importance. 80 We have previously conducted cluster RCTs using primary care electronic health records, with the Clinical Practice Research Datalink (CPRD) 81 as the data source. These cluster trials were in implementation research focusing on primary care management and appropriate prescribing for respiratory infections 82 and stroke secondary prevention.…”

Section: Rapid Trials Using Electronic Health Recordsmentioning

confidence: 99%

Enhanced invitation methods and uptake of health checks in primary care: randomised controlled trial and cohort study using electronic health records

McDermott

Wright

Cornelius

et al. 2016

Health Technol Assess

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BackgroundA national programme of health checks to identify risk of cardiovascular disease (CVD) is being rolled out but is encountering difficulties because of low uptake.ObjectiveTo evaluate the effectiveness of an enhanced invitation method using the question–behaviour effect (QBE), with or without the offer of a financial incentive to return the QBE questionnaire, at increasing the uptake of health checks. The research went on to evaluate the reasons for the low uptake of invitations and compare the case mix for invited and opportunistic health checks.DesignThree-arm randomised trial and cohort study.ParticipantsAll participants invited for a health check from 18 general practices. Individual participants were randomised.Interventions(1) Standard health check invitation only; (2) QBE questionnaire followed by a standard invitation; and (3) QBE questionnaire with offer of a financial incentive to return the questionnaire, followed by a standard invitation.Main outcome measuresThe primary outcome was completion of the health check within 6 months of invitation. Ap-value of 0.0167 was used for significance. In the cohort study of all health checks completed during the study period, the case mix was compared for participants responding to invitations and those receiving ‘opportunistic’ health checks. Participants were not aware that several types of invitation were in use. The research team were blind to trial arm allocation at outcome data extraction.ResultsIn total, 12,459 participants were included in the trial and health check uptake was evaluated for 12,052 participants for whom outcome data were collected. Health check uptake was as follows: standard invitation, 590 out of 4095 (14.41%); QBE questionnaire, 630 out of 3988 (15.80%); QBE questionnaire and financial incentive, 629 out of 3969 (15.85%). The increase in uptake associated with the QBE questionnaire was 1.43% [95% confidence interval (CI) –0.12% to 2.97%;p = 0.070] and the increase in uptake associated with the QBE questionnaire and offer of financial incentive was 1.52% (95% CI –0.03% to 3.07%;p = 0.054). The difference in uptake associated with the offer of an incentive to return the QBE questionnaire was –0.01% (95% CI –1.59% to 1.58%;p = 0.995). During the study period, 58% of health check cardiovascular risk assessments did not follow a trial invitation. People who received an ‘opportunistic’ health check had greater odds of a ≥ 10% CVD risk than those who received an invited health check (adjusted odds ratio 1.70, 95% CI 1.45 to 1.99;p < 0.001).ConclusionsUptake of a health check following an invitation letter is low and is not increased through an enhanced invitation method using the QBE. The offer of a £5 incentive did not increase the rate of return of the QBE questionnaire. A high proportion of all health checks are performed opportunistically and not in response to a standard invitation letter. Participants receiving opportunistic checks are at higher risk of CVD than those responding to standard invitations. Future research should aim to increase the accessibility of preventative medical interventions to increase uptake. Research should also explore the wider use of electronic health records in delivering efficient trials.Trial registrationCurrent Controlled Trials ISRCTN42856343.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 84. See the NIHR Journals Library website for further project information.

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Section: Rapid Trials Using Electronic Health Recordsmentioning

confidence: 99%

Enhanced invitation methods and uptake of health checks in primary care: randomised controlled trial and cohort study using electronic health records

McDermott

Wright

Cornelius

et al. 2016

Health Technol Assess

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“…For example, a new anti-diabetic medication could be "Approved for Randomisation" whereby the HTA agency asks a pharmaceutical company to gather more evidence about the long-term cardiovascular benefits and harms of its product -relative to other drugs in the same therapeutic class -in low-cost, head-to-head randomised trials. 31 It is increasingly feasible to embed such simple trials in clinical practice, with follow-up data on real-world outcomes such as myocardial infarction, or death, extracted from routinely collected administrative data and electronic health records. 32 Any clinician or patient seeking to access a new diabetes medication which currently lacks adequate evidence of benefit could be requested to specify the treatment option they would have used before the drug was approved.…”

Section: Raising the Bar For Market Entry By Health Technology Assessmentioning

confidence: 99%

Rethinking the appraisal and approval of drugs for type 2 diabetes:

Naci

Lehman

Wouters

et al. 2015

BMJ

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The process for approving new drugs for type 2 diabetes illustrates the significant shortcomings of the regulatory standards for licensing, reimbursing, and adopting new drugs. Regulatory reform is needed to improve the real-world therapeutic value of anti-diabetic drugs. BackgroundThe overarching aim of drug regulation is to ensure that only effective and safe treatments reach patients. Ideally, regulatory decisions are based on good quality data from large trials measuring real-world, patient-centred outcomes. Licensing agencies, however, routinely permit the market entry of treatments on the basis of small placebo-controlled trials evaluating short-term, surrogate endpoints in selected populations. Consequently, medicines are commonly prescribed in the absence of good quality data on their long-term benefits and harms.1,2 Current licensing standards are inadequate to predict the real-world therapeutic value of new medications.

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“…There may be ethical questions because traditionally in trials, people are told what their data are being used for, whereas with big data, the uses of their data may not always be known yet. However, some big datasets, such as NHANES and the Health Survey for England, have been studied for many different purposes over the years [18]. One example of where big-data techniques could help to settle a health controversy is around the prescribing of statins to otherwise healthy people.…”

Section: Data Repositoriesmentioning

confidence: 99%

Big Data and Health Economics: Strengths, Weaknesses, Opportunities and Threats

Collins

2015

PharmacoEconomics

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'Big data' is the collective name for the increasing capacity of information systems to collect and store large volumes of data, which are often unstructured and time stamped, and to analyse these data by using regression and other statistical techniques. This is a review of the potential applications of big data and health economics, using a SWOT (strengths, weaknesses, opportunities, threats) approach. In health economics, large pseudonymized databases, such as the planned care.data programme in the UK, have the potential to increase understanding of how drugs work in the real world, taking into account adherence, co-morbidities, interactions and side effects. This 'real-world evidence' has applications in individualized medicine. More routine and larger-scale cost and outcomes data collection will make health economic analyses more disease specific and population specific but may require new skill sets. There is potential for biomonitoring and lifestyle data to inform health economic analyses and public health policy.

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Pragmatic randomised trials using routine electronic health records: putting them to the test

Cited by 143 publications

References 17 publications

Enhanced invitation methods and uptake of health checks in primary care: randomised controlled trial and cohort study using electronic health records

Enhanced invitation methods and uptake of health checks in primary care: randomised controlled trial and cohort study using electronic health records

Rethinking the appraisal and approval of drugs for type 2 diabetes:

Big Data and Health Economics: Strengths, Weaknesses, Opportunities and Threats

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