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Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study)

Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study)
Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study)
Background: there is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Practice Research Datalink (CPRD).

Methods: two trials were completed in primary care: one aimed to reduce inappropriate antibiotic prescribing for acute respiratory infection; the other aimed to increase physician adherence with secondary prevention interventions after first stroke. The paper draws on documentary records and trial datasets to report on the methodological experience with respect to research ethics and research governance approval, general practice recruitment and allocation, sample size calculation and power, intervention implementation, and trial analysis.

Results: we obtained research governance approvals from more than 150 primary care organizations in England, Wales, and Scotland. There were 104 CPRD general practices recruited to the antibiotic trial and 106 to the stroke trial, with the target number of practices being recruited within six months. Interventions were installed into practice information systems remotely over the internet. The mean number of participants per practice was 5,588 in the antibiotic trial and 110 in the stroke trial, with the coefficient of variation of practice sizes being 0.53 and 0.56 respectively. Outcome measures showed substantial correlations between the 12 months before, and after intervention, with coefficients ranging from 0.42 for diastolic blood pressure to 0.91 for proportion of consultations with antibiotics prescribed, defining practice and participant eligibility for analysis requires careful consideration.

Conclusions: cluster randomized trials may be performed efficiently in large samples from UK general practices using the electronic health records of a primary care database. The geographical dispersal of trial sites presents a difficulty for research governance approval and intervention implementation. Pretrial data analyses should inform trial design and analysis plans
clinical trial, cluster randomization, electronic health records, primary care, implementation science, decision support
1745-6215
220
Gulliford, Martin C.
5c557aa2-db12-43a2-8778-eac74cf42138
van Staa, Tjeerd P.
3e33e405-5ea6-4196-9693-7258f7fba8cb
McDermott, Lisa
5e895229-decd-4a30-8d08-dd9cc5b8f443
McCann, Gerard
d970a747-db34-4088-9fc5-63befb3479d3
Charlton, Judith
27682a6d-c126-45fb-a8a1-dbde57ccb4e9
Dregan, Alex
3e9f701f-54d9-4519-a7b7-e18e05b427c7
Gulliford, Martin C.
5c557aa2-db12-43a2-8778-eac74cf42138
van Staa, Tjeerd P.
3e33e405-5ea6-4196-9693-7258f7fba8cb
McDermott, Lisa
5e895229-decd-4a30-8d08-dd9cc5b8f443
McCann, Gerard
d970a747-db34-4088-9fc5-63befb3479d3
Charlton, Judith
27682a6d-c126-45fb-a8a1-dbde57ccb4e9
Dregan, Alex
3e9f701f-54d9-4519-a7b7-e18e05b427c7

Gulliford, Martin C., van Staa, Tjeerd P., McDermott, Lisa, McCann, Gerard, Charlton, Judith and Dregan, Alex (2014) Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study). Trials, 15 (1), 220. (doi:10.1186/1745-6215-15-220).

Record type: Article

Abstract

Background: there is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Practice Research Datalink (CPRD).

Methods: two trials were completed in primary care: one aimed to reduce inappropriate antibiotic prescribing for acute respiratory infection; the other aimed to increase physician adherence with secondary prevention interventions after first stroke. The paper draws on documentary records and trial datasets to report on the methodological experience with respect to research ethics and research governance approval, general practice recruitment and allocation, sample size calculation and power, intervention implementation, and trial analysis.

Results: we obtained research governance approvals from more than 150 primary care organizations in England, Wales, and Scotland. There were 104 CPRD general practices recruited to the antibiotic trial and 106 to the stroke trial, with the target number of practices being recruited within six months. Interventions were installed into practice information systems remotely over the internet. The mean number of participants per practice was 5,588 in the antibiotic trial and 110 in the stroke trial, with the coefficient of variation of practice sizes being 0.53 and 0.56 respectively. Outcome measures showed substantial correlations between the 12 months before, and after intervention, with coefficients ranging from 0.42 for diastolic blood pressure to 0.91 for proportion of consultations with antibiotics prescribed, defining practice and participant eligibility for analysis requires careful consideration.

Conclusions: cluster randomized trials may be performed efficiently in large samples from UK general practices using the electronic health records of a primary care database. The geographical dispersal of trial sites presents a difficulty for research governance approval and intervention implementation. Pretrial data analyses should inform trial design and analysis plans

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More information

Accepted/In Press date: 22 May 2014
Published date: 11 June 2014
Keywords: clinical trial, cluster randomization, electronic health records, primary care, implementation science, decision support
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 379982
URI: https://eprints.soton.ac.uk/id/eprint/379982
ISSN: 1745-6215
PURE UUID: 27cfecad-de03-4f0d-808e-44c0c4b4f8ba

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Date deposited: 27 Aug 2015 12:27
Last modified: 21 Oct 2019 19:10

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