Individual patient data meta-analysis of self-monitoring of blood pressure (BP-SMART): a protocol

Katherine L Tucker, James P Sheppard, Richard Stevens, Hayden B Bosworth, Alfred Bove, Emma P Bray, Marshal Godwin, Beverly Green, Paul Hebert, F D Richard Hobbs, Ilkka Kantola, Sally Kerry, David J Magid, Jonathan Mant, Karen L Margolis, Brian McKinstry, Stefano Omboni, Olugbenga Ogedegbe, Gianfranco Parati, Nashat QamarJuha Varis, Willem Verberk, Bonnie J Wakefield, Richard J McManus

Research output: Contribution to journalArticlepeer-review

Abstract

INTRODUCTION: Self-monitoring of blood pressure is effective in reducing blood pressure in hypertension. However previous meta-analyses have shown a considerable amount of heterogeneity between studies, only part of which can be accounted for by meta-regression. This may be due to differences in design, recruited populations, intervention components or results among patient subgroups. To further investigate these differences, an individual patient data (IPD) meta-analysis of self-monitoring of blood pressure will be performed.

METHODS AND ANALYSIS: We will identify randomised trials that have compared patients with hypertension who are self-monitoring blood pressure with those who are not and invite trialists to provide IPD including clinic and/or ambulatory systolic and diastolic blood pressure at baseline and all follow-up points where both intervention and control groups were measured. Other data requested will include measurement methodology, length of follow-up, cointerventions, baseline demographic (age, gender) and psychosocial factors (deprivation, quality of life), setting, intensity of self-monitoring, self-monitored blood pressure, comorbidities, lifestyle factors (weight, smoking) and presence or not of antihypertensive treatment. Data on all available patients will be included in order to take an intention-to-treat approach. A two-stage procedure for IPD meta-analysis, stratified by trial and taking into account age, sex, diabetes and baseline systolic BP will be used. Exploratory subgroup analyses will further investigate non-linear relationships between the prespecified variables. Sensitivity analyses will assess the impact of trials which have and have not provided IPD.

ETHICS AND DISSEMINATION: This study does not include identifiable data. Results will be disseminated in a peer-reviewed publication and by international conference presentations.

CONCLUSIONS: IPD analysis should help the understanding of which self-monitoring interventions for which patient groups are most effective in the control of blood pressure.

Original languageEnglish
Pages (from-to)e008532
JournalBMJ Open
Volume5
Issue number9
DOIs
Publication statusPublished - 15 Sep 2015

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