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 Qamar, Juha Varis, Willem Verberk, Bonnie J Wakefield, Richard J McManus
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.