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

BMJ Open. 2015 Sep 15;5(9):e008532. doi: 10.1136/bmjopen-2015-008532.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antihypertensive Agents / therapeutic use*
  • Blood Pressure / drug effects*
  • Comorbidity
  • Humans
  • Hypertension / drug therapy*
  • Life Style
  • Meta-Analysis as Topic
  • Quality of Life
  • Self Care / methods*

Substances

  • Antihypertensive Agents