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Individual patient data meta-analysis of self-monitoring of blood pressure (BP-SMART): a protocol
  1. Katherine L Tucker1,
  2. James P Sheppard1,
  3. Richard Stevens1,
  4. Hayden B Bosworth2,
  5. Alfred Bove,
  6. Emma P Bray3,4,
  7. Marshal Godwin5,
  8. Beverly Green6,
  9. Paul Hebert7,
  10. F D Richard Hobbs1,
  11. Ilkka Kantola8,
  12. Sally Kerry9,
  13. David J Magid10,
  14. Jonathan Mant11,
  15. Karen L Margolis12,
  16. Brian McKinstry13,
  17. Stefano Omboni14,
  18. Olugbenga Ogedegbe15,
  19. Gianfranco Parati16,
  20. Nashat Qamar17,
  21. Juha Varis8,
  22. Willem Verberk18,
  23. Bonnie J Wakefield19,
  24. Richard J McManus1
  1. 1Nuffield Department of Primary Care, University of Oxford, Oxford, UK
  2. 2Center for Health Services Research in Primary Care, Durham VAMC, Durham, North Carolina, USA
  3. 3Department of Cardiology, Temple University School of Medicine, Philadelphia, USA
  4. 4School of Psychology, University of Central Lancashire, Preston, UK
  5. 5Family Medicine, Memorial University of Newfoundland, St. John's, Newfoundland, Canada
  6. 6Group Health Research Institute, Seattle, Washington, USA
  7. 7Department of Health Services, University of Washington School of Public Health, Washington, DC, USA
  8. 8Department of Medicine, Turku University Hospital, Turku, Finland
  9. 9Centre for Primary Care and Public Health, Queen Mary University of London, London, UK
  10. 10Colorado School of Public Health, University of Colorado, Denver, Colorado, USA
  11. 11Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
  12. 12Health Partners Institute for Education and Research, Minneapolis, Minnesota, USA
  13. 13Centre for Population Health Sciences, University of Edinburgh, Edinburgh, Midlothian, UK
  14. 14Clinical Research Unit, Italian Institute of Telemedicine, Solbiate Arno, Varese, Italy
  15. 15Division of Health and Behavior, Department of Population Health, Center for Healthful Behavior Change, New York University, Langone School of Medicine, New York, USA
  16. 16Departments of Cardiology, and Clinical Medicine and Prevention, University of Milano Bicocca, Milan, Italy
  17. 17Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK
  18. 18Departments of Internal Medicine, Cardiovascular Research Institute Maastricht, Maastricht University Maastricht, The Netherlands
  19. 19Department of Veterans (VA) Health Services Research, Development Centre for Comprehensive Access and Delivery Research and Evaluation (CADRE), Iowa City VA Medical Centre, University of Iowa, Iowa City, Iowa, USA
  1. Correspondence to Professor Richard McManus; Richard.McManus{at}phc.ox.ac.uk

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.

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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