title: Individual patient data meta-analysis of self-monitoring of blood pressure (BP-SMART): a protocol.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
authors.affiliation: Nuffield Department of Primary Care, University of Oxford, Oxford, UK.
authors.forename: Katherine L
authors.initials: KL
authors.lastname: Tucker
authors.affiliation: Nuffield Department of Primary Care, University of Oxford, Oxford, UK.
authors.forename: James P
authors.initials: JP
authors.lastname: Sheppard
authors.affiliation: Nuffield Department of Primary Care, University of Oxford, Oxford, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Stevens
authors.affiliation: Center for Health Services Research in Primary Care, Durham VAMC, Durham, North Carolina, USA.
authors.forename: Hayden B
authors.initials: HB
authors.lastname: Bosworth
authors.affiliation: Nuffield Department of Primary Care, University of Oxford, Oxford, UK Center for Health Services Research in Primary Care, Durham VAMC, Durham, North Carolina, USA Department of Cardiology, Temple University School of Medicine, Philadelphia, USA School of Psychology, University of Central Lancashire, Preston, UK Family Medicine, Memorial University of Newfoundland, St. John's, Newfoundland, Canada Group Health Research Institute, Seattle, Washington, USA Department of Health Services, University of Washington School of Public Health, Washington, DC, USA Department of Medicine, Turku University Hospital, Turku, Finland Centre for Primary Care and Public Health, Queen Mary University of London, London, UK Colorado School of Public Health, University of Colorado, Denver, Colorado, USA Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK Health Partners Institute for Education and Research, Minneapolis, Minnesota, USA Centre for Population Health Sciences, University of Edinburgh, Edinburgh, Midlothian, UK Clinical Research Unit, Italian Institute of Telemedicine, Solbiate Arno, Varese, Italy Division of Health and Behavior, Department of Population Health, Center for Healthful Behavior Change, New York University, Langone School of Medicine, New York, USA Departments of Cardiology, and Clinical Medicine and Prevention, University of Milano Bicocca, Milan, Italy Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK Departments of Internal Medicine, Cardiovascular Research Institute Maastricht, Maastricht University Maastricht, The Netherlands Department 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.
authors.forename: Alfred
authors.initials: A
authors.lastname: Bove
authors.affiliation: Department of Cardiology, Temple University School of Medicine, Philadelphia, USA School of Psychology, University of Central Lancashire, Preston, UK.
authors.forename: Emma P
authors.initials: EP
authors.lastname: Bray
authors.affiliation: Family Medicine, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
authors.forename: Marshal
authors.initials: M
authors.lastname: Godwin
authors.affiliation: Group Health Research Institute, Seattle, Washington, USA.
authors.forename: Beverly
authors.initials: B
authors.lastname: Green
authors.affiliation: Department of Health Services, University of Washington School of Public Health, Washington, DC, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Hebert
authors.affiliation: Nuffield Department of Primary Care, University of Oxford, Oxford, UK.
authors.forename: F D Richard
authors.initials: FD
authors.lastname: Hobbs
authors.affiliation: Department of Medicine, Turku University Hospital, Turku, Finland.
authors.forename: Ilkka
authors.initials: I
authors.lastname: Kantola
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Kerry
authors.affiliation: Colorado School of Public Health, University of Colorado, Denver, Colorado, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Magid
authors.affiliation: Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Mant
authors.affiliation: Health Partners Institute for Education and Research, Minneapolis, Minnesota, USA.
authors.forename: Karen L
authors.initials: KL
authors.lastname: Margolis
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, Edinburgh, Midlothian, UK.
authors.forename: Brian
authors.initials: B
authors.lastname: McKinstry
authors.affiliation: Clinical Research Unit, Italian Institute of Telemedicine, Solbiate Arno, Varese, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Omboni
authors.affiliation: Division of Health and Behavior, Department of Population Health, Center for Healthful Behavior Change, New York University, Langone School of Medicine, New York, USA.
authors.forename: Olugbenga
authors.initials: O
authors.lastname: Ogedegbe
authors.affiliation: Departments of Cardiology, and Clinical Medicine and Prevention, University of Milano Bicocca, Milan, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Parati
authors.affiliation: Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Nashat
authors.initials: N
authors.lastname: Qamar
authors.affiliation: Department of Medicine, Turku University Hospital, Turku, Finland.
authors.forename: Juha
authors.initials: J
authors.lastname: Varis
authors.affiliation: Departments of Internal Medicine, Cardiovascular Research Institute Maastricht, Maastricht University Maastricht, The Netherlands.
authors.forename: Willem
authors.initials: W
authors.lastname: Verberk
authors.affiliation: Department 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.
authors.forename: Bonnie J
authors.initials: BJ
authors.lastname: Wakefield
authors.affiliation: Nuffield Department of Primary Care, University of Oxford, Oxford, UK.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: McManus
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D015897:Comorbidity; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008019:Life Style; D015201:Meta-Analysis as Topic; D011788:Quality of Life; D012648:Self Care / Q000379:methods*
chemical_list: D000959:Antihypertensive Agents