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  • Arm Based on LEg blood pressures (ABLE-BP): can systolic leg blood pressure measurements predict systolic brachial blood pressure? Protocol for an individual participant data meta-analysis from the INTERPRESS-IPD Collaboration

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Cardiovascular medicine
Protocol
Arm Based on LEg blood pressures (ABLE-BP): can systolic leg blood pressure measurements predict systolic brachial blood pressure? Protocol for an individual participant data meta-analysis from the INTERPRESS-IPD Collaboration
  1. Sinead T J McDonagh1,
  2. James P Sheppard2,
  3. Fiona C Warren1,
  4. Kate Boddy3,
  5. Leon Farmer4,
  6. Helen Shore4,
  7. Phil Williams4,
  8. Philip S Lewis5,
  9. Rachel Baumber6,
  10. Jayne Fordham7,
  11. Una Martin8,
  12. Victor Aboyans9,
  13. Christopher E Clark1
  14. on behalf of the INTERPRESS-IPD Collaborators
    1. 1Primary Care Research Group, University of Exeter, Exeter, UK
    2. 2Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
    3. 3NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter, Exeter, UK
    4. 4Patient and Public Involvement Advisor, Exeter, UK
    5. 5Department of Cardiology, Stockport NHS Foundation Trust, Stockport, UK
    6. 6Royal National Orthopaedic Hospital Stanmore, Stanmore, UK
    7. 7Mid Devon Medical Practice, Exeter, UK
    8. 8Institute of Clinical Sciences, University of Birmingham, Birmingham, UK
    9. 9Department of Cardiology, Centre Hospitalier Universitaire de Limoges, Limoges, France
    1. Correspondence to Dr Christopher E Clark; c.e.clark{at}exeter.ac.uk

    Abstract

    Introduction Blood pressure (BP) is normally measured on the upper arm, and guidelines for the diagnosis and treatment of high BP are based on such measurements. Leg BP measurement can be an alternative when brachial BP measurement is impractical, due to injury or disability. Limited data exist to guide interpretation of leg BP values for hypertension management; study-level systematic review findings suggest that systolic BP (SBP) is 17 mm Hg higher in the leg than the arm. However, uncertainty remains about the applicability of this figure in clinical practice due to substantial heterogeneity.

    Aims To examine the relationship between arm and leg SBP, develop and validate a multivariable model predicting arm SBP from leg SBP and investigate the prognostic association between leg SBP and cardiovascular disease and mortality.

    Methods and analysis Individual participant data (IPD) meta-analyses using arm and leg SBP measurements for 33 710 individuals from 14 studies within the Inter-arm blood pressure difference IPD (INTERPRESS-IPD) Collaboration. We will explore cross-sectional relationships between arm and leg SBP using hierarchical linear regression with participants nested by study, in multivariable models. Prognostic models will be derived for all-cause and cardiovascular mortality and cardiovascular events.

    Ethics and dissemination Data originate from studies with prior ethical approval and consent, and data sharing agreements are in place—no further approvals are required to undertake the secondary analyses proposed in this protocol. Findings will be published in peer-reviewed journal articles and presented at conferences. A comprehensive dissemination strategy is in place, integrated with patient and public involvement.

    PROSPERO registration number CRD42015031227.

    • risk management
    • cardiology
    • primary care
    http://creativecommons.org/licenses/by-nc/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

    https://doi.org/10.1136/bmjopen-2020-040481

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      Footnotes

      • Twitter @jamessheppard48, @INTERPRESS_IPD

      • Collaborators The following collaborating authors contributed data to the original INTERPRESS-IPD Collaboration and the subsequent ABLE-BP project: Vietnam Experience Study: James White; INCHIANTI: Luigi Ferrucci; Heinz-Nixdorf Recall Study: Raimund Erbel; SMART: Jan Westerink; San Diego Population Study: Michael Criqui; Fuencarral Health Center: Carlos Lahoz; EPIDEMCA: Maëlenn Guerchet; MESA: Matthew Allison; LIFE & WALCS: Mary McDermott; Look AHEAD: Mark Espeland; ViWoCo: Marie Dahl; SUMMIT: Angela Shore; MARK Study: Rafel Ramos Blanes

      • Contributors This protocol was first drafted by STJM, CEC, FCW, JPS, UM, LF, KB and VA, then revised and edited by all authors, including HS, PW, PSL, RB and JF. The final manuscript has been read, reviewed and approved by all authors.

      • Funding The INTERPRESS-IPD Collaboration was established with a grant from the NIHR Research for Patient Benefit programme (award/grant number: PB-PG-0215-36009). This current project is supported by the Stroke Association (award/grant number: SA PG 19/100043) and by the Thalidomide Trust (award/grant number: not applicable).

      • Disclaimer The views expressed are those of the authors and not necessarily those of the Stroke Association, the Thalidomide Trust, the NIHR, the NHS or the Department of Health.

      • Competing interests CEC has been loaned a bilateral blood pressure monitor for unrestricted evaluation by Microlife AG, and has received honoraria from Bayer AG. No company has had, or will have, any involvement in the design or conduct of this study.

      • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

      • Patient consent for publication Not required.

      • Provenance and peer review Not commissioned; externally peer reviewed.