Generalizability of blood pressure lowering trials to older patients: cross-sectional analysis
Generalizability of blood pressure lowering trials to older patients: cross-sectional analysis
BACKGROUND/OBJECTIVES: Randomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these trials represent the general population attending routine clinical practice. This study aimed to define the proportion and characteristics of patients eligible for hypertension trials conducted in older people.
DESIGN: Cross-sectional study.
SETTING: A total of 24 general practices in England.
PARTICIPANTS: Anonymized electronic health record data from all individuals aged 80 and older.
MEASUREMENTS: Descriptive statistics were used to define the proportion and characteristics of patients eligible for two previous medication intensification trials (HYVET, SPRINT) and one medication reduction trial (OPTiMISE). A logistic regression model was constructed to estimate predictors of eligibility for each trial.
RESULTS: Of 15,376 patients identified, 268 (1.7%; 95% confidence interval [CI] = 1.5-2.0%), 5,290 (34.4%; 95%CI = 33.7-35.2%), and 3,940 (25.6%; 95%CI = 24.9-26.3%) were eligible for the HYVET, SPRINT, and OPTiMISE trials, respectively. Between 5.6% and 30.7% of exclusions from each trial were due to eligibility criteria excluding those with high or uncontrolled blood pressure. Frailty (odds ratio [OR] = .44; 95%CI = .36-.54 [OPTiMISE]), cardiovascular polypharmacy (OR = .61; 95%CI = .55-.68 [SPRINT]) and multimorbidity (OR = .72; 95%CI = .64-.82 [SPRINT]) were associated with a lower likelihood of being eligible for one or more of the trials.
CONCLUSION: A possible unintended consequence of blood pressure criteria used by trials attempting to answer different primary questions is that for many older patients, no trial evidence exists to inform treatment decisions in routine practice. Caution should be exercised when applying results from existing trials to patients with frailty or multimorbidity.
cardiovascular disease, electronic health records, frailty, hypertension, randomized controlled trials
2508-2515
Sheppard, James P.
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Lown, Mark
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Burt, Jenni
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Temple, Eleanor
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Lowe, Rebecca
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Ashby, Hannah
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Todd, Oliver
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Allen, Julie
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Ford, Gary A.
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Fraser, Rosalyn
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Heneghan, Carl
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Hobbs, F.D. Richard
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Jowett, Sue
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Little, Paul
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Mant, Jonathan
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Mollison, Jill
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Payne, Rupert
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Williams, Marney
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Yu, Ly-Mee
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McManus, Richard J.
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November 2020
Sheppard, James P.
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Lown, Mark
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Burt, Jenni
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Temple, Eleanor
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Lowe, Rebecca
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Ashby, Hannah
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Todd, Oliver
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Allen, Julie
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Ford, Gary A.
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Fraser, Rosalyn
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Heneghan, Carl
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Hobbs, F.D. Richard
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Jowett, Sue
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Little, Paul
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Mant, Jonathan
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Mollison, Jill
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Payne, Rupert
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Williams, Marney
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Yu, Ly-Mee
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McManus, Richard J.
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Sheppard, James P., Lown, Mark, Burt, Jenni, Temple, Eleanor, Lowe, Rebecca, Ashby, Hannah, Todd, Oliver, Allen, Julie, Ford, Gary A., Fraser, Rosalyn, Heneghan, Carl, Hobbs, F.D. Richard, Jowett, Sue, Little, Paul, Mant, Jonathan, Mollison, Jill, Payne, Rupert, Williams, Marney, Yu, Ly-Mee and McManus, Richard J.
(2020)
Generalizability of blood pressure lowering trials to older patients: cross-sectional analysis.
Journal of the American Geriatrics Society, 68 (11), .
(doi:10.1111/jgs.16749).
Abstract
BACKGROUND/OBJECTIVES: Randomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these trials represent the general population attending routine clinical practice. This study aimed to define the proportion and characteristics of patients eligible for hypertension trials conducted in older people.
DESIGN: Cross-sectional study.
SETTING: A total of 24 general practices in England.
PARTICIPANTS: Anonymized electronic health record data from all individuals aged 80 and older.
MEASUREMENTS: Descriptive statistics were used to define the proportion and characteristics of patients eligible for two previous medication intensification trials (HYVET, SPRINT) and one medication reduction trial (OPTiMISE). A logistic regression model was constructed to estimate predictors of eligibility for each trial.
RESULTS: Of 15,376 patients identified, 268 (1.7%; 95% confidence interval [CI] = 1.5-2.0%), 5,290 (34.4%; 95%CI = 33.7-35.2%), and 3,940 (25.6%; 95%CI = 24.9-26.3%) were eligible for the HYVET, SPRINT, and OPTiMISE trials, respectively. Between 5.6% and 30.7% of exclusions from each trial were due to eligibility criteria excluding those with high or uncontrolled blood pressure. Frailty (odds ratio [OR] = .44; 95%CI = .36-.54 [OPTiMISE]), cardiovascular polypharmacy (OR = .61; 95%CI = .55-.68 [SPRINT]) and multimorbidity (OR = .72; 95%CI = .64-.82 [SPRINT]) were associated with a lower likelihood of being eligible for one or more of the trials.
CONCLUSION: A possible unintended consequence of blood pressure criteria used by trials attempting to answer different primary questions is that for many older patients, no trial evidence exists to inform treatment decisions in routine practice. Caution should be exercised when applying results from existing trials to patients with frailty or multimorbidity.
Text
jgs.16749
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More information
Accepted/In Press date: 11 May 2020
e-pub ahead of print date: 8 September 2020
Published date: November 2020
Additional Information:
Funding Information:
This work received joint funding from the National Institute for Health Research (NIHR) Oxford Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health National Health Service (NHS) Foundation Trust (reference P2‐501) and the NIHR School for Primary Care Research (SPCR; reference 335). James Sheppard and Richard J. McManus were funded by an NIHR professorship (NIHR‐RP‐R2‐12‐015). James Sheppard now receives funding from the Wellcome Trust/Royal Society via a Sir Henry Dale Fellowship (reference 211182/Z/18/Z) and an NIHR Oxford Biomedical Research Centre (BRC) Senior Fellowship. Richard J. McManus, Jonathan Mant, Carl Heneghan, and Gary A. Ford are supported by NIHR Senior Investigator awards. Carl Heneghan also receives support from the NIHR SPCR and NIHR Oxford BRC. F.D. Richard Hobbs acknowledges part support from the NIHR SPCR, the NIHR CLAHRC Oxford, and the NIHR Oxford BRC. Oliver Todd is funded by a Dunhill Medical Trust doctoral research fellowship (reference RTF107/0117). Rupert Payne receives funding from the NIHR for polypharmacy and medicines optimization research. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Publisher Copyright:
© 2020 The Authors. Journal of the American Geriatrics Society published by Wiley Periodicals LLC on behalf of The American Geriatrics Society.
Keywords:
cardiovascular disease, electronic health records, frailty, hypertension, randomized controlled trials
Identifiers
Local EPrints ID: 443720
URI: http://eprints.soton.ac.uk/id/eprint/443720
ISSN: 0002-8614
PURE UUID: 9b3e85fe-d8b2-4fbd-9a95-74f0a3f4f786
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Date deposited: 09 Sep 2020 16:34
Last modified: 17 Mar 2024 03:37
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Contributors
Author:
James P. Sheppard
Author:
Jenni Burt
Author:
Eleanor Temple
Author:
Rebecca Lowe
Author:
Hannah Ashby
Author:
Oliver Todd
Author:
Julie Allen
Author:
Gary A. Ford
Author:
Rosalyn Fraser
Author:
Carl Heneghan
Author:
F.D. Richard Hobbs
Author:
Sue Jowett
Author:
Jonathan Mant
Author:
Jill Mollison
Author:
Rupert Payne
Author:
Marney Williams
Author:
Ly-Mee Yu
Author:
Richard J. McManus
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