The University of Southampton
University of Southampton Institutional Repository
Warning ePrints Soton is experiencing an issue with some file downloads not being available. We are working hard to fix this. Please bear with us.

Generalizability of blood pressure lowering trials to older patients: cross-sectional analysis

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
0002-8614
2508-2515
Sheppard, James P.
5468331c-e231-4103-b407-28c8161cc6d7
Lown, Mark
4742d5f8-bcf3-4e0b-811c-920e7d010c9b
Burt, Jenni
af1903e7-2bb8-464d-8e82-ec1076fdbb2e
Temple, Eleanor
02a2b007-950c-45dd-93e7-489ae924fe7f
Lowe, Rebecca
677baa34-e8ac-43ac-93ac-c1eb09cacf85
Ashby, Hannah
5275afd8-ee12-4b51-8c1e-4d47e02d8e86
Todd, Oliver
e28a65ea-2d10-48c6-b886-864325068f46
Allen, Julie
f478888a-0653-4505-acea-1134b5d80a1c
Ford, Gary A.
c03a4c65-e4ef-4d39-a8be-dbdc20cfef0b
Fraser, Rosalyn
7d97bdb2-2630-4ae4-ad7b-cad4cb75a8c0
Heneghan, Carl
ab54c700-8c86-420a-98b9-45e071b1c842
Hobbs, F.D. Richard
9a0f0240-ff92-43ed-882a-2c3be3472559
Jowett, Sue
97638e31-26f6-4d01-8a58-8bca0eb80053
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Mant, Jonathan
15d82dfc-6b6a-4dd4-b466-97c43fca38c6
Mollison, Jill
555564a2-d739-4725-aea0-74d6c89c5740
Payne, Rupert
7942b13c-a1a6-4f55-8ce5-37c875a8ec33
Williams, Marney
aed0fd5f-500d-48d9-844f-814b08c037fd
Yu, Ly-Mee
ae5bebd5-e49c-4fb1-ada1-a7d669f8a87f
McManus, Richard J.
481f6284-d599-4c77-8869-d1c6b63b9b02
Sheppard, James P.
5468331c-e231-4103-b407-28c8161cc6d7
Lown, Mark
4742d5f8-bcf3-4e0b-811c-920e7d010c9b
Burt, Jenni
af1903e7-2bb8-464d-8e82-ec1076fdbb2e
Temple, Eleanor
02a2b007-950c-45dd-93e7-489ae924fe7f
Lowe, Rebecca
677baa34-e8ac-43ac-93ac-c1eb09cacf85
Ashby, Hannah
5275afd8-ee12-4b51-8c1e-4d47e02d8e86
Todd, Oliver
e28a65ea-2d10-48c6-b886-864325068f46
Allen, Julie
f478888a-0653-4505-acea-1134b5d80a1c
Ford, Gary A.
c03a4c65-e4ef-4d39-a8be-dbdc20cfef0b
Fraser, Rosalyn
7d97bdb2-2630-4ae4-ad7b-cad4cb75a8c0
Heneghan, Carl
ab54c700-8c86-420a-98b9-45e071b1c842
Hobbs, F.D. Richard
9a0f0240-ff92-43ed-882a-2c3be3472559
Jowett, Sue
97638e31-26f6-4d01-8a58-8bca0eb80053
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Mant, Jonathan
15d82dfc-6b6a-4dd4-b466-97c43fca38c6
Mollison, Jill
555564a2-d739-4725-aea0-74d6c89c5740
Payne, Rupert
7942b13c-a1a6-4f55-8ce5-37c875a8ec33
Williams, Marney
aed0fd5f-500d-48d9-844f-814b08c037fd
Yu, Ly-Mee
ae5bebd5-e49c-4fb1-ada1-a7d669f8a87f
McManus, Richard J.
481f6284-d599-4c77-8869-d1c6b63b9b02

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), 2508-2515. (doi:10.1111/jgs.16749).

Record type: Article

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 - Version of Record
Available under License Creative Commons Attribution.
Download (879kB)

More information

Accepted/In Press date: 11 May 2020
e-pub ahead of print date: 8 September 2020
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
ORCID for Mark Lown: ORCID iD orcid.org/0000-0001-8309-568X

Catalogue record

Date deposited: 09 Sep 2020 16:34
Last modified: 10 Jan 2022 03:04

Export record

Altmetrics

Contributors

Author: James P. Sheppard
Author: Mark Lown ORCID iD
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: Paul Little
Author: Jonathan Mant
Author: Jill Mollison
Author: Rupert Payne
Author: Marney Williams
Author: Ly-Mee Yu
Author: Richard J. McManus

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×