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Generalizability of Blood Pressure Lowering Trials to Older Patients: Cross‐Sectional Analysis
Author(s) -
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 LyMee,
McManus Richard J.
Publication year - 2020
Publication title -
journal of the american geriatrics society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.992
H-Index - 232
eISSN - 1532-5415
pISSN - 0002-8614
DOI - 10.1111/jgs.16749
Subject(s) - medicine , polypharmacy , confidence interval , odds ratio , clinical trial , generalizability theory , sprint , blood pressure , logistic regression , population , randomized controlled trial , physical therapy , geriatrics , environmental health , mathematics , psychiatry , statistics
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.