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

J Sheppard, Mark Lown*, Jenni Burt, Eleanor Temple, R. Lowe, Hannah Ashby, Oliver Todd, J. Allen, Gary A. Ford, Rosalyn Fraser, Carl Heneghan, F D Richard Hobbs, Sue Jowett, Paul Little, Jonathan Mant, Jill Mollison, Rupert A Payne, Marney Williams, Ly-Mee Yu, Richard McManus

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

34 Citations (Scopus)
33 Downloads (Pure)


Background/objectives: Randomised 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: 24 general practices in England

Participants: Anonymised electronic health record data from all individuals aged ≥80 years.
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%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 HYVET, SPRINT and OPTiMISE trials respectively. Between 5.6%-30.7% of exclusions from each trial were due to eligibility criteria excluding those with high or uncontrolled blood pressure. Frailty (OR 0.44, 95%CI 0.36-0.54 [OPTiMISE]), cardiovascular polypharmacy (OR 0.61, 95%CI 0.55-0.68 [SPRINT]) and multi-morbidity (OR 0.72, 95%CI 0.64-0.82 [SPRINT]) were associated with a lower likelihood of being eligible for one or more of the trials.

Conclusions: 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 multi-morbidity.
Original languageEnglish
Pages (from-to)2508-2515
Number of pages8
JournalJournal of the American Geriatrics Society
Issue number11
Early online date8 Sept 2020
Publication statusE-pub ahead of print - 8 Sept 2020


  • Hypertension
  • cardiovascular disease
  • frailty
  • electronic health records, randomised controlled trials


Dive into the research topics of 'Generalisability of blood pressure lowering trials to older patients: cross-sectional analysis'. Together they form a unique fingerprint.

Cite this