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.
- cardiovascular disease
- electronic health records, randomised controlled trials