Abstract
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.
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 language | English |
|---|---|
| Pages (from-to) | 2508-2515 |
| Journal | Journal of the American Geriatrics Society |
| Volume | 68 |
| Issue number | 11 |
| Early online date | 8 Sept 2020 |
| DOIs | |
| Publication status | E-pub ahead of print - 8 Sept 2020 |
Keywords
- Hypertension
- cardiovascular disease
- electronic health records
- frailty
- randomised controlled trials
