Randomized controlled trials: do they have external validity for patients with multiple comorbidities?

Ann Fam Med. 2006 Mar-Apr;4(2):104-8. doi: 10.1370/afm.516.


Purpose: Many randomized controlled trials (RCTs) exclude patients who have multiple comorbidities. The aim of this study was to illustrate the prevalence of comorbidities among patients followed up in primary care who would have met the inclusion criteria of selected RCTs focusing on treatment of a particular condition. We used hypertension as an example of a particular chronic condition.

Methods: We used an existing database of 980 patients (660 women) that was representative of a population consulting primary care family doctors and that contained information about all chronic conditions. We randomly selected 5 RCTs that focused on patients with hypertension. The inclusion and exclusion criteria used in each of the 5 RCTs were applied (1 study at a time) to the patients in our database. The patients from our data set who met the inclusion criteria of a given RCT were considered eligible for that RCT.

Results: Of the patients from our data set who were eligible for each of the RCTs, 89% to 100% had multiple chronic conditions. The mean number of chronic conditions of patients eligible for each RCT ranged from 5.5 +/- 3.3 to 11.7 +/- 5.3.

Conclusions: Results from this study suggest that RCTs targeting a chronic medical condition such as hypertension could find that, in a sample taken from family practice, most eligible patients have comorbid conditions. Whether these patients are sampled or excluded should be reported. Research results intended to be applied in medical practice should take the complex reality of effective treatment of these patients into consideration.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Chronic Disease
  • Comorbidity*
  • Eligibility Determination
  • Humans
  • Hypertension / epidemiology
  • Hypertension / therapy
  • Prevalence
  • Primary Health Care / statistics & numerical data
  • Randomized Controlled Trials as Topic*
  • Reproducibility of Results
  • Retrospective Studies