Randomized Controlled Trials: Do They Have External Validity for Patients With Multiple Comorbidities?
Ann Fam Med Fortin et al.
4: 104
The Article in Brief
Background Randomized controlled trials, or RCTs (studies in which research participants are randomly selected to receive different treatments or approaches) are often used to help develop guidelines for treating medical conditions. Many RCTs may be of limited usefulness, however, because they exclude participants with multiple medical conditions (comorbidities), or they do not assess the effect of the treatment/approach on more than one medical condition. This report looks at the rate of multiple medical conditions among patients who were eligible to participate in RCTs studying treatment of hypertension (high blood pressure).
What This Study Found Eighty-nine to 100% of patients eligible for 5 RCTs of hypertension treatment had more than 1 chronic medical condition. The RCTs, however, did not fully report how many patients with multiple conditions were included or excluded.
Implications
- Excluding participants with multiple medical conditions from randomized controlled trials makes it more difficult to apply the results to a wide variety of patients.
- Randomized controlled trials should report whether participants with multiple conditions were included or excluded.
- If research results are going to be applied in medical practice, studies must focus on the realities of the types of patients who need care.
