How Well Do Randomized Controlled Trials Reflect Standard Care: A Comparison between Scientific Research Data and Standard Care Data in Patients with Intermittent Claudication undergoing Supervised Exercise Therapy

Objective The aim of the present study was to assess the degree and impact of patient selection of patients with intermittent claudication undergoing supervised exercise therapy in Randomized Controlled Trials (RCTs) by describing commonly used exclusion criteria, and by comparing baseline characteristics and treatment response measured as improvement in maximum walking distance of patients included in RCTs and patients treated in standard care. Methods We compared data from RCTs with unselected standard care data. First, we systematically reviewed RCTs that investigated the effect of supervised exercise therapy in patients with intermittent claudication. For each of the RCTs, we extracted and categorized the eligibility criteria and their justifications. To assess whether people in RCTs (n = 1,440) differed from patients treated in daily practice (n = 3,513), in terms of demographics, comorbidity and walking capacity, we assessed between group-differences using t-tests. To assess differences in treatment response, we compared walking distances at three and six months between groups using t-tests. Differences of >= 15% were set as a marker for a clinically relevant difference. Results All 20 included RCTs excluded large segments of patients with intermittent claudication. One-third of the RCTs eligibility criteria were justified. Despite, the numerous eligibility criteria, we found that baseline characteristics were largely comparable. A statistically significant and (borderline) clinically relevant difference in treatment response after three and six months between trial participants and standard care patients was found. Improvements in maximum walking distance after three and six months were significantly and clinically less in trial participants. Conclusions The finding that baseline characteristics of patients included in RCTs and patients treated in standard care were comparable, may indicate that RCT eligibility criteria are used implicitly by professionals when referring patients to standard physiotherapy care. The larger treatment response reported in standard physiotherapy care compared to clinical trials, might suggest that scientific studies underestimate the benefits of supervised exercise therapy in patients with intermittent claudication.