“To whom do the results of this trial apply?”: External validity of a randomized controlled trial involving 130 patients scheduled for primary total hip replacement

Abstract

Background Although the randomized controlled trial (RCT) is regarded as the gold standard for evaluation of the effect of an intervention, its external validity has been questioned. RCTs cannot be expected to produce results that are directly relevant to all patients and all settings, but they should at least allow patients and clinicians to judge to whom trial results can reasonably be applied. We assessed the external validity of an RCT investigating the efficacy of a fast-track program after total hip replacement. Methods 130 patients were identified as potential participants.18 patients were excluded, 33 enrolled patients declined to participate, and 79 patients were enrolled and randomized. We studied the distribution of preoperative characteristics and postoperative clinical variables in these 3 groups. Results A significant difference was found in both preoperative characteristics and clinical outcome variables. The non-consenters were older, less healthy, and needed more help from the home care system. Furthermore, they were hospitalized longer and were more often transferred to a rehabilitation ward. Interpretation Our findings demonstrate the importance of patient inclusion criteria in RCTs. Moreover, they may account for the lack of reproducibility of RCT results in clinical practice dealing with fast-track programs.