One of the most common challenges of randomized controlled trials (RCTs), both published and unpublished, is related to problems with recruitment. Investigators' enthusiasm for ambitious recruitment in a trial often dissipates quickly with the realization that ambitious recruitment is often misguided. This common error has been dubbed "Lasagna's Law" (1) and Muench's Third Law. (2) Both laws point to the same principle: investigators greatly overestimate the pool of available patients who meet the inclusion criteria. (3)
Insufficient or untimely patient recruitment into RCTs has serious consequences. The length of the trial may need to be extended, leading to increased resource use and costs. Lengthy trials delay the availability of potentially beneficial treatments to the public. (4) The integrity and validity of the study also rely on an adequate sample size. If the sample size is not achieved, there is an increased chance of committing a type II error (e.g., you are more likely to find no difference between treatments when one actually exists). The trial may have to be abandoned, and the results may not be publishable.
The recruitment rate is influenced by both patient and investigator factors. A recent systematic review by Abraham and colleagues (5) identified reasons why eligible patients may not want to participate in real or hypothetical surgical RCTs. Surgeons were also asked why they did not want to enroll eligible patients into real or hypothetical surgical trials. The top reasons for patient nonentry were that the patient had a preference for a certain therapy, he or she did not understand the trial (trial too complex), the patient did not want to be randomly assigned to a treatment and he or she feared a negative outcome or receiving a treatment that he or she felt was inferior. Investigators had similar reasons for not entering eligible patients, including difficulty following the study protocol (trial too complex) and completing the follow-up requirements, preference for a certain therapy and difficulties obtaining informed consent from patients. Understanding and addressing potential patient and investigator concerns is important when developing a recruitment strategy.
In this article, we discuss the common issues encountered in recruiting patients for surgical trials. It is intended for anyone conducting surgical trials, including medical students, residents, and junior and senior researchers. By the end of this article, readers will be able to develop strategies to avoid some of the common pitfalls in recruitment and, if these difficulties occur, to rectify them.
STUDY PROTOCOL PHASE
It is at this stage of the trial that the issue of recruitment needs to be considered and addressed carefully. This section highlights the key elements in protocol development that directly affect patient recruitment in surgical trials.
Type of trial (explanatory v. effectiveness)
Early in protocol development, investigators need to decide if their trial will be an explanatory (efficacy) or a management (effectiveness, pragmatic) trial. (6) We will use the following 2 hypothetical questions to explain these concepts.
Question 1: In an academic setting and under the care of a plastic surgeon, is endoscopic...