Elsevier

Surgery

Volume 139, Issue 4, April 2006, Pages 469-483
Surgery

Clinical review
A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials

https://doi.org/10.1016/j.surg.2005.08.014Get rights and content

Background

The low recruitment rates into surgical randomized controlled trials (RCTs) threaten the validity of their findings. We reviewed the reasons for nonentry of eligible patients into surgical RCTs that would form the basis for future prospective research.

Methods

A systematic review of the English language literature for studies reporting reasons for nonentry of eligible patients into surgical RCTs and of recommendations made to improve the low recruitment rates.

Results

We reviewed 401 articles, including 94 articles presenting the results of 62 studies: 23 reports of recruitment into real surgical RCTs, 11 surveys of patients regarding hypothetical surgical RCTs, 10 surveys of clinicians and 18 literature reviews. The most frequently reported patient-related reasons for nonentry into surgical RCTs were preference for one form of treatment, dislike of the idea of randomization, and the potential for increased demands. Distrust of clinicians caused by a struggle to understand, explicit refusal of a no-treatment (placebo) arm, and the mere inability to make a decision were frequently reported in studies of real RCTs and patient surveys, but were not emphasized in surveys of clinicians and review articles. Difficulties with informed consent, the complexity of study protocols, and the clinicians’ loss of motivation attributable to lack of recognition were the most commonly reported clinician-related reasons.

Conclusions

There seems to be a discrepancy between real reasons for nonentry of eligible patients into surgical RCTS and those perceived by the clinicians, which require further prospective research. A summary and discussion of main recommendations sighted in the literature is presented.

Section snippets

Methods

The aim of the current study was to systematically review the literature for reported reasons for nonentry of some eligible patients or potential patients into true or hypothetical surgical RCTs to ascertain characteristics of eligible patients who are most likely to decline entry into a trial and recommendations made to improve the low recruitment rates. A surgical RCT for the purpose of the current study was defined as one that dealt with the prevention, detection, or management of a surgical

Search results

The literature search detected 6348 potentially relevant publications. All abstracts were reviewed. Reference was made to nonentry of eligible patients in RCTs in 378 abstracts; these were selected for article retrieval. Pearling helped identify a further 23 articles. In total, 401 articles were reviewed. Ninety-four articles presenting the results of 62 studies fulfilled the inclusion criteria: 51 articles presented the results of 23 studies of nonentry of eligible patients into real surgical

Discussion

This study has shown that the 3 most commonly reported patient-related reasons for nonentry of eligible patients into surgical RCTs were preference for one form of treatment, dislike of the idea of randomization and the potential for increased demands on the patient. Four other patient-related reasons for failure to enroll in surgical RCTs were emphasized in reports of real RCTs and in surveys of patients or potential patients, but not in surveys of clinicians and review articles. These 4

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