Clinical reviewA systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials
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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2022, European Journal of Obstetrics and Gynecology and Reproductive BiologyCitation Excerpt :Research around randomisation descriptions indicates that where HCPs find gambling metaphors helpful, participants dislike the idea of random chance and do not find metaphors such as ‘tossing a coin’ or ‘drawing straws’ useful [2,8,16]. Women may not want to leave their babies survival ‘to chance’, and some participants do not want to lose decision making control [2] women also declined randomisation because they wanted personalised decisions made about their care [7]. Terminology used at sites had implications about the perception of ECC.