Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis (original) (raw)
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Trials, 2021
Background Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. Design Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. Setting NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone. Participants Thirty-seven health professionals including UK-based spinal and orthopaedic surgeon...
Contemporary Clinical Trials Communications, 2016
RCT Randomized controlled trial CROSSBAT Combined randomized and observational study of surgery for type B ankle fracture treatment OTA Orthopedic trauma association a b s t r a c t Background: Randomized controlled trials (RCTs) are considered the most robust research design to determine the effectiveness of interventions. RCTs comparing surgery to non-surgical alternatives are particularly difficult to perform, partly due to difficulties with recruitment. Low recruitment rates can limit the internal and external validity of a trial thus understanding their causes may be important for avoiding protracted recruitment periods. This study aimed to report patient factors that influenced participation in a trial comparing surgery to a non-surgical treatment approach. Methods: This study was a cross-sectional study nested within CROSSBAT (Combined Randomized and Observational Study of Surgery For Type B Ankle Fracture Treatment). Eligible participants willing to be randomized were randomized while those who declined randomization were offered participation in an observational cohort. Participants from both groups (randomized and observational) were asked to indicate their level of agreement on a 100 mm line with statements concerning reasons for acceptance or rejection of randomization. A subset were asked to state the primary reason for agreeing to participate or not in the trial. Results: The nested study included 312 participants; 113 who accepted and 199 who declined randomization. Participants unwilling to be randomized (those in the observational arm of the study) predominantly received a non-surgical intervention. They were significantly more worried about receiving treatment by chance (55 mm vs. 33 mm; p < 0.0001) and had a significantly higher preference for one particular treatment (less equipoise) (82 mm vs 43 mm; p < 0.0001) compared to participants willing to be randomized. Influence from clinicians and risk avoidance were primary influences of participation. Participants' responses regarding protocol burden, study follow-up requirements and altruism did not significantly differ between groups. Conclusion: Patient non-participation in an RCT comparing surgery to no surgery is related to concern about receiving a treatment through chance and the presence of a strong preference for a particular treatment, particularly a non-surgical one. To avoid protracted recruitment periods, investigators can increase the number of study sites and ensure personnel involved have equipoise and are trained to provide a balanced view of both treatment arms.
Journal of empirical research on human research ethics : JERHRE, 2015
This study explored participants' experiences of randomized controlled trial (RCT) participation to examine their understanding of the trial design and whether their consent was indeed informed. A nested qualitative interview study was conducted with 38 participants from a sample of 282 who participated in a complex RCT evaluating the effectiveness of laser compared with needle acupuncture for chronic knee pain. Overall participants had a good understanding of the RCT, and concepts such as randomization and placebo. Their experiences of being in the trial were largely positive, even if they did not experience any knee pain improvement. Their responses to unblinding at the end of the study were accepting. Participants had a good functional understanding of the RCT, sufficient for valid informed consent.
Orthopaedic surgeons prefer to participate in expertise-based randomized trials
Clinical Orthopaedics and …, 2008
Empiric data and theoretical arguments suggest an alternative randomized clinical trial (RCT) design, called expertise-based RCT, has enhanced validity, applicability, and ethical integrity compared with conventional RCT. Little is known, however, about whether physicians will participate in an expertise-based RCT. In a crosssectional survey of Canadian orthopaedic surgeons, we evaluated preference for and willingness to participate in an expertise-based versus a conventional RCT if given the opportunity to participate in a trial investigating the effectiveness of high tibial osteotomy versus unicompartmental knee arthroplasty. Using an electronic survey (Ó2005 SurveyMonkey.com), we invited all 767 members of the Canadian Orthopaedic Association (2005) to participate; 276 surgeons completed the questionnaire (37.5% response rate). One hundred two surgeons (53.4%) were willing to participate in an expertise-based RCT compared with 35 surgeons (18.3%) willing to participate in a conventional RCT. Ninety-seven surgeons (52.4%) strongly or moderately preferred the expertise-based design compared with 25 (13.5%) who preferred the conventional design. For the clinical example we presented, the majority of Canadian orthopaedic surgeons were willing to participate in and preferred the expertise-based design. The expertise-based randomized clinical trial design may overcome some of the barriers to conducting clinical trials in orthopaedic surgery and improve the validity of their conclusions. Each author certifies that he or she has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. Each author certifies that his or her institution has approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.
Contemporary Clinical Trials, 2005
Identifying barriers to recruitment into a randomized clinical trial can help researchers adjust recruitment strategies to maximize enrollment. To determine barriers to enrollment of patients in trials of knee osteoarthritis treatments, we recruited from three centers patients over age 45 who had both knee osteoarthritis and a meniscal tear. We described a hypothetical randomized trial of arthroscopic partial meniscectomy versus non-operative management and assessed patients' willingness to participate in such a trial. We elicited preferences for treatment along with information on age, sex, education level, race, work status, and pain. We examined the association between these factors and willingness to participate in the trial. Orthopedic surgeons identified 106 eligible osteoarthritis patients, of whom 12 could not be reached, 6 refused and 88 (83%) completed interviews. 63% were female, 55% were college graduates, 23% were non-white and mean age was 60F8. The mean WOMAC pain score was 56F23. 22% of patients stated that they were definitely willing to participate in the hypothetical trial, and 24% stated they were probably willing. Subjects lacking strong preferences for treatment stated a greater willingness to 1551-7144/$ -see front matter D (J.N. Katz). www.elsevier.com/locate/conclintrial participate than those with strong preferences (36-14% definitely willing, v 2 for trend, p=0.005). WOMAC pain score, age, education, work status and race were not associated with willingness to participate. Males were more likely than females to state a willingness to participate (39-11% definitely willing, p=0.005). Since OA affects females disproportionately, a better understanding of barriers to females' participation in trials may enhance future research on treatment of osteoarthritis. Effectively addressing a priori treatment preferences through patient education about the advantages and drawbacks of treatments may increase willingness to participate in trials. D
Implementation of research evidence in orthopaedics: a tale of three trials
BMJ Quality & Safety, 2019
ObjectiveTo examine implementation of evidence in orthopaedic practice following publication of the results of three pivotal clinical trials.DesignCase studies based on three orthopaedic trials funded in sequence by the National Institute for Health Research Health Technology Assessment (HTA) programme. These trials dealt with treatment of fractures of the humerus, radius and ankle, respectively. For each case study, we conducted time-series analyses to examine the relationship between publication of findings and the implementation (or not) of the findings.ResultsThe results of all three trials favoured the less expensive and less invasive option. In two cases, a change of practice, in line with the evidence that eventually emerged, preceded publication. Furthermore, the upturn in use of the intervention most supported by each of these two trials corresponded to the start of recruitment to the respective trial. The remaining trial failed to influence practice despite yielding clear-...
International Journal of Environmental Research and Public Health
Background: Randomized controlled trials (RCTs) are regarded as the most internally valid means of estimating the effectiveness of complex public health interventions, but the recruitment of participants can be difficult. The aim of this study was to explore factors that may have affected the recruitment of employees with musculoskeletal disorders (MSDs) to a multicenter worksite health promotion program from the perspective of recruiting case managers. Methods: Factors in recruitment to the RCT were explored using three focus group discussions with case managers. Data were processed using MAXQDA and analyzed with a combination of content and sequence analysis. Results: Findings showed that randomization is a major challenge for recruitment. Case managers adapted their communication with, and approaches to possible participants because of the randomization design and employed coping strategies to compensate for allocation into the control arm of the study. Perceptions of the superio...
Journal of Clinical Epidemiology, 2011
Objective: To compare the accuracy of estimates of potential recruitment from a prospective 8-week screening study compared with a retrospective chart review across sites participating in two fracture management trials. Study Design and Setting: During the planning phase of two large, multicenter, randomized controlled fracture management trials, 74 clinical sites provided estimates of the annual recruitment rate both retrospectively (based on chart reviews) and prospectively. The prospective estimate was generated by screening, for 8 weeks, all incoming patients for eligibility in the concerning trial, without actually enrolling any patient. We compared these prospective and retrospective estimates with one another (for 74 sites in the two trials) and with actual 1-year recruitment rates in the definitive trial (for nine sites in one trial). Results: There was a median difference of four patients (interquartile range: À14 to 18 patients; P 5 0.89) between a center's prospective estimate and its retrospective estimate. Both predictions were overestimations of recruitment in the definitive trial; only 31% (95% confidence interval [CI]: 28, 35) of retrospectively estimated patients, and 31% (95% CI: 27, 35) of prospectively estimated patients were recruited in the definitive trials. Conclusion: Compared with relatively simple chart reviews, prospectively screening for eligible patients at clinical sites, which is associated with substantial costs, did not result in more accurate predictions of accrual in large, multicenter, randomized controlled trials.
Obtaining informed consent for clinical pain research: patients' concerns and information needs
Pain, 2001
Investigators who conduct clinical pain research are required to obtain voluntary informed consent from patients. However, little is known about what information patients expect when they decide whether to enroll in such studies. It is important that investigators understand these information needs so they can effectively and clearly describe the research risks and potential benefits that matter to potential subjects. By understanding these needs for information, investigators may also be better able to anticipate patients' concerns and to recruit subjects more efficiently. This study was designed to define information needs that patients have when they decide whether to participate in clinical pain research. This paper describes these information needs, and identifies clinical and demographic variables associated with specific needs.