Abstract
BackgroundRecruitment is one of the most serious challenges in performing randomized controlled trials. Often clinical trials with participants diagnosed with schizophrenia are terminated prematurely because of recruitment challenges resulting in a considerable waste of resources in the form of time, funding, and the participants’ efforts. Dropout rates in schizophrenia trials are also high.Recruitment challenges are often due to patients not wanting to participate in research but can also be due to clinicians’ concerns regarding individuals diagnosed with schizophrenia as participants in research. This paper reports how overcoming recruitment challenges not related to patients revealed high readiness to take part and low dropout rates in a one year long randomized controlled trial testing Guided Self-Determination (GSD) among outpatients with schizophrenia receiving treatment in Assertive Outreach Teams in the northern part of Denmark.MethodsGSD is a shared decision-making and mutual problem-solving method using reflection sheets, which was developed in diabetes care and adjusted for this study and utilized by patients with schizophrenia. Descriptive data on strategies to overcome recruitment challenges were derived from notes and observations made during the randomized controlled trial testing of GSD in six outpatient teams.ResultsThree types of recruitment challenges not related to patients were identified and met during the trial: 1) organizational challenges, 2) challenges with finding eligible participants and 3) challenges with having professionals invite patients to participate. These challenges were overcome through: 1) extension of time, 2) expansion of the clinical recruitment area and 3) encouragement of professionals to invite patients to the study. Through overcoming these challenges, we identified a remarkably high patient-readiness to take part (101 of 120 asked accepted) and a low dropout rate (8%).ConclusionDistinction between recruitment challenges was important in discovering the readiness among patients with schizophrenia to take part in and complete a trial with the GSD-intervention.
Highlights
Recruitment is one of the most serious challenges in performing randomized controlled trials
This paper reports how recruitment challenges not related to patient issues were overcome and revealed the true readiness to take part in and complete a complex clinical trial testing Guided Self-Determination (GSD) among outpatients with schizophrenia in the northern part of Denmark
Identifying and overcoming challenges not related to patients disclosed remarkably high patient-readiness to take part in the trial and a remarkably a low dropout rate (Figure 1: Overcoming recruitment challenges not related to patients revealed a high patient readiness)
Summary
Recruitment is one of the most serious challenges in performing randomized controlled trials. Dropout rates in schizophrenia trials are high. This paper reports how overcoming recruitment challenges not related to patients revealed high readiness to take part and low dropout rates in a one year long randomized controlled trial testing Guided Self-Determination (GSD) among outpatients with schizophrenia receiving treatment in Assertive Outreach Teams in the northern part of Denmark. Randomized controlled trials (RCTs) are widely accepted as the most powerful design for evaluating the efficacy and effectiveness of health care interventions. It is a common understanding that especially people with schizophrenia are difficult to recruit into trials [5,6,7]. In a review of 74 trials testing psychosocial treatment among individuals diagnosed with schizophrenia, withdrawal either prior to or during treatment was estimated to be approximately 13% [9]. Withdrawal from treatment in trials, high dropout and underpowered trials have consequences with increases in cost and shortcomings in the scientific value of the intervention being tested [10]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
