Clinical Trials: Methods

CONGRESS ANNUAL CONFERENCE ABSTRACTS

Clinical Trials: Methods Poster 61 Kick-Starting a Spinal Cord Injury Pain Research Program in Ontario: Getting 5 Grants From 1. Kathryn Boschen (Toronto Rehabilitation Institute, Canada), Judith Hunter, Sander Hitzig, Joel Katz, B. Catherine Craven, Linda Rapson, Keith Walker, Shauna Petrie, Mark Tonack, Adam Thrasher, Milos Popovic. Disclosure: None declared. Objective: To develop, with a team planning and development grant from Canadian Institutes of Health Research (CIHR), an Ontario program of research focused on improving management of spinal cord injury (SCI) chronic pain based on current Ontario data indicating that 30% to 80% of SCI clients living in the community continue to experience pain-related decreased quality of life (QOL) years after initial injury. Design: Modified Delphi consensus-building approach for research priorities identification; introduction of targeted pilot study seed funds to stimulate research team-building and grant application submissions. Setting: Ontario rehabilitation research institutes, SCI centers, universities, and pain clinics and services. Participants: Rehabilitation researchers, SCI clinicians, SCI consumers, and federal and provincial rehabilitation research funders. Interventions: A 1-day working meeting of participants to arrive at consensus on SCI pain and QOL research priorities; and launching of seed funds competition. Main Outcome Measures: Consensus on priority research areas and number of seed fund applications. Results: 5 priorities identified by consensus: pain management/treatment; mechanisms of pain; measurement tools; health services policy and advocacy; and knowledge transfer. 5 pilot study submissions. Conclusions: CIHR’s research development strategy has succeeded in spawning 5 new pilot studies in the SCI pain and QOL field in Ontario, a solid return on CIHR’s initial investment. Key Words: Pain; Quality of life; Rehabilitation; Spinal cord injuries. Poster 62 Establishing a Network for Conducting Multicenter Trials of Neurorehabilitation Interventions. Prudence Plummer-D’Amato (University of California Los Angeles, United States), Valeriy Nenov, Bruce Dobkin. Disclosure: None declared. Objectives: To unite clinicians in an international network to conduct multicenter, randomized controlled trials (RCTs) of simple, lowcost interventions, to promote education and research among clinicians who might not otherwise have opportunities to participate in clinical trials, and to study the effects of daily reinforcement of walking speed on recovery of gait and the duration of inpatient care in people after stroke. Design: RCT. Setting: Acute inpatient rehabilitation facilities. Participants: People admitted to inpatient rehabilitation after stroke. Interventions: Participants will be randomized to receive daily reinforcement or no reinforcement of walking speed during their usual therapy. Main Outcome Measures: Gait speed at discharge from inpatient rehabilitation. Secondary outcomes are distance walked in 3 minutes and inpatient length of stay. Results: More than 40 sites from 20 different countries have joined the multicenter RCT network. At least 15 sites will start the first trial in 2007. Conclusions: A multicenter RCT that includes sites and patients who might not otherwise have the opportunity to participate in clinical research may enrich their experience about rehabilitation, improve outcomes, and open other possibilities for modestly funded, clinically relevant trials. Key Words: Randomized controlled trials; Rehabilitation; Stroke.

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Poster 63 Utility of Treatment Implementation Methods in a Clinical Trial With Rehabilitation Teams. Alan B. Stevens (Scott and White Memorial Hospital, United States), Dale Strasser, Jay Uomoto, Susan Bowen, Judith Falconer. Disclosure: None declared. (Clinicaltrials.gov number NCT00237757). Objective: To evaluate the utility of treatment implementation methods in the design and implementation of a team training intervention in a national clinical trial on process improvement and rehabilitation team functioning. Design: Description of research methods. Setting: Veterans Affairs hospitals. Participants: 29 team leaders from 15 intervention sites. Intervention: 6-month intervention (concentrated skills training workshop, written information feedback; consultation) for 2 team leaders from each site. Main Outcome Measures: Treatment implementation indicators for intervention delivery, receipt, and enactment. Results: Positive findings reported (1) consistent and accurate presentation of intervention components and (2) evidence of receipt and enactment of intervention strategies by study participants. For example, for intervention receipt, 81% of the workshop participants strongly agreed that the workshop provided skills to enhance team functioning. For intervention enactment, 9 (60%) of the 15 sites reported implementation of team activities revealed during the workshop exercises to address problematic areas of their own team functioning. Conclusions: Treatment implementation methodology helps organize the information content and intervention delivery in a consistent, reliable manner, and provides a framework to monitor the actual enactment of a team training intervention. Key Words: Health care team; Rehabilitation; Training programs. Poster 64 Rehabilitation Researchers’ Receptivity and Perceived Barriers to Designing Intervention Studies to Facilitate Knowledge Translation. Pimjai Sudsawad (University of Wisconsin-Madison, United States). Disclosure: None declared. Objective: To examine rehabilitation researchers’ receptivity and perceived barriers to using a model of designing intervention studies that includes (1) incorporating research user’s input when selecting topic and questions; (2) seeking research user’s feedback on feasibility of intervention; (3) incorporating research users’ input in choosing outcomes; (4) using outcome measures that reflect performance in natural settings; and (5) demonstrating intervention effectiveness by its positive impact on everyday lives. Design: Telephone focus group and Internet survey. Setting: Nationwide. Participants: 74 rehabilitation researchers who published intervention studies in peer-reviewed journals. Interventions: Not applicable. Main Outcome Measures: Survey questionnaire and focus group transcript. Results: Most respondents viewed this model positively and agreed that it would be useful in making intervention studies more applicable to practice. Perceived barriers to using this model to design future studies included (1) lack of good measurement tools to capture real-life performance in natural settings; (2) universally accepted intervention difficult to achieve; (3) study topic/question dictated by other factors; and (4) self-reported performance (in natural settings) from study participants may not be valid. Conclusions: There is a need to examine the logistics of and overcome barriers to creating intervention studies that can be applied in practice to facilitate knowledge translation in rehabilitation. Key Words: Intervention studies; Rehabilitation; Researchers.

Arch Phys Med Rehabil Vol 88, October 2007