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Challenges in conducting a multi-center trial in US military hospitals

Primary: Roberta W.. Scherer
Author(s): Roberta W.. Scherer Lee Sensinger Craig Formby TRTT Research Group
Johns Hopkins Bloomberg School of Public Health Johns Hopkins Bloomberg School of Public Health University of Alabama

SCT Annual Meeting 2018

Background: Tinnitus is the perception of sound in the absence of external sound and may sometimes be caused by loud noises. For some individuals, tinnitus is intolerable and impacts quality of life. Tinnitus retraining therapy (TRT) uses tinnitus-specific counseling (TC) and sound therapy (ST) to facilitate habituation to the tinnitus, improving quality of life. Methods: The Tinnitus Retraining Therapy Trial (TRTT), a randomized, double-blind, placebo-controlled, multi-center trial for individuals with intolerable tinnitus, evaluated the efficacy of TRT and its two components. Treatment groups included TRT (TC and conventional sound generators (SGs)), partial TRT (TC and placebo SGs) and standard of care. All groups were encouraged to use environmental sound enrichment. The primary outcome was change in score on the Tinnitus Questionnaire assessed longitudinally between treatment and follow-up (3, 6, 12 and 18 months). The TRTT was conducted at US military hospitals, based on the assumption that these sites would provide an enriched population due to noise exposure and as federal sites, were exempt from indirect costs associated with NIH funding and clinicians could donate time and effort to the trial. Results: We experienced unexpected difficulties in conducting the TRTT in US military hospitals. Site selection took considerable up-front time and effort by the trial’s principal investigator. Of 19 potential sites visited, 10 expressed interest, 8 completed certification, 6 enrolled study participants, and 5 completed the trial. Once selected, each site needed a Cooperative Research and Development Agreements to receive funds; obtaining all required signatures often took longer than expected (range = 6 to 26 months). Delays in institutional review approval were due to separate independent boards with most meeting infrequently. We learned that support from the entire chain of command (site investigators, commanders, consultants, and if possible, Surgeon General) is essential because continuity of support at a site was not assured when changes in authority occurred. Staff replacement due to retirement or transfer occurred frequently and often resulted in an extended period of inactivity due to military hiring restrictions and prolonged security checks. During the trial, 54 persons were certified at 6 participating sites, including 19 coordinators, 29 audiologists, and 16 others. Rules regarding recruitment materials were neither uniform across all sites nor consistent over time at single sites. Difficulties in scheduling study visits resulted from staff or participant transfers, temporary duty assignments, and military priorities overriding scheduled visits. Federal government barriers manifested as Base Realignment and Closure at trial start and sequestration during the trial; the latter resulted in restricted workloads with priority for clinical responsibilities. Security issues included firewalls preventing internet access to the TRTT web-based database and restrictions on civilian staff prior to clearance for computer access. On the positive side however, the TRTT study population was diverse (30% women; 27% minorities, matching the US armed forces demographics). We had few protocol violations, and audiologists were enthusiastic about learning a new approach for tinnitus treatment. Conclusion: Although it was possible to conduct a multi-center trial in US military hospitals, planning and perseverance was required.

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