Archives of neurology · 2008
Communicating clinical trial results to research participants.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Dorsey E Ray, Beck Christopher A, Adams Mary, Chadwick Gary, de Blieck Elisabeth A, McCallum Colleen, Briner Leslie, Deuel Lisa, Clarke Anthony, Stewart Rick, Shoulson Ira, Huntington Study Group TREND-HD Investigators
Аннотация
BACKGROUND: Communicating clinical trial results to research participants is seldom accomplished in a timely or an effective manner.
OBJECTIVE: To evaluate the effectiveness of a plan to communicate results in an industry-sponsored randomized controlled trial for Huntington disease.
DESIGN, SETTING, AND PARTICIPANTS: Postal survey to research participants at 28 of 41 research sites (including 217 of 316 participants) in Canada and the United States.
INTERVENTION: We communicated trial results by means of (1) a media release from the investigators within a day after a sponsor-issued press release; (2) a subsequent telephone call from the site staff to the participants; and (3) a conference call for research participants 2 weeks after the results were released.
MAIN OUTCOME MEASURES: Source and timing for learning study results and satisfaction with their communication.
RESULTS: Of the 217 study participants surveyed, 114 (52.5%) responded. Most (73.1%) first learned the study results from their site's telephone call, and 46.3% learned the results within 1 day of the sponsor's press release. Participants reported high or complete satisfaction with the site telephone call (89.3%) and conference call (82.1%) but relatively low satisfaction with the sponsor's press release (50.0%). Most respondents reported good understanding of the risks and benefits of the experimental treatment and the next steps for their participation.
CONCLUSION: Surveyed research participants learned of the clinical trial results soon after public release and highly valued the personalized and accurate communication efforts by the study investigators.
OBJECTIVE: To evaluate the effectiveness of a plan to communicate results in an industry-sponsored randomized controlled trial for Huntington disease.
DESIGN, SETTING, AND PARTICIPANTS: Postal survey to research participants at 28 of 41 research sites (including 217 of 316 participants) in Canada and the United States.
INTERVENTION: We communicated trial results by means of (1) a media release from the investigators within a day after a sponsor-issued press release; (2) a subsequent telephone call from the site staff to the participants; and (3) a conference call for research participants 2 weeks after the results were released.
MAIN OUTCOME MEASURES: Source and timing for learning study results and satisfaction with their communication.
RESULTS: Of the 217 study participants surveyed, 114 (52.5%) responded. Most (73.1%) first learned the study results from their site's telephone call, and 46.3% learned the results within 1 day of the sponsor's press release. Participants reported high or complete satisfaction with the site telephone call (89.3%) and conference call (82.1%) but relatively low satisfaction with the sponsor's press release (50.0%). Most respondents reported good understanding of the risks and benefits of the experimental treatment and the next steps for their participation.
CONCLUSION: Surveyed research participants learned of the clinical trial results soon after public release and highly valued the personalized and accurate communication efforts by the study investigators.