TY - JOUR
T1 - Communicating clinical trial results to research participants
AU - the Huntington Study Group TREND-HD Investigators
AU - Dorsey, E. Ray
AU - Beck, Christopher A.
AU - Adams, Mary
AU - Chadwick, Gary
AU - De Blieck, Elisabeth A.
AU - McCallum, Colleen
AU - Briner, Leslie
AU - Deuel, Lisa
AU - Clarke, Anthony
AU - Stewart, Rick
AU - Shoulson, Ira
AU - Dorsey, E. R.
AU - Shoulson, I.
AU - Leavitt, B.
AU - Ross, C.
AU - Beck, C. A.
AU - de Blieck, E. A.
AU - Greenamyre, J. T.
AU - Hersch, S. M.
AU - Kieburtz, K.
AU - Marder, K.
AU - McCallum, C.
AU - Moskowitz, C.
AU - Oakes, D.
AU - Rosenblatt, A.
AU - Shinaman, A.
AU - Frucht, S.
AU - Marder, K.
AU - Moskowitz, C.
AU - Margolis, R.
AU - Shannon, K.
AU - Jaglin, J.
AU - Sanchez-Ramos, J.
AU - Guttman, M.
AU - Raymond, L. A.
AU - Decolongon, J.
AU - Como, P.
AU - Barbano, R.
AU - Zimmerman, C.
AU - Seward, A.
AU - Suchowersky, O.
AU - Higgins, D.
AU - Wojcieszek, J.
AU - Jog, M.
AU - Horn, C.
AU - M. Dubinsky, R.
AU - Martin, W.
AU - Feigin, A.
AU - Shannon, B.
AU - Morgan, John Christopher
PY - 2008/12/1
Y1 - 2008/12/1
N2 - 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%) firstlearned 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.
AB - 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%) firstlearned 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.
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U2 - 10.1001/archneurol.2008.503
DO - 10.1001/archneurol.2008.503
M3 - Article
C2 - 19064746
AN - SCOPUS:61449158785
SN - 0003-9942
VL - 65
SP - 1590
EP - 1595
JO - Archives of Neurology
JF - Archives of Neurology
IS - 12
ER -