TY - JOUR
T1 - Patient responses to passive enrollment into a large, pragmatic clinical trial
T2 - A qualitative content analysis
AU - Rozema, Emily J.
AU - Creekmur, Beth
AU - Musigdilok, Visanee V.
AU - Steltz, Jennifer
AU - Gould, Michael K.
AU - Slatore, Christopher G.
N1 - Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022/10
Y1 - 2022/10
N2 - Background: While passive enrollment or “opt-out” recruitment methods facilitate pragmatic clinical trials, they pose unique challenges, and it is unclear how participants feel about them. Here, we describe patient responses to passive enrollment into the Watch the Spot Trial, a pragmatic trial comparing two sets of guidelines for small lung nodule follow-up. Methods: For this nested qualitative study, we analyzed participant-initiated calls and emails. We performed a qualitative content analysis, using a team-coding approach to identify reasons that eligible participants contacted the study team. We calculated the proportion of contacts containing each code, and how often each code coincided with study opt-outs and other codes. Results: Of 23,412 eligible participants across seven sites, 1494 (6.4%) contacted the study team, with 1560 total contacts. Among the total contacts, the most common codes (i.e., reasons for contacting the team) were study opt-outs (n = 614, 39.0%), clarification of study procedures (n = 328, 21.0%), and unawareness of the nodule prior to research notification (n = 244, 15.6%). The least common codes were concerns about sharing of protected health information with the study team (n = 22, 1.4%) or outside of the healthcare system (n = 26, 1.7%), and disapproval of the opt-out approach (n = 10, 0.6%); most patients with these concerns opted-out. Nodule unawareness sometimes coincided with anger (n = 24) or distress (n = 15), and questions about nodule care sometimes coincided with distress (n = 20) and questions about follow-up surveys (n = 26). Conclusion: Most participants did not report concerns about passive enrollment. Patient perspectives are an invaluable resource for minimizing risks and inconveniences of future pragmatic trials using this recruitment method.
AB - Background: While passive enrollment or “opt-out” recruitment methods facilitate pragmatic clinical trials, they pose unique challenges, and it is unclear how participants feel about them. Here, we describe patient responses to passive enrollment into the Watch the Spot Trial, a pragmatic trial comparing two sets of guidelines for small lung nodule follow-up. Methods: For this nested qualitative study, we analyzed participant-initiated calls and emails. We performed a qualitative content analysis, using a team-coding approach to identify reasons that eligible participants contacted the study team. We calculated the proportion of contacts containing each code, and how often each code coincided with study opt-outs and other codes. Results: Of 23,412 eligible participants across seven sites, 1494 (6.4%) contacted the study team, with 1560 total contacts. Among the total contacts, the most common codes (i.e., reasons for contacting the team) were study opt-outs (n = 614, 39.0%), clarification of study procedures (n = 328, 21.0%), and unawareness of the nodule prior to research notification (n = 244, 15.6%). The least common codes were concerns about sharing of protected health information with the study team (n = 22, 1.4%) or outside of the healthcare system (n = 26, 1.7%), and disapproval of the opt-out approach (n = 10, 0.6%); most patients with these concerns opted-out. Nodule unawareness sometimes coincided with anger (n = 24) or distress (n = 15), and questions about nodule care sometimes coincided with distress (n = 20) and questions about follow-up surveys (n = 26). Conclusion: Most participants did not report concerns about passive enrollment. Patient perspectives are an invaluable resource for minimizing risks and inconveniences of future pragmatic trials using this recruitment method.
KW - Lung nodule
KW - Passive enrollment
KW - Pragmatic clinical trial
KW - Qualitative research
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U2 - 10.1016/j.cct.2022.106925
DO - 10.1016/j.cct.2022.106925
M3 - Article
C2 - 36108887
AN - SCOPUS:85138185932
SN - 1551-7144
VL - 121
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106925
ER -