Golembiewski Elizabeth H, Mainous Arch G, Rahmanian Kiarash P, Brumback Babette, Rooks Benjamin J, Krieger Janice L, Goodman Kenneth W, Moseley Ray E, Harle Christopher A
Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota
Department of Health Services Research, Management and Policy, University of Florida, Gainesville, Florida.
Ann Fam Med. 2021 Jan-Feb;19(1):16-23. doi: 10.1370/afm.2610.
Patients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research.
A multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months.
A majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09; <.001) and subjective understanding (B = 18.04; SE = 2.58; <.001). At 6-month follow-up, compared with the interactive e-consent, participants who used the trust-enhanced e-consent reported greater satisfaction (B = 0.9; SE = 1.0; <.001) and subjective understanding (B = 32.2; SE = 2.6, <.001).
Patients who used e-consents with interactive research details and trust-enhancing messages reported higher satisfaction and understanding at 6-month follow-up. Research institutions should consider developing and further validating e-consents that interactively deliver information beyond that required by federal regulations, including facts that may enhance patient trust in research.
患者经常被要求分享他们的个人健康信息。本研究的目的是比较三种电子同意书（电子知情同意书）版本对患者体验的影响，这三种版本要求患者分享其健康记录用于研究。
2017年11月至2018年11月进行了一项多组随机对照试验。从佛罗里达州的4家家庭医学诊所招募成年患者（n = 734）。使用平板电脑，参与者被随机分为（1）标准电子知情同意书（标准组），（2）包含标准信息以及指向其他交互式详细信息的超链接的电子知情同意书（交互式组），或（3）包含标准信息、交互式超链接以及有关数据保护和研究人员培训的事实性信息的电子知情同意书（增强信任组）。在即时、1周和6个月时测量满意度（1至5分）、主观理解度（0至100分）以及其他结果。
大多数参与者（94%）同意未来将其健康记录信息用于研究。在即时或1周随访时，各版本之间的研究结果未观察到差异。在6个月随访时，与标准电子知情同意书相比，使用交互式电子知情同意书的参与者报告了更高的满意度（B = 0.43；标准误 = 0.09；P <.001）和主观理解度（B = 18.04；标准误 = 2.58；P <.001）。在6个月随访时，与交互式电子知情同意书相比，使用增强信任电子知情同意书的参与者报告了更高的满意度（B = 0.9；标准误 = 1.0；P <.001）和主观理解度（B = 32.2；标准误 = 2.6，P <.001）。
在6个月随访时，使用带有交互式研究细节和增强信任信息的电子知情同意书的患者报告了更高的满意度和理解度。研究机构应考虑开发并进一步验证电子知情同意书，这些同意书以交互式方式提供超出联邦法规要求的信息，包括可能增强患者对研究信任的事实。
