Sternschuss Michal, Lattanzi Michael, Vertosick Emily, Austria Mia, Martin Sené, Regazzi Ashley, Buckely Michael T, Lengfellner Joseph, Riely Gregory J, Solit David B, Rosenberg Jonathan E, Iyer Gopa, Stetson Peter D, Morris Michael J, Vickers Andrew J, Funt Samuel A
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.
JCO Oncol Pract. 2025 Jun 16:OP2401041. doi: 10.1200/OP-24-01041.
Telemedicine is increasingly used in oncology research including informed consent discussions, but data evaluating the potential impact of telemedicine on the quality of informed consent are scarce.
Consecutive patients with genitourinary malignancies who underwent informed consent discussions for biomarker (next-generation sequencing) or therapeutic (phase I to III) clinical studies at the Memorial Sloan Kettering Cancer Center were asked to complete modified versions of the validated Quality of Informed Consent (QuIC) questionnaire evaluating objective (QuIC A) and subjective (QuIC B) understanding. The method used for the informed consent discussion (in-person or telemedicine) was at the physician's discretion. QuIC scores were compared between telemedicine and in-person cohorts using separate linear regression models for QuIC A and B scores and for biomarker and therapeutic protocols. Cochran's Q was calculated to evaluate heterogeneity between biomarker and therapeutic protocols.
Of 320 eligible patients approached between January 2021 and July 2022, 239 patients completed the QuIC questionnaires after informed consent discussion for biomarker (n = 128) or therapeutic (n = 111) protocols, conducted via telemedicine (n = 49) or in person (n = 190). We did not find evidence that telemedicine and in-person consent differed between the biomarker and therapeutic studies for either QuIC A or B (heterogeneity = .13 and = .5, Respectively), and so the main analyses combined both study types. There were no differences between groups for QuIC A (adjusted difference, -1.3 [95% CI, -4.6 to 1.9]; = .4), but QuIC B scores were significantly higher for telemedicine versus in-person consent for the therapeutic cohort (adjusted difference, -5.2 [95% CI, -10.3 to -0.01]; = .049).
Our results support the use of telemedicine for informed consent discussions in clinical cancer research studies of biomarkers and clinical trials.
远程医疗在肿瘤学研究中越来越多地被用于包括知情同意讨论在内的方面，但评估远程医疗对知情同意质量潜在影响的数据却很稀少。
在纪念斯隆凯特琳癌症中心，连续入选的泌尿生殖系统恶性肿瘤患者，若其参加生物标志物（下一代测序）或治疗性（I期至III期）临床研究并进行了知情同意讨论，则被要求完成经过验证的知情同意质量（QuIC）问卷的修改版，以评估客观（QuIC A）和主观（QuIC B）理解情况。用于知情同意讨论的方法（面对面或远程医疗）由医生自行决定。使用针对QuIC A和B分数以及生物标志物和治疗方案的单独线性回归模型，比较远程医疗组和面对面组的QuIC分数。计算 Cochr an's Q以评估生物标志物和治疗方案之间的异质性。
在2021年1月至
