Quality of Informed Consent via Telemedicine Compared With In-Person for Clinical Cancer Research.

PURPOSE

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.

METHODS

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.

RESULTS

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).

CONCLUSION

Our results support the use of telemedicine for informed consent discussions in clinical cancer research studies of biomarkers and clinical trials.