Patients' experiences and preferences for opt-in models and health professional involvement in biobanking consent: A cross-sectional survey of Australian cancer outpatients.

BACKGROUND: Many biobanks rely upon patients' willingness to donate biospecimens and healthcare professionals to initiate opt-in consent processes. This study explored if: (1) patients accept opt-in or opt-out consent models with varying levels of professional involvement; (2) professionals discuss participation with specific patient groups; and (3) this discussion is associated with patient knowledge of biobanking processes. METHODS: Outpatients completed surveys at a tertiary cancer center in New South Wales, Australia. Eligible participants were English-speaking adults who recently had cancer-related surgery. Participants completed 27 questions exploring acceptable consent models, biobanking experiences, knowledge, and willingness. Logistic regression and chi-square tests examined differences in the characteristics and knowledge of participants who were offered the opportunity to participate versus those who were not. RESULTS: A total of 113 outpatients participated (97% response). Most participants (92%) found opt-out, patient-initiated consent acceptable; however, high acceptability was reported for all models except for opt-in, patient-initiated consent (58%). University or technical qualifications (P  =  0.001) was associated with increased odds (OR = 4.5) of being offered biobanking. The majority did not know what occurred to samples after surgery (59.3%) or pathology review (81.4%) and ability to answer these questions was associated with discussion of participation (P < 0.001). Of the few outpatients who discussed biobanking with their doctor (29%), all consented. CONCLUSION: Professional-initiated, opt-in consent resulted in a few educated patients being approached; greater professional initiation of consent would be fruitful as most patients were willing to participate if asked. However, other consent approaches minimizing professional involvement were as acceptable to participants warranting further consideration.

Enlisting the willing: A study of healthcare professional-initiated and opt-in biobanking consent reveals improvement opportunities throughout the registration process.

Biobanking consent processes should accord with patients' preferences and be offered in a consistent and systematic manner. However, these aims can be difficult to achieve under healthcare professionals' (HCPs) time-constrained workflows, resulting in low participation rates. This current perspective provides a brief overview of HCP involvement in consent and reports new data on participant attrition at each step of the biobanking consent process as experienced by 113 patients at an Australian tertiary cancer centre. To determine attrition in this HCP-driven consent process, we reviewed medical records for the following events: inclusion of biobanking consent forms; visible patient and HCP signatures; consent status selected (decline or accept) and specimen registration with local biobank. Accessible medical records revealed the following data: 75 of 85 records included viewable forms; 22 of 85 records included patient and 19 of 85 included HCP signatures; 15 of 85 records included signed and completed forms and 3 of 85 had samples banked with annotated clinical data. We compared these data with self-reported experiences of being approached to participate by HCPs. Of the 15 participants (17.6%) who successfully completed consent, only five could recall being asked and providing consent. The low enrolment rate is a considerable lost opportunity because most patients (59%) who were not asked to participate indicated they would have consented if asked. Furthermore, in comparing self-reported experiences with medical records, we believe cancer patients' preferences for participation are mismatched with actual biobanking enrolment, which has considerable attrition at each step in the consent process.

Protocol for a Randomized Controlled Trial of Proactive Web-Based Versus Telephone-Based Information and Support: Can Electronic Platforms Deliver Effective Care for Lung Cancer Patients?

BACKGROUND: Community-based services such as telephone support lines can provide valuable informational, emotional, and practical support for cancer patients via telephone- or Web-based (live chat or email) platforms. However, very little rigorous research has examined the efficacy of such services in improving patient outcomes. OBJECTIVE: This study will determine whether: proactive telephone or Web-delivered support produces outcomes superior to printed information; and Web-delivered support produces outcomes comparable to telephone support. METHODS: A consecutive sample of 501 lung cancer outpatients will be recruited from 50 Australian health services to participate in a patient-randomized controlled trial (RCT). Eligible individuals must: be 18 years or older; have received a lung cancer diagnosis (including mesothelioma) within the previous 4 months; have an approximate life expectancy of at least 6 months; and have Internet access. Participants will be randomly allocated to receive: (1) an information booklet, (2) proactive telephone support, or (3) proactive Web support, chat, and/or email. The primary patient outcomes will be measured by the General Health Questionnaire (GHQ-12) and Health Education and Impact Questionnaire (heiQ) at 3 and 6 months post recruitment. The acceptability of proactive recruitment strategies will also be assessed. RESULTS: It is hypothesized that participants receiving telephone or Web support will report reduced distress (GHQ-12 scores that are 0.3 standard deviations (SD) lower) and greater self-efficacy (heiQ scores that are 0.3 SDs higher) than participants receiving booklets. Individuals receiving Web support will report heiQ scores within 0.29 SDs of individuals receiving telephone support. CONCLUSIONS: If proven effective, electronic approaches such as live-chat and email have the potential to increase the accessibility and continuity of supportive care delivered by community-based services. This evidence may also inform the redesigning of helpline-style services to be effective and responsive to patient needs.