Consent Model Research Articles

"I just felt supported": Transgender and non-binary patient perspectives on receiving transition-related healthcare in family planning clinics.

Transgender and non-binary people face challenges in accessing gender affirming hormone therapy. Family planning clinics across the United States have greatly expanded transgender care services in the last ten years offering increased access to these services. This national qualitative study describes transgender and non-binary patients' experiences of receiving transgender care in family planning clinics. We completed 34 in-depth interviews with transgender and non-binary people over age 18 who had received transition-related care at a family planning clinic in the last year from 2019-2020. We analyzed interview data in Dedoose using constant comparative analysis and inductive thematic analysis. Patients reported overwhelmingly positive experiences at family planning clinics and were especially surprised at the ease and speed of the informed consent process. Barriers to care remain for patients in rural areas, low income patients, and patients who need specialized care. Some of the barriers relate to the gender binary and transphobia built into the medical systems, which cause patients and providers to have to find "work arounds" the binary medical and insurance systems. Patients also shared their idealized visions of transition related care that center on strong referral networks and hiring of LGBTQ staff at the clinics. Family planning clinics currently provide affirming and supportive care, especially those that use the informed consent model. Family planning clinics could provide increased access to transgender healthcare outside of major metropolitan areas and for transgender and gender non-conforming clients across the lifespan.

Respect for Autonomy and Dementia Care in Nursing Homes: Revising Beauchamp and Childress’s Account of Autonomous Decision-Making

Specifying the moral demands of respect for the autonomy of people with dementia (PWD) in nursing homes (NHs) remains a challenging conceptual task. These challenges arise primarily because received notions of autonomous decision-making and informed consent do not straightforwardly apply to PWD in NHs. In this paper, I investigate whether, and to what extent, the influential account of autonomous decision-making and informed consent proposed by Beauchamp and Childress has applicability and relevance to PWD in NHs. Despite its otherwise practical orientation and suitability for acute care settings, I identify three problems with this account when applied to PWD in NHs. These problems include (1) intentionality as an all-or-nothing condition of autonomous decision-making, (2) construing consent as one-off authorization, and (3) unresolved ambiguities around the primacy of precedent autonomy over best interest considerations. To address these problems, I propose and defend a number of revisions to Beauchamp and Childress’s account. First, I suggest that we consider intentionality as a non-binary criterion of autonomous decision-making. Second, I argue for a model of process consent to overcome the moral inadequacy of construing consent as one-off authorization in NHs. And, to overcome the third problem, I suggest accounting for both precedent and extant autonomy of PWD, considering mandates of precedent autonomy not as prescriptive but as informative, and drawing a less rigid distinction between autonomy considerations and best interest judgements. I conclude that this revised version of Beauchamp and Childress’s account fares better than the original version in capturing relevant autonomy considerations to care for PWD in NHs.

Religious and cultural aspects of organ donation: Narrowing the gap through understanding different religious beliefs.

The supply of viable organ donations falls significantly below the demand. Discrepancies concerning the availability of transplants cannot be explained solely by the various consent models used in different countries. There is evidence that religious beliefs of patients, potential donors, and healthcare professionals also play an important role in the decision-making process. However, to date, very little research has been conducted on the consequences of specific religious beliefs on transplantation rates. The aim of this review was to outline the religious views of Christians, Muslims, Jews, Hindus, and Buddhists on organ donation. Additionally, different approaches to address this topic throughout the world are presented and can function as a helpful background for medical professionals. The umbrella organizations of the five largest religious movements were asked for written statements concerning the subject of organ transplantation, and a literature review was performed. All German religious umbrella organizations have a positive view on organ donation, if certain rules are respected. Particularly, deceased donations are supported as a sign of altruism, love, and respect for another human being. Different aspects of the transplant process (e.g., consent, brain death, and respect for the dead body) are particularly stressed in some religions. In general, the religious groups addressed here are in favor of organ donations. Nevertheless, there are important particularities to be considered. Hopefully, understanding the different religious views on organ donations will help in reducing religious concerns about transplantation and narrowing the gap between the need and the availability of organ donations.

How Do Prescribing Clinicians Obtain Consent to Initiate Gender-Affirming Hormones?

Multiple consent models exist for initiating gender-affirming hormone therapy (GAHT). Our study aim was to examine the variety of approaches utilized by clinicians. Online and in-person recruitment of clinicians involved in gender-affirming care was undertaken from June 2019 through March 2020. Participants completed an online survey. Of the 175 respondents, 148 prescribed GAHT. Sixty-one (41.2%) prescribed to adults only, 11 (7.4%) to minors only, and 76 (51.4%) prescribed to adults and minors. Of those who prescribed to adults, more than half (n=74, 54.4%) utilized a written consent model, one-fourth only verbal consent (n=33, 24.3%), and one-fifth required an additional mental health assessment (MHA) (n=29, 21.3%). Of those prescribing to minors, most required either written consent (n=39, 44.8%) or an additional MHA (n=35, 40.2%). Only 11 (12.6%) utilized only verbal consent for minors. Rationales provided for requiring an additional MHA in adults included protection from litigation, lack of competence in assessing psychosocial readiness for GAHT, and believing that this is the best way to ensure the patient has processed the information. Practicing in multidisciplinary clinics was associated with not requiring an MHA for adult GAHT. Clinicians across fields are utilizing different models to provide the same treatment, with varying rationales for the same model. As a result, patients receive nonstandard access to care despite similar clinical presentations. Our study highlights an important area for further improvement in GAHT care.

“Yes means Yes”. Theoretical dilemmas and new definition of rape and sexual assault in Slovenian Criminal Law

The legislation of crimes against sexual integrity was initially aimed at safeguarding specific interests such as the honour of the father, the family, virginity, and the social security of women. Accordingly, the extent of rape victims was for a long time limited only to women (e.g. under Article 100 of the Criminal Code of the Socialist Republic of Slovenia from 1977, the execution of rape was only possible as immission penis in vaginam). In modern society, legislators seek to protect the self-determination of the individual, sexual and physical integrity, and sexual autonomy. This reversal demonstrates that modern criminal law revolves around the essential question of whether sexual intercourse is engaged in through free choice, that is, autonomously. Domestic legislators have been put under the pressure of media campaigns and controversial case law to modernise criminal law accordingly. In the spirit of the reforms, the Republic of Slovenia in 2021 adopted the amendments of Rape and Sexual Assault in the Criminal Code (KZ-1H) consistent with the affirmative consent model (“yes means yes”).

Raising Consent Awareness With Gamification and Knowledge Graphs

Consent is one of GDPR’s lawful bases for data processing and specific requirements for it apply. Consent should be specific, unambiguous and most of all informed. However, an informed consent request does not guarantee having individuals who are aware of what it means to consent and the implications that follow. Consent is often given blindly now, in particular because of information overload from long privacy policies written in legal language and complex interface designs that cause consent fatigue on the users' side. This paper presents a knowledge graph-based user interface for consent solicitation, which uses gamification to raise the legal awareness and ease individual’s comprehension of consent. The knowledge graph models informed consent in a machine-readable format and provides a unified consent model to all entities involved in the data sharing process. The evaluation shows that with the help of gamification, the interface can raise individuals' average legal awareness to 92.86%.

"Mental Readiness" and Gatekeeping in Trans Healthcare.

Gatekeeping refers to clinicians' strict application of eligibility criteria to determine a trans patient's "fitness" to engage in medical transition, resulting in significant barriers to gender-affirming care. Gatekeeping often uses "mental readiness" as a prerequisite to medical transition, which contributes to patient distress and systemic discrimination. Changing international trans health guidelines (the new World Professional Association for Transgender Health Standards of Care version 8) recommends clinicians shift from a gatekeeping model towards an informed consent model, which improves access to care. This commentary offers recommendations on how clinicians can reconsider existing "mental readiness" frameworks around medical transition to facilitate improved access to care.

A novel model of consent to promote embodied safety and trust between care providers and patients

The International Journal of Integrated Care (IJIC) is an online, open-access, peer-reviewed scientific journal that publishes original articles in the field of integrated care on a continuous basis.IJIC has an Impact Factor of 5.120 (2020 JCR, received in June 2021)The IJIC 20th Anniversary Issue was published in 2021.

Education and Consent for Population-Based DNA Screening: A Mixed-Methods Evaluation of the Early Check Newborn Screening Pilot Study.

A challenge in implementing population-based DNA screening is providing sufficient information, that is, understandable and acceptable, and that supports informed decision making. Early Check is an expanded newborn screening study offered to mothers/guardians whose infants have standard newborn screening in North Carolina. We developed electronic education and consent to meet the objectives of feasibility, acceptability, trustworthiness, and supporting informed decisions. We used two methods to evaluate Early Check among mothers of participating infants who received normal results: an online survey and interviews conducted via telephone. Survey and interview domains included motivations for enrollment, acceptability of materials and processes, attitudes toward screening, knowledge recall, and trust. Quantitative analyses included descriptive statistics and assessment of factors associated with knowledge recall and trust. Qualitative data were coded, and an inductive approach was used to identify themes across interviews. Survey respondents (n = 1,823) rated the following as the most important reasons for enrolling their infants: finding out if the baby has the conditions screened (43.0%), and that no additional blood samples were required (20.1%). Interview respondents (n = 24) reported the value of early knowledge, early intervention, and ease of participation as motivators. Survey respondents rated the study information as having high utility for decision making (mean 4.7 to 4.8 out of 5) and 98.2% agreed that they had sufficient information. Knowledge recall was relatively high (71.8–92.5% correct), as was trust in Early Check information (96.2% strongly agree/agree). Attitudes about Early Check screening were positive (mean 0.1 to 0.6 on a scale of 0–4, with lower scores indicating more positive attitudes) and participants did not regret participation (e.g., 98.6% strongly agreed/agreed Early Check was the right decision). Interview respondents further reported positive attitudes about Early Check materials and processes. Early Check provides a model for education and consent in large-scale DNA screening. We found evidence of high acceptability, trustworthiness and knowledge recall, and positive attitudes among respondents. Population-targeted programs need to uphold practices that result in accessible information for those from diverse backgrounds. Additional research on those who do not select screening, although ethically and practically challenging, is important to inform population-based DNA screening practices.

What influences a person's willingness to share health information for both direct care and uses beyond direct care? Findings from a focus group study in Ireland.

Background: The sharing of health information is invaluable for direct care provision and reasons beyond direct care, such as for health services management. Previous studies have shown that willingness to share health information is influenced by an individual's trust in a healthcare professional or organisation, privacy and security concerns, and fear of discrimination based on sensitive information. The importance of engaging the public in policy and practice development relating to the use and sharing of health information has been identified as an essential step for countries to take. This study's aim was to examine the factors that influence the Irish public's willingness to share their health information as part of a national public engagement on health information. Methods: A qualitative study using online focus groups was conducted as part of a wider national public engagement on health information. Participants were purposively recruited from a combination of public, patient, and service user groups in Ireland. Focus group interviews were audio-recorded, transcribed verbatim and analysed using inductive content analysis. Results: In total, 85 participants took part in 14 focus groups between January and March 2021. Two major themes were identified, trust and personal and public benefits of sharing health information. The ability to exercise control over personal information, perceived transparency of the process, and the extent to which the healthcare service was viewed as confidential, all influenced the level of trust a person held. Perceived benefits were influenced by the extent to which participants believed information sharing would support improved care or provide broader public benefit, and balanced against the potential for personal harm. Conclusions: The findings allow for new insights into the views of the public on the use and sharing of personal health information and can be used to inform the development of a consent model for health information.

Organoid biobanking, autonomy and the limits of consent.

In the debates regarding the ethics of human organoid biobanking, the locus of donor autonomy has been identified in processes of consent. The problem is that, by focusing on consent, biobanking processes preclude adequate engagement with donor autonomy because they are unable to adequately recognize or respond to factors that determine authentic choice. This is particularly problematic in biobanking contexts associated with organoid research or the clinical application of organoids because, given the probability of unforeseen and varying purposes for which a donor's organoids could be employed and given the different ways in which a donor can relate to her biospecimens, a donor can value her organoids differently in different contexts, and her reasons for autonomously permitting use of her cells and tissues in one case may not support an autonomous decision in another. In response, this paper has three aims: first, to make the case for why organoid biobanks ought to respect donor autonomy conceived as authentic choice; second, to explore the autonomy‐respecting limits of established and widely prevalent models of biobank consent; and third, to propose certain conditions that organoid biobanks ought to support or facilitate in order to respect donor autonomy.

Moving from 'fully' to 'appropriately' informed consent in genomics: The PROMICE framework.

Genomic sequencing technologies (GS) pose novel challenges not seen in older genetic technologies, making traditional standards for fully informed consent difficult or impossible to meet. This is due to factors including the complexity of the test and the broad range of results it may identify. Meaningful informed consent is even more challenging to secure in contexts involving significant time constraints and emotional distress, such as when rapid genomic testing (RGS) is performed in neonatal intensive care units. In this article, we propose that informed consent matters not for its own sake, but because obtaining it furthers a range of morally important goals, such as promoting autonomy, well‐being, and trust in medicine. These goals form the basis of a new framework [PROmoting Morally Important Consent Ends (PROMICE)] for assessing the ethical appropriateness of various informed consent models. We illustrate this framework with two examples: (a) a tiered and layered consent model for obtaining consent for GS, and (b) consent for RGS in critically ill newborns. We conclude that appropriately—rather than fully—informed consent provides the correct standard for genomic medicine and research.

Evaluating models of consent in changing health research environments

While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective as well as the perspective of research as a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss.

CONSENT, INTERACTION, AND THE VALUE OF SHARED UNDERSTANDING

ABSTRACTRecent years have seen a proliferation of philosophical work on consent. Within this body of work, philosophers often appeal to an account of the interests, values, or functions that underpin the power of consent. By far the most commonly cited value realized by the power of consent is the promotion and protection of the power-holder's autonomy. This focus on autonomy yields what I call the Gate Opener Model of consent, according to which the central valuable function of consent is to give the power-holder control over whether other people can act in certain ways. In this article, I argue that the Gate Opener Model of consent is inadequate. I then defend an alternative Relational Model of consent, according to which a central valuable function of consent is to enable a non-instrumentally valuable form of interaction between people.

Abstract OT2-21-01: A randomized, multicenter pragmatic trial comparing bone pain from a single dose of pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy (REaCT-5G)

Abstract Background: Current guidelines recommend the use of granulocyte colony-stimulating factors (G-CSF) as primary prophylaxis to prevent febrile neutropenia (FN) associated with commonly used breast cancer chemotherapy regimens. Filgrastim (FIL) is a short-acting G-CSF injection that requires daily subcutaneous injection starting 24-72 hours after chemotherapy for 5 to 10 days. Pegfilgrastim (PEG) is a long-acting, pegylated formulation that requires a single injection 24-72 hours after chemotherapy. G-CSF causes bone pain in approximately 70% of patients, which can be severe in over 25% of cases. While registration trials for PEG showed bone pain from PEG was comparable to FIL when given for a median duration of 11 days, many oncologists are now only prescribing FIL for 5 days based on a multicenter RCT showing that 5 days of FIL is non-inferior to 7 or 10 days of FIL in terms of FN and treatment-related hospitalizations. Furthermore, the cost of 5 days of FIL ($CA 721.55 for 300 mcg dose) is half of the price of a single dose of PEG ($CA 1424.63). Therefore, if 5 days of FIL leads to significantly less bone pain, this may improve health-related quality of life (HR-QoL) for patients, improve adherence to G-CSF, and improve cost-effectiveness. Methods: Patients receiving neo-/adjuvant chemotherapy for early stage breast cancer requiring primary FN prophylaxis with G-CSF will be approached for this pragmatic, multicenter, open-label superiority RCT. Using the Rethinking Clinical Trials (REaCT) methodology that incorporates an integrated oral consent model, eligible and consented patients will be randomized to either 5 days of FIL or one day of PEG with each cycle of chemotherapy. The primary endpoint is bone pain during the first 5 days after G-CSF injection using area under the curve (AUC) of the daily pain score from days 1-5 (AUC score 0 to 40) of the Bone Pain Diary. Secondary endpoints include incidence of FN and treatment-related hospitalizations, incidence of chemotherapy delay, dose-reduction, or discontinuation, incidence of chemotherapy-related mortality, rate of G-CSF compliance, healthcare resource utilization, HR-QoL, and cost-effectiveness. Participants will also complete a Treatment Preference Questionnaire (TPQ) exploring the relative importance of different factors in deciding between PEG vs. 5 days of FIL both before randomization and at the end of the study. To achieve 80% power in an ANCOVA analysis and assuming 5% are loss to follow-up, the planned sample size is 232 patients (116 per arm). The randomization (1:1 ratio) will be stratified by treatment center (4 centers) and chemotherapy regimen (taxane-based vs. anthracycline-based in the first 4 cycles). Results: The study opened for enrollment on June 9, 2021. As of July 6, 2021, the study has opened at one site, and 13 patients have been randomized.Conclusion: This will be the first RCT using a patient-reported Bone Pain Diary that was co-developed by patient partners to measure bone pain between 5 days of FIL vs. PEG. In collaboration with patient partners, the study incorporates a tool (TPQ) that explores factors that may be important in deciding between PEG and FIL, with the aim of translating the findings of this study into real world clinical practice. Citation Format: Terry L. Ng, Monica Taljaard, Marie-France Savard, Carol Stober, Stuart Nicholls, Lisa Vandermeer, Kednapa Thavorn, Claudia Hampel, Jennifer Shamess, Natalie Mills, John F. Hilton, Mark Clemons. A randomized, multicenter pragmatic trial comparing bone pain from a single dose of pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy (REaCT-5G) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-21-01.

Abstract OT1-06-01: A randomised trial comparing continuation or de-escalation of bone modifying agents (BMA) in patients treated for over 2 years for bone metastases from either breast or castration-resistant prostate cancer (REaCT-HOLD BMA)

Abstract Background: Current guidelines recommend bone modifying agents (BMAs), such as bisphosphonates and denosumab, every 4 to 12 weeks to reduce the incidence of and delay the onset of symptomatic skeletal events (SSEs) in patients with bone metastases from breast cancer and castration-resistant prostate cancer (CRPC). Given the absence of level one evidence, the optimal frequency and duration of BMAs after 2 years of treatment is unknown. This is an important clinical question as the risk of SSEs decreases with time, while the risk of treatment-related toxicities increases. Methods: Patients with bone metastases from breast cancer or CRPC who have received ≥ two years of BMA treatment will be approached for this pragmatic, multicenter, open-label RCT. Using the Rethinking Clinical Trials (REaCT) methodology that incorporates the integrated oral consent model, eligible and consented patients will be randomized to either continue standard schedule BMA (every 4 or 12 weeks) or de-escalated BMA (every 24 weeks). This is a non-inferiority study. The co-primary endpoints are the physical functioning subscale of EORTC-QLQ-C30 and functional interference subscale of EORTC-QLQ-BM22. Secondary endpoints include number of patients with ≥ 1 SSE, time to development of SSE, SSE-free survival, skeletal morbidity rate, EORTC-QLQ-C30 and BM22 scores, BMA-related toxicity, and treatment adherence. To achieve 80% power for both co-primary endpoints and assuming a 10% non-compliance and 20% death rate, the planned sample size is 240 patients (120 per arm). Randomization (1:1 ratio) will be stratified by cancer type (breast vs prostate) and treatment schedule prior to randomization (Q4weeks vs. Q12weeks). A subgroup analysis comparing patients with 2-3 years vs. > 3 years of prior BMA treatment will be conducted. Results: The study has been open for enrollment since Oct 2020. As of July 5, 2021, the study has opened at 2 sites, 48 patients have been randomized and 8 are in screening. The study needs 60 patients randomized by September 2021 to continue to receive funding. There is a plan to open the study at two other academic centers in Ontario, Canada. Conclusion: This will be the first RCT providing level one evidence regarding the optimal frequency of BMA treatment that accounts for health-related quality of life after ≥ two years of prior BMA in this patient population. Citation Format: Terry L. Ng, Gregory R. Pond, Marta Sienkiewicz, Kednapa Thavorn, Mark Clemons. A randomised trial comparing continuation or de-escalation of bone modifying agents (BMA) in patients treated for over 2 years for bone metastases from either breast or castration-resistant prostate cancer (REaCT-HOLD BMA) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT1-06-01.

Abstract OT1-01-01: A randomized, pragmatic trial investigating the timing of radiotherapy and endocrine in patients with early stage breast cancer (REaCT-RETT trial)

Abstract The optimal timing of commencing adjuvant endocrine therapy (ET) relative to adjuvant radiotherapy (RT) (i.e. concurrent with or sequential to radiotherapy) remains unknown. A systematic review performed by our team was unable to answer this question due to a lack of high quality, randomized data on concurrent versus sequential ET and RT. Surveys of physicians confirmed this uncertainty and highlighted theoretical concerns for increased side effects with concurrent treatment. Respondents showed keen interest in obtaining real world, randomized data to guide clinical practice. REaCT-RETT is a pragmatic, randomized, non-inferiority trial comparing concurrent and sequential ET and RT in early breast cancer (EBC). The primary endpoint will assess the change in ET side effects at baseline and 3 months post radiation, using the Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES), with primary analysis based on an analysis of covariance (ANCOVA). With a sample size of 176 patients (88 per arm), an ANCOVA would have 80% power (α=0.05) to detect effect sizes as small as 0.25 regardless of the correlation with covariates. It is hypothesized that concurrent therapy will be non-inferior to sequential therapy in terms of ET side effects. Secondary endpoints will examine RT toxicity, ET compliance, quality of life, and cost-effectiveness. Patients with HR positive EBC planned to receive both adjuvant ET and RT were eligible. Patients who previously received ET for invasive breast cancer, or RT in the same breast, were excluded. The trial is conducted by The Ottawa Hospital’s (TOH) innovative Rethinking Clinical Trials (REaCT) program (https://react.ohri.ca/) which strives to improve access to patient-centered, pragmatic clinical trials by removing barriers for patients and researchers. Integral features of the program include broad eligibility criteria, a verbal consent model, and pragmatic data collection and assessment procedures. REaCT is the largest pragmatic cancer clinical trials program in Canada, with over 3,200 patients randomized in 18 clinical trials at 15 sites across Canada. REaCT-RETT accrued patients from September 2019 to January 2021. Data collection is ongoing, with final patient follow up expected April 2022. The timing of accrual provided a unique opportunity to adapt in response to restrictions due to the COVID-19 pandemic, which began to impact trial sites in March 2020. The target sample size was met with 262 patients randomized (1:1) across 3 sites in Ontario, 98% from TOH. A mean of 19 patients/month were accrued prior to the pandemic, compared to a mean of 13 patients/month after March 2020. Twenty-two patients were removed due to withdrawal of consent, ineligibility, or physician choice, and the pandemic was not a significant contributing factor. Since March 2020 there have been 772 patient follow ups, of which 47% (364/772) have been virtual. Only 10% (102/1028) of trial mandated appointments have been missed to date. Compliance with baseline and 3-month FACT-ES questionnaires for the primary endpoint in evaluable patients was 90% (215/240) and 83% (198/240), respectively. The pandemic posed several challenges to the REaCT-RETT study including a decline in patient accrual, poor accrual at peripheral sites due to delayed opening, and a rapid switch to virtual patient care. However, the nimble REaCT methodology enabled virtual patient consent and data collection during the pandemic, allowing the trial to continue successfully, with final data expected for presentation summer 2022. Finally, despite the challenges of COVID-19 we have seen that patients and physicians remain interested in research, and we are applying valuable lessons learned to forthcoming REaCT trials to strengthen their performance during and beyond the ongoing pandemic. Citation Format: Sharon F Mc Gee, Mark Clemons, Michelle Liu, Mashari Jemaan Alzahrani, Terry Ng, Arif Awan, Sandeep Sehdev, John Hilton, Jean Michel Caudrelier, Marie France Savard, Lesley Fallowfield, Vikaash Kumar, Orit Freedman, Dean Fergusson, Gregory Pond, Brian Hutton, Jean Marc Bourque. A randomized, pragmatic trial investigating the timing of radiotherapy and endocrine in patients with early stage breast cancer (REaCT-RETT trial) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT1-01-01.

Abstract OT1-11-02: A pragmatic, randomised, multicentre trial evaluating the dose timing (morning vs evening) of endocrine therapy and its effects on tolerability and compliance (REaCT-CHRONO Study)

Abstract Background. Endocrine therapy (ET) is the mainstay treatment for hormonal receptor positive (HR+) breast cancer. ET non-compliance and non-persistence vary from 30 to 70% and are associated with reduced disease-free and overall survival. ET side effects are an important cause of non-adherence. In clinical practice, there are anecdotal reports that time of the day at which ET is taken may affect ET side effects and compliance. However, we are not aware of any high-quality studies supporting this practice. In other fields of medicine, there is evidence to suggest that the time of the day at which medication is taken can alter its effect and/or the adherence. This is known as chronotherapy. Methods. In this pragmatic, open-label, multicenter trial, eligible and consented patients with an early stage or locally advanced HR+ breast cancer will be randomized (1:1) to receive either: an ET morning dose (Arm A: within 1 hour of the patient wake up time) or an ET evening dose (Arm B: within 1 hour of patient bed time). The primary endpoint is endocrine toxicity and tolerability measured by the change in total Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) score from baseline to 12 weeks following the beginning of ET. Secondary endpoints include: endocrine toxicity/tolerability and quality of life measured respectively by the change in total score and individual items of FACT-ES and FACT-B (a validated Functional Assessment of Cancer Therapy for patients with a Breast cancer) from baseline to 4, 8, 12 and 52 weeks following the beginning of ET, rates of non-persistence or non-compliance and cost-effectiveness. A timing preference questionnaire will be filled out at the beginning and the end of the study by patients to evaluate their preferred time. As per the Rethinking Clinical Trials (REaCT) program, the integrated consent model will be used and patients will complete questionnaires in the online patient portal. For randomization, a permuted block design developed by the Ottawa Methods Centre will be used and patients will be stratified by center, type of endocrine therapy (tamoxifen yes/no) and if prior chemotherapy was received. Using a two-sided, alpha=0.05 Fisher’s exact test, and assuming a 10% of loss to follow up, the planned sample size is 235 patients. Accrual. This study opened for enrollment at The Ottawa Hospital Cancer Centre on June 30, 2021 and will open soon at the Thunder Bay Regional Health Sciences Centre. The maximum accrual period is 2 years. Conclusion. This will be world’s first prospective randomized clinical trial to evaluate ET dose timing (morning versus evening) and its effects on tolerability and adherence. Changing the time of the day at which a medication is taken is a new, simple and easy intervention that does not generate additional costs and can improve the quality of life of breast cancer patients. Funding provided by: NOAMA (Northern Ontario Academic Medicine Association) Innovation Grant (2021) Clinical Trial Registration: NCT04864405 Citation Format: Marie-France Savard, Mohammed Ibrahim, Gregory Pond, Deanna Saunders, Lisa Vandermeer, Ana-Alicia Beltran-Bless, Lesley Fallowfield, Mark Clemons. A pragmatic, randomised, multicentre trial evaluating the dose timing (morning vs evening) of endocrine therapy and its effects on tolerability and compliance (REaCT-CHRONO Study) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT1-11-02.

Gender-Affirming Hormone Therapy for the Trans, Gender Diverse, and Nonbinary Community: Coordinating World Professional Association for Transgender Health and Informed Consent Models of Care.

Before commencing gender-affirming hormone therapy, people undergo assessments through the World Professional Association for Transgender Health (WPATH) model (typically with a mental health clinician), or an informed consent (IC) model (without a formal mental health assessment). Despite growing demand, these remain poorly coordinated in Australia. We aimed to compare clients attending WPATH and IC services; compare binary and nonbinary clients; and characterize clients with psychiatric diagnoses or longer assessments. Cross-sectional audit of clients approved for gender-affirming treatment (March 2017-2019) at a specialist clinic (WPATH model, n=212) or a primary care clinic (IC model, n=265). Sociodemographic, mental health, and clinical data were collected from electronic records, and analyzed with pairwise comparisons and multivariable regression. WPATH model clients had more psychiatric diagnoses (mean 1.4 vs. 1.1, p<0.001) and longer assessments for hormones (median 5 vs. 2 sessions, p<0.001) than IC model clients. More IC model clients than WPATH model clients were nonbinary (27% vs. 15%, p=0.016). Nonbinary clients had more psychiatric diagnoses (mean 1.7 vs. 1.1, p<0.001) and longer IC assessments (median 3 vs. 2 sessions, p<0.001) than binary clients. Total psychiatric diagnoses were associated with nonbinary identities (β 0.7, p=0.001) and health care cards (β 0.4, p=0.017); depression diagnoses were associated with regional/remote residence (adjusted odds ratio [aOR] 2.2, p=0.011); and anxiety disorders were associated with nonbinary identities (aOR 2.8, p=0.012) and inversely associated with employment (aOR 0.5, p=0.016). WPATH model clients are more likely to have binary identities, mental health diagnoses, and longer assessments than IC model clients. Better coordination is needed to ensure timely gender-affirming care.

The state of affirmative mental health care for Transgender and Gender Non-Confirming people: an analysis of current research, debates, and standards of care.

Following the growth in visibility of Transgender and Gender Non-Confirming-identified people (TGNC) in popular culture and media, along with the increase in number of health clinics focusing on working with this population, and the development of a special interest in health professionals in TGNC-related issues, flourishing scientific literature and updated guidelines to help Mental Health Professionals (MHPs) work affirmatively with transgender individuals is pertinent. Despite the increased attention toward TGNC individuals, this population is still faced with political, economic, legal, and medical obstacles affecting their mental health and access to health care. Moreover, MHPs still report having limited training and experience in TGNC-affirmative care. This article aims at providing professionals with the most updated information and research findings to help them develop a more trans-affirmative practice. After defining key terms and providing a definition of TGNC-affirmative health care, this article will focus on summarizing the main documents that inform MHPs working with this population. This article offers research-based guidelines and discusses the major theoretical frameworks professionals are encouraged to incorporate in their work when developing TGNC-affirmative care. Additionally, this article will present the current debate around the diagnoses of Gender Dysphoria (DSM-V) and Gender Incongruence (ICD-11). The controversy between the Medical Model based on the Diagnosis of Gender Dysphoria and the emerging Informed Consent Model will be reviewed.