Awareness and Perception of Healthcare Providers about Proxy Consent in Critical Care Research

Objective. Proxy consent respects patients’ autonomy when they are incapable of providing consent for research participation. Healthcare providers need to understand the ethical regulations and practices relevant to the proxy consent process. Thus, this study aimed to assess the knowledge and attitudes of healthcare providers about research proxy consent in the ICU setting. Methods. A cross-sectional survey-based design was used in the study. Study participants were resident and specialist physicians, registered nurses, and registered pharmacists from ICU units in Jordan. Participants were asked to fill out a questionnaire developed to assess their knowledge and attitudes towards informed proxy consent for research studies conducted at the ICU. Results. In this study, 145 healthcare providers completed the study questionnaire. The healthcare providers agreed that the purpose of the proxy consent is to inform the participants about the potential benefits (66.9%) and risks (66.9%) related to the research to study and respect patient's autonomy (44%), to discuss alternative options (62.1%), and to protect the researchers from any litigation (84.1%). Regarding the assessment of proxy consent, 65.5% of respondents believed that relatives are considered as an authorized legal representative for an informed consent decision on behalf of their ICU patients (65.5%) as they are knowledgeable about patients' values and preferences and have the desire to provide the necessary help. Respondents also agreed that the informed consent process should explain research protocols and procedures (76.6%), therapeutic alternatives (84.1%), potential benefits (41.4%), and potential risks (44.1%) and that participation in the research is voluntary (66.9%). No significant differences in the responses were found among different groups of healthcare providers. Conclusion. The majority of healthcare providers had inadequate awareness about the ethical aspects regarding the informed proxy consent process. Providing training regarding the informed consent process can improve the quality of the proxy consent process in clinical research studies in the ICU setting.

Over my dead body: Self-determination, proxy consent, and proportionate reason in the treatment of a Jehovah's Witness patient with severe traumatic hemorrhagic shock

When a Jehovah’s Witness patient is traumatically injured, the lack of uniform professional consensus guidelines and the cultural knowledge deficit of many clinicians adds an additional layer of legal and ethical complexity to the inherent difficulty of managing a critically ill patient. We present here the case of an incapacitated Jehovah's Witness patient with severe traumatic hemorrhagic shock. We go on to discuss the historical and contemporary case law on proxy refusal of blood transfusion for the incapacitated adult, as well as the ethics of self-determination and the application of the principle of proportionate reason in the management of the critically injured Jehovah's Witness patient.

P103 Research governance audit on quality of documentation of hyperacute ATTEST 2 stroke trial, focusing on the informed consent process

Background The time constraints of hyperacute stroke trials can make documentation challenging. 70% of acutely ill patients lack capacity, thereby requiring proxy consent, and faultless documentation of informed consent in order to avoid ambiguity. This retrospective audit looked at quality of documentation, focusing on informed consent, in the ATTEST 2 trial. The ATTEST 2 trial is a multicentre randomised controlled trial comparing the efficacy of the experimental drug tenecteplase to alteplase (which is used in current practice) for IV thrombolysis to treat acute ischaemic stroke. Methods The consent forms and hospital notes of 13 participants of ATTEST 2 recruited into the trial at the Newcastle Royal Victoria Infirmary hospital from January-August 2018 were inspected. Criteria included documentation of all research visits (day 1, 2 and 5), inclusion and exclusion criteria being met, and presence of a dated, timed and signed consent form. Adherence to 38 criteria in patient records was assessed. Standards were based on GCP guidelines for documentation, especially section 4.8 on informed consent, and on the requirements for data recording set by the ATTEST 2 trial coordinators. This was stratified by date to compare documentation earlier and later on in the trial. Results Most criteria were adequately fulfilled. However, 22% of the criteria had a compliance of less than 60%. These included recording time of consent, the day 5 follow up visit, the attempt to reconsent if patient lacked capacity earlier, the voluntary nature of the trial, the risks and benefits, and that the patient had an opportunity to ask questions. The practices with compliance less than 60% decreased from 26% from January-April 2018 to 21% from May-August 2018. Conclusions The level of documentation varied between patient records, and though most criteria were met, some did not meet ideal standards. This seemed to improve over the course of the ATTEST 2 trial. This audit findings were presented to the team involved. Inconsistency of documentation was discussed and documentation standards were reviewed. A re-audit should be carried out and it should be investigated whether the quality of documentation continued to improve over time.

Health data research on sudden cardiac arrest: perspectives of survivors and their next-of-kin

Background Consent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and health-related data for observational research. Methods We conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues. Results Sudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives. Conclusions Sudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well.

Impact of Age on Consent in a Geriatric Orthopaedic Trauma Patient Population

Introduction: Persistent misconceptions of frailty and dementia in geriatric patients impact physician-patient communication and leave patients vulnerable to disempowerment. Physicians may inappropriately focus the discussion of treatment options to health care proxies instead of patients. Our study explores the consenting process in a decision-making capable orthogeriatric trauma patient population to determine if there is a relationship between increased patient age and surgical consent by health care proxy. Methods: Patients aged 65 and older who underwent operative orthopaedic fracture fixation between 1 of 2 Level 1 Trauma Centers were retrospectively reviewed. Decision-making capable status was defined as an absence of patient history of cognitive impairment and a negative patient pre-surgical Confusion Assessment Method (CAM) and Mini-Cog Assessment screen. Provider of surgical consent was the main outcome and was determined by signature on the consent form. Results: 510 patients were included, and 276 (54.1%) patients were deemed capable of consent. In 27 (9.8%) of 276 decision-capable patients, physicians obtained consent from health care proxies. 20 of these 27 patients (74.1%) were 80 years of age or older. However, in patients aged 70 to 79, only 7 health care proxies provided consent. (p = 0.07). For every unit increase in age, the log odds of proxy consent increased by .0008 (p < 0.001). Age (p < 0.001), income level (p = 0.03), and physical presence of proxy at consult (p < 0.001) were factors associated with significantly increased utilization of health care proxy provided consent. Language other than English was a significant predictor of proxy-provided consent (p = 0.035). 48 (22%) decision-making incapable patients provided their own surgical consent. Discussion: The positive linear association between age and health care proxy provided consent in cognitively intact geriatric orthopaedic patients indicates that increased patient age impacts the consenting process. Increased physician vigilance and adoption of institutional consenting guidelines can reinforce appropriate respect of geriatric patients’ consenting capacity.

Should parents be asked to consent for life-saving paediatric interventions?

Informed consent, when given by proxy, has limitations: chiefly, it must be made in the interest of the patient. Here we critique the standard approach to parental consent, as present in Canada and the UK. Parents are often asked for consent, but are not given the authority to refuse medically beneficial treatment in many situations. This prompts the question of whether it is possible for someone to consent if they cannot refuse. We present two alternative and philosophically more consistent frameworks for paediatric proxy consent. The first allows meaningful consent (parents may say ‘yes’ or ‘no’ to treatment), provided that parents are medically informed/competent and intend the health and well-being of their child. In the second solution, medical practitioners or the state consent for treatment, with parents only being consulted to help give insight to the child’s circumstances. While we contend that either of these two options is superior to the insincerity of the present paradigm, we suggest that the first solution is preferable.

Older Persons’ and Their Caregivers’ Perspectives and Experiences of Research Participation With Impaired Decision-Making Capacity: A Scoping Review

Background and Objectives Human research ethics statements support equitable inclusion of diverse groups. Yet older people are under-represented in clinical research, especially those with impaired decision-making capacity. The aim of this study was to identify perspectives and experiences of older persons and their caregivers of research participation with impaired decision-making capacity. Research Design and Methods Scoping review of literature and online sources in January-February 2019 (updated June 2020) according to Joanna Briggs Institute methodology and PRISMA Extension for Scoping Reviews. English-language peer-reviewed research articles and Australian online narratives were included. Data were tabulated and narratively synthesized. Results From 4171 database records and 93 online resources, 22 articles (2000-2019, 82% United States, 16 first authors) and one YouTube webinar (2018) were initially included; updated searches yielded an additional article (2020) and YouTube webinar (2020). Studies were heterogeneous in terminology, methods and foci, with hypothetical scenarios, quantitative analyses and examination of proxy consent predominating. Participants (n=7331) were older persons (71%), caregivers of older persons with dementia/cognitive impairment (23%) and older persons with dementia/cognitive impairment (6%). Synthesis identified two themes: willingness to participate and decision-making approaches. Discussion and Implications Research participation by older persons with dementia may be optimized through reducing risks and burdens and increasing benefits for participants, greater consumer input into study development, and shared and supported decision-making. Older persons’ and caregivers’ perspectives and experiences of research participation with impaired decision-making capacity require investigation in a greater range of countries and conditions other than dementia, and dissemination through more varied media.

Does electronic consent improve the logistics and uptake of hpv vaccination in adolescent girls? A mixed methods theory informed evaluation of an intervention

Background Technological solutions may improve the logistics of obtaining parental consent in school-based immunisation programmes. In 2018/19 a health care organisation in London, England, piloted an electronic consent intervention in the adolescent girls’ HPV vaccination programme. We conducted a mixed-methods evaluation to examine the usability and acceptability of the intervention and assess its impact on consent form returns and HPV vaccine uptake. Methods The intervention was implemented in 14 secondary schools in seven South London boroughs. Each e-consent school was matched with a school that used standard paper consent. Matching was based on location and the proportion of students: i. with English as a second language, ii. receiving free school meals (socio-economic status proxy). Consent form return rates and HPV vaccine uptake were compared quantitatively between intervention and matched schools. Data from immunisation session observations (n=7), school feedback forms (n=14), individual and group interviews with implementers (n=8), parents and adolescents (n=12) and a focus group discussion with adolescents was analysed thematically to document user’s experiences investigate the implementation of the intervention. Results HPV vaccination uptake did not differ between e-consent and matched paper consent schools, but timely consent form return was significantly lower in the e-consent schools (73.3% (n=11) vs 91.6% (n=11), p=0.008). The transition to using the system was not straightforward, whilst schools and staff understood the potential benefits, they found it difficult to adapt to new ways of working which removed some level of control from schools. Part of the reason for lower consent form return in e-consent schools was that some parents found the intervention difficult to access and use. Adolescents highlighted the potential for e-consent interventions to by-pass their information needs. Conclusions The e-consent intervention did not improve consent form return or vaccine uptake due to challenges encountered in transitioning to a new way of working. New technologies require embedding before they become incorporated in everyday practice. The intervention is undergoing further iterative development to improve its usability, ensure schools are appropriately involved and adolescents receive tailored immunisation information. A re-evaluation once stakeholders are accustomed to e-consent may be required to understand its impact.

Does electronic consent improve the logistics and uptake of hpv vaccination in adolescent girls? A mixed methods theory informed evaluation of an intervention

Background Technological solutions may improve the logistics of obtaining parental consent in school-based immunisation programmes. In 2018/19 a health care organisation in London, England, piloted an electronic consent intervention in the adolescent girls’ HPV vaccination programme. We conducted a mixed-methods evaluation to examine the usability and acceptability of the intervention and assess its impact on consent form returns and HPV vaccine uptake. Methods The intervention was implemented in 14 secondary schools in seven South London boroughs. Each e-consent school was matched with a school that used standard paper consent. Matching was based on location and the proportion of students: i. with English as a second language, ii. receiving free school meals (socio-economic status proxy). Consent form return rates and HPV vaccine uptake were compared quantitatively between intervention and matched schools. Data from immunisation session observations (n=7), school feedback forms (n=14), individual and group interviews with implementers (n=8), parents and adolescents (n=12) and a focus group discussion with adolescents was analysed thematically to document user’s experiences investigate the implementation of the intervention. Results HPV vaccination uptake did not differ between e-consent and matched paper consent schools, but timely consent form return was significantly lower in the e-consent schools (73.3% (n=11) vs 91.6% (n=11), p=0.008). The transition to using the system was not straightforward, whilst schools and staff understood the potential benefits, they found it difficult to adapt to new ways of working which removed some level of control from schools. Part of the reason for lower consent form return in e-consent schools was that some parents found the intervention difficult to access and use. Adolescents highlighted the potential for e-consent interventions to by-pass their information needs. Conclusions The e-consent intervention did not improve consent form return or vaccine uptake due to challenges encountered in transitioning to a new way of working. New technologies require embedding before they become incorporated in everyday practice. The intervention is undergoing further iterative development to improve its usability, ensure schools are appropriately involved and adolescents receive tailored immunisation information. A re-evaluation once stakeholders are accustomed to e-consent may be required to understand its impact.