Patient and proxies’ attitudes towards deferred consent in randomised trials of acute treatment for stroke: A qualitative survey

Introduction Deferral of consent for participation in a clinical study is a relatively novel procedure, in which informed consent is obtained after randomisation and study treatment. Deferred consent can be used in emergency situations, where small therapeutic time windows limit possibilities for patients to provide informed consent. We aimed to investigate patients’ or their proxies’ experiences and opinions regarding deferred consent in acute stroke randomised trials. Patients and methods For this qualitative study, Dutch Collaboration for New Treatments of Acute Stroke (CONTRAST) trial participants were selected. Study participants were either patients or their proxies who provided consent and were selected with theoretical sampling based on patient characteristics. Semi-structured interviews were conducted face-to-face or by telephone. Themes and subthemes were iteratively defined. Results Twenty of the 23 interviewed participants (16 patients and 7 proxies) considered deferred consent acceptable. The received study treatment and consent conversation were remembered by 18 participations, although the concept of randomisation and treatment comparison were generally not well understood. Sixteen participants felt capable of overseeing the decision to give deferred consent. Distress in the first days after stroke, lack of understanding and neurological deficits were reasons for feeling incapable of providing consent. Four participants would have preferred a different timing of the consent conversation, of whom two prior to treatment. Conclusion Our study found that deferred consent was considered acceptable by most study participants who provided consent for acute stroke randomised trials. Though they felt capable, the recall and comprehension of consent were overall limited.

Higher versus Lower Oxygen Concentration during Respiratory Support in the Delivery Room in Extremely Preterm Infants: A Pilot Feasibility Study

Background: Optimal starting oxygen concentration for delivery room resuscitation of extremely preterm infants (<29 weeks) remains unknown, with recommendations of 21–30% based on uncertain evidence. Individual patient randomized trials designed to answer this question have been hampered by poor enrolment. Hypothesis: It is feasible to compare 30% vs. 60% starting oxygen for delivery room resuscitation of extremely preterm infants using a change in local hospital policy and deferred consent approach. Study design: Prospective, single-center, feasibility study, with each starting oxygen concentration used for two months for all eligible infants. Population: Infants born at 23 + 0–28 + 6 weeks’ gestation who received delivery room resuscitation. Study interventions: Initial oxygen at 30% or 60%, increasing by 10–20% every minute for heart rate < 100 bpm, or increase to 100% for chest compressions. Primary outcome: Feasibility, defined by (i) achieving difference in cumulative supplied oxygen concentration between groups, and (ii) post-intervention rate consent >50%. Results: Thirty-four infants were born during a 4-month period; consent was obtained in 63%. Thirty (n = 12, 30% group; n = 18, 60% group) were analyzed, including limited data from eight who died or were transferred before parents could be approached. Median cumulative oxygen concentrations were significantly different between the two groups in the first 5 min. Conclusion: Randomized control trial of 30% or 60% oxygen at the initiation of resuscitation of extremely preterm neonates with deferred consent is feasible. Trial registration: Clinicaltrials.gov NCT03706586

Communicating consent in sport: A typological model of athletes’ consent practices within combat sports

This paper provides a systematic attempt to empirically describe the ways in which athletes’ consent to take part in sport is socially constructed, communicated and understood by others. Due to a notable lack of prior research on this topic, we draw on insights from sex research to theorise consent as a communicative social practice, specifically applying this notion to interpreting the world of competitive combat sports. To do so, we combine data from across numerous studies using the method of concatenated exploration, producing a post hoc, longitudinal, cross-contextual qualitative analysis of the ways in which consent is practiced in such settings. We then outline a four-point typology of how consent is performed, including the following categories: overt communication; subtle communication; assumed consent and deferred consent. We conclude by arguing that the apparent predominance of subtle, assumed and deferred consent presents some worrying implications for athletes’ freedom, potentially undermining the morally transformative potential of consent within these ostensibly ‘violent’, often injurious sports contexts.

Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey

Background In some acute care trials, immediate informed consent is not possible, but deferred consent is often considered problematic. We investigated the opinions of patients, proxies, and physicians about deferred consent in an acute stroke trial to gain insight into its acceptability and effects. Methods Paper-based surveys were sent to patients who were randomly assigned in the Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage (ULTRA) trial between 2015 and 2018 in two tertiary referral centers and to physicians of centers who agreed or declined to participate. The primary outcome measure was the proportion of respondents who agreed with deferral of consent in the ULTRA trial. Secondary outcomes included respondents’ preferred consent procedure for the ULTRA trial, the effect of deferred consent on trust in physicians and scientific research, and the willingness to participate in future research. Results Eighty-nine of 135 (66%) patients or proxies and 20 of 30 (67%) physicians completed the survey. Of these, 82 of 89 (92%) patients or proxies and 14 of 20 (70%) physicians agreed with deferral of consent in the ULTRA trial. When asked for their preferred consent procedure for the ULTRA trial, 31 of 89 (35%) patients or proxies indicated deferred consent, 15 of 89 (17%) preferred immediate informed consent, and 32 of 89 (36%) had no preference. None of the patients’ or proxies’ trust in physicians or scientific research had decreased because of the deferred consent procedure. Willingness to participate in future studies remained the same or increased in 84 of 89 (94%) patients or proxies. Conclusions A large majority of the surveyed patients and proxies and a somewhat smaller majority of the surveyed physicians agreed with deferred consent in the ULTRA trial. Deferred consent may enable acute care trials in an acceptable manner without decreasing trust in medicine. Future research should investigate factors facilitating the responsible use of deferred consent, such as in-depth interviews, to study the minority of participants who agreed with deferred consent but still preferred immediate informed consent.

Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent

Background Deferred consent is used to recruit patients in emergency research, when informed consent cannot be obtained prior to enrolment. This model of consent allows studies to recruit larger numbers of participants, especially where a surrogate-decision maker may be unavailable to provide consent. Whilst deferred consent offers the potential to promote trial diversity by including under-served groups, it is ethically complex and views about its use amongst these populations require further exploration. The aim of this article is to build upon recent initiatives to improve inclusivity in trials, such as the NIHR INCLUDE project, and consider whether trials methodology research is inclusive, focusing on ethnic minority populations’ attitudes towards the use of deferred consent. Main text Findings from the literature suggest that research regarding attitudes toward recruitment methods like deferred consent largely fail to adequately represent ethnic minorities. Many studies fail to report the composition of patient samples or conduct analyses on any differences between specific patient groups. In those that do, the categorisation of ethnic groups is ambiguous. Frequently diversely different groups are considered as more homogenous than they are. Whilst deferred consent is deemed generally acceptable, analysis of patient sub-groups shows that this attitude is not universal. Those from racial and ethnic minority backgrounds reported higher levels of unacceptability, which was impacted by previous first or second-hand experience of its use and historical mistrust in research. However, whilst deferred consent was found to increase the numbers of black participants enrolled in some trials, their over-enrolment in other trials may raise further concerns. Conclusions Inclusivity in clinical trials is important, as highlighted by the COVID-19 pandemic. To improve this, we must ensure that methodological studies such as those exploring attitudes to research are inclusive. More effort is needed to understand the views of under-served groups, such as ethnic minorities, toward research in order to improve participation in clinical trials. Our findings echo those from the INCLUDE project, in that better reporting is needed and increasing the confidence of ethnic minority groups in research requires improving representation throughout the research process. This will involve diversifying research teams and ethics committees.

Deferred consent model for an observational study in a pediatric emergency department

.

Exploring the Inclusion of Under-Served Groups in Trials Methodology Research: An Example from Ethnic Minority Populations’ Views on Deferred Consent

Background: Deferred consent is used to recruit patients in emergency research, when informed consent cannot be obtained prior to enrolment. This model of consent allows studies to recruit larger numbers of participants, especially where a surrogate-decision maker may be unavailable to provide consent. Whilst deferred consent offers the potential to promote trial diversity by including under-served groups, it is ethically complex and views about its use amongst these populations requires further exploration. The aim of this article is to build upon recent initiatives to improve inclusivity in trials, such as the NIHR INCLUDE project, and consider whether trials methodology research is inclusive, focusing on ethnic minority populations’ attitudes towards the use of deferred consent.Main text: Findings from the literature suggest that research regarding attitudes toward recruitment methods like deferred consent largely fail to adequately represent ethnic minorities. Many studies fail to report the composition of patient samples or conduct analyses on any differences between specific patient groups. In those that do, the categorisation of ethnic groups is ambiguous. Frequently diversely different groups are considered as more homogenous than they are. Whilst deferred consent is deemed generally acceptable, analysis of patient sub-groups shows that this attitude is not universal. Those from racial and ethnic minority backgrounds reported higher levels of unacceptability, which was impacted by previous first or second-hand experience of its use and historical mistrust in research. However, whilst deferred consent was found to increase the numbers of black participants enrolled in some trials, their over-enrolment in other trials may raise further concerns. Conclusions: Inclusivity in clinical trials is important, as highlighted by the COVID-19 pandemic. To improve this, we must ensure that methodological studies such as those exploring attitudes to research are inclusive. More effort is needed to understand the views of under-served groups, such as ethnic minorities, toward research in order to improve participation in clinical trials. Our findings echo those from the INCLUDE project, in that better reporting is needed and increasing the confidence of ethnic minority groups in research requires improving representation throughout the research process. This will involve diversifying research teams and ethics committees.

Co-enrolment to UK Critical Care Studies – A 2019 update

In 2013, a group of clinicians on behalf of the National Institute for Health Research, collaborated with ICU Steps to produce guidance about people being enrolled in more than one critical care trial. This is referred to as “co-enrolment” and can be where a person takes part in one study at the same time as another study (or one after the other in a short time-frame). For instance, being part of a study looking at sepsis drugs and a mechanical ventilation weaning study. The drivers for developing this guidance were a lack of any existing guidance, nationally and internationally, at that time, and a desire to ensure high quality research is conducted. The emphasis was on making trials as safe as possible for patients and ensuring robust trial outcomes. Critical care was seen to lead in this, with our exemplar guidance used across all health research. We wish to revisit this guidance now that there is more experience of coenrolment in critical care trials. There is also more awareness of different consent models, such as deferred consent (taking consent when a person is awake and able to give consent) and consultee consent (asking families or independent professionals to consent). Consenting to coenrolment is an important ethical consideration for the revision of this guidance.