An Evaluation of Sex-Based Differences in Surrogate Consent for Older Adults Undergoing Surgical Intervention
Nupur Nagarkatti, Samuel M. Miller, Vanita Ahuja, Eric B. Schneider, Sanjay Mohanty, Lisa M. Kodadek
Journal of Surgical Research, August 2023; 288 pp 246-251
Abstract
Introduction
Differences between female and male patients have been identified in many facets of medicine. We sought to understand whether differences in frequency of surrogate consent for operation exist between older female and male patients.
Materials and methods
A descriptive study was designed using data from the hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program. Patients age 65 y and older who underwent operation between 2014 and 2018 were included.
Results
Of 51,618 patients identified, 3405 (6.6%) had surrogate consent for surgery. Overall, 7.7% of females had surrogate consent compared to 5.3% of males (P < 0.001). Stratified analysis based on age categories showed no difference in surrogate consent between female and male patients aged 65-74 yy (2.3% versus 2.6%, P = 0.16), but higher rates of surrogate consent in females than males among patients aged 75-84 y old (7.3% versus 5.6%, P < 0.001) and age ≥85 y (29.7% versus 20.8%, P < 0.001). A similar relationship was seen between sex and preoperative cognitive status. There was no difference in preoperative cognitive impairment in female and male patients age 65-74 y (4.4% versus 4.6%, P = 0.58), but higher rates of preoperative cognitive impairment were seen in females than males for those age 75-84 (9.5% versus 7.4%, P < 0.001) and aged ≥85 y (29.4% versus 21.3%, P < 0.001). Matching for age and cognitive impairment, there was no significant difference between rate of surrogate consent in males and females.
Conclusions
Female patients are more likely than males to undergo surgery with surrogate consent. This difference is not based on patient sex alone – females undergoing operation are older than their male counterparts and more likely to be cognitively impaired.

Asking informed consent may lead to significant participation bias and suboptimal cardiovascular risk management in learning healthcare systems
Research
Anna G. M. Zondag, T. Katrien J. Groenhof, Rieke van der Graaf, Wouter W. van Solinge, Michiel L. Bots, Saskia Haitjema
BMC Medical Research Methodology, 22 April 2023; 23(98)
Open Access
Abstract
Background
The Utrecht Cardiovascular Cohort – CardioVascular Risk Management (UCC-CVRM) was set up as a learning healthcare system (LHS), aiming at guideline based cardiovascular risk factor measurement in all patients in routine clinical care. However, not all patients provided informed consent, which may lead to participation bias. We aimed to study participation bias in a LHS by assessing differences in and completeness of cardiovascular risk management (CVRM) indicators in electronic health records (EHRs) of consenting, non-consenting, and non-responding patients, using the UCC-CVRM as an example.
Methods
All patients visiting the University Medical Center Utrecht for first time evaluation of a(n) (a)symptomatic vascular disease or condition were invited to participate. Routine care data was collected in the EHR and an informed consent was asked. Differences in patient characteristics were compared between consent groups. We performed multivariable logistic regression to identify determinants of non-consent. We used multinomial regression for an exploratory analysis for the determinants of non-response. Presence of CVRM indicators were compared between consent groups. A waiver (19/641) was obtained from our ethics committee.
Results
Out of 5730 patients invited, 2378 were consenting, 1907 non-consenting, and 1445 non-responding. Non-consent was related to young and old age, lower education level, lower BMI, physical activity and haemoglobin levels, higher heartrate, cardiovascular disease history and absence of proteinuria. Non-response increased with young and old age, higher education level, physical activity, HbA1c and decreased with lower levels of haemoglobin, BMI, and systolic blood pressure. Presence of CVRM indicators was 5–30% lower in non-consenting patients and even lower in non-responding patients, compared to consenting patients. Non-consent and non-response varied across specialisms.
Conclusions
A traditional informed consent procedure in a LHS may lead to participation bias and potentially to suboptimal CVRM, which is detrimental for feedback on findings in a LHS. This underlines the importance of reassessing the informed consent procedure in a LHS.

Expanding the boundaries of previously obtained informed consent in research: Views from participants in the Personalised Risk-based Mammascreening study
Lutomski JE, Rainey L, de Jong M, Manders P, Broeders MJM
Health Expectations: an International Journal of Public Participation in Health Care and Health Policy, 4 April 2023
Abstract
Introduction
Understanding participants’ concerns and information needs regarding broadened consent is crucial to ensure transparency and participant autonomy. Our study qualitatively examined these issues in women participating in the Personalized RISk-based MAmmascreening study (PRISMA). The original PRISMA informed consent was project-specific (i.e., breast cancer research), limiting the scope of secondary research. We explored participants’ needs for broadened consent to preserve informed decision-making while maximising the potential re-use of data.
Methods
Focus groups (FGs) were performed following a semistructured discussion guide. Two independent researchers analysed the data thematically using an inductive approach.
Findings
Twenty-three asymptomatic women and 13 women diagnosed with breast cancer were randomly divided into six FGs. Four superordinate themes were identified: (1) Normalization, (2) Attitude towards the pharmaceutical industry, (3) Privacy and (4) Knowledge. Our participants viewed data sharing as an important conduit for advancing medical science. Perceived integrity was more often attributed to noncommercial than commercial parties, with a marked mistrust towards the pharmaceutical industry. Most requested information needs related to data protection. Participants’ ideal consent process would confer a range of options; for example, they would be able to choose with whom data can be shared, whether data will be de-identified or anonymous, the expiration date of their consent and how, if requested, general and personal study results would be disclosed.
Conclusion
Our participants expressed clear information needs and a strong desire to be actively engaged in future data sharing decisions. Given that many researchers collaborate with commercial parties, building public confidence in these institutions would be beneficial. Illustrative examples addressing privacy concerns and clarifying difficult terms would aid consent decision-making. Although our participants displayed great altruism in sharing their data and accepted that broad consent would ultimately facilitate future research, broad consent did not reflect their ideal situation. Dynamic consent may be an option but warrants further feasibility research.
Patient and public contribution
Women were recruited from the general breast cancer screening population. Their perceptions and information needs, as reported in this study, will not only inform broadened consent for PRISMA but ideally guide other consent templates and decisions regarding consent processes.

Consent: A Pocket Guide for Nursing and Health Care
Book
Marc Cornock
April 2023 [Scion Publishing Ltd]
Excerpt
Consent is a concept that can be complex and difficult to understand, but it does not have to be. This book is a handy pocket-sized guide to the consent process that treats consent as an essential part of your everyday practice. From assent to self-determination, via legally valid consent, it’s full of practical detail about: what consent is, who can give consent, the ways in which consent can be given…

To Consent or Not to Consent to Screening, That Is the Question
Bjørn Hofmann
Healthcare, 30 March 2023
Abstract
The objective of this article is to address the controversial question of whether consent is relevant for persons invited to participate in screening programs. To do so, it starts by presenting a case where the provided information historically has not been sufficient for obtaining valid informed consent for screening. Then, the article investigates some of the most relevant biases that cast doubt on the potential for satisfying standard criteria for informed consent. This may indicate that both in theory and in practice, it can be difficult to obtain valid consent for screening programs. Such an inference is profoundly worrisome, as invitees to screening programs are healthy individuals most suited to make autonomous decisions. Thus, if consent is not relevant for screening, it may not be relevant for a wide range of other health services. As such, the lack of valid consent in screening raises the question of the relevance of one of the basic ethical principles in healthcare (respect for autonomy), one of the most prominent legal norms in health legislation (informed consent), and one of the most basic tenets of liberal democracies (individual autonomy). Thus, there are good reasons to provide open, transparent, and balanced information and minimize biases in order to ascertain informed consent in screening.

Editor’s note: This article belongs to the Special Issue The Rationalities of Medical Screening.

Posthumous autonomy: Agency and consent in body donation
Tom Farsides, Claire F. Smith
Philosophical Psychology, 6 April 2023
Abstract
Six people were interviewed about the possibility of becoming posthumous body donors. Interview transcripts were analyzed using interpretative phenomenological analysis. Individual-level analysis suggested a common interest in Personhood Concerns and a common commitment to Enlightenment Values. Investigations of these possible themes across participants resulted in identification of two sample-level themes, each with two subthemes: Autonomy, with subthemes of agency and consent, and Rationality, with subthemes of knowledge/epistemology and materialism/ontology. This paper concentrates on the former. Consent for posthumous body donation was felt to sometimes fall short of adequately identifying donors’ preferences about what happened after consent was given, even with respect to actions for which consent established permission. In turn, paucity of information about donors’ preferences limited others’ ability to act as proxy agents to facilitate donors’ posthumous autonomy. Thus, while consent may curtail violations of people’s autonomy by authorizing actions for which permission has been established, it may fall short of facilitating their autonomy in ways that might be possible with greater knowledge of those people’s desires. Alternative methods of establishing consent are explored that might better-determine people’s desires and thereby improve others’ ability to act as proxy agents for them to facilitate their subsequent (even posthumous) autonomy.