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.

A Multi-Institutional Informed Consent Proposal as a Prevention Tool for Combined Oral Contraceptive Intake and Thrombotic Risk
Marina Vinciguerra, Eliano Cascardi, Bruno Lamanna, Maricla Marrone, Fortunato Pititto, Enrica Macorano, Romualdo Sciorio, Giorgio Maria Baldini, Antonio Malvasi, Andrea Ballini, Gerardo Cazzato, Antonella Vimercati, Senthil Kumaran, Ettore Cicinelli, Salvatore Scacco, Miriam Dellino
Journal of Personalised Medicine, 27 March 2023
Open Access
Abstract
Combined oral contraceptives (COC), are among the most widely used contraceptive methods in the world today. Despite the different changes in terms of estrogen/progestogen combinations and dosages, the thromboembolic risk for a woman who takes combined oral contraceptives persists to date.
Methods
The review of relevant literature and international guidelines on prescription of combined oral contraceptives made it possible to create a proposal for informed consent to be used for prescribing.
Results
The several sections of our consent proposal were designed according to a rationale in order to cover all the aspects presented by worldwide guidelines: how to take, adverse effects, advertisements, extra-contraceptive benefits and effects, a checklist for condition at risk of thromboembolism, the signature of the woman.
Conclusions
An informed consent to standardize combined oral contraceptives prescription can improve women’s eligibility, mitigate thromboembolic risk, and assure legal protection to healthcare providers. In this systematic review in particular, we refer to the Italian medical–legal scenario, to which our group of researchers belongs. However, the model proposed was designed in the respect of main healthcare organization guidelines, and it could be easily used by any center in the world.

Measuring Impact of Simulation-Based Informed Consent Training on Surgical Intern’s Long-Term Confidence
Original Reports
Gwyneth A. Sullivan, Kelly Harmon, Genevieve F. Gill-Wiehl, Seungjun Kim, Jose M. Velasco, Edie Y. Chan, Scott W. Schimpke
Journal of Surgical Education, 24 March 2023
Objective
Our objective was to evaluate the outcome of a training program on long-term confidence of interns and attending physicians.
Design
In this prospective cohort study, general surgery interns underwent a training program on informed consent that involved didactics, standardized patient encounters, and supplemental procedure specific guides at the start of the academic year. At the end of the academic year, we surveyed interns from the classes of 2020 (trained) and 2019 (untrained) about their experience and confidence in obtaining an informed consent. Further, we queried attending physicians on their experience and confidence in the interns at the end of each academic year.
Setting
Single academic general surgery residency program based at 2 urban tertiary hospitals.
Participants
General surgery interns including unmatched preliminary residents and categorical interns from general surgery, interventional radiology, and urology.
Results
Twenty-four incoming interns participated in the training program. Intern confidence discussing operation benefits improved from a median score of 4 to 5 (p = 0.03), and total confidence improved from a median score of 15 to 17.5 (p = 0.08). There was no difference in median total confidence scores (15 vs. 17.5; p = 0.21) between classes. Attending physicians had similar median total confidence scores following intervention (10 vs. 11; p = 0.87). Intern satisfaction was 80% with the didactic session, and 90% with standardized patient encounters. Twenty percent of learners used the supplemental procedure specific guides.
Conclusions
Implementation of an intern targeted program on informed consent that incorporated didactics and standardized patient encounters was viewed as useful and may contribute to long-term improvements in confidence.

Editor’s note: The publication refers to research conducted by members of Rush University Medical Center in Chicago, Illinois.

Informed Consent in Reproductive Therapy
Book Chapter
Ofra G. Golan
Hot Topics in Human Reproduction, 17 March 2023 [Springer]
Abstract
This chapter examines the unique aspects of informed consent to reproductive therapy. It discusses the significance of the informed consent process for this patients’ population, as the core of patient-centered care. Professionals’ and patients’ perception of the process are reviewed, as well as relevant case law. Further, the issues that are most important for patients are revealed, and some guidance is given accordingly as to the information on which emphasis should be put and to the decision points toward which it should be explained and discussed with the patients.

Evaluating the Efficacy of Surgical Consent
Carlos A. Delgado, Michelle R. McCullers, Scott W. Bloom
The American Surgeon, 15 March 2023
Abstract
Background
Patient autonomy is the most important of the core values of medical ethics, yet the process of obtaining surgical consent remains a lesser scrutinized area of modern surgical practice. Informed consent implies a patient’s understanding of nature of the operation, indications, risks, benefits, and alternatives. Surgical consent has traditionally been obtained through verbal communication and formalized by signing a legal document. This process oftentimes leaves patients unequipped with adequate knowledge about the procedure they just consented to. In most cases, it is simply impossible for the non-medically trained layperson to fully understand the nuances of surgery in a conversation. Some may argue a degree of paternalism may be inevitable; we believe there is room for improvement.
Methods
We chose to examine English-speaking adult patients undergoing common procedures (laparoscopic cholecystectomy, open inguinal hernia repair, and skin mass/soft tissue excision). We asked 71 patients to complete a free response survey on the risks, benefits, and alternatives to the operation they had just consented to. The patients were administered the survey either in the outpatient clinic or in the preoperative area.
Results
Our analysis showed that most of our patients understand the inherent risks, benefits, and alternatives when being consented but that less than 50% of those consented were considered to have adequate understanding of the procedures they were consented for.
Discussion
This study highlights key deficits and potential areas of improvement in the informed consent process. Based on the results, we have significant room for improvement and the responsibility to do so.

Comparison of the Structured Consent Process Using Modified Delphi Technique with the Standard Process in Obtaining Informed Consent for Procedures in ENT by PHASE III MBBS Students
Original Article
Sapna Sreedharan Nambiar
Indian Journal of Otolaryngology and Head & Neck Surgery, 15 March 2023
Open Access
Abstract
Communication skill is a core competency and the training must begin in the undergraduate period itself. The Phase III MBBS students during their ENT posting are required to obtain informed consent for procedures and surgeries in ENT which forms the basis for efficient communication skills in house-surgency (internship) and residency. Informed consent taking is an important aspect and in the clinical postings, the teaching of communication skills along with history taking and physical examination can go a long way in making a strong foundation to good doctor patient relationships. This study aimed to compare the structured consent process using modified Delphi technique with the standard process in obtaining informed consent for procedures in ENT by PHASE III MBBS students. The need to sensitise the MBBS students on appropriate consent taking procedures with familiarisation of the essential elements of the Kalamazoo consensus statement were raised, accepted and final OSCE assessment attributes decided by the modified Delphi technique. The Modified Delphi technique is a unique means to obtain opinions of experts across the field in various spheres so as to identify lacunae if any in the existing teaching with means to reach a valid and reliable consensus. Our study included Phase III MBBS students posted to the Department of ENT, Govt Medical College Kozhikode during Jan–Feb 2022 wherein one batch of 30 students were taught with 2 classes on informed consent taking by the structured process obtained after Modified Delphi technique and included as; “MD” group and another batch of 30 students from the entire batch taught by the standard process was included as; “T” group respectively. After completion of the clinical postings an assessment was carried out with OSCE stations in Mar 2022; wherein 10 students were evaluated for each of the 6 common ENT procedures, 5 students from “T” group and 5 students from “MD” group respectively. Median total score of MD group was 6.5 (3.25–8) and median score of T group was 4.5 (2.25–6.75). The difference in mean ranks of these scores was statistically significant, p < 0.0001. The feedback assessment using the questionnaire with Likert scale had all 30(100%) students recommend this method of structured consent taking for enhancement of communications skills. However 20% of the students were not satisfied with the teaching learning method expressing the need for more time allocation and demonstrations. Informed consent taking requires the appropriate training in the undergraduate period itself as seen by the improved OSCE scores on assessment after teaching by the structured consent taking process as well as from the feedback of the students.