Blockchain innovation for consent self-management in health information exchanges
Chad Anderson, Arthur Carvalho, Mala Kaul, Jeffrey W. Merhout
Decision Support Systems, 30 May 2023
Abstract
With the increasing digitalization of health data, patients need to make informed decisions about the online sharing of their protected health information. This necessitates a robust technical infrastructure that enables patients to self-manage consent and the trusted exchange of this information across sharing entities. Unfortunately, current health information exchange systems in the U.S. are limited in both these regards. While there is recent work on digital patient consent management, there is limited work that provides effective solutions for patient self-management of consent. Further, interoperability issues in the way health information exchanges are currently architected and differences in regulations across localities exacerbate the challenges of consent management. In this research, we survey potential patients’ willingness to self-manage healthcare-related consent. Having established the desire for consent self-management, we propose a solution that enables the seamless sharing of patient consent across different healthcare providers and health information exchanges. Specifically, we use a rigorous design science approach to create a blockchain-based, self-managed patient consent system and we evaluate the design through an instantiated prototype. The results of our study should be useful to researchers in healthcare information management as well as to practitioners designing consent management systems. Our research contributes to design science research with an innovative, rigorously evaluated, design principles-based artifact that addresses a critical problem of sharing protected health information.

The evolution of informed consent in gastroenterology
Research Article
Fallon O’Neill, Parker O’Neill, Sierra Schaffer, Andrew Poullis
Medico-Legal Journal, 30 May 2023
Abstract
    With medical litigation on the rise, physicians require a nuanced understanding of the legalities of consenting patients to reduce their liability while practising evidence-based medicine. This study aims to a) clarify the legal duties of gastroenterologists in the UK and USA when gaining informed consent and b) provide recommendations at the international and physician level to improve the consent process and reduce liability.

A bibliometric analysis of the Web of Science database with the MeSH terms “gastroenterology” and “informed consent” yielded 383 articles, of which 228 were excluded due to not meeting the inclusion criteria. Of the top 50 articles, 48% were from American institutions and 16% were from the UK. Thematic analysis showed 72% of the articles discussed informed consent in relation to diagnostic procedures, 14% regarding treatment, and 14% regarding research participation.

Both the USA and the UK have progressed from previously paternalistic Natanson case (1960) and Bolam test (1957), respectively, where physicians were held to the standard of a “reasonable and prudent medical doctor”. The American Canterbury case (1972) and the British Montgomery case (2015) radically shifted the standard of disclosure during the consent process by requiring physicians to explain all information pertinent to a “reasonable patient”.

It is our recommendation that a two-pronged approach be taken; a) creation of international guidelines for consenting patients for invasive procedures in gastroenterology, and b) development of internationally standardised endoscopy consent forms containing all the details pertinent to a “reasonable patient”.

Examining the variation in consent in general surgery
Research Article
A Sebastian, L Wyld, JL Morgan
The Annals of The Royal College of Surgeons of England, 23 May 2023
Abstract
Introduction
Consent is a fundamental aspect of surgery and expectations around the consent process have changed following the Montgomery vs Lanarkshire Health Board (2015) court ruling. This study aimed to identify trends in litigation pertaining to consent, explore variation in how consent is practised among general surgeons and identify potential causes of this variation.
Methods
This mixed-methods study examined temporal variation in litigation rates relating to consent (between 2011 and 2020), using data obtained from National Health Service (NHS) Resolutions. Semi-structured clinician interviews were then conducted to gain qualitative data regarding how general surgeons take consent, their ideologies and their outlook on the recent legal changes. The quantitative component included a questionnaire survey aiming to explore these issues with a larger population to improve the generalisability of the findings.
Results
NHS Resolutions litigation data showed a significant increase in litigation pertaining to consent following the 2015 health board ruling. The interviews demonstrated considerable variation in how surgeons approach consent. This was corroborated by the survey, which illustrated considerable variation in how consent is documented when different surgeons are presented with the same case vignette.
Conclusion
A clear increase in litigation relating to consent was seen in the post-Montgomery era, which may be due to legal precedent being established and increased awareness of these issues. Findings from this study demonstrate variability in the information patients receive. In some cases, consent practices did not adequately meet current regulations and therefore are susceptible to potential litigation. This study identifies areas for improvement in the practice of consent.

Completion of the informed consent in radioguided surgery by the General Surgery and Nuclear Medicine services of a radioguided surgery unit
Original Article
Jiménez-Granero, J.I. Rayo-Madrid, J.R. Infante-de-la-Torre, J. Serrano-Vicente, A. Martínez-Esteve, A. Baena-García, A. Utrera-Costero, R. Juárez-Vela
Revista Española de Medicina Nuclear e Imagen Molecular, 16 May 2023
Abstract
Objective
To identify the frequency of errors in informed consent documents in radioguided surgery in a third level hospital and to detect possible causes or factors associated with a greater risk of error.
Material and methods
Informed consent forms of a total of 369 radioguided surgery interventions, completed by the Nuclear Medicine and General Surgery services, were analyzed, and the degree of completion of the forms and its correlation with the physicians responsible, type of pathology, intervention, and waiting time were compared with the completion of consent by another specialty.
Results
Errors were identified in 22 consent forms from Nuclear Medicine and 71 from General Surgery. The most common error was the absence of identification of the physician responsible (17 in Nuclear Medicine, 51 in General Surgery), and the second most common was the absence of a document (2 in Nuclear Medicine, 20 in General Surgery). There were significant differences in the errors made depending on the doctor in charge, with no significant correlation with the other variables.
Conclusions
The physicians responsible were the main factor associated with a greater risk of error in the completion of informed consent forms. Further studies are needed to analyze the causal factors and possible interventions to minimize errors.

Identifying which adverse events associated with dry needling should be included for informed consent: A modified e-Delphi study
Research Report
Edmund C Ickert, David Griswold, Ken Learman, Chad Cook
Physiotherapy Theory and Practice, 9 May 2023
Abstract
Objective
Dry needling (DN) uses a monofilament needle to reduce pain and is performed by various healthcare professions. Due to the invasive needle puncture, adverse events (AEs) have been associated with DN. It is unclear, which AEs should be included in a risk statement for Informed Consent (IC). The purpose of this study was to identify which AEs should be included in a risk statement for IC.
Methods
A three-round e-Delphi study was undertaken using a panel of DN experts. Expert inclusion criteria included: (1) ≥5 years practice performing DN and one of the following secondary criteria: (A) certification in DN; (B) completion of a manual therapy fellowship that included DN training; or (C) ≥1 publication involving the use of DN. Participants rated their level of agreement using a 4-point Likert scale. Consensus was defined as either: 1) ≥80% agreement; or 2) ≥70% and <80% agreement with median ≥3, interquartile range ≤1, and standard deviation ≤1.
Results
A total of 14 (28%) AEs achieved final consensus in Round 3 for inclusion on IC. Kendall’s Coefficient of agreement for Round 2 was 0.213 and improved to 0.349 after Round 3. Wilcoxon rank tests revealed statistically significant changes for 12 of the 50 AEs.
Conclusion
Consensus was attained for 14 AEs for inclusion on IC. The AEs identified can be used for the development of a shorter, more concise IC risk statement. A total of 93.6% of experts agreed on definitions for AE classification.

‘First ensure no regret’: a decision-theoretic approach to informed consent in clinical practice
Short report
Narcyz Ghinea
Journal of Medical Ethics, 8 May 2023
Abstract
Decision theorists recognise that information is valuable only insofar as it has the potential to change a decision. This means that since acquiring more information is time-consuming and sometimes expensive, judgements need to be made about what information is most valuable to acquire, and whether it is worth acquiring at all. In this article I apply this idea to informed consent and argue that the most valuable information relates not to what the best treatment option may be but to possible futures a patient may regret. I conclude by proposing a regret-minimisation framework for informed consent that I contend better captures the true nature of shared decision making than existing formulations.

Informed consent in assisted reproduction: an Ethics Committee opinion
Ethics Committee of the American Society for Reproductive Medicine
Fertility and Sterility, 5 May 2023
Summary
Informed consent is a complex topic in bioethics and clinical practice. This opinion focuses on the ethical principles underpinning the provision of informed consent for the clinical care of patients seeking fertility treatment. Although there may be an overlap in the ethical and legal requirements for informed consent, this opinion will focus specifically on the ethical requirements for informed consent. Moreover, unlike legal requirements that may vary by jurisdiction, ethical requirements are universal. Ethical analyses of informed consent also must distinguish whether the consent is for clinical care or for research, because the research goals of obtaining knowledge differ from the goals of treatment. Ethical informed consent for fertility care requires sufficient understanding on the part of the patient to make a well-reasoned decision in furtherance of their values. It is a process in which the patient is supported in developing understanding and coming to an informed, voluntary, and carefully considered decision. Best practices for this process include understanding the patient’s condition; discussing without bias the known and potential risks, benefits, and likely outcomes of available alternatives, including no treatment; eliciting the patient’s values; and considering how alternatives may or may not realize these values. Special care may need to be taken when patients are in stressful situations, such as when they may be subject to pressure from partners or family; when they lack experience with what they may undergo (such as pregnancy or childbirth); when the risks, benefits, and processes of care are difficult to explain and understand; or when their first language is not English. Ethical informed consent may also require the disclosure of information specific to a particular facility, such as conflicts of interest, prior experience, or policies that may be important to patients in making decisions about their care. Education is an important prerequisite to informed consent but is not a substitute for it…

Patient consent for medical student pelvic exams under anesthesia: an exploratory retrospective chart review
Jessica A. Jushchyshyn, Lakeisha Mulugeta-Gordon, Cara Curley, Florencia Greer Polite, F. Merz
Health Sciences, 18 April 2023
Abstract
Background
Legal requirements and clinical practices of securing patient consent for medical student pelvic examinations under anesthesia (EUA) vary widely, while ethical arguments and patients’ preferences for being asked for consent are well known.
Objective
This study was performed to examine patients’ choices to permit or refuse medical student pelvic EUAs during planned gynecologic procedures.
Study Design
An exploratory retrospective chart review of electronic consent forms at a single academic medical center, using contingency table and logistic regression to explore relationships between patient and provider characteristics and consent.
Results
Electronic consent forms were downloaded for a census of 4000 patients undergoing gynecologic surgery from September 2020 through calendar year 2022 and linked to anonymized medical record information, including patient age, race, religion, and insurance carrier, along with physician name. Physicians were coded by gender, departmental affiliation, and status (attending, resident, or fellow). Of the 4000 patients, 142 (3.6%) were informed but not presented with a choice, and these patients were removed from further analysis. Of the remainder, 308 (8.0%) were asked for EUA consent more than once. Overall, of 3858 patients, 3308 (85.7%) consented every time asked and 550 (14.2%) refused or limited EUA consent at least once. Nine patients limited their consent to female students, and 2 patients refused medical student participation at all. Of the 308 asked more than once, 46 were not consistent. Exploratory multiple logistic regression analysis showed that patients identifying as Black or African American (OR=0.492, p<0.001) or Asian (OR=0.292, p<0.001), or of Moslem/Muslim/Islamic faith (OR=0.579, p=0.006) were substantially less likely to grant EUA consent than other patients. Moreover, male physicians, most of whom were attendings, were much more likely to secure consent from patients than their female colleagues (OR=2.124, p<0.001).
Conclusions
The finding that some patients are more likely than others to refuse a pelvic EUA magnifies the dignitary harm from a nonconsensual invasion of intimate bodily integrity and perpetuates the historic wrongs visited upon vulnerable people of color and religious minorities. Patient’s rights to control over their own bodies can only be respected if their physicians take seriously the ethical obligation to inform their patients and ask them for permission.

The Alendronate Conundrum: Balancing the Competing Influences for Truly Informed Consent About Drug Safety in an Era of Rapid Change
Commentary
Marcia M. Boumil, Paul R. Beninger
Clinical Therapeutics, April 2023; 45(4) pp 376-381
Abstract
This commentary highlights critical decision points regarding the responsibilities of the key stakeholders—pharmaceutical companies, the US Food and Drug Administration, clinicians, and patients—regarding the communication of the risk of a medication. It addresses responsibility for remaining current about emerging drug reactions that often cannot be appreciated during the initial approval period of new drugs and biologics. Further complicating the issue are the medical systems that limit a clinician’s time and bandwidth to keep abreast of emerging adverse reactions and to engage in an informed consent process with a lay patient who often has a limited understanding of medical terms and quantitative methods that can provide context for understanding rare complications and adverse drug reactions. Nevertheless, the risk of not finding an amenable way forward for all stakeholders is a descent into the unending crippling malpractice settlements that will only inexorably raise the costs of health care and encourage the exodus of clinicians from the profession.

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.