Status of Informed Consent in Surgical Patients in Hospitals of Sindh Pakistan
Tariq Abdullah, Muhammad Akbar, Shahnawaz Khatti, Ishrat Rahim Katyar, Karim Bux, Muhammad Anwar
Pakistan Journal of Medical & Health Sciences, March 2023
Abstract
Background
Informed consent (IC) is a critical step in ensuring that patients understand implications of their treatment decisions.
Materials and Methods
It is observational cross-sectional study. Non probability purposive sampling was used to collect data from different surgical units. Adult postsurgical patients were questioned using a standardized questionnaire between the first- and fifth-day following surgery in two general hospitals in Sindh province (Hyderabad and Jamshoro). Data was analyzed using SPSS and Microsoft excel.
Results
A total of 78% of individuals who claimed to have read it found informed consent to be easy to understand. Less than half of patients thought information brought them some emotional solace, while 23.2% of patients reported feeling more anxious after hearing information. This study suggests enhancing the process of obtaining consent forms by including additional information and avenues for discussion on written documents rather than relying solely on verbal communication.
Conclusion
Patients under age of sixty and patients who had completed more schooling tended to read written informed consent forms more frequently. Orally communicated pre-operative information suited patients’ requirements better than written informed consent. Surgeon needs to get informed permission from patient and inform them about operation type, potential consequences and other treatment options.
Month: May 2023
Patient choice: the shape of consent post-Montgomery
Patient choice: the shape of consent post-Montgomery
Shaun Sellars, Lauren Sutherland
British Dental Journal, 12 May 2023; 234, pp 655 – 659
Abstract
The law relating to consent and the process dentists need to go through to gain valid and informed consent to treat patients changed significantly following the landmark ruling of Montgomery v Lanarkshire Health Board. In this paper, we revisit the history of patient consent, give an update on the current legal situation in the UK, and produce a unique ‘consent workflow’ to aid in the process of gaining valid and informed consent to treat. The aim is to clarify the legal standing and provide a framework that dentists and other healthcare professionals can adapt to their current clinical practice while increasing the confidence of those involved in the consent process; both professionals and patients.
Disclosing Privacy and Discrimination Protections in Informed Consent
Disclosing Privacy and Discrimination Protections in Informed Consent
Anya E.R. Prince
Health Matrix: The Journal of Law – Medicine, May 2023; 33(1)
Open Access
Abstract
Recent empirical work shows that providing greater detail about limitations of genetic anti discrimination protections in informed consent documents is likely to lower individuals’ willingness to participate in research studies. This article presents these empirical findings and analyzes the implications of the findings for clinical care and for privacy and discrimination risks beyond genetic discrimination. While the paper argues that further research is needed to fully understand the potential implications of disclosure of legal protections in the clinical setting, there are clear implications in the research setting. Since individuals are likely to alter their decision to participate in research based on the depth of information provided, informed consent should contain detailed information about privacy and discrimination risks. However, for participants to truly understand the risk of loss of privacy and potential for discrimination that flows from information disclosures in research, they arguably must have a robust understanding of both when and how information may be shared, but also the legal protections and limitations that govern use of that data. Now, more than ever, it is essential to understand the privacy risks associated with joining a study since research trends related to big data and secondary research are vastly increasing the privacy risks for participants. Yet, while it is easy to state that individuals should be told of both privacy and anti-discrimination laws and their respective limitations, disclosing these in practice is much more complex. For every law, there are countless limitations that could be enumerated, but such disclosures would quickly make informed consent unwieldy and counterproductive. Thus, this paper argues that institutional review boards (“IRBs”) can help to find a limiting principle to the disclosures by assessing the likelihood of harm and contextualizing the risks to the study population. This will balance between over- and under-disclosure of legal protections and limitations while still fulfilling important foundational goals of informed consent.
Organ and Tissue Donation Consent Model and Intent to Donate Registries: Recommendations From an International Consensus Forum
Organ and Tissue Donation Consent Model and Intent to Donate Registries: Recommendations From an International Consensus Forum
Phil Walton, Alicia Pérez-Blanco, Stephen Beed, Alexandra Glazier, Daniela Ferreira Salomao Pontes, Jennifer Kingdon, Kim Jordison, Matthew J. Weiss
Transplant Direct, 23 April 2023; 9(5)
Open Access
Abstract
Background
Consent model and intent to donate registries are often the most public facing aspects of an organ and tissue donation and transplantation (OTDT) system. This article describes the output of an international consensus forum designed to give guidance to stakeholders considering reform of these aspects of their system.
Methods
This Forum was initiated by Transplant Québec and cohosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. This article describes the output of the consent and registries domain working group, which is 1 of 7 domains from this Forum. The domain working group members included administrative, clinical, and academic experts in deceased donation consent models in addition to 2 patient, family, and donor partners. Topic identification and recommendation consensus was completed over a series of virtual meetings from March to September 2021. Consensus was achieved by applying the nominal group technique informed by literature reviews performed by working group members.
Results
Eleven recommendations were generated and divided into 3 topic groupings: consent model, intent to donate registry structure, and consent model change management. The recommendations emphasized the need to adapt all 3 elements to the legal, societal, and economic realities of the jurisdiction of the OTDT system. The recommendations stress the importance of consistency within the system to ensure that societal values such as autonomy and social cohesion are applied through all levels of the consent process.
Conclusions
We did not recommend one consent model as universally superior to others, although considerations of factors that contribute to the successful deployment of consent models were discussed in detail. We also include recommendations on how to navigate changes in the consent model in a way that preserves an OTDT system’s most valuable resource: public trust.
Completion of the informed consent in radioguided surgery by the General Surgery and Nuclear Medicine services of a radioguided surgery unit
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
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
‘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
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
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
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.
Center for Informed Consent Integrity 