Assessment of the Factors Influencing the Patient’s Comprehension of the Informed Consent to Interventional Pain Procedures
Research Article
Mohammad Ghorbanhoseini, Kyle Kang, Allen Yang, Mohammadreza Abbasian, Eduard Vaynberg
Pain Research and Management, 8 February 2023
Open Access
Abstract
Background
Informed consent is the first step of every medical procedure and is considered a standard of care for patients undergoing medical interventions. Our study seeks to evaluate patients’ understanding of the procedure they consented to and the factors affecting the degree of understanding.
Methods
In this cross-sectional study, we used an anonymous postprocedural questionnaire to assess our patients’ understanding of the procedure being performed and their level of satisfaction. It was conducted between June 2021 and January 2022 on every consenting patient who declined English interpreter services and was undergoing a first elective lumbar epidural steroid injection.
Results
The mean age of 201 subjects was 57.3 (23–90) years, with a race distribution of Black (44.3%), White (31.8%), and other races (23.9%). 15.9% of our subjects worked in the medical field. Older age and patients identified as Black and other races had a positive correlation with the propensity to predict a poor understanding of consent. This study failed to demonstrate any difference in understanding of informed consent content between the different subgroups when stratified by assigned sex at birth, level of education, and profession. Patients’ expectation from the treatment was classified as desperate (will take any help they can) in 78 patients (38.8%), feeling hopeful (expecting partial improvement in their symptoms) in 52 patients (25.9%), and being optimistic (will obtain full recovery from this injection) in 71 patients (35.3%). 192 patients (95.5%) were very satisfied with the consent process. Seven patients (3.5%) stated that they wanted more information, and 2 patients (1.0%) did not understand the explanation. 180 patients (89.6%) were satisfied with the overall experience, while 21 patients (10.4%) were not. The Wilks test (likelihood-ratio test) resulted in a  value of 0.023 and was deemed statistically significant for a relationship between understanding of consent and the satisfaction of the patient from the procedure.
Conclusions
Although patients carry a variable expectation of procedures, most patients in our pain clinic have a high level of satisfaction despite having a poor understanding of the procedure provided via informed consent. Although our patients’ level of objective comprehension is low, those with a better understanding of the procedure tend to have a more satisfactory experience.

Informed or misinformed consent and use of modified texture diets in dysphagia
Debate
Shaun T. O’Keeffe, Paula Leslie, Tracy Lazenby-Paterson, Arlene McCurtin, Lindsey Collins, Aoife Murray, Alison Smith, Siofra Mulkerrin
BMC Medical Ethics, 7 February 2023; 24(7)
Open Access
Abstract
Background
Use of modified texture diets—thickening of liquids and modifying the texture of foods—in the hope of preventing aspiration, pneumonia and choking, has become central to the current management of dysphagia. The effectiveness of this intervention has been questioned. We examine requirements for a valid informed consent process for this approach and whether the need for informed consent for this treatment is always understood or applied by practitioners.
Main text
Valid informed consent requires provision of accurate and balanced information, and that agreement is given freely by someone who knows they have a choice. Current evidence, including surveys of practitioners and patients in different settings, suggests that practice in this area is often inadequate. This may be due to patients’ communication difficulties but also poor communication—and no real attempt to obtain consent—by practitioners before people are ‘put on’ modified texture diets. Even where discussion occurs, recommendations may be influenced by professional misconceptions about the efficacy of this treatment, which in turn may poison the well for the informed consent process. Patients cannot make appropriate decisions for themselves if the information provided is flawed and unbalanced. The voluntariness of patients’ decisions is also questionable if they are told ‘you must’, when ‘you might consider’ is more appropriate. Where the decision-making capacity of patients is in question, inappropriate judgements and recommendations may be made by substitute decision makers and courts unless based on accurate information.
Conclusion
Research is required to examine the informed consent processes in different settings, but there is ample reason to suggest that current practice in this area is suboptimal. Staff need to reflect on their current practice regarding use of modified texture diets with an awareness of the current evidence and through the ‘lens’ of informed consent. Education is required for staff to clarify the importance of, and requirements for, valid informed consent and for decision making that reflects people’s preferences and values.

Informed consent research at a tertiary hospital: How impactful is competency in simpler versus standard consent forms for intravitreal injection therapy?
Hamidu Hamisi Gobeka, Yiğit Şenol, Saadet Alijanli, Mustafa Doğan, İbrahim Ethem Ay
Journal of Clinical Medicine of Kazakhstan, February 2023
Open Access
Abstract
Aim
To compare the impact of competency in intravitreal injection therapy (IVIT)-related simpler versus standard consent forms (CFs).
Material and methods
Four hundred patients scheduled for IVIT in a tertiary hospital were enrolled between April 1, 2022 and June 30, 2022. These patients were eligible for the study if they had their first IVIT in one eye; those scheduled for IVIT in the other eye were not. Data, including age, gender, educational level, whether the patient was admitted alone or with a companion, and prior IVIT status were collected. A trained clinic secretary first gave the patients the commonly used standard CFs, followed by simpler CFs.
Results
The mean age was 66.10±9.90 years. 93.80% had previously received IVIT. 53.80% of the patients consented on their own. While 98.00% consented without reading standard CFs, 56.00% consented after reading simpler CFs (p<0.001). The need for IVIT-related extra information and the desire against having IVIT were significantly higher in simpler than standard CFs (p<0.001). 5.00% of those who approved IVIT without reading both forms were illiterate, and 29.20% had vision issues. The probability of simpler CF reading increased by 4.653 and 7.510 times in high school and university graduates, respectively, relative to primary school graduates.
Conclusion
Simpler CFs had a much higher reading rate, which was linked to a higher rate of patients opting against IVIT. In medical fields like ophthalmology, where many procedures and research are performed, ethically approved informed consent requires consideration of patients’ education and prior treatment experience.

The ethics of consent during labour and birth: episiotomies
Marit van der Pijl, Corine Verhoeven, Martine Hollander, Ank de Jonge, Elselijn Kingma
Journal of Medical Ethics, 30 January 2023
Abstract
Unconsented episiotomies and other procedures during labour are commonly reported by women in several countries, and often highlighted in birth activism. Yet, forced caesarean sections aside, the ethics of consent during labour has received little attention. Focusing on episiotomies, this paper addresses whether and how consent in labour should be obtained. We briefly review the rationale for informed consent, distinguishing its intrinsic and instrumental relevance for respecting autonomy. We also emphasise two non-explicit ways of giving consent: implied and opt-out consent. We then discuss challenges and opportunities for obtaining consent in labour and birth, given its unique position in medicine. We argue that consent for procedures in labour is always necessary, but this consent does not always have to be fully informed or explicit. We recommend an individualised approach where the antenatal period is used to exchange information and explore values and preferences with respect to the relevant procedures. Explicit consent should always be sought at the point of intervening, unless women antenatally insist otherwise. We caution against implied consent. However, if a woman does not give a conclusive response during labour and the stakes are high, care providers can move to clearly communicated opt-out consent. Our discussion is focused on episiotomies, but also provides a useful starting point for addressing the ethics of consent for other procedures during labour, as well as general time-critical medical procedures.

Attitude of perinatal pathologists to seeking consent for autopsies from parents: a web-based survey
Kim, T.Y. Khong
Pathology, February 2023
Abstract
Background
Perinatal pathologists who know the value and process of autopsy rarely see parents, and there is argument among perinatal pathologists whether or not they should see parents regarding the autopsy. Consent rates for perinatal autopsies have dropped significantly. Poor communication between professionals and parents about autopsies and uncertainty about the value of autopsies from the professionals are two of many reasons for reduced perinatal autopsy rate.
Methods
Members of the Australian and New Zealand Paediatric Pathology Group were invited to participate in a web-based survey exploring their experiences in obtaining consent for perinatal autopsies and their views on being involved in discussion with parents.
Results
Of 14 of 69 pathologists who responded, 10 have seen parents for obtaining consent for autopsies with three still seeing parents. Fifty-seven percent of the participants (8/14) did not want to speak with parents and six of them did not change their mind even with additional funding. More than half (8/14, 57%) believe pathologists should speak with parents regarding autopsies.
Conclusion
Promoting perinatal pathologists, who have positive views on being involved in discussion with parents, to participate in the process of obtaining consent and educating treating clinicians, may increase the perinatal autopsy rate.

Informed Consent and Shared Decision Making in the Perioperative Environment
Review Article
Elizabeth D. Krebs, Sook C. Hoang
Clinical Colon Rectal Surgery, 28 January 2023
Abstract
Informed consent and shared decision making (SDM) are crucial portions of preoperative patient management. Informed consent is a standard for surgery from both a legal and ethical standpoint, involving disclosure of potential risks of a procedure and ensuring patient understanding of these risks. SDM is a process in which a clinician and patients decide between two or more treatment plans, taking into account the patient’s goals and values. SDM is a particularly important aspect of patient-centered care when two or more treatment options exist or in situations where an indicated treatment may not align with the patient’s long-term goals. This article details aspects of and issues surrounding informed consent and SDM.

Regulation, data management, informed consent, and legal issues for ART
Ilaria Soave, Roberto Marci
Management of Infertility, 19 January 2023
Abstract
The number of assisted reproduction treatments undertaken worldwide has risen steadily since 1990. However when it comes to regulation, due to political, ethical, and social reasons related to assisted reproduction practice, each country has a different perspective. Several factors contribute to these differences, including financial issues (affordability, treatment costs), customary law, cultural and belief dimensions. In addition, individual and professional options may play different roles in different societies. The different restrictions across different countries, highlight a very complex reality, whose legislation represents a constant topic of debate and undergoes continuous evolution. In the daily practice, patient counseling and informed consent have both legal and ethical dimensions. The aim of this chapter is to provide an overview of assisted reproductive technology regulation, presenting its major legal issues and to underline the specific aspects of quality or data management and informed consent in assisted reproductive technology treatments.

Editor’s note: In this article ART stands for assisted reproduction treatment.

Legally Sound, Evidence-Based Informed Consent Form for Total Hip Arthroplasty
Original Article
Satvik N. Pai, Bishnu Prasad Patro, Naveen Jeyaraman, Arulkumar Nallakumarasamy & Madhan Jeyaraman
Indian Journal of Orthopaedics, 18 January 2023
Abstract
Introduction
Informed consent documentation is often the first area of interest for lawyers and insurers when a medico-legal malpractice suit is concerned. However, there is a lack of uniformity and standard procedure for obtaining informed consent for total hip arthroplasty (THA). We aimed to develop a solution for this need for a pre-designed, evidence-based informed consent form for THA cases.
Materials and Methods
We extensively reviewed the literature on the medico-legal aspects of THA, medico-legal aspects of informed consent, and medico-legal aspects of informed consent in THA. We then conducted semi-structured interviews with orthopaedic surgeons and patients who had previously undergone THA in the previous year. Based on all of the above, we developed an informed consent form that was evidence-based. We then had the form reviewed by a legal expert. The final form was utilised for THA cases at our institution for 1 year.
Results
Legally sound, evidence-based Informed Consent Form for Total Hip Arthroplasty is given in Form A.
Conclusion
The use of legally sound, evidence-based informed consent for total hip arthroplasty cases would be beneficial to orthopaedic surgeons and patients alike. It would uphold the rights of the patient, and promote open discussion and transparency. In the event of a lawsuit, it would be a vital document in the defence of the surgeon and withstand the scrutiny of lawyers and the judiciary.