Autonomy and consent assessment for electroconvulsive therapy (ECT). A retrospective study of medical records
Jørgen Dahlberg Siri Øverstad, Vegard Dahl, Alina Coman
International Journal of Law and Psychiatry, July–August 2021; 77
The Norwegian Mental Health Act allows involuntary treatment for patients who lack consent capacity, however it allows only administration of pharmaceutical treatment and nutrition and not ECT. In lack of specific regulations, the legal access to ECT without valid consent has been grounded on the general rule of necessity in the Norwegian Penal code. This restriction and lack of legal regulation has implications for patients’ rights and legal security.
The study’s aim was to assess the documented consent provided by patients for electroconvulsive therapy (ECT), whether ECT was administered without valid consent or under coercion, and the documented reasons, and ultimately compare practice with the legal requirements. We analysed systematically all the relevant medical records for hospitalised patients and outpatients receiving ECT during 2011–2016. We categorized data from these two groups into seven defined categories describing the attitude and quality of the consents to the ECT (or lack thereof).
378 patients received 498 ECT series´. The noted consents varied from treatment based on request (54 treatments), consent upon recommendation (209 treatments), consent after hesitation (88 treatments), consent presumed or noted without specification (114 treatments), to no consent (21 treatments) whereof the majority with documented coercion applied (19 treatments). All cases of ECT without consent referred to a “plea of necessity”. The remaining treatments (12) lacked notifications specifying the consent (or attitude) expressed. Specific notes on the patient’s capacity to consent for the respective ECT were generally lacking.
This study indicates a large spread in patients´ acceptance and valid consent to ECT. The main reason for administering ECT without consent and/or against patients’ will was for life-saving reasons. Such treatments were justified legal under a plea of necessity in the Penal Code or lacked noted legal justification. The legal vacuum for ECT without a valid consent needs to be addressed as this kind of disputed treatment is used in some cases.
Junior doctor experiences and challenges in obtaining surgical informed consent: A qualitative systematic review & meta-ethnography
Josephine de Costa, Mandy Shircore, Alande Costa
Journal of Surgical Research, November 2021; 267 pp 143-150
Surgical informed consent (SIC) to procedures is necessary to ensure patient autonomy is adequately respected. It is also necessary to protect doctors, and their institutions, from claims of negligence. While SIC is often acquired by senior consultants, it also commonly falls to the junior doctors on a team to ensure SIC is adequately acquired and documented. A growing body of literature suggests that junior doctors are not sufficiently educated about the legal and practical issues concerned with obtaining medical consent. This may open up this cohort, and their hospitals, to medico-legal liability.
to provide a systematic review of the qualitative literature on junior doctors’ experiences and challenges in consenting surgical patients and to synthesize evidence on this issue in order to guide policy-makers in the medicolegal and medical education spheres.
a systematic review of qualitative literature was performed. Analysis of the literature was guided by Noblit and Hare’s seven-step approach to meta-ethnography, with the final synthesis presented as a thematic analysis of the literature.
This research concludes that a significant proportion of SIC is likely to be acquired by junior doctors, many of whom are Post-Graduate Year (PGY) 1-2 and who lack adequate training and education. This cohort face challenges in assessing capacity, in ensuring adequate disclosure related to surgical procedures, and in adequately documenting consent. This may impact the validity of any SIC they acquire. Medical educators and policy-makers should be aware of these issues when creating policies impacting SIC, and when designing surgical education programs for medical students and junior doctors alike.
Principles related to informed consent in functional and aesthetic rhinoplasty: A prospective study
Aloua Rachid, Sabr Ayoub, Kerdoud Ouassime, Opoko Ulrich, Savadogo Sayouba, Belem Ousmane, Konsem Tarcissus, Slimani Faiçal
International Journey of Surgery Open, 17 June 2021
Rhinoplasty is one of the most complex surgical procedures in plastic surgery.
Patient requirement is often mixed, aesthetic and functional, for resolution of functional respiratory problems is therefore as important as correction of nasal deformity. Informed consent in rhinoseptoplasty is a difficult process because of the complexity of the operative technique, which presents a wide range of potential complications.
Patients and method
Type of study: This is a prospective, descriptive study conducted in the department of oral and maxillofacial surgery. Fifty-two patients, who consulted for rhinoplasty, participated in the study. Patients were informed about the complications commonly discussed during the consent process in rhinoplasty surgery. Each patient was contacted one month after the initial consultation to assess recall of complications and acceptance of surgery.
The aim of our study is to highlight the importance of informed consent in rhinoplasty surgery in terms of complications, and to identify gaps in the consent process.
Confidence level, challenges, and obstacles faced by orthopedic residents in obtaining informed consent
Abdulaziz Z. Alomar
Journal of Orthopaedic Surgery and Research, 17 June 2021; 16(390)
The objective is to evaluate the opinions of orthopedic residents on current practices, experiences, training, confidence level, difficulties, and challenges faced when obtaining informed consent.
This is a cross-sectional, multi-center, and questionnaire-based study.
The study was done in forty-four training centers across Saudi Arabia.
In total, 313 orthopedic residents participated.
Material and methods
The web-based questionnaire examined the perceptions of residents regarding practices, experience, training, difficulties, and challenges surrounding the obtention of informed consent, as well as residents’ confidence in obtaining informed consent for different orthopedic situations and eight common orthopedic procedures.
Most residents were allowed to obtain consent independently for all emergency, trauma, primary, and revision cases at their institution (92.7%). Only 33.5% of the residents received formal training and teaching on obtaining informed consent, with 67.1% having believed that they needed more training. Only 4.2% of the residents routinely disclosed all essential information of informed consent to patients. Inadequate knowledge (86.3%) and communication barriers (84.7%) were the most reported difficulties. Generally, 77.3% of the residents described their confidence level in obtaining informed consent as good or adequate, and 33.9% were confident to discuss all key components of the informed consent. Residents’ confidence level to independently obtain informed consent decreased with procedure complexity. Receiving formal training, senior level (postgraduate year (PGY) 4 and 5), and being frequently involved in obtaining informed consent correlated with increased confidence level.
Many residents incompletely disclosed key information upon obtaining informed consent and reported lacking confidence in their ability to perform the procedure in their daily practices. To improve patient care and residents’ performance and overcome these difficulties and challenges, institutions should develop effective strategies to standardize the informed consent process, provide formal training for obtaining informed consent, and provide supervision for residents during obtention of informed consent.
Obstetrician–Gynecologists’ Practices in Postpartum Sterilization Without a Valid Medicaid Consent Form
Kavita Shah Arora, Roselle Ponsaran, Laura Morello, Leila Katabi, Rosemary T. Behmer Hansen, Nikki Zite, Kari White
Obstetrics & Gynecology, 10 June 2021
To explore the practices of obstetrician–gynecologists (ob-gyns) in the United States surrounding postpartum sterilization when the Medicaid consent form was not valid.
Using the American College of Obstetricians and Gynecologists’ online directory, we conducted a qualitative study where we recruited ob-gyns practicing in 10 geographically diverse U.S. states for a qualitative study using semi-structured interviews conducted by telephone. We analyzed interview transcripts using the constant comparative method and principles of grounded theory.
Thirty ob-gyns (63% women, 77% nonsubspecialized, and 53% academic setting) were interviewed. Although most physicians stated that they did not perform sterilizations without a valid Medicaid sterilization form, others noted that they sometimes did due to a sense of ethical obligation toward their patient’s health, being in a role with more authority or seniority, interpreting the emergency justification section of the form more broadly, or backdating the form. The physicians who said that they never went ahead without a signed form tended to work at large institutions and were concerned with losing funding and engaging in potentially illegal or fraudulent behavior.
Physicians’ varied behaviors related to providing postpartum sterilization without a valid Medicaid consent form demonstrate that the policy is in need of revision. Unclear terminology and ramifications of the Medicaid sterilization policy need to be addressed to ensure equitable care.
Antenatal and intrapartum consent: Implications of the NSW Consent Manual 2020
Hans Peter Dietz, Jessica Caudwell Hall, Natalie Weeg
ANZJOG, 7 June 2021
The provision of informed consent for antenatal and intrapartum care remains a contentious issue among healthcare professionals and has been the topic of controversies in the pages of this journal. Recently, the New South Wales (NSW) Department of Health has fundamentally changed the ground rules for the provision of maternity care within the state. In this opinion piece, we try to provide guidance to clinicians to help them deal with the medicolegal environment created by this document which is likely to affect practitioners not just in NSW.
Anxiety is associated with unfulfilled information needs and pain at the informed consent consultation of spine surgery patients: a longitudinal study
Sabine Fischbeck, Katja Petrowski, Mirjam Renovanz, Rebecca Nesbigall, Julian Haaf, Florian Ringel
European Spine Journal, 5 June 2021
Meeting the information needs of patients adequately is of high importance in informed consent consultations in surgery. However, information needs often remain unmet in the informed consent consultation. The aim of this study was to assess anxiety and pain in relation to the patients’ information needs fulfillment perioperatively.
We applied a question prompt list (QPL) for patients undergoing spine surgery (SN-QPL) before (t1) and a question answering list (SN-QAL) after (t2) the informed consent consultation. The patients additionally completed the “State-Trait Anxiety Operation Inventory” (STOA, cognitive and affective scale) at t1, as well as a pain numerical rating scale (NRS) at t2 and postoperative (t3). We analyzed (1) the association between anxiety, information needs and pain and (2) anxiety and pain scores regarding information needs fulfillment after the consent consultation.
A total of n = 118 patients was included. Affective and cognitive state anxiety was only reduced postoperatively (affective p < .001, cognitive p < .05). The higher trait anxiety was, the more patients longed for information at t1–t3 (t1: r = .58/r = .74, each p < .001), (t2: r = .38/r = .49, each p < .001) and (t3: r = .29, p < .01/r = 34, p < .001). Higher grades of trait anxiety resulted in lower information needs fulfilment. Higher state anxiety levels were associated with higher pain levels. Information needs more often remained unfulfilled in high trait and state anxiety patients.
Patients’ anxiety was associated with (un)fulfilled information needs. Meeting information needs should be optimized in the process of surgeon–patient communication. Adapting the information to the patients’ anxiety levels seem to be an effective way to reduce anxiety.
Arthroscopic Surgery Is Not Minor Surgery: Shared Decision Requires Comprehensive Informed Consent
Arthroscopy, 1 June 2021; 37(6) pp 1755-1756
Kwadwo Adu Owusu-Akyaw
Arthroscopic surgery of the shoulder has revolutionized the way we address intra-articular and tendinous injuries about the joint. Nevertheless, despite the apparent minimally invasive nature of our trade, there remain potential long-term consequences to every operation. This is especially true if future arthroplasty is indicated, as the risk of prosthetic joint infection is increased in patients having a previous procedure. True partnership with our patients necessitates that they have a clear understanding of the full implications of any surgery, no matter how small it may seem. True informed consent necessitates that our patients understand not only the immediate implications of the current operation but the potential effects on a future operation. This can only be accomplished by effective and honest communication about the full scope of the risk undertaken when an arthroscopic surgery is performed.
[The “right” patient for implant surgery in urology : Why patient selection, informed consent, and communication are so important for patient satisfaction].
Leiber C, Katzenwadel A, Schlager D
The Urologist, 1 June 2021, 60(6) pp 732-739
In implant surgery for erectile dysfunction and urinary incontinence, adequate patient selection is essential for postoperative therapy success. Several scientific studies report patient satisfaction rates for penile implants and artificial urinary sphincter implantation of over 90%. Nevertheless, studies also report, that between 5 and 30% of the patients are not satisfied with the result of their operation. Sufficient patient information and consent prior surgical procedure in urological prosthetics are a key determinant for later patient satisfaction and therapy success. Diligent assessment of realistic expectations, possible complications, and risks must be made. Unrealistic and exaggerated expectations need to be met and discussed with the patient. Therefore adequate physician-patient communication is essential. Especially in the case of surgical revision or for patients with risk factors, the probability of complications is higher and may significantly increase later dissatisfaction. Also, the involvement of the partner plays a major role in later patient satisfaction in urological implant surgery. Finally, there is a group of patients for which the risk of later dissatisfaction is particularly high. These are patients with compulsive/obsessive behavior, unrealistic expectations, patients after revision surgery, self-entitled patients, as well as those patients who deny the extent of their illness, visit multiple surgeons (surgeon hopping) or have psychiatric illnesses. These patients are referred to with the acronym “CURSED” patients.
Editor’s note: This is a German language publication.
A Novel Blended Curriculum for Communication of Informed Consent With Surgical Interns
Tiffany N. Anderson, Aboubacar Kaba, Eniola Gros, Ingrid S. Schmiederer, Robert Shi, Lauren R. Aalami, Dana T. Lin, James N. Lau
Journal of Graduate Medical Education, June 2021; 13(3) pp 411–416
Interns often conduct procedural informed consent discussions (ICDs), identified as a core entrustable professional activity. Deficiencies in the training process for ICDs span across specialties.
We provide evidence for a curriculum and assessment designed to standardize the training process and ensure ICD competency in surgical interns.
In March 2019, PowerPoint educational materials were emailed to one academic institution’s new surgical interns, who in June participated in an onsite 1-hour role-play “hot seat” group activity (GA) with an untrained simulated patient, and in October completed a single trained simulated patient (real-time raters) verification of proficiency (VOP) assessment. Curriculum evaluation was measured through intern pre-/post-confidence (5-point scale), and the VOP’s Cronbach’s alpha and test-retest were examined. Data were analyzed with descriptive statistics, paired t tests, and 2-way random effects models.
Of 44 new interns, 40 (91%) participated in the remote teaching and live GA and were assessed by the VOP. Pre-/post-GA confidence increased a mean difference of 1.3 (SD = 0.63, P < .001). The VOP’s Cronbach’s alpha was 0.88 and test-retest was 0.84 (95% CI 0.67–0.93, P < .001), with a 95% pass rate. The 2 first-time fail students required remediation. Time commitment included 1 hour maximum for individual training and implementation and 30 minutes for assessment. The use of volunteers and donated space mitigated additional costs.
Remote asynchronous and group skills teaching for new general surgical interns improved their confidence in conducting procedural ICDs. A patient-simulation verification process appeared feasible with preliminary evidence of retest and internal consistency.