How important are informed consent, informed choice, and patient-doctor relationships, when prescribing antipsychotic medication?
Article
Journal of Mental Health, 8 March 2022
Abstract
Background
Antipsychotic medications (APs) are used for people with psychosis diagnoses and, increasingly for other problems and groups.
Aims
This study examines how APs are prescribed, from the perspective of recipients.
Methods
757 people, from 30 countries, responded to questions about their experiences with APs in an online survey.
Results
Most (70%) were told nothing about adverse effects. Fewer than 2% recall being told about the risks of diabetes, suicidality, sexual dysfunction or reduced life span. None recalled being told about reduced brain volume or withdrawal effects. Only 28% recalled being offered other treatments; with only 14% offered talking therapies. 46% were not told how long to take the APs; and, of those, 48% were told to take them forever. Most respondents (76%) were not told how APs work. Only 19% were satisfied with the prescribing process, and only 25% reported a good, or very good, relationship with the prescriber. Information, satisfaction with the process and prescriber relationship were all positively related to three self-reported outcomes: reduction of problems the drugs were prescribed for, general helpfulness, and quality of life.
Conclusions
Steps need to be taken to ensure people prescribed antipsychotics are fully informed, especially about adverse effects and alternatives.
Month: April 2022
Utilizing the “teach-back” method to improve surgical informed consent and shared decision-making: a review
Utilizing the “teach-back” method to improve surgical informed consent and shared decision-making: a review
Review
Kevin D. Seely, Jordan A. Higgs, Andrew Nigh
Patient Safety in Surgery, 5 March 2022; 16(12)
Open Access
Abstract
The teach-back method is a valuable communication tool that can be employed to improve patient safety and shared decision-making. Its utility in patient care has been studied extensively in many areas of clinical medicine. However, the literature on the use of teach-back in surgical patient education and informed consent is limited. Additionally, there is some ambiguity about the functional definition and performance of the teach-back method in the literature, consequently rendering this valuable tool an enigma. This review examines the current standards and ethics of preoperative informed consent and provides a concise, actionable definition of teach-back. The manner in which teach-back has been implemented in medicine and surgery is then examined in detail. Studies analyzing the use of teach-back in medicine have demonstrated its effectiveness and benefit to patient care. Further study on the use of teach-back to improve preoperative informed consent is supported by the few preliminary trials showing a positive effect after implementing the teach-back method in critical patient interactions.
Informed consent for stochastic effects of ionising radiation in diagnostic imaging
Informed consent for stochastic effects of ionising radiation in diagnostic imaging
Commentary
Richard Mendelson
British Journal of Radiology, 24 February 2022
Abstract
The ethical and legal principles underpinning the requirement for informed consent for medical procedures are widely accepted. A recent BJR article has applied these principles to the issue of consent to ionising radiation (IR) from diagnostic imaging (DI), but the authors chose to put aside the practical problems associated with this. These problems should not be underestimated and arise from: uncertainties about the existence and magnitude of risk of stochastic effects of IR exposure in DI; the delayed manifestation of its effects; the heterogeneity of risk related to factors associated with individual sensitivity to IR, and dose variation even within examination classes and across clinical indications; and the difficulty of communication of these uncertainties and variations to patients. This article discusses these practical issues associated with consent for IR in DI.
A study of adequacy of informed consent before caesarean section in a tertiary care hospital
A study of adequacy of informed consent before caesarean section in a tertiary care hospital
Nishu Bhushan, Aakriti Manhas
International Journal of Reproduction, Contraception, Obstetrics and Gynecology, February 2022; 11(2)
Abstract
Background
Informed consent is an ethical and legal requirement and is practiced before all the surgical procedures. Caesarean section is the commonest obstetric surgery so, this study was aimed to assess the adequacy of informed consent in patients who underwent caesarean section at SMGS Hospital, GMC, Jammu.
Methods
A cross-sectional study was done. A total of 230 patients were included in the study. A pre-tested and pre-validated questionnaire was used for the study. The data were expressed as percentage of proportion.
Results
230 patients participated in the study. About 96.95% patients knew the name of the procedure. 91.73% patients were informed about the indication of the surgery. 95.21% of the patients were aware about the benefits of surgery and about 93.41% of the patients were knowing risks of surgery. About 83.04% patients were informed about the procedure of the surgery. About 94.78% and 94.34% of the patients were aware about the need for the blood transfusion and future pregnancy options. Only about 4.35% of the patients were informed about the requirement and type of anaesthesia. 22.18% of the patients knew about the choice for alternate procedure and merely 2.18% of the patients were informed about the right to refuse the procedure.
Conclusions
It was found that majority of the patients were well informed about the procedure and the related consequences. Still we can improve some elements of the consent process which can be done by proper awareness and training of health care professionals.
Shared decision making and surgical informed consent in general surgery: A pilot study on differences in perspectives of physicians and patients [BOOK CHAPTER]
Shared decision making and surgical informed consent in general surgery: A pilot study on differences in perspectives of physicians and patients [BOOK CHAPTER]
Wouter K.G. Leclercq, Willem Zwaans, Loes Janssen, Johan Legemaate, Laurents P.S. Stassen, Marc R. Scheltinga
Máximazing the quality of perioperative patient counselling: Surgical informed consent and postoperative e-health in present day surgical care, 2021; Chapter 7 [Maastricht University]
Open Access
Abstract
Introduction
Shared decision making (SDM) and surgical informed consent (SIC) are increasingly recognized as important aspects of preoperative consultation in general surgery. Different perspectives of physicians and patients may result in suboptimal levels of communication, expectations and knowledge exchange. Goal of this study is to assess the quality of, and relation between, SDM and SIC in a general surgery outpatient department.
Methods
Randomly selected surgical patients completed a questionnaire concerning SDM aspects of their preoperative consultation (SDM-Q-9). Their surgeons completed the doctor’s version termed SDM-Q-Doc. SDM-Q-9 and SDM-Q-Doc scores (0-100), and SIC scores based upon the medical record (0-10) were calculated and analysed using standard statistical methods, including calculation of intraclass correlation coefficients (ICC).
Results
A total of 38 sets of both SDM-Q-9 and SDM-Q-Doc questionnaires were available for analysis. Median total SDM-Q-9 scores were higher than SDM-Q-Doc scores (90 vs. 79, P<0.05). Significant differences were found in 3 of 9 items of the patient’s and surgeon’s SDM questionnaires. SIC scores were low (4.1±1.3). Correlations between SDM-Q-9, SDM-Q-Doc and SIC scores were low (all ICCs <0.1).
Discussion
This pilot studying both shared decision making (SDM) and informed consent (SIC) in a surgical outpatient department indicates an imbalance in expectations between surgical patients, their surgeons and consent recordings. Future initiatives should be aimed at reducing this imbalance to optimize the physician-patient relationship with respect to legal standards.
Informed Consent, Error and Suspending Ignorance: Providing Knowledge or Preventing Error?
Informed Consent, Error and Suspending Ignorance: Providing Knowledge or Preventing Error?
Arnon Keren, Ori Lev
Ethical Theory and Moral Practice, 26 February 2022
Abstract
The standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to prevent autonomy-undermining ignorance. The problem with the standard account, we argue, is that it fails to distinguish between different forms of ignorance–in particular, error and suspending ignorance–that have very different effects on individuals’ ability to provide valid consent. While error often undermines our ability to provide valid consent, suspending ignorance, we argue, does not. Once the moral weight of this distinction is appreciated, it becomes apparent that valid informed consent requires far less knowledge than suggested by the standard account.
Lack of Informed Consent Form Reading in Online Studies
Lack of Informed Consent Form Reading in Online Studies
Case Study
Michael M. Knepp
SAGE Research Methods: Doing Research Online, 2022
Abstract
This case study will discuss the design and, unlike most methods cases, findings of an experiment in order to highlight issues around collecting informed consent and help the reader decide how to best obtain informed consent for their project. My interest in this field of research began when a colleague of mine conducted a study where multiple subjects withdrew during the second hour of his study when requested to do an awkward stress task. That situation inspired a study exploring the rates at which subjects read informed consent forms before signing them. This investigation emphasized how one could improve a severe lack of reading consent forms in an online setting where there is no additional researcher oversight. Four hundred fifty-eight students participated in a study advertised as an adult temperament study. The study actually examined whether answering five questions about the informed consent form improved the likelihood of noticing a manipulation placed in the form’s method section in the laboratory and online settings. The additional questions did improve reading the full form in both laboratory and online settings; yet, overall reading rates were still low. The study concluded that there are serious online research consent issues given subject reading rates in the online setting as only 13% of students in the online-no questions read enough of the form to notice the manipulation.
Ethics and consent in more-than-human research: Some considerations from/with/as Gumbaynggirr Country, Australia
Ethics and consent in more-than-human research: Some considerations from/with/as Gumbaynggirr Country, Australia
Aunty Shaa Smith, Uncle Bud Marshall, Neeyan Smith, Sarah Wright, Lara Daley, Paul Hodge
Transactions of the Institute of British Geographers, 21 November 2021
Open Access
Abstract
A considerable body of recent work within the social sciences has attempted to engage more deeply with place, place-based knowledge, and more-than-human agency. Yet what this might look like in relation to ethical research practice, especially in the case of research proceeding on unceded Indigenous lands, is unclear. Taking more-than-human agency seriously means ethical research practice must be extended beyond a human-centric approach. As a Gumbaynggirr and non Gumbaynggirr research collective researching on, with, and as Gumbaynggirr Country in so-called Australia, we offer a contribution to discussions of research ethics and protocols that centres the consent of Country: the lands, waters, and skies of Aboriginal and Torres Strait Islander homelands, and the human and more-than-human beings that co-become there. In this paper, we share some of our learnings and discuss how we have tried not just to listen to Country but also to honour its agencies, knowledges, and sovereignties. As part of this honouring, we prioritise in particular the deeply placed Gumbaynggirr knowledges of Aunty Shaa Smith and Uncle Bud Marshall to explore what being guided by Gumbaynggirr Law/Lore and sovereignty means in practice and the challenges and possibilities of gaining consent of Country in ways underpinned by Indigenous Law/Lore. We propose a more expansive understanding of consent that includes attention to more- than- human sovereignties and draw on our collective’s learning to reframe the need for limits on research as openings rather than closures. In sharing our Gumbaynggirr-led and Country-led perspectives, we aim to deepen decolonising research praxis within human geography and the social sciences more broadly.
Editor’s note: We note that the article references the knowledges of Aunty Shaa Smith and Uncle Bud Marshall while also being lead authors on the paper.
Center for Informed Consent Integrity 