Patients’ Experiences of Informed Consent and Preoperative Education

Patients’ Experiences of Informed Consent and Preoperative Education
Research Article
Elif Akyüz, Yurdagül Erdem
Clinical Nursing Research, 7 October 2020
Abstract
The aim of this descriptive cross-sectional study was to determine adult surgery patients’ experiences of informed consent and preoperative education. Research was conducted between September 2018 and February 2019. The sample consisted of 201 adult patients of a university hospital in Turkey. Data were collected using a 48-item questionnaire developed by the researchers based on literature. More than half of the participants (54.2%) were fully informed while 36.8% were partially informed about their surgery process and 61.2% were informed by physicians. Overall, 33.3% had unanswered questions about surgery, with questions relating mostly to the type of surgery (26.8%) and its effect on their body (25.4%). Participants were least informed about preoperative deep breathing and cough exercises (47.8%). More than half (58.4%) of participants expected healthcare professionals to avoid using medical terminology when informing them. Physicians and nurses perform invasive interventions on patients and, therefore, should be sensitive about informing patients.

Consent for spine surgery: an observational study

Consent for spine surgery: an observational study
Original Article
Angela Li Ching Ng, Lucinda S. McRobb, Sarah J. White, John A. Cartmill, Allan M. Cyna, Kevin Seex
ANZ Journal of Surgery, 5 October 2020
Abstract
Background
The tension between the ideal of informed consent and the reality of the process is under‐investigated in spine surgery. Guidelines around consent imply a logical, plain‐speaking process with a clear endpoint, agreement and signature yet surgeons’ surveys and patient interviews suggest that surgeons’ explanation is anecdotally variable and patient understanding remains poor. To obtain a more authentic reflection of practice, spine surgeons obtaining ‘informed consent’ for non‐instrumented spine surgery were studied via video recording and risk/benefit discussions were analysed.
Methods
A prospective observational study was conducted at a single neurosurgical institution. Twelve video recordings involving six surgeons obtaining an informed consent for non‐instrumented spine surgery were transcribed verbatim and blindly analysed using descriptive quantification and linguistic ethnography.
Results
Ten (83%) consultations discussed surgical benefit but less than half (41%) quantified the likelihood of benefit from surgery. The most discussed risks were nerve damage or paralysis (92%), bleeding (92%), infection (92%), cerebrospinal fluid leak (83%) and bowel and bladder dysfunction (75%). Surgeons commonly used a quantitative statement of risk (58%) but only half of the risks were explained in words patients were likely to understand.
Conclusions
This study highlights inconsistencies in the way spine surgeons explain risks and obtain informed consent for ‘simple’ spine procedures in a real‐world setting. There are wide disparities in the provision of informed consent, which may be encountered in other surgical fields. Direct observation and qualitative analysis can provide insights into the limitations of current informed consent practice and help guide future practice.

Are We Meeting the Current Standards of Consent for Anesthesia? An International Survey of Clinical Practice

Are We Meeting the Current Standards of Consent for Anesthesia? An International Survey of Clinical Practice
Tomas Jovaisa, Ieva Norkiene, Juri Karjagin, Iveta Golubovska, Lukas Gambickas, Migle Kalinauskaite, Evaldas Kauzonas, Dhuleep Wijayatilake
Medical Science Monitor, 5 October 2020
Open Access
Abstract
Background
International application of existing guidelines and recommendations on anesthesia-specific informed consent is limited by differences in healthcare and legal systems. Understanding national and regional variations is necessary to determine future guidelines.
Material and Methods
Anonymous paper surveys on their practices regarding anesthesia-specific patient informed consent were sent to anesthesiologists in Estonia, Latvia, and Lithuania.
Results
A total of 233 responses were received, representing 36%, 26%, and 24% of the practicing anesthesiologists in Lithuania, Latvia, and Estonia, respectively. Although 85% of responders in Lithuania reported using separate forms to secure patient informed consent for anesthesia, 54.5% of responders in Estonia and 50% in Latvia reported using joint forms to secure patient informed consent for surgery and anesthesia. Incident rates were understated by 14.2% of responders and overstated by 66.4% (P<0.001), with the latter frequently quoting incident rates that are several to tens of times higher than those published internationally. Physicians obtaining consent in the outpatient setting were more satisfied with the process than those obtaining consent on the day of surgery, with 62.5% and 42.6%, respectively, agreeing that the informed consent forms provided a satisfactory description of complications (P=0.03). Patients were significantly less likely to read consent information when signing forms on the day of surgery than at earlier times (8.5% vs. 67.5%, P<0.001). Only 46.2% of respondents felt legally protected by the current consent process.
Conclusions
Anesthesia-specific informed patient consent practices differ significantly in the 3 Baltic states, with these practices often falling short of legal requirements. Efforts should be made to improving information accuracy, patient autonomy, and compliance with existing legal standards.

Readability of foot and ankle consent forms in Queensland

Readability of foot and ankle consent forms in Queensland
Original Article
Giuseppe Pastore, Philip M. Frazer, Andrew Mclean, Tom P. Walsh, Simon Platt
ANZ Journal of Surgery, 5 October 2020
Abstract
Background
The aim of this study was to conduct a readability analysis on both patient take‐home information and consent forms for common foot and ankle procedures. Our hypothesis was that the objective reading skills required to read and comprehend the documentation currently in use would exceed the recommendations in place by both national and international bodies.
Methods
The current Queensland Health consent forms are divided into specific subsections. The readability of consent form subsections C and G (sections containing detailed information on risks of the procedure and pertaining to informed patient consent specifically) and patient take‐home information (provided as take‐home leaflet from the consent form which is procedure specific) was assessed by an online readability software program using five validated methods calculated by application of the algorithms for (i) Flesch–Kincaid grade level, (ii) the SMOG (Simple Measure of Gobbledygook), (iii) Coleman–Liau index, (iv) automated readability index and the (v) Linsear Wriste formula.
Results
The mean ± standard deviation reading grade level of risk (section C), grade level of patient consent (section G) and grade level for procedure‐specific take‐home patient information were 8.7 ± 0.9, 11.6 ± 1.2 and 7.5 ± 0.2, respectively.
Conclusion
The readability of sections C and G of the Queensland Health consent form exceeds the recommendations by national and international bodies, but the patient take‐home information appears suitable. Consideration should be given to lower the reading grade level of patient consent forms to better reflect the reading grade of the Australian population.

‘Hobson’s choice’: a qualitative study of consent in acute surgery

‘Hobson’s choice’: a qualitative study of consent in acute surgery
Anthony Howard, Jonathan Webster, Naomi Quinton, Peter V Giannoudis
BMJ Open, 25 August 2020; 10
Open Access
Abstract
Objectives
The study aimed to understand through qualitative research what patients considered material in their decision to consent to an acute surgical intervention.
Participants, setting and intervention
The patients selected aged between 18 and 90, having been admitted to a major trauma centre to undergo an acute surgical intervention within 14 days of injury, where English was their first language. Data saturation point was reached after 21 patients had been recruited. Data collection and analysis were conducted simultaneously, through interviews undertaken immediately prior to surgery. The data were coded using NVIVO V.12 software.
Results
The key theme that originated from the data analysis was patients were unable to identify any individual risk that would modify their decision-making process around giving consent. The patient’s previous experience and the experience of others around them were a further theme. Patients sensed that there were no nonoperative options for their injuries.
Conclusion
This is the first study investigating what patient considered a material risk in the consent process. Patients in this study did attribute significance to past experiences of friends and family as material, prompting us to suggest that the surgeon asks about these experiences as part of the consent process. Concern about functional recovery was important to patients but insufficient to stop them from consenting to surgery, thus could not be classified as material risk.

What Do you Mean by “Informed Consent”? Ethics in Economic Development Research

What Do you Mean by “Informed Consent”? Ethics in Economic Development Research
Featured Article
Anna Josephson, Melinda Smale
Applied Economic Perspectives and Policy, 27 October 2020
Open Access
Abstract
The ethical conduct of research requires the informed consent and voluntary participation of research participants. Institutional Review Boards (IRBs) work to ensure that these ethical standards are met. However, incongruities in perspective and practice exist across regions. In this article, we focus on informed consent as practiced by agricultural and applied economists, with emphasis on research conducted in low income and/or developing countries. IRB regulations are clear but heterogeneous, emphasizing process rather than outcome. The lack of IRBs and institutional reviews in some contexts and the particulars of the principles employed in others may fail to adequately protect research participants.

Philosophical and Cognitive Elements of Risk Communication in Informed Consent [BOOK CHAPTER]

Philosophical and Cognitive Elements of Risk Communication in Informed Consent [BOOK CHAPTER]
Daniele Chiffi
Clinical Reasoning: Knowledge, Uncertainty, and Values in Health Care, 2 October 2020; pp 145-157
Abstract
There is growing scientific interest in studying the multidisciplinary aspects of risk. Still, no universally accepted definition of risk has been agreed upon. When dealing with the sector of health-related risk, there should be an essential interplay between risk perception and risk communication. The present chapter argues that the effectiveness of risk communication in the health domain can be considerably improved by taking into consideration the cognitive and emotional biases along with all the factors affecting risk perception. I contend that risk communication is effective when based on the negotiation of meanings and therapeutic options in the clinical encounter, which is essential in the context of informed consent and in a person-centred and humanistic perspective in health care.

Informed Consent: A Monthly Review
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October 2020

This digest aggregates and distills key content adressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_October 2020

Consent in the time of COVID-19

Consent in the time of COVID-19
Helen Lynne Turnham, Michael Dunn, Elaine Hill, Guy T Thornburn, Dominic Wilkinson
BMJ Medical Ethics, 26 August 2020; 46(9) pp 565-568
Open Access
Abstract
The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy.

The ethics of deferred consent in times of pandemics

The ethics of deferred consent in times of pandemics
Rieke van der Graaf, Marie-Astrid Hoogerwerf, Martine C. de Vries
Nature Medicine, 10 July 2020; 26 pp 1328–1330
Open Access
Excerpt
In the current COVID-19 pandemic, many researchers are applying to research ethics committees for deferred-consent procedures for protocols that aim either to test treatments or to obtain tissue or samples from research participants. However, the deferred-consent procedure has not been developed for pandemics. In this Comment, we interpret existing guidance documents and argue when and under which conditions deferred consent can be considered ethically acceptable in a pandemic…