Consent in gastrointestinal endoscopy: valid, informed and nurse-led

Consent in gastrointestinal endoscopy: valid, informed and nurse-led
Christine Metcalf
Gastrointestinal Nursing, 19 Jun 2019; 17(5)
Abstract
Gastrointestinal endoscopy is generally safe, but these diagnostic and therapeutic interventions come with potential risks and thus require written, valid and informed consent, except in emergencies. Informed consent requires patients to receive and discuss information on the benefits, risks and nature of the procedure, as well as any alternatives. To consent, a patient must have the mental capacity to understand the information and use it to make and communicate a decision. Consent is a multi-stage procedure, beginning when endoscopy is first proposed and continuing into the intervention, as patients can withdraw consent during the procedure, whether sedated or not. For high-volume, low-risk procedures, the consent process can be safely delegated to qualified endoscopy nurses, with sufficient and relevant training, knowledge and support from the trust. Nurses competencies and other elements of the consent process should be regularly audited.

The Reading Level of Surgical Consent Forms in Hand Surgery

The Reading Level of Surgical Consent Forms in Hand Surgery
Original Research
Kevin Mertz, Matthew B. Burn, Sara L. Eppler, Robin N. Kamal
Journal of Hand Surgery Global Online, 19 June 2019
Abstract
Purpose
The average United States adult reads at an eighth-grade reading level. In an effort to ensure that patients understand written medical information, the National Institutes of Health and American Medical Association suggest that patient-directed material be written at a sixth- to eighth-grade reading level. We hypothesized that the mean reading level of surgical consent forms for hand surgery is not at or below an eighth-grade reading level (the suggested maximum from the National Institutes of Health).
Methods
We conducted a retrospective review of consecutive consent forms used for hand surgery patients from 7 hand surgeons at our institution from June, 2017 to October, 2017. Consent forms were reviewed to collect the hand-written portion describing the procedure. We also assessed our institution’s consent form template. This text was assessed for readability and reading level with the following tools: Flesch-Kincaid Grade Level and Flesch Reading Ease. We categorized the procedures written on each consent form by procedure type and then created simplified language for the same procedure below an eighth-grade reading level.
Results
Mean Flesch-Kincaid grade level of all consent forms was 10.5 (SD, 5.8) and mean Flesch readability was 33.6 (SD, 38.8), or difficult to read. A total of 78% and 58% of forms were written above the sixth- and eighth-grade reading levels, respectively. Readability was remarkedly poor; 94% and 88% of consent forms were written above sixth- and eighth-grade readability, respectively. The grade level of the consent form template was 17.1.
Conclusions
Most consent forms were written above a sixth- to eighth-grade reading level and may not have been well-understood by patients. It is possible for physicians to write on surgical consent forms at a reading level that patients are more likely to understand by opting for less specialty-specific words and writing in shorter sentences. Improving the readability of patient-directed materials is an approach to improving patient-centered care.

Informed Consent in Plastic Surgery, Evaluation of its Effectiveness for Mutual Satisfaction of Patient and Doctor: Comparison of Methods

Informed Consent in Plastic Surgery, Evaluation of its Effectiveness for Mutual Satisfaction of Patient and Doctor: Comparison of Methods
Paolo G. Morselli, Andrea Lippi, Federico A. Giorgini, Erich Fabbri, Valentina Pinto
Journal of Plastic, Reconstructive & Aesthetic Surgery, 5 June 2019
Abstract
Background
The acquisition of signed informed consent is not always enough to ensure adequate medical protection. Particularly in plastic surgery improving the doctor-patient relationship by understanding the patient’s emotions and expectations becomes a determining factor when choosing the best therapeutic strategy for the subject in question, which may also include non-surgical eligibility.
Methods
90 patients, with various plastic surgery disabilities, were recruited and randomly divided into three groups: the 1st group underwent the “traditional” clinical interview, the 2nd to the clinical approach called Shared Decision Making (SDM), the third group received both the SDM and a questionnaire evaluating patient expectations (Expectation Questionnaire-Pgm). At the end of each interview, a specialist physician in Plastic, Reconstructive and Aesthetic Surgery was asked to fill in a questionnaire regarding his/her satisfaction with the method used. Likewise, the patient filled in a questionnaire on his/her satisfaction with the interview.
Results
For the doctors, the third method was superior in investigating patient expectations, emotions and personal preferences. For the patients, the third method score significantly higher than the first one for overall satisfaction, ability to evaluate personal preferences and needs; and higher than the first and second in assessing expectations.
Conclusions
For doctors, the SDM coupled with the Expectation Questionnaire-Pgm proved to be the most useful tool to understand patient expectations and emotions and thus improve the medical-patient relationship through shared decision-taking. The third method therefore makes for better patient coverage and improved informed consent, reducing the likelihood of litigation and better assessing non-fitness for operation.

Consent Obtained by Residents: Informed by the Uninformed?

Consent Obtained by Residents: Informed by the Uninformed?
Tait AR
The Journal of Clinical Ethics, 1 Jan 2019; 30(2) pp 163-166
Abstract
Informed consent is central to the bioethical principle of respect for persons, a process that involves a discussion between the physician and patient with disclosure of information sufficient to allow the patient to make an informed decision about her or his care. However, despite the importance of informed consent in clinical practice, the process is often ritualized, perfunctory, and performed by individuals with little or no training in the consent process. This article discusses the lack of medical students’ and residents’ training in informed consent and questions the practice of allowing untrained residents and surrogates to obtain consent from patients.

Informed Consent: A Monthly Review
___________________________

June 2019

This digest is intended to aggregate and distill key content around 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 GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

Publisher
David R. Curry
President & CEO
GE2P2 Global Foundation
david.r.curry@ge2p2global.org

PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_June 2019

Reflections on informed consent by children and adolescents for the provision of clinical healthcare services

Reflections on informed consent by children and adolescents for the provision of clinical healthcare services
Barcia M, Zunini C
Uruguayan Medical Journal, 2019; 35(2) pp 146-150 
Abstract
The Convention on the Rights of the Child has established a change in the concept of childhood. Children become subjects of rights and protection instead of being objects of society. The health contexts, as a sphere for social processes needs to keep pace with this paradigm. It is necessary for children and adolescents to participate in the making of decisions affecting their health in the clinical context. The study aims to discuss the specific characteristics of informed consent in children and adolescents within the context of the provision of healthcare services from the paradigm proposed by the Convention of the Rights of the Child of 1989. Informed consent as an expression of will, needs to meet three requirements to be valid: competence to make autonomous decisions, information and freedom. The main challenge of the health team lies in defining the moment when a child and adolescent may grant a valid consent. This study will reflect on the characteristics of informed consent within the context of the provision of health care services. The health team must guarantee the participation of children and adolescents in the making of decisions, understanding autonomy is gradually acquired.

Editor’s note: This is a Spanish language publication.

An Educational Video Improves Consent in Pediatric Lumbar Puncture: A Randomized Control Trial

An Educational Video Improves Consent in Pediatric Lumbar Puncture: A Randomized Control Trial
Research Paper
MaryDunbar, GillianPaton, AshutoshSinghal
Pediatric Neurology, 13 May 2019
Abstract
Background
Lumbar puncture is a low-risk procedure performed on pediatric patients for a variety of indications. Parents are consented to this procedure but are often left with concerns. There are no published studies on the nature of the concerns of parents in North America, and no studies examining a process to improve pediatric lumbar puncture consent.
Objective
Identify parent concerns with lumbar puncture and determine the utility of an adjunctive educational video.
Methods
Seventy-two patient-parent dyads were enrolled in a randomized control trial to receive standard consent with or without an educational video. A survey was provided to determine parent self-rated understanding of the procedure, their perception of its safety, their perception of the painfulness and their overall comfort with their child undergoing lumbar puncture. In addition, demographic characteristics and qualitative information about parent concerns were collected.
Results
The video resulted in significantly greater parent understanding of the procedure (p=0.015) and perception of its safety (p=0.021) compared to controls. Parent comfort with the procedure increased after viewing the video (p = 0.002). Parents’ top three concerns were pain, infection, and neurologic injury.
Conclusions
Parent concerns in pediatric lumbar puncture include pain, infection and neurologic injury, and viewing an educational video improved parent perception of understanding and safety compared to controls. In addition, there was reduced variability of responses in those who viewed the video. Thus, a short educational video on a handheld device is an effective means to address parent concerns and standardize the process of pediatric lumbar puncture consent.

Evaluation of Legal Legislation Compliance and Readability of Clinical Trial Informed Consent Forms

Evaluation of Legal Legislation Compliance and Readability of Clinical Trial Informed Consent Forms
Research Article
Buket Gungor, Mualla Aylin, Ayse Asena, Elif Inci Somuncuoglu, Nihan Burul Bozkurt, Serife Reyhan Ucku, Ayse Gelal
Therapeutic Innovation & Regulatory Science, 19 May 2019
Abstract
Background
The volunteers approached for participation in a clinical trial should be given detailed and understandable information about the study through an informed consent form (ICF) before enrollment. In this study, we evaluated clinical trial files submitted to the Turkish Medicines and Medical Devices Agency (TITCK) to investigate the compliance to legal legislation and readability of ICFs as well as the factors affecting them.
Methods
This is a descriptive, cross-sectional study. We evaluated 160 ICFs in the phase II-IV clinical trial files submitted to TITCK in 2016 to determine their compliance to legislation (n = 160) and to assess their readability (n = 152) using Atesman formula. Overall compliance score was calculated. ICFs were also evaluated in terms of written format (font size, line spacing, section headings) and page count. Statistical analysis was performed with chi-square, Student’s t test, analysis of variance, Mann-Whitney U, and Kruskal Wallis analysis.
Results
Compliance to legislation and suitability of written format of international trial ICFs were significantly higher than those of national trial ICFs. Most of the national trials were investigator initiated. Readability was low in both national and international trial ICFs where the text was longer in the latter.
Conclusion
Results showed that researchers need easy-to-read ICF writing training that fits legal regulations.

Need for greater transparency in documenting informed consent

Need for greater transparency in documenting informed consent
Commentary
Peter Tugwell, J. Andre Knottnerus
Journal of Clinical Epidemiology, May 2019; 109 pp v–vii
Abstract
Kotz et al. in a Commentary [1] call for a re-examination of patient consent in randomised clinical trials. Although informing potential participants about the aims and procedures of a trial is mandatory when seeking their consent, current practice in obtaining informed consent appears to have been shaped the legal duty of disclosure; consent is seen as an action, concluded by signing a form. In line with this administrative attitude toward informed consent, the procedure is standardly reported in a research article. However, there is evidence that the exact information that is given to potential participants is often not understood by them. This is unacceptable, so the authors argue that details about informed consent procedures of randomized controlled trials should be reported transparently with the essential features of the information for participants summarized in the methods section of a trial report and that the full, original participant information letter is published as supplementary material.

Ethical tensions in the informed consent process for randomized clinical trials in emergency obstetric and newborn care in low and middle-income countries

Ethical tensions in the informed consent process for randomized clinical trials in emergency obstetric and newborn care in low and middle-income countries
Debate
Dan K. Kaye, Gershom Chongwe, Nelson K. Sewankambo
BMC Medical Ethics, 27 April 2019; 20(27)
Abstract
Background
There is unanimous agreement regarding the need to ethically conduct research for improving therapy for patients admitted to hospital with acute conditions, including in emergency obstetric care. We present a conceptual analysis of ethical tensions inherent in the informed consent process for randomized clinical trials for emergency obstetric care and suggest ways in which these could be mitigated.
Discussion
A valid consenting process, leading to an informed consent, is a cornerstone of this aspect necessary for preservation and maintenance of respect for autonomy and dignity. In emergency obstetric care research, obtaining informed consent can be problematic, leading to ethical tension between different moral considerations. Potential participants may be vulnerable due to severity of disease, powerlessness or impaired decisional capacity. Time for the consent process is limited, and some interventions have a narrow therapeutic window. These factors create ethical tension in allowing potentially beneficial research while avoiding potential harms and maintaining respect for dignity, human rights, justice and autonomy of the participants.
Conclusion
Informed consent in emergency obstetric care in low- and middle-income countries poses numerous ethical challenges. Allowing research on vulnerable populations while maintaining respect for participant dignity and autonomy, protecting participants from potential harms and promoting justice underlie the ethical tensions in the research in emergency obstetric and newborn care. Those involved in research conduct or oversight have a duty of fair inclusion, to avoid denying participants the right to participate and to any potential research benefits.