Association Between the Communication Skills of Physicians and the Signing of Do-Not-Resuscitate Consent for Terminally Ill Patients in Emergency Rooms (Cross-Sectional Study)
Original Research
Chih-Hung Chen, Ya-Hui Cheng, Fen-Ju Chen, Eng-Yen Huang, Po-Ming Liu, Chia-Te Kung, Chao-Hui Su, Shu-Hwa Chen, Peng-Chen Chien, Ching-Hua Hsieh
Risk Management and Healthcare Policy, 11 December 2019; 12 pp 307—315
Abstract
Background
The signing of do-not-resuscitate (DNR) consent is mandatory in providing a palliative approach in the end-of-life care for the terminally ill patients and requires an effective communication between the physician and the patients or their family members. This study aimed to investigate the association between the communication skills of physicians who participated in the SHARE (supportive environment, how to deliver the bad news, additional information, reassurance, and emotional support) model course on the patient notification and the signing of do-not-resuscitate (DNR) consent by the terminally ill patients at emergency rooms.
Methods
Between May 1, 2017 and April 30, 2018, a total of 109 terminally ill patients were enrolled in this study, of which 70 had signed a DNR and 39 had not. Data regarding the patients’ medical records, a questionnaire survey completed by family members, and patient observation forms were used for the assessment of physicians’ communication skills during patient notification. The observation form was designed based on the SHARE model. A multivariate logistic regression model was applied to identify the independent significant factors of the patient and family member variables as well as the four main components of the observation form.
Results
The results revealed that knowing how to convey bad news and providing reassurance and emotional support were significantly correlated with a higher rate of signing DNR consent. Additionally, physician-initiated discussion with family members and a predicted limited life expectancy were negative independent significant factors for signing DNR consent.
Conclusion
This study revealed that good communication skills help to increase the signing of DNR consent. The learning of such skills from attendance of the SHARE model course is encouraged for the physicians in the palliative care of terminally ill patients in an emergency room.
Informed consent for anaesthesia: Presential or non-presential information?
Informed consent for anaesthesia: Presential or non-presential information?
Faura A, Izquierdo E, Escriche L, Nogué G, Videla S
Journal of Healthcare Quality Research, 21 Nov 2019
Abstract
Introduction
The anaesthesia informed consent (AIC) is a process of communication between a clinician and a patient that results in the patient agreeing to undergo a specific anaesthetic procedure after understanding all the information needed to make a free, voluntary and conscious decision. This information is traditionally given during a face-to-face pre-operative visit.
Objective
To evaluate patient perceptions when they receive the information about AIC, face-to-face or by phone.
Patients and Methods
A single centre, randomised, double-blind, parallel-group pilot clinical trial was conducted on patients > 18 years of age undergoing major ambulatory surgery procedures with a surgical complexity that did not require a face-to-face pre-operative visit. Patients were randomly assigned to be informed by telephone (experimental group) or in a face-to-face visit (control group). Fifteen days after the surgery a questionnaire was used to gather patient perceptions in understanding the anaesthetic procedure and risks, autonomy (to ask for explanations), as well as and satisfaction.
Results
Of the 160 patients that gave their consent, 142 were interviewed: 70 from the experimental group and 72 from the control group. Both groups were comparable in age, gender, anaesthetic risk, and surgical complexity. The percentage of patients that understood the information provided on the anaesthetic technique was 71% and 81%, respectively (P=.429); on its risks: 67% and 69% (P=.951); autonomy: 56% and 74% (P=.036) and satisfaction rate: 46% and 46% (P=.835).
Conclusion
There is no difference between the groups in the level of understanding of the information that the patient perceives and the level of satisfaction. Nevertheless, almost half of them did not remember to have been given the possibility to clear-up doubts.
Compassionate and Clinical Behavior of Residents in a Simulated Informed Consent Encounter
Compassionate and Clinical Behavior of Residents in a Simulated Informed Consent Encounter
Waisel DB, Ruben MA, Blanch-Hartigan D, Hall JA, Meyer EC, Blum RH
Anesthesiology, 20 November 2019
Abstract
What We Know About This Topic
Compassionate behavior in clinicians includes understanding patients’ psychosocial, physical, and medical needs; promptly attending to needs; and engaging patients to the extent they wish.
What This Article Will Tell Us That Is New
The investigators evaluated compassionate behavior of anesthesia residents in a simulated preoperative encounter with a patient in pain before urgent surgery. Anesthesia residents had variable and, at times, flawed recognition of patient cues, responsiveness to patient cues, pain management, and patient interactions.
Background
Compassionate behavior in clinicians is described as seeking to understand patients’ psychosocial, physical and medical needs, timely attending to these needs, and involving patients as they desire. The goal of our study was to evaluate compassionate behavior in patient interactions, pain management, and the informed consent process of anesthesia residents in a simulated preoperative evaluation of a patient in pain scheduled for urgent surgery.
Methods
Forty-nine Clinical Anesthesia residents in year 1 and 16 Clinical Anesthesia residents in year 3 from three residency programs individually obtained informed consent for anesthesia for an urgent laparotomy from a standardized patient complaining of pain. Encounters were assessed for ordering pain medication, for patient-resident interactions by using the Empathic Communication Coding System to code responses to pain and nausea cues, and for the content of the informed consent discussion.
Results
Of the 65 residents, 56 (86%) ordered pain medication, at an average of 4.2 min (95% CI, 3.2 to 5.1) into the encounter; 9 (14%) did not order pain medication. Resident responses to the cues averaged between perfunctory recognition and implicit recognition (mean, 1.7 [95% CI, 1.6 to 1.9]) in the 0 (less empathic) to 6 (more empathic) system. Responses were lower for residents who did not order pain medication (mean, 1.2 [95% CI, 0.8 to 1.6]) and similar for those who ordered medication before informed consent signing (mean, 1.9 [95% CI, 1.6 to 2.1]) and after signing (mean, 1.9 [95% CI, 1.6 to 2.0]; F (2, 62) = 4.21; P = 0.019; partial η = 0.120). There were significant differences between residents who ordered pain medication before informed consent and those who did not order pain medication and between residents who ordered pain medication after informed consent signing and those who did not.
Conclusion
In a simulated preoperative evaluation, anesthesia residents have variable and, at times, flawed recognition of patient cues, responsiveness to patient cues, pain management, and patient interactions.
Informed about Informed Consent: A Qualitative Study of Ethics Education
Informed about Informed Consent: A Qualitative Study of Ethics Education
Rocksheng Zhong, John K. Northrop, Puneet K.C. Sahota, Anthony L. Rostain
Online Journal of Health Ethics, January 2019 ;15(2)
Open Access
Abstract
Iformed consent is a foundational concept in modern medicine. Despite physicians’ ethical and legal obligations to obtain informed consent, no standard curriculum exists to teach residents relevant knowledge and skills. This paper presents a qualitative study of residents at one academic medical center. The authors conducted focus groups with trainees in the Departments of Internal Medicine, Emergency Medicine, and Ob/Gyn and analyzed their responses using rigorous qualitative methods. Four themes emerged: First, participants agreed that informed consent and decision-making capacity were relevant in many clinical situations. Second, participants varied widely in their understandings of consent. Third, current resident training was insufficient. Fourth, more training was needed. These results add to the growing literature that ethics education in residency is desired and useful. The findings will help educators craft instruments assessing the prevalence and degree of deficiencies related to informed consent competencies and aid in the development of a model curriculum.
Informed consent within a learning health system: A scoping review
Informed consent within a learning health system: A scoping review
Research Report
Annabelle Cumyn, Adrien Barton, Roxanne Dault, Anne‐Marie Cloutier, Rosalie Jalbert, Jean‐François Ethier
Learning Health Systems, 4 December 2019
Open Access
Abstract
Introduction
A major consideration for the implementation of a learning health system (LHS) is consent from participants to the use of their data for research purposes. The main objective of this paper was to identify in the literature which types of consent have been proposed for participation in research observational activities in a LHS. We were particularly interested in understanding which approaches were seen as most feasible and acceptable and in which context, in order to inform the development of a Quebec‐based LHS.
Methods
Using a scoping review methodology, we searched scientific and legal databases as well as the gray literature using specific terms. Full‐text articles were reviewed independently by two authors on the basis of the following concepts: (a) LHS and (b) approach to consent. The selected papers were imported in NVivo software for analysis in the light of a conceptual framework that distinguishes various, largely independent dimensions of consent.
Results
A total of 93 publications were analysed for this review. Several studies reach opposing conclusions concerning the best approach to consent within a LHS. However, in the light of the conceptual framework we developed, we found that many of these results are distorted by the conflation between various characteristics of consent. Thus, when these characteristics are distinguished, the results mainly suggest the prime importance of the communication process, by contrast to the scope of consent or the kind of action required by participants (opt‐in/opt‐out). We identified two models of consent that were especially relevant for our purpose: metaconsent and dynamic consent.
Conclusions
Our review shows the importance of distinguishing carefully the various features of the consent process. It also suggests that the metaconsent model is a valuable model within a LHS, as it addresses many of the issues raised with regards to feasibility and acceptability. We propose to complement this model by adding the modalities of the information process to the dimensions relevant in the metaconsent process.
Informed Consent: A Monthly Review
___________________________
December 2019
This digest aggregates and distills 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_December 2019
United Republic of Tanzania lowers age of consent for HIV testing
United Republic of Tanzania lowers age of consent for HIV testing
UNAIDS
29 November 2019
Press Release
The United Republic of Tanzania has approved a change to the law that lowers the age of consent for HIV testing from 18 years to 15 years. The amendment to legislation also makes self-testing for HIV legal, also from the age of 15 years.
“These amendments will significantly accelerate our intention to meet the 90–90–90 goals, which aim at ending the AIDS epidemic by 2030,” said Ummy Mwalimu, Minister of Health, Community Development, Gender, Elderly and Children. The ministry was instrumental in tabling the amendments to the legislation.
The 90–90–90 targets are ambitious treatment targets to help end the AIDS epidemic. They aim to ensure that, by 2020, 90% of all people living with HIV will know their HIV status, 90% of all people who know their HIV status will be on antiretroviral therapy and 90% of all people on antiretroviral therapy will be virally suppressed.
The changes to the law will contribute to improved access to HIV testing for adults aged 15 years and over.
At the end of 2018, the progress on the 90–90–90 targets in the United Republic of Tanzania was 78–92–87. In 2018, there were 72 000 new HIV infections in the country. While this is a 13% reduction from 2010, it is below the 28% reduction across eastern and southern Africa.
“I congratulate the Government of the United Republic of Tanzania on its leadership and high-level political commitment to the AIDS response. UNAIDS will continue to work hand-in-hand with all our partners to ensure that access to HIV testing and treatment continues to expand,” said Leo Zekeng, UNAIDS Country Director in the United Republic of Tanzania.
Guidelines for ethical research on sexual exploitation involving children
Guidelines for ethical research on sexual exploitation involving children
ECPAT – ECPAT is the only child right’s organisation that is solely focusing on ending the sexual exploitation of children (ecpat.org)
29 November 2019
Press Release
…The Guidelines for Ethical Research on Sexual Exploitation involving Children offer a framework for ethical research design in this area. They guide the reader through four steps in research design and implementation and set up a series of ‘ethical tasks’ that should be undertaken in your research project…
Excerpt
Introduction
Doing research involving children in the context of sexual exploitation raises a range of ethical questions and dilemmas. Some of these are similar for any research with human participants or vulnerable groups; but others are very specific to children affected by sexual exploitation (see ‘Ethics of Research on Sexual Exploitation Involving Children’ for a review of the literature). This document provides guidance for negotiating these ethical questions for a range of people engaged in field research (from lead researchers to data collectors)…
Informed Consent
…Even though not always legally required, with research involving children, it is also ethically appropriate to also obtain ‘assent ’from child participants. Obtaining ‘assent’ means to formally get permission from the child that they want to participate (not to just assume they do because a parent/caregiver gave consent). Children have the right to participate, but they also have the right to choose whether to express or not express those views6 This “means that the child must not be manipulated or subjected to undue influence or pressure…”
Abstract 391: Variation in Time to Notification After Enrollment in Trials Conducted Under Exception From Informed Consent for Emergency Research [POSTER PRESENTATION]
Abstract 391: Variation in Time to Notification After Enrollment in Trials Conducted Under Exception From Informed Consent for Emergency Research [POSTER PRESENTATION]
Graham Nichol, Rui Zhuang, Tom P Aufderheide, Eileen Bulger, Clifton W Callaway, Jim Christenson, Mohamud R Daya, Ahamed H Idris, Peter Kudenchuk, Laurie J Morrison, Martin A Schreiber, George Sopko, Jeremy Sugarman, Christian Vaillancourt, Henry E Wang, Myron Weisfeldt, Susanne May
Circulation, 11 November 2019; 140(supplement 2)
Open Access
Abstract
Context
Research in an emergency setting is challenging because the window of opportunity to treat may be short, and preclude time to obtain informed consent from the patient or their representative. Such research can be conducted under exception from informed consent (EFIC) if specific criteria are met. In the United States, this includes notification of an enrolled subject or their representative as soon as feasible after enrollment so that they have autonomy to opt out from ongoing study participation. To date, there is limited empiric information about time to notification (TTN).
Objective
To describe variation in TTN among sites participating in randomized trials conducted under exception from informed consent for emergency research.
Methods
Notification strategies were determined at each site prior to initiation of subject enrollment, and approved by a local institutional review board or equivalent. TTN was summarized overall, as well as stratified by site and clinical outcome among patients enrolled in multiple trials conducted by the Resuscitation Outcomes Consortium (ROC).
Results
Included were 34,868 patients enrolled in four trials. Of these, 33,805 had with out-of-hospital cardiac arrest; and 1,063 had life-threatening traumatic injury. TTN varied (Table).
Conclusions
There is large variation in TTN in trials conducted under EFIC for emergency research. Early notification is difficult; delayed notification may reduce the autonomy of patients or their representative.
Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation
Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation
Research Article
Rajesh Ranjan, Nidhi B. Agarwal, Prem Kapur, Amit Marwah, Rizwana Parveen
Asia Pacific Journal of Public Health, 3 November 2019
Abstract
Process to obtain informed consent is an essential component in research involving human subjects. However, much is not known about the level of awareness participants have about optimal consenting process and the motives that drive their participation in the trials. A cross-sectional study was conducted among volunteers who had been participating in clinical trials in contract research organizations of Delhi. Validated questionnaires were used to assess their knowledge, attitude, and practice of informed consent process. Most of the volunteers, 226 (56.5%), had participated in 1 to 3 clinical trials. Majority (54%) were unaware about any informed consent document. None of them were aware of their right of profession competence, privacy and integrity, transparency, nonexploitation, and nonusage of their biological samples. Effective implementation of principles of informed consenting is largely lacking among contract research organizations in Delhi, India. This could potentially cause risk to the participants.