Using a Multimedia Tool for Informed Consent in Mohs Surgery: A Randomized Trial Measuring Effects on Patient Anxiety, Knowledge, and Satisfaction
Macey Delcambre, Dylan Haynes, Tamar Hajar, Spring Golden, Anna Bar, Emile Latour, Justin J. Leitenberger
Dermatologic Surgery, 11 October 2019
Abstract
Background
Multimedia educational materials have been found to improve aspects of informed consent, although data in the context of Mohs micrographic surgery (MMS) is limited.
Objective
To assess whether a preoperative educational video decreases anxiety, increases comprehension, and improves overall satisfaction for patients undergoing same-day office consultation and MMS.
Materials and Methods
This single-center randomized controlled trial included patients above the age of 18 years undergoing MMS for skin cancer between October 2015 and December 2015. Patients were randomized to view a short preoperative video on MMS in addition to traditional informed consent versus informed consent without video viewing. Questionnaires were used to assess preoperative anxiety, knowledge, and satisfaction.
Results
From 231 consecutively enrolled subjects, there were no significant differences in anxiety (p = .626) or satisfaction (p = .065) between groups. Subjects receiving the intervention were able to more accurately recognize risks of MMS (88% vs 69% of controls, p < .001) and had improved subject-reported confidence in understanding procedural risks and benefits (89% vs 71% of controls, p = .049). Composite comprehension scores were similar between groups (p = .131).
Conclusion
A preoperative MMS educational video increased recognition of procedural risks, but did not improve patient anxiety or satisfaction.
Month: November 2019
Improving the chemotherapy consent: From paper to tablet
Improving the chemotherapy consent: From paper to tablet
Aarti Sonia Bhardwaj, Jessica Parra, Kavita Rampertaap, Katherine FitzPatrick, Raina Caridi, Mark Liu, Victoria Casani, Donna Berizzi, Luis M. Isola, Cardinale B. Smith
Journal of Clinical Oncology, 20 September 2019; 37(27) pp 298-298
Abstract
Background
A comprehensive chemotherapy informed consent process improves shared decision-making. Additionally, the Oncology Care Model (OCM) emphasizes providing patients with a documented care plan that contains the 13 components in the Institute of Medicine Care Management Plan. Within our health system, we incorporated the care plan into our existing chemotherapy consent process and utilized technology to increase compliance and reduce administrative burden.
Methods
Our 2 phase PDSA included: 1) updating our existing paper chemotherapy form with the 13 components of the IOM care plan and then 2) piloting an electronic version of the chemotherapy consent form. We updated our new chemotherapy consent with the addition of Prognosis, Expected Response to Treatment, Potential Effect on Quality of Life, Potential Benefits/Goals of Treatment, and added more options for potential side effects/harm. Given the increased administrative burden, we created and piloted the use of an electronic version of the consent form in our breast oncology program.
Results
Baseline, monthly random chart audit of 20-40 patients revealed compliance with completing every question of the paper chemotherapy consent at 30% of all patients receiving IV chemotherapy at our cancer center that month- 7/2018. When the new chemotherapy consent incorporating the IOM elements was rolled out, compliance initially rose to 50% (8/2018), however the following months dropped to 10-20% (9-11/2018) and then back up to 41% briefly (12/2018). The results were low and inconsistent. A pareto chart confirmed that redundancy and too many questions were the reasons for under-completion. By auto-populating fields for certain questions on the paper consent, compliance increased to 75% (2/2019). Finally within our breast cancer pilot group our compliance rose to 100% (3-4/2019), by converting to an electronic form with the maximum options for auto-population and drop-down selections for certain fields.
Conclusions
Incorporating regulatory requirements into an existing workflow can reduce administrative burden. The use of innovative technology can further increase clinician and OCM compliance while delivering value to patients.
Broad consent for biobanks is best – provided it is also deep
Broad consent for biobanks is best – provided it is also deep
Debate
Rasmus Bjerregaard Mikkelsen, Mickey Gjerris, Gunhild Waldemar, Peter Sandøe
BMC Medical Ethics, 15 October 2019; volume 20(71)
Open Access
Abstract
Background
As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in what ways samples deposited in a biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent.
Main text
In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants’ values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication.
Conclusion
We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research.
Neurological Deficits in Stroke Patients that May Impede the Capacity to Provide Informed Consent for Endovascular Treatment Trials
Neurological Deficits in Stroke Patients that May Impede the Capacity to Provide Informed Consent for Endovascular Treatment Trials
Paula M.Janssen, VickyChalos, Sophie A.van den Berg, Erwin J.O.Kompanje, Paul J.Nederkoorn, Bart H.van der Worp, Wim H.van Zwam, Diederik W.J.Dippel
Journal of Stroke and Cerebrovascular Diseases, 14 October 2019
Abstract
Background
We assessed the occurrence of neurological deficits that may impede the capacity to provide consent for trial participation in patients with an acute stroke, who are eligible for endovascular treatment (EVT).
Methods
We used data from the Multicenter Randomized Controlled Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry, a prospective observational cohort study. We included 1526 patients with an anterior large vessel occlusion, undergoing EVT between March 2014 and June 2016. We based our assessment of decision-making capacity for trial participation on neurological symptoms influencing conditions concerning informed consent as stated in the declaration of Helsinki. We formulated a strict and a mild capacity assessment rule, using 2 different cut points in item scores on the National Institutes of Health Stroke Scale (NIHSS).
Results
Applying the strict and mild rule, respectively 1469 (96%) and 1220 (80%) patients deemed not capable of decision-making for trial participation on admission, and 1077 (79%) and 825 (60%) patients at 24-48 hours after admission. Highest frequencies of predefined scores suggesting incapacity based on the strict rule were on the NIHSS items “Level of Consciousness Questions” (59%), “Best Gaze” (68%), and “Best Language” (58%). Patients who were considered incapable were older (median 71 versus 66 years, P = .043), had higher NIHSS scores (median 16 versus 8, P < .001), and had more often left hemisphere strokes (55% versus 28%, P < .001) than patients who were presumably capable.
Conclusions
In the majority of patients with an anterior circulation stroke who are eligible for EVT, neurological deficits are present that may impede the capacity to provide informed consent for trial participation.
‘It’s a tough decision’: a qualitative study of proxy decision-making for research involving adults who lack capacity to consent in UK
‘It’s a tough decision’: a qualitative study of proxy decision-making for research involving adults who lack capacity to consent in UK
Victoria Shepherd, Kerenza Hood, Mark Sheehan, Richard Griffith, Fiona Wood
Age and Ageing, 9 October 2019; 48(6) pp 903–909
Abstract
Background
Research into dementia and other conditions connected with cognitive impairments is essential but conducting research with populations who lack capacity to provide consent involves a number of ethical, legal and practical challenges. In England and Wales, family members can act as a consultee or legal representative on behalf of someone who lacks capacity. However, there is a paucity of research about how family members make decisions concerning research participation.
Objective
To explore family members’ experiences of proxy decision-making for research. Understanding how proxy decisions are made could lead to interventions to support greater inclusion of individuals in research who have impaired decision-making capacity.
Methods
Semi-structured interviews were conducted with a purposive sample of 17 family members who had experience as a proxy for making decisions about participation in research, including those who had agreed to participation and those who declined. Thematic analysis was used to examine experiences and generate findings for research practice and to develop future supportive interventions.
Results
Proxy decision-making is highly contextualised. Proxies balance a number of factors when deciding about research participation, including the person’s values and preferences, within the specific context of the study, and the practicalities of being involved. Proxies use these factors to construct a decision that is authentic to the person they care for.
Conclusions
Proxy decision-making for research is a complex process with inter-woven layers of decision-making. Decisions can be problematic for some proxies who may benefit from decision support to make an informed decision about research participation on behalf of a family member.
Informed Consent From Children
Informed Consent From Children
Tim Moore
SAGE Research Methods Foundations, 9 September 2019
Abstract
Children’s informed consent in participatory research is an essential component to ethical research practice. Although there has been significant attention from researchers about the importance of seeking children’s informed consent prior to their participation in data collection, some commentators see consent as an ongoing process rather than a hurdle to be overcome prior to data collection. After discussing the participation of children in research, this entry presents five steps that may help researchers consider how to embed informed consent in research activities as well as examples to show how researchers can assist children to understand, indicate, utilize, and reflect on their consent.
Variability in Informed Consent Practices for Non-Emergent Procedures in Pediatric Emergency Departments
Variability in Informed Consent Practices for Non-Emergent Procedures in Pediatric Emergency Departments
Research Article
Lorrie Edwards, Heidi Werner, Yorghos Tripodis, David Dorfman, Tehnaz Boyle, Megan Bair-Merritt, Arvin Garg
Clinical Pediatrics, 26 September 2019
Abstract
Although informed consent is a cornerstone of medical ethics, it is unclear if the practice for obtaining informed consent is consistent among pediatric emergency departments. This study’s goal is to describe the current practice for written informed consent in academic pediatric emergency departments for non-emergent procedures. A questionnaire distributed to pediatric emergency medicine fellowship directors queried whether written informed consent was standard of care for 15 procedures and assessed departmental consent policies and use of “blanket” consent-to-treat forms. Response rate was 80% (n = 64). Institutions obtained written consent for a mean of 4.4 procedures. Written informed consent was most commonly obtained for procedural sedation (82.5%), blood transfusion (72.9%), and lumbar puncture (66.5%). Twenty-one institutions (32.8%) had policies specifying procedures requiring written consent. Thirty-five institutions (54.7%) used “blanket” consent-to-treat forms. Our results suggest that there is variability in the use of written informed consent for non-emergent procedures among academic pediatric emergency departments.
Nigerian laws on informed consent before a surgical procedure
Nigerian laws on informed consent before a surgical procedure
Research Article
Mabel Ijeoma Ezeuko
Medico-Legal Journal, 7 October 2019
Abstract
Informed consent is a process of communication between a clinician and a patient, which results in the patient’s agreement to undergo a medical procedure. Rule 19 Part A: Code of Medical Ethics of Nigeria and Section 23 of the National Health Act 2004 prescribe the process of obtaining consent before a medical intervention. The equitable law of torts and/or criminal liabilities that deal with medical negligence should be invoked more often by patients whose right to informed consent is denied by medical practitioners.
Patients’ informed consent to medical services in Georgia
Patients’ informed consent to medical services in Georgia
Research Article
Tengiz Verulava, Revaz Jorbenadze, Vakhtang Surguladze
Medico-Legal Journal, 3 October 2019
Abstract
Informed consent requires that a patient understands the purpose, benefits and potential risks of a medical or surgical intervention and then agrees to it. It is important not only ethically and legally but for the effectiveness of care. Studies show that, in some cases, patients have no real information on the medical service to be provided so their informed consent is just a formality. This study aims to determine problems arising from a patient’s informed consent. As part of a cross-sectional study, surgical patients were interviewed using a semi-structured questionnaire. 34% of patients (n = 68) did not know what the surgical intervention was; 57% (n = 114) received sufficient information on their diagnosis and methods of treatment; however, 26% (n = 52) agreed with it only partially; 62% (n = 124) of patients knew they needed surgery; 66% (n = 132) were adequately informed on risks and benefits of alternative ways of treatment; 58% (n = 116) were informed of potential risks during surgery. The study demonstrated patients need to be better informed about different treatment options, consequences of treatment refusal. Doctors have to provide information to patients in a manner understandable to them. Medical personnel need to be educated as to what constitutes informed consent and the importance of adhering to such requirements.
Clinical information, informed consent and medical deontology. A recent relationship
Clinical information, informed consent and medical deontology. A recent relationship
García-Guerrero J
Cuadernos de bioética, September-December 2019; 30(100) pp 303-313
Abstract
In Spain, the right to clinical information and informed consent as a practical expression of the principle of autonomy, are legal conquests achieved in the late twentieth century. From the law they have been transferred to the codes of medical deontology. The aim of this work is to study the pace of this transfer. Historical review of the different codes of medical deontology in Spain since the Civil War, seeking the presence of these ideas in them. Until code of medical deontology of 1979, the idea of clinical information did not appear in the contemporary deontological norm, and the rules on consent did so in very restricted cases. As of that date, their appearance is progressive in the successive codes. Currently, both concepts are fully developed in Spanish deontological regulations. Medical Deontology has take on the ideas of patient information and informed consent. This has been a long process which have brought considerable changes the deontological orientations of the traditional form of doctor-patient relationship. In these aspects, medical deontology has drifted, from emphasizing the prudence of the doctor, to emphasize the duty to inform and give ample space to the patient’s decisions, which he recognizes as an autonomous and reflective moral agent, capable of taking his own decisions about your health.
Editor’s note: This is a Spanish Language publication.
Center for Informed Consent Integrity 