Consent in Pediatric Critical Care Trials: Duty or Burden?
Editorial
Mark J. Peters, Kate Plant
Pediatric Critical Care Medicine, September 2024
Excerpt
Clinical practice is highly variable. Some of our colleagues use more maintenance fluids than we would choose for our patients. Or we might continue antibiotics beyond when they would stop them. We suspect any reader could think of similar examples in their own teams.
We currently accept this variability as commonplace in a complex setting such as a PICU. After all, there are tens, if not hundreds, of minor management decisions for each patient each day (1). If there were no differences between clinicians, our job could be replicated by robots or at least protocolized. There is a reasonable argument that this variability brings an additional level of safety. Practice regresses toward a mean such that over the duration of an admission any more extreme requests by one clinician will tend to be moderated by the colleague who takes over on the following shift.
Although we share our decision-making and plans with parents and patients where appropriate, we do not typically seek consent for these small variations in practice between staff…
Year: 2024
Assessment of decision-making autonomy in chronic pain patients: a pilot study
Assessment of decision-making autonomy in chronic pain patients: a pilot study
Research
Marguerite d’Ussel, Emmanuelle Sacco, Nathan Moreau, Julien Nizard, Guillaume Durand
BMC Medical Ethics, 18 September 2024
Open Access
Abstract
Background
Patient decision-making autonomy refers to the patients’ ability to freely exert their own choices and make their own decisions, given sufficient resources and information to do so. In pain medicine, it is accepted that appropriate beneficial management aims to propose an individualized treatment plan shared with the patients, as agents, to help them live as autonomously as possible with their pain. However, are patients in chronic pain centers sufficiently autonomous to participate in the therapeutic decisions that concern them? As this question still remains unanswered, a pilot study was set up to that aim.
Methods
Over a 2-month period, first-time patients within a tertiary multidisciplinary pain center underwent a systematic evaluation of their autonomy using the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), considered the benchmark tool for measuring a patient’s ability to consent to treatment. Demographic data and pain characteristics of the patients were collected and their respective attending pain physicians were asked to clinically assess their patients’ degree of autonomy. Another physician, who had not participated in the initial patient evaluation, subsequently administered the MacCAT-T questionnaire to the same patients.
Results
Twenty-seven patients were included during the study period (21 women and 6 men), with an average age of 50 years. The average duration of pain was 8 years. Based on their clinical experience, the 4 different pain physicians in charge of these patients considered that out of 25 assessed patients, 22 of them (89%) had full decision-making capacity, with no deficit in autonomy. According to the MacCAT-T results, only 13 of these 25 patients (48%) had no deficit, while 7 (26%) had a major deficit in autonomy. The only patient characteristic that appeared to be related to autonomy was pain type, specifically nociplastic pain. The average time taken to complete the test was 20 min, and patients were very satisfied with the interview.
Conclusion
Results from the present pilot study suggest that patients suffering from chronic pain do not appear to be entirely autonomous in their decision to consent to the proposed treatment plan according to the MacCAT-T questionnaire, and physicians seem to find it difficult to properly assess this competence in a clinical setting. Further studies with larger samples are needed to better evaluate this concept to improve the complex management of these patients.
Consent to voluntary antipsychotic drug treatment-Is it free and informed?
Consent to voluntary antipsychotic drug treatment-Is it free and informed?
Refael Yonatan-Leus, Nili Karako-Eyal
Psychiatric Rehabilitation Journal, 16 September 2024
Abstract
Objective
The present research investigates the dynamics of consent in the context of antipsychotic drug therapy, with a particular emphasis on the essential attributes that constitute free and informed consent within medical treatment scenarios.
Method
Twenty individuals treated with antipsychotic drugs with consent underwent semistructured interviews.
Results
The following major themes were identified: (a) lack or total absence of information regarding the treatment, emphasizing side effects, risks, chances of success, and treatment alternatives. (b) A subjective experience of the lack of free choice that was sometimes also accompanied by the conditioning of psychiatric rehabilitation services or receiving treatment in an open ward by taking antipsychotic medication.
Conclusions and implications for practice
The research findings may indicate a problem in obtaining informed consent for antipsychotic treatment that should be addressed. The themes highlight the need to examine the interface between rehabilitation services and psychiatric treatment from the legal and ethical perspective of the autonomy of individuals receiving care.
Enhancing Assent and Treatment Outcomes: A Case Study on Responding to Aversive Ambient Auditory Stimuli for an Autistic Adult
Original Article
Faris R. Kronfli, J. Stephanie Gonzalez, Malchijah T. Williams, Timothy R. Vollmer
Journal of Developmental and Physical Disabilities, 3 September 2024
Abstract
We explored assent procedures to promote assent and treatment effectiveness for an autistic adult. The objective, at the request of the participant, was to evaluate an innovative approach to (a) identify aversive auditory stimuli and (b) teach Steven, a 19-year-old male, appropriate responses in the presence of these stimuli without directly exposing him to the stimuli. The results suggest that the procedures effectively identified auditory stimuli for assessment and taught the participant to avoid the aversive stimuli appropriately (that is, in ways that were not dangerous). Through the implementation of this novel approach, assent and treatment effectiveness were enhanced for the autistic individual.
Communication Strategies in Negotiating Autonomy and Consent for Persons with Dementia (PWD)
Communication Strategies in Negotiating Autonomy and Consent for Persons with Dementia (PWD)
Josephine Misaro, Jimoh J. Braimoh, Josephine Akuamoah Boateng
International Journal of Enhanced Research in Medicines & Dental Care (IJERMDC), August 2024
Open Access
Abstract
Objectives
The aim of this study is to explore the communication strategies deployed by administrators and staff in Assisted Living communities in negotiating sexual autonomy. Furthermore, the study investigates outcomes and effectiveness of such strategies in maintaining independence and freedom for Persons With Dementia (PWD)’s sexual and intimacy desires.
Method
This research relies on thematic qualitative design using interviews for collecting data. Semi-structured interviews with administrators and staff from 7 assisted living communities were analyzed based on how PWDs are communicated with and the outcomes.
Results
The findings revealed that some communication strategies, namely, Watchful Oversight/Oversurveillance, Redirecting, and Reporting ensure safety but often compromise residents’ autonomy and well-being. Formal policies on sexual rights and comprehensive staff training could foster a more supportive and inclusive environment.
Discussion
This research is important because it emphasizes the unique communication strategies that support the autonomy and dignity of PWD. It was evident from the findings that while the communication strategies of Oversight/Oversurveillance, Redirecting, and Reporting ensure safety and compliance, they often compromise residents’ autonomy and well-being. Balancing these strategies with empathy, formal policies on sexual rights, and comprehensive staff training is crucial for a supportive and respectful environment in AL communities.
Application of Standard Informed Consent Procedure Amongst Practicing Anesthetists in Tertiary Care Hospitals of Karachi
Application of Standard Informed Consent Procedure Amongst Practicing Anesthetists in Tertiary Care Hospitals of Karachi
Asif Hassan, Mahendar Wanwari, Adeel ur Rehman, Tarique Aziz, Kashif Naeem, Fahad
Journal of Health and Rehabilitation Research, 4 August 2024
Abstract
Background
Informed consent is a critical component of anesthesia practice, ensuring patient autonomy and safety. However, variability in the application of consent procedures among anesthetists may impact patient understanding and care quality.
Objective
To evaluate the application of standard informed consent procedures among practicing anesthetists in tertiary care hospitals in Karachi.
Methods
A cross-sectional study was conducted from February 15, 2021, to August 14, 2021, across five tertiary care hospitals in Karachi. A total of 112 anesthetists, including consultants and residents with at least two years of experience, were recruited through consecutive sampling. Data were collected using a custom-made 16-item questionnaire. Responses were scored from 0 to 64, with scores ≥32 considered acceptable. Data were analyzed using SPSS version 25, employing descriptive statistics and Chi-square tests for comparisons.
Results
The mean age of participants was 34.04 ± 8.15 years, with 5.43 ± 5.9 years of experience. Compliance with consent standards was 99.11%, with 111 out of 112 participants scoring ≥32. No significant differences were observed across age, gender, or qualification (p > 0.05).
Conclusion
Anesthetists in Karachi showed high adherence to informed consent standards, though enhancements in risk disclosure are recommended to further improve patient care.
Pitfalls of the green transition: Towards a genuine understanding of the right to free, prior and informed consent of the Indigenous peoples
Pitfalls of the green transition: Towards a genuine understanding of the right to free, prior and informed consent of the Indigenous peoples
Yuko Osakada
Polar Science, 6 September 2024
Abstract
This article examines the changes required to make the green transition more inclusive and sustainable from an international human rights perspective. Indigenous peoples have been challenging the ways in which this transition is taking place, using the phrase “green colonialism.” Although, in many countries, it has become common to consult Indigenous peoples to reach an agreement before licensing the establishment of green energy facilities, previous studies that dealt with the Sámi’s struggle against the green transition have revealed that asymmetric power relationship between Indigenous peoples, sovereign states and business enterprises contributed to disguised dialogues and/or agreements among them. Therefore, this article concludes that a genuine transition from the obligation to consult Indigenous peoples to their right to free, prior, and informed consent (FPIC) is crucial when establishing green energy facilities that might affect them. In doing so, this article emphasizes that the meaning of the right to FPIC for Indigenous peoples should be understood correctly from an international human rights perspective. In particular, it argues that the right to FPIC should be ensured not only before the project affecting Indigenous peoples is licensed, but also at all stages of implementing the project with participatory monitoring.
Electronic Surgical Consent Delivery Via Patient Portal to Improve Perioperative Efficiency
Electronic Surgical Consent Delivery Via Patient Portal to Improve Perioperative Efficiency
Original Investigation
Karen Trang, Hannah C. Decker, Andrew Gonzalez, Logan Pierce, Amy M. Shui, Genevieve B. Melton-Meaux, Elizabeth C. Wick
JAMA Surgery, 11 September 2024
Abstract
Importance
Many health systems use electronic consent (eConsent) for surgery, but few have used surgical consent functionality in the patient portal (PP). Incorporating the PP into the consent process could potentially improve efficiency by letting patients independently review and sign their eConsent before the day of surgery.
Objective
To evaluate the association of eConsent delivery via the PP with operational efficiency and patient engagement.
Design, Setting, and Participants
This mixed-methods study consisted of a retrospective quantitative analysis (February 8 to August 8, 2023) and a qualitative analysis of semistructured patient interviews (December 1, 2023, to January 31, 2024) of adult surgical patients in a health system that implemented surgical eConsent. Statistical analysis was performed between September 1, 2023, and June 6, 2024.
Main Outcomes and Measures
Patient demographics, efficiency metrics (first-start case delays), and PP access logs were analyzed from electronic health records. Qualitative outcomes included thematic analysis from semistructured patient interviews.
Results
In the PP-eligible cohort of 7672 unique patients, 8478 surgical eConsents were generated (median [IQR] age, 58 [43-70] years; 4611 [54.4%] women), of which 5318 (62.7%) were signed on hospital iPads and 3160 (37.3%) through the PP. For all adult patients who signed an eConsent using the PP, patients waited a median (IQR) of 105 (17-528) minutes to view their eConsent after it was electronically pushed to their PP. eConsents signed on the same day of surgery were associated with more first-start delays (odds ratio, 1.59; 95% CI, 1.37-1.83; P < .001). Themes that emerged from patient interviews included having a favorable experience with the PP, openness to eConsent, skimming the consent form, and the importance of the discussion with the surgeon.
Conclusions and Relevance
These findings suggest that eConsent incorporating PP functionality may reduce surgical delays and staff burden by allowing patients to review and sign before the day of surgery. Most patients spent minimal time engaging with their consent form, emphasizing the importance of surgeon-patient trust and an informed consent discussion. Additional studies are needed to understand patient perceptions of eConsent, PP, and barriers to increased uptake.
Systematic Review and Meta-Analysis of Interactive multimedia Interventions used in the Informed Consent Process
Systematic Review and Meta-Analysis of Interactive multimedia Interventions used in the Informed Consent Process
Joshua Michael Clements, Jake Simon Clements, Mike Clarke, Stephen Kirk
British Journal of Surgery, 9 September 2024
Abstract
Aim
The use of digital technology to improve the informed consent process has increased over the past decade. A wide range of multimedia modalities are now available. This review aimed to assess the impact of interactive multimedia interventions on the informed consent process.
Methods
This was a subgroup analysis of a larger systematic review and meta-analysis conducted in accordance with a predefined protocol registered on PROSPERO (CRD42023380406). Five databases were searched using pre-defined search criterion in December 2022 for randomised trials of interactive multimedia interventions designed to improve the informed consent process. Adults >18 years undergoing invasive interventions with the capacity to consent were included. The Cochrane Risk of Bias (RoB) tool was used to assess study quality. Standardised mean difference for continuous variables and risk ratios for dichotomous variables were used to assess effect. Meta-analyses were performed in RevMan5.
Results
21 studies (22 interventions arms) with 2090 participants were included. All studies involved patients undergoing informed consent in an elective hospital setting for various surgical, cardiological and radiological procedures. Statistically significant improvement in immediate (SMD 0.40, 95% CI 0.18 to 0.62, I2=55%) and short-term knowledge (SMD 0.47, 95% CI 0.16 to 0.79, I2=45%) were demonstrated. No statistically significant differences were found for long term knowledge, generalised anxiety, satisfaction with the consent process or length of consultation.
Conclusions
Interactive multimedia interventions improve immediate and short-term knowledge in patients undergoing invasive interventions and could be considered as an adjunct to enhance patient knowledge during the informed consent process.
How Making Consent Procedures More Interactive can Improve Informed Consent: An Experimental Study and Replication
How Making Consent Procedures More Interactive can Improve Informed Consent: An Experimental Study and Replication
Research Article
Marije aan het Rot, Ineke Wessel
Journal of Empirical Research on Human Research Ethics, 28 August 2024
Open Access
Abstract
Prospective research participants do not always retain information provided during consent procedures. This may be relatively common in online research and is considered particularly problematic when the research carries risks. Clinical psychology studies using the trauma film paradigm, which aims to elicit an emotional response, provide an example. In the two studies presented here, 112–126 participants were informed they would be taking part in an online study using a variant of this paradigm. The information was provided across five digital pages using either a standard or an interactive format. In both studies, compared to the control condition, participants in the interactive condition showed more retention of information. However, this was only found for information about which they had been previously asked via the interactive format. Therefore, the impact of adding interactivity to digital study information was limited. True informed consent for an online study may require additional measures.
Center for Informed Consent Integrity 