Video-Assisted informed consent in endoscopic urology: a randomized trial on ureterorenoscopy
Research Article
Dr. Guglielmo Mantica, Dr. Francesco Esperto, Dr. Rafaela Malinaric, Dr. Francesca Ambrosini, Dr. Loris Cacciatore, Prof. Rocco Papalia, Dr. Daniele Panarello, Prof. Roberto Mario Scarpa, Prof. Carlo Terron
Journal of Endourology, 17 May 2024
Abstract
Purpose
The aim of this study is to evaluate the possible beneficial effect of using the video – consent in the preoperative URS consent giving process.
Material and Methods
Prospective randomized trial took place at two Italian tertiary-care centers from March 2022 to September 2022. Patients were randomly assigned to two groups: Group A (standard verbal/written informed consent) and Group B (informed consent supported by video). We investigated the impact of both types of the informed consent on the level of patients’ anxiety assessed with the STAI questionnaire pre- and postoperatively. Additionally, we evaluated the effect of informed consents on the postoperative pain, measured with the VAS scale, and the number of assistances calls during hospitalization as secondary outcomes. To assess the satisfaction level related to the whole process, we asked patients to rate their experience on a scale of 1-10, with 1 indicating “not satisfied” and 10 indicating “completely satisfied.”
Results
Overall, 166 patients were randomized 1:1 in each group. According to the multivariable regression model, the video-assisted informed consent significantly increased the difference between postoperative and preoperative STAI, reducing the level of anxiety. The video-assisted informed consent significantly predicted the number of assistance calls during the hospitalization.
Conclusions
Video-consent for ureteroscopies are a valid tool to improve patients’ satisfaction and awareness of the procedure. Video-consent is able to reduce patients’ anxiety related to the procedure and assistance calls during the postoperative period, resulting in a useful tool to administer a better-informed consent for endourological procedures.
Month: May 2024
The Impact of a Computer-Based Interactive Informed Consent for Surgery on Decision Conflict
The Impact of a Computer-Based Interactive Informed Consent for Surgery on Decision Conflict
Scientific Article
Sina Ramtin, Floor Davids, Amir Reza Farhoud, Raul Tejada, David Ring
The Journal of Hand Surgery, 12 May 2024
Abstract
Purpose
Informed consent for surgery can address the legal aspects of care while also being simple, informative, and empathic. We developed interactive informed consents and compared them with standard printed informed consents asking: (1) are there any factors associated with lower decision conflict or greater patient-rated clinician empathy including consent format? (2) Are there any factors associated with rating the consent process as informative, comfortable, and satisfying including consent format?
Methods
Ninety-four adult patients accepted an offer of surgery from one of three hand surgeons to address one of six common hand surgery diagnoses: carpal tunnel release, cubital tunnel release, trigger finger release, plate and screw fixation of a distal radius fracture, removal of a benign mass, including a ganglion cyst, and Dupuytren contracture release. Fifty-three patients were randomized to complete an interactive consent, and 41, a standard written consent. Symptoms of anxiety, depression, and unhelpful thoughts were measured. Patients completed the Decision Conflict Scale and the Jefferson Scale of Patient’s Perceptions of Physician Empathy and rated the consent as informative, comfortable, and satisfactory on a scale of 0–10.
Results
Greater decisional conflict was slightly associated with greater patient unhelpful thoughts about symptoms and was not associated with consent format. A higher rating of comfort with the consent process was slightly associated with patient choice to proceed with surgical treatment, but not with consent format. Accounting for potential confounding in multivariable analysis, a higher rating of the consent process as informative was slightly associated with patient preference for surgical over nonsurgical treatment,
Conclusions
The observation that an interactive consent form was not related to decision conflict or other aspects of patient experience suggests that such tools may not have much weight relative to the interaction between patient and clinician.
Clinical relevance
Efforts to improve informed consent may need to focus on the dialog between patient and surgeon rather than how information is presented.
Power to the people? Time to improve and implement patient decision aids to strengthen shared decision-making
Power to the people? Time to improve and implement patient decision aids to strengthen shared decision-making
Invited Commentary
Sandra B Lauck, Krystina B Lewis, Michelle Carter, Catriona Jennings
European Journal of Cardiovascular Nursing, 26 April 2024
Excerpt
For many people living with heart disease, the journey from their diagnosis to their consent for treatment and beyond is rarely a straight path. Barriers along the way include the maze of diagnostic testing and consultations, the steep learning curve to grasp what options might be appropriate and feasible, the evolving emotions accompanying the diagnosis and the need for treatment, and the diverse power dynamics that might be at play with health care providers. These challenges are often compounded by the need to manage their increasing burden of symptoms. In this complex context of care, patients must make decisions about their treatment, decisions that can have implications for their current and future health and quality of life.
Recognizing the importance of engaging and supporting patients to achieve a high-quality treatment decision in partnership with their providers, multiple cardiovascular guidelines have endorsed shared decision-making (SDM) as a core principle of patient-centred communication in multidisciplinary team best practices. This bi-directional exchange of information is a mechanism to promote patient empowerment, consideration of patients’ preferences, values and priorities, and ultimately, the provision of true informed consent. Patient decision aids (PtDAs) are evidence-based, patient-facing interventions developed according to international standards and designed to facilitate SDM. Patient decision aids explicitly state the decision to be made, provide information about options (inclusive of the option of not actively intervening and choosing watchful waiting/active surveillance) and outcomes associated with each option, while helping patients clarify their values and preferences…
Obtaining Consent for Research on Risky Behaviours Among Adolescents in Canada: A Scoping Review
Obtaining Consent for Research on Risky Behaviours Among Adolescents in Canada: A Scoping Review
Lillian MacNeill, A Luke MacNeill, Shelley Doucet, Alison Luke, Alex Goudreau
Journal Of Empirical Research On Human Research Ethics, 15 May 2024
Open Access
Abstract
This scoping review explores current practices for obtaining consent in research on risky behaviours among adolescents in Canada. The JBI methodology for scoping reviews was used. The database search was conducted in August 2021 and updated in November 2022. Papers published in 2010 or later were included. Extracted data included study characteristics, sample characteristics, and consent procedures. The review included 83 reports covering 57 studies. Nearly 60% of studies relied on adolescent self-consent for participation. Adolescent self-consent was more common than parental/guardian consent for studies using in-person research methods, older adolescent groups, and particularly vulnerable populations. Parental/guardian consent was more common for studies using younger age groups and general population samples. Adolescent self-consent was more common than parental/guardian consent for most risky behaviours covered by this review. These results provide insight into current consent practices in this area and offer guidance to researchers and institutional review boards in Canada.
Racial and Ethnic Disparity in Approach for Pediatric Intensive Care Unit Research Participation
Racial and Ethnic Disparity in Approach for Pediatric Intensive Care Unit Research Participation
Sarah L. Mayer, Michelle R. Brajcich, Lionola Juste, Jesse Y. Hsu, Nadir Yehya
Original Investigation Pediatrics
JAMA Network Open, 15 May 2024
Key Points
Question
Are sociodemographic factors associated with rates of approach and consent for pediatric intensive care unit (PICU) research?
Findings
This cohort study of 3154 children found disparities in approach and consent according to race and ethnicity, language, religion, and degree of social deprivation. Lower consent rates were partly mediated by lower approach rates, with reduced approach mediating approximately half of the lower rates of consent for Black children.
Meaning
In this study, multiple sociodemographic variables were associated with disparate consent rates for PICU research, and strategies to increase approaches could contribute to equitable enrollment in PICU studies.
Abstract
Importance
While disparities in consent rates for research have been reported in multiple adult and pediatric settings, limited data informing enrollment in pediatric intensive care unit (PICU) research are available. Acute care settings such as the PICU present unique challenges for study enrollment, given the highly stressful and emotional environment for caregivers and the time-sensitive nature of the studies.
Objective
To determine whether race and ethnicity, language, religion, and Social Deprivation Index (SDI) were associated with disparate approach and consent rates in PICU research.
Design, Setting, and Participants
This retrospective cohort study was performed at the Children’s Hospital of Philadelphia PICU between July 1, 2011, and December 31, 2021. Participants included patients eligible for studies requiring prospective consent. Data were analyzed from February 2 to July 26, 2022.
Exposure
Exposures included race and ethnicity (Black, Hispanic, White, and other), language (Arabic, English, Spanish, and other), religion (Christian, Jewish, Muslim, none, and other), and SDI (composite of multiple socioeconomic indicators).
Main Outcomes and Measures
Multivariable regressions separately tested associations between the 4 exposures (race and ethnicity, language, religion, and SDI) and 3 outcomes (rates of approach among eligible patients, consent among eligible patients, and consent among those approached). The degree to which reduced rates of approach mediated the association between lower consent in Black children was also assessed.
Results
Of 3154 children included in the study (median age, 6 [IQR, 1.9-12.5] years; 1691 [53.6%] male), rates of approach and consent were lower for Black and Hispanic families and those of other races, speakers of Arabic and other languages, Muslim families, and those with worse SDI. Among children approached for research, lower consent odds persisted for those of Black race (unadjusted odds ratio [OR], 0.73 [95% CI, 0.55-0.97]; adjusted OR, 0.68 [95% CI, 0.49-0.93]) relative to White race. Mediation analysis revealed that 51.0% (95% CI, 11.8%-90.2%) of the reduced odds of consent for Black individuals was mediated by lower probability of approach.
Conclusions and Relevance
In this cohort study of consent rates for PICU research, multiple sociodemographic factors were associated with lower rates of consent, partly attributable to disparate rates of approach. These findings suggest opportunities for reducing disparities in PICU research participation.
Ethical Frameworks of Informed Consent in the Age of Pediatric Precision Medicine
Ethical Frameworks of Informed Consent in the Age of Pediatric Precision Medicine
David Chen
Precision Medicine, 6 May 2024
Abstract
Precision medicine is an emergent medical paradigm that uses information technology to inform the use of targeted therapies and treatments. One of the first steps of precision medicine involves acquiring the patient’s informed consent to protect their rights to autonomous medical decision making. In pediatrics, there exists mixed recommendations and guidelines of consent related practices designed to safeguard pediatric patient interests while protecting their autonomy. Here, we provide a high-level, clinical primer of 1) ethical informed consent frameworks widely used in clinical practice and 2) promising modern adaptations to improve informed consent practices in pediatric precision medicine. Given the rapid scientific advances and adoption of precision medicine, we highlight the dual need to both consider the clinical implementation of consent in pediatric precision medicine workflows as well as build rapport with pediatric patients and their substitute decision-makers working alongside interdisciplinary health teams.
Editor’s note: The modern adaptions mentioned by the authors include having a two-step consent process, providing options for pediatric patients to exercise their right to re-consent for continued use of genomic data at the age of majority, and using broad consent strategies.
The Role of Parental Consent in Counseling for Minors: Requirement or Necessity?
The Role of Parental Consent in Counseling for Minors: Requirement or Necessity?
Novianti Novianti, Nandang Budiman, Nadia Aulia Nadhirah
Indonesian Journal of Guidance and Counseling Research, 27 April 2024
Abstract
The purpose of this study is to determine the Role of Parental Consent in Counseling Minors. This research uses the systematic literature review (SLR) method. Based on the results of the synthesis, the urgency of parental consent before the implementation of counseling for minors is as a condition, not a necessity, which means that it must only be fulfilled administratively so that counseling can be carried out but does not have a significant impact on the implementation of counseling. The conclusion of the study reveals that counselors must continue to prioritize the rights and trust of children in conducting counseling, the limits of decisions that can be taken by minors without intervention from parents need to be studied more deeply in further research. The contribution of this research can be used as one of the ethical references for school counselors both theoretically and practically, especially when dealing with minors.
Consent and Inclusion of People Living with Dementia (PLWD) in Research: Establishing a Canadian Agenda for Inclusive Rights-Based Practices
Consent and Inclusion of People Living with Dementia (PLWD) in Research: Establishing a Canadian Agenda for Inclusive Rights-Based Practices
Amanda Grenier, Deborah O’Connor, Krista James, Daphne Imahori, Daniella Minchopoulos, Nicole Velev, Laura Tamblyn-Watts, Jim Mann
Canadian Journal on Aging, 20 May 2024
Abstract
Background
People living with dementia (PLWD) may want to participate in research, but the guidelines and processes enacted across various contexts may prohibit this from happening.
Objective
Understanding the experiences of people with lived experiences of dementia requires meaningful inclusion in research, as is consistent with rights-based perspectives. Currently, the inclusion of PLWD in Canadian research is complex, and guidelines and conceptual frameworks have not been fully developed.
Methods
This research note outlines a three-year proof-of-concept grant on the inclusion and consent of PLWD in research.
Findings
It presents a brief report on some of the contradictions and challenges that exist in legislation, research guidelines, and research practices and raises a series of questions as part of an agenda on rights and inclusion of PLWD in research.
Discussion
It suggests conceptual, legal, and policy issues that need to be addressed and invites Canadian researchers to re-envision research practices and to advocate for law and policy reform that enables dementia research to align and respect the rights and personhood of PLWD.
Framework to elicit consent from lightly sedated mechanically ventilated intensive care patients in nursing practice
Framework to elicit consent from lightly sedated mechanically ventilated intensive care patients in nursing practice
Yoko Onishi, Yoshiko Murai, Emiko Nakajima
Japan Journal Of Nursing Science, 2 May 2024
Abstract
Aim
The study aimed to ascertain a framework of nursing practices to elicit consent from lightly sedated ventilated patients.
Methods
Study participants were nurses working in intensive care and critical care wards, whose observations and semi-structured interviews were assessed using a modified grounded theory approach.
Results
A total of 15 concepts were generated, from which three categories and three subcategories were generated. Category 1: Nurses taking the lead in providing assistance by sharing signs of change while continuing the invasive treatment, working to maintain the patient’s life, alleviation of pain, promotion of awareness of the current situation, and acclimating them to the treatment environment as the basis for building a relationship between patients and nurses. Category 2: Searching for points of agreement and reaching a compromise involves the nurse drawing out the patient’s thoughts, hopes, and expectations, and transforming the relationship into a patient-centered one by sharing goals with the patient in order to achieve them. Category 3: Organizing collaboration within care supported the patient’s ability to move safely while maintaining the patient’s pace to achieve shared goals, and guided the patient’s independent actions.
Conclusions
Even when patients recover from an acute life-threatening situation, their physical sensations remain vague and their functional decline continues. Rather than simply eliciting consent from patients, the structure of nursing practice to elicit such response from patients involves drawing out the patient’s thoughts, hopes, and expectations, as well as guiding the patient toward goals that they have created together with the nurse and utilizing the patient’s strengths to achieve these goals.
Exploring the consent process among pregnant and breastfeeding women taking part in a maternal vaccine clinical trial in Kampala, Uganda: a qualitative study
Exploring the consent process among pregnant and breastfeeding women taking part in a maternal vaccine clinical trial in Kampala, Uganda: a qualitative study
Research
Agnes Ssali, Rita Namugumya, Phiona Nalubega, Mary Kyohere, Janet Seeley, Kirsty Le Doare
BMC Medical Ethics, 16 May 2024
Open access
Abstract
Background
The involvement of pregnant women in vaccine clinical trials presents unique challenges for the informed consent process. We explored the expectations and experiences of the pregnant women, spouses/partners, health workers and stakeholders of the consent process during a Group B Streptococcus maternal vaccine trial.
Methods
We interviewed 56 participants including pregnant women taking part in the trial, women not in the trial, health workers handling the trial procedures, spouses, and community stakeholders. We conducted 13 in-depth interviews and focus group discussions with 23 women in the trial, in-depth interviews with 5 spouses, and 5 women not in the trial, key informant interviews with 5 health workers and 5 other stakeholders were undertaken.
Results
Decision-making by a pregnant woman to join a trial was done in consultation with spouse, parents, siblings, or trusted health workers. Written study information was appreciated by all but they suggested the use of audio and visual presentation to enhance understanding. Women stressed the need to ensure that their male partners received study information before their pregnant partners joined a clinical trial. Confidentiality in research was emphasised differently by individual participants; while some emphasised it for self, others were keen to protect their family members from being exposed, for allowing them to be involved in research. However, others wanted their community participation to be acknowledged.
Conclusion
We found that pregnant women make decisions to join a clinical trial after consulting with close family. Our findings suggest the need for an information strategy which informs not only the pregnant woman, but also her family about the research she is invited to engage in.
Please refer to the editor’s note regarding ‘Relational, Culturally-Conditioned, Decolonized Consent’ here.
Center for Informed Consent Integrity 