Informed Consent for Psychotherapy: The Moderating Role of Therapeutic Alliance, Prior Knowledge and Autonomous Motivation on Decision-Making and Treatment Expectation.

BACKGROUND: Informed consent is an ethical prerequisite for psychotherapy. There are no routinely used standardized strategies for obtaining informed consent. A new optimized informed consent consultation (OIC) strengthened treatment-relevant aspects. It remains unclear which factors influence the OIC efficacy regarding clinical and decision-related outcomes. METHODS: N = 122 adults were included in a randomized controlled online trial. Participants received an information brochure on psychotherapy (TAU; n = 61) or OIC + TAU (n = 61). The main and interaction effects of group allocation, therapeutic alliance, prior knowledge about psychotherapy and treatment motivation on treatment expectations, decisional conflict and capacity to consent were tested. Floodlight analyses were conducted for significant interactions. RESULTS: Large interaction effects were shown between treatment motivation and group allocation on treatment expectations (ß = -0.53) and between prior knowledge and group assignment on capacity to consent (ß = 0.68). The interaction between treatment motivation and group allocation was significant up to a motivation score of 5.54 (range: 1-7). The interaction between prior knowledge and group assignment was significant up to a knowledge score of 14.38 (range: 5-20). CONCLUSION: Moderator analyses indicated varying efficacy degrees for the OIC regarding decisional outcomes and expectation. Especially patients with little treatment motivation or low prior knowledge benefited from optimized information about the efficacy and possible side effects of psychotherapy. TRIAL REGISTRATION: PsychArchives (https://doi.org/10.23668/psycharchives.4929): 17.06.2021.

The Power of Proximity: Toward an Ethic of Accompaniment in Surgical Care.

Although the field of surgical ethics focuses primarily on informed consent, surgical decision-making, and research ethics, some surgeons have started to consider ethical questions regarding justice and solidarity with poor and minoritized populations. To date, those calling for social justice in surgical care have emphasized increased diversity within the ranks of the surgical profession. This article, in contrast, foregrounds the agency of those most affected by injustice by bringing to bear an ethic of accompaniment. The ethic of accompaniment is born from a theological tradition that has motivated work to improve health outcomes in those at the margins through its emphasis on listening, solidarity against systemic drivers of disease, and proximity to individuals and communities. Through a review of surgical ethics and exploration of a central patient case, we argue for applying an ethic of accompaniment to the care of surgical patients and their communities.

The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting.

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

What Is "Key Information"? Consideration of the Reasons People Do or Do Not Take Part in Research.

We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

Might the bioethical principle of individual decisional autonomy have a politically liberalizing effect on soft authoritarian communities?

According to the bioethical principle of individual decisional autonomy, the patient has a right of informed consent to any medical or experimental procedure. The principle is politically liberal by advocating significant individual freedom as guaranteed by law and secured by civil liberties. When practiced in illiberal communities, might it have a political liberalizing effect? I respond first by analyzing cross-national norms of individual decisional autonomy to identify tensions with illiberal community; second, by examining examining Singapore in a single case study to show that liberal bioethics does not promote political liberalization; and third, by showing that the possibility of practicing liberal bioethics in research, clinically as well as in education, does not require a democratic order, and that liberal bioethics is unlikely to encourage the liberalization of illiberal political communities. Hence, it may never contribute to the development of globally effective cross-national norms for the legal regulation of bioethical research and clinical practice. Fourth, to bolster this analysis, I anticipate several possible objections to various of its aspects.

Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III.

BACKGROUND: The process of obtaining prior informed consent for experimental treatment does not fit well into the clinical reality of acute and intensive care. The therapeutic window of interventions is often short, which may reduce the validity of the consent and the rate of enrolled participants, to delay trial completion and reduce the external validity of the results. Deferred consent and 'opt-out' are alternative consent methods. The SafeBoosC-III trial was a randomised clinical trial investigating the benefits and harms of cerebral oximetry monitoring in extremely preterm infants during the first 3 days after birth, starting within the first 6 h after birth. Prior, deferred and opt-out consent were all allowed by protocol. This study aimed to evaluate the use of different consent methods in the SafeBoosC-III trial, Furthermore, we aimed to describe and analyse concerns or complaints that arose during the first 6 months of trial conduct. METHODS: All 70 principal investigators were invited to join this descriptive ancillary study. Each principal investigator received a questionnaire on the use of consent methods in their centre during the SafeBoosC-III trial, including the possibility to describe any concerns related to the consent methods used during the first 6 months of the trial, as raised by the parents or the clinical staff. RESULTS: Data from 61 centres were available. In 43 centres, only prior informed consent was used: in seven, only deferred consent. No centres used the opt-out method only, but five centres used prior and deferred, five used prior, deferred and opt-out (all possibilities) and one used both deferred and opt-out. Six centres applied to use the opt-out method by their local research ethics committee but were denied using it. One centre applied to use deferred consent but was denied. There were only 23 registered concerns during the execution of the trial. CONCLUSIONS: Consent by opt-out was allowed by the protocol in this multinational trial but only a few investigators opted for it and some research ethics boards did not accept its use. It is likely to need promotion by the clinical research community to unfold its potential.

Are Psychedelic Experiences Transformative? Can We Consent to Them?

Psychedelic substances have great promise for the treatment of many conditions, and they are the subject of intensive research. As with other medical treatments, both research and clinical use of psychedelics depend on our ability to ensure informed consent by patients and research participants. However, some have argued that informed consent for psychedelic use may be impossible, because psychedelic experiences can be transformative in the sense articulated by L. A. Paul (2014). For Paul, transformative experiences involve either the acquisition of knowledge that cannot be obtained in any other way or changes in the self. Either of these characteristics may appear to undermine informed consent. This article argues, however, that there is limited evidence that psychedelic experiences are transformative in Paul's sense, and that they may not differ in their transformative features from other common medical experiences for which informed consent is clearly possible. Further, even if psychedelic experiences can be transformative, informed consent is still possible. Because psychedelic experiences are importantly different in several respects from other medical experiences, this article closes with recommendations for how these differences should be reflected in informed consent processes.

Understanding the language barriers to translating informed consent documents for maternal health trials in Zambia: a qualitative study.

OBJECTIVE: Providing comprehensible information is essential to the process of valid informed consent. Recruitment materials designed by sponsoring institutions in English-speaking, high-income countries are commonly translated for use in global health studies in other countries; however, key concepts are often missed, misunderstood or 'lost in translation'. The aim of this study was to explore the language barriers to informed consent, focusing on the challenges of translating recruitment materials for maternal health studies into Zambian languages. DESIGN: We used a qualitative approach, which incorporated a multistakeholder workshop (11 participants), in-depth interviews with researchers and translators (8 participants) and two community-based focus groups with volunteers from community advisory boards (20 participants). Content analysis was used to identify terms commonly occurring in recruitment materials prior to the workshop. The framework analysis approach was used to analyse interview data, and a simple inductive thematic analysis approach was used to analyse focus group data. SETTING: The study was based in Lusaka, Zambia. RESULTS: The workshop highlighted difficulties in translating research terms and pregnancy-specific terms, as well as widespread concern that current templates are too long, use overly formal language and are designed with little input from local teams. Framework analysis of in-depth interviews identified barriers to participant understanding relating to design and development of recruitment materials, language, local context and communication styles. Focus group participants confirmed these findings and suggested potential solutions to ensure the language and content of recruitment materials can be better understood. CONCLUSION: Our findings demonstrate that the way in which recruitment materials are currently designed, translated and disseminated may not enable potential trial participants to fully understand the information provided. Instead of using overly complex institutional templates, recruitment materials should be created through an iterative and interactive process that provides truly comprehensible information in a format appropriate for its intended participants.

[Key considerations in the process of assent in children and adolescents: an integrative review]. / Consideraciones claves en el proceso de asentimiento en niños, niñas y adolescentes: revisión integrativa.

The participation of children and adolescents in research requires bioethical measures to safeguard their autonomy and well-being through the application of the informed consent process. OBJECTIVE: To critically analyze the factors involved in the process of assent/consent in children and adolescents in research. METHODOLOGY: Integrative review of scientific evidence carried out between April and June 2023, from manuscripts published between 2014 and 2023 in Web of Science, PubMed, CUIDEN, and CINAHL databases, using the descriptors Process Assessment OR Assent AND Informed Consent AND Bioethics AND Minors OR Child OR Children AND adolescent OR teenage AND Pediatrics AND Research. Twenty primary articles were found, and the results were subjected to content analysis. RESULT: Three categories were identified: shared consent/assent; child-specific factors for giving assent (age of the child to give assent and autonomy of the child to give assent), and key aspects of the assent process (assent form format; assent form content, and context for applying the assent process). CONCLUSIONS: The assent process is a key tool for legal and ethical compliance with the rights of children and adolescents in clinical trial participation. In addition to favoring participation in informed decision-making together with the parents, it is also an instance where the participant's competencies, capacity for understanding, and autonomy are valued.

Informed consent in cancer clinical care: Perspectives of healthcare professionals on information disclosure at a tertiary institution in Uganda.

INTRODUCTION: While there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners' experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals' perspectives on information disclosure during the consenting process in cancer care. METHODS: A qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results. RESULTS: There were five key themes, and these included information disclosure to patients; assessment of patients' cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process. CONCLUSION: Overall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.

Cribado de Enfermedad Renal Crónica en Farmacia Comunitaria. Estudio CRIERFAC: descripción de la metodología / Screening for Chronic Kidney Disease in Community Pharmacy. CRIERFAC study: description of the methodology

La enfermedad renal crónica (ERC) es la presencia de alteraciones de estructura o función renal con consecuencias para la salud. Suele considerarse cuando el filtrado glomerular estimado (FGe) baja de 60 ml/min/1,73m2. Su progresión lleva al tratamiento renal sustitutivo (diálisis o trasplante) cuando baja de 15 ml/min/1,73m2. El cribado en poblaciones de riesgo ha demostrado ser coste-efectivo. El objetivo de este trabajo es hacer un cribado de ERC en farmacia comunitaria y en esta publicación exponemos la metodología de forma detallada y justificada.Metodología: los farmacéuticos de las farmacias comunitarias participantes seleccionan pacientes que cumplan criterios de inclusión y no de exclusión. Se les mide la creatinina mediante punción en el dedo y se calcula el FGe con la fórmula CKD-EPI. Si es menor de un determinado valor, que depende de la edad, se deriva al médico de atención primaria.Resultados: 141 de un total de 200 farmacias participaron en el estudio. 2.116 pacientes fueron reclutados y hubo una pérdida de 116 pacientes, alcanzando un tamaño muestral final de 2.000 pacientes.Discusión: El protocolo ha sido implementado con éxito por los farmacéuticos comunitarios y ha tenido una excelente acogida por parte de los usuarios de la farmacia comunitaria. El ajuste por edad de los puntos de corte para FGe aporta un filtro adicional novedoso, con el objetivo de no sobrecargar los centros de atención primaria con potenciales derivaciones de falsos positivos. La confirmación del diagnóstico queda sujeta a la comunicación voluntaria por parte del paciente al farmacéutico.(AU)

[Shared decision-making in metaclinical medicine: from informed consent to shared probability]. / Il processo decisionale condiviso nella medicina metaclinica: dal consenso informato alla probabilità condivisa.

At the dawn of "metaclinical medicine" era, shared decision-making represents the overcoming of modern medicine guidelines and classical medicine experience. The patient's life plan, the doctor's health plan, the scientist's evidence-based plan, the administrator's plan and the beliefs of the society for healthcare options should be integrated into the shared decision-making process to avoid patient's unrealistic expectations, doctor's self-referential and defensive medicine, the science without compassion of the scientist, the administered medicine of the politician, the herd mentality of artificial intelligence. For a doctor who must evaluate according to science and conscience, it becomes difficult to make decisions about a patient who thinks that there can be "no decisions about me without me". It risks being a pure declamatory statement in the absence of clinical knowledge and the associated concept of probability. The idea of moving from informed consent to shared probability is convenient for both the doctor and the patient but not for litigation professionals. Even in metaclinical medicine, clinical decision support systems, if well governed, would facilitate the choice of the best treatment according to the definition of absolute risk reduction and the number of patients to be treated to avoid an event, leaving it up to the doctor-patient relationship the narrative and the choice of the most appropriate treatment, which also requires taking care of the emotional and compassionate aspects.

Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study.

BACKGROUND: Participants considering early-phase cancer clinical trials (CTs) need to understand the unique risks and benefits prior to providing informed consent. This qualitative study explored the factors that influence patients' decisions about participating in early-phase cancer immunotherapy CTs through the ethical lens of relational autonomy. METHODS: Using an interpretive descriptive design, interviews were conducted with 21 adult patients with advanced cancer who had enrolled in an early-phase CT. Data was analyzed using relational autonomy ethical theory and constant comparative analysis. RESULTS: The extent to which participants perceived themselves as having a choice to participate in early-phase cancer immunotherapy CTs was a central construct. Perceptions of choice varied according to whether participants characterized their experience as an act of desperation or as an opportunity to receive a novel treatment. Intersecting psychosocial and structural factors influenced participants' decision making about participating in early-phase cancer immunotherapy trials. These relational factors included: (1) being provided with hope; (2) having trust; (3) having the ability to withdraw; and (4) timing constraints. CONCLUSIONS: Findings highlight the continuum of perceived choice that exists among patients with cancer when considering participation in early-phase cancer immunotherapy CTs. All participants were interpreted as exhibiting some degree of relational autonomy within the psychosocial and structural context of early-phase CT decision making. This study offers insights into the intersection of cancer care delivery, personal beliefs and values, and established CT processes and structures that can inform future practices and policies associated with early-phase cancer immunotherapy CTs to better support patients in making informed decisions.