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Factors associated with organ donation by trauma patients in Nova Scotia.

BACKGROUND: Trauma patients represent a significant pool of potential organ donors (PODs), and previous research suggests that this population is underutilized for organ donation (OD). Our objective was to assess factors associated with OD in the trauma population. METHODS: We retrospectively analyzed OD in Nova Scotia over a 7-year period (2009-2016) using data from the Nova Scotia Trauma Registry and Nova Scotia Legacy of Life Donor Registry. All trauma patients who died in the hospital were included. Multiple logistic regression was used to assess factors associated with donation. We also

Sex between people with "mental retardation": an ethical evaluation.

Is sex between people with "mental retardation" [1] morally permissible and, if at all, under what conditions? This paper tries to answer this question, but only with regard to sex between biologically mature individuals with mild or moderate mental retardation. First, the concepts of "sexual activity" and mental retardation" are analysed briefly, which is challenging given the widely divergent and sometimes rather awkward definitions of these concepts. On the basis of this analysis, it is argued that the liberal principle of mutual consent, if taken as a necessary condition of permissible sex

Toward Consent in Molecular HIV Surveillance?: Perspectives of Critical Stakeholders.

BACKGROUND: The emergence of molecular HIV surveillance (MHS) and cluster detection and response (CDR) programs as key features of the United States (US) HIV strategy since 2018 has caused major controversies. HIV surveillance programs that re-use individuals' routinely collected clinical HIV data do not require consent on the basis that the public benefit of these programs outweighs individuals' rights to opt out. However, criticisms of MHS/CDR have questioned whether expanded uses of HIV genetic sequence data for prevention reach beyond traditional public health ethics frameworks. This study

The Use of Electronic Consent (eConsent) Within the Ketamine for Long-Lasting Pain Relief After Surgery (KALPAS) Multicenter Trial.

BACKGROUND: The informed consent process has traditionally taken place in person. The introduction of electronic consent (eConsent) has made remote consenting processes possible. Use of eConsent has increased since the COVID-19 pandemic. It has streamlined the process of consenting patients and has been shown to benefit the research study team and participants. ECONSENT IN THE KETAMINE ANALGESIA FOR LONG-LASTING PAIN RELIEF AFTER SURGERY KALPAS STUDY: The KALPAS study is a multicenter, double-blind, randomized controlled study investigating the effectiveness of ketamine in reducing chronic po

Patient-Reported Perceptions of Surgical Informed Consent Communication in Elective General Surgery: A Cross-Sectional Study in a Chinese Tertiary Hospital.

BACKGROUND: Informed consent supports voluntary surgical decision-making, yet patients' routine perceptions of consent communication remain insufficiently described. In China, where family involvement and time-pressured care are common, understanding how patients retrospectively perceive written and oral consent communication is important. METHODS: We conducted a cross-sectional survey of 627 consecutive adult patients undergoing elective general surgery in a tertiary general hospital in Fuzhou, Fujian Province, China. Participants were interviewed face-to-face on postoperative days 2-7 using

[Questioning the informed consent for conservation and research use of human biospecimens].

The availability for research of biobanked human biological materials and their derived data is submitted to several legal regulations, incl … ews with different actors of one of the hospital sites concerned by the biobank and the analysis of consent forms by a group of individuals in poverty situations, using focus-group method. The description of the context shows the emotional situation related to the announcement of cancer and therefore difficulties understanding complex information in that very m …

Factors determining vaccine uptake in Western Australian adolescents.

AIM: Adolescence is the final opportunity for a large-scale immunisation programme before adulthood. The Western Australian (WA) school-based vaccination programme provides Year 7 students with free vaccination against hepatitis B virus (HBV); diphtheria, tetanus and pertussis (dTpa); varicella zoster virus (VZV); and human papilloma virus (HPV). We aimed to identify factors determining consent form return and vaccination uptake. METHODS: Data were collected via a statewide, web-based database in 2009 and 2010. Proportions of students who returned a vaccine consent form, and completed HBV and

Perspectives and practices of counselling, consent and debriefing for cesarean sections: a mixed-methods study in two Indian states.

BACKGROUND: Effective counselling, consent, and debriefing (CCD) are essential for respectful, quality cesarean section (CS) services but li … tures. Women's signatures were mandatory in Karnataka. Public hospitals had standard short one-page consent forms in English, while private hospitals had detailed forms in local languages. The term debriefing was not known or used, and concerned practice was rarely observed. Variation in quality of CCD practices was observed with providers' attitudes and commun …

Immersive Virtual Reality for Enabling Patient Experience and Enrollment in Oncology Clinical Trials: A Feasibility Study.

Background/Objectives: Informed consent is a crucial part of the clinical trial enrollment process in which patients are asked to understand and provide approval for medical interventions. Consent forms can be complex and hinder patient comprehension, highlighting the need for novel tools to improve the patient enrollment experience. This feasibility study aimed to develop an immersive technology to enroll human subjects in oncology clinical trials and provide 3D avatar-based informed consent in a virtual reality (VR) environment. Methods: Clinical feasibility and the effects of head-mounted V…

Readability of Prostate Cancer Patient Education Materials: A Comprehensive Assessment Using Readability Metrics.

INTRODUCTION: Patient education materials (PEMs) play a vital role in ensuring that patients understand their medical conditions and treatment options. In prostate cancer, complex medical terminology can hamper comprehension and informed decision-making. This study evaluates the readability of prostate cancer PEMs to determine if they meet recommended standards for lay audiences. METHODS: A selection of standardized prostate cancer PEMs, including standard surgical consent forms and patient brochures from major German cancer organizations, was analyzed. Readability was assessed using establis…

Consenting to invasive contraceptives: an ethical analysis of adolescent decision-making authority for long-acting reversible contraception.

Since USA constitutional precedent established in 1976, adolescents have increasingly been afforded the right to access contraception without first obtaining parental consent or authorisation. There is general agreement this ethically permissible. However, long-acting reversible contraception (LARC) methods have only recently been prescribed to the adolescent population. They are currently the most effective forms of contraception available and have high compliance and satisfaction rates. Yet unlike other contraceptives, LARCs are associated with special procedural risks because they must be i

Informed consent for genetic research.

BACKGROUND: Rapid technological advances in genetic research and public concern about genetic discrimination have led to anticipatory safeguards in the informed consent process in the absence of legal examples of proven discrimination. Despite federal and state regulations to restrict access to personal health information, including genetic information, institutional review boards have required the addition of language to informed consent documents that warns about the risks of discrimination with participation in genetic research. OBJECTIVE: To determine the reasons that families refused con

Literacy in the health care system: a study on open heart surgery patients.

PURPOSE: To determine if patients recovering from open heart surgery were able to read and understand written discharge instructions and further to analyze the level of difficulty of standard discharge instructions and consent forms for open heart surgery. DATA SOURCES: After screening for visual acuity and efficiency, literacy was assessed with the Rapid Estimate of Adult Literacy in Medicine test (REALM) and comprehension was tested by a post-test of five questions based on the discharge instructions. Flesch-Kincaid scores were calculated on four sets of standard written discharge instructi…

Study protocol for a randomised controlled trial of consenting processes and their effects on patient decision-making when undergoing spinal injections: the Risks In Spinal Consenting for Surgery (RISCS) trial.

INTRODUCTION: There are major differences between legal and medical approaches to informed consent. Medically, consent is obtained prospectively for an intended procedure, to inform the patient of choices, risks and benefits, and to manage expectations. Legally, consent is reviewed retrospectively, usually following unmet expectations and/or the occurrence of complications. Recent legal cases relating to clinical negligence define the establishment of causation and breach of duty related to informed consent. However, there is no prospective evidence to validate the current judicial perspective

Translation approaches to support systemic anti-cancer therapy consent for individuals with limited English proficiency.

PurposeLimited English proficiency (LEP) is associated with poor cancer outcomes, and written information about systemic anticancer treatment (SACT) is often provided in English only. Unsupervised machine translation of medical information is common, but its effectiveness and accuracy are unclear. This study aimed to (a) compare professional and machine translation of written SACT information and (b) investigate whether providing a bilingual SACT consent form altered comprehension of key information during an interpreted SACT consent consultation.MethodsThis randomised study included healthy,

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… Out of a maximum Total Comprehension Score of 6, participants randomised to receive the bilingual consent form had a median score of 4 compared to 3 for those receiving the English-only consent form (Supplementary Fig. 2 ). … of translated consent forms limits oncologic clinical trial enrollment for limited English proficiency participants. …

Seeking consent for organ donation: Process evaluation of implementing a new Specialist Requester nursing role.

AIM: To explain the differences in organ donation consent outcomes of a new nursing role (Specialist Requesters) derived from the United States (US) compared with the existing nursing role (Specialist Nurses in Organ Donation). DESIGN: Thirty-month observational qualitative process evaluation: Implementation theory-informed analysis. METHODS: Qualitative content analysis of free text describing challenges, processes and practice from 996 bespoke routinely collected potential organ donor 'approach forms' from two regions: one where there was no difference, and one with an observed difference

Decision-making capacity for research participation among addicted people: a cross-sectional study.

BACKGROUND: Informed consent is a key element of ethical clinical research. Addicted population may be at risk for impaired consent capacity. However, very little research has focused on their comprehension of consent forms. The aim of this study is to assess the capacity of addicted individuals to provide consent to research. METHODS: 53 subjects with DSM-5 diagnoses of a Substance Use Disorder (SUD) and 50 non psychiatric comparison subjects (NPCs) participated in the survey from December 2014 to March 2015. This cross-sectional study was carried out at a community-based Outpatient Treatmen…

Fiberoptic endoscopic evaluation of swallowing (FEES): proposal for informed consent.

Fiberoptic endoscopic evaluation of swallowing (FEES) is now a first choice method for studying swallowing disorders on account of the various advantages it offers: easy to use, very well tolerated, allows bedside examination and is economic. Nevertheless, this diagnostic procedure is not without risks, the most probable consequences of which include discomfort, gagging and/or vomiting, vasovagal syncope, epistaxis, mucosal perforation, adverse reactions to topical anaesthetics and laryngospasm. The risks involved with FEES stress the importance of informing the patient of these; this is an im

Audio-visual presentation of information for informed consent for participation in clinical trials.

BackgroundInformed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented, for example, on the Internet or on DVD) are one such method. We updated a 2008 review of the effects of these interventions for informed consent for trial participation.ObjectivesTo assess the effects of audio-visual information interventions regarding informed consent compared with standard information or placebo audio-visual interventions regarding info

Practices and attitudes of herbalists regarding informed consent in Uganda: a qualitative study.

BACKGROUND: Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely ap … sibility within families or societies. Documented IC procedures are rare among herbalists, who deem consent forms unnecessary, although they recognize the potential benefits of IC in fostering trust and professionalism. Challenges hindering IC implementation included regulatory gaps, inadequate skills, and the absence of mechanisms to protect the intellectual p …