What is helpful and unhelpful when people try to withdraw from antipsychotics: An international survey.

OBJECTIVE: Antipsychotics remain the first-line treatment for people diagnosed with psychotic disorders despite adverse effects which lead many people to stop their medication. Many stop without the support of the prescriber, who may fear relapse. The objective of this study is to better understand the process of withdrawal from antipsychotics, from the perspective of people taking antipsychotics. DESIGN: Online survey. METHODS: An international online survey elicited quantitative responses about pre-withdrawal planning (560) and qualitative responses about what was helpful and unhelpful when withdrawing from antipsychotics (443). Responses came from users of antipsychotics in 29 countries. RESULTS: Forty-seven per cent did not consult their psychiatrist before discontinuing. Only 40% made preparations, most commonly making a plan, gathering information and informing family. The most frequently reported helpful factors were focussing on the benefits of getting off the drugs (including ending adverse effects and feeling more alive), information about withdrawal symptoms and how to withdraw safely, withdrawing slowly, and support from psychologists, counsellors and psychotherapists. The most common unhelpful factor was the psychiatrist/doctor, largely because of their lack of knowledge, refusal to support the patient's wishes and the threat or use of coercion. CONCLUSIONS: Evidence-based, respectful, collaborative responses to patients' concerns about adverse effects and desires to withdraw would probably reduce relapse rates and improve long-term outcomes. It would definitely help end pervasive breaching of the principle of informed consent and human rights legislation.

Consent in Limb Lengthening Surgery: Predicting the True Incidence of Material Risk.

Aim: The consent process involves supported decision-making between the surgeon and the patient. Both potential benefits and material risks of the procedure require explanation, with adequate time for reflection. The complexity of limb reconstruction surgery includes the potential for multiple types of complications. In an attempt to delineate the material risks in lower limb lengthening, a literature review was undertaken to ascertain the published rates of complications. Materials and methods: A review of articles from 2003 to 2023 via PubMed and Google Scholar, including keywords 'lengthening', 'tibia', 'lengthening nail' and 'external fixator' was undertaken. Studies with a minimum of 20 patients, undergoing lengthening of the femur, tibia, or both by an external fixator and/or an intramedullary lengthening nail were included for analysis. Complications were reported according to Paley's problems, obstacles, and complications. Results: Twenty-two papers met the inclusion criteria. The commonest complications listed following lengthening using an external fixator were pin site infections (52% in the femur and 18.8% in the tibia), delayed consolidation (8.3%), bone re-fracture (13%), and joint stiffness (18.8%). Following femoral lengthening using the intramedullary lengthening nails reported complication rates were lower, including implant issues (8%) and delayed consolidation (6%). Conclusion: Patients require a full understanding of both benefits and potential harms when undergoing any surgical intervention. Our study has identified the published rates of complications following lower limb lengthening. These figures can be used to guide the consultation and enable surgeons to audit their own surgical results against the published literature. How to cite this article: Makvana S, Robertson A, Britten S, et al. Consent in Limb Lengthening Surgery: Predicting the True Incidence of Material Risk. Strategies Trauma Limb Reconstr 2024;19(2):61-66.

Role of procedure-specific consent forms in clinical practice: a systematic review.

INTRODUCTION: Consent forms play an active role in the consent process with generic, handwritten consent forms (GCF) often the standard across the National Health Service. Increasingly, procedure-specific consent forms (PSCF) are being used as an alternative. However, concerns remain about whether they meet the standard for consent. We therefore conducted a systematic review with the objectives of investigating evidence for PSCF, study methodology and medicolegal criteria. METHODS: This systematic review was prospectively registered on PROSPERO (CRD42023392693) and conducted from 1 January 1990 to 17 March 2023 using the MEDLINE, Embase, CINAHL, CENTRAL and Emcare databases. A grey literature search was also performed. All studies evaluating PSCF in medical and surgical settings were included. Risk-of-bias analysis was performed using 'RoB 2' and 'ROBINS-I'. Meta-analysis was not possible because of the results' heterogeneity. FINDINGS: We identified 21 studies investigating PSCF with no systematic reviews and meta-analyses reported. Most studies were quality improvement projects (n = 10) followed by randomised studies (n = 5). No definitive legal guidance for PSCFs and no studies assessing their role in litigation post-procedural complications were identified. PSCFs were associated with improved documentation (70%-100%; n = 11) and legibility (100%; n = 2) compared with GCF. Randomised studies (n = 4) investigating patient understanding and recall for PSCF were inconclusive compared with GCF. CONCLUSIONS: The heterogeneous evidence available merely demonstrates superior documentation of PSCF compared with GCF. Studies do not adequately investigate the impact on informed consent and fail to address the associated legal concerns. Further randomised studies with patient-centric outcomes and consideration for medicolegal criteria are needed.

Ethical challenges in qualitative sociology: a systematic literature review.

Qualitative researchers often encounter ethical challenges during their research process. Due to the large number of papers in which researchers reflect on specific and various ethical challenges within their projects, it proves difficult to keep track of them. To capture these reflexive practices, we conducted a literature review of 72 papers in sociology. Our review shows who reflects on research ethics and when and where such reflections occur. We identify 11 ethical issues that sociologists reflect on. Some issues address the challenges of implementing established ethical principles, such as (1) informed consent, (2) voluntary participation, (3) avoiding harm, (4) anonymization, and (5) confidentiality. Others go beyond these principles and refer to (6) the relationship between researchers and participants, (7) power asymmetries, (8) protecting yourself as a researcher, (9) deviant actions, (10) covert research, and (11) leaving the field. Our findings help researchers gain an overview of ethical challenges, enhancing their reflexivity.

Challenges in Paediatric Xenotransplantation: Ethical Components Requiring Distinct Attention in Children and Obligations to Patients and Society.

The transplantation of non-human organs into humans, or xenotransplantation (XTx), has recently garnered new attention and is being developed to help address the problem of organ scarcity in transplantation. Ethical issues surrounding XTx have been studied since initial interest arose decades ago and have experienced renewed discussion in the literature. However, the distinct and relevant differences when applied to children has largely been overlooked with few groups attending to the concerns that XTx in children raises. In this paper, we explore ethical challenges to be expected in paediatric XTx, in particular exploring organ sizing concerns, infectious risks, psychological burdens, and issues of moral hazard. We review these domains with the aim of highlighting the implications of pursuing paediatric XTx and the cross-disciplinary approach needed to solve these issues. Children require a unique analysis from a bioethical perspective to best prepare for the issues XTx presents.

The role of institutional ethics committees in Austria : Report of the Commission on Ethics and Scientific Integrity of the Karl Landsteiner University of Health Sciences 2018-2023.

Research involving human subjects or identifiable human material and data must be assessed by an ethics committee. The Karl Landsteiner University of Health Sciences has established a Commission on Ethics and Scientific Integrity to evaluate medical research conducted by its faculty and students and at its affiliated hospitals.All projects submitted to the Commission on Ethics and Scientific Integrity between 2018 and 2023 were analyzed regarding their major characteristics, the duration of the evaluation process, and votes issued.A total of 520 applications were electronically submitted during the observation period. Most of the studies were retrospective data analyses in the field of oncology, psychology and surgery. Most studies included less than 100 volunteers. Of the applications 50% received a final vote within 5 months, during which several revision rounds took place. Overall, about 77% of votes issued during the observation period were positive and 2% were rejections. In 11% files were closed due to withdrawal. In 11% final votes were pending at the end of the observation period due to requests for revisions.Our results emphasize the importance of institutional ethics committees using the example of the Commission on Ethics and Scientific Integrity at the Karl Landsteiner University. Such committees fill a gap in evaluating research not covered by Austrian legal regulations. Continuous development of standards, operating procedures, and national and international collaborations are required to assess and minimize risks to trial subjects and to provide a safe and productive environment for research in human medicine and related fields.

Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives.

The research team, prospective participants, and written materials all influence the success of the informed consent process. As digital health research becomes more prevalent, new challenges for successful informed consent are introduced. This exploratory research utilized a human centered design process in which 19 people were enrolled to participate in one of four online focus-groups. Participants discussed their experiences with informed consent, preferences for receiving study information and ideas about alternative consent approaches. Data were analyzed using qualitative methods. Six major themes and sixteen sub-themes were identified that included study information that prospective participants would like to receive, preferences for accessing information and a desire to connect with research team members. Specific to digital health, participants expressed a need to understand how the technologies worked and how the volume of granular personal information would be collected, stored, and shared.

Women's reflections on induction of labour and birthing interventions and what they would do differently next time: A content analysis.

BACKGROUND: Induction of labour (IOL) and birth intervention is increasingly conducted in Australia, and rates of maternal dissatisfaction and birth trauma are also on the rise. METHODS: The Birth Experience Study (BESt) national survey was conducted to explore women's experiences of birthing in Australia. This content analysis categorises components pertaining to IOL, and women's responses to the open-ended question: "Would you do anything different if you were to have another baby?" FINDINGS: In total, 591 responses on IOL resulted in 819 coded comments being coded into multiple categories/subcategories. In the first main category 'increasing the chance of a spontaneous labour next time by resisting IOL' (93.3 %), three subcategories were identified: 'I would resist the pressure or refuse, especially if not a good indication' (54.8 %, 419); 'I will await spontaneous onset or delay the IOL until later' (25.0 %, 191); and 'I will be better informed next time' (20.2 %, 154). In the second main category 'accepting IOL was necessary or desirable' (6.7 %), two subcategories were identified: 'my IOL was justified or desired' (38.2 %, 21) and 'my IOL was justified or desired, but if there is a next time, I'd want more say in what happens' (61.8 %, 34). CONCLUSION: Overwhelmingly women expressed a desire to avoid IOL, along with the intention to: resist pressure, allow more time for spontaneous labour onset, and arm themselves with more knowledge to advocate against non-medically indicated justifications. Amongst the minority accepting of their previous IOLs, the majority stated wanting more say regarding when and how IOL was conducted.

Ethical constraints and dilemmas in the provision of in-vitro fertilization treatment in Ghana: from the perspectives of experts.

BACKGROUND: Infertility presents both medical and public health challenges, with in vitro fertilization (IVF) emerging as a prominent solution, particularly when other alternatives are exhausted. However, IVF treatment raises significant ethical questions that have been under explored in the Ghanaian context. This study aimed to explore ethical constraints and dilemmas in the provision of in vitro fertilization (IVF) treatment in Ghana. METHODS: A descriptive phenomenological qualitative design was employed. Purposive sampling techniques were used to recruit 12 participants including ART experts from three in vitro fertilization (IVF) centres, ethicists and a legal practitioner. In-depth face-to-face interviews guided by an open-ended interview guide were conducted. Thematic analysis of the interviews was performed to identify major themes. RESULTS: Providing IVF treatment in Ghana raises several ethical issues, including inequitable access due to high costs and limited availability, which favour wealthier individuals and leave marginalized populations with fewer options. There are significant ethical considerations in balancing the potential benefits of successful IVF treatment outcomes against the health risks and emotional tolls on patients. Decisions about the fate of surplus embryos present moral dilemmas, including whether to preserve, donate, or discard them. Differing personal beliefs about the moral status of the embryo further complicate the ethical landscape. Ensuring informed consent is challenging due to the complex medical, ethical, and emotional implications of IVF treatment, potentially leading to compromised consent. Additionally, there are ongoing risks of breaches in confidentiality, given the sensitive nature of reproductive health data and the importance of protecting patient privacy. CONCLUSION: This study revealed that several ethical dilemmas confront both healthcare providers and couples in the process of IVF. There is an urgent need for the development of clear and uniform regulations to govern the practice of IVF treatment in Ghana, with further attention given to mitigating financial barriers and enhancing support systems for couples considering IVF treatment.

Enhancing patient-provider encounters when proposing SDF therapy by utilizing a qualitative analysis of parental feedback.

Purpose: Silver Diamine Fluoride (SDF) is a minimally invasive option for caries arrest, part of a paradigm shift in the management of pediatric dental caries. The perspective of parents regarding the long-term pros and cons of this therapy should be understood in order to achieve optimal patient-centered care. Methods: This study used Constant comparative analysis as an analytic approach, applying the Precaution-Adoption Process Model (PAPM) as the Grounded Theory framework in the qualitative analysis of 30 parental unformatted, spontaneous comments collected at the end of a questionnaire to evaluate their satisfaction with treatment provided at a University Clinic. Results: Our analysis provided important insights about the factors that influenced the parents' decision to act and have their child receive SDF therapy, their perception of the outcomes, the necessary follow-ups after the therapy, and what impacted on their overall satisfaction with the completed procedure. Both positive and negative themes were identified. The positive themes point to SDF treatment's ease of application and addressing the immediate treatment needs on children with limited cooperation. The negative themes identified the adverse consequences of SDF treatment, specifically, the duration and appearance of the cosmetic consequences, as well as the parents' misunderstandings and incorrect expectations of the long-term sustainability of the treatment, which in many instances requires further interventions. It was also evident from the parents' comments that they needed additional educational guidance on other aspects of the treatment, such as the necessity for clinical follow-ups, information that impacted parents' overall satisfaction with the treatment their child received. Conclusion: Our results highlight the need to discuss the short and long term benefits of the treatment, as well as, its short and long-term limitations. Specifically, while it is important to discuss immediate outcomes and consequences, such as the ease of treatment and the resultant staining, to ensure that parental consent for the treatment is truly well-informed, it is also important to prepare parents, when this procedure is initially proposed, of the likely need for additional oral care interventions in the future.

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 applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent. METHODS: To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were conducted. The data were analyzed thematically using NVivo version 12 software. RESULTS: Sixteen of the twenty-one participants acquired oral herbal medicine knowledge from their relatives. Although a positive inclination toward obtaining IC was evident, the focus was on disclosing basic information. Discussions of alternative treatments and herbal specifics were less frequent. Disease management decisions often involve shared responsibility 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 property rights of herbal medicine. CONCLUSION: This study illuminates how educational, cultural, familial, and regulatory factors influence herbalists' practices and attitudes toward informed consent.

Capacity to consent: a scoping review of youth decision-making capacity for gender-affirming care.

BACKGROUND: Transgender and gender expansive (TGE) youth often seek a variety of gender-affirming healthcare services, including pubertal suppression and hormone therapy requiring that TGE youth and their parents participate in informed consent and decision making. While youth must demonstrate the ability to understand and appreciate treatment options, risks, benefits, and alternatives as well as make and express a treatment choice, standardized approaches to assess the capacity of TGE youth to consent or assent in clinical practice are not routinely used. This scoping review identified the currently available data regarding adolescent capacity to consent to gender-affirming medical treatments. METHODS: Articles relevant to assessing adolescent capacity for clinical decision-making were identified using OVID Medline, Web of Science, and PubMed. Articles were reviewed and thematically analyzed. RESULTS: Eight relevant articles were identified using three tools for measuring adolescent clinical decision-making capacity: Measure of Understanding, Measure of Competence, and MacArthur Competence Assessment Tool (MacCAT). These studies explored hypothetical treatment decisions, mental health treatment decisions, HIV treatment decisions, genetic testing decisions, and gender-affirming medical decisions. Only one study specifically examines the capacity of TGE youth to consent to medical treatments. Age was correlated with capacity in most, but not all studies. Other studies found cognitive measures (IQ, literacy, numeracy) may impact important aspects of capacity (understanding and reasoning). CONCLUSIONS: For clinicians caring for TGE youth, tools such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) may prove useful, in conjunction with consideration of youth developmental abilities and utilization of shared decision-making practices. A standardized, collaborative approach to assessing TGE youth capacity would benefit TGE youth and their parents, and allow clinicians to more easily resolve ethical concerns.

Practices of Informed Written Consent for Elective Urological Procedures at a Tertiary Care Hospital in Sudan.

Objective This study aimed to assess informed consent practices in elective urological surgeries at a tertiary care facility. Materials and methods A retrospective cross-sectional survey was carried out between March 1, 2023 and April 1, 2023, at the Department of Urology, Omdurman Military Hospital, Sudan. We included all patients who had undergone elective urological procedures under local, spinal, or general anesthesia. The medical records were accessed to analyze the consent forms' standards. A total of 42 consent forms were included and analyzed. We use the General Medical Council's (GMC) Guidance on Professional Standards and Ethics for Doctors: Decision Making and Consent, and the Royal College of Surgeons (RCS) of England's Consent: Supported Decision-Making as the standard for our study. The GMC and the RCS of England have provided comprehensive and standardized guidelines for obtaining informed written consent, including indications, benefits, risks involved, and alternatives in addition to demographics, patient details, responsible consultant, diagnosis, and title of the surgery, intended benefits, probable risks, type of anesthesia, consenting doctor's name, designation, and signature, and the patient's signature and name. Results A total of 42 consent forms were included. The diagnosis and the intended surgical procedure were mentioned in all consents. The potential benefits and risks were discussed in 36 (85.7%) and 18 (42.9%) cases, respectively. The type of anesthesia was discussed in 39 (92.9%) of cases. The likely result of not having the procedure and the alternative treatment: Recorded completion rates of 10 (23.8%) and 12 (28.6%), respectively. Patient demographics were completely documented in 41 (97.6%) forms. Senior doctors were only involved in 14 (33.3%) of the consents. Details of the consenting doctor, including name, title, and signature, were present in 30 cases (71.4%), and the date of signing the consent was documented in 38 cases (90.5%). The completeness of the consent form correlated with the level of the doctor obtaining it, with consultants achieving the highest completion rates (100%), followed by registrars (66.7%) and medical officers (35.7%). Conclusion The current practices of informed consent were found to be substandard. Handwritten consent forms do not adhere to the recommended guidelines for informed consent in elective urological procedures. It is preferable to utilize a pre-designed consent form, allowing for personalized additions based on the patient's specifics. Our recommendation is to organize an educational session for junior doctors to emphasize proper consent procedures, and deepen their knowledge of common urological elective procedures, and associated risks. This approach promotes adherence to best clinical practices and minimizes the risk of legal challenges.

Bias in obtaining broad consent in a German general practice? - Preliminary results from a cross-sectional study.

Background: The growing importance of collecting Broad Consent (BC) for research utilizing electronic health records in Germany has brought attention to the need for a deeper understanding of potential selection bias in the process. Since 2020, the BeoNet-Halle outpatient database has been collecting anonymous and pseudonymous patient data from primary care and specialty practices throughout Germany, with the practice being an integral part of this data collection effort. The primary objective of the pilot study is to explore potential socioeconomic discrepancies between patients who provided BC and the general practice population. Method: This is a single-center, cross-sectional study. The study was performed with patients from one Medical Care Center including eight GPs. We categorized patients with at least one interaction with a general practitioner from March 2021 to January 2023 into two sets: patients who approved BC versus a randomly chosen representative sample (RS) of non-BC inquirers. We mailed a sociodemographic survey to both groups. Results: A total of 561 patients were analyzed, with the BC group responding more actively (60.7%) than the RS group (29.7%). Age and gender were similar between the BC group and RS group. Being widowed, divorced, or unmarried and being neither open nor hostile toward research was associated with an increased likelihood of giving consent. Analysis of personality traits did not show any impact on giving consent. Conclusions: Overall, this study outlines that there is some bias between BC and RS. Possible associations in BC decisions that offer insights into complex decisions to participate in medical research are marital status, immigrant background, income, and age. Findings emphasize the potential of BC for outpatient research, warranting further investigation to optimize its application in the general practice setting.

Data professionals' attitudes on data privacy, sharing, and consent in healthcare and research.

Objective: Individuals who work on health data systems and services are uniquely positioned to understand the risks of health data collection and use. We designed and conducted a survey assessing the perceptions of those who work with health data around health data consent, sharing, and privacy practices in healthcare and clinical research. Methods: A 43-item online survey was distributed via a market research firm to individuals (18+) who work with health data in the United States from March to April 2023. Descriptive statistics were calculated for all variables. Associations with demographic variables were assessed using Pearson's X 2 tests and ordinal logistic regression. Results: Most of our respondents (61.7%) reported that they would trust people to use their health data across various sectors, but more respondents trusted those working in academic medical research (86.5%) and healthcare offices (89.9%) compared to those working in industry (68.2%). Despite this reported trust, a strong majority believed that individuals should have complete control over their health data (97.3%), specific consent should be obtained for each use of their health data (92.0%), and that there should be higher standards of consent and privacy for health records data than other types of data (93.7%). Conclusions: Based on our findings, we might infer that people who work with health data generally trust institutions across sectors to protect their health data. However, many would prefer to have complete control over who has access to their health data and how it is used. These insights should be explored further through qualitative studies.

Reevaluating Informed Consent: Integrating Shared Decision-Making into Spinal Surgery for Better Patient Outcomes.

STUDY DESIGN: Narrative review. OBJECTIVES: The objectives of this study were to answer the following questions: (1) What is the quality of informed consent in spine surgery, including both neurosurgery and orthopaedic spine surgery? (2) What limitations impede the ability of surgeons to engage in effective shared decision-making (SDM) and obtain adequate informed consent? (3) What strategies and solutions may improve the quality of informed consent and SDM? (4) What factors decrease the incidence of litigation in spine surgery? METHODS: N/A. RESULTS: SDM is a collaborative process where patients are involved in their treatment choices through open communication about risks, alternatives, and postoperative expectations. Informed consent is a vital component of this process, ensuring that patients are fully informed and empowered to make decisions based on their values and preferences. This review highlights the current state of informed consent within the context of SDM in spine surgery and explores how enhancing this process can improve patient outcomes, reduce dissatisfaction, and decrease litigation. By emphasizing patient autonomy and improving the quality of risk communication, SDM fosters better physician-patient relationships and more positive clinical outcomes. CONCLUSIONS: Orthopaedic surgery and neurosurgery are highly litigated specialties, with failure to obtain informed consent frequently cited in lawsuits. These legal challenges are costly and time-consuming for both physicians and patients. Integrating SDM into the informed consent process can help mitigate these issues, leading to improved patient satisfaction and fewer legal disputes.

Attitudes and awareness in autonomous decision on medical treatment or inclusion in clinical trials amongst Slovenian adolescents: an online survey.

BACKGROUND: In Europe and elsewhere in the world, activities are taking place to improve the awareness of children and adolescents (hereinafter: adolescents) regarding their rights and obligations in autonomous decision-making about their own medical treatment and participation in clinical research. METHODS: The cross-sectional survey of adolescents was carried out using an anonymous online questionnaire. We obtained consent from the Commission of the Republic of Slovenia for Medical Ethics. Participating young people were invited through the network of primary and secondary schools, the Society of Dystrophy of Slovenia and through the dissemination of electronic messages. The online questionnaire was open from April 25 to May 6, 2023. Young people aged 13 to 20 joined the survey. The association between several factors and awareness of the minimum age limit was tested by univariate logistic regression. All statistical testing was performed at a significance level of 0.05. RESULTS: The responses of 458 respondents were analysed, of which 281 were male. Only 8.3% of participating adolescents knew the age limit set by law for autonomous decision-making about medical treatment at 15 years old. Most answered that a medical institution should inform them about their rights (62.4%). Only 5.02% responded that they do not need their parents' consent when making decisions; 2.6% of respondents answered that they autonomously decided to undergo treatment without their parents' knowledge. The majority obtained information about treatment from a doctor (more than 70%); 42.8% were in favour of new forms of treatment, especially chronic patients (more than 70%); 44.8% had already heard about clinical research, most of them through the media (55.4%); 70% of the respondents answered correctly about making an autonomous decision about participation in research at the age of 18. About three-quarters (75.6%) of respondents who had heard of clinical research believe that an individual should be paid for participating. CONCLUSIONS: Our research showed insufficient awareness of the age limit of adolescents regarding medical treatment decisions and clinical research. The prevailing view is that health professionals should inform young people more about their rights. Most adolescents believe they should be paid to participate in clinical research.

Ethical Principles of Clinical and Translational Research.

There are potential ethical pitfalls when performing clinical and translational research. The growing emphasis on evidence-based medicine and an understanding of basic ethical principles demands attention from the clinician scientist. Underlying principles such as respect for autonomy and considering the risk-benefit profile for each participant should remain the foundation when considering ethical issues in clinical research. Developing technology, the growth of large databases, and unanticipated health crises require ethical guidelines to be dynamic and continuously reviewed to adequately address potential ethical quandaries. Although there are various international guidelines in this area, there remains heterogeneity in their interpretation and application.

Reporting ethical approval in case reports and case series in 12 consecutive years: A systematic review.

Our study describes the reported rate of the Institutional Review Board (IRB) approval, declaration of Helsinki (DoH), and informed consent in the case reports and case series and investigates factors associated with the ethical approval report. We searched PubMed for case reports and case series from 2006 to 2017. Annually, we obtained the first 20 articles of a case report cluster from 20 distinct publications. This analysis initially contained at least 2400 papers, with 100 papers each study design and year. Only 26 (5.4%) of 480 included studies reported IRB approval, DoH approval, and participant informed consent; 58 (12.1%) reported two out of three ethical statements (DoH, informed consent, IRB); and 151 (31.5%) reported only one, leading to nearly 245 studies (51.0%) did not report any ethical approval item. Both clusters mentioned the DoH the least. Only years, ages, ethical item types, and cluster types were associated with ethical reporting practices. This study found the serious under-reporting of ethical practices in both case reports and case series.

Introduction of an Educational Video to Enhance the Informed Consent Process in Postoperative Radiation Therapy of Breast Cancer Patients.

BACKGROUND/OBJECTIVES: Informed consent is crucial in medical practice, especially for complex treatments such as postoperative radiotherapy for patients with breast cancer. Conventional consent procedures are often based on verbal declarations with a highly condensed but nevertheless large amount of information, which can exceed the recording capacity of patients and lead to misunderstandings. The aim of this study was to develop and test an educational video on breast cancer patients to enhance the informed consent process by improving patients' understanding and reducing the duration of the subsequent consultation. METHODS: The educational video was created after the underlying content was determined by a modified Delphi method in which a panellist of radiation oncologists, nurses, radiation therapists, and former patients participated in successive rounds of topic scoring. After achieving content consent, the video included 19 items to cover key aspects of postoperative radiotherapy in a patient-friendly manner. Fifty breast cancer patients scheduled for postoperative radiotherapy were randomised to watch the video prior to their verbal consultation (n = 25) or to the control group participating in the traditional informed consent process only (n = 25). The duration of the informed consent processes in both arms was recorded. To assess the educational effect of the video, a multiple-choice test was created. In addition, patients' satisfaction was recorded using a separate questionnaire. Both questionnaires were completed by the patients one to two hours after signing the consent form. RESULTS: The patients in the video group evidenced significantly higher knowledge scores than those who received standard verbal explanations (median number of correct answers 9 vs. 8 out of 10, p = 0.0039). The whole informed consent process was also completed faster in the video group (mean duration 34.7 vs. 46.2 min, p < 0.001). Median satisfaction scores were high in both groups (34 vs. 33 out of 35 points), with no significant differences observed (p > 0.05). CONCLUSION: The educational video effectively improved patient understanding and streamlined the informed consent process without compromising patients' satisfaction. This approach also helps to standardise the delivery of complex medical information, and it can also be adapted to improve the informed consent process for other cancer treatments.