Evaluation of financial conflicts of interest and quality of evidence in Japanese gastroenterology clinical practice guidelines.

BACKGROUND: Clinical practice guidelines assist healthcare professionals in providing evidence-based care. However, pharmaceutical companies' financial interests often influence guideline content. This study aimed to elucidate the magnitude of financial ties among Japanese gastroenterology guideline authors and the pharmaceutical industry. METHODS: Using pharmaceutical company disclosed payment data, we evaluated financial conflicts of interest (COI) among Japanese Society of Gastroenterology guideline authors between 2016 and 2021. Additionally, we assessed the evidence quality supporting guideline recommendations and associations with financial COI. Finally, we evaluated author COI management during guideline development against global standards. RESULTS: Overall, 88.2% (231/262) of guideline authors received a median of $12 968 (interquartile range [IQR]: $1839-$70 374) in payments between 2016 and 2019 for lectures, writings, and consulting. Chairpersons received significantly higher payments (median: $86 444 [IQR: $15 455-$165 679]). Notably, 41 (15.6%) authors had undeclared payments exceeding declaration requirements. Low or very low-quality evidence supported 41.0% of recommendations. There was a negative association between the median 4-year payment per author and the proportion of recommendations based on low-quality evidence (odds ratio: 0.966 [95% confidence interval [95% CI]: 0.945-0.987], P = 0.002) and positive association with moderate-quality evidence (odds ratio: 1.018 [95% CI: 1.011-1.025], P < 0.001). Still, the Japanese Society of Gastroenterology guideline development process remains less transparent, with insufficient COI policies relative to global standards. CONCLUSION: There were extensive financial COI between pharmaceutical companies and guideline authors, and more than 40% of recommendations were based on low-quality evidence. More rigorous and transparent COI policies for guideline development adhering to global standards are warranted.

Mapping ethico-legal principles for the use of artificial intelligence in gastroenterology.

The rapid development of artificial intelligence (AI) and digital health raise concerns about equitable access to innovative interventions, appropriate use of health data and privacy, inclusiveness, bias and discrimination, and even changes to the clinician-patient relationship. This article outlines a number of ethical and legal issues when examining the use of AI in gastroenterology. Substantive ethico-legal principles including respect for persons, privacy and confidentiality, integrity, conflict of interest, beneficence, nonmaleficence, and justice, are discussed. Much of what we articulated is relevant to the use of AI in other medical fields. Going forward, consorted efforts should be use to address more particular and concrete problems, but for now, a principle-based approach is best used in problem-solving.

Many Paradoxes of My Gastroenterology Practice.

ABSTRACT: A paradox describes the clash between 2 seemingly reasonable prepositions whose joint occurrence appears impossible. Like any other human endeavor, medicine is also filled with paradoxes that await resolution. This editorial lists several common paradoxes frequently encountered by clinical gastroenterologists. These examples illustrate the interplay between risk and benefit, cost and effect, disease and cure, and escape and exposure. It is hoped that addressing these paradoxes and trying to resolve their underlying contradictions will ultimately lead to a more efficacious and rational delivery of healthcare.

Preventing Self-Harm From Repeat Foreign-Body Ingestion.

Mental health disorders in adolescents present some of the most challenging of all ethical dilemmas. This is particularly true when they lead to self-injurious behavior that can only be prevented by either limiting the freedom of the adolescent or forcing treatments on them that they do not want. Intentional and repeated foreign-body ingestion (FBI) in youth is a poorly understood self-injurious behavior that can be life-threatening. It poses unique clinical and ethical challenges. Ingestion of sharp or magnetic objects increases the need for endoscopic retrieval or surgical intervention with associated risks, including perforation and anesthesia-related adverse events. When behavior modification efforts fail to prevent recurrent FBI, the cumulative risk of medical intervention mounts. Sometimes, as a last resort, doctors consider surgical procedures that limit jaw movement and may physically prevent recurrent FBI. In this Ethics Rounds article, we present a case in which doctors consider whether it is in the best interest of a teenager with this behavior to undergo orthodontic jaw wiring as a next step in treatment of repeated FBI. Doctor commentary on the ethical decision-making process is provided.

[Biosimilars in Gastroenterology - how much uncertainly is ethically acceptable?] / Biosimilars in der Gastroenterologie ­ Wie viel Unsicherheit ist ethisch akzeptabel?

Biosimilars use raises uncertainties with regards to efficacy despite potentially significant cost reductions. This requires a classical harm-benefit analysis. Important stakeholders include physicians and patients, companies producing biologica (drugs containing biotechnology-derived proteins as active substance), and companies producing biosimilars, as well as health insurance companies and politicians. They all have their distinct interests. In a rule-setting process, transparency is needed to protect the trust between patients and physicians. In an ideal world, the price of biologica without patent protection would be negotiated in a way that makes biosimilars unnecessary.

Ethical issues in gastroenterology research.

Ethical issues have become increasingly important in gastroenterology research. This is for several reasons, including (i) an understanding of how conflicts of interest might affect research, (ii) the influence of the drug and device industries on research, (iii) ghostwriting (taking credit for something you did not write), (iv) the occurrence of ethically inappropriate research and scientific misconduct, and (v) respect for the rights of research subjects. These include the rights (i) to give informed consent to participate after understanding the purposes, risks, and benefits of the research; (ii) to ask questions; and (iii) to withdraw from participation at any time. Notions of doing good (beneficence), avoiding harm (non-maleficence), confidentiality, and, most important, the primacy of the welfare of the patient or research subject can be traced to antiquity. In the modern era, the Nuremburg Code (1947), the Declaration of Helsinki (1964), the Belmont report (1979), and other events and reports have led to the refinement of ethical practices in both clinical and research domains, have reinforced those long observed principles, and have given rise to the newer principles of autonomy and justice. The ethical conduct of research not only promotes good research but also is in the best interests of research subjects, investigators, sponsors, patients, and the public.

Nine medico-legal pitfalls in inflammatory bowel disease in the United States.

The optimal care of patients with inflammatory bowel disease depends on adherence to standards of care regarding diagnosis, informing the patient of potential risks of treatment, obtaining recommended baseline studies, and monitoring the patient for efficacy and adverse effects. In clinical research as well as practice, financial conflicts of interest must be disclosed and managed to insure that patients have sufficient information to make a decision regarding participation in a study and to insure their safety. Medical education of care-givers in training carries the obligation and liability to oversee the care of the IBD patient and insure that safe and optimal care. This review addresses medicolegal issues that can arise in the care of the patient with IBD. Clinicians who provide optimal care for patients with inflammatory bowel diseases (IBD) must employ appropriate diagnostic and therapeutic options and also adhere to standards of care and ethical principles. Ethical and medicolegal issues can arise from the failure to adhere to the standards of medical care, clinical research and education. In a report in the New England Journal of Medicine in 2011, gastroenterologists in the U.S. ranked 6th out of 26 subspecialities as the most commonly sued for malpractice, with the mean payment to the plaintiff of just under $200,000 [1]. It is noteworthy that two other specialties that involve invasive procedures ranked lower on the list than Gastroenterology. For example, Cardiology and Anesthesiology ranked 11th and 17th, respectively. In this review, nine of the pitfalls to adherence to the standards of practice for IBD are reviewed.

Social media in the health-care setting: benefits but also a minefield of compliance and other legal issues.

Throughout the past 20 years, the rising use of social media has revolutionized health care as well as other businesses. It allows large groups of people to create and share information, ideas, and experiences through online communications, and develop social and professional contacts easily and inexpensively. Our Gastroenterology organizations, among others, have embraced this technology. Although the health-care benefits may be many, social media must be viewed through a legal lens, recognizing the accompanying burdens of compliance, ethical, and litigation issues. Theories of liability and risk continue to evolve as does the technology. Social media usage within the medical community is fraught with potential legal issues, requiring remedial responses to meet patients' needs and comply with current laws, while not exposing physicians to medical malpractice and other tort risks.

Ordinary tales from endoscopic odysseys: fiction, ethics, and the gastroenterological journey.

Fiction (i.e. novels, short stories, and movies) provides an opportunity for imaginative moral reflection and can serve as a basis for moral argument. Narratives play a role in moral reasoning because they are exemplars as well as tests. Those who care for sick people, should be interested in patient's and literary stories. Exploring the representation of gastroenterological ailments in fiction gives insight in the experience of undergoing colonoscopy, farting, pain, the borders of intimacy, hygiene and the lack of it, taboos and the doctor-patient-relationship. Included authors are, among others: Michel Faber, Alan Bennett, Charles Bukowski, Charlotte Roche and James Joyce. Several movies are discussed as well. Though in general gastroenterological problems don't seem often at foreground in fiction, in some cases they are represented in a more symbolic way, and touch upon some fundamental aspects of the human condition.

A Canadian Working Group report on fecal microbial therapy: microbial ecosystems therapeutics.

A working group from across Canada comprised of clinician and basic scientists, epidemiologists, ethicists, Health Canada regulatory authorities and representatives of major funding agencies (Canadian Institutes of Health Research and the Crohn's and Colitis Foundation of Canada) met to review the current experience with fecal microbial therapy and to identify the key areas of study required to move this field forward. The report highlights the promise of fecal microbial therapy and related synthetic stool therapy (together called 'microbial ecosystems therapeutics') for the treatment of Clostridium difficile colitis and, possibly, other disorders. It identifies pressing clinical issues that need to be addressed as well as social, ethical and regulatory barriers to the use of these important therapies.

The gastroenterologist and industry: changing winds.

The medical device and pharmaceutical industry is facing mounting pressure to produce cost-effectiveness and clinical-effectiveness data in order for their products to be acceptable for approval by the Federal Drug Administration and then for payer reimbursement. The implications of these increasing burdens on our field will become apparent in everyday practice. This article outlines these challenges and discusses possible ways to improve the situation.