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Drawing on ethical and legal frameworks in the Netherlands, the United States and France, we examine whether physicians are expected to inform patients about potentially relevant opportunities for expanded access to investigational drugs. While we found no definitive legal obligation, we argue that physicians have a moral obligation to discuss opportunities for expanded access with patients who have run out of treatment options to prevent inequality, to promote autonomy, and to achieve beneficence. [ABSTRACT FROM AUTHOR]

Objective: To assess the frequency and determinants of medical interventions during childbirth without women's consent at the population level., Methods: The nationwide cross-sectional Enquête Nationale Périnatale 2021 provided a representative sample of women who delivered in metropolitan France with a 2-month postpartum follow-up (n = 7394). Rates and 95% confidence intervals (CI) of interventions during childbirth (oxytocin administration, episiotomy or emergency cesarean section) without consent were calculated. Associations with maternal, obstetric, and organizational characteristics were assessed using robust variance Poisson regressions, after multiple imputation for missing covariates, and weighted to account for 2-month attrition., Results: Women reporting failure to seek consent were 44.7% (CI: 42.6-47.0) for oxytocin administration, 60.2% (CI: 55.4-65.0) for episiotomy, and 36.6% (CI: 33.3-40.0) for emergency cesarean birth. Lack of consent for oxytocin was associated with maternal birth abroad (adjusted prevalence ratio [aPR] 1.20; 95% CI: 1.06-1.36), low education level, and increased cervical dilation at oxytocin initiation, whereas women with a birth plan reported less frequently lack of consent (aPR 0.79; 95% CI: 0.68-0.92). Delivery assisted by an obstetrician was more often associated with lack of consent for episiotomy (aPR 1.46; 95% CI: 1.11-1.94 for spontaneous delivery and aPR 1.39; 95% CI: 1.13-1.72 for instrumental delivery, reference: spontaneous delivery with a midwife). Cesarean for fetal distress was associated with failure to ask for consent for emergency cesarean delivery (aPR 1.58; 95% CI: 1.28-1.96)., Conclusion: Women frequently reported that perinatal professionals failed to seek consent for interventions during childbirth. Reorganization of care, particularly in emergency contexts, training focusing on adequate communication and promotion of birth plans are necessary to improve women's involvement in decision making during childbirth., (© 2024 The Author(s). International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Objective: The objective of this study is to analyze guidance about medical decision making contained in ethics codes. The primary question we address is which of the main decision-making models - informed decision making (IDM), shared decision making (SDM), or paternalism - is promoted by these codes.Methods: We manually searched codes of medical ethics for guidance on medical decision making. Our analysis focused on the major international code, the World Medical Association International Code of Medical Ethics (ICME), and national codes of the US, Canada, Australia, New Zealand, the UK, Ireland, Germany, France and Norway.Results: The ICME does not promote any specific model of medical decision making. 10 of the 11 analyzed national codes contain guidance about IDM, while only four refer to SDM. Some codes contain articles which are imprecise with regard to the question of medical decision making.Conclusions: All of the analyzed national codes should be updated or amended. In particular, given the great importance of SDM in medicine, codes which do not contain relevant guidance should be updated.Practice Implications: Relevant amendments introduced to ethics codes could contribute to promoting of adequate standards of medical decision making (especially those regarding SDM) among doctors. [ABSTRACT FROM AUTHOR]

Purpose: In this study, we aimed to assess (1) the agreement between patient self-reports and general practitioner (GP) reports of the chronic conditions affecting the patients and (2) the agreement between patients and GPs on health priorities in a primary care setting.Method: Patients were recruited in the Parisian area of France by a convenience sample of GPs; eligibility criteria required that the GP was the patient's listed primary care provider for at least 12 months. Participants were asked to report all the patient's current chronic conditions by using a previously developed list of 124 chronic conditions and write a list of up to 3 priority conditions.Results: From April to May 2017, 233 patients were recruited from 16 GP practices. Agreement between the number of conditions reported by patients and by GPs was moderate (intraclass correlation coefficient 0.59, 95% CI, 0.50 to 0.69). Agreement between patient self-reports and GP reports of each chronic condition ranged from very good (eg, κ = 0.85 for hypothyroidism) to poor (eg, κ = 0.12 for chronic anxiety disorder). Among the 153 patient-GP pairs for which both the patient and GP wrote a priority list, 45 (29.4%) of patients' first priorities did not appear anywhere on the corresponding GPs' lists, and 19 (12.4%) pairs had no matching priority condition.Conclusions: Agreement between patients and their GPs varied widely depending on the diseases reported. Low agreement on health priorities suggests a need for improvement to ensure better alignment between patient and physician perspectives. [ABSTRACT FROM AUTHOR]

and purpose: In France, women lack information to make a shared decision to start breast cancer screening. Decision aids are useful to facilitate this discussion, yet few meet international standards. The objective of this project was to build, validate and measure the quality of a decision aid for organized breast screening in France, in line with international standards, intended for both women and healthcare professionals. This mixed-methods study was conducted between January 2017 and June 2022. The prototype was developed from a qualitative study, systematic review and targeted literature review and alpha tested during two Delphi rounds. Readability was evaluated with the Flesch score and content with International Patient Decision Aid Standards Instrument (IPSASi). An online decision aid, accessible at www.Discutons-mammo.fr , written in French was developed. The content included eligibility, information about breast screening the advantages and disadvantages of screening, patient preferences and a patient-based discussion guide using text, infographics, and videos. The Flesch readability test score was 65.4 and the IPDASi construct quality score was 176 out of 188. This decision aid complies with IPDASi standards and could help women eligible for breast screening in France make a shared decision with a specialized healthcare professional about whether or not to participate in organized breast screening. • A prototype online decision aid for organized breast screening was developed. • The decision aid uses text, infographics, and videos. • The decision aid informs women about advantages and disadvantages of screening. • The decision aid obtained an IPDASi construct quality score of 176 out of 188. • The decision aid obtained Flesch readability test score of 65.4. [ABSTRACT FROM AUTHOR]

Abstract: Background: Using a large national sample of women undergoing an abortion in France, we explore the factors associated with medical or surgical abortion. We draw particular attention to the influence of women''s preferences in the decision-making process. Study Design: The data are drawn from a nationally representative survey of 8245 women undergoing an elective abortion in France in 2007. Analyses of factors associated with the type of abortion technique were performed among the 4650 women who were identified as being eligible for the two techniques. Results: Sixty-eight percent of all abortions were medical procedures among women eligible for both techniques. The type of abortion technique was not dependent on women''s age, parity, cohabitation status, socioeconomic circumstances nor on the type of facility providing the abortion (private or public). Conversely, women''s participation in the decision-making process was strongly associated with the type of abortion method. Among the 50% of women who reported they had been given a choice, 84% underwent a medical procedure vs. 52% of those who were not offered a choice. Among the 2286 women who were not involved in the decision, 35% indicated they trusted their doctor to make the best choice for them, while 44% were told it was too late for a medical procedure, although they had consulted before 8 weeks of amenorrhea. Conclusion: In this sample of French women who participated in a national survey on abortion, those who were involved in the decision-making process as to whether to have a medical or surgical procedure showed a strong preference for the medical procedure. [Copyright &y& Elsevier]

Background: Controversies around organized breast cancer screening emphasize the need for information for women. In France, the institute of cancer (INCa) is in charge of conveying this information. Cancer Rose's website (CR) provides complementary information considering INCa's incomplete. The objective of this study was to identify if these informations meet criteria for decision aid., Methods: Information documents were selected and analyzed using International Patient Decision Aid Standards (IPDAS). Each item was noted A (absent), P (present) or I (present but incomplete)., Results: Information booklet and press kit for INCa and studies section for CR were the document meeting most criteria. The document meeting fewer criteria were the INCa's video and information leaflet for CR. Videos are more accessible tools for people with lower levels of health literacy. INCa's video did not present the risks of screening and CR's emphasized the risks., Conclusion: These documents have not been evaluated for intelligibility, clarity and readability. Addressing these criteria limits social inequities and improves health literacy., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)