A Médecins Sans Frontières Ethics Framework for Humanitarian Innovation.

Kiran Jobanputra and colleagues describe an ethics framework to support the ethics oversight of innovation projects in medical humanitarian contexts.

Innovations in research ethics governance in humanitarian settings.

BACKGROUND: Médecins Sans Frontières (MSF) is one of the world's leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper. DISCUSSION: We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices: • A new framework to guide ethics review • The introduction of a policy exempting a posteriori analysis of routinely collected data • The preapproval of "emergency" protocols • General ethical approval of "routine surveys" • Evaluating the impact of approved studies. The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced. SUMMARY: We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out research in fragile contexts and for ethics committees reviewing such research.

A Call for the Application of Patient Safety Culture in Medical Humanitarian Action: A Literature Review.

OBJECTIVES: The aims of the study were to assess lessons learned on patient safety in Organization for Economic Cooperation and Development (OECD) countries and to assess whether they are applied or can be applied to the humanitarian medicine. METHODS: This is (a) a 2013-2018 rapid literature review of reviews and systematic reviews articles (PubMed database) on "patient safety" and "medical error" to look for lessons learned regarding patient safety in OECD countries and (b) a rapid literature review (PubMed and Embase databases) on "humanitarian medicine" and "patient safety," from their creation to 2018, to find any articles related to patient safety in humanitarian medicine. In both reviews were excluded articles specifically related to one device, disease, or medical act. These reviews were complemented by a Google search. RESULTS: Of the 245 references retrieved, 104 met the inclusion criteria. Of 308 references, 39 respected the inclusion criteria. In OECD countries, patient safety comprises correlated measures taken at three levels. The micro level focuses on individual staff involved in healthcare provision or management; the meso level focuses on medical institutions; the macro level focuses on national healthcare systems. Only one reference mentioned the implementation of a medical error reporting and analysis system in medical humanitarian organization. CONCLUSIONS: The adoption of strategies and a culture of safety will need to be adapted to address the variety of intervention contexts and to respond first to the fears and expectations of humanitarian staff. Medical humanitarian organizations, in the absence of an overarching authority for the sector, have a major responsibility in the development of a general patient safety policy applicable in all their operations.

Knowledge, attitudes, and Expectations of Medical Staff Toward Medical Error Management Policies in Humanitarian Medicine: A Qualitative Study.

BACKGROUND: Patient safety, a major component of quality of care, is now an attribute of health care systems in developed countries at least. Although there is ever more research on this subject in developed countries, humanitarian medicine, mainly implemented in resource-poor countries, has yet to structure its own set of policies and strategies on patient safety and the management of medical errors. OBJECTIVES: We assessed the knowledge, attitudes, and expectations of medical humanitarian staff regarding the development of policies and strategies related to patient safety and medical error management in medical humanitarian action. METHODS: We conducted 36 semistructured interviews with international medical and paramedical staff active in 6 medical humanitarian organizations after having interviewed the medical directors or the person in charge of quality of care and the legal advisors. Interviews were transcribed verbatim and subjected to a thematic analysis. RESULTS: The interviews confirmed the current absence of clear investments in dealing with safety risks in the selected medical humanitarian organizations. The difficulties experienced by medical staff in reporting medical errors such as blame culture, lack of training, and absence of leadership committed on patient safety are nonspecific. Other arguments are related to the specific conditions of humanitarian settings: coexistence of different medical culture, absence of international or local regulations or external pressures, and great diversity of activities and contexts. CONCLUSIONS: Interviewed staff expressed high expectations of receiving guidance from their organizations and support to adopt clear patient safety and medical error management policies adapted to their complex operational and clinical realities.

[Complementary and alternative medicines (CAM): towards an "evidence-based" consensus in the university hospital]. / Médecines complémentaires: vers un consensus "evidence- based" a l'hôpital universitaire.

While a popular vote supported a new article on complementary and alternative medicines (CAM) in the Swiss Constitution, this assessment in 14 wards of the University Hospital of Lausanne, Switzerland, attempted at answering the question: How can CAM use be better taken into account and patients informed with more rigor and respect for their choices? Confronted with a review of the literature (> 2000 publications in "Evidence-based complementary medicines" since 1998), respondents declared their ignorance of the clinical data presently available on CAM. All were in favour of more teaching and information on the subject, plus an official statement from the Hospital direction, ensuring production and diffusion of rigorous and clinically significant information on CAM.

Research Ethics Governance in Times of Ebola.

The Médecins Sans Frontières (MSF) ethics review board (ERB) has been solicited in an unprecedented way to provide advice and review research protocols in an 'emergency' mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at (very) early development stages. This article examines the MSF ERB's experience addressing issues related to both the process of review and substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees (ECs), we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the 'optimal' ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process.

How effective are breast cancer screening programmes by mammography? Review of the current evidence.

Randomised controlled trials showed that breast cancer screening by mammography reduces breast cancer mortality in women over age 50 by 25-30%. However, it was not clear if this effect would persist outside the controlled trial environment or even could be enhanced. We review the current evidence of the impact of long-standing breast cancer screening programmes (Australia, Canada, Denmark, Finland, Iceland, Italy, the Netherlands, Spain, Sweden and the United Kingdom) on breast cancer mortality. The decrease observed in women invited to screening ranges from 16% to 36%. Breast cancer mortality reductions range from 24% to 48% in women having attended at least one screen after correcting for selection bias. Although evaluation design, time period studied, participation rates achieved differ, the trend in mortality reduction is consistent. Adjuvant therapy is estimated to contribute about one third to this decrease. We conclude that mammography screening programmes implemented for at least 10 years achieve a similar, but not greater mortality reduction as the randomised controlled trials. However, it may take some more years before the full impact of these mammography screening programmes can be assessed.

Cost-effectiveness of opportunistic versus organised mammography screening in Switzerland.

BACKGROUND: Various centralised mammography screening programmes have shown to reduce breast cancer mortality at reasonable costs. However, mammography screening is not necessarily cost-effective in every situation. Opportunistic screening, the predominant screening modality in several European countries, may under certain circumstances be a cost-effective alternative. In this study, we compared the cost-effectiveness of both screening modalities in Switzerland. METHODS: Using micro-simulation modelling, we predicted the effects and costs of biennial mammography screening for 50-69 years old women between 1999 and 2020, in the Swiss female population aged 30-70 in 1999. A sensitivity analysis on the test sensitivity of opportunistic screening was performed. RESULTS: Organised mammography screening with an 80% participation rate yielded a breast cancer mortality reduction of 13%. Twenty years after the start of screening, the predicted annual breast cancer mortality was 25% lower than in a situation without screening. The 3% discounted cost-effectiveness ratio of organised mammography screening was euro11,512 per life year gained. Opportunistic screening with a similar participation rate was comparably effective, but at twice the costs: euro22,671-24,707 per life year gained. This was mainly related to the high costs of opportunistic mammography and frequent use of imaging diagnostics in combination with an opportunistic mammogram. CONCLUSION: Although data on the performance of opportunistic screening are limited, both opportunistic and organised mammography screening seem effective in reducing breast cancer mortality in Switzerland. However, for opportunistic screening to become equally cost-effective as organised screening, costs and use of additional diagnostics should be reduced.