Doris Schopper

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.

Innovations in research ethics governance in humanitarian settings

BackgroundMédecins 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.DiscussionWe 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 studiesThe 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.SummaryWe 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.

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.

Responding to the needs of survivors of sexual violence: Do we know what works?

During the past twelve months, the issue of sexual violence in conflict and emergencies has received an unprecedented amount of attention at the highest political and institutional levels. In 2013, the United Kingdoms Department for International Development (DFID) launched a Call to Action to mobilize donors, UN agencies, non-governmental organizations (NGOs) and other stakeholders on protecting women and girls in humanitarian emergencies, culminating in the high-level event “Protecting Girls and Women in Emergencies” in November 2013. As of August 2014, over forty partners (including governments, United Nations (UN) agencies and NGOs) had made commitments to the Call to Action. Furthermore, in June 2014 the “Global Summit to End Sexual Violence in Conflict”, co-chaired by the UK Foreign Secretary and Angelina Jolie, Special Envoy for the UN High Commissioner for Refugees (UNHCR), gathered 1,700 delegates and 129 country delegations. In his summary, the chair of the Global Summit states: “We must apply the lessons we have learned and move from condemnation to concrete action. We must all live up to the commitments we have made.”1 In September 2014, the United States organized a Call to Action event in New York during the UN General Assembly with the purpose of sharing progress on commitments made in November 2013. It thus seems that efforts to raise awareness about sexual violence in conflict and emergencies and advocate for a much stronger commitment to action are well under way. But is this enough? Is there enough evidence from lessons learned to allow us to increase and improve our response?

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.

Research Ethics Governance in Disaster Situations

Ethical scrutiny of research in disaster situations has to abide by the same ethical principles as any research involving humans. However, due to time constraints, ethics review procedures need to be particularly timely and flexible, and at the same time sufficiently stringent due to the potentially greater vulnerability of study communities. Given the dearth of guidance for ethics review of disaster research, several approaches have recently been proposed either embedded in broader ethics guidelines or examining explicitly the specific requirements for disaster research. Some of these approaches are being implemented in practice by the Ethics Review Board instituted by Medecins Sans Frontieres (MSF ERB), such as adapting the stringency of the review process to the potential risk of the research, functioning in a decentralised manner through electronic media, using an expedited review mechanism and preapproval of a “generic” research protocol. While doing so, some issues are given special attention: enhanced vulnerability, harms and benefits to the disaster-stricken population, informed consent, community involvement, dual use of tissue samples, and the humanitarian/therapeutic misconception.

What Needs to Be Taught

Rape in war and genocide always involves particularities of place, time, context, and experience. No one can teach or learn about them all. Which histories and experiences, what places and contexts are the most important to consider, and how does one best make such decisions? This chapter concentrates not only on these questions but also on what motivates people—primarily but not exclusively men—to resort to such violence and on what the consequences turn out to be. The contributors concentrate on helping teachers and students to identify the most important causes of rape in war and genocide and what it takes to intervene effectively against them.

When and Where

Good teaching always involves careful planning about courses and classrooms. Are some types of classes better than others for treating the subject of rape in war and genocide? Are there particularly “teachable moments” with regard to this topic? What might such “moments” include, and how can they best be used to good advantage? Beyond questions that focus mainly on schools, colleges, and universities, what about settings for teaching and learning that do not fit that model? What other teaching and learning venues deserve consideration—those connected to the internet, for example, or those “in the field” where urgent humanitarian work is under way? This chapter responds to these pivotal questions.