Breast cancer screening in sub-Saharan Africa: a systematic review and ethical appraisal.

BACKGROUND: The aim of this systematic review was to evaluate the evidence and clinical outcomes of screening interventions and implementation trials in sub-Saharan Africa (SSA) and also appraise some ethical issues related to screening in the region through quantitative and qualitative narrative synthesis of the literature. METHODS: We searched Pubmed, OvidMEDLINE, Embase, and Web of Science to identify studies published on breast cancer screening interventions and outcomes in SSA. Descriptive statistics were used to summarize the frequency and proportions of extracted variables, and narrative syntheses was used to evaluate the clinical outcomes of the different screening modalities. The mixed methods appraisal tool was used to assess the quality of studies included in the review. RESULTS: Fifteen studies were included, which consisted of 72,572 women in ten countries in SSA. 63% (8/15) of the included publications evaluated Clinical Breast Examination (CBE), 47% (7/15) evaluated mammography and 7% (1/15) evaluated ultrasound screening. The cancer detection rate was < 1/1000 to 3.3/1000 and 3.3/100 to 56/1000 for CBE and mammography screening respectively. There was a lot of heterogeneity in CBE methods, target age for screening and no clear documentation of screening interval. Cost-effective analyses showed that CBE screening linked to comprehensive cancer care is most cost effective. There was limited discussion of the ethics of screening, including the possible harms of screening in the absence of linkage to care. The gap between conducting good screening program and the appropriate follow-up with diagnosis and treatment remains one of the major challenges of screening in SSA. DISCUSSION: There is insufficient real-world data to support the systematic implementation of national breast cancer screening in SSA. Further research is needed to answer important questions about screening, and national and international partnerships are needed to ensure that appropriate diagnostic and treatment modalities are available to patients who screen positive.

The implementation of non-invasive prenatal testing (NIPT) in the Netherlands.

In the Netherlands prenatal screening is offered as a mean to increase reproductive choices of couples. All women are counseled on the existing options by trained midwives. The government puts a great emphasis on informed choice and on womens' opinions and reactions to screenings options. Since 2017 non-invasive prenatal testing (NIPT, cf-DNA) is offered as first tier screening for aneuploidies in the genome-wide (GW) variant at the cost of 175 Euro's. Uptake is around 50%. This screenings offer is perceived as unconventional for the traditionally cautious Dutch system.

The future of newborn screening for lysosomal disorders.

The goal of newborn screening is to enhance the outcome of individuals with serious, treatable disorders through early, pre-symptomatic detection. The lysosomal storage disorders (LSDs) comprise a group of more than 50 diseases with a combined frequency of approximately 1:7000. With the availability of existing and new enzyme replacement therapies, small molecule treatments and gene therapies, there is increasing interest in screening newborns for LSDs with the goal of reducing disease-related morbidity and mortality through early detection. Novel screening methods are being developed, including efforts to enhance accuracy of screening using an array of multi-tiered, genomic, statistical, and bioinformatic approaches. While NBS data for Gaucher disease, Fabry disease, Krabbe disease, MPS I, and Pompe disease has demonstrated the feasibility of widespread screening, it has also highlighted some of the complexities of screening for LSDs. These include the identification of infants with later-onset, untreatable, and uncertain phenotypes, raising interesting ethical concerns that should be addressed as part of the NBS implementation process. Taken together, these efforts will provide critical, detailed data to help guide objective, ethically sensitive decision-making about NBS for LSDs.

Bystander Ethics and Good Samaritanism: A Paradox for Learning Health Organizations.

In 2012, a U.S. Institute of Medicine report called for a different approach to health care: "Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets." The answer, they suggested, would be a "continuously learning" health system. Ethicists and researchers urged the creation of "learning health organizations" that would integrate knowledge from patient-care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation-a trial known as IMPACT-AFib-gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be "bystanders" in relation to a control group receiving suboptimal care. In response, the researchers designed a "workaround" that allowed the project to go forward. We believe the experience suggests that what we call "bystander ethics" will create challenges for the kinds of quality improvement research that LHOs are designed to do.

Smoking cessation interventions in substance use treatment facilities: clinical implications and recommendations for implementation. / Abordaje del tabaquismo en centros de tratamiento de drogodependencias: implicaciones clínicas y recomendaciones para su implementación.

Letter to Editor.

Carta al Editor.

Ethical considerations for the design and implementation of child injury prevention interventions: the example of delivering and installing safety equipment into the home.

INTRODUCTION: Public health ethics is a growing field of academic interest but ethical discussion of injury prevention seems to have received limited attention. Interventions that promise to be effective are not necessarily-without explicit justification-'good' and 'right' interventions in every sense. This paper explores public health ethics in the context of child injury prevention with the objective to initiate interdisciplinary dialogue on the ethics of child safety interventions. METHOD: A framework of seven public health ethics principles (non-maleficence, health maximisation, beneficence, respect for autonomy, justice, efficiency and proportionality) were applied to an intervention to promote child safety in the home. RESULTS: Preventing child injury in the home is ethically challenging due to the requirement for the state to intervene in the private sphere. Non-maleficence and beneficence are difficult to judge within this intervention as these are likely to be highly dependent on the nature of intervention delivery, in particular, the quality of communication. Respect for autonomy is challenged by an intervention occurring in the home. The socioeconomic gradient in child injury risk is an important factor but a nuanced approach could help to avoid exacerbating inequalities or stigmatisation. Equally, a nuanced approach may be necessary to accommodate the principles of proportionality and efficiency within the local context. CONCLUSION: We conclude that this intervention is justifiable from an ethical perspective but that this type of reflection loop is helpful to identify the impact of interventions beyond effectiveness.

[25 years of work: The Interdisciplinary Team for Fetal Malformation at the Institute of Mother and Child in Warsaw - from counselling to clinical ethics].

Perinatology is a dynamically developing field of medicine. The progress of technology in recent decades has made it possible to recognize birth defects very early, including those which are lethal or genetically determined. In many clinical situations, it is no longer possible to work alone to reach a definitive diagnosis, plan treatment or predict the clinical course of the affected fetus/newborn. There is a need for teamwork, which ensures the proper, early care starting in the fetal period, not only in the delivery room or NICU. This paper discusses the ethical foundations of creating interdisciplinary teams, taking as an example the Interdisciplinary Team for Fetal Malformation at the Institute of Mother and Child in Warsaw, which has been active for 25 years, and presents how it works in practice. On the basis of the clinical cases that are examined, practical guidelines were formulated for both the work of medical teams and the way parents are informed about the clinical situation of their child and about sharing the care after the birth of the child. A document was also proposed with information on prenatal diagnosis, decisions made by the interdisciplinary team regarding the mother and child, as well as the conclusions resulting from discussions with parents.

[The impact of the EU Regulation 536/2014 on the tasks and functioning of ethics committees in Germany]. / Die EU-Verordnung 536/2014 und ihr Einfluss auf die Aufgaben und Arbeitsweisen der Ethikkommissionen in Deutschland.

The EU Clinical Trial Regulation 536/2014 (CTR) and its implementation in Germany led to substantial changes of the established, well-accepted and effective system of reviewing clinical trial applications by ethics committees (ECs), which impair their independence. For the first time, the German federal legislator specified in detail the composition, functioning, tasks and responsibilities of ECs. ECs have to be registered with the federal drug authority BfArM and if an EC does not perform properly the registration can be withdrawn. In addition, the drug authorities may override the negative opinion expressed by an EC. The ECs will also lose their financial autonomy as the fees will be fixed by the federal government. The tasks and responsibilities of the ECs remain almost entirely unchanged, however. The ECs remain involved in the assessment of both parts of the application dossier. Part I is assessed together with the drug authorities, the drug authorities having the lead. The assessment of part II remains the sole responsibility of the EC. As the deadlines for the assessment became rather short, in particular for multinational trials, and the communication with the sponsor will be in writing only, the established procedures of ECs have to be modified. Up to now it was common to verbally discuss problematic issues with the sponsor. The CTR is focused on written communication with the sponsor via the EU portal. ECs, their office staff and chairpersons will need considerable professionalism and respective training. The future workflow requires substantial IT support. The ECs and the Association of Medical Ethics Committees in Germany will do their utmost to protect efficiently the research subjects and to promote Germany as a major destination for clinical research.

Conscientious objection as a barrier for implementing voluntary termination of pregnancy in Uruguay: Gynecologists' attitudes and behavior.

OBJECTIVE: To analyze the attitudes and behavior of gynecologists in Uruguay with respect to the right to conscientious objection that is included in the law concerning voluntary termination of pregnancy. METHODS: The relevant laws and decrees, academic articles, legal or administrative claims, and the positions published by the institutions representing physicians or by groups of gynecologists were analyzed. RESULTS: In general, the institutions positioned themselves in favor of correct application of conscientious objection and the immense majority of gynecologists followed this conduct. Small groups mounted a strong opposition and in one department (province) all gynecologists declared themselves to be objectors. CONCLUSION: Most gynecologists, whether or not they are objectors, proved to have a "loyalty to duty," fulfilling their primary obligation to abide by the ethical duty to give treatment to the persons who need it. A small group used conscientious objection to impede the provision of care to the women who needed the service, some group members being genuine objectors and others pseudo-objectors.

Ethics for pandemics beyond influenza: Ebola, drug-resistant tuberculosis, and anticipating future ethical challenges in pandemic preparedness and response.

The unprecedented outbreak of Ebola virus disease (EVD) in West Africa has raised several novel ethical issues for global outbreak preparedness. It has also illustrated that familiar ethical issues in infectious disease management endure despite considerable efforts to understand and mitigate such issues in the wake of past outbreaks. To improve future global outbreak preparedness and response, we must examine these shortcomings and reflect upon the current state of ethical preparedness. To this end, we focus our efforts in this article on the examination of one substantial area: ethical guidance in pandemic plans. We argue that, due in part to their focus on considerations arising specifically in relation to pandemics of influenza origin, pandemic plans and their existing ethical guidance are ill-equipped to anticipate and facilitate the navigation of unique ethical challenges that may arise in other infectious disease pandemics. We proceed by outlining three reasons why this is so, and situate our analysis in the context of the EVD outbreak and the threat posed by drug-resistant tuberculosis: (1) different infectious diseases have distinct characteristics that challenge anticipated or existing modes of pandemic prevention, preparedness, response, and recovery, (2) clear, transparent, context-specific ethical reasoning and justification within current influenza pandemic plans are lacking, and (3) current plans neglect the context of how other significant pandemics may manifest. We conclude the article with several options for reflecting upon and ultimately addressing ethical issues that may emerge with different infectious disease pandemics.

Ascension health's demonstration of full disclosure protocol for unexpected events during labor and delivery shows promise.

Communicating openly and honestly with patients and families about unexpected medical events-a policy known as full disclosure-improves outcomes for patients and providers. Although many certification and licensing organizations have declared full disclosure to be imperative, the adoption of and adherence to a full disclosure protocol is not common practice in most clinical settings. We conducted a case study of Ascension Health's implementation of a full disclosure protocol at five labor and delivery demonstration sites. Twenty-seven months after implementation, the rate of full disclosure had increased by 221 percent. Practitioners saw insurers' acceptance of the full disclosure protocol, consistent and ongoing leadership by local practitioners and hospitals, the establishment of a well-trained local investigation and disclosure team, and disclosure training for practitioners as key catalysts for change. Lessons learned from this multisite initiative can inform liability insurers and guide providers who are committed to ensuring that full disclosure becomes the only response to unexpected medical events.

Considering ethics in community eye health planning: perspectives from an existing model.

Despite the widespread acceptance of the principles of the Alma Ata Declaration of 1978 and the subsequent amendments, health for all has remained a distant dream in many parts of the developing world. Concerns such as the economic efficiency of health systems and their reach and coverage have dominated discussions of public health, with ethics remaining at best a shadowy set of assumptions or at worst completely ignored. Similarly, questions of ethics have been taken for granted and rarely addressed directly in the design of public health models across sectors and are rarely explicitly addressed. This paper uses the experience of the L V Prasad Eye Institute's (LVPEI) pyramidal model of eye healthcare delivery to explore ethical issues in the design and implementation of public health interventions. The LVPEI model evolved over time from its beginnings as a tertiary care centre to a network that spans all levels of eye care service delivery from the community through primary and secondary levels. A previously published analytical framework is applied to this model and the utility of this framework as well as the ethics of the LVPEI model are interrogated. An analytical and prescriptive framework is then evolved that could be used to build in and evaluate ethics in other public health delivery models.

The influence of professional values on the implementation of Aboriginal health policy.

OBJECTIVE: This article explores the role of professional values and the culture of the Australian health care system in facilitating and constraining the implementation of an Aboriginal health policy. METHODS: Thirty-five semi-structured in-depth interviews were conducted in a case study on the implementation of the Northern Territory Preventable Chronic Disease Strategy (PCDS). RESULTS: PCDS included three major evidence-based components - primary prevention, early detection and better management. The research revealed that PCDS changed as it was implemented. The values of the medical and nursing professions favoured the implementation of the clinically-based component of PCDS - better management. But there was dissonance between the values of these dominant professional groups and the values and expertise in public health that were necessary to implement fully the primary prevention component of PCDS. While Aboriginal health workers have valuable knowledge and skills in this area, they were not accorded sufficient power and training to influence decision-making on priorities and resources, and were able to exercise only limited influence on the components of the PCDS that were implemented. CONCLUSION: The findings highlight the role that a myriad of values play in influencing which aspects of a policy are implemented by organizations and their agents. Comprehensive and equitable implementation of policy requires an investigation and awareness of different professional values, and an examination of whose voices will be privileged in the decision-making process. If the advances in developing evidence-based, culturally-appropriate and inclusive policy are to be translated into practice, then care needs to be taken to monitor and influence whose values are being included at what point in the policy implementation process.

How will Australian general practitioners respond to an influenza pandemic? A qualitative study of ethical values.

OBJECTIVES: To explore general practitioners' perceptions of their preparedness for an influenza pandemic, the changes they would make to their practice, and the ethical justifications for their planned actions. DESIGN AND SETTING: A qualitative study was performed among South Australian GPs between March and October 2007. A semi-structured interview was carried out with each participant in his or her practice, and the interviews were audio-recorded, transcribed and analysed thematically. PARTICIPANTS: 10 GPs were recruited: five from a metropolitan Division and five from a rural Division of General Practice. RESULTS: Some participants felt they would not be able to cope with an influenza pandemic, while others felt it would simply mean an increase in their workloads. Most respondents considered creating separate waiting rooms, moving the reception desk outside of the practice and delaying all non-urgent consultations in order to deal with a pandemic more effectively. Respondents mentioned the conflict between their various roles and responsibilities as a primary source of tension when thinking about the way they would organise their work in the event of a pandemic. A number of GPs said they would not practise in the event of a pandemic, as they felt their responsibility to their families outweighed that to their patients. CONCLUSIONS: Professional codes of ethics should include guidance about the scope of the duty to treat during infectious disease outbreaks. The community has to uphold the value of reciprocity, and ensure that GPs and their families are provided with support during a pandemic and are given the opportunity to be actively involved in pandemic preparedness planning.

[Experiences and difficulties in implementing immunization registries in Saxony-Anhalt]. / Erfahrungen und Schwierigkeiten bei der Implementierung von Impfregistern in Sachsen-Anhalt.

In the German Federal State of Saxony-Anhalt, the Health Department must be notified of vaccines administered to children <7 years of age including their names. The goal of this mandatory notification is to improve and stabilize the age-appropriate vaccination coverage. However, difficulties have been encountered in implementing mandatory notification. Therefore, the Health Departments of Magdeburg and Halle have launched a model project focusing on analysing and eliminating these problems. Mandatory notification requires parents' approval, endorsement of vaccantors, and availability of human and technicely resources in the Health Department. An enquiry among paediatricians and family doctors in private practice revealed widespread reservations about mandatory notification because of privacy issues related to data and legal protection. Furthermore, family doctors believed that parents disapproved of notification by name. However, a survey among young mothers revealed this not to be the case. Winning young mothers' approval depends largely on the positive attitude of the vaccinators. To implement the mandatory notification of vaccinations to the Health Department, it is necessary to dispel physicians' concerns and to inform young parents about the practical benefits. However, this places high demands on the Health Departments for maintaining immunization registries, communicating with physicians and notifying parents when immunisations are due or late.