Academic literature on the topic 'Medical ethics – New Zealand'

Abstract:This article describes the well-developed and long-standing medical ethics teaching programs in both of New Zealand’s medical schools at the University of Otago and the University of Auckland. The programs reflect the awareness that has been increasing as to the important role that ethics education plays in contributing to the “professionalism” and “professional development” in medical curricula.

In considering what makes New Zealand unique for medical anthropological focus, this think piece sets out four themes. These reflect New Zealand’s particular historical, political, social and cultural landscape, and reveal the relevance of local scholarship for wider global debates about health. By tracing the neoliberal reform of state healthcare, indigenous approaches to wellbeing, local cultural practices of health, and the complex ethics involved in health and illness, this paper spotlights the opportunities that New Zealand medical anthropology affords us for addressing the important health and wellbeing challenges that we face today.

The paper considers the development of Codes of Health Research Ethics. It also considers the need for codes of ethics governing the provision of health care, and its relationship to research ethics. Is there a need for codes to regulate both research and treatment? Should the norms of the International Ethical Guidelines for Biomedical Research Involving Human Subjects (ClaMS) be incorporated into an International Convention which is binding on signatory states. The paper considers the rights of human subjects and patients to be fully informed about the research and treatment. How can the law or ethics protect this right? It considers whether New Zealand law and ethics measures up to the ClaMS Guidelines. The ClaMS Guidelines provide that any subject who is physically injured as a result of participating in research is entitled to receive financial or other assistance so as to compensate them equitably for any temporary or permanent disability. The paper looks at the effect of New Zealand legislation particularly the Accident Rehabilitation and Compensation Insurance Act 1992, and considers whether New Zealand is providing adequate compensation in compliance with the Guidelines.

This paper describes the development of New Zealand policy on posthumous reproduction in assisted human reproduction. It outlines five perspectives: medical, ethical, cultural, psychosocial and legal and shows the multidisciplinary approach taken by the National Ethics Committee. It is argued that each of these perspectives has important contributions to make to the multidisciplinary approach. The guidelines determined by the Committee are outlined, along with the processes used in arriving at these.

Advance directives convey consumers’ wishes about accepting or refusing future treatment if they become incompetent. They are designed to communicate a competent consumer’s perspective regarding the preferred treatment, should the consumer later become incompetent. There are associated ethical issues for health practitioners and this article considers the features that are relevant to nurses. In New Zealand, consumers have a legal right to use an advance directive that is not limited to life-prolonging care and includes general health procedures. Concerns may arise regarding a consumer’s competence and the document’s validity. Nurses need to understand their legal and professional obligations to comply with an advance directive. What role does a nurse play and what questions arise for a nurse when advance directives are discussed with consumers? This article considers the cultural dimensions, legal boundaries, consumers’ and providers’ perspectives, and the medical and nursing positions in New Zealand.

Background: Acting ethically, in accordance with professional and personal moral values, lies at the heart of nursing practice. However, contextual factors, or obstacles within the work environment, can constrain nurses in their ethical practice – hence the importance of the workplace ethical climate. Interest in nurse workplace ethical climates has snowballed in recent years because the ethical climate has emerged as a key variable in the experience of nurse moral distress. Significantly, this study appears to be the first of its kind carried out in New Zealand. Aim/objective: The purpose of this study was to explore and describe how registered nurses working on a medical ward in a New Zealand hospital perceive their workplace ethical climate. Research design/participants/context: This was a small, qualitative descriptive study. Seven registered nurses were interviewed in two focus group meetings. An inductive method of thematic data analysis was used for this research. Ethical considerations: Ethics approval for this study was granted by the New Zealand Ministry of Health’s Central Regional Health and Disability Ethics Committee on 14 June 2012. Findings: The themes identified in the data centred on three dominant elements that – together – shaped the prevailing ethical climate: staffing levels, patient throughput and the attitude of some managers towards nursing staff. Discussion: While findings from this study regarding staffing levels and the power dynamics between nurses and managers support those from other ethical climate studies, of note is the impact of patient throughput on local nurses’ ethical practice. This issue has not been singled out as having a detrimental influence on ethical climates elsewhere. Conclusion: Moral distress is inevitable in an ethical climate where the organisation’s main priorities are perceived by nursing staff to be budget and patient throughput, rather than patient safety and care.

Objective:Ethics committees (ECs) of medical colleges and other medical associations have become part of their professional experience only in recent years. This is probably attributable to such factors as greater professional accountability and informed consumerism. Relatively little is known about the procedures and agendas of such committees. The aim of the present study was to examine the EC of the Royal Australian and New Zealand College of Psychiatrists, with respect to its practices, in order to learn how a medical college grapples with ethical concerns. Methods:Two members of the College's EC, including its foundation chairman, assembled relevant documents, and subjected them to detailed scrutiny. Consensus was used, preceded by independent attempts at categorising these issues covering the period from the EC's inception in 1978 to June, 1995. Results:Three hundred and sixty-seven issues were dealt with by the EC over a 17 year period, covering clinical practice, financial aspects, forensic psychiatry, teaching and research, liaison with other organisations and preparation of guidelines and a code of ethics. Conclusions:An EC can play a vital role in advising its parent body and members in the ethics of day-to-day professional life as well as formulating (and revising) a code of ethics and supplementary ethical guidelines.

The provision of medical care to top-level athletes in New Zealand comes with a number of challenging ethical issues. Some of these arise out of the commercial interest present in sport that links sporting success with funding, sponsorship deals and media interest. The requirement that athletes stay at peak physical function in order to be successful can, at times, be at odds with concepts of well-being and good health. The employment structure under which doctors are engaged by teams and the employment contracts which define these relationships can be the source of divided loyalty for doctors. For example, sharing health information beyond the doctor-athlete relationship may be in line with contractual obligations, but at odds with what the athlete requests. Divided loyalties also exist when athletes wish to participate in sport despite high risk of harm. Here there is a difference between what the doctor understands as the athlete�s best interest, and the athlete�s consideration of best interest. This thesis adopts two strategies for examining the area of sports medicine in elite athletes in New Zealand. The first section utilizes qualitative research. Sixteen sports doctors were interviewed and the data analysed. The next section involves normative reflection. Here two issues (where a range of behaviours were exhibited by participants) selected from the data are considered and discussion is presented on how doctors should respond to these issues. An examination of the level of guidance offered to sports doctors from the Australasian College of Sports Physician�s Code of Ethics follows. The level of guidance offered is considered inadequate and the thesis ends with a call to attend to these concerns.

Background Infection with Campylobacter is thought to account for about 5% - 14% of all food and waterborne diarrhoea cases worldwide. By international standards, New Zealand has extremely high rates of campylobacteriosis which are thought to be the highest reported rates worldwide. The incidence has been steadily increasing since 1980 (when the disease became notifiable), reaching a peak of cases in 2003 (396/100,000). Although different surveillance systems complicate international comparisons, New Zealand's particularly high rate still lacks a conclusive explanation. Aims This study investigates the geographical distribution of campylobacteriosis in New Zealand and the relative importance of factors assumed to be affecting the distribution of this disease, including those related to climate, landuse, water and food. The approach aims to explain why certain areas might increase the probability of becoming infected. Methodology A Geographical Information System (GIS) is used to visualise the disease rate, investigate potential disease clustering and identify outliers. Hierarchical regression, including the analysis of residuals, is applied to analyse the variables in their complex interrelation and to investigate whether there is statistical evidence explaining the geographical variation in campylobacteriosis. This study is undertaken at the territorial local authority level, as all required data are available at this spatial scale and covers the period 1997 to 2005. Results and conclusion There is a large geographical variation in campylobacteriosis across New Zealand, ranging from an average annual rate of 97/100,000 to 526/100,000 per territorial local authority (TLA). Generally, there is statistical evidence for global and local clustering of the disease rate. There are upper and lower outliers of campylobacteriosis in New Zealand; however, higher rates primarily appear in the South Island. The hierarchical modelling confirms statistical significance for some of the environmental and sociodemographic variables. The final model explains about 58% of the variation in campylobacteriosis, and the residuals reflect this variation relatively accurately in approximately 75% of all TLAs. Although the evaluation of the results is confronted with a number of challenges, it is concluded that socioeconomic and demographic factors are crucial factors in explaining the observed spatial patterns in the notification data.

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Abstract Background Asthma is a common problem in New Zealand, and is associated with significant morbidity and costs to children, their families, and wider society. Previously published New Zealand literature suggested that Māori and Pacific children were less likely than NZ European children to receive asthma medications and elements of asthma education, had poorer knowledge of asthma, and experienced greater morbidity and hospitalisations. However, none of the previous literature had been specifically designed to assess the nature of asthma care in the community, or to specifically answer whether there were ethnic disparities in care. A systematic review of studies published in the international literature that compared asthma management among different ethnic groups drawn from community-based samples was undertaken. The results of this review suggested that minority ethnic group children were less likely to receive elements of asthma medication use, asthma education and self-management (action) plans. Objectives The primary objectives of the study were to: • describe the use of medications, medication delivery systems, asthma education, and self-management plans in primary care for Māori, Pacific, and Other ethnic group children • ascertain whether there were any ethnic disparities in the use of medications, medication delivery systems, asthma education, and self-management plans in primary care after controlling for differences in socio-economic position and other potential confounders. Secondary objectives were to: • describe the asthma-related utilisation of GP, after hours medical care, emergency departments, and hospital admissions among Māori, Pacific, and Other ethnic group children with asthma • ascertain whether differences in medication use, the provision of asthma education, and the provision of self-management plans explained ethnic differences in health service utilisation. Methods A cross-sectional survey was conducted in Auckland, New Zealand. The caregivers of 647 children who were aged 2–14 years, had a diagnosis of asthma or experienced ‘wheeze or whistling in the chest’, and had experienced symptoms in the previous 12 months were identified using random residential address start points and door knocking. Ethnically stratified sampling ratios were used to ensure that approximately equal numbers of children of Māori, Pacific and Other ethnicity were enrolled into the study. A face-to-face interview was conducted with the caregivers of these children. Data was collected about: socio-demographic factors; asthma morbidity; asthma medications and delivery devices; exposure to, and experiences of, asthma education and asthma action plans; and asthma-related health services utilisation. Results In this study, the caregivers of 647 eligible children were invited to participate and 583 completed the interview, giving an overall completion rate of 90.1%. There were no ethnic differences in completion rates. The overall use of inhaled corticosteroid medications had increased since previous New Zealand research was published. Multivariable modelling that adjusted for potential confounders did not identify ethnic differences in the use of inhaled corticosteroids or oral steroids. Some findings about medication delivery mechanisms indicated that care was not consistent with guidelines. About 15% of participants reported they had not received asthma education from a primary care health professional. After adjusting for potential confounders there were no ethnic differences in the likelihood of having received asthma education from a health professional. Among those participants who had received education from a primary care health professional, significantly fewer Māori and Pacific caregivers reported receiving education about asthma triggers, pathophysiology and action plans. Lower proportions of Pacific (77.7%; 95% confidence interval (95%CI) 70.3, 85.1) and Māori (79.8%; 95% CI 73.6, 85.9) caregivers were given information about asthma triggers compared to Other caregivers (89.2%; 95% CI 84.9, 93.6; p=0.01). Fewer Māori (63.6%; 95% CI 55.7, 71.4) and Pacific (68.1%; 95% CI 60.1, 76.1) caregivers reported receiving information about pathophysiology (Other 75.9%; 95% CI 69.5, 82.3; p=0.05). Information about asthma action plans had been given to 22.7% (95% CI 15.5, 29.9) of Pacific and 32.9% (95% CI 25.3, 40.6) of Māori compared to Other participants (36.5%; 95% CI 28.6, 44.3; p=0.04). In addition, fewer Māori (64.2%; 95% CI 56.1, 72.3) and Pacific (68.5%; 95% CI 60.1, 77.0) reported that the information they received was clear and easy to understand (Other 77.9%; 95% CI 71.8, 84.1; p=0.03). About half of those who had received education from a health professional reported receiving further education and, after adjustment for potential confounders, Pacific caregivers were less likely to have been given further education (odds ratio 0.57; 95% confidence interval 0.33, 0.96). A minority of participants (35.3%) had heard about action plans and, after adjustment for potential confounders, Pacific caregivers were less likely to have heard about these plans (odds ratio 0.54; 95% confidence interval 0.33, 0.96). About 10% of the sample was considered to have a current action plan. The mean number of visits to a GP for acute and routine asthma care (excluding after-hours doctors and medical services) in the previous twelve months were significantly higher for Pacific (3.89; CI 3.28, 4.60) and Māori (3.56; CI 3.03, 4.16) children than Other ethnic group children (2.47; CI 2.11, 2.85; p<0.0001). Multivariable modelling of health service utilization outcomes (‘number of GP visits for acute and routine asthma care in the previous twelve months’, ‘high use of hospital emergency departments’, and ‘hospital admissions’) showed that adjustment for potential confounding and asthma management variables reduced, but did not fully explain, ethnic differences in these outcomes. Māori children experienced 22% more GP visits and Pacific children 28% more visits than Other children (p=0.05). Other variables that were significantly associated with a higher number of GP visits were: regular source of care they always used (regression coefficient (RC) 0.24; p<0.01); lower household income (RC 0.31; p=0.004) and having a current action plan (RC 0.38; p=0.006). Increasing age (RC -0.04; p=0.003), a lay source of asthma education (RC -0.41; p=0.001), and higher scores on asthma management scenario (RC -0.03; p=0.05) were all associated with a lower number of GP visits. Pacific (odds ratio (OR) 6.93; 95% CI 2.40, 19.98) and Māori (OR 2.60; 95% CI 0.87, 8.32) children were more likely to have used an emergency department for asthma care in the previous twelve months (p=0.0007). Other variables that had a significant effect on the use of EDs in the multivariable model were: not speaking English in the home (OR 3.72; 95% CI 1.52, 9.09; p=0.004), male sex (OR 2.43; 95% CI 1.15, 5.15; p=0.02), and having a current action plan (OR 7.85; 95% CI 3.49, 17.66; p<0.0001). Increasing age was associated with a reduced likelihood of using EDs (OR 0.90; 95% CI 0.81, 1.00; p=0.05). Hospitalisations were more likely in the Pacific (OR 8.94; 95% CI 2.25, 35.62) and Māori (OR 5.40; 95% CI 1.28, 23.06) ethnic groups (p=0.007). Four other variables had a significant effect on hospital admissions in the multivariable model. Participants who had a low income (OR 3.70; 95% CI 1.49, 9.18; p=0.005), and those who had a current action plan (OR 8.39; 95% CI 3.85, 18.30; p<0.0001) were more likely to have been admitted to hospital in the previous 12 months. Increasing age (OR 0.88; 95% CI 0.80, 0.98; p=0.02) and parental history of asthma (OR 0.39; 95% CI 0.18, 0.85; p=0.02) were associated with reduced likelihood of admission. Conclusions The study is a robust example of cross-sectional design and has high internal validity. The study population is representative of the population of children with asthma in the community. The three ethnic groups are also considered to be representative of those ethnic groups in the community. The study, therefore, has good representativeness and the findings of the study can be generalised to the wider population of children with asthma in the Auckland region. The results suggested that some aspects of pharmacological management were more consistent with guideline recommendations than in the past. However, given the higher burden of disease experienced by Māori and Pacific children, the lack of observed ethnic differences in the use of preventative medications may reflect under treatment relative to need. There are important ethnic differences in the provision of asthma education and action plans. Future approaches to improving care should focus on interventions to assist health professionals to implement guideline recommendations and to monitor ethnic disparities in their practice. Asthma education that is comprehensive, structured and delivered in ways that are effective for the people concerned is needed.

This thesis examines the public debate on homosexuality in New Zealand in the period 1960-86. Its focus is primarily on male homosexuality because the central issue was the continued criminalization of male same-sex sexual acts. The thesis notes irresolvable problems of definition of homosexuality involving discussions of behaviour, orientation and identity. Nevertheless, the debate proceeded on a binary basis, that homosexuals and heterosexuals were two clearly defined groups of people. The thesis begins by noting the repression and invisibility of homosexuals in the 1960s. It then explores the origins and significance of the New Zealand Homosexual Law Reform Society and the gay liberation movement. Because of the significance of religion in regard to the debate, a chapter is devoted to major change and cleavage that occurred within the churches relating to homosexuality in the period reviewed. Finally the intense fifteen months of debate that occurred prior to decriminalization of male homosexual activity in July 1986 is studied at depth. The thesis highlights the intensity of feeling that the debate engendered. This was the result of the clash of fundamentally different worldviews and value systems. Behind the particular issue lay the question of the moral and social status of homosexuals and homosexual acts. So fundamental was this division that from both sides the very future of society seemed to be at stake. Worlds were in collision.
Note: Thesis now published. Guy, L (2002). Worlds in collision : the gay debate in New Zealand, 1960-1986. Wellington [N.Z.]: Victoria University Press, 2002. ISBN 0864734387

The risk of developing type 2 diabetes is four fold higher in New Zealand(NZ) Polynesians compared to Caucasians. Hence diabetes is more prevalent in Maori (16.5% of the general population) and Pacific Island people (10.1%) compared to NZ Caucasians (9.3%). It is generally accepted that type 2 diabetes has major genetic determinants and heterozygous mutations in a number of genes have previously been identified in some subsets of type 2 diabetes and certain ethnic groups. The high prevalence of diabetes in NZ Polynesians, when compared with NZ Caucasians, after controlling for age, income and body mass index (BMI), suggest that genes may be important in this population. Therefore, the prevalence of allelic variations in the genes encoding amylin and insulin promoter factor-1 (IPF-1), and exon 2 of the hepatocyte nuclear factor-1α (HNF-1α) gene in NZ Polynesians with type 2 diabetes was determined. These genes are known to produce type 2 diabetes in other populations. The genes investigated were screened for mutations by PCR amplification and direct sequencing of promoter regions, exons and adjacent intronic sequences from genomic DNA. DNA was obtained from 146 NZ Polynesians (131 Maori and 15 Pacific Island) with type 2 diabetes and 387 NZ Polynesian non-diabetic control subjects (258 Maori and 129 Pacific Island). Sequences were compared to previously published sequences in the National Centre for Biotechnology Information database. Allelic variations in IPF-1 and exon 2 of the HNF-1α gene were not associated with type 2 diabetes in NZ Polynesians. However, in the amylin gene, two new and one previously described allele was identified in the Maori population including: two alleles in the promoter region (-132G>A and -215T>G), and a missense mutation in exon 3 (QlOR). The -215T>G allele was observed in 5.4% and l% of type 2 diabetic and non-diabetic Maori respectively, and predisposed the carrier to diabetes with a relative risk of 7.23. The -215T>G allele was inherited with a previously described amylin promoter polymorphism(-230A>C) in 3% of Maori with type 2 diabetes, which suggests linkage equilibrium exists between these two alleles. Both Q10R and -132G>A were observed in 0.76% of type 2 diabetic patients and were absent in non-diabetic subjects. Together these allelic variations may account for approximately 7% of type 2 diabetes in Maori. These results suggest that the amylin gene maybe an important candidate marker gene for type 2 diabetes in Maori.

Military ethics serve as a normative code of behaviour for the armed forces of a state, acting as a mechanism of definition and control within the force, between the force and its client, and between the force, its adversaries and the wider public. They have two, intrinsically linked, functions: a preventative function, which defines the moral and legal parameters of conduct, and a constructive function, which creates and maintains an effective and controllable force. Preceded by the code of chivalry, they were largely a creation of the era of conventional interstate warfare that was waged across the European continent from the Treaty of Westphalia through to the desolate end of the Second World War; yet, the operations upon which armed forces, and in particular, the New Zealand Army are deployed have changed, dramatically. Wars no longer, current operations are generally justified on moral principles and involve a multinational, joint and interagency deployment sent to intervene in an irregular, intrastate conflict occurring in an underdeveloped region and conducted under the intense glare of the media. This disjuncture between the changing nature of operations and the context in which military ethics were formulated provides the fundamental question for the thesis: if the milieu in which military ethics developed has changed significantly, what is their current utility? Using the New Zealand Army as the frame of reference, first the contemporary operational environment and then the specific operational environment in Timor-Leste were examined to assess the current utility of military ethics. It was found that the preventative function has an increasing utility because it ensures conduct is within expected norms in an era where the perception of the adversary, the local populace and the domestic and international audience is key to operational success. Despite the reduction in conflict intensity, the constructive function has a remaining utility through its mediation and amelioration of the stressors engendered by the growing complexity of the operational environment. The retention of utility for the constructive function appears to have been facilitated by an adaptation of the warrior ethos, from a narrow traditional outlook to a broad and comprehensive modern interpretation.

The introduction of the new Glasgow medical curriculum provided an opportunity for evaluation of ethics education in the context of a modern curriculum.  The constraints imposed prevented a comprehensive evaluation of ethics teaching in the new curriculum.  Its focus had to be narrowed. This thesis builds on a dissertation submitted for a MMEd Degree at Dundee University, which covered the evaluation of ethics education in the first year of the new curriculum and produced the first three papers in the series being presented. It was decided to perform both process and outcome evaluation in year 1, where the largest proportion of formal curricular ethics sessions takes place.  Outcome evaluation continued throughout the curriculum.  The aims of the first year process evaluation were: 1) To judge the value of the curricular experiences provided for students in terms of: a) Acceptability to both students and tutors.  b) Feasibility.  c) Relevance of material to aims of teaching. 2) To judge the effectiveness of clinical tutors as facilitators of learning. The aim of the outcome evaluation was to test the following hypotheses: 1.  Small group ethics teaching, in the first year of an integrated medical curriculum, will have a positive impact on students’ potential behaviour when facing ethical dilemmas. 2.  The effect will be greater than that produced by a discrete lecture and large group teaching based course early in a traditional curriculum. 3.  Students’ performance will be adversely affected as they progress through the medical curriculum. 4.  The effect will be less pronounced in students undertaking the modern curriculum compared to those undertaking the traditional curriculum.

Statistics New Zealand produces and disseminates national statistics so is interested in the statistical capability of key groups of user such as government; the media and Maori (indigenous New Zealanders). In 2006 a network of academics in official statistics (NAOS) was established and its members have presented short courses for government staff (on ethics and legislation, interpreting opinion polls and demography) and actively contributed to the design and delivery of formal qualifications including the Certificate of Official Statistics and an honours/ masters paper in official statistics. This paper will be taught simultaneously to students in at least three universities by individuals from five separate institutions using video-conferencing facilities. The collaborative process and the key roles of the national statistics association in forming collegial relationships and the national statistics office in facilitating between-university cooperation are discussed.

The International Health Regulations (2005) are legally binding on 196 States Parties, Including all WHO Member States. The IHR aims to keep the world informed about public health risks, through committing all signatories to cooperate together in combating any future “illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans.” Under IHR, countries agreed to strengthen their public health capacities and notify the WHO of any such illness in their populations. The WHO would be the centralized body for all countries facing a health threat, with the power to declare a “public health emergency of international concern,” issue recommendations, and work with countries to tackle a crisis. Although, with the sudden and rapid spread of COVID-19 in the world, many countries varied in implementing the WHO guidelines and health recommendations. While some countries followed the WHO guidelines, others imposed travel restrictions against the WHO’s recommendations. Some refused to share their data with the organization. Others banned the export of medical equipment, even in the face of global shortages. The UN Compliance Research group will focus during the current cycle on analyzing the compliance of the WHO member states to the organizations guidelines during the COVID-19 pandemic.

Overview Skin cancer prevention is a component of the new Cancer Plan 2022–27, which guides the work of the Cancer Institute NSW. To lessen the impact of skin cancer on the community, the Cancer Institute NSW works closely with the NSW Skin Cancer Prevention Advisory Committee, comprising governmental and non-governmental organisation representatives, to develop and implement the NSW Skin Cancer Prevention Strategy. Primary Health Networks and primary care providers are seen as important stakeholders in this work. To guide improvements in skin cancer prevention and inform the development of the next NSW Skin Cancer Prevention Strategy, an up-to-date review of the evidence on the effectiveness and feasibility of skin cancer prevention activities in primary care is required. A research team led by the Daffodil Centre, a joint venture between the University of Sydney and Cancer Council NSW, was contracted to undertake an Evidence Check review to address the questions below. Evidence Check questions This Evidence Check aimed to address the following questions: Question 1: What skin cancer primary prevention activities can be effectively administered in primary care settings? As part of this, identify the key components of such messages, strategies, programs or initiatives that have been effectively implemented and their feasibility in the NSW/Australian context. Question 2: What are the main barriers and enablers for primary care providers in delivering skin cancer primary prevention activities within their setting? Summary of methods The research team conducted a detailed analysis of the published and grey literature, based on a comprehensive search. We developed the search strategy in consultation with a medical librarian at the University of Sydney and the Cancer Institute NSW team, and implemented it across the databases Embase, MEDLINE, PsycInfo, Scopus, Cochrane Central and CINAHL. Results were exported and uploaded to Covidence for screening and further selection. The search strategy was designed according to the SPIDER tool for Qualitative and Mixed-Methods Evidence Synthesis, which is a systematic strategy for searching qualitative and mixed-methods research studies. The SPIDER tool facilitates rigour in research by defining key elements of non-quantitative research questions. We included peer-reviewed and grey literature that included skin cancer primary prevention strategies/ interventions/ techniques/ programs within primary care settings, e.g. involving general practitioners and primary care nurses. The literature was limited to publications since 2014, and for studies or programs conducted in Australia, the UK, New Zealand, Canada, Ireland, Western Europe and Scandinavia. We also included relevant systematic reviews and evidence syntheses based on a range of international evidence where also relevant to the Australian context. To address Question 1, about the effectiveness of skin cancer prevention activities in primary care settings, we summarised findings from the Evidence Check according to different skin cancer prevention activities. To address Question 2, about the barriers and enablers of skin cancer prevention activities in primary care settings, we summarised findings according to the Consolidated Framework for Implementation Research (CFIR). The CFIR is a framework for identifying important implementation considerations for novel interventions in healthcare settings and provides a practical guide for systematically assessing potential barriers and facilitators in preparation for implementing a new activity or program. We assessed study quality using the National Health and Medical Research Council (NHMRC) levels of evidence. Key findings We identified 25 peer-reviewed journal articles that met the eligibility criteria and we included these in the Evidence Check. Eight of the studies were conducted in Australia, six in the UK, and the others elsewhere (mainly other European countries). In addition, the grey literature search identified four relevant guidelines, 12 education/training resources, two Cancer Care pathways, two position statements, three reports and five other resources that we included in the Evidence Check. Question 1 (related to effectiveness) We categorised the studies into different types of skin cancer prevention activities: behavioural counselling (n=3); risk assessment and delivering risk-tailored information (n=10); new technologies for early detection and accompanying prevention advice (n=4); and education and training programs for general practitioners (GPs) and primary care nurses regarding skin cancer prevention (n=3). There was good evidence that behavioural counselling interventions can result in a small improvement in sun protection behaviours among adults with fair skin types (defined as ivory or pale skin, light hair and eye colour, freckles, or those who sunburn easily), which would include the majority of Australians. It was found that clinicians play an important role in counselling patients about sun-protective behaviours, and recommended tailoring messages to the age and demographics of target groups (e.g. high-risk groups) to have maximal influence on behaviours. Several web-based melanoma risk prediction tools are now available in Australia, mainly designed for health professionals to identify patients’ risk of a new or subsequent primary melanoma and guide discussions with patients about primary prevention and early detection. Intervention studies have demonstrated that use of these melanoma risk prediction tools is feasible and acceptable to participants in primary care settings, and there is some evidence, including from Australian studies, that using these risk prediction tools to tailor primary prevention and early detection messages can improve sun-related behaviours. Some studies examined novel technologies, such as apps, to support early detection through skin examinations, including a very limited focus on the provision of preventive advice. These novel technologies are still largely in the research domain rather than recommended for routine use but provide a potential future opportunity to incorporate more primary prevention tailored advice. There are a number of online short courses available for primary healthcare professionals specifically focusing on skin cancer prevention. Most education and training programs for GPs and primary care nurses in the field of skin cancer focus on treatment and early detection, though some programs have specifically incorporated primary prevention education and training. A notable example is the Dermoscopy for Victorian General Practice Program, in which 93% of participating GPs reported that they had increased preventive information provided to high-risk patients and during skin examinations. Question 2 (related to barriers and enablers) Key enablers of performing skin cancer prevention activities in primary care settings included: • Easy access and availability of guidelines and point-of-care tools and resources • A fit with existing workflows and systems, so there is minimal disruption to flow of care • Easy-to-understand patient information • Using the waiting room for collection of risk assessment information on an electronic device such as an iPad/tablet where possible • Pairing with early detection activities • Sharing of successful programs across jurisdictions. Key barriers to performing skin cancer prevention activities in primary care settings included: • Unclear requirements and lack of confidence (self-efficacy) about prevention counselling • Limited availability of GP services especially in regional and remote areas • Competing demands, low priority, lack of time • Lack of incentives.

Background Lung cancer is the number one cause of cancer death worldwide.(1) It is the fifth most commonly diagnosed cancer in Australia (12,741 cases diagnosed in 2018) and the leading cause of cancer death.(2) The number of years of potential life lost to lung cancer in Australia is estimated to be 58,450, similar to that of colorectal and breast cancer combined.(3) While tobacco control strategies are most effective for disease prevention in the general population, early detection via low dose computed tomography (LDCT) screening in high-risk populations is a viable option for detecting asymptomatic disease in current (13%) and former (24%) Australian smokers.(4) The purpose of this Evidence Check review is to identify and analyse existing and emerging evidence for LDCT lung cancer screening in high-risk individuals to guide future program and policy planning. Evidence Check questions This review aimed to address the following questions: 1. What is the evidence for the effectiveness of lung cancer screening for higher-risk individuals? 2. What is the evidence of potential harms from lung cancer screening for higher-risk individuals? 3. What are the main components of recent major lung cancer screening programs or trials? 4. What is the cost-effectiveness of lung cancer screening programs (include studies of cost–utility)? Summary of methods The authors searched the peer-reviewed literature across three databases (MEDLINE, PsycINFO and Embase) for existing systematic reviews and original studies published between 1 January 2009 and 8 August 2019. Fifteen systematic reviews (of which 8 were contemporary) and 64 original publications met the inclusion criteria set across the four questions. Key findings Question 1: What is the evidence for the effectiveness of lung cancer screening for higher-risk individuals? There is sufficient evidence from systematic reviews and meta-analyses of combined (pooled) data from screening trials (of high-risk individuals) to indicate that LDCT examination is clinically effective in reducing lung cancer mortality. In 2011, the landmark National Lung Cancer Screening Trial (NLST, a large-scale randomised controlled trial [RCT] conducted in the US) reported a 20% (95% CI 6.8% – 26.7%; P=0.004) relative reduction in mortality among long-term heavy smokers over three rounds of annual screening. High-risk eligibility criteria was defined as people aged 55–74 years with a smoking history of ≥30 pack-years (years in which a smoker has consumed 20-plus cigarettes each day) and, for former smokers, ≥30 pack-years and have quit within the past 15 years.(5) All-cause mortality was reduced by 6.7% (95% CI, 1.2% – 13.6%; P=0.02). Initial data from the second landmark RCT, the NEderlands-Leuvens Longkanker Screenings ONderzoek (known as the NELSON trial), have found an even greater reduction of 26% (95% CI, 9% – 41%) in lung cancer mortality, with full trial results yet to be published.(6, 7) Pooled analyses, including several smaller-scale European LDCT screening trials insufficiently powered in their own right, collectively demonstrate a statistically significant reduction in lung cancer mortality (RR 0.82, 95% CI 0.73–0.91).(8) Despite the reduction in all-cause mortality found in the NLST, pooled analyses of seven trials found no statistically significant difference in all-cause mortality (RR 0.95, 95% CI 0.90–1.00).(8) However, cancer-specific mortality is currently the most relevant outcome in cancer screening trials. These seven trials demonstrated a significantly greater proportion of early stage cancers in LDCT groups compared with controls (RR 2.08, 95% CI 1.43–3.03). Thus, when considering results across mortality outcomes and early stage cancers diagnosed, LDCT screening is considered to be clinically effective. Question 2: What is the evidence of potential harms from lung cancer screening for higher-risk individuals? The harms of LDCT lung cancer screening include false positive tests and the consequences of unnecessary invasive follow-up procedures for conditions that are eventually diagnosed as benign. While LDCT screening leads to an increased frequency of invasive procedures, it does not result in greater mortality soon after an invasive procedure (in trial settings when compared with the control arm).(8) Overdiagnosis, exposure to radiation, psychological distress and an impact on quality of life are other known harms. Systematic review evidence indicates the benefits of LDCT screening are likely to outweigh the harms. The potential harms are likely to be reduced as refinements are made to LDCT screening protocols through: i) the application of risk predication models (e.g. the PLCOm2012), which enable a more accurate selection of the high-risk population through the use of specific criteria (beyond age and smoking history); ii) the use of nodule management algorithms (e.g. Lung-RADS, PanCan), which assist in the diagnostic evaluation of screen-detected nodules and cancers (e.g. more precise volumetric assessment of nodules); and, iii) more judicious selection of patients for invasive procedures. Recent evidence suggests a positive LDCT result may transiently increase psychological distress but does not have long-term adverse effects on psychological distress or health-related quality of life (HRQoL). With regards to smoking cessation, there is no evidence to suggest screening participation invokes a false sense of assurance in smokers, nor a reduction in motivation to quit. The NELSON and Danish trials found no difference in smoking cessation rates between LDCT screening and control groups. Higher net cessation rates, compared with general population, suggest those who participate in screening trials may already be motivated to quit. Question 3: What are the main components of recent major lung cancer screening programs or trials? There are no systematic reviews that capture the main components of recent major lung cancer screening trials and programs. We extracted evidence from original studies and clinical guidance documents and organised this into key groups to form a concise set of components for potential implementation of a national lung cancer screening program in Australia: 1. Identifying the high-risk population: recruitment, eligibility, selection and referral 2. Educating the public, people at high risk and healthcare providers; this includes creating awareness of lung cancer, the benefits and harms of LDCT screening, and shared decision-making 3. Components necessary for health services to deliver a screening program: a. Planning phase: e.g. human resources to coordinate the program, electronic data systems that integrate medical records information and link to an established national registry b. Implementation phase: e.g. human and technological resources required to conduct LDCT examinations, interpretation of reports and communication of results to participants c. Monitoring and evaluation phase: e.g. monitoring outcomes across patients, radiological reporting, compliance with established standards and a quality assurance program 4. Data reporting and research, e.g. audit and feedback to multidisciplinary teams, reporting outcomes to enhance international research into LDCT screening 5. Incorporation of smoking cessation interventions, e.g. specific programs designed for LDCT screening or referral to existing community or hospital-based services that deliver cessation interventions. Most original studies are single-institution evaluations that contain descriptive data about the processes required to establish and implement a high-risk population-based screening program. Across all studies there is a consistent message as to the challenges and complexities of establishing LDCT screening programs to attract people at high risk who will receive the greatest benefits from participation. With regards to smoking cessation, evidence from one systematic review indicates the optimal strategy for incorporating smoking cessation interventions into a LDCT screening program is unclear. There is widespread agreement that LDCT screening attendance presents a ‘teachable moment’ for cessation advice, especially among those people who receive a positive scan result. Smoking cessation is an area of significant research investment; for instance, eight US-based clinical trials are now underway that aim to address how best to design and deliver cessation programs within large-scale LDCT screening programs.(9) Question 4: What is the cost-effectiveness of lung cancer screening programs (include studies of cost–utility)? Assessing the value or cost-effectiveness of LDCT screening involves a complex interplay of factors including data on effectiveness and costs, and institutional context. A key input is data about the effectiveness of potential and current screening programs with respect to case detection, and the likely outcomes of treating those cases sooner (in the presence of LDCT screening) as opposed to later (in the absence of LDCT screening). Evidence about the cost-effectiveness of LDCT screening programs has been summarised in two systematic reviews. We identified a further 13 studies—five modelling studies, one discrete choice experiment and seven articles—that used a variety of methods to assess cost-effectiveness. Three modelling studies indicated LDCT screening was cost-effective in the settings of the US and Europe. Two studies—one from Australia and one from New Zealand—reported LDCT screening would not be cost-effective using NLST-like protocols. We anticipate that, following the full publication of the NELSON trial, cost-effectiveness studies will likely be updated with new data that reduce uncertainty about factors that influence modelling outcomes, including the findings of indeterminate nodules. Gaps in the evidence There is a large and accessible body of evidence as to the effectiveness (Q1) and harms (Q2) of LDCT screening for lung cancer. Nevertheless, there are significant gaps in the evidence about the program components that are required to implement an effective LDCT screening program (Q3). Questions about LDCT screening acceptability and feasibility were not explicitly included in the scope. However, as the evidence is based primarily on US programs and UK pilot studies, the relevance to the local setting requires careful consideration. The Queensland Lung Cancer Screening Study provides feasibility data about clinical aspects of LDCT screening but little about program design. The International Lung Screening Trial is still in the recruitment phase and findings are not yet available for inclusion in this Evidence Check. The Australian Population Based Screening Framework was developed to “inform decision-makers on the key issues to be considered when assessing potential screening programs in Australia”.(10) As the Framework is specific to population-based, rather than high-risk, screening programs, there is a lack of clarity about transferability of criteria. However, the Framework criteria do stipulate that a screening program must be acceptable to “important subgroups such as target participants who are from culturally and linguistically diverse backgrounds, Aboriginal and Torres Strait Islander people, people from disadvantaged groups and people with a disability”.(10) An extensive search of the literature highlighted that there is very little information about the acceptability of LDCT screening to these population groups in Australia. Yet they are part of the high-risk population.(10) There are also considerable gaps in the evidence about the cost-effectiveness of LDCT screening in different settings, including Australia. The evidence base in this area is rapidly evolving and is likely to include new data from the NELSON trial and incorporate data about the costs of targeted- and immuno-therapies as these treatments become more widely available in Australia.

Progress towards a world where all can enjoy optimal health and health care is crucially dependent on all kinds of research including research involving humans. Involving humans in medical research is necessary to improve the knowledge base on which medicine should be based. At the same time, individuals participating in health-related research have individual human rights and have a right to be protected against the risks that research may bring to them. The tension between these two considerations has led the medical community to endorse ethical guidelines for health-related research. Research Ethics Committees can use these guidelines to evaluate whether a given research protocol is ethically acceptable or not. -- In the late 1970s, CIOMS set out, in cooperation with WHO, to prepare guidelines to indicate how the ethical principles set forth in the Declaration of Helsinki of the World Medical Association, could be effectively applied, particularly in low-resource settings, given their socio-economic circumstances, laws and regulations, and executive and administrative arrangements. Since then, revised editions of the CIOMS ethical guidelines were published in 1993 and 2002. New developments in research prompted CIOMS to again revise their ethical guidelines. The result is available in this publication. -- In the 2016 version of the ethical Guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research. In providing this revised version, CIOMS hopes to ensure that the ethical Guidelines remain a living document that provides reasoned conditions for research in order to meet the challenges of modern research.