Search

Introduction: Patient involvement is increasingly recognized as critical to the development, introduction and use (i.e. the lifecycle) of new and effective therapies, particularly those for rare diseases, where natural histories and the impact on patients and families are less well-understood than for common diseases. However, little is known about how patients and families would like to be involved during the lifecycle. Objective: The aim of this study was to explore ways in which Canadian patients with rare diseases and their families would like to be involved in the lifecycle of therapies and identify their priorities for involvement. Methods: Patients with rare diseases and their families were recruited to participate in two deliberative sessions, during which concepts related to decision-making uncertainty and the technology lifecycle were introduced before eliciting input around ways in which they could be involved. This was followed by a webinar, which was used to further identify opportunities for involvement. The data were then analyzed qualitatively using eclectic coding. Results: Patients and families identified opportunities that fell into three goals: (1) incorporation of their 'lived experience' in coverage decision making (i.e. decisions by governments on funding new therapies); (2) improved care for patients; and (3) greater awareness of rare diseases, with the first being a priority. Conclusions: Opportunities for patients and families to contribute their 'lived experience' are needed throughout the orphan drug lifecycle, but the ideal mechanisms for providing this input have yet to be determined.

Issue addressed: Australian policymakers have acknowledged that implementing obesity prevention regulations is likely to be facilitated or hindered by public opinion. Accordingly, we investigated public views about possible regulations. Methods: Cross-sectional survey of 2732 persons, designed to be representative of South Australians aged 15 years and over. Questions examined views about four obesity prevention regulations (mandatory front-of-pack nutrition labelling for packaged foods; zoning restrictions to prohibit fast food outlets near schools; taxes on unhealthy high fat foods; and taxes on sugar-sweetened beverages). Levels of support (Likert scale) for each intervention and reasons for support/opposition were ascertained. Results: Views about the regulations were mixed: support was highest for mandatory nutrition labelling (90%) and lowest for taxes (40%-42%). High levels of support for labelling were generally underpinned by a belief that this regulation would educate "Other" people about nutrition. Lower levels of support for zoning restrictions and taxes were associated with concerns about government overreach and the questionable effectiveness of these regulations in changing behaviours. Levels of support for each regulation, and reasons for support or opposition, differed by gender and socioeconomic status. Conclusions: Sociodemographic differences in support appeared to reflect gendered responsibilities for food provision and concerns about the material constraints of socioeconomic deprivation. Engagement with target populations may offer insights to optimise the acceptability of regulations and minimise unintended social consequences. So what?: Resistance to regulations amongst socioeconomically disadvantaged target populations warrants attention from public health advocates. Failure to accommodate concerns identified may further marginalise these groups.

Introduction: Reimbursement decisions on orphan drugs carry significant uncertainty, and as the amount increases, so does the risk of making a wrong decision, where harms outweigh benefits. Consequently, patients often face limited access to orphan drugs. Managed access programmes (MAPs) are a mechanism for managing risk while enabling access to potentially beneficial drugs. Patients and their caregivers have expressed support for these programmes and see patient input as critical to successful implementation. However, they have yet to be systematically involved in their design. Objective: The aim of this study was to co-design with patients and caregivers a tool for the development of managed access programmes. Methods: Building upon established relationships with the Canadian Organization for Rare Disorders, the project team collaborated with patients and caregivers using the principles of participatory action research. Data were collected at two workshops and analysed using a thematic network approach. Results: Patients and caregivers co-designed a checklist comprised of six aspects of an ideal MAP relating to accountability (programme goals); governance (MAP-specific committee oversight, patient input, international collaboration); and evidence collection (outcome measures and continuation criteria, on-going monitoring and registries). They recognized that health-care resources are finite and considered disease or drug eligibility criteria for deciding when to use a MAP (eg drugs treating diseases for which there are no other legitimate alternatives). Conclusions: A patient and caregiver-designed checklist was created, which emphasized patient involvement and transparency. Further research is needed to examine the feasibility of this checklist and roles for other stakeholders.

Introduction: Unhealthy foods are widely available in public settings across Canada, contributing to diet-related chronic diseases, such as obesity. This is a concern given that public facilities often provide a significant amount of food for consumption by vulnerable groups, including children and seniors. Healthy food procurement policies, which support procuring, distributing, selling, and/or serving healthier foods, have recently emerged as a promising strategy to counter this public health issue by increasing access to healthier foods. Although numerous Canadian health and scientific organizations have recommended such policies, they have not yet been broadly implemented in Canada. Methods: To inform further policy action on healthy food procurement in a Canadian context, we: (1) conducted an evidence synthesis to assess the impact of healthy food procurement policies on health outcomes and sales, intake, and availability of healthier food, and (2) hosted a consensus conference in September 2014. The consensus conference invited experts with public health/nutrition policy research expertise, as well as health services and food services practitioner experience, to review evidence, share experiences, and develop a consensus statement/recommendations on healthy food procurement in Canada. Results: Findings from the evidence synthesis and consensus recommendations for healthy food procurement in Canada are described. Specifically, we outline recommendations for governments, publicly funded institutions, decision-makers and professionals, citizens, and researchers. Conclusion: Implementation of healthy food procurement policies can increase Canadians' access to healthier foods as part of a broader vision for food policy in Canada.

Objective: Including and prioritising community voice in policy development means policy is more likely to reflect community values and priorities. This project trialled and evaluated a storyboard approach in a deliberative community forum to engage Australian Aboriginal people in health policy priority setting. Methods: The forum was co-constructed with two Aboriginal community-controlled organisations. A circle storyboard was used to centre Aboriginal community knowledge and values and encourage the group to engage with broader perspectives and evidence. The forum asked a diverse (descriptively representative) group of Aboriginal people in a rural town what governments should do to support the wellbeing of children and youth, particularly to encourage them to eat well and be active. Results: The storyboard provided a tactile device to allow shared stories and identification of community issues. The group identified policies they believed governments should prioritise, including strategies to combat racism and provide local supports and outlets for young people. Conclusions: An informed deliberative storyboard approach offers a novel way of engaging with Aboriginal communities in a culturally appropriate and inclusive manner. Implications for public health: The identification of racism as a major issue of concern in preventing children from living healthy lifestyles highlights the need for policy responses in this area.

Background: Patients and their families have become more active in healthcare systems and research. The value of patient involvement is particularly relevant in the area of rare diseases, where patients face delayed diagnoses and limited access to effective therapies due to the high level of uncertainty in market approval and reimbursement decisions. It has been suggested that patient involvement may help to reduce some of these uncertainties. This review explored existing and proposed roles for patients, families, and patient organizations at each stage of the lifecycle of therapies for rare diseases (i.e., orphan drug lifecycle). Methods: A scoping review was conducted using methods outlined by Arksey and O'Malley. To validate the findings from the literature and identify any additional opportunities that were missed, a consultative webinar was conducted with members of the Patient and Caregiver Liaison Group of a Canadian research network. Results: Existing and proposed opportunities for involving patients, families, and patient organizations were reported throughout the orphan drug lifecycle and fell into 12 themes: research outside of clinical trials; clinical trials; patient reported outcomes measures; patient registries and biorepositories; education; advocacy and awareness; conferences and workshops; patient care and support; patient organization development; regulatory decision-making; and reimbursement decision-making. Existing opportunities were not described in sufficient detail to allow for the level of involvement to be assessed. Additionally, no information on the impact of involvement within specific opportunities was found. Based on feedback from patients and families, documentation of existing opportunities within Canada is poor. Conclusions: Opportunities for patient, family, and patient organization involvement exist throughout the orphan drug lifecycle. However, based on the information found, it is not possible to determine which opportunities

Evidence-based profiling of obesity and overweight in Indigenous Australian children has been poor. This study systematically reviewed evidence of the prevalence and patterns of obesity/overweight, with respect to gender, age, remoteness, and birth weight, in Indigenous Australian children, 0-18 years (PROSPERO CRD42014007626). Study quality and risk of bias were assessed. Twenty-five publications (21 studies) met inclusion criteria, with large variations in prevalence for obesity or overweight (11 to 54%) reported. A high degree of heterogeneity in study design was observed, few studies (6/21) were representative of the target population, and few appropriately recruited Indigenous children (8/21). Variability in study design, conduct, and small sample sizes mean that it is not possible to derive a single estimate for prevalence although two high-quality studies indicate at least one in four Indigenous Australian children are overweight or obese. Four of six studies reporting on gender, found overweight/obesity higher in girls and eight studies reporting on overweight/obesity by age suggest prevalence increases with age with one high quality large national study reporting total overweight/obesity as 22.4% of children aged 2-4 years, 27.5% of those aged 5-9, 38.5% aged 10-14, and 36.3% aged 15-17. Three of four studies, reporting obesity/overweight by region, found lower rates for children living in more remote areas than urban areas.

Purpose: Public engagement in health technology assessment (HTA) is increasingly considered crucial for good decision making. Determining the "right" type of engagement activity is key in achieving the appropriate consideration of public values. Little is known about the factors that determine how HTA organizations (HTAOs) decide on their method of public engagement, and there are a number of possible factors that might shape these decisions. The purpose of this paper is to understand the potential drivers of public engagement from an organizational perspective. Design/methodology/approach: The published HTA literature is reviewed alongside existing frameworks of public engagement in order to elucidate key factors influencing the choice of public engagement process undertaken by HTAOs. A conceptual framework is then developed to illustrate the factors identified from the literature that appear to influence public engagement choice. Findings: Determining the type of public engagement undertaken in HTA is based on multiple factors, some of which are not always explicitly acknowledged. These factors included the: perceived complexity of the policy-making issue, perceived impact of the decision, transparency and opportunities for public involvement in governance, as well as time and resource constraints. The influences of these factors vary depending on the context, indicating that a one size fits all approach to public engagement may not be effective. Originality/value: Awareness of the various factors that might influence the type of public engagement undertaken would enable decision makers to reflect on their choices and be more accountable and transparent about their choice of engagement process in eliciting public values and preferences in a HTAO.

Intense concern about obesity in the public imagination and in political, academic and media discourses has catalysed advocacy efforts to implement regulatory measures to reduce the occurrence of obesity in Australia and elsewhere. This article explores public attitudes towards the possible implementation of regulations to address obesity by analysing emotions within popular discourses. Drawing on reader comments attached to obesity-relevant news articles published on Australian news and current affairs websites, we examine how popular anxieties about the 'obesity crisis' and vitriol directed at obese individuals circulate alongside understandings of the appropriate role of government to legitimise regulatory reform to address obesity. Employing Ahmed's theorisation of 'affective economies' and broader literature on emotional cultures, we argue that obesity regulations achieve popular support within affective economies oriented to neoliberal and individualist constructions of obesity. These economies preclude constructions of obesity as a structural problem in popular discourse; instead positioning anti-obesity regulations as a government-endorsed vehicle for discrimination directed at obese people. Findings implicate a new set of ethical challenges for those championing regulatory reform for obesity prevention.

The potential for regulatory measures to address escalating rates of obesity is widely acknowledged in public health circles. Many advocates support regulations for their potential to reduce health inequalities, in light of the well-documented social gradient in obesity. This paper examines how different social groups understand the role of regulations and other public health interventions in addressing obesity. Drawing upon focus group data from a metropolitan city in southern Australia, we argue that implementing obesity regulations without attention to the ways in which disadvantaged communities problematise obesity may lead to further stigmatisation of this key target population. Tuana's work on the politics of ignorance, and broader literature on classed asymmetries of power, provides a theoretical framework to demonstrate how middle class understandings of obesity align with dominant 'obesity epidemic' discourses. These position obese people as lacking knowledge; underpinning support for food labelling and mandatory nutrition education for welfare recipients as well as food taxes. In contrast, disadvantaged groups emphasised the potential for a different set of interventions to improve material circumstances that constrain their ability to act upon existing health promotion messages, while also describing priorities of everyday living that are not oriented to improving health status. Findings demonstrate how ignorance is produced as an explanation for obesity, widely replicated in political settings and mainstream public health agendas. This politics of ignorance and its logical reparation serve to reproduce power relations in which particular groups are constructed as lacking capacity to act on knowledge, whilst maintaining others in privileged positions of knowing.

Background: Governments use a variety of processes to incorporate public perspectives into policymaking, but few studies have evaluated these processes from participants' point of view. Objective: The objective of this study was twofold: to understand the perspectives of selected stakeholders with regard to involvement processes used by Australian Advisory Committees to engage the public and patients; and to identify barriers and facilitators to participation. Design: Twelve semi-structured interviews were conducted with representatives of different stakeholder groups involved in health technology funding decisions in Australia. Data were collected and analysed using a theoretical framework created by Rowe and Frewer, but adapted to more fully acknowledge issues of power and influence. Results: Stakeholder groups disagreed as to what constitutes effective and inclusive patient involvement. Barriers reported by interviewees included poor communication, a lack of transparency, unworkable deadlines, and inadequate representativeness. Also described were problems associated with defining the task for patients and their advocates and with the timing of patient input in the decision-making process. Interviewees suggested that patient participation could be improved by increasing the number of patient organizations engaged in processes and including those organizations at different stages of decision making, especially earlier. Conclusions: The different evaluations made by stakeholder groups appear to be underpinned by contrasting conceptions of public involvement and its value, in line with Graham Martin's work which distinguishes between 'technocratic' and 'democratic' public involvement. Understanding stakeholders' perspectives and the contrasting conceptions of public involvement could foster future agreement on which processes should be used to involve the public in decision making.

We collected and analysed views of key stakeholders on the processes used to involve patient organisations in health care funding decision making in Australia. We conducted 12 semi-structured interviews with patient organisation representatives and members of Advisory Committees that provide advice to the Australian Department of Health and employ Health Technology Assessment (HTA) as an evaluation framework. Using two theoretical frameworks, we analysed structural and contextual elements pertaining to the involvement processes. The findings reported in this article relate to interviewees' perspectives on contextual elements, analysed using a Foucauldian lens. These elements include: the perspectives of marginalised voices; the diversity of views on what ought to be considered valid evidence in a HTA setting; and the relationships between stakeholders, along with how these relationships impact on involvement processes and the outcomes of those processes. The findings demonstrate that the involvement processes currently used are deemed inadequate by both patient organisation representatives and Advisory Committee members, but for different reasons connected to how different stakeholders conceptualise evidence. Advisory Committee members viewed evidence as encompassing clinical outcomes and patient preferences, whereas patient organisation representatives tended to view evidence as encompassing aspects not directly related to a disease entity, such as the social and emotional aspects of patients' experiences in living with illness. Patient organisation representatives reported interacting with other stakeholders (especially industry) to increase the influence of their conception of evidence on decision making. The use of this strategy by interviewees illustrates how power struggles occur in government decision-making processes which involve both medical expertise and patients' accounts. Such struggles, and the power differentials they reflect, need to be considered by

High prevalence of overweight and obesity remains a significant international public health problem. Law has been identified as a tool for obesity prevention and selected high-profile measures have been reported. However, the nature and extent of enacted legislation internationally are unclear. This research provides an overview of regulatory approaches enacted in the United States, the European Union, and EU Member States since 2004. To this end, relevant databases of primary and secondary legislation were systematically searched to identify and explore laws addressing dietary risk factors for obesity. Across jurisdictions, current regulatory approaches to obesity prevention are limited in reach and scope. Target groups are rarely the general population, but instead sub-populations in government-supported settings. Consumer information provision is preferred over taxation and marketing restrictions other than the regulation of health and nutrition claims. In the EU in particular, product reformulation with industry consent has also emerged as a popular small-scale measure. While consistent and widespread use of law is lacking, governments have employed a range of regulatory measures in the name of obesity prevention, indicating that there is, in principle, political will. Results from this study may serve as a starting point for future research and policy development.

Background:Early diagnosis and improved treatment outcomes have increased breast cancer survival rates that, in turn, have led to increased numbers of women undergoing follow-up after completion of primary treatment. The current workload growth is unsustainable for breast cancer specialists who also provide care for women newly diagnosed or with a recurrence. Appropriate and acceptable follow-up care is important; yet, currently we know little about patient preferences. The aim of this study was to explore the preferences of Australian breast cancer survivors for alternative modes of delivery of follow-up services.Methods:A self-administered questionnaire (online or paper) was developed. The questionnaire contained a discrete choice experiment (DCE) designed to explore patient preferences with respect to provider, location, frequency and method of delivery of routine follow-up care in years 3, 4 and 5 after diagnosis, as well as the perceived value of 'drop-in' clinics providing additional support. Participants were recruited throughout Australia over a 6-month period from May to October 2012. Preference scores and choice probabilities were used to rank the top 10 most preferred follow-up scenarios for respondents.Results:A total of 836 women participated in the study, of whom 722 (86.4%) completed the DCE. In the absence of specialist follow-up, the 10 most valued surveillance scenarios all included a Breast Physician as the provider of follow-up care. The most preferred scenario is a face-to-face local breast cancer follow-up clinic held every 6 months and led by a Breast Physician, where additional clinics focused on the side effects of treatment are also provided.Conclusion:Beyond the first 2 years from diagnosis, in the absence of a specialist led follow-up, women prefer to have their routine breast cancer follow-up by a Breast Physician (or a Breast Cancer Nurse) in a dedicated local breast cancer clinic, rather than with their local General Practitioner. Drop

Immunization against pertussis, influenza, and rubella reduces morbidity and mortality in pregnant women and their offspring. Health care professionals (HCPs) caring for women perinatally are uniquely placed to reduce maternal vaccine preventable diseases (VPDs). Despite guidelines recommending immunization during the perinatal period, maternal vaccine uptake remains low. This qualitative study explored the role of obstetricians, general practitioners, and midwives in maternal vaccine uptake. Semi-structured interviews (n = 15) were conducted with perinatal HCPs at a tertiary maternity hospital in South Australia. HCPs were asked to reflect on their knowledge, beliefs, and practice relating to immunization advice and vaccine provision. Interviews were transcribed and coded using thematic analysis. Data collection and analysis was an iterative process, with collection ceasing with theoretical saturation. Participants unanimously supported maternal vaccination as an effective way of reducing risk of disease in this vulnerable population, however only rubella immunity detection and immunization is embedded in routine care. Among these professionals, delegation of responsibility for maternal immunization was unclear and knowledge about maternal immunization was variable. Influenza and pertussis vaccine prevention measures were not included in standard pregnancy record documentation, information provision to patients was "ad hoc" and vaccinations not offered on-site. The key finding was that the incorporation of maternal vaccinations into standard care through a structured process is an important facilitator for immunization uptake. Incorporating vaccine preventable disease management measures into routine obstetric care including incorporation into the Pregnancy Record would facilitate HCPs in implementing recommendations. Rubella prevention provides a useful "template" for other vaccines. 2014 Landes Bioscience.

Investigating patients' reports on the quality and consistency of melanoma follow-up care in Australia would assist in evaluating if this care is effective and meeting patients' needs. The objective of this study was to obtain and explore the patients' account of the technical and interpersonal aspects of melanoma follow-up care received. An online survey was conducted to acquire details of patients' experience. Participants were patients treated in Australia for primary melanoma. Qualitative and quantitative data about patient perceptions of the nature and quality of their follow-up care were collected, including provision of melanoma specific information, psychosocial support, and imaging tests received. Inconsistencies were reported in the provision and quality of care received. Patient satisfaction was generally low and provision of reassurance from health professionals was construed as an essential element of quality of care. "Gaps" in follow-up care for melanoma patients were identified, particularly provision of adequate psychosocial support and patient education. Focus on strategies for greater consistency in the provision of support, information, and investigations received, may generate a cost dividend which could be reinvested in preventive and supportive care and benefit patient well-being.

Background Clinical practice guidelines should aim to assist clinicians in making evidence-based choices in the care of their patients. This review attempts to determine the extent of evidence-based support for clinical practice guideline recommendations concerning cutaneous melanoma follow up and to evaluate the methodological quality of these guidelines. Methods Current guidelines providing graded recommendations regarding patient follow up were identified through a systematic literature review. The authors reviewed the evidence base used to formulate recommendations in each of the guidelines and appraised the quality of the guidelines using the AGREE II (Appraisal of Guidelines for Research and Evaluation) instrument. Results Most guideline recommendations concerning the frequency of routine skin examinations by a clinician and the use of imaging and diagnostic tests in the follow up of melanoma patients were based on low-level evidence or consensus expert opinion. Melanoma follow-up guidelines are of variable methodological quality, with some guidelines not recommended by the appraisers for use in clinical practice. Conclusion Clinicians should be aware of how scant the evidence base is for many recommended courses of action. As a consequence of the paucity of evidence in the field of melanoma follow up, there is considerable variability in the guidance provided. The variable methodological quality of guidelines for melanoma follow up could be improved by attention to the criteria described in AGREE II. 2014 The Authors International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

Research is needed into current melanoma follow-up practices and their implications for patients and society. We highlight the need and suggest a way forward. 2013 AHHA.