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1.
Int J Health Policy Manag ; 13: 7405, 2024.
Article in English | MEDLINE | ID: mdl-39099531

ABSTRACT

BACKGROUND: Evidence on the impact of policies that regulate unhealthy food marketing demonstrates a need for a shift from pure industry self-regulation toward statutory regulation. Institutional rules, decision-making procedures, actor practices, and institutional norms influence the regulatory choices made by policy-makers. This study examined institutional processes that sustain, support, or inhibit change in the food marketing regulation in Australia using the three pillars of institutions framework - regulatory, normative, and cultural cognitive pillars. METHODS: This was a qualitative study. Twenty-four in-depth semi-structured interviews were conducted with industry, government, civil society, and academic actors who are involved in nutrition policy in Australia. RESULTS: The regulatory pillar was perceived to inhibit policy change through the co-regulation and self-regulation frameworks that assign rulemaking, monitoring and enforcement to industry bodies with minimal oversight by regulatory agencies and no involvement of health actors. The normative pillar was perceived to provide pathways for comprehensive statutory regulation through institutional goals and norms for collaboration that centre on a whole-of-government approach. The framing of food marketing policies to highlight the vulnerability of children is a cultural cognitive element that was perceived to be essential for getting support for policy change; however, there was a lack of shared understanding of food marketing as a policy issue. In addition, government ideologies that are perceived to be reluctant to regulate commercial actors and values that prioritize economic interest over public health make it difficult for health advocates to argue for statutory regulation of food marketing. CONCLUSION: Elements of all three pillars (regulatory, normative, and cultural-cognitive) were identified as either inhibitors or pathways that support policy change. This study contributes to the understanding of factors that inhibit policy change and potential pathways for implementing comprehensive statutory regulation of unhealthy food marketing.


Subject(s)
Food Industry , Marketing , Nutrition Policy , Policy Making , Qualitative Research , Humans , Australia , Marketing/legislation & jurisprudence , Nutrition Policy/legislation & jurisprudence , Food Industry/legislation & jurisprudence , Government Regulation
2.
Antimicrob Resist Infect Control ; 13(1): 12, 2024 01 25.
Article in English | MEDLINE | ID: mdl-38273403

ABSTRACT

BACKGROUND: Vietnam is among 11 countries in the Western Pacific region that has developed a National Action Plan for Antimicrobial Resistance (NAPCA). METHODS: This scoping review characterises health system barriers to the implementation of the Vietnam NAPCA, with reference to the WHO Health Systems Framework. RESULTS: Over 7 years, between 2013 and 2020, the Ministry of Health (MOH) of Vietnam has been implementing activities to achieve the six NAPCA objectives. They include revision of regulations needed for antimicrobial resistance (AMR) prevention programs; formation and operation of national management bodies; improvement of antimicrobial stewardship (AMS) in hospitals; maintenance of surveillance systems for AMR; provision of trainings on AMR and antibiotics use to doctors and pharmacists; and organization of nation-wide educational campaigns. Limited cooperation between MOH management bodies, shortages of human resource at all health system levels, a low degree of agreement between national and hospital guidelines on antibiotic use, low capability in the domestic supply of standardised drugs, and unequal training opportunities for lower-level health professionals present ongoing challenges. Actions suggested for the next period of the NAPCA include a final review of what has been achieved by the plan so far and evaluating the effectiveness of the different components of the plan. Different options on how to improve coordination across sectors in the development of a new NAPCA should be put forward. CONCLUSIONS: The 6-year implementation of the Vietnam NAPCA has yielded valuable lessons for AMS in Vietnam, guiding the development of future national plans, with a central focus on scaling up AMS in hospitals and promoting community AMS programs to combat AMR.


Subject(s)
Anti-Bacterial Agents , Drug Resistance, Bacterial , Humans , Anti-Bacterial Agents/therapeutic use , Vietnam , Health Personnel , Pharmacists
3.
Int J Health Policy Manag ; 12: 7031, 2023.
Article in English | MEDLINE | ID: mdl-37579444

ABSTRACT

BACKGROUND: Global policy to guide action on musculoskeletal (MSK) health is in a nascent phase. Lagging behind other non-communicable diseases (NCDs) there is currently little global policy to assist governments to develop national approaches to MSK health. Considering the importance of comparison and learning for global policy development, we aimed to perform a comparative analysis of national MSK policies to identify areas of innovation and draw common themes and principles that could guide MSK health policy. METHODS: Multi-modal search strategy incorporating a systematic online search targeted at the 30 most populated nations; a call to networked experts; a specified question in a related eDelphi questionnaire; and snowballing methods. Extracted data were organised using an a priori framework adapted from the World Health Organization (WHO) Building Blocks and further inductive coding. Subsequently, texts were open coded and thematically analysed to derive specific sub-themes and principles underlying texts within each theme, serving as abstracted, transferable concepts for future global policy. RESULTS: The search yielded 165 documents with 41 retained after removal of duplicates and exclusions. Only three documents were comprehensive national strategies addressing MSK health. The most common conditions addressed in the documents were pain (non-cancer), low back pain, occupational health, inflammatory conditions, and osteoarthritis. Across eight categories, we derived 47 sub-themes with transferable principles that could guide global policy for: service delivery; workforce; medicines and technologies; financing; data and information systems; leadership and governance; citizens, consumers and communities; and research and innovation. CONCLUSION: There are few examples of national strategic policy to address MSK health; however, many countries are moving towards this by documenting the burden of disease and developing policies for MSK services. This review found a breadth of principles that can add to this existing work and may be adopted to develop comprehensive system-wide MSK health approaches at national and global levels.


Subject(s)
Noncommunicable Diseases , Policy Making , Humans , Health Policy , World Health Organization , Workforce , Global Health
4.
Health Res Policy Syst ; 21(1): 49, 2023 Jun 13.
Article in English | MEDLINE | ID: mdl-37312183

ABSTRACT

BACKGROUND: Low back pain (LBP) is a major cause of disease burden around the world. There is known clinical variation in how LBP is treated and addressed; with one cited reason the lack of availability, or use of, evidence-based guidance for clinicians, consumers, and administrators. Despite this a considerable number of policy directives such as clinical practice guidelines, models of care and clinical tools with the aim of improving quality of LBP care do exist. Here we report on the development of a repository of LBP directives developed in the Australian health system and a content analysis of those directives aimed at deepening our understanding of the guidance landscape. Specifically, we sought to determine: (1) What is the type, scale, and scope of LBP directives available? (2) Who are the key stakeholders that drive low back pain care through directives? (3) What content do they cover? (4) What are their gaps and deficiencies? METHODS: We used online web search and snowballing methods to collate a repository of LBP policy documents collectively called 'directives' including Models of Care (MOC), information sheets, clinical tools, guidelines, surveys, and reports, from the last 20 years. The texts of the directives were analysed using inductive qualitative content analysis adopting methods from descriptive policy content analysis to categorise and analyse content to determine origins, actors, and themes. RESULTS: Eighty-four directives were included in our analysis. Of those, 55 were information sheets aimed at either healthcare providers or patients, nine were clinical tools, three were reports, four were guidelines, four were MOC, two were questionnaires and five were referral forms/criteria. The three main categories of content found in the directives were 1. Low back pain features 2. Standards for clinical encounters and 3. Management of LBP, each of which gave rise to different themes and subthemes. Universities, not-for-profit organizations, government organisations, hospitals/Local Health Districts, professional organisations, consumers, and health care insurers were all involved in the production of policy directives. However, there were no clear patterns of roles, responsibilities or authority between these stakeholder groups. CONCLUSION: Directives have the potential to inform practice and to contribute to reducing evidence-policy-practice discordance. Documents in our repository demonstrate that while a range of directives exist across Australia, but the evidence base for many was not apparent. Qualitative content analysis of the directives showed that while there has been increasing attention given to models of care, this is not yet reflected in directives, which generally focus on more specific elements of LBP care at the individual patient and practitioner level. The sheer number and variety of directives, from a wide range of sources and various locations within the Australian health system suggests a fragmented policy landscape without clear authoritative sources. There is a need for clearer, easily accessible trustworthy policy directives that are regularly reviewed and that meet the needs of care providers, and information websites need to be evaluated regularly for their evidence-based nature and quality.


Subject(s)
Health Policy , Low Back Pain , Humans , Australia , Cost of Illness , Low Back Pain/therapy
5.
Global Health ; 18(1): 94, 2022 11 12.
Article in English | MEDLINE | ID: mdl-36371287

ABSTRACT

BACKGROUND: Government's investment policy is an important driver of food system activities, which in turn influence consumers practices, dietary consumption patterns and nutrition-related health of populations. While governments globally have committed to developing coherent public policies to advance population nutrition, the objectives of investment policies are seen as being divorced from nutrition and health goals. This study aimed to examine investment policy in Thailand and explore how key actors variously define and frame their objectives in food investment policy, how nutrition issues are represented by the actors, and what discursive effects of the nutrition results were represented within the field of investment in Thailand. METHODS: This study conducted semi-structured interviews with 16 actors (from 23 recruited actors) from government, civil society, academia and industry. A coding framework was developed based on Bacchi's analytical framework encapsulated in the question "What's the problem represented to be?" which examines the problem and assumptions underlying a policy. Data coding was first undertaken by a lead researcher and then double-coded and cross-checked by research team. Disagreements were resolved with discussion until consensus was achieved. The interview data were analysed using thematic analysis. RESULTS: The principal "problem" represented in food investment policy in Thailand was the perceived irrelevance of nutrition to governmental commitments towards increasing productivity and economic growth. Technological innovation in food production and processing such as ultra-processed foods was perceived as a key driver of economic growth. The key assumption underlying this representation was the primacy of a "productivist" policy paradigm, via which the government focuses on industrially driven food and agriculture and expansion to increase productivity and economic growth. This entails that the nutrition needs of Thai people are silenced and remain unacknowledged in investment policy contexts, and also does not take cognisance of the term "nutrition" and its importance to economic growth. CONCLUSION: The findings show that nutrition was not perceived as a political priority for the government and other investment actors. Promoting productivity and economic growth were clearly positioned as the primary purposes of investment within the dominant discourse. Nutrition regulation, particularly of UPF, may conflict with current investment policy directions which prioritise development of modern food production and processing. The study suggests that comprehensive policy communication about nutrition and food classification is needed.


Subject(s)
Goals , Nutrition Policy , Humans , Thailand , Government , Organizations , Health Policy
6.
Health Res Policy Syst ; 20(1): 44, 2022 Apr 20.
Article in English | MEDLINE | ID: mdl-35443690

ABSTRACT

BACKGROUND: Effective integration of evidence and youth perspectives into policy is crucial for supporting the future health and well-being of young people. The aim of this project was to translate evidence from the Access 3 project to support development of a new state policy on youth health and well-being within New South Wales (NSW), Australia. Ensuring the active contribution of young people within policy development was a key objective of the knowledge translation (KT) process. METHODS: The KT activity consisted of a 1-day facilitated forum with 64 purposively sampled stakeholders. Participants included eight young people, 14 policy-makers, 15 academics, 22 clinicians or managers from NSW health services, four general practitioners and one mental health service worker. Research to be translated came from the synthesized findings of the NSW Access 3 project. The design of the forum included stakeholder presentations and group workshops, guided by the 2003 Lavis et al. KT framework that was improved by the Grimshaw et al. KT framework in 2012. Members of the Access 3 research team took on the role of knowledge brokers throughout the KT process. Participant satisfaction with the workshop was evaluated using a brief self-report survey. Policy uptake was determined through examination of the subsequent NSW Youth Health Framework 2017-2024. RESULTS: A total of 25 policy recommendations were established through the workshop, and these were grouped into six themes that broadly aligned with the synthesized findings from the Access 3 project. The six policy themes were (1) technology solutions, (2) integrated care and investment to build capacity, (3) adolescent health checks, (4) workforce, (5) youth participation and (6) youth health indicators. Forum members were asked to vote on the importance of individual recommendations. These policy recommendations were subsequently presented to the NSW Ministry of Health, with some evidence of policy uptake identified. The majority of participants rated the forum positively. CONCLUSIONS: The utilization of KT theories and active youth engagement led to the successful translation of research evidence and youth perspectives into NSW youth health policy. Future research should examine the implementation of policy arising from these KT efforts.


Subject(s)
Mental Health Services , Translational Science, Biomedical , Administrative Personnel , Adolescent , Health Policy , Humans , Policy Making
7.
Global Health ; 18(1): 29, 2022 03 09.
Article in English | MEDLINE | ID: mdl-35264200

ABSTRACT

BACKGROUND: Governance processes play an important role in shaping the formulation and implementation of policy measures such as restrictions on marketing of ultra-processed foods. However, there is limited analysis of the factors that affect governance for nutrition, especially in low- and middle-income countries such as Thailand and the Southeast Asia region. This study aimed to examine governance factors that create opportunities and challenges for the introduction of policy to restrict food marketing in Thailand, in line with the WHO recommendations to restrict food marketing to children. METHODS: A qualitative study design was used. Interviews were conducted with 20 actors with experience and in depth knowledge of food marketing in Thailand, including government, civil society, industry and international organisations. Open questions were asked about experiences and perceptions of the governance processes related to policies for restricting food marketing in Thailand. Themes were derived from the 3-i Framework which relates to interests, ideas and institutions influencing the introduction of food marketing policy were identified and analysed using abductive methods. RESULTS: Actors viewed institutional challenges as a significant barrier to advancing effective regulation of food marketing. Three major clusters emerged from the data: interests (priorities, relationships), institutions (formal structures, informal structures, broader institutional strategies), and ideas (norms). The study has three major findings in relation to these factors, highlighting the influence of formal structures, institutional interests in food marketing issues, and ideas in promoting multisectoralism. The siloed nature of policymaking was reflected in the government failing to stimulate engagement among key actors, posing challenges for implementation of effective policy change. Contested interests led to disagreements between actors over food marketing agenda and thus competing policy priorities. Consistent with these findings, the lack of effective mechanisms to promote multisectoral coordination across diverse actors reinforced barriers to policy change. CONCLUSION: The findings highlight ongoing challenges to the government's aim to strengthen policy to restrict food marketing which, without greater coordination in governance mechanisms, will hinder effective regulation and the achievement of public health goals. This analysis suggests that the Government should prioritise the development of a holistic, multisectoral approach to improve governance for better nutrition outcomes by overcoming policy silos.


Subject(s)
Marketing , Nutrition Policy , Child , Food , Health Policy , Humans , Policy Making , Thailand
8.
Health Policy Technol ; 11(2): 100607, 2022 Jun.
Article in English | MEDLINE | ID: mdl-35190790

ABSTRACT

Objectives: Australia had one of the most successful early responses to the COVID-19 pandemic. Border closures and effective public health responses to outbreaks kept infection and death rates to amongst the lowest in the world. The strategy was premised on an eventual escape through the development and availability of vaccines. While effective vaccines appeared earlier than many expected, Australia's the next stage of crisis management stalled. Vaccination rates were, in mid-2021, one of the lowest in the OECD. By the end of 2021, however, Australia had a comparatively high vaccination rate. This paper accounts for this paradoxical situation. Methods: The analysis uses Moran and Tuohy's concept of the 'health care state' to show how interlocking elements of consumption, production, governance and statecraft created the conditions for Australia's contradictory response to the crisis. Results: The paper locates problems commonly attributed to 'leadership failure' in an analysis of the evolving dynamics of the Australian healthcare state and the governance regimes concerning collective consumption, the health professions, and technologies. Vaccine supply was delayed by the Federal government's preference for local production. The initial problems of the vaccine rollout arose from a failed experiment with outsourcing, initiated at the height of the crisis. Conclusion: Australia's ultimate success in achieving high vaccination rates emerged from the agile stability embedded in its health care state. This delivered where 'market inspired innovation' had failed.

9.
Arch Public Health ; 80(1): 16, 2022 Jan 05.
Article in English | MEDLINE | ID: mdl-34983653

ABSTRACT

BACKGROUND: The COVID-19 pandemic increased the need for new valid scientific evidence to support urgent clinical and policy decision making; as well as improved processes for the rapid synthesis, uptake and application of that evidence. Evidence informed policymaking (EIPM) can be considered as a way to access and use the results of evidence in practice. This study aimed to determine what effects COVID-19 had on the way Iranian health managers and policymakers use evidence in their decisions. METHODS: This study was conducted in 2021 applying a qualitative research design. Data was collected through semi-structured interviews. Thirty health care managers, policy makers and medical university faculty members were recruited as the study participants, initially via a purposive sample, followed by snowballing. A conventional content analysis presented by Hsieh and Shannon (2005) was applied for data analysis. RESULTS: Ten main themes emerged from the data including: 1) roles and duties of knowledge brokers (KBs); 2-5) the roles, benefits, barriers and necessities of applying Knowledge Translation Exchange (KTE) tools; 6-8) the facilitators, benefits and barriers to the application of evidence during COVID-19; 9) challenges of rapid evidence production evidence during COVID-19 and 10) consequences of not applying evidence during COVID-19. According to the present conceptual framework, KBs act as an intermediator between the large amounts of knowledge produced and decision makers. KTE tools should be applied to enhance EIPM during COVID-19. Attention should be paid to the facilitators, barriers, benefits and necessities of evidence application during COVID-19 to avoid negative consequences for the health system. CONCLUSIONS: Results of this study show that developing KTE tools and activating KBs can be among the main strategies to produce applied actionable messages for policymakers to move toward EIPM; and that this applies even when rapid decision making is required, such as during the COVID-19 pandemic. It is strongly recommended to reinforce the local capacities through supporting scientific networks and relationships between research centers and local and national policymakers. At the same time, attention to local barriers to and facilitators of the application of evidence while facing a pandemic can pave the way to better identification of health system`s problems and rapid responses.

11.
Glob Health Res Policy ; 6(1): 24, 2021 05 28.
Article in English | MEDLINE | ID: mdl-34256865

ABSTRACT

BACKGROUND: Musculoskeletal (MSK) conditions, MSK pain and MSK injury/trauma are the largest contributors to the global burden of disability, yet global guidance to arrest the rising disability burden is lacking. We aimed to explore contemporary context, challenges and opportunities at a global level and relevant to health systems strengthening for MSK health, as identified by international key informants (KIs) to inform a global MSK health strategic response. METHODS: An in-depth qualitative study was undertaken with international KIs, purposively sampled across high-income and low and middle-income countries (LMICs). KIs identified as representatives of peak global and international organisations (clinical/professional, advocacy, national government and the World Health Organization), thought leaders, and people with lived experience in advocacy roles. Verbatim transcripts of individual semi-structured interviews were analysed inductively using a grounded theory method. Data were organised into categories describing 1) contemporary context; 2) goals; 3) guiding principles; 4) accelerators for action; and 5) strategic priority areas (pillars), to build a data-driven logic model. Here, we report on categories 1-4 of the logic model. RESULTS: Thirty-one KIs from 20 countries (40% LMICs) affiliated with 25 organisations participated. Six themes described contemporary context (category 1): 1) MSK health is afforded relatively lower priority status compared with other health conditions and is poorly legitimised; 2) improving MSK health is more than just healthcare; 3) global guidance for country-level system strengthening is needed; 4) impact of COVID-19 on MSK health; 5) multiple inequities associated with MSK health; and 6) complexity in health service delivery for MSK health. Five guiding principles (category 3) focussed on adaptability; inclusiveness through co-design; prevention and reducing disability; a lifecourse approach; and equity and value-based care. Goals (category 2) and seven accelerators for action (category 4) were also derived. CONCLUSION: KIs strongly supported the creation of an adaptable global strategy to catalyse and steward country-level health systems strengthening responses for MSK health. The data-driven logic model provides a blueprint for global agencies and countries to initiate appropriate whole-of-health system reforms to improve population-level prevention and management of MSK health. Contextual considerations about MSK health and accelerators for action should be considered in reform activities.


Subject(s)
Bone and Bones/injuries , Delivery of Health Care/statistics & numerical data , Disabled Persons/statistics & numerical data , Global Health/statistics & numerical data , Muscles/injuries , Musculoskeletal Pain/therapy , Bone and Bones/physiopathology , Disabled Persons/rehabilitation , Muscles/physiopathology , World Health Organization
12.
Health Res Policy Syst ; 19(1): 86, 2021 May 25.
Article in English | MEDLINE | ID: mdl-34034745

ABSTRACT

INTRODUCTION: Pakistan has made slow progress towards reducing the newborn mortality burden; as a result, it has the highest burden of newborn mortality worldwide. This article presents an analysis of the current policies, plans, and strategies aimed at reducing the burden of newborn death in Pakistan for the purpose of identifying current policy gaps and contextual barriers towards proposing policy solutions for improved newborn health. METHODS: We begin with a content analysis of federal-level policies that address newborn mortality within the context of health system decentralization over the last 20 years. This is then followed by a case study analysis of policy and programme responses in a predominantly rural province of Pakistan, again within the context of broader health system decentralization. Finally, we review successful policies in comparable countries to identify feasible and effective policy choices that hold promise for implementation in Pakistan, considering the policy constraints we have identified. RESULTS: The major health policies aimed at reduction of newborn mortality, following Pakistan's endorsement of global newborn survival goals and targets, lacked time-bound targets. We found confusion around roles and responsibilities of institutions in the implementation process and accountability for the outcomes, which was exacerbated by an incomplete decentralization of healthcare policy-making and health service delivery, particularly for women around birth, and newborns. Such wide gaps in the areas of target-setting, implementation mechanism, and evaluation could be because the policy-making largely ignored international commitments and lessons of successful policy-making in comparable regional counties. CONCLUSIONS: Inclusion of clear goals and targets in newborn survival policies and plans, completion of the decentralization process of maternal and child healthcare service delivery, and policy-making and implementation by translating complex evidence and using regional but locally applicable case studies will be essential to any effective policy-making on newborn survival in Pakistan.


Subject(s)
Infant Health , Perinatal Death , Child , Female , Health Policy , Humans , Infant, Newborn , Pakistan , Policy Making
13.
Nutrients ; 11(2)2019 Jan 25.
Article in English | MEDLINE | ID: mdl-30691024

ABSTRACT

The Codex Alimentarius has approved ongoing work for international guidance on front-of-pack (FoP) nutrition labelling, which is a core intervention for prevention of diet-related noncommunicable disease. This guidance will have implications for national policy decision-making regarding this important public health issue. However, FoP nutrition labelling is also a trade and commerce policy issue. In this study, we analyze the global governance of FoP nutrition labelling and current policy processes, to inform public health policy and advocacy. We present findings from a qualitative governance and institutional analysis, based on key informant interviews with 28 global actors. The study found that Codex guidance was perceived as likely to have a high impact on FoP nutrition labelling globally. However, a small and highly interconnected "regime complex" of international institutions surrounds FoP nutrition labelling at the global level, and influence on Codex discussions is being exerted differentially by actors at the national and global level, particularly by government and industry actors. There are thus risks associated with conflicts of interests in the development of global guidance on FoP nutrition labelling. There are also opportunities for more strategic and coordinated public health engagement.


Subject(s)
Food Labeling/legislation & jurisprudence , Health Promotion/legislation & jurisprudence , Nutrition Policy/legislation & jurisprudence , Australia , Consumer Behavior , Humans , Internationality , Public Health
14.
Am J Public Health ; 109(1): 35-40, 2019 01.
Article in English | MEDLINE | ID: mdl-30495997

ABSTRACT

To summarize the current understanding of the global burden of musculoskeletal pain-related conditions, consider the process of evidence generation and the steps to generate global pain estimates, identify key gaps in our understanding, and propose an agenda to address these gaps, we performed a narrative review. In the 2010 Global Burden of Disease Study (GBD), which broadened the scope of musculoskeletal conditions that were included over previous rounds, low back pain imposed the highest disability burden of all specific conditions assessed, and subsequent GBD reports further reinforce the size of this burden. Over the past decade, the GBD has produced compelling evidence of the leading contribution of musculoskeletal pain conditions to the global burden of disability, but this has not translated into global health policy initiatives. However, system- and service-level responses to the disease burden persist across high-, middle-, and low-income settings. There is a mismatch between the burden of musculoskeletal pain conditions and appropriate health policy response and planning internationally that can be addressed with an integrated research and policy agenda.


Subject(s)
Global Burden of Disease , Musculoskeletal Pain/epidemiology , Disability Evaluation , Disabled Persons , Global Health , Humans , Quality-Adjusted Life Years
15.
Implement Sci ; 9: 113, 2014 Sep 27.
Article in English | MEDLINE | ID: mdl-25413978

ABSTRACT

BACKGROUND: Process evaluation is vital for understanding how interventions function in different settings, including if and why they have different effects or do not work at all. This is particularly important in trials of complex interventions in 'real world' organisational settings where causality is difficult to determine. Complexity presents challenges for process evaluation, and process evaluations that tackle complexity are rarely reported. This paper presents the detailed protocol for a process evaluation embedded in a randomised trial of a complex intervention known as SPIRIT (Supporting Policy In health with Research: an Intervention Trial). SPIRIT aims to build capacity for using research in health policy and program agencies. METHODS: We describe the flexible and pragmatic methods used for capturing, managing and analysing data across three domains: (a) the intervention as it was implemented; (b) how people participated in and responded to the intervention; and (c) the contextual characteristics that mediated this relationship and may influence outcomes. Qualitative and quantitative data collection methods include purposively sampled semi-structured interviews at two time points, direct observation and coding of intervention activities, and participant feedback forms. We provide examples of the data collection and data management tools developed. DISCUSSION: This protocol provides a worked example of how to embed process evaluation in the design and evaluation of a complex intervention trial. It tackles complexity in the intervention and its implementation settings. To our knowledge, it is the only detailed example of the methods for a process evaluation of an intervention conducted as part of a randomised trial in policy organisations. We identify strengths and weaknesses, and discuss how the methods are functioning during early implementation. Using 'insider' consultation to develop methods is enabling us to optimise data collection while minimising discomfort and burden for participants. Embedding the process evaluation within the trial design is facilitating access to data, but may impair participants' willingness to talk openly in interviews. While it is challenging to evaluate the process of conducting a randomised trial of a complex intervention, our experience so far suggests that it is feasible and can add considerably to the knowledge generated.


Subject(s)
Health Plan Implementation/organization & administration , Health Policy , Health Services Research/statistics & numerical data , Process Assessment, Health Care/organization & administration , Data Collection/methods , Documentation , Government Agencies/organization & administration , Humans , New South Wales , Randomized Controlled Trials as Topic
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