Reprint of: 'A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance'.

The UK Medical Research Council's widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.

Lobbying against tobacco tax increases in France: arguments and strategies of the tobacco industry and tobacconists analysed through their trade press.

INTRODUCTION: Raising taxes is one of the most cost-effective measures to reduce tobacco use. France has a unique profile: it has high tobacco use prevalence and a state monopoly on tobacco sales for tobacconists who are both agents of the customs administration and a recognised tobacco industry (TI) front group. In this paper, we investigate the lobbying tactics and arguments against tobacco taxation mobilised by the TI and tobacconists in France. METHODS: We conducted a quantitative and qualitative analysis of the two leading French tobacco trade media outlets (La Revue des Tabacs and Le Losange) between 2000 and 2020. We performed a manual thematic content analysis based on existing conceptual models of TI political activity, including the policy dystopia model. RESULTS: Tobacconists actively lobbied against tobacco taxation, using traditional arguments highlighted in conceptual models (ie, the claim that 'taxation increases illicit trade and is ineffective'), but also France-centric arguments (ie, tobacconists denounced the impact of cross-border shopping and highlighted their role as pivotal to community life in rural areas). We also found lobbying strategies mirroring those identified previously (ie, coalition, information management and direct influence in public policy). CONCLUSIONS: Tobacconists in France hold a specific status that gives them privileged access to government bodies that can be exploited to successfully lobby against tobacco taxation. NGOs need to expose these lobbying activities and alert the public authorities to Article 5.3 of the WHO Framework Convention on Tobacco Control that requires countries to protect policies from TI interests.

The absence of mandatory pregnancy warning labels in online alcohol purchasing contexts.

INTRODUCTION: As people increasingly migrate to online shopping platforms, hard-won improvements in requirements for consumer information provision at the point of sale are being eroded. An example is the alcohol pregnancy warning label for packaged alcoholic beverages that has been recently introduced in Australia and New Zealand. The aim of the present study was to assess the extent to which the pregnancy warning was visible at the online point of sale when the requirement became mandatory in August 2023. METHODS: Data for alcohol products sold on the websites of the two largest alcohol retailers in Australia were web-scraped from 1 to 3 August 2023. The captured data for 8343 alcoholic beverages were inspected to determine whether the pregnancy warning was visible. RESULTS: Virtually no products (0.1%) had the mandatory warning visible on the main sales page, and only 7% enabled visibility of the warning via optional product image rotation functionality. DISCUSSION AND CONCLUSIONS: The almost complete absence of the mandatory pregnancy warnings on the main product pages of major alcohol retailers' websites highlights the regulatory problems posed by the emerging shift to online shopping. The very low prevalence of visible pregnancy warnings is likely to be an overestimate of the extent to which consumers would be exposed to warnings due to images being counted as being present regardless of their quality or readability. New regulation is needed to ensure that mandatory information requirements for harmful products are applied to online shopping contexts.

Agnogenic practices and corporate political strategy: the legitimation of UK gambling industry-funded youth education programmes.

Agnogenic practices-designed to create ignorance or doubt-are well-established strategies employed by health-harming industries (HHI). However, little is known about their use by industry-funded organizations delivering youth education programmes. We applied a previously published framework of corporate agnogenic practices to analyse how these organizations used them in three UK gambling industry-funded youth education programmes. Evidential strategies adopted previously by other HHI are prominent in the programmes' practitioner-facing materials, evaluation design and reporting and in public statements about the programmes. We show how agnogenic practices are employed to portray these youth education programmes as 'evidence-based' and 'evaluation-led'. These practices distort the already limited evidence on these educational initiatives while legitimizing industry-favourable policies, which prioritize commercial interests over public health. Given the similarities in political strategies adopted by different industries, these findings are relevant to research and policy on other HHI.

Under the influence: system-level effects of alcohol industry-funded health information organizations.

There is now an established body of evidence that the alcohol industry seeks to obstruct public health policies that could affect the availability, affordability or marketing of alcohol. In parallel, the alcohol industry is active in funding corporate social responsibility initiatives, with a particular focus on 'responsible drinking' campaigns, often facilitated by national-level charities established and/or funded by the alcohol industry and associated organizations. While evidence continues to grow regarding biases in the content produced by such health information organizations, they remain active in partnerships with government health departments on national health promotion campaigns and provide a range of health-related information to the public, community organizations and schools. To understand the implications of such access for policymakers, researchers and the public, there is a need to consider the wider, system-level influences of such organizations and their place in wider alcohol industry strategies. In this article, we describe evolving evidence of the direct and indirect strategic effects of such organizations and demonstrate how they serve key roles in the alcohol industry through their existence, content, partnerships and public profiles. We end by considering the implications for how we conceptualize charities established or funded (entirely or partly) by harmful commodity industries, and to what extent current conflicts of interest guidelines are sufficiently effective.

Explaining differential socioeconomic effects in population health interventions: development and application of a new tool to classify intervention agentic demand.

BACKGROUND: The agentic demand of population health interventions (PHIs) might influence how interventions work. Highly agentic interventions (eg, information campaigns) rely on recipients noticing and responding to the intervention. Resources required for individuals to benefit from highly agentic interventions have a socioeconomical pattern, thus agentic demand might affect intervention effectiveness and equity. Systematic evidence exploring these associations is missing due to the absence of adequate tools to classify agentic demands. We aimed to develop such a tool and test its application. METHODS: Our iterative development process involved: (1) systematic identification of diet and physical activity PHIs; (2) coding of intervention actors and actions; (3) data synthesis; (4) expert qualitative feedback; and (5) reliability assessment. We searched nine databases for articles published between Jan 1, 2010, and Aug 17, 2020. For all included articles, we coded the actors (people required to act within an intervention) and their actions (what they were required to do for the intervention to have its intended effects). We combined these codes for similar intervention types to develop overarching schematic flow chart diagrams used to identify concepts, and we organised these into a draft tool. After expert feedback, and we assessed inter-rater reliability of the final version. We applied the final tool in a proof-of-concept review, extracting studies from three existing equity-focused systematic reviews on tool category, overall intervention effect, and differential socioeconomic effects and visualised findings. FINDINGS: We identified three concepts affecting agentic demands of intervention components: exposure, two levels (how recipients encounter the intervention); mechanism of action, five levels; and engagement, two levels (how recipients respond to the intervention). We then combined these concepts to form 20 categories that grouped together interventions with similar agentic demands. In the review, we applied the tool to 26 PHIs that included 163 components. Intervention components were concentrated in a small number of categories, and their categorisation was related to intervention equity but not to effectiveness. INTERPRETATION: We present a novel tool to classify the agentic demand of PHIs and demonstrate its feasibility within a systematic review. Linking intervention types to their effect on inequalities enables these factors to be considered when designing or selecting interventions. Users of the tool can avoid implementing intervention types that are likely to widen inequalities or implement them alongside counter-strategies to minimise any adverse equity effects. Applying this tool within future research, policy, and practice to design, select, evaluate, and synthesise evidence from PHIs has the potential to advance our understanding of how interventions work and their effect on socioeconomic inequalities. FUNDING: Public Health Policy Research Unit (PH-PRU), National Institute for Health and Care Research (NIHR) Policy Research Programme.

The Commercial Determinants of Health and Evidence Synthesis (CODES): methodological guidance for systematic reviews and other evidence syntheses.

BACKGROUND: The field of the commercial determinants of health (CDOH) refers to the commercial products, pathways and practices that may affect health. The field is growing rapidly, as evidenced by the WHO programme on the economic and commercial determinants of health and a rise in researcher and funder interest. Systematic reviews (SRs) and evidence synthesis more generally will be crucial tools in the evolution of CDOH as a field. Such reviews can draw on existing methodological guidance, though there are areas where existing methods are likely to differ, and there is no overarching guidance on the conduct of CDOH-focussed systematic reviews, or guidance on the specific methodological and conceptual challenges. METHODS/RESULTS: CODES provides guidance on the conduct of systematic reviews focussed on CDOH, from shaping the review question with input from stakeholders, to disseminating the review. Existing guidance was used to identify key stages and to provide a structure for the guidance. The writing group included experience in systematic reviews and other forms of evidence synthesis, and in equity and CDOH research (both primary research and systematic reviews). CONCLUSIONS: This guidance highlights the special methodological and other considerations for CDOH reviews, including equity considerations, and pointers to areas for future methodological and guideline development. It should contribute to the reliability and utility of CDOH reviews and help stimulate the production of reviews in this growing field.

Characterizing restrictions on commercial advertising and sponsorship of harmful commodities in local government policies: a nationwide study in England.

BACKGROUND: Commercial advertising and sponsorship drive the consumption of harmful commodities. Local authorities (LAs) have considerable powers to reduce such exposures. This study aimed to characterize local commercial policies across all English LAs. METHODS: We conducted a census of all English LAs (n = 333) to identify local commercial policies concerning advertising and sponsorship of tobacco, alcohol, less healthy foods and gambling, through online searches and Freedom of Information requests. We explored policy presence, commodity frequency and type, and associations with LA characteristics (region, urban/rural and deprivation). RESULTS: Only a third (106) of LAs in England had a relevant policy (32%). These included restrictions on tobacco (91%), gambling (79%), alcohol (74%) and/or less healthy foods (24%). Policy prevalence was lowest in the East of England (22%), North East (25%) and North West (27%), higher in urban areas (36%) than rural areas (28%) and lower in the least (27%) compared with the most (38%) deprived areas. Definitions in policies varied, particularly for alcohol and less healthy foods. CONCLUSIONS: English LAs currently underutilize their levers to reduce the negative impacts of harmful commodity industry marketing, particularly concerning less healthy foods. Standardized guidance, including clarity on definitions and application, could inform local policy development.

TRIPLE C reporting principles for case study evaluations of the role of context in complex interventions.

BACKGROUND: Guidance and reporting principles such as CONSORT (for randomised trials) and PRISMA (for systematic reviews) have greatly improved the reporting, discoverability, transparency and consistency of published research. We sought to develop similar guidance for case study evaluations undertaken to explore the influence of context on the processes and outcomes of complex interventions. METHODS: A range of experts were recruited to an online Delphi panel, sampling for maximum diversity in disciplines (e.g. public health, health services research, organisational studies), settings (e.g. country), and sectors (e.g. academic, policy, third sector). To inform panel deliberations, we prepared background materials based on: [a] a systematic meta-narrative review of empirical and methodological literatures on case study, context and complex interventions; [b] the collective experience of a network of health systems and public health researchers; and [c] the established RAMESES II standards (which cover one kind of case study). We developed a list of topics and issues based on these sources and encouraged panel members to provide free text comments. Their feedback informed development of a set of items in the form of questions for potential inclusion in the reporting principles. We circulated these by email, asking panel members to rank each potential item twice (for relevance and validity) on a 7-point Likert scale. This sequence was repeated twice. RESULTS: We recruited 51 panel members from 50 organisations across 12 countries, who brought experience of a range of case study research methods and applications. 26 completed all three Delphi rounds, reaching over 80% consensus on 16 items covering title, abstract, definitions of terms, philosophical assumptions, research question(s), rationale, how context and complexity relates to the intervention, ethical approval, empirical methods, findings, use of theory, generalisability and transferability, researcher perspective and influence, conclusions and recommendations, and funding and conflicts of interest. CONCLUSION: The 'Triple C' (Case study, Context, Complex interventions) reporting principles recognise that case studies are undertaken in different ways for different purposes and based on different philosophical assumptions. They are designed to be enabling rather than prescriptive, and to make case study evaluation reporting on context and complex health interventions more comprehensive, accessible and useable.

Conceptualising the commercial determinants of suicide: broadening the lens on suicide and self-harm prevention.

Suicide is preventable, yet, in many settings, robust suicide prevention strategies have not been implemented. Although a commercial determinants of health lens is increasingly being applied to industries important to the field of suicide prevention, the interplay between the vested interests of commercial actors and suicide has received little attention. There is a need to shift attention to the causes of the causes, directing more focus to the ways that commercial determinants influence suicide and shape suicide prevention strategies. Such a shift in perspective, with an evidence base and precedents to draw upon, has transformative potential for research and policy agendas dedicated to understanding and addressing upstream modifiable determinants of suicide and self-harm. We propose a framework intended to help guide efforts to conceptualise, research, and address the commercial determinants of suicide and their inequitable distribution. We hope these ideas and lines of inquiry help to catalyse connections between disciplines and open further debate and discussion as to how to take such an agenda forward.

Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE-equity reporting guideline.

BACKGROUND: Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. METHODS: We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. DISCUSSION: Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.

Defining and conceptualising the commercial determinants of health.

Although commercial entities can contribute positively to health and society there is growing evidence that the products and practices of some commercial actors-notably the largest transnational corporations-are responsible for escalating rates of avoidable ill health, planetary damage, and social and health inequity; these problems are increasingly referred to as the commercial determinants of health. The climate emergency, the non-communicable disease epidemic, and that just four industry sectors (ie, tobacco, ultra-processed food, fossil fuel, and alcohol) already account for at least a third of global deaths illustrate the scale and huge economic cost of the problem. This paper, the first in a Series on the commercial determinants of health, explains how the shift towards market fundamentalism and increasingly powerful transnational corporations has created a pathological system in which commercial actors are increasingly enabled to cause harm and externalise the costs of doing so. Consequently, as harms to human and planetary health increase, commercial sector wealth and power increase, whereas the countervailing forces having to meet these costs (notably individuals, governments, and civil society organisations) become correspondingly impoverished and disempowered or captured by commercial interests. This power imbalance leads to policy inertia; although many policy solutions are available, they are not being implemented. Health harms are escalating, leaving health-care systems increasingly unable to cope. Governments can and must act to improve, rather than continue to threaten, the wellbeing of future generations, development, and economic growth.

How Do Industry-Funded Alcohol and Gambling Conferences Frame the Issues? An Analysis of Conference Agendas.

OBJECTIVE: There is a growing evidence base that unhealthy commodity industries (including alcohol and gambling) promote industry-favorable framings of product harms and solutions. These framings adopt a focus on the individual while overlooking broader influences and solutions. One potential method to influence the framing of harms and solutions is funding and organizing conferences. This study aims to examine how industry-funded alcohol and gambling conferences present themselves and frame product harms and solutions. METHOD: We conducted a descriptive examination and framing analysis of industry-funded alcohol and gambling conference descriptions and agendas or programs to examine how conferences were presented. We also examined how the included topics framed the issues of product harm and solutions. A hybrid approach (using both deductive and inductive coding) was used for framing analysis, informed by previous research. RESULTS: All the included conferences were targeted at professionals outside of the respective industry, many specifically mentioning researchers or policy makers. Several of the conferences offered professional credits for attendance. We identified four key frames that are consistent with the existing evidence base: a complex link between product consumption and harm, focus on the individual, deflection from population-level approaches, and medicalization/specialization of solutions. CONCLUSIONS: We found industry-favorable framings of harms and solutions within the alcohol and gambling conferences included in our sample. These conferences are aimed at professionals outside of the industry, including researchers and policy makers, with several offering professional credits for attendance. Greater awareness of the potential for industry-favorable framings at conference settings is required.

Typology of how 'harmful commodity industries' interact with local governments in England: a critical interpretive synthesis.

INTRODUCTION: Industries that produce and market potentially harmful commodities or services (eg, tobacco, alcohol, gambling, less healthy foods and beverages) are a major influence on the drivers of behavioural risk factors for non-communicable diseases. The nature and impact of interactions between public bodies and 'harmful commodity industries' (HCIs) has been widely recognised and discussed at national and international levels, but to date little is known about such interactions at local or regional government levels. This study aimed to identify and characterise actual and potential interactions and proposes a typology of interactions between HCIs and English local authorities (LAs). METHODS: Five electronic databases covering international literature (PubMed, EBSCO, OVID, Scopus and Web of Science) were searched up to June 2021. We also performed online searches for publicly available, web-based grey literature and documented examples of interactions in an English LA context. We conducted a critical interpretive synthesis of the published and grey literature to integrate and conceptualise the data in the context of English LAs. RESULTS: We included 47 published papers to provide the frame for the typology, which was refined and contextualised for English LAs through the available grey literature. Three categories were developed, describing the medium through which interactions occur: (1) direct involvement with LAs, (2) involvement through intermediaries and (3) involvement through the local knowledge space. Within these, we grouped interactions into 10 themes defining their nature and identified illustrative examples. CONCLUSION: Our typology identifies complex inter-relationships and characterises interactions between HCIs and LAs, with illustrative examples from English LAs. Drawn from well-established theories and frameworks in combination with contextual information on English LAs, this typology explores the LA perspective and could help local decision-makers to maximise population health while minimising negative impacts of HCIs. PROSPERO REGISTRATION NUMBER: CRD42021257311.