Introducing the revised framework for developing and evaluating complex interventions: A challenge and a resource for nursing research.

This invited discussion paper highlights key updates in the MRC/NIHR's revised framework for the development and evaluation of complex nursing interventions and reflects on the implications for nursing research.

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The UK Medical Research Council's widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent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.

Assessing the effects of population-level political, economic and social exposures, interventions and policies on inclusive economy outcomes for health equity in high-income countries: a systematic review of reviews.

BACKGROUND: A fairer economy is increasingly recognised as crucial for tackling widening social, economic and health inequalities within society. However, which actions have been evaluated for their impact on inclusive economy outcomes is yet unknown. OBJECTIVE: Identify the effects of political, economic and social exposures, interventions and policies on inclusive economy (IE) outcomes in high-income countries, by systematically reviewing the review-level evidence. METHODS: We conducted a review of reviews; searching databases (May 2020) EconLit, Web of Science, Sociological Abstracts, ASSIA, International Bibliography of the Social Sciences, Public Health Database, Embase and MEDLINE; and registries PROSPERO, Campbell Collaboration and EPPI Centre (February 2021) and grey literature (August/September 2020). We aimed to identify reviews which examined social, political and/or economic exposures, interventions and policies in relation to two IE outcome domains: (i) equitable distribution of the benefits of the economy and (ii) equitable access to the resources needed to participate in the economy. Reviews had to include primary studies which compared IE outcomes within or between groups. Quality was assessed using a modified version of AMSTAR-2 and data synthesised informed by SWiM principles. RESULTS: We identified 19 reviews for inclusion, most of which were low quality, as was the underlying primary evidence. Most reviews (n = 14) had outcomes relating to the benefits of the economy (rather than access to resources) and examined a limited set of interventions, primarily active labour market programmes and social security. There was limited high-quality review evidence to draw upon to identify effects on IE outcomes. Most reviews focused on disadvantaged groups and did not consider equity impacts. CONCLUSIONS: Review-level evidence is sparse and focuses on 'corrective' approaches. Future reviews should examine a diverse set of 'upstream' actions intended to be inclusive 'by design' and consider a wider range of outcomes, with particular attention to socioeconomic inequalities.

Evaluating the impact of minimum unit pricing for alcohol in Scotland: a theory-based synthesis of the evidence.

BACKGROUND: In May 2018, the Scottish Government set a minimum unit price (MUP) of £0·50 per unit of alcohol sold in Scotland to reduce alcohol-related health harms. We synthesised evidence to establish the effects of MUP on alcohol-related health and social harms, at population level and within specific societal groups. METHODS: We did a theory-based synthesis of academic and grey research evidence about impacts of MUP in Scotland, including compliance, price, consumption, health outcomes, social outcomes, public attitudes, and the alcoholic drinks industry. We searched the Public Health Scotland's MUP evaluation portfolio and relevant grey and academic literature for studies published between Jan 1, 2018, and Jan 31, 2023. We conducted systematic searches and screening of bibliographic databases (Scopus, Public Health Database, EconLit, MEDLINE, ProQuest Public Health, Social Policy and Practice, NHS Scotland Knowledge Network Library Search, medRxiv, bioRxiv, SSRN, Idox Knowledge Exchange, Social Policy & Practice, and Google Search). Search terms were tailored to specific databases but included variants of the terms "minimum unit pricing", "alcohol", and "policy". Eligibility literature included English-language research into impacts of MUP on either the population of Scotland or a specific subpopulation. We excluded conference abstracts, literature reviews, articles that did not report research, and research based solely on data from before the introduction of MUP. FINDINGS: We included 40 reports in our analysis. On the balance of evidence, MUP improved population-level health outcomes, demonstrated most starkly by a 13·4% reduction in alcohol-attributable deaths in Scotland compared with England. There was no evidence of substantial negative effects on the alcoholic drinks industry or social harms at the population level. While population-level outcomes were predominantly positive, some qualitative evidence suggests that MUP might have exacerbated health and social harms for some individuals or groups, especially those with alcohol dependence who were financially vulnerable. INTERPRETATION: MUP in Scotland has been effective in reducing alcohol-related health harms, with little evidence of any effect on social harms. If MUP continues, policymakers should consider raising the £0·50 per unit threshold and supplementing the intervention with policies or services to address any unintended negative effects experienced by specific groups. The synthesis is persuasive due to the prospective, theory-based design of the evaluation portfolio and the quality and comprehensiveness of the evidence. FUNDING: Scottish Government.

An evaluation of an employment assistance program focused on people living with HIV in Toronto, Canada.

Unemployment is more common among people living with HIV (PLWH) compared to the general population. PLWH who are employed have better physical and mental health outcomes compared to unemployed PLWH. The main objective of this mixed-methods study was to conduct a program evaluation of Employment Action (EACT), a community-based program that assists PLWH in Toronto, Ontario, Canada to maintain meaningful employment. We extracted quantitative data from two HIV services databases used by EACT, and collected qualitative data from 12 individuals who had been placed into paid employment through EACT. From 131 clients included in the analysis, 38.1% (n = 50) maintained their job for at least 6 weeks within the first year of enrollment in the EACT program. Gender, ethnicity, age, and first language did not predict employment maintenance. Our interviews highlighted the barriers and facilitators to effective service delivery. Key recommendations include implementing skills training, embedding PLWH as EACT staff, and following up with clients once they gain employment. Investment in social programs such as EACT are essential for strengthening their data collection capacity, active outreach to service users, and sufficient planning for the evaluation phase prior to program implementation.

Increasing Treatment Rates for Hepatitis C in Primary Care.

BACKGROUND: Despite antiviral agents that can cure the disease, many individuals with Hepatitis C Virus (HCV) remain untreated. Primary care clinicians can play an important role in HCV treatment but often feel they do not have the requisite skills. METHODS: We implemented a population-based improvement intervention over 10 months to support treatment of HCV in a primary care setting. The intervention included a decision-support tool, education for clinicians, enhanced interprofessional team supports, mentorship, and proactive patient outreach. We used process and outcome measures to understand the impact on the proportion of patients who initiated treatment and achieved Sustained Virologic Response (SVR). We used physician focus groups and pharmacist interviews to understand the context and mechanisms influencing the impact of the intervention. RESULTS: Between December 2018 and June 2020, the percentage of HCV RNA positive patients who started treatment rose from 66.0% (354/536) to 75.5% (401/531) with 92.5% (371/401) of those starting treatment achieving SVR. Qualitative findings highlighted that the intervention helped raise awareness and confidence among physicians for treating HCV in primary care. A collaborative team environment, education, mentorship, and a decision-support tool integrated into the electronic record were all enablers of success although patient psychosocial complexity remained a barrier to engagement in treatment. CONCLUSION: A multifaceted primary care improvement initiative increased clinician confidence and was associated with an increase in the proportion of HCV RNA positive patients who initiated curative treatment.

Healthcare system action on employment as a social determinant of health in people living with HIV: A qualitative study.

BACKGROUND: Employment is a key social determinant of health. People living with HIV (PLWH) have higher unemployment rates than the general population. Vocational rehabilitation services have been shown to have significant and positive impact on employment status for PLWH. Understanding whether integrating vocational rehabilitation with health care services is acceptable, from the perspectives of PLWH and their health care providers, is an area that is understudied. METHODS: We conducted a qualitative study and collected data from focus groups and interviews to understand the perspectives of stakeholders regarding the potential for vocational rehabilitation and health care integration. We completed five focus groups with 45 health care providers and one-to-one interviews with 23 PLWHs. Participants were sampled from infectious disease, primary care clinics, and AIDS Service Organizations in Toronto and Ottawa, Canada. Interviews were audio-recorded and transcribed. We conducted a reflexive thematic analysis of the transcripts. FINDINGS: We found health care providers have little experience assisting patients with employment and PLWH had little experience receiving employment interventions from their health care team. This lack of integration between health care and vocational services was related to uncertainties around drug coverage, physician role and living with an episodic disability. Health care providers thought that there is potential for a larger role for health care clinics in providing employment interventions for PLWH however patients were divided. Some PLWH suggest that health care providers could provide advice on the disclosure of status, work limitations and act as advocates with employers. INTERPRETATION: Health care providers and some PLWH recognize the importance of integrating health services with vocational services but both groups have little experience with implementing these types of interventions. Thus, there needs to be more study of such interventions, including the processes entailed and outcomes they aim to achieve.

Priorities for Artificial Intelligence Applications in Primary Care: A Canadian Deliberative Dialogue with Patients, Providers, and Health System Leaders.

BACKGROUND: Artificial intelligence (AI) implementation in primary care is limited. Those set to be most impacted by AI technology in this setting should guide it's application. We organized a national deliberative dialogue with primary care stakeholders from across Canada to explore how they thought AI should be applied in primary care. METHODS: We conducted 12 virtual deliberative dialogues with participants from 8 Canadian provinces to identify shared priorities for applying AI in primary care. Dialogue data were thematically analyzed using interpretive description approaches. RESULTS: Participants thought that AI should first be applied to documentation, practice operations, and triage tasks, in hopes of improving efficiency while maintaining person-centered delivery, relationships, and access. They viewed complex AI-driven clinical decision support and proactive care tools as impactful but recognized potential risks. Appropriate training and implementation support were the most important external enablers of safe, effective, and patient-centered use of AI in primary care settings. INTERPRETATION: Our findings offer an agenda for the future application of AI in primary care grounded in the shared values of patients and providers. We propose that, from conception, AI developers work with primary care stakeholders as codesign partners, developing tools that respond to shared priorities.

Implementing artificial intelligence in Canadian primary care: Barriers and strategies identified through a national deliberative dialogue.

BACKGROUND: With large volumes of longitudinal data in electronic medical records from diverse patients, primary care is primed for disruption by artificial intelligence (AI) technology. With AI applications in primary care still at an early stage in Canada and most countries, there is a unique opportunity to engage key stakeholders in exploring how AI would be used and what implementation would look like. OBJECTIVE: To identify the barriers that patients, providers, and health leaders perceive in relation to implementing AI in primary care and strategies to overcome them. DESIGN: 12 virtual deliberative dialogues. Dialogue data were thematically analyzed using a combination of rapid ethnographic assessment and interpretive description techniques. SETTING: Virtual sessions. PARTICIPANTS: Participants from eight provinces in Canada, including 22 primary care service users, 21 interprofessional providers, and 5 health system leaders. RESULTS: The barriers that emerged from the deliberative dialogue sessions were grouped into four themes: (1) system and data readiness, (2) the potential for bias and inequity, (3) the regulation of AI and big data, and (4) the importance of people as technology enablers. Strategies to overcome the barriers in each of these themes were highlighted, where participatory co-design and iterative implementation were voiced most strongly by participants. LIMITATIONS: Only five health system leaders were included in the study and no self-identifying Indigenous people. This is a limitation as both groups may have provided unique perspectives to the study objective. CONCLUSIONS: These findings provide insight into the barriers and facilitators associated with implementing AI in primary care settings from different perspectives. This will be vital as decisions regarding the future of AI in this space is shaped.

Challenges faced by people experiencing homelessness and their providers during the COVID-19 pandemic: a qualitative study.

BACKGROUND: People experiencing homelessness are vulnerable to SARS-CoV-2 infection and its consequences. We aimed to understand the perspectives of people experiencing homelessness, and of the health care and shelter workers who cared for them, during the COVID-19 pandemic. METHODS: We conducted an interpretivist qualitative study in Toronto, Canada, from December 2020 to June 2021. Participants were people experiencing homelessness who received SARS-CoV-2 testing, health care workers and homeless shelter staff. We recruited participants via email, telephone or recruitment flyers. Using individual interviews conducted via telephone or video call, we explored the experiences of people who were homeless during the pandemic, their interaction with shelter and health care settings, and related system challenges. We analyzed the data using reflexive thematic analysis. RESULTS: Among 26 participants were 11 men experiencing homelessness (aged 28-68 yr), 9 health care workers (aged 33-59 yr), 4 health care leaders (aged 37-60 yr) and 2 shelter managers (aged 47-57 yr). We generated 3 main themes: navigating the unknown, wherein participants grappled with evolving public health guidelines that did not adequately account for homeless individuals; confronting placelessness, as people experiencing homelessness often had nowhere to go owing to public closures and lack of isolation options; and struggling with powerlessness, since people experiencing homelessness lacked agency in their placelessness, and health care and shelter workers lacked control in the care they could provide. INTERPRETATION: Reduced shelter capacity, public closures and lack of isolation options during the COVID-19 pandemic exacerbated the displacement of people experiencing homelessness and led to moral distress among providers. Planning for future pandemics must account for the unique needs of those experiencing homelessness.

Association of Homelessness with COVID-19 Positivity among Individuals Visiting a Testing Centre: A Cross-Sectional Study.

Among those visiting a testing centre in Toronto, ON, between March and April 2020, people experiencing homelessness (n = 214) were more likely to test positive for COVID-19 compared with those not experiencing homelessness (n = 1,836) even after adjustment for age, sex and medical co-morbidity (15.4% vs. 6.7%, p < 0.001; odds ratio [OR] 2.41, 95% confidence interval [CI: 1.51, 3.76], p < 0.001).

Use of natural experimental studies to evaluate 20mph speed limits in two major UK cities.

INTRODUCTION: Reductions in traffic speed can potentially offer multiple health and public health benefits. In 2016, implementation of 20mph (30kph) speed limit interventions began in Edinburgh (city-wide) and Belfast (city centre). The aims of this paper are to describe 1) the broad theoretical approach and design of two natural experimental studies to evaluate the 20mph speed limits in Edinburgh and Belfast and 2) how these studies allowed us to test and explore theoretical mechanisms of 20mph speed limit interventions. METHODS: The evaluation consisted of several work packages, each with different research foci, including the political decision-making processes that led to the schemes, their implementation processes, outcomes (including traffic speed, perceptions of safety, and casualties) and cost effectiveness. We used a combination of routinely and locally collected quantitative data and primary quantitative and qualitative data. RESULTS: The evaluation identified many contextual factors influencing the likelihood of 20mph speed limits reaching the political agenda. There were substantial differences between the two sites in several aspects related to implementation. Reductions in speed resulted in significant reductions in collisions and casualties, particularly in Edinburgh, which had higher average speed at baseline. The monetary value of collisions and casualties prevented are likely to exceed the costs of the intervention and thus the overall balance of costs and benefits is likely to be favourable. CONCLUSIONS: Innovative study designs, including natural experiments, are important for assessing the impact of 'real world' public health interventions. Using multiple methods, this project enabled a deeper understanding of not only the effects of the intervention but the factors that explain how and why the intervention and the effects did or did not occur. Importantly it has shown that 20mph speed limits can lead to reductions in speed, collisions and casualties, and are therefore an effective public health intervention.

Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update.

BACKGROUND: The Medical Research Council published the second edition of its framework in 2006 on developing and evaluating complex interventions. Since then, there have been considerable developments in the field of complex intervention research. The objective of this project was to update the framework in the light of these developments. The framework aims to help research teams prioritise research questions and design, and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. METHODS: There were four stages to the update: (1) gap analysis to identify developments in the methods and practice since the previous framework was published; (2) an expert workshop of 36 participants to discuss the topics identified in the gap analysis; (3) an open consultation process to seek comments on a first draft of the new framework; and (4) findings from the previous stages were used to redraft the framework, and final expert review was obtained. The process was overseen by a Scientific Advisory Group representing the range of relevant National Institute for Health Research and Medical Research Council research investments. RESULTS: Key changes to the previous framework include (1) an updated definition of complex interventions, highlighting the dynamic relationship between the intervention and its context; (2) an emphasis on the use of diverse research perspectives: efficacy, effectiveness, theory-based and systems perspectives; (3) a focus on the usefulness of evidence as the basis for determining research perspective and questions; (4) an increased focus on interventions developed outside research teams, for example changes in policy or health services delivery; and (5) the identification of six 'core elements' that should guide all phases of complex intervention research: consider context; develop, refine and test programme theory; engage stakeholders; identify key uncertainties; refine the intervention; and economic considerations. We divide the research process into four phases: development, feasibility, evaluation and implementation. For each phase we provide a concise summary of recent developments, key points to address and signposts to further reading. We also present case studies to illustrate the points being made throughout. LIMITATIONS: The framework aims to help research teams prioritise research questions and design and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. In many of the areas of innovation that we highlight, such as the use of systems approaches, there are still only a few practical examples. We refer to more specific and detailed guidance where available and note where promising approaches require further development. CONCLUSIONS: This new framework incorporates developments in complex intervention research published since the previous edition was written in 2006. As well as taking account of established practice and recent refinements, we draw attention to new approaches and place greater emphasis on economic considerations in complex intervention research. We have introduced a new emphasis on the importance of context and the value of understanding interventions as 'events in systems' that produce effects through interactions with features of the contexts in which they are implemented. The framework adopts a pluralist approach, encouraging researchers and research funders to adopt diverse research perspectives and to select research questions and methods pragmatically, with the aim of providing evidence that is useful to decision-makers. FUTURE WORK: We call for further work to develop relevant methods and provide examples in practice. The use of this framework should be monitored and the move should be made to a more fluid resource in the future, for example a web-based format that can be frequently updated to incorporate new material and links to emerging resources. FUNDING: This project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514).

Interventions are actions taken to make a change, for example heart surgery, an exercise programme or a smoking ban in public. Interventions are described as complex if they comprise several stages or parts or if the context in which they are delivered is complex. A framework on how to develop and evaluate complex interventions was last published by the Medical Research Council in 2006 (Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and Evaluating Complex Interventions. London: Medical Research Council; 2006). This document describes how the framework has been updated to include advances in research methods and thinking and presents the new framework document. The updating process had four stages: (1) review of the literature to identify areas requiring update; (2) workshop of experts to discuss topics to update; (3) open consultation on a draft of the framework; and (4) writing the framework. The updated framework divides the research process into four phases: development, feasibility, evaluation and implementation. Key updates include: the definition of a complex intervention was changed to include both the content of the intervention and the context in which it is conductedaddition of systems thinking methods: an approach that considers the broader system an intervention sits withinmore emphasis on interventions that are not developed by researchers (e.g. policy changes and health services delivery)emphasis on the usefulness of evidence as the key goal of complex intervention researchidentification of six elements to be addressed throughout the research process: context; theory refinement and testing; stakeholder involvement; identification of key uncertainties; intervention refinement; and economic considerations. The updated framework is intended to help those involved in funding and designing research to consider a range of approaches, questions and methods and to choose the most appropriate. It also aims to help researchers conduct and report research that is as useful as possible to users of research.

What Are the Implications of Applying Equipoise in Planning Citizens Basic Income Pilots in Scotland?

We have been asked to consider the feasibility of piloting a Citizens' Basic Income (CBI): a basic, unconditional, universal, individual, regular payment that would replace aspects of social security and be introduced alongside changes to taxes. Piloting and evaluating a CBI as a Cluster Randomized Control Trial (RCT) raises the question of whether intervention and comparison groups would be in equipoise, and thus whether randomization would be ethical. We believe that most researchers would accept that additional income, or reduced conditions on receiving income would be likely to improve health, especially at lower income levels. However, there are genuine uncertainties about the impacts on other outcomes, and CBI as a mechanism of providing income. There is also less consensus amongst civil servants and politicians about the impacts on health, and substantial disagreement about whether these would outweigh other impacts. We believe that an RCT is ethical because of these uncertainties. We also argue that the principle of equipoise should apply to randomized and non-randomized trials; that randomization is a fairer means of allocating to intervention and comparison groups; and that there is an ethical case for experimentation to generate higher-quality evidence for policymaking that may otherwise do harm.

Knowing the goal: an inclusive economy that can address the public health challenges of our time.

OBJECTIVE: Inequality is deeply embedded in our economic structures-it is necessary to address these economic inequalities if we are to reduce health inequalities. An inclusive economic approach was conceptualised as a way to reduce these economic inequalities, although the attributes of this approach are unclear. Public health practitioners are increasingly asked to provide a health perspective on the economic recovery plans in the light of the COVID-19 pandemic. This paper aims to identify the attributes of an inclusive economy to enable the public health profession to influence an inclusive economic recovery. APPROACH: We conducted a rapid review of grey and peer-reviewed literature to identify the attributes of an inclusive economy as currently defined in the literature. ATTRIBUTES OF AN INCLUSIVE ECONOMY: Twenty-two concepts were identified from 56 reports and articles. These were collapsed into four distinct attributes of an inclusive economy: (1) an economy that is designed to deliver inclusion and equity, (2) equitable distribution of the benefits from the economy (eg, assets, power, value), (3) equitable access to the resources needed to participate in the economy (eg, health, education), and (4) the economy operates within planetary boundaries. CONCLUSION: As economies are (re)built following the COVID-19 pandemic, these attributes of an inclusive economy-based on the current literature-can be used to develop, and then monitor progress of, economic policy that will reduce health inequalities, improve health and mitigate against climate change.