Original Research••

Development of an overarching framework for anticipating and assessing adverse and other unintended consequences of public health interventions (CONSEQUENT): a best-fit framework synthesis

Abstract

Introduction Despite the best intentions and intended beneficial outcomes, public health (PH) interventions can have adverse effects and other unintended consequences (AUCs). AUCs are rarely systematically examined when developing, evaluating or implementing PH interventions. We, therefore, used a multipronged, evidence-based approach to develop a framework to support researchers and decision-makers in anticipating and assessing AUCs of PH interventions.

Methods We employed the ‘best-fit’ synthesis approach, starting with an a priori framework and iteratively revising this based on systematically identified evidence. The a priori framework was designed using key elements of the WHO-INTEGRATE framework and the Behaviour Change Wheel, to root it in global health norms and values, established mechanisms of PH interventions and a complexity perspective. The a priori framework was advanced based on theoretical and conceptual publications and systematic reviews on the topic of AUCs in PH. Thematic analysis was used to revise the framework and identify new themes. To test the framework, it was coded against four systematic reviews of AUCs of PH interventions.

Results The Cosequences of Public Health Interventions (CONSEQUENT) framework includes two components: the first focuses on AUCs and serves to categorise them; the second (supplementary) component highlights the mechanisms through which AUCs may arise. The first component comprises eight domains of consequences: health, health system, human rights, acceptability and adherence, equality, and equity, social and institutional, economic and resources, and the environment.

Conclusion The CONSEQUENT framework is intended to facilitate classification and conceptualisation of AUCs of PH interventions during their development or evaluation to support evidence-informed decision-making.

What is already known on this topic

  • Adverse and other unintended Consequences of Public Health Interventions (CONSEQUENT) exist and should be balanced against benefits in public health and health policy decision-making.

  • While there is an increasing interest among public health researchers in describing and identifying harms of public health interventions, the existing typologies and classifications have not been developed systematically and largely focus on health rather than broader societal consequences.

What this study adds

  • The CONSEQUENT framework was developed using a systematic, multicomponent approach integrating existing conceptual and empirical knowledge.

  • The framework is rooted in global health norms and values and embraces a complexity perspective highlighting a range of social, ecological and economic consequences in addition to health outcomes.

  • The framework offers structured definitions and examples for each of eight domains of CONSEQUENT, as well as potential mechanisms leading to these.

How this study might affect research, practice or policy

  • The CONSEQUENT framework can serve as a tool for researchers to assess and classify the adverse and other unintended CONSEQUENT and to explore underlying mechanisms. The framework may facilitate structured reflections on the adverse and other unintended consequences while developing, evaluating and implementing public health interventions.

Introduction

Promoting and improving the physical and mental health of populations is the central goal of public health (PH) interventions all over the globe. However, despite the best intentions, these interventions can have adverse effects, such as effects in the opposite direction of that intended or expected (paradoxical effects) or effects on unrelated outcomes (unintended externalities).1 For example, providing pre-exposure prophylaxis against HIV may lead to an increase in risky sexual behaviour and in sexually transmitted infections other than HIV.2 The drilling of groundwater wells, which successfully reduced diarrhoeal disease mortality due to polluted surface water, has exposed an estimated 40 million Bangladeshis to harmful concentrations of arsenic contained in the groundwater.3 It has also been shown how obesity-focused PH interventions have led to an increase in stigmatisation and social exclusion of those living with obesity.4 5

To truly promote PH, it is essential not only to evaluate intended beneficial outcomes of PH interventions, but also to anticipate and assess their possible adverse and other unintended consequences (AUCs). Unlike the scrutiny used for evaluating adverse drug reactions—which still remain susceptible to underestimating harm6 7—assessing the AUCs of PH interventions presents unique challenges: while adverse drug reactions primarily result directly from the drugs themselves and affect those taking them, PH interventions often function as ‘events in systems’,8 where effects of the intervention arise as a result of the interaction between the intervention and the social, economic or political context in which it is implemented.8–10 Individuals and populations not targeted by the intervention may even be those (most severely) affected by AUCs.11 12 While adverse drug reactions are mostly health related, PH interventions usually have social, economic, ecological or political ramifications (eg, large-scale usage of the insecticide dichlorodiphenyltrichloroethane (DDT) in malaria prevention leading to adverse effects on the ecosystem).13–16 Furthermore, consideration of an unintended effect of an intervention as adverse, beneficial or neutral is not always clear, as it depends on the perspective of the observer, as well as underlying sociocultural norms; both of these may change over time. For example, whether increased meat consumption is considered an adverse effect (beyond the effect of this on human health) is likely to depend on whether the evaluating person works in the meat industry or is an animal rights activist, whether the assessment takes place in Argentina or Nepal, and whether this is assessed the 1980s compared with the 2020s.

Anticipating and understanding AUCs should be a priority for those deciding on or implementing PH interventions—as there are moral, ethical, political and practical reasons for avoiding health and societal harms.1 17 18 However, these are often not thoroughly examined in PH research, practice and policy, especially AUCs not directly related to health.19–21 While unintended consequences of social action have been discussed in the broader scientific literature,22–30 they constitute a largely neglected topic in empirical PH research,17 31 except for specific areas, such as cancer screening32 or illicit drug use.33

In recent years, PH researchers have begun to identify and describe harms and to suggest typologies or classifications of harms.17 31 However, these have primarily focused on health rather than broader societal consequences and/or have not been developed in a systematic manner.17 31 Important questions remain on how to identify the unintended and potentially harmful effects of PH interventions,21 how best to evaluate them,20 27 and how to incorporate the consideration of harms into the process of evidence-informed decision-making.16 21 34 35 Being able to identify PH interventions and policies with substantive harmful effects and to subsequently adapt or deimplement these interventions is essential for programme implementers, service providers and policy-makers.

The primary objective of the research project was to develop a framework which supports PH researchers, practitioners and decision-makers in anticipating and assessing foreseeable AUCs of PH interventions (the consequences component of framework). The secondary objective was to map and conceptualise the mechanisms through which AUCs may arise (as a supplementary mechanisms component of framework).

Materials and methods

Overview of framework development process

The framework development process is rooted in an understanding that interventions have both intended and unintended consequences, depending on whether these consequences are the outcomes the intervention is supposed to produce30 from the perspective of those conceptualising and implementing the intervention. A specification of further terms used in this manuscript can be found in online supplemental file 1.

We developed the final framework using the ‘best-fit’ framework synthesis approach.36 37 This approach involves generating an initial framework based on existing frameworks, conceptual models or theories, followed by coding evidence identified through systematic literature searches against the initial framework, and revising it in an iterative process considering further evidence. Within the ‘best-fit’ framework synthesis approach,36 37 this initial framework is referred to as an ‘a priori’ framework.

We used key elements from the WHO-INTEGRATE framework35 and the Behaviour Change Wheel (BCW)38 to create an a priori framework of AUCs and the possible mechanisms leading to these.36 37 We then advanced and refined the framework based on theoretical and conceptual papers describing frameworks or systems of AUCs of PH interventions and/or their mechanisms, as well as empirical research on the AUCs of PH interventions implemented in policy and practice. These papers were identified using systematic searches in health databases and reference searches (online supplemental files 2–4). Thematic analysis was used to identify new themes and topics and thereby to revise the framework. In the final step, the findings in systematic reviews of the AUCs of four specific PH interventions were coded against the empirically advanced framework components,39–42 which were conducted by or in cooperation with the members of the research team. This served to test the framework using examples from practice. The framework revisions across all steps were guided by discussions within the study team. The entire framework development process is visualised in figure 1. We used the Standards for Reporting Qualitative Research reporting guideline.43

Figure 1
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Figure 1

Framework development process. AUC, adverse and other unintended consequences; CONSEQUENT framework, Consequences of Public Health Interventions framework.

Development of the a priori framework

For the categorisation of consequences, we used the criteria and subcriteria of the WHO-INTEGRATE framework version 1.0.35 44 45 The WHO-INTEGRATE framework is an Evidence-to-Decision (EtD) framework which was developed in a research project commissioned by the WHO, to support evidence-informed decision-making, in particular in the context of guideline development. It consists of six substantive criteria, balance of health benefits and harms, human rights and sociocultural acceptability, health equity, equality and non-discrimination, societal implications, financial and economic considerations, and feasibility and health system considerations, as well as the meta-criterion quality of evidence. We chose this EtD framework, as (1) it provides a reference frame that is firmly rooted in global health norms and values, as well as key PH ethics frameworks; (2) it is embedded in a complexity perspective, viewing PH interventions as events in (complex) systems8 9 46 and (3) it considers outcomes of PH interventions beyond health, including social, ecological and economic consequences.

For the categorisation of mechanisms, we used the BCW.38 The BCW is a framework for describing, designing and evaluating behaviour change interventions. At its core, the ‘COM-B system’ emphasises three factors - physical and psychological capability (C), social and physical opportunity (O), and automatic and reflective motivation (M) - affecting behaviour change (B). Surrounding these core factors are nine intervention functions (eg, enablement, incentivisation or coercion) and seven policy categories (eg, environmental/social planning, service provision or regulation). We chose BCW as (1) it is the most widely used approach for examining behaviour change and (2) it considers impacts at both individual and societal levels. We focused on the nine intervention functions in BCW and derived a priori mechanisms based on these, including restriction, education, persuasion, incentivisation, coercion, training, enablement, modelling and environmental restructuring.

Through brainstorming and discussions within the research team, these two frameworks were iteratively revised and advanced, resulting in the two components of the a priori framework (online supplemental files 5 and 6).

Identification of eligible publications for ‘best-fit’ framework synthesis

To retrieve the publications of relevance to advance the a priori framework, we conducted comprehensive literature searches in Medline (Ovid), Embase (Ovid) and the Cochrane library for systematic reviews up until November 2020. The search strategy was developed by expanding the search strategy of the 2014 scoping review by Allen-Scott et al31 and by following a guidance document by the Cochrane Adverse Effects Methods Group.47–49 In brief, the search strategy combined terms related to unintended consequences with those related to PH. The search strategy for Embase (Ovid) is provided as an example in online supplemental file 2. Additionally, we conducted forward and backward citation searches of all included studies. We conducted these searches in Scopus, Google Scholar and Microsoft Academic.

First, to incorporate existing concepts of AUCs of PH interventions, we examined theoretical or conceptual papers which categorised, explored or explained AUCs in-depth, grounded in or alluding to empirical findings. These included papers (1) providing typologies or taxonomies of AUCs of PH interventions, such as those by Allen-Scott et al31 or Lorenc and Oliver,17 (2) describing, discussing or exploring mechanisms of how PH interventions may lead to unintended consequences, such as those by Allen-Scott et al31 and Bonell et al1 and (3) offering guidance for identifying unintended consequences of PH interventions, such as those by Bonell et al1 and Mittelmark.50

Second, to incorporate empirical insights to date, we retrieved and assessed systematic reviews with the primary objective to assess AUCs of PH interventions. Reviews with a primary focus on the effectiveness of interventions (ie, the intended beneficial effects of PH interventions) were excluded.

After removal of duplicate studies, the eligibility of studies was assessed independently by two researchers (JMS and RLB). Disagreements were resolved by discussion, and where necessary, by consulting with the full research team.

In selecting papers for inclusion, we adopted a broad approach to PH interventions. These encompass a variety of measures aimed at health promotion, disease prevention, health protection and overall improvements in population health and quality of life.51 We deliberately excluded studies focusing solely on the iatrogenic effects of medical preventive measures like vaccines, medications, medical procedures and screening or counselling services designed for individual patients. This exclusion covered medical primary prevention (eg, drug prophylaxis for malaria), as well as secondary (eg, prostate or breast cancer screenings) and tertiary preventive measures.

While studies examining the iatrogenic effects of individual-level prevention were excluded, we did include research evaluating the AUCs of population-level prevention programmes. For example, we incorporated studies that assessed the impact of vaccination programmes on broader health behaviour or vaccine acceptance,52 53 while omitting those focused solely on adverse reactions related to vaccines. Detailed inclusion and exclusion criteria are provided in online supplemental additional file 2.

Conceptual advancement of the a priori framework

As outlined above, we used the identified literature to revise the two components of the a priori framework. For this, we applied thematic analysis using a mix of inductive and deductive coding.36 37 Specifically, the included papers were coded deductively against the categories and themes of the a priori framework, while the new themes not covered in the a priori framework were derived inductively.36 37 The coding was done by two authors (JMS and RLB) using the software MAXQDA V.20 (Verbi, Berlin). The thematic analysis and the framework revisions were implemented in an iterative manner (see figure 1). The coding was conducted simultaneously for the consequences component and the mechanisms component of the framework.

First, the two components were revised and expanded based on the coding of the included theoretical and conceptual papers and the resulting new themes. The revisions were discussed in-depth within the research team, yielding conceptually advanced components. Next, the two components were further revised based on the coding of the systematic reviews of AUCs of PH interventions and discussions in the research team, yielding empirically advanced components.

Evaluating the empirically advanced framework through case studies

To assess the comprehensiveness of our empirically advanced framework, we applied it to four systematic reviews examining the unintended consequences of diverse PH interventions. These test case studies spanned various topics: setting-based drug prevention,42 prevention of SARS-CoV-2 transmission in schools,39 international travel-related control measures to control COVID-1940 and measures to reduce the consumption of sugar-sweetened beverages.41

We intentionally chose these case studies to represent a wide and heterogeneous array of PH interventions.54 Our selection criteria aimed to encompass different aspects, such as addressing communicable and non-communicable diseases; encompassing setting-based versus policy-level interventions; and covering interventions from providing information to creating incentives to restricting and eliminating choice—while still falling within the research team’s areas of expertise. The systematic reviews of the AUCs of these PH interventions had been conducted by or in cooperation with research team members. After a final review and discussion within the research team, the two-component framework was finalised as the adverse and other unintended Consequences of Public Health Interventions (CONSEQUENT) framework.

Patient and public involvement

The primary target group of the framework are PH and healthy policy decision makers. In a next step of the project, we aim to conduct workshops with members of the primary target group in order to disseminate the findings as well as to receive feedback on the framework itself as well as the practical application guidance. Based on this feedback, the framework and/or guidance will be revised accordingly.

Results

After the removal of duplicates, the literature searches identified 2998 records. The full texts of 150 records were screened for eligibility, and 15 records met the criteria for inclusion as theoretical or conceptual publications.1 17 21 31 50 51 55–61 By screening the reference lists of the included records, as well as of the identified reviews, we included another three records.62–64 We also identified 15 systematic reviews11 33 65–76 reporting on AUCs of different PH interventions through the database searches. No additional records yielding systematic reviews were identified through searches of the reference lists. Eventually, 18 unique records of theoretical or conceptual publications and 15 unique systematic reviews were included for thematic analysis and coding. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) flow chart visualising this process is presented in online supplemental file 4.77

The two-component CONSEQUENT framework is presented in figure 2.

Figure 2
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Figure 2

CONSEQUENT framework comprising consequences and mechanisms. AUC, adverse or other unintended consequences; CONSEQUENT framework, Consequences of Public Health Interventions framework; M, mechanisms.

The consequences component of the CONSEQUENT framework comprises eight first-order domains: (1) health, (2) health system, (3) human rights, (4) acceptability and adherence, (5) equality and equity, (6) social and institutional, (7) economic and resource related and (8) ecological. Each first-order domain also comprises several specific second-order domains. For example, the first-order domain health includes consequences for physical health and health behaviour, as well as psychosocial health and well-being as second-order domains. Depending on the purpose and context of framework application, either the more generic first-order domains and/or the more granular second-order domains may be considered; second-order domains may also be adapted as needed (eg, differentiating the first order domain consequence health in COVID-19-related and non-COVID-19-related health consequences for the assessment of PH and social measures during the COVID-19 pandemic). Descriptions of first-order and second-order domains are provided in table 1, some examples are provided in table 2 and further examples—in online supplemental additional file 6.

Table 1
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Consequences in the CONSEQUENT framework: first-order domains, second-order domains, definition
Table 2
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Consequences in the CONSEQUENT framework: examples

The mechanisms component of the CONSEQUENT framework, which may be treated as a supplementary component, consists of eight mechanisms (figure 2). AUCs may arise through: (1) biophysiological mechanisms, (2) (re)action or behaviour change, (3) perception, experience and assessment, (4) available opportunities for (re)action, (5) environments and environmental exposures, (6) social norms and practices, (7) economic and market mechanisms and (8) the functioning of systems and system components. Each mechanism also includes a non-exhaustive list of more specific processes. For example, the mechanism of (re)action or behaviour change includes the following processes: affecting behavioural practice(s), evasive, resistant or counteractive (re)actions or practices, supplementing practices or products, human error or misuse, triggering automated behaviours and lack of action or (behaviour) change. In contrast to the second-order domains of consequences, these specific processes are not intended as standalone ‘submechanisms’, but rather illustrate how the mechanisms may operate and are likely to vary for different PH interventions. Descriptions of the mechanisms and specific processes are presented in table 3; further details and examples are provided in online supplemental additional file 7. The relationship between the final framework and the a priori and interim versions of the framework is depicted in online supplemental additional files 4 and 5.

Table 3
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Mechanisms component of the CONSEQUENT framework: description and specific process

Discussion

The CONSEQUENT framework represents a novel comprehensive system to anticipate and assess AUCs of PH interventions, as well as the potential mechanisms leading to these. The framework is rooted in global health norms and values as it was developed drawing on the WHO-INTEGRATE framework35; it also reflects current best insights regarding behavioural science, given its roots in the BCW.38 Furthermore, it explicitly embraces a complexity perspective,46 and thus emphasises unintended consequences of PH interventions beyond the health of individuals and populations.

Conceptualisation of the relation of consequences and mechanisms in the CONSEQUENT framework

AUCs may arise through relatively simple or long and complex processes (this is displayed in online supplemental file 9, figure A1). AUCs may arise directly from the intervention (pathway A in online supplemental figure A1). For example, the taxation of sugar-sweetened beverages may lead to reduced revenue of vendors (the consequence) through an increase in prices a subsequently a reduction in demand (the mechanisms). AUCs may also arise indirectly, when a mediator on the intended pathway leads to an unintended consequence (pathway B). For example, a PH campaign promoting physical activity may lead to an increase in road traffic injuries (consequence) due to uptake of cycling and increased exposure of cyclists to accident-prone environments (mechanism). Intended consequences may also lead to unintended consequences (pathway C). For example, skin cancer prevention programmes via a successful reduction of sun exposure (intended consequence) may further lead to vitamin D deficiencies and related health consequences (unintended consequence).17 Furthermore, AUCs can arise through one mechanism (pathway A) or through a combination of multiple mechanisms interacting with each other (pathway D).

Finally, an unintended consequence may lead to additional ‘secondary’ unintended consequences: an unintended consequence may lead to further unintended consequences in a chain (pathway E). For example, a PH media campaign promoting healthy eating patterns may interact with and reinforce social norms and attitudes regarding obesity and obese individuals more broadly, ultimately leading to an increase in weight-based discrimination and adversely affecting the mental health of obese individuals (eg, depression). It may also lead to lower levels of physical activity among obese individuals due to behaviours that aim to avoid further stigmatisation.4 5

The length and complexity of the causal pathways leading to AUCs depend on the perspective of the users conceptualising these: this entails the degree to which one ‘zooms in’ on a particular pathway. Consider the example of conceptualising the unintended consequences of a PH nutrition guideline to reduce the consumption of cholesterol. This may lead to an increase in the consumption of trans fats in margarine (change in health behaviour) and because of pathophysiological mechanisms to a further increase of cardiovascular mortality. The pathway leading to an increase in cardiovascular mortality can be adequately depicted as a long-interlinked chain of biophysiological processes in the human body. While this conceptualisation can be helpful from a biomedical perspective, a detailed understanding of the exact chain of biophysiological mechanisms may not be useful for PH decision-makers developing or wanting to use the PH nutrition guideline. In line with a complexity perspective,46 we suggest that the degree to which the users ‘zoom in’ or ‘zoom out’ on the causal pathways and thereby the level of detail considered in theorising these pathways, should be guided by the principle of usefulness for the question at hand, rather than, by the principle of comprehensiveness.

Application of the framework

The framework was developed with two uses in mind:

The first intended use of the framework is to help PH researchers, practitioners and decision-makers conceptualise AUCs. That is, it can be used as a supporting tool to reflect on and anticipate AUCs of PH interventions when developing, evaluating or implementing an intervention. In this context, we refer to anticipating as the use of the framework as a tool to support stakeholders in systematically reflecting on (potential) AUCs of PH interventions when developing, evaluating or implementing PH interventions. In this application, the consequences listed in the first component of the framework are intended to guide deliberations on the potential AUCs of implementing the intervention in a given context, while the mechanisms listed in the second component of the framework are intended to support the identification of consequences through thinking about the pathways through which those consequences may arise. A comprehensive consideration of AUCs is important to appropriately judge the balance between benefits and harms of PH interventions, and anticipation of AUCs will inform their evaluation, as well as implementation of potential cointerventions or countermeasures. The CONSEQUENT framework is intended to organise these procedures and ensure that all relevant AUCs and mechanisms are considered. However, balancing the identified unintended consequences against each other and against the intended benefits involves value judgements and is part of the decision-making process, which falls beyond the scope of this framework. There are specialised tools available to aid decision-makers in this process.16 44 45

Box 1 offers an abbreviated guidance on how to apply the framework in this conceptual manner. The full guidance and an illustration of this application is provided in online supplemental file 10.

Box 1

Abbreviated guidance on the conceptual use of the Consequences of Public Health Interventions (CONSEQUENT) framework

Step 1: Develop an initial logic model: Begin by crafting a logic model or a complex system map to illustrate how the intended intervention will operate within its implementation context.1 114

Step 2: Extend the model using the CONSEQUENT framework: Enhance your preliminary logic model using the CONSEQUENT framework in two key areas:

  • 2 a. Identify the consequences: Use the framework’s list of potential unintended consequences.

  • 2b. Examine the mechanisms: Use the framework’s list of mechanisms to reflect on processes that might be triggered by the intervention, along with their potential consequences.

Step 3: Map affected populations: Conduct a mapping exercise to identify specific (sub)populations that could be uniquely affected by the intervention. Revise the extended logic model accordingly.

Step 4: Review the literature: Review publications on similar interventions, identified via systematic or non-systematic literature searches, to discern causal pathways and potential adverse unintended consequences. Update the logic model based on these insights.

Step 5: Engage stakeholders: Engage with affected stakeholder groups to incorporate unique insights into the specific contexts and operational dynamics of the intervention.1 This should also include the viewpoints of those who oppose the intervention.30

  • Although the steps are outlined in a linear fashion, we recommend an iterative approach, revisiting and refining different steps to enhance the final logic model.

The second intended use of the framework is to provide researchers with a classification system of unintended consequences of PH interventions and the mechanisms leading to them. This can be the starting point for exploring and assessing unintended consequences in monitoring the implementation of PH interventions or in designing primary research to evaluate their effects, such a classification system can also reveal important gaps in the literature.39–42 For example, a preliminary version of the framework was used in a systematic review of PH interventions to prevent illicit drug use. The application of the framework showed that most publications examined in the review did not follow a structured approach for the assessment of AUCs or solely focused on health-related consequences. Furthermore, potential mechanisms were rarely described or explored. This indicated a gap in the literature on illicit drug use specifically related to the societal and ecological consequences of PH interventions for prevention.42

Relationship with other frameworks of intervention harms

The proposed framework shares many features with other frameworks and classification systems of the harms of PH interventions.17 31 We describe these below.

Allen-Scott et al31 propose five underlying factors of AUCs of PH interventions, such as ‘ignoring root causes’, ‘limited and/or poor quality evidence’ and ‘lack of community engagement’. These underlying factors deviate from what we refer to as mechanisms in the CONSEQUENT framework. We consider the underlying factors proposed by Allen-Scott et al to operate on a more upstream level and rather align with what we refer to as root mechanisms. These are understood as mechanisms operating when planning or implementing a PH intervention. Based on the publications by Allen-Scott et al,31 ,22 24 26 we discuss a range of relevant root mechanisms, notably: (1) not taking context into account, (2) insufficient buy-in and participation of relevant stakeholders, (3) (not) acting based on poor quality or insufficient information, (4) neglecting root causes and acting based on simple answers to complex problems and (5) (mis)allocating scarce resources. However, more work to explore these root mechanisms is needed.

While most categories of potential harms in the framework by Lorenc and Oliver17 are also covered in our framework, the category of ‘opportunity cost’ is not. We did not include it in the current framework, as it requires numerous assumptions about a counterfactual reality in which the intervention would not have been implemented. However, we consider this aspect as part of the root mechanisms (ie, ‘through (mis)allocating scarce resources’).

Unintended consequences regarding equity and equality have been addressed in several publications, such as in the framework by Glover et al for identifying and mitigating the equity harms of COVID-19 policy interventions.17 55 73 While these are covered in the framework component of consequences, they are not explicitly mentioned in the framework component on mechanisms as a standalone mechanism. This decision was made, as equity and inequality can arise through different mechanisms in different populations (eg, an increase in health inequality (the consequence) can arise through different populations acting within the constraints of different df (ie, opportunities).

Strengths and limitations of the framework development process

A significant strength of the CONSEQUENT framework is the systematic, multipronged and iterative development of the framework. The framework has a strong and explicit normative foundation as it was modelled based on the WHO-INTEGRATE framework,35 and incorporates key insights from behavioural sciences.38 It was advanced using theoretical/conceptual, as well as empirical literature on AUCs of PH interventions derived from systematic literature searches; new insights were integrated using a mix of inductive and deductive approaches of qualitative inquiry.

However, the project also has a few limitations. First, the literature searches regarding theoretical/conceptual papers and systematic reviews focusing on AUCs of PH interventions were likely not comprehensive. We conducted searches (primarily) in health-related databases, it is, therefore, likely that we missed insights on a broader range of consequences arising from PH interventions assessed and published by other disciplines (eg, economics literature, environmental sciences literature). Second, the identified empirical literature itself is likely not comprehensive regarding all unintended consequences that may have occurred; for example, unintended ecological consequences were rarely addressed. Third, while we achieved content saturation in the coding process (ie, themes were covered by multiple publications and those coded at a later stage did not provide new consequences or mechanisms), further publications may suggest additional consequences and mechanisms. For example, consideration of more publications on the AUCs of economic or market-based PH interventions derived from economic research may lead to additional insights. Fourth, we focused on the literature of AUCs of PH interventions. In some cases, the distinction between economic or social policy measures and PH interventions was challenging. We aimed to overcome this issue through extensive discussions in the team and a clear definition of inclusion and exclusion criteria. For example, we are aware of the extensive literature on unintended consequences of social action from outside the field of PH. Therefore, expanding the framework based on this body of literature may provide additional insights. Finally, our database searches for theoretical and conceptual papers were conducted in the early phase of the SARS-CoV-2 pandemic. The pandemic has since increased awareness about AUCs of PH interventions, leading to various publications on the topic.13 53 55 78–82 However, to the best of our knowledge, none of these publications would necessitate a change in the structure of our framework. Indeed, one such publication, co-led by coauthors of the CONSEQUENT framework, uses the CONSEQUENT first order domains in a conceptual framework of PH and social measures during health emergencies.83

We; therefore, suggest that further application and testing should take place by applying it to a more diverse set of PH interventions. Based on this, a systematic collation of the experiences may lead to a further advancement of the CONSEQUENT framework, extending it into areas that are currently insufficiently covered and/or adding further granularity, such as for the second-order domains of consequences or for specific mechanisms.

Conclusion

The CONSEQUENT framework is a two-component framework to anticipate and assess the AUCs of PH interventions, reflecting on both outcomes (ie, consequences), as well as the processes leading to these outcomes (ie, mechanisms). The framework may help PH researchers, practitioners and decision-makers in anticipating AUCs when developing, evaluating or implementing PH intervention. Furthermore, the framework can be used by researchers to assess AUCs of PH interventions, for example, to reveal gaps in the literature. Application and user-testing of the framework for practical utility may also inform further adaptations.

Overview

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