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Abstract

This article explores adverse and unintended consequences (AUCs) of setting-based public health interventions to prevent illicit drug use, including the mechanisms leading to these AUCs. Additionally, the reporting of AUCs in systematic reviews was assessed. Therefore, we conducted a systematic review of reviews and searched four big databases were searched. We included systematic reviews concerned with setting-based interventions to prevent illicit drug use. We used AMSTAR 2 to rate the overall confidence of the results presented in the reviews. Data on study characteristics, types and mechanisms of AUCs were extracted. An a priori categorisation of consequences drew on the WHO-INTEGRATE framework, and the categorisation of mechanisms on the Behaviour Change Wheel. For reviews reporting AUCs, the same information was also retrieved from relevant primary studies. Findings were synthesised narratively and in tables. Finally, we included 72 reviews, of which 18 reported on AUCs. From these, 11 primary studies were identified. Most of the reviews and primary studies were conducted in educational settings. The most prevalent AUCs reported in systematic reviews and primary studies were paradoxical health effects (i.e. increase of drug use). Potential mechanisms discussed primarily focussed on the change though social norms and practices. Changes of knowledge and perception were also mentioned. Concluding, the identified reviews and primary studies paid insufficient attention to AUCs of public health interventions to prevent illicit drug use. Where reported, it was mostly as an afterthought and narrowly framed as health related. No mentions of potential broader social consequences were found.

Keywords

Primary prevention substance abuse adverse effects systematic review

Introduction

Illicit drug use represents a major public health challenge. This can lead to substance addiction, a chronic and often relapsing behavioural disorder with medical and social implications for individuals, families and society at large.^1–3 Primary prevention tends to focus on reducing or delaying first use or on preventing the transition from experimental use to addiction.^4–6 According to the international standards on drug use prevention by the United Nations Office on Drugs and Crime (UNODC) and the World Health Organisation (WHO), setting-based approaches such as those concerned with families, schools, universities, communities and workplaces are of particular importance in making individuals less vulnerable to drug use and associated risky behaviours.⁶

Interventions aiming to prevent illicit drug use, as well as public health interventions in general, need to balance intended (or unintended) beneficial effects against any adverse effects. To do so, decision makers need to take into consideration adverse or unintended consequences (AUCs) – where unintended consequences could be beneficial or harmful – resulting from public health interventions, so that harm can be prevented or mitigated. Importantly, they need to take into account that AUCs are not limited to health but might become manifest in multiple other areas or sectors (e.g. social consequences, economic consequences).⁷ However, uncertainties remain regarding how to identify AUCs of public health interventions in a comprehensive manner^8,9 and how to evaluate them best.¹⁰

The documentation of adverse events is well established in trials of clinical interventions, but even here, studies have shown that these are often insufficiently reported or underreported.^11,12 In fact, the ability of short-term clinical trials to detect a broad range of adverse events is limited, and studies are usually powered for efficacy, but do not have sufficient power to detect adverse events.^13–15 In contrast, the AUCs of public health interventions are very rarely studied and poorly reported.^11,12,16 In recent years, researchers have begun to identify and describe harms and to suggest typologies or classifications of such harms^7,17; these imply that the potential impact of harmful effects caused by public health interventions may be considerable.^14,18

As the majority of adults with illicit drug use problems start using drugs during their adolescence, most prevention efforts are concerned with settings where young people live, learn or socialise (e.g. schools, family).^4,19,20 Multi-component interventions aiming to prevent or stop young people from using illicit drugs tend to be complex and interact with the characteristics of the settings in which they are implemented^21,22 representing a range of sources of uncertainty.^22,23 It is important to take these complexities and sources of uncertainty into account and to acknowledge the multitude of intended and unintended consequences when planning or evaluating setting-based interventions to prevent illicit drug use.²⁴

Therefore, this systematic review of reviews has the primary objective to assess and categorise the AUCs of setting-based interventions to prevent illicit drug use, and to describe the mechanisms examined or hypothesised to lead to them. As a secondary objective, this study seeks to assess the reporting of AUCs in systematic reviews and to describe differences in the reporting of AUCs.

Methods

We conducted a systematic review of reviews of setting-based interventions to prevent illicit drug use and additionally retrieved relevant primary studies reported in the identified reviews. We used an unregistered predefined protocol.

Definitions and terminology

We use the term ‘adverse or unintended consequences’ or AUCs to describe events that were noticeable or observable and are assumed to be related to the intervention of interest. These AUCs are not necessarily health-related but may extend beyond health (e.g. economic, social, environmental). The judgement of whether an AUC is beneficial or adverse, will be made by taking the perspective of the affected individuals and/or the researchers reporting on the consequence into account. It is often not possible to establish or rule out a causal relationship between an AUC and the intervention of interest (e.g. when a suicide occurs in the intervention arm of a school-based drug education intervention), so we consider every observed AUC as potentially caused by the intervention.

For the purposes of this review, the term ‘illicit drug use’ refers to the use of psychoactive substances outside of their legitimate use for medical or scientific purposes.⁶ We will focus on psychoactive substances such as cannabis, inhalants (e.g. nitrous oxide often called ‘laughing gas’, nitrides often called ‘poppers’), and new psychoactive substances (so-called ‘legal highs’ or ‘smart drugs’). Although considered illegal in some jurisdictions, this review will not address drugs such as coffee/caffeine, tobacco/nicotine or alcohol.

Search methods for identification of studies

Searches of articles published up to 14 June 2020 in MEDLINE, EMBASE, the Cochrane Library and Epistemonikos were performed, using two linked blocks of key terms associated with (1) illicit drug use and (2) setting-based prevention. Results were limited to systematic reviews and meta-analysis. The search strategy was adapted for each database (see Supplemental Appendix Tables 1 and 2). The language was restricted to English and German. Citations of included systematic reviews were subsequently hand-searched for additional relevant studies.

Identification of eligible systematic reviews

Screening of titles and abstracts and screening of full texts was initially performed according to predefined inclusion and exclusion criteria regarding Population, Intervention, Comparison and Study design (Table 1). All eligible systematic reviews were subsequently screened for reporting on AUCs, that is, outcomes. The corresponding full-texts of all primary studies reporting on AUCs were retrieved and assessed for eligibility (Table 1). Screening was performed independently by two researchers (JS, RB) using the software Rayyan.25 Any discrepancies were discussed and resolved by consensus.

Table 1.

Eligibility criteria for reviews.

		Inclusion criteria	Exclusion criteria
Population		• Humans of any age who are not currently consuming any illicit drugs (e.g. marijuana, hashish, heroin, opium, opioids, cocaine, amphetamine, methamphetamine, benzodiazepine, ketamine, lysergic acid diethylamide, mescaline, psilocybin, inhalants) or are consuming these but are not dependent on them yet	• Humans who are addicted to one or more illicit drugs
Intervention		• Setting-based interventions (e.g. in schools, families, workplaces, communities, neighbourhoods) to prevent illicit drug use	• Interventions to treat or support people using illicit drugs in healthcare settings (e.g. hospital, psychiatric institution)
		• No intervention	• Interventions to prevent only tobacco or alcohol consumption or prevent any other form of addiction (e.g. gambling)
		• No intervention	• Secondary and tertiary prevention of illicit drug use as well as harm reduction programmes
Comparison		• Any other setting-based intervention to prevent illicit drug use	• None excluded
Comparison		• Any other intervention to prevent illicit drug use	• None excluded
Outcome		• Health-related intended or unintended events, effects or consequences (e.g. metabolic outcomes, mental health outcomes, effectiveness outcomes)	• Studies only reporting economic measures (e.g. cost-effectiveness)
Outcome		• Non health-related intended or unintended events, effects or consequences (e.g. changes in behaviours, educational outcomes, environmental outcomes)
Study designs	For reviews	• Systematic reviews (of quantitative and/or qualitative studies) assessing the effects of setting-based interventions to prevent illicit drug use	• The study is not a systematic review or meta-analysis
	For primary studies	• All empirical study designs (e.g. epidemiological studies, qualitative studies)	• Mathematical modelling studies

Data extraction and management

Data extraction was performed by one author (RB) using a pre-defined form and checked by a second author (JMS) for accuracy and comprehensiveness. The following information was extracted for systematic reviews and primary studies: (1) general information about the study (i.e. title, reference, publication year), (2) objective of the study and study characteristics, (3) approach to assessing the quality of included studies, (4) whether or not the study reports on AUCs, (5) the type, scope and scale of the AUCs (6) the reported mechanism leading to the observed effects, (7) conflicts of interest statements and funding sources. We extracted the following additional information for included primary studies: (1) characteristics of the intervention under investigation, (2) characteristics of the population and context.

Authors of included studies were contacted and requested to provide any missing data. Where the data available or provided was insufficient to decide on eligibility, the study was excluded.

Quality assessment

The confidence in the results of eligible systematic reviews was assessed using the AMSTAR 2 checklist and rating scheme.²⁶ We did not conduct a risk of bias or quality assessment of primary studies.

Data analysis

The assessment and analysis of the type, scope, scale and potential mechanisms leading to the AUCs from systematic reviews and primary studies was done independently by two authors (JMS, RB); conflicts were resolved through discussion. Findings are presented narratively and through tables.

Classification of AUCs

We classified AUCs according to their type and scope (e.g. adverse health-related effects such as injuries; or beneficial social outcomes such as reduced unemployment rates). We used the WHO-INTEGRATE framework, an evidence-to-decision framework,^27–29 as it explores public health interventions from a complexity perspective going beyond health effects and explicitly considering societal consequences. We directly applied the six criteria of the framework as first-order domains but adapted the so-called sub-criteria of the framework as second-order domains (Table 2). Whenever the classification of a given AUC was unclear or if it fitted into more than one domain of the adapted WHO-INTEGRATE framework, this conflict was resolved through discussion within the research group.

Table 2.

Framework used to categorise consequences.

WHO-INTEGRATE framework domains used to derive consequences^27,29	Classification categories for identified consequences	Definition and description
Health-related consequences	Physical health and well-being	This domain captures consequences for the physical health and well-being of individuals and populations, including related behavioural, environmental or metabolic risk factors as well as the risk of accidents and being affected by violence.
Health-related consequences	Psychosocial health and well-being	This domain includes consequences for mental health and well-being, including risk- and protective factors and practices, quality of life and social well-being.
Human and fundamental rights consequences	Human and fundamental rights	This domain covers consequences for all human and fundamental rights, including the right to physical integrity, autonomy, self-determination or privacy.
Consequences related to acceptability and adherence	Acceptability	This category captures consequences regarding the acceptability of the intervention in the target population as well as other affected populations. Acceptability includes the willingness to implement, adhere to or enforce the intervention.
Consequences related to acceptability and adherence	Adherence and compliance	This category describes the degree to which a population targetted by an intervention adheres to or refuses to comply with the intervention.
Consequences for equality and equity	Health-related equality and equity	This category covers the consequences regarding relative and absolute inequalities – whether assessed neutrally or judged with respect to their fairness – in health-related outcomes, as well as the relative capabilities of individuals to achieve health.
Consequences for equality and equity	Socio-economic equality and equity	This domain captures consequences for social outcomes and participation of individuals and groups, including aspects such as household income, housing and education. It furthermore captures consequences regarding the availability, accessibility, acceptability and quality of social services aiming to contribute to social outcomes and participation.
Societal implications	Social outcomes and participation	This domain captures consequences for social outcomes and participation of individuals and groups, including aspects such as household income, housing and education. It furthermore captures consequences regarding the availability, accessibility, acceptability and quality of social services aiming to contribute to social outcomes and participation.
	Communities and social cohesion	This category captures consequences for communities, including social cohesion, solidarity and the risk of social and political division. This includes consequences affecting actors and institutions of civil society, social life and culture which contribute to the functioning of communities.
	Social norms and values	This category covers consequences regarding social norms and values, including the social roles and role expectations of individuals within a given society or community and their identities.
Financial and economic considerations	Financial consequences	This domain captures consequences regarding financial costs, available financial resources, and budgetary implications regarding the intervention itself, as well as individuals (micro level), stakeholder groups or institutions affected by the intervention (meso level) or the society and their institutions (macro level). The financial consequences can, but do not necessarily lead to economic consequences (e.g. bankruptcy of businesses)
	Resource-related consequences	This domain addresses consequences for the availability, accessibility, affordability and quality of non-financial resources, such as devices and products, human resources, and infrastructure, beyond the health system. It captures these consequences for individuals (micro level), stakeholder groups or institutions affected by the intervention (meso level) or the society and their institutions (macro level).
	Economic consequences	This domain captures consequences for economic activities (e.g. producing, distributing, and consuming goods and services), for the economic situation (e.g. poverty, bankruptcy), as well as the stability, resilience, and sustainability of the economic activities and the economic situation. This includes individuals (micro level) and stakeholder groups or institutions (meso level) in their role as economic actors (e.g. in the form of employees or businesses), as well as the local, regional, national or supranational economy as a whole (macro level).
Health system consequences	Access to and utilisation of healthcare	This domain captures consequences regarding the availability, accessibility, acceptability and quality of preventative and curative health services and institutions.
Health system consequences	Health system functioning	This domain addresses how the intervention interacts (synergistically or adversely) with other interventions in the same setting or population and other not directly-related components of the health system.
Environmental consequences	Energy consumption and greenhouse gas emissions	This domain addresses consequences for energy consumption and energy efficiency as well as consequences regarding changes in the discharge of fossil carbon dioxide, methane and other greenhouse gases.
	Availability and quality of air, land and water	This domain captures different consequences regarding the quality (incl. risk of contamination) and availability (where applicable) of surface and ground water, land, soil, air and atmosphere.
	Animals, ecosystems and biodiversity	This domain captures the consequences regarding animal health and well-being (beyond their direct implications for human health and their economic value and function), integrity and functioning of ecosystems and (natural) biodiversity.

Classification of mechanisms leading to AUCs

Where potential mechanisms of AUCs were reported or discussed, these were categorised using a framework based on the Behaviour Change Wheel (BCW).³⁰ The BCW was chosen as it is the most widely used approach for examining behaviour change and its influences at individual as well as societal levels. For the purposes of classifying mechanisms, we focussed on the nine intervention functions of the BCW and derived potential mechanisms leading to AUCs (e.g. through restrictions, through improving skills and abilities, through changing perceptions and attitudes) (Table 3). In Table 3 we present an adapted version of the proposed framework.

Table 3.

Framework used to categorise mechanisms.

Behaviour Change Wheel categories used to derive mechanisms³⁰	Mechanisms	Description
BHW-framework in general	Through changing behaviours	A measure leads to changes in behaviour, which affect health or other outcomes of interest (e.g. changes in smoking behaviour, practicing unsafe sex, diet changes).
BHW-framework in general	Through affecting metabolic or physiological reactions	A measure leads to metabolic changes, which affect health or other outcomes of interest (e.g. changes in immune response, metabolic changes affecting atherosclerosis).
Restrictions	Through restricting practices, goods or services	A consequence may arise implementing or lifting restrictions leading to reduced or increased the opportunity to engage in behaviour practices as well as to provide or utilise goods or services.
Education and training	Through increasing knowledge or understanding	A consequence may arise through changes in knowledge, understanding or skills based on new information as well as opportunities to train skills, as well as the lack thereof. This can include false, inadequate or overgeneralised information, leading to an erroneous knowledge or understanding as well as the consequences of not receiving information or training.
Training	Through improving skills and abilities	A consequence may arise though improving skills and abilities. These changes can be based on training or knowledge transfer.
Persuasion	Through changing perceptions and attitudes	A consequence may arise through changes in perceptions and attitudes, as well as through knowledge or information which evokes an emotional response regarding diseases and disorders (incl. risk factors), as well as individuals affected by them. Changes in the perception of individuals or populations affected by a disease or disorder includes public stigma, self-stigma and label avoidance, changes in the perceived severity or susceptibility, and risk compensation.
Persuasion	Through affecting psychological reactions	A consequence may arise through psychological reactions or effects, which affect health or other outcomes of interest (e.g. experiencing a stress reaction or anxiety following a test result).
Incentivisation and coercion	Through providing financial, economic or social incentives (or disincentives)	A consequence may arise from (dis)incentives and the reaction to them. Incentives refers to the expectation of gain or rewards, which could be financial, economic or social. Disincentives refer to the expectation in cost or punishment.
Environmental restructuring (environmental context)	Through changing environmental exposures	A consequence may arise through changes in environmental exposures, which directly affects health or other outcomes of interest (e.g. higher risk of accidents, exposure to pollutants, exposure to infectious agents). Environmental is defined broadly, it includes factors such as exposure to air, atmosphere, food, water, chemicals, physical agents, microbiological pathogens, noise, vibration, radiation, temperature, etc.; as well as factors increasing the risk of being affected by accidents and violence.
	Through triggering automated responses	A consequence may arise from (intended or unintended) alterations of the environment in a way that trigger automatic cognitive processes leading to changes in practices. This includes changes in the saliency of and cognitive load associated with practices or goods.
	Through changing the availability, accessibility or quality of goods or services	A consequence may arise though the availability, accessibility, affordability or quality in goods or services.
Environmental restructuring (social context) modelling	Through changing social practices and norms	A consequence may arise through changes in individual behaviours and social practices (rooted in social norms and values) though (i) copying the action of other individuals in an ambiguous social situations where people are unable to determine the appropriate mode of behaviour (social proof), (ii) providing examples for people to aspire to or imitate (modelling), or (iii) through imitating the social practices in a social group and incorporating the norms, values and social practices associated with them (habit formation). These can lead to changes in the perception of norms and values within a community, as well as the identities of individuals and the roles of individuals within a community.
Enablement	Through empowering individuals and communities	A consequence may arise through empowering or disempowering individuals and thereby enabling or hinder them to act in a specific way (e.g. through building up confidence).

Assessment of the reporting of AUCs in systematic reviews

We used data on the year of publication (before/after the year 2010) as well AMSTAR 2 rating of the systematic reviews to identify differences in the reporting of AUCs over time and according to systematic review quality. The year 2010 as chosen as the first PRISMA statement was published 2009 and the authors encourage to also consider adverse effects in systematic reviews.³¹ We assumed that that this publication has changed the reporting within systematic reviews and that the implementation might have taken some time. Additionally, we investigated whether the reviews specified AUCs as an outcome of interest (in the Methods section) and whether they reported AUCs in the Results or Discussion section.

Results

Characteristics of included reviews and studies

After the removal of duplicates, the literature searches identified 2422 records. The full texts of 162 records were reviewed in more detail and 72 reviews met the criteria for inclusion (see Supplemental Appendix Table 3 for a list of excluded references). A total of 18 systematic reviews reported on AUCs of setting-based interventions to prevent illicit drug use (see Table 4)^4,32–48; from these 11 eligible primary studies were retrieved (see Table 5).^49–59 The PRISMA flow-chart³¹ visualising this process is presented in Figure 1.

Table 4.

Characteristics of review reporting on AUCs.

Study ID [Ref. No.]	Confidence in results (AMSTAR 2 rating)	Objective/rationale	Outcome of interest	Target population	Setting	AUCs specified as outcome of interest under methods?	Reported AUCs	Type(s) of AUCs	Reported mechanisms
Reviews focussing on educational interventions
Berberian et al.³²	Critically low	Assessing the effectiveness of school-based drug abuse prevention programmes	Substance use (multiple)	Students	Multiple	No	‘Overidentification with ex-addicts’ in the intervention group^b	Social norms and values	Through changing social practices and norms
Hansen³⁴	Critically low	Reviewing the state of knowledge on what is effective in achieving substance abuse prevention	Substance use (multiple)	Adolescents	Educational settings	No	Increased substance use (i.e. alcohol, cannabis, tobacco)^a	Psychosocial health and well-being	Through changing social practices and norms; Through increasing knowledge or understanding
Mellanby et al.⁴⁰	Critically low	Evaluating school-based health education programmes which have set out to compare the effects of peers or adults delivering the same material	Substance use (multiple)	Students	School	No	Increased substance use (i.e. alcohol)^a	Psychosocial health and well-being	Not reporting or discussing mechanisms
White and Pitts⁴⁷	Critically low	Assessing effectiveness of interventions directed at the prevention or reduction of use of illicit substances by young people or those directed at reducing harm caused by continuing use	Substance use (multiple)	Children/young people (aged 8–25 years)	Multiple	No	Increased substance use^a	Psychosocial health and well-being	Not reporting or discussing mechanisms
Reviews focussing on multiple interventions
Bröning et al.³³	Critically low	Assessing evaluations of selective preventive interventions in childhood and adolescence targetted at this specific group	Substance use (multiple)	Children and adolescent (and their families)	Multiple	Yes	No relevant AUCs identified by the review^a,b	-	-
Faggiano et al.⁴	High	Assessing the effectiveness of universal school-based interventions in reducing drug use compared to usual curricular activities or no intervention	Illicit drug use	Students	School	Yes	Increased substance drug use (i.e. marijuana, other drug, alcohol)^a,b	Psychosocial health and well-being	Chance finding
Langford et al.³⁶	High	Assessing the effectiveness of the Health Promoting Schools (HPS) framework in improving the health and well-being of students and their academic achievement	Substance use (multiple)	Students (aged 4–18 years)	Multiple	Yes	No relevant AUCs identified by the review^a,b	-	-
Lin et al.³⁷	Critically low	Assessing the impact of comprehensive community initiatives on population-level child, youth, and family outcomes	Substance use (multiple)	Children and youth	Community	No	Increased illicit drug use (i.e. inhalants, MDMA, Ecstasy)^a	Psychosocial health and well-being	Not reporting or discussing mechanisms
MacArthur et al.³⁹	Moderate	Assessing the effect of peer-led interventions that sought to prevent tobacco, alcohol and/or drug use	Substance use (multiple)	Students	School	No	Increased substance use^a	Psychosocial health and well-being	Through changing social practices and norms
MacArthur et al.³⁸	High	Assessing the effects of interventions implemented up to 18 year of age for the primary or secondary prevention of multiple risk behaviours among young people.	Substance use (multiple)	Children and adolescents (aged up to 18 years)	Multiple	Yes	Increased illicit drug use^a	Psychosocial health and well-being	Chance finding
Onrust et al.⁴¹	Critically low	Overview of the different universal and targetted substance use prevention programmes offered at school	Substance use (multiple)	Students	School	No	Increased substance use^a,b	Psychosocial health and well-being	Through changing social practices and norms
Ruiz-Casares et al.⁴²	Critically low	Assessing the quality of studies that have evaluated programmes for ethno-culturally diverse parents and adolescents that specifically address mental health promotion and prevention	Substance use (multiple)	Ethno-cultural populations	Multiple	No	No relevant AUCs identified by the review^a	-	-
Snijder et al.⁴³	Critically low	Assessing the effectiveness of substance use prevention programmes for Indigenous adolescents in the USA, Canada, Australia and New Zealand	Substance use (multiple)	Indigenous adolescents (aged 10–19 years)	Multiple	No	Increased illicit drug use^a	Psychosocial health and well-being	Not reporting or discussing mechanisms
Soole et al.⁴⁴	Critically low	Assessing the effectiveness of school-based drug prevention programmes in preventing illicit drug use	Substance use (multiple)	Students	School	No	Increased illicit drug use (i.e. marijuana and other illicit drugs)^a	Psychosocial health and well-being	Not reporting or discussing mechanisms
Tobler et al.⁴⁶	Critically low	Assessing effectiveness of different types of drug prevention programmes in USA and Canada	Substance use (multiple)	Students (grade 6–12)	School	No	Increased substance use^a,b	Psychosocial health and well-being	Chance finding
Wilson et al.⁴⁸	Critically low	Assessing the effectiveness of the subset of prevention practices that occur in schools or are implemented by school staff and are designed to reduce the occurrence of these problem behaviours	Substance use (multiple)	Students	School	No	Increased substance use^a,b	Psychosocial health and well-being	Not reporting or discussing mechanisms
Reviews focussing on other interventions
Hodder et al.³⁵	High	Assessing whether universal school-based ‘resilience’ interventions are effective in reducing the prevalence of tobacco, alcohol, or illicit substance use by adolescents	Substance use (multiple)	Students	School	Yes	No AUCs identified by the review^a	-	-
Thomas et al.⁴⁵	High	Assessing the effectiveness of mentoring to prevent adolescent alcohol/drug use	Substance use (multiple)	Adolescents (aged 13–18)	Multiple	No	No AUCs identified by the review^a	-	-

AUCs: adverse and other unintended consequences; n.s.: not specified.

Review reported AUCs in the Results section.

Review discussed the presence or absence of AUCs.

Table 5.

Characteristics of primary studies reporting on AUCs.

Study ID [Ref. No.]	Outcome of interest	Objective/rationale	Study design	Target population	Setting	AUCs specified as outcome of interest under methods?	Reported AUCs	Type(s) of AUCs	Reported mechanisms
Primary studies focussing on educational interventions
Botvin et al.⁴⁹	Illicit drug use	Assessing the effectiveness of a cognitive-behavioural substance abuse prevention approach	RCT	Students (eighth grade)	School	No	Increase of alcohol consumption in the teacher booster session^a,b	Psychosocial health and well-being	Not reporting or discussing mechanisms
Dixon et al.⁵¹	Substance use (multiple)	Assessing how a non-targetted group of ethnic minority youth might or might not benefit from a prevention intervention focussed on other cultural groups (keepin’ it R.E.A.L. curriculum)	RCT	Students (seventh grade)	School	No	Increase of alcohol consumption among American Indian participants^a,b	Psychosocial health and well-being	Through changing social practices and norms
Ellickson and Bell⁵²	Illicit drug use	Results of Project ALERT, a multi-site, longitudinal test of a school-based prevention programme (curriculum)	RCT	Students (seventh grade)	School	No	Increased smoking in teen-led intervention^a,b	Psychosocial health and well-being	Through changing social practices and norms
Furr-Holden et al.⁵³	Illicit drug use	Assessing the potential early impact of two developmentally inspired universal preventive interventions on the risk of early-onset alcohol, inhalant, tobacco, and illegal drug use through early adolescence	RCT	Students (first grade)	School	No	Potential increase of drug use^a	Psychosocial health and well-being	Chance finding
Hansen et al.⁵⁵	Illicit drug use	Assessing the efficacy of two drug abuse prevention curricula in preventing the onset of tobacco, alcohol and marijuana use among adolescents (Project SMART)	RCT	Students	School	No	Increase of drug consumption in the affective intervention^a,b	Psychosocial health and well-being	Through changing perceptions and attitudes; Chance finding
Hansen and Graham⁵⁴	Illicit drug use	Assessing the efficacy of two strategies (i.e. refusal skill training, change in normative perceptions) for preventing the onset of alcohol, marijuana and tobacco	RCT	Students	School	No	Increase of marihuana consumption in the peer pressure resistance group^a,b	Psychosocial health and well-being	Through changing social practices and norms; Through changing perceptions and attitudes
Hawkins et al.⁵⁶	Substance use (multiple)	Assessing whether the Communities That Care (CTC) prevention system reduced levels of risk and adolescent problem behaviours community wide 8 year after implementation of CTC	Community-randomised trial	Students (5th–12th grade)	Multiple	No	Increase of ecstasy consumption among 12th graders^a,b	Psychosocial health and well-being	Chance finding
Jalling et al.⁵⁷	Substance use (multiple)	Assessing the effects of parent programmes (Comet and ParentSteps) on measures of antisocial behaviour when given under real world conditions to parents of at-risk adolescents	RCT	Adolescents (aged 12–18) and parents	Multiple	Yes	Increased risk of drug use^a,b	Psychosocial health and well-being	Chance finding
Sánchez et al.⁵⁸	Illicit drug use	Assessing the fidelity of implementation within a treatment effectiveness trial of the Reconnecting Youth (RY) prevention programme	RCT	Teacher	School	No	Increase of marihuana use in the teacher led intervention^a,b	Psychosocial health and well-being	Not reporting or discussing mechanisms
Valente et al.⁵⁹	Illicit drug use	Assessing whether a social network tailored substance abuse prevention programme can reduce substance use among high-risk adolescents without creating deviancy training (iatrogenic effects)	RCT	Students	School	No	Increased drug consumption in the network curriculum interventions^a,b	Psychosocial health and well-being	Through changing social practices and norms
Primary studies focussing on multiple interventions
Cuijpers et al.⁵⁰	Substance use (multiple)	Assesses the effects of the ‘Healthy School and Drugs’ project, a Dutch school-based drug prevention project	Quasi-experimental	Students (aged 12–18)	School	No	Increased drug consumption in the intervention group^a,b	Psychosocial health and well-being	Not reporting or discussing mechanisms

AUCs: adverse or other unintended consequences.

Study reported AUCs in the Results section.

Study discussed the presence or absence of AUCs.

Figure 1.

PRISMA flow-chart.³¹

Reviews

Seventy two reviews were included. Of these 34 investigated interventions based in an educational setting (pre-school, school and higher education),^{4,34,35,39–41,44,46,48,60–84} three in a family setting,^85–87 three in a community setting,^37,88,89 one in a church⁹⁰ and 31 in multiple settings.^{32,33,36,38,42,43,45,47,91–113} Most reviews used the age of participants as an inclusion criterion, resulting in 62 studies focussed on children and adolescents.^{4,32–41,43–48,60–70,72–85,87,89,92–95,97–107,110,113} The types of interventions varied between the reviews but mostly focussed on educational interventions (n = 16)^{32,34,40,47,61,62,64,66,67,70,72,75,77,81,83,110} or included multiple interventions (n = 42).^{4,33,36–39,41–44,46,48,60,65,68,69,71,73,74,76,78–80,82,84,85,87,88,90,95–100,103–105,107,108,111,113} Some interventions employed computer-based approaches to prevent substance abuse (n = 4).^{47,94,109,112} Some of the included reviews focussed on interventions in certain countries, especially the United States (n = 18).^{46,61,62,66,67,70,72–74,77,83,88,90,95,96,101,106,111} Detailed characteristics of all included reviews are presented in Supplemental Appendix Table 4. The subset of 18 reviews reporting on AUCs is presented in Table 4.

The overall confidence in the results of 56 out of 72 reviews was rated ‘critically low’,^{32–34,37,40–48,61–73,77–81,83–91,94–96,99–101,103–113} 10 reviews were rated ‘low’,^{60,74–76,82,92,93,98,102} one was rated ‘moderate’,³⁹ while six reviews were rated ‘high’^{4,35,36,38,45,97} (see detailed assessment in Supplemental Appendix Table 5). The five reviews rated ‘high’ were mostly Cochrane reviews,^36,38,45,97 with one being a regular peer-reviewed publication.³⁵ Reviews performed most poorly concerning the following AMSTAR 2 items:

- Reporting sources of funding for included studies (36 out of 72)

- Use of satisfactory risk of bias assessment (42 out of 72)

- Establishing review methods prior to review conduct (54 out of 72)

- Justification for excluding individual studies (65 out of 72)

Primary studies

In total 11 primary studies^49–59 reported AUCs of interventions aiming to prevent drug abuse. Nine primary studies were concerned with multi-component interventions.^{49–55,57,58} These interventions sought to prevent and reduce the consumption of multiple drugs (illicit drugs, tobacco, alcohol). All interventions, apart from two implemented in multiple settings,^56,57 were based in schools (n = 9/11).^{49–55,58,59} Ten out of 11 studies assessed educational interventions (n = 10/11)^49,51–59, one study investigated multiple interventions (e.g. education, school regulation).⁵⁰ Characteristics of included primary studies are presented in Table 5.

Adverse and unintended consequences

All included reviews and primary studies were analysed using the a priori frameworks described in the method section. The results of the categorisation are presented verbally in the following text and tables. The text passages which were used to assign a category of the framework are presented in the Supplemental Appendix.

Among 18 reviews reporting on AUCs, an increase in substance use (no differentiation between illicit drugs, alcohol, or tobacco) was the most prevalent AUC (n = 8/18).^{4,34,39–41,46–48} Similarly, an increase of illicit drug consumption was frequently reported (n = 4/18).^37,38,43,44 Both AUCs were assessed as an effect on the outcome of interest with an unexpected negative or paradoxical direction. Even though the AUCs described above do not imply an established disorder, we categorised these under ‘Psychosocial health and well-being’.

Only one review reported on a different AUC, describing a change in expectations regarding drug consumption among some of the participants (i.e. positive drug and alcohol expectations) through identifying with ex-addicts and was therefore categorised under ‘Social norms and values’.³²

Five reviews did not observe any AUCs related to illicit drug prevention in the school setting, but did report AUCs in other settings or in other substance prevention interventions.^{33,35,36,42,45}

Among 11 primary studies retrieved from the included reviews and reporting AUCs, an increase in substance consumption (drug use included) was most prevalent (n = 8/11).^50,53–59 Other AUCs were an increase in alcohol consumption (n = 2/11)^49,51 and smoking (n = 1/11).⁵² Therefore, all AUCs reported in primary studies were categorised under ‘Psychosocial health and well-being’.

Mechanisms leading to AUCs

Mechanisms were only reported in a minority of the identified reviews (n = 7/18) The mechanisms described were most often categorised as ‘Through changing social practices and norms’ (n = 6/18).^{32,34,36,39–41} Authors discussed the interaction of social norms, peer pressure, deviance training, ethno-cultural backgrounds and personal beliefs. AUCs were then described as a potential consequence of supposedly unfavourable interactions. Some reviews considered the observed AUCs a ‘Chance finding/bias’ (n = 3/18)^4,38,46 as a result of statistical effects or design issues. One review discussed the potential effects of the delivered information/content as well as the didactic methods used³⁴ was therefore coded as the mechanism ‘Through increasing knowledge or understanding’.

A majority of the primary studies discussed mechanisms of AUCs (n = 8/11). In 4 out of 11 primary studies the observed AUCs were described as a ‘Chance finding’,^{45,53,55–57} referring to the small number of participants and potential measurement error. Other mechanisms discussed were categorised as ‘Through changing social practices and norms’ (n = 4/11)^{45,51,52,54,59} based on discussions of group differences, social influence of teachers, ethno-cultural differences, peer influence and social acceptability in the primary studies. Two primary studies discussed the mechanism ‘Through changing perceptions and attitudes’,^54,55 suggesting that misinformation and a change in perception might have led to AUCs.

Reporting of AUCs

Reporting and discussion of AUCs differed substantially in the identified reviews and primary studies. Most of the reviews (n = 64) did not report or discuss any AUCs. Many of the 18 reviews and 11 primary studies reporting AUCs did not assess these as an outcome of interest, nor did they report them in the Results section.

We observed among the seven reviews with an AMSTAR 2 rating of ‘High’ or ‘Moderate’^{4,35,36,38,39,45,97} all but one ⁹⁷ reported on AUCs but only three reviews referred to these AUCs in the discussion.^4,36,39 The 65 reviews with a ‘Low’ or ‘Critically Low’ AMSTAR 2 rating varied in their reporting and discussion of AUCs. Only 11 reviews^{33,34,37,40–44,46–48} with such rating reported AUCs and six discussed these findings^{33,34,40,41,46,48} (see Table 6). Therefore, studies with a higher AMSTAR 2 rating were found to be more likely to report on AUCs. We also observed a higher rate of AUCs reported in reviews published before 2010 compared to reviews published after or in the same year (see Table 6). The complexity and scope of the discussion differed between the studies. Some reviews (n = 7/18)^{4,34,39–41,46,48} and primary studies (n = 7/11)^{45,51,54–59} reported AUCs in the results section and briefly discussed these finding but only a fraction considered AUCs as an outcome of interest (i.e. five reviews,^{4,33,35,36,38} one primary study^45,57). Several studies specifically referred to the occurrence of AUCs as a chance finding and did not expand on the possibility that the AUC might be causally related to the intervention under investigation.

Table 6.

Comparison of selected review characteristics.

	No. of reviews reporting on AUCS	No. of reviews not reporting on AUCS	Odds ratio (95% confidence interval)
Published before 2010 (reference category)	7	14	1.82 (0.59–5.61)
Published after 2010	11	40
Low or critically low AMSTAR 2 rating (reference category)	12	53	0.04 (0.004–0.34)
High or moderate AMSTAR 2 rating	6	1

AUCs: adverse or other unintended consequences.

Discussion

This systematic review of reviews assessed AUCs of setting-based interventions to prevent illicit drug use and explored the mechanisms leading to these AUCs, as reported or assumed in the included studies. We found that the majority of the reported AUCs were paradoxical health consequences and a few broader societal consequences, that is, the intervention led to an unintended increase rather than the intended decrease in drug use, and identification with ex-addicts. Potential mechanisms discussed primarily focussed on the change though social norms and practices, but knowledge as well as understanding and the change of perception were also mentioned.

The social mechanisms leading to unintended deviant behaviour caused by prevention or treatment interventions are often referred to as ‘deviancy training’.^{16,93,114,115} This phenomenon describes that group interventions may lead to AUCs or generate harms by promoting interaction between people who are in higher behavioural risk groups and change the perception of social norms.^115,116 As discussed by Lorenc and Oliver,⁷ social norms and contexts play a role with regards to AUCs but are often neglected in the evaluation of health interventions.

Additionally, this systematic review of reviews described differences in the reporting of these AUCs across included reviews. Reviews with a higher AMSTAR 2 rating, especially Cochrane reviews, reported AUCs more often than reviews with a lower AMSTAR 2 rating; similarly, more recent reviews (i.e. those published after 2010) were more likely to examine AUCs.

The majority of reviews or studies did not anticipate the occurrence of AUCs (e.g. AUCs specified as an outcome of interest under Methods section) or discussed these findings extensively. Most of these AUCs could, however, have been anticipated. Different strategies to do so or at least acknowledge the possibility of AUCs in public health interventions (e.g. dark logic models) have been discussed by multiple authors.^93,117,118 Acknowledging the broader social and environmental context as the complex system in which individuals and interventions interact plays a key role in trying to understand the potential mechanisms leading to AUCs.^21,22,24 As discussed by Morell¹¹⁷ and Oliver et al.,^9,10 stakeholders initiating evaluations tend to prefer a ‘narrative of success’⁹ which might lead to a publication bias, explaining the low reporting of AUCs across studies. The lack of reported harms requires careful interpretation as reasons may be diverse. AUCs might not have occurred (actual null event), not have been investigated or might have been observed but not reported (reporting bias).¹⁴ Additionally, the reporting of AUCs in systematic reviews depends on the reporting of AUCs in primary studies. Even in clinical research reporting of AUCs is an important issue as reporting guidelines exist but AUCs are nevertheless not reported in all cases.^14,24,119

Strengths and limitations

To the knowledge of the authors, this review made use of the best available a priori frameworks to categorise AUCs and potential mechanisms. This allowed us to systematically investigate AUCs and identify potential gaps in the available data. Both consequences and mechanisms were examined not only from an individual and biomedical but also from a societal perspective. We used a predefined protocol to conduct this review and used a standardised review approach.

Despite these efforts, this review and its findings can only be as good as the underlying evidence base. The reporting and exploration of AUCs was scarce and in most cases focussed on individual health rather than society at large. It is likely, that further AUCs or mechanisms leading to them were not identified and/or not reported in the primary studies. This is not doing justice to the scope of AUCs and the likely mechanisms leading to AUCs.

Conclusion

All health interventions potentially lead to AUCs. However, while it is widely accepted that clinical interventions lead to AUCs or complications, this is not always the case for public health interventions.^7,24 Safety studies or harm reviews are often conducted in clinical research (i.e. health technology assessments, safety trials, real-world trials) but have not yet been established to the same degree in the broader health sciences.^7,18,24 When primary studies fail to assess AUCs, these cannot be documented in subsequent reviews. Existing tools like the Cochrane Handbook for Systematic Reviews of Interventions¹²⁰ or the PRISMA Harms Checklist¹²¹ as well as dark logic models⁹³ informed by existing frameworks (e.g. WHO-INTEGRATE²⁷) can be useful tools in the planning and evaluation of public health interventions as these to highlight the complexity if public health interventions and can help to acknowledge the occurrence of AUCs. Systematic reviews and primary studies evaluating certain interventions (especially such in complex systems) should be aware of different types of AUCs, the scope of the AUCs and potential mechanisms so that these can be assessed systematically.^7,24 These frameworks could also be used to develop study protocols so that AUCs can be assessed systematically taking multiple domains/categories into account, which is particularly important in public health interventions, as these tend to be complex and integrate multiple factors consequently aggravating the anticipation of potential AUCs. This is important as AUCs will most probably not be identified if one is not searching for it or at least considering the existence of such consequences.

Supplemental Material

sj-docx-1-phj-10.1177_22799036221103362 – Supplemental material for Adverse and other unintended consequences of setting-based interventions to prevent illicit drug use: A systematic review of reviews

Supplemental material, sj-docx-1-phj-10.1177_22799036221103362 for Adverse and other unintended consequences of setting-based interventions to prevent illicit drug use: A systematic review of reviews by Renke L Biallas, Eva Rehfuess and Jan M Stratil in Palliative Medicine

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This work was partially supported by a grant to develop an integrated framework of unintended consequences of public health interventions by the German Ministry of Education and Research (BMBF).

Significance for public health

This review is one of the very few that presents adverse and unintended consequences (AUCs) of setting-based interventions to prevent illicit drug use and uses a priori frameworks to categorise them and explore possible mechanisms. This allowed us to systematically examine AUCs and identify potential gaps in the available data. Both consequences and mechanisms were examined not only from an individual and biomedical perspective but also from a societal perspective. This review promotes the importance of recognising AUCs in the design, implementation and evaluation of public health interventions.

Supplemental material

Supplemental material for this article is available online.

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