No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
'Dark logic': Theorising the harmful consequences of public health interventions
Abstract
Although it might be assumed that most public health programmes involving social or behavioural rather than clinical interventions are unlikely to be iatrogenic, it is well established that they can sometimes cause serious harms. However, the assessment of adverse effects remains a neglected topic in evaluations of public health interventions. In this paper, we first argue for the importance of evaluations of public health interventions not only aiming to examine potential harms but also the mechanisms that might underlie these harms so that they might be avoided in the future. Second, we examine empirically whether protocols for the evaluation of public health interventions do examine harmful outcomes and underlying mechanisms and, if so, how. Third, we suggest a new process by which evaluators might develop 'dark logic models' to guide the evaluation of potential harms and underlying mechanisms, which includes: theorisation of agency-structure interactions; building comparative understanding across similar interventions via reciprocal and refutational translation; and consultation with local actors to identify how mechanisms might be derailed, leading to harmful consequences. We refer to the evaluation of a youth work intervention which unexpectedly appeared to increase the rate of teenage pregnancy it was aiming to reduce, and apply our proposed process retrospectively to see how this might have strengthened the evaluation. We conclude that the theorisation of dark logic models is critical to prevent replication of harms. It is not intended to replace but rather to inform empirical evaluation.
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
... This included: the proposed theory of change; key contextual influences; barriers and facilitators to implementation; appropriate and priority outcomes; and unintended consequences. Given the scarcity of research evidence in the Danish context, there was a notable need to understand the potential harmful effects as a new intervention interacting with system conditions (Bonell et al., 2015;O'Cathain et al., 2019). The final version of the programme theory, as refined and confirmed by the reference group and panels (Figure 1), was developed based on Actions 7 and 8 and are therefore reported consequently. ...
... This search aimed to deepen knowledge on how this activity would theoretically and practically function. In total, nine studies were identified to report evidence on 'buddy' system interventions targeting older people with physical and/or psychosocial frailties (Andrews et al., 2003;Salari et al., 2006;Allen and Wiles, 2014;Bonell et al., 2015;Carr et al., 2015;Kharicha et al., 2017;Moriarty and Manthorpe, 2017;O'Cathain et al., 2019;Wiles et al., 2019;Winzer et al., 2019;Merchant et al., 2021). From the evidence base, we identified key considerations to take into account, such as the potential need to match buddies based on gender and other relevant socio-demographic characteristics and the boundaries or responsibility it would be appropriate for a 'buddy' to have (e.g. ...
... The interventions' theory of change illustrated in and described through articulation of the programme theory could potentially withhold inadequate or insufficient knowledge to reach the intended outcomes of the intervention entailing unintended consequences (Bonell et al., 2015). Several possible unintended consequences were brought up during the discussions in stakeholder panels and identified through the research literature. ...
Adults often experience a loss of social relations and sense of belonging in later life, leading to the risk of social isolation. Municipal senior centres offer a potential site for intervention, as they provide social communities targeting older people. However, not all older people find it easy to access these social communities due to experiencing physical and/or psychosocial frailties and could therefore continue to experience a decline in social relations and sense of belonging, which potentiates poor physical and psychosocial health and well-being. To date, there are limited evidence-based interventions in Denmark. The present article describes the development of an intervention to increase belongingness and decrease social isolation among older people with frailties who attend Danish municipal senior centres. The development process was conducted with reference to the INDEX (IdentifyiNg and assessing different approaches to DEveloping compleX intervention) guidance. The development process resulted in a 6-month supportive intervention, consisting of four elements: skills development workshops for all staff members; a start conversation including frailty screening; allocation of a ‘buddy’ among existing service users; and monthly follow-up conversations with staff members. This theory-informed approach can progress to feasibility testing and outcome evaluation in order to generate an evidence base. Concurrently, the article reflects on current guidance for intervention development and how it may be used and optimized to strengthen developmental processes in the future.
... BMJ Public Health (paradoxical effects) or effects on unrelated outcomes (unintended externalities). 1 For example, providing preexposure 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. ...
... 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][20][21] While unintended consequences of social action have been discussed in the broader scientific literature, [22][23][24][25][26][27][28][29][30] they constitute a largely neglected topic in empirical PH research, 17 31 except for specific areas, such as cancer screening 32 or illicit drug use. ...
... 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. ...
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 Consequences 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.
... Here, it is simply often the case that stakeholder expectations must be sufficiently raised from the outset of intervention planning activities so as to enable the investment of necessary volumes of political or financial capital. However, as a result of heightened "multiple win" expectations throughout this process, it may appearto some stakeholders at least, and not unlike in the context of public health (Bonell et al., 2015) that ostensibly 'new and improved' conservation models entail relatively limited potential for iatrogenic impacts upon livelihoods or human wellbeing (Mbaria and Ogada, 2016;Nel, 2021;Fletcher, 2023). This is particularly so as many conservation organizations are increasingly at pains to distance themselves from the injustices associated with past and present forms of exclusionary 'fortress conservation'. ...
... Seeking to contribute to the literature in this regard, this article foregrounds the concept of a "dark logic model", inspired by related debates in medicine and public health Lorenc and Oliver, 2014;Bonell et al., 2015). In short, dark logic models complement existing logical frameworks ("logframes") and theory of changebased programme designs by challenging intervention designers and implementers "to anticipate the most plausible and most harmful unintended impacts and associated mechanisms" that may arise from their activities (Bonell et al., 2015: 97). ...
... Meessen et al., 2003), dark logic approaches emerge from both researcher and practitioner efforts to better understand counterintuitive or "paradoxical" results arising from seemingly wellintentioned public health or welfare interventions. Here, seminal examples in the literature include interventions to reduce rates of teenage pregnancy that were found to actually increase these rates (Bonell et al., 2015), or initiatives to address substance abuse that appearedlikewise, counter-intuitivelyto provide new opportunities for certain stakeholders to continue or even intensify harmful behaviours (e.g. Werch and Owen, 2002, see also Biallas et al., 2022). ...
... ToC has been used successfully in LMICs, including Ethiopia (Abayneh et al., 2020). Pathways to potential unintended consequences, including harms (the so-called "dark logic model"), also require consideration (Bonell et al., 2015). ...
... . Bonell et al. (2015) . Evidence base and local experts consulteed. . ...
... Following Bonell et al. (2015), we examined assumptions made by our ToC and potential harms of the adapted intervention's inputs, processes, mechanisms, and contextual interactions. RK considered unintended interactions between individual actions and social structures in response to the intervention, and compared our ToC map with logic models, descriptions, and process evaluations of similar interventions. ...
Objective:
To adapt an evidence-based psychological intervention for pregnant women experiencing depressive symptoms and intimate partner violence (IPV) in rural Ethiopia.
Method:
We conducted a desk review of contextual factors in Sodo, Ethiopia, followed by qualitative interviews with 16 pregnant women and 12 antenatal care (ANC) providers. We engaged stakeholders through participatory theory of change (ToC) workshops, to select the intervention and articulate a programme theory. We used "ADAPT" guidance to adapt the intervention to the context, before mapping potential harms in a "dark logic model".
Results:
Brief problem-solving therapy developed for South Africa was the most contextually relevant model. We adapted the delivery format (participants prioritised confidentiality and brevity) and training and supervision (addressing IPV). Consensus long-term outcomes in our ToC were ANC providers skilled in detecting and responding to emotional difficulties and IPV, women receiving appropriate support, and emotional difficulties improving. Our dark logic model highlighted the risk of more severe IPV and mental health symptoms not being referred appropriately.
Conclusion:
Although intervention adaptation is recommended, the process is rarely reported in depth. We comprehensively describe how contextual considerations, stakeholder engagement, programme theory, and adaptation can tailor psychological interventions for the target population in a low-income, rural setting.
... The first possibility is that participants will deteriorate on the primary or secondary outcomes (for example, mental health symptoms), rather than improve as hoped. The second possibility is that other, unexpected negative outcomes will occur, which may not be measured because they are not hypothesized positive outcomes 39 . For example, a group intervention focused on reducing depressive symptoms might conceivably affect social relationships in a negative way (as has been found 17 ), perhaps because it encourages self-focused introspection. ...
... The second way to identify potential harmful outcomes is to consult with people in schools that may have useful insights into how interventions will be delivered and experienced 39,43,44 . This input can be sought before, during and after the intervention. ...
... 4 Increased attention to possible unintended effects of public health interventions may provide in-depth knowledge of what works for whom under which circumstances and why. 3 5 Further, conducting studies on negative unintended effects has been highlighted as crucial to prevent replication of harms in future interventions. 6 Interventions operating on multiple levels targeting the structural and individual levels are considered key in changing behaviours. ...
... Moreover, there is generally a call for evaluations and research to report intended as well as unintended effects of interventions to guide and inform future efforts aimed towards increasing public health. 6 Lorenc and Oliver's framework of unintended effects of public health interventions 18 describe several mechanisms which may be present in the Focus intervention and lead to unexpected effects which could counteract the purposes of the intervention. 18 First, as an example of direct harms previous research has raised the concern that introduction of comprehensive smoking bans in school may lead to an increase in other substance use (also called substitution use), including alternative tobacco and nicotine products (smokeless tobacco, ie, snus, snuff and chewing tobacco, hookah and e-cigarettes) or cannabis. ...
Objectives
Public health interventions are designed to improve specific health-related outcomes; however, they may also produce negative side effects, such as substitution use, psychological or social harms. Knowledge about the unintended effects of school-based smoking preventive interventions is sparse. Hence, this study examined these potential unintended effects of the smoking-reducing intervention, Focus, among students in the vocational education and training setting.
Design
Cluster randomised controlled trial stratified by school type with 5 months follow-up.
Setting and participants
Across Denmark, eight schools were randomised to the intervention group (n=844 students, response proportion 76%) and six schools to the control group (n=815 students, response proportion 75%). This study focused solely on students who smoked at baseline (N=491).
Interventions
The intervention was developed systematically based on theory and a thoroughly mixed-methods needs assessment. Intervention components included a comprehensive school tobacco policy (smoke-free school hours) supported by a 3-day course for school staff and launched by an edutainment session for students; class-based lessons and a quit-and-win competition; and individual telephone smoking cessation support.
Outcomes
Alternative tobacco and nicotine products (regular use of smokeless tobacco, hookah and e-cigarettes), regular cannabis use, boredom and loneliness at school, stress and perceived stigmatisation among smokers.
Results
We found no statistically significant unintended effects of the intervention. Nonetheless, insignificant findings indicated that students in the intervention group were less likely to be bored during school hours (OR 0.59, 95% CI 0.32 to 1.10) and experience stress (OR 0.62, 95% CI 0.35 to 1.10), but more likely to report feeling stigmatised compared with the control group (OR 1.55, 95% CI 0.71 to 3.40).
Conclusions
Overall, findings suggested no unintended effects of the Focus trial with respect to substitution use, psychological, nor group or social harms. Future research is encouraged to report potential harmful outcomes of smoking preventive interventions, and interventions should be aware of the possible stigmatisation of smokers.
Trial registration number
ISRCTN16455577.
... The programme theory we developed drew on Funnel & Rogers' elaboration of how to present programme theories [36]. Intended and unintended effects of the intervention may also become apparent through in-depth theorisation of a programme theory [28,37]. Knowledge about both the intentional and unintentional workings of an intervention is a considerable advantage of adopting the realist approach. ...
... We identified the five most dominant generative mechanisms assumed to be essential for the intervention to produce the intended outcomes. While considering potentially unintended consequences identified through this study, the CMOcs constitute the framework for the ongoing evaluation [37]. ...
A distinct inequality in maternity care exists, and women with psychosocial risks are at a greater risk of adverse birth outcomes. In several high-income countries, a psychosocial risk assessment early in pregnancy is recommended so that expectant parents are offered an appropriate level of care which facilitates relevant, tailored interventions for those in need. In 2017, a cross-sectoral and interdisciplinary intervention for expectant parents with psychosocial risks was developed and implemented in the North Denmark Region. The development process of the intervention has not been reported and theory-based knowledge about how supportive interventions bring about change for expectant parents with psychosocial risks is scarce. Through the initial phase of a realist evaluation, we aimed to elicit key contexts and mechanisms of change regarding the intervention for expectant parents with psychosocial risks. Through an initial programme theory, this article illustrates how, for whom and in which contexts the intervention is intended to work. Data is comprised of intervention documents, 14 pilot observations and 29 realist interviews with key stakeholders. A thematic analytical approach inspired by retroductive thinking was applied to identify and analyse patterns related to the incentive of the intervention, its structure, intended outcomes, generative mechanisms and contextual matters. Generative mechanisms responsible for bringing about change in the intervention were identified as healthcare professionals’ approach, continuity, trust, early intervention and social network. Cross-sectoral collaboration and healthcare professionals’ competencies were assumed to be central stimulating contextual factors. The initial programme theory developed in this study will serve as the basis for further refinement via empirical testing in a later phase of the realist evaluation.
... mental health symptoms), rather than improve as hoped. The second possibility is that other, unexpected negaKve outcomes will occur, which may not be measured because they are not hypothesised posiKve outcomes 29 . For example, a group intervenKon focused on reducing depressive symptoms might conceivably affect social relaKonships in a negaKve way (as has been found 13 ), perhaps because it encourages self-focused introspecKon. ...
... The second way to idenKfy potenKal harmful outcomes is to consult with people in schools that may have useful insights into how intervenKons will be delivered and experienced 29,33,34 . This input can be sought before, during and acer the intervenKon. ...
There is growing evidence that universal school-based mental health interventions can lead to negative outcomes in young people. This is a critical ethical issue, especially when young people cannot easily opt-out of interventions run during school hours. To date, however, there is no guidance available about potential harms for researchers designing and running these interventions. In this Perspective, we set out five research recommendations: (1) acknowledge the possibility of potential harms; (2) identify types of potential harms; (3) measure and report potential harms in all outputs; (4) consider adverse events (e.g. a suicide attempt) and (5) consider participant dropout and disengagement. Using simulated data, we demonstrate that even if trials show small negative effects, this could lead to considerable harm if interventions are scaled up across the population. Furthering research in this area will help ensure the field delivers interventions that are most effective and least harmful for everyone.
... Interventions for parents in vulnerable positions are offered worldwide as part of maternity care services but few are evidence based, and more systematic evaluation is needed to determine their effectiveness (Hollowell et al., 2011). Broad variation in such interventions calls for uncovering how and why care models work to enable activating and replicating mechanisms responsible for both positive outcomes (Symon et al., 2016) and potential harmful unintended consequences (Bonell et al., 2015). ...
... The data allowed identification of causal links driving unintended consequences (Bonell et al., 2015). These are illustrated in CMOC 6-8. ...
Interprofessional collaboration and trusting parent-professional relationships can be key to delivering interprofessional care to meet the needs of expectant and new parents in vulnerable positions. This, however, presents challenges. This study aimed to gain deeper understanding of how and under what circumstances trusting parent-professional relationships develop and work within interprofessional team-based care for this group, from the professionals' perspectives. Realist evaluation was undertaken based on 14 semi-structured, realist interviews with midwives and health visitors and 11 observations. Multiple interrelated mechanisms were identified including patient/family-centered care, timely and relevant interprofessional involvement in care, gentle interprofessional bridging, transparency of intervention roles and purposes, and relational continuity. Good interprofessional collaboration was a primary condition for these mechanisms. Developed, trusting relationships supported parents' engagements with interprofessional care and constituted a supportive safety net that promoted parenting skills and coping abilities. We identified harmful mechanisms: distanced encounters, uncertainty of interprofessional involvement, and compromising the safe space. These mechanisms caused distrust and disengagement. Ensuring trusting parent-professional relationships within interprofessional team-based care demands each professional involved competently engages in relational work and interprofessional collaboration. Uncontrollability is thus influenced regarding interpersonal connection and potentially gives an explanation when trust-building efforts fail.
... This systems map helps to make this complexity apparent; it could help to better predict how the system responds to changes, 41,51 demonstrate why some changes may be unpredictable [110][111][112] and lead to unintended outcomes. 41,44,113 Importantly, while this map offers valuable insights into the complexity surrounding UCI influence, some parts of this map may be less relevant in specific settings, such as authoritarian regimes 114 versus liberal democracies, 115 or free markets 116,117 versus mixed or controlled economies. 117,118 For example, given the global prioritisation of GDP growth as a key driver of development, 119 Theme 3 (…prioritisation of commercial profits and growth) may be more widely applicable. ...
Background: Unhealthy commodity industries (UCIs) engage in political practices to influence public health policy, which poses barriers to protecting and promoting public health. Such influence exhibits characteristics of a complex system. Systems thinking would therefore appear to be a useful lens through which to study this phenomenon, potentially deepening our understanding of how UCI influence are interconnected with one another through their underlying political, economic and social structures. As such this study developed a qualitative systems map to depict the complex pathways through which UCIs influence public health policy and how they are interconnected with underlying structures. Methods: Online participatory systems mapping workshops were conducted between November 2021 and February 2022. As a starting point for the workshops, a preliminary systems map was developed based on recent research. Twenty-three online workshops were conducted with 52 geographically diverse stakeholders representing academia, civil society, public office and global governance organisations. Analysis of workshop data in NVivo and feedback from participants resulted in a final systems map. Results: The preliminary systems map consisted of 40 elements across six interdependent themes. The final systems map consisted of 64 elements across five interdependent themes, representing key pathways through which UCIs impact health policymaking: 1) direct access to public sector decision-makers; 2) creation of confusion and doubt about policy decisions; 3) corporate prioritisation of commercial profits and growth; 4) industry leveraging the legal and dispute settlement processes; and 5) industry leveraging policymaking, norms, rules, and processes. Conclusion: UCI influence on public health policy is highly complex, involves interlinked practices, and is not reducible to a single point within the system. Instead, pathways to UCI influence emerge from the complex interactions between disparate national and global political, economic and social structures. These pathways provide numerous avenues for UCIs to influence public health policy, which poses challenges to formulating a singular intervention or limited set of interventions capable of effectively countering such influence. Using participatory methods, we made transparent the interconnections that could help identify interventions future work.
... The traditional data analysis models for representing cause and effect are useful for direct investigations of main causal aspects of phenomena, because they deliver linear and simplistic representations, but they also do not identify how the variables relate and modify the information set [35]. Therefore, although multicomponent interventions may not positively influence certain parameters, observing the changes that occur in different intervention scenarios may offer several clues as to how to interact with specific outcomes, providing relevant data for the implementation of strategies aimed at tackling complex systems [36]. This means that it is not a perspective that specifies a new intervention for each scenario, but rather to identify the main intervention mechanisms that can modify the behavioral patterns of that system through different interaction approaches. ...
Objective
To analyze the relationships between sociodemographic, behavioral, breastfeeding, body composition, physical fitness, and insulin biomarkers before and after a multicomponent intervention among adolescents with overweight and obesity using network analysis.
Methods
This was a quasi-experimental study with 37 adolescents with overweight/obesity (17 and 20 participants in the intervention and control groups, respectively). The program lasted 6 months, with three weekly sessions comprising physical exercises and nutritional and psychological orientation. The assessment of body composition, physical fitness, insulin biomarkers, and lifestyle indicators was performed before and after the intervention. The network analysis was carried out using three centrality indicators: proximity, strength, and expected influence; which identify the most influential or central nodes or edges, indicating their importance or crucial role in the structure and dynamics of the network.
Results
Two networks, one each for before and after the intervention, were generated. Before the intervention, the results were as follows: for closeness, sex (1.059) and pubertal stage (1.268); for strength, pubertal stage (1.268), physical activity (1.160), and screen time (1.388); for expected influence, age (1.658), HOMA-IR (1.171), glucose (1.304), and waist circumference (1.394). After the intervention, for closeness, sex (1.102), type of school (1.221), and waist/hip ratio (1.221); for strength, breastfeeding (1.099), screen time (1.465), waist/hip ratio (1.131), and groups (1.280); for expected influence, breastfeeding (1.574), HOMA-IR (1.017), resistin (2.276), body mass index (1.008), and waist circumference (1.154).
Conclusion
The multicomponent intervention demonstrated beneficial relationships by modifying and approximating the clusters of factors of body composition, physical fitness, and insulin biomarkers.
... They should be mindful of the stigma mothers with obesity already experience (54) and of concerns that medical practice draws on prevailing "biomedical discourse" to justify controlling women's bodies (55). This highlights the potential merits Frontiers in Public Health 12 frontiersin.org of using 'dark logic' models in the early development of preconception health interventions, to explore the potential for unintended harmful effects (56). Future research should explore whether it may be more acceptable for these interventions to focus on weight-related behaviors, such as diet and exercise, rather than having explicit weight-based goals. ...
Background
Systematic review evidence suggests preconception health interventions may be effective in improving a range of outcomes. However, few studies have explored women’s views on potential content and delivery methods for these interventions.
Methods
Participants were purposively sampled from respondents (n = 313) of a survey. Semi-structured, in-depth interviews were conducted to explore their views on seven candidate delivery methods for preconception health interventions: general practitioners (GPs), nurse practitioners, pharmacists, social media, personal texts and emails, pregnancy tests, and health education in schools. Data were analyzed using a data-driven framework analysis.
Results
Twenty women were interviewed. Women wanted interventions to be easily accessible but allow them to conceal their pregnancy plans. They preferred to choose to receive preconception interventions but were receptive to health professionals raising preconception health during ‘relevant’ appointments such as contraceptive counseling and cervical smear tests. They wanted intervention content to provide trustworthy and positively framed information that highlights the benefits of good preconception health and avoids stigmatizing women for their weight and preconception actions. The inclusion of support for preconception mental health and the use of visual media, personalization, simple information, and interesting and unfamiliar facts were viewed favorably.
Conclusion
Interventions to improve preconception health should reflect the sensitivities of pregnancy intentions, be easy to access in a way that enables discretion, and be designed to seek consent to receive the intervention. These interventions should ideally be tailored to their target populations and provide trustworthy information from reputable sources. The potential for unintended harmful effects should be explored.
... Papaioannou et al. Trials (2024) 25:163 Case studies have been put forward that describe the approach to recording harms on specific behaviour change or public health trials [27][28][29], and a method "the Dark Logic model" [30] describes how to identify harms plausible from an intervention and is recommended by the CONSORT Social and Psychological Interventions extension [3]. ...
Background
Harms, also known as adverse events (AEs), are recorded and monitored in randomised controlled trials (RCTs) to ensure participants’ safety. Harms are recorded poorly or inconsistently in RCTs of Behaviour Change Interventions (BCI); however, limited guidance exists on how to record harms in BCI trials. This qualitative study explored experiences and perspectives from multi-disciplinary trial experts on recording harms in BCI trials.
Methods
Data were collected through fifteen in-depth semi-structured qualitative interviews and three focus groups with thirty-two participants who work in the delivery and oversight of clinical trials. Participants included multi-disciplinary staff from eight CTUs, Chief investigators, and patient and public representatives. Interviews and focus group recordings were transcribed verbatim and thematic analysis was used to analyse the transcripts.
Results
Five themes were identified, namely perception and understanding of harm, proportionate reporting and plausibility, the need for a multi-disciplinary approach, language of BCI harms and complex harms for complex interventions. Participants strongly believed harms should be recorded in BCI trials; however, making decisions on “how and what to record as harms” was difficult. Recording irrelevant harms placed a high burden on trial staff and participants, drained trial resources and was perceived as for little purpose. Participants believed proportionate recording was required that focused on events with a strong plausible link to the intervention. Multi-disciplinary trial team input was essential for identifying and collecting harms; however, this was difficult in practice due to lack of knowledge on harms from BCIs, lack of input or difference in opinion. The medical language of harms was recognised as a poor fit for BCI trial harms but was familiar and established within internal processes. Future guidance on this topic would be welcomed and could include summarised literature.
Conclusions
Recording harms or adverse events in behaviour change intervention trials is complex and challenging; multi-disciplinary experts in trial design and implementation welcome forthcoming guidance on this topic. Issues include the high burden of recording irrelevant harms and use of definitions originally designed for drug trials. Proportionate recording of harms focused on events with a strong plausible link to the intervention and multi-disciplinary team input into decision making are essential.
... The studies suggest that every campaign should be viewed as an intervention, with the campaign briefs containing the following: a de ned behavioural aim (for example, under "consumer objectives"), message (for example, under "focal insight"), message source/voice and method (for example, under "deliverables"), target audience (for example, under "target group"), and anticipated reach and indicators (for example, under "objectives/outcomes"). Campaigns should take into account the likelihood of unintended outcomes and use the existing frameworks to reduce these risks 54 . In this case, rather than publishing only about the usage and the health bene ts of a toilet by the government, the government can also emphasize that people should have a right to have a toilet in their households and that they should approach government o ces for help in building a toilet in their households. ...
Community sanitation is a fundamental human right and need. Every year, as per the World Bank, total cost of providing sanitation services is estimated at around 114 billion USD per year. In India, Swachh Bharat Abhiyan (SBA), a public welfare scheme (PWS), is aimed at addressing community sanitation problems. Despite the successful implementation of SBA, local communities still practise open defaecation. To deduce the behavioural patterns governing communal toilet use, interviews were conducted with the local communities in the Kho Nagorian area of Jaipur, Rajasthan, India. This qualitative survey examined attitudes towards the construction of a toilet, awareness towards the SBA scheme, and the willingness to use sewage-based manure. The study then discusses the factors that increase the local community’s willingness to use these toilets. Results show that open defaecation is still prevalent in society. One way to foster the adoption of toilets is that the construction materials should mainly consist of local materials. As a recourse, places of worship could be used to influence people`s perception of hygiene. In addition, community toilets should be cleaned often as well. PWS should not be made accessible at no cost to prevent a sense of entitlement among the people. A small sum should be charged to increase social responsibility towards the PWS. Another way to curb open defaecation is to tap into the sense of entitlement by making effective use of social campaign programs. Further, cross-table analysis revealed that the locals were inclined to use a toilet if they have invested in it. Advertisements were found to be ineffective, and proposals were made to make them effective. These findings aid in understanding public perceptions and can guide the development of public policies. The findings also assist in making tax distribution decisions that reflect public concerns, attitudes, and values.
... Additionally, it is important to investigate innovative outcome measurement methods and use a triangulation of various methods in line with the principles of CCA. CCA can further provide a detailed examination of the intervention's potential impact on disadvantaged groups, trade-offs between various outcomes, potential unintended consequences, and the distribution of benefits and consequences among different population groups [89,90]. ...
Community-based health promotion (CBHP) interventions are promising approaches to address public health problems; however, their economic evaluation presents unique challenges. This review aims to explore the opportunities and limitations of evaluating economic aspects of CBHP, focusing on the assessment of intervention costs and outcomes, and the consideration of political-level changes and health equity. A systematic search of the PubMed, Web of Science and PsycInfo databases identified 24 CBHP interventions, the majority of which targeted disadvantaged communities. Only five interventions included a detailed cost/resource assessment. Outcomes at the operational level were mainly quantitative, related to sociodemographics and environment or health status, while outcomes at the political level were often qualitative, related to public policy, capacity building or networks/collaboration. The study highlights the limitations of traditional health economic evaluation methods in capturing the complexity of CBHP interventions. It proposes the use of cost-consequence analysis (CCA) as a more comprehensive approach, offering a flexible and multifaceted assessment of costs and outcomes. However, challenges remain in the measurement and valuation of outcomes, equity considerations, intersectoral costs and attribution of effects. While CCA is a promising starting point, further research and methodological advancements are needed to refine its application and improve decision making in CBHP.
... Deterioration rates in our study ranged between 4% for PTSD and 9 and 11% for anxiety and depression and were thus smaller than empirically observed waitlist for PTSD and comparable to other stabilisation (Melegkovits et al., 2023) or waitlist findings for depression (Jayawickreme et al., 2017;Hoppen et al., 2022). Although we can cautiously conclude that our group waitlist intervention is almost as safe as trauma-focused therapy and safer than previous stabilisation or waitlist for PTSD symptoms, the importance of understanding mechanisms of symptom deterioration in health interventions has recently been emphasised (Bonell et al., 2015). Further research evaluating this group needs to study adverse effects, deterioration, and engagement in evidence-based treatments to establish cost-benefit analyses. ...
Background
Large numbers of people showing complex presentations of post-traumatic stress disorder (PTSD) in the NHS Talking Therapies services routinely require multi-faceted and extended one-to-one National Institute of Clinical Excellence (NICE) recommended treatment approaches. This can lead to longer waits for therapy and prolong patient suffering. We therefore evaluated whether a group stabilisation intervention delivered to patients on the waitlist for individual trauma-focused psychological treatment could help address this burden.
Aims
The study aimed to ascertain a trauma-focused stabilisation group’s acceptability, feasibility, and preliminary clinical benefit.
Method and results
Fifty-eight patients with PTSD waiting for trauma-focused individual treatment were included in the study. Two therapists delivered six 5-session groups. The stabilisation group was found to be feasible and acceptable. Overall, PTSD symptom reduction was medium to large, with a Cohen’s d of .77 for intent-to-treat and 1.05 for per protocol analyses. Additionally, for depression and anxiety, there was minimal symptom deterioration.
Conclusions
The study provided preliminary evidence for the acceptability, feasibility and clinical benefit of attending a psychoeducational group therapy whilst waiting for one-to-one trauma therapy.
... However, knowledge about unintended consequences contributes important information and recommendations for future research in this field, both in terms of strengthening the implementation of health checks and in relation to the knowledge gap that exist in the literature. Including attention to unintended consequences of preventive health checks, might help rethink any of the activities involved in order to reduce negative unintended side effects or enable researchers to explore the unintended side effects and in this way hinder or enhance outcomes [116]. We suggest that future preventive health checks incorporate attention to unintended side effects in order to fully understand the impact of the health checks. ...
Background
Preventive health checks are assumed to reduce the risk of the development of cardio-metabolic disease in the long term. Although no solid evidence of effect is shown on health checks targeting the general population, studies suggest positive effects if health checks target people or groups identified at risk of disease. The aim of this study is to explore why and how targeted preventive health checks work, for whom they work, and under which circumstances they can be expected to work.
Methods
The study is designed as a realist synthesis that consists of four phases, each including collection and analysis of empirical data: 1) Literature search of systematic reviews and meta-analysis, 2) Interviews with key-stakeholders, 3) Literature search of qualitative studies and grey literature, and 4) Workshops with key stakeholders and end-users. Through the iterative analysis we identified the interrelationship between contexts, mechanisms, and outcomes to develop a program theory encompassing hypotheses about targeted preventive health checks.
Results
Based on an iterative analysis of the data material, we developed a final program theory consisting of seven themes; Target group; Recruitment and participation; The encounter between professional and participants; Follow-up activities; Implementation and operation;Shared understanding of the intervention; and Unintended side effects. Overall, the data material showed that targeted preventive health checks need to be accessible, recognizable, and relevant for the participants’ everyday lives as well as meaningful to the professionals involved.
The results showed that identifying a target group, that both benefit from attending and have the resources to participate pose a challenge for targeted preventive health check interventions. This challenge illustrates the importance of designing the recruitment and intervention activities according to the target groups particular life situation.
Conclusion
The results indicate that a one-size-fits-all model of targeted preventive health checks should be abandoned, and that intervention activities and implementation depend on for whom and under which circumstances the intervention is initiated. Based on the results we suggest that future initiatives conduct thorough needs assessment as the basis for decisions about where and how the preventive health checks are implemented.
... A theory of change (ToC) was developed ( Fig. 1), which surfaced mechanisms about how the intervention was expected to work at different stages (intermediate outcomes), and the conditions required to enable change (assumptions), in order to achieve the desired longerterm outcomes [31,32]. We hypothesised negative mechanisms ('dark logic models') that could potentially undermine implementation or cause adverse outcomes for those delivering or receiving the intervention [33]. The ceiling of accountability separates the future impact (i.e. ...
Background
Health systems have a critical role in a multi-sectoral response to domestic violence against women (DVAW). However, the evidence on interventions is skewed towards high income countries, and evidence based interventions are not easily transferred to low-and middle-income countries (LMIC) where significant social, cultural and economic differences exist. We evaluated feasibility and acceptability of implementation of an intervention (HERA—Healthcare Responding to Violence and Abuse) to improve the response to DVAW in two primary health care clinics (PHC) in Brazil.
Methods
The study design is a mixed method process and outcome evaluation, based on training attendance records, semi-structured interviews (with 13 Primary Health Care (PHC) providers, two clinic directors and two women who disclosed domestic violence), and identification and referral data from the Brazilian Epidemiological Surveillance System (SINAN).
Results
HERA was feasible and acceptable to women and PHC providers, increased providers’ readiness to identify DVAW and diversified referrals outside the health system. The training enhanced the confidence and skills of PHC providers to ask directly about violence and respond to women’s disclosures using a women centred, gender and human rights perspective. PHC providers felt safe and supported when dealing with DVAW because HERA emphasised clear roles and collective action within the clinical team. A number of challenges affected implementation including: differential managerial support for the Núcleo de Prevenção da Violência (Violence Prevention Nucleus—NPV) relating to the allocation of resources, monitoring progress and giving feedback; a lack of higher level institutional endorsement prioritising DVAW work; staff turnover; a lack of feedback from external support services to PHC clinics regarding DVAW cases; and inconsistent practices regarding documentation of DVAW.
Conclusion
Training should be accompanied by system-wide institutional change including active (as opposed to passive) management support, allocation of resources to support roles within the NPV, locally adapted protocols and guidelines, monitoring progress and feedback. Communication and coordination with external support services and documentation systems are crucial and need improvement. DVAW should be prioritised within leadership and governance structures, for example, by including DVAW work as a specific commissioning goal.
... Conviene señalar que existe también suficiente cuerpo de conocimiento que indica que algunas intervenciones escolares para la salud mental pueden causar daños iatrogénicos (Andrews et al., 2022;Bonell et al., 2015;Guzman-Holst et al., 2022). Aún no se conocen bien los mecanismos por los que esto ocurre, pero parece razonable pensar que contar con un trabajo de calidad es, al menos, una condición primordial. ...
Los problemas de salud mental y las dificultades de ajuste psicológico entre los adolescentes se erigen como un desafío
personal, familiar, educativo y socio-sanitario. Se hace necesario abordar este reto social emergente mediante el estudio y
la implementación de estrategias de promoción del bienestar psicológico y prevención de los problemas de salud mental
en contextos educativos. El objetivo del presente trabajo es poner de manifiesto, a la luz de los datos epidemiológicos
derivados del proyecto PSICE (Psicología Basada en la Evidencia en Contextos Educativos), la importancia de abordar
la salud mental en entornos educativos. En primer lugar, se realiza una introducción al estudio del comportamiento
humano y los problemas de ajuste psicológico. En segundo lugar, se aborda la importancia de los centros educativos
como el lugar natural donde promocionar el bienestar psicológico y la salud mental infanto-juvenil. En tercer lugar, se
mencionan los resultados de prevalencia derivados del estudio PSICE. Se finaliza con un apartado de recapitulación
señalando la ineludible necesidad de promover, proteger y cuidar la salud mental durante la infancia y la adolescencia
en los entornos educativos. La promoción del bienestar psicológico y la prevención de los problemas de salud mental en
contextos educativos supone la mejor inversión por parte de la sociedad, los gobiernos y las instituciones.
... It is worth noting that there is also a sufficient body of knowledge indicating that some school-based mental health interventions can cause iatrogenic harm (Andrews et al., 2022;Bonell et al., 2015;Guzman-Holst et al., 2022). The mechanisms by which this occurs are not yet well understood, but it seems reasonable to think that having quality work is at least a primary condition. ...
Mental health problems and psychological adjustment difficulties among young people are emerging as a personal, family, educational, social, and health challenge. It is necessary to address this emerging social defiance by studying and implementing strategies to promote emotional well-being and prevent psychological problems in educational contexts. The aim of this work is to highlight, based on the epidemiological data derived from the PSICE (Evidencebased Psychology in Educational Contexts) project, the importance of addressing mental health in school settings. First, an introduction to the study of human behavior and psychological adjustment problems is given. Secondly, the importance of educational centers as the natural place to promote the psychological well-being and child and adolescent mental health is discussed. Thirdly, the prevalence results derived from the PSICE study are mentioned. To conclude, a summary section highlights the imperative need to promote, protect, and care for mental health during childhood and adolescence in educational settings. The promotion of psychological well-being and the prevention of mental health problems in educational contexts are the best investments on the part of societies, governments, and institutions.
... 4 Medical errors, such as when a surgeon makes an incision in the wrong place, are widely studied and discussed, 5 yet very little attention has been given to public health errors -actions (or inactions) of public health systems that can affect an entire population. 6 Studies on policy errors (including regulatory errors), 7 the harmful effects of some public health interventions, 8 and public health errors 9 have treated errors in various ways. 10 While there is a general agreement in the literature that errors can be of action or omission, disagreement exists about whether culpability should be regarded as an inherent feature of public health errors. ...
Studies of public health decisions that have had harmful effects tend to disagree about what constitutes a public health error. Debates exist about whether public health errors must be culpable or not, as well as about what the criteria for judging public health errors should be.
... Analysis of literature and interview transcripts will be conducted using retroductive reasoning, that is, working back from the data to identify the context-dependent mechanisms underlying the impacts described in online forums. Particular attention will be paid to accounts of potential negative impacts ('dark logic models' 38 ) and those that are unexpected or challenge our initial programme theories. ...
Introduction
Peer online mental health forums are commonly used and offer accessible support. Positive and negative impacts have been reported by forum members and moderators, but it is unclear why these impacts occur, for whom and in which forums. This multiple method realist study explores underlying mechanisms to understand how forums work for different people. The findings will inform codesign of best practice guidance and policy tools to enhance the uptake and effectiveness of peer online mental health forums.
Methods and analysis
In workstream 1, we will conduct a realist synthesis, based on existing literature and interviews with approximately 20 stakeholders, to generate initial programme theories about the impacts of forums on members and moderators and mechanisms driving these. Initial theories that are relevant for forum design and implementation will be prioritised for testing in workstream 2.Workstream 2 is a multiple case study design with mixed methods with several online mental health forums differing in contextual features. Quantitative surveys of forum members, qualitative interviews and Corpus-based Discourse Analysis and Natural Language Processing of forum posts will be used to test and refine programme theories. Final programme theories will be developed through novel triangulation of the data.
Workstream 3 will run alongside workstreams 1 and 2. Key stakeholders from participating forums, including members and moderators, will be recruited to a Codesign group. They will inform the study design and materials, refine and prioritise theories, and codesign best policy and practice guidance.
Ethics and dissemination
Ethical approval was granted by Solihull Research Ethics Committee (IRAS 314029). Findings will be reported in accordance with RAMESES (Realist And MEta-narrative Evidence Syntheses: Evolving Standards) guidelines, published as open access and shared widely, along with codesigned tools.
Trial registration number
ISRCTN 62469166; the protocol for the realist synthesis in workstream one is prospectively registered at PROSPERO CRD42022352528.
... We also recommend that both the intended and unintended consequences of implementing policies and interventions to change travel behaviour are identified through discussions between researchers and stakeholders. To date this has not been common but can be facilitated using dark logic models and group model building (Bonell et al., 2015). It would also benefit the wider sustainable transport agenda if proposed changes were considered in relation to the whole system and the potential impact was reviewed. ...
... 59 Any potential harms, overdiagnosis, labelling effect and consequences of receiving the intervention will be scrutinised during the study. 60 Age-related visual impairment diagnoses including glaucoma and AMD meet the requirements for screening formulated by WHO. 61 During the analysis, both benefits and harms of the intervention will be investigated and presented as results. ...
Introduction
The number of people living with visual impairment is increasing. Visual impairment causes loss in quality of life and reduce self-care abilities. The burden of disease is heavy for people experiencing visual impairment and their relatives. The severity and progression of age-related eye diseases are dependent on the time of detection and treatment options, making timely access to healthcare critical in reducing visual impairment. General practice plays a key role in public health by managing preventive healthcare, diagnostics and treatment of chronic conditions. General practitioners (GPs) coordinate services from other healthcare professionals. More involvement of the primary sector could potentially be valuable in detecting visual impairment.
Methods
We apply the Medical Research Council framework for complex interventions to develop a primary care intervention with the GP as a key actor, aimed at identifying and coordinating care for patients with low vision. The development process will engage patients, relatives and relevant health professional stakeholders. We will pilot test the feasibility of the intervention in a real-world general practice setting. The intervention model will be developed through a participatory approach using qualitative and creative methods such as graphical facilitation. We aim to explore the potentials and limitations of general practice in relation to detection of preventable vision loss.
Ethics and dissemination
Ethics approval is obtained from local authority and the study meets the requirements from the Declaration of Helsinki. Dissemination is undertaken through research papers and to the broader public through podcasts and patient organisations.
... This is possible because, unlike technologies in clinical settings, patient-facing technologies (eg, patient portals, mHealth, and health-related websites) are more likely to be unregulated and unmoderated. Bonell et al [11] termed this the "dark logic" of interventions where digital health could result in unintended trauma-related consequences despite a generally virtuous intention. ...
Background:
The use of digital health technologies is becoming increasingly common across the globe as they offer immense potential to enhance health care delivery by promoting accessibility, flexibility, and personalized care, connecting patients to health care professionals, and offering more efficient services and treatments to remote residents. At the same time, there is an increasing recognition of how digital health can inadvertently foment psychological trauma. This phenomenon has led to the adoption of trauma-informed care in designing and deploying digital health technologies. However, how trauma-informed care is defined and characterized, and the various trauma-informed care strategies used in designing and deploying digital health technologies remain unexplored.
Objective:
This scoping review aims to explore and synthesize the literature on how trauma-informed care is defined and characterized in digital health and the various trauma-informed care principles, strategies, or recommendations used in designing and deploying digital health.
Methods:
This review will draw on the Joanna Briggs Institute's updated methodological guidance for scoping reviews. A search will be conducted on CINAHL, PubMed, Embase, Compendex Engineering Village, Web of Science, Scopus, and PsycINFO. This review will consider published research studies and unpublished work (gray literature). Studies will be included if they applied trauma-informed care in designing or deploying digital health for patients across all geographical locations or provide trauma-informed recommendations on how web developers should develop digital health. Studies will be limited to publications within the past 10 years and studies in all languages will be considered. Two independent reviewers will screen the titles and abstracts, and then perform a full-text review. Data will be extracted into a data extraction tool developed for this study.
Results:
The scoping review was undergoing a full search as of April 2023. The main results will synthesize the peer-reviewed and gray literature on adopting trauma-informed care practices in digital health research and development. The study is expected to be completed by December 2023 and the results are expected to be published in a peer-reviewed journal.
Conclusions:
This review is expected to provide the knowledge base on the adoption of trauma-informed care in designing and deploying digital health. This knowledge can lead to more engaging, and likely, more effective digital health interventions that have less potential for harm. A synthesis of the various trauma-informed care strategies in digital health will also provide a trauma-informed language by enabling researchers and digital health developers to consider trauma as a critical factor in each stage of the design process.
International registered report identifier (irrid):
DERR1-10.2196/46842.
... For new drugs, pre-clinical studies also provide valuable evidence about harms that are difficult to observe in people, such as effects on developing embryos and drug interactions. For policy interventions and public health interventions, multiple studies might be needed to evaluate possible psychological harms, social harms, and effects on equity [70,71]. Separate reviews of benefits and harms could include different types of evidence that address different types of questions about intervention effects. ...
Guidance for systematic reviews of interventions recommends both benefits and harms be included. Systematic reviews may reach conclusions about harms (or lack of harms) that are not true when reviews include only some relevant studies, rely on incomplete data from eligible studies, use inappropriate methods for synthesizing data, and report results selectively. Separate reviews about harms could address some of these problems, and we argue that conducting separate reviews of harms is a feasible alternative to current standards and practices. Systematic reviews of potential benefits could be organized around the use of interventions for specific health problems. Systematic reviews of potential harms could be broader, including more diverse study designs and including all people at risk of harms (who might use the same intervention to treat different health problems). Multiple reviews about benefits could refer to a single review of harms. This approach could improve the reliability, completeness, and efficiency of systematic reviews.
... From an economic perspective, EBDM can reduce the wastage of scarce public resources [14], thus increasing government capacity to improve efficiency and the quality of services. On the other hand, non-evidence decision making results in public policies and programs that are introduced at a substandard scale resulting in well-intended programs that can have unintended outcomes [16]. This underscores a social and ethical need to consider evidence during policy design and implementation [14]. ...
The existence and availability of evidence on its own does not guarantee that the evidence will be demanded and used by decision and policy makers. Decision and policy-makers, especially in low-income settings, often confront ethical dilemmas about determining the best available evidence and its utilization. This dilemma can be in the form of conflict of evidence, scientific and ethical equipoise and competing evidence or interests. Consequently, decisions are made based on convenience, personal preference, donor requirements, and political and social considerations which can result in wastage of resources and inefficiency. To mitigate these challenges, the use of "Value- and Evidence-Based Decision Making and Practice" (VEDMAP) framework is proposed. This framework was developed by Joseph Mfutso-Bengo in 2017 through a desk review. It was pretested through a scoping study under the Thanzi la Onse (TLO) Project which assessed the feasibility and acceptability of using the VEDMAP as a priority setting tool for Health Technology Assessment (HTA) in Malawi. The study used mixed methods whereby it conducted a desk review to map out and benchmark normative values of different countries in Africa and HTA; focus group discussion and key informant interviews to map out the actual (practised) values in Malawi. The results of this review confirmed that the use of VEDMAP framework was feasible and acceptable and can bring efficiency, traceability, transparency and integrity in decision- policy making process and implementation.
... By doing this and not only determining whether a programme works, realist evaluation adds to securing and bettering the safety of a programme intentions ( Pawson and Tilley, 1997 ). Realist evaluation makes it possible to identify potential unintended outcomes caused by the programme by identifying its "dark-logic", i.e., conditions and processes leading to unintended harmful effects ( Bonell et al., 2015 ). Hence, realist evaluations provide decisionmakers with knowledge that can reduce potential harm caused by the programme. ...
Objective:
to explore how contextual conditions influence midwives' relational competencies, ability and confidence to undertake psychosocial assessment of pregnant women and their partners during the first antenatal consultation that identifies expectant parents in vulnerable positions.
Design:
a realist evaluation carried out through three phases: 1) development 2) testing and 3) refinement of programme theories. Data was generated through realist interviews and observations.
Setting:
nine community-based and hospital-based midwife clinics in the North Region of Denmark.
Intervention:
a dialogue-based psychosocial assessment programme in the the North Region of Denmark was evaluated.
Participants and data:
15 midwives were interviewed and 16 observations of midwives undertaking psychosocial assessment during the first antenatal consultation were conducted.
Findings:
contextual conditions at multiple levels which supported midwives' relational competencies, autonomy and the power of peer reflection-and thus facilitation of a woman-centred approach and trust-were identified, i.e., being experienced, having interest, organisational prioritisation of peer reflection and flexibility. Where midwives lacked experience, competency development regarding psychosocial assessment, opportunities for peer reflection and autonomy to individualise care for expectant parents in vulnerable positions, the approach to assessment tended to become institution-centred which caused a distant dialogue and instrumental assessment which potentially harmed the midwife-woman/couple relationship.
Conclusion:
midwives' ability and confidence to undertake psychosocial assessment were affected by whether individual and organisational contextual conditions empowered them to assess and care for expectant parents within a philosophy of woman-centred care. Accordingly, development of trustful midwife-woman/couple relationships - which is essential for disclosure - was achievable. These conditions become fundamental for securing quality of antenatal care for expectant parents in vulnerable positions.
... Speaking directly to this issue, Bonell et al. (2015) advocate, and correctly so, for increased attention to harmful consequences when developing program theories. The authors propose: ...
The motivation for this guide is to promote awareness and a better understanding of different types of program theories. Towards this aim, the guide describes and visually illustrates ten different types of program theories, ranging from more common logic models and theories of change to less common causal loop diagrams and hybrid models. The focus of the guide is intentionally on the visual models and strategies illustrated by these different types of program theories. Our modest hope is that the present guide will serve to inspire evaluators and other developers and users of program theories to pursue (or at least consider) a broader range of program theories in their future work.
... We can strengthen RCTs to deal better with complexity. We can try to gain a better understanding of the system interactions and anticipate how they may play out, perhaps through "dark logic" exercises that try to trace potential harms rather than just benefits 63 . For example, we might anticipate that sending parents text messages encouraging them to talk to their children about the school science curriculum may achieve this outcome at the expense of other school-supporting behaviours-as turned out to be the case 64 . ...
Recent years have seen a rapid increase in the use of behavioural science to address the priorities of public and private sector actors. There is now a vibrant ecosystem of practitioners, teams and academics building on each other's findings across the globe. Their focus on robust evaluation means we know that this work has had an impact on important issues such as antimicrobial resistance, educational attainment and climate change. However, several critiques have also emerged; taken together, they suggest that applied behavioural science needs to evolve further over its next decade. This manifesto for the future of applied behavioural science looks at the challenges facing the field and sets out ten proposals to address them. Meeting these challenges will mean that behavioural science is better equipped to help to build policies, products and services on stronger empirical foundations-and thereby address the world's crucial challenges.
... This is possible because, unlike technologies in clinical settings, patient-facing technologies (eg, patient portals, mHealth, and health-related websites) are more likely to be unregulated and unmoderated. Bonell et al [11] termed this the "dark logic" of interventions where digital health could result in unintended trauma-related consequences despite a generally virtuous intention. ...
BACKGROUND
Digital health is becoming increasingly common across the globe. At the same time, there is an increasing recognition of how digital health can inadvertently foment psychological trauma. This phenomenon has led to the adoption of trauma-informed care in designing and deploying digital health. However, how trauma-informed care is discussed, and the various trauma-informed care strategies employed in designing and/or deploying digital health technologies remain unexplored and ill-understood.
OBJECTIVE
The Objective of this scoping review is to explore and synthesize the literature on how trauma-informed care is defined in digital health and the various trauma-informed care principles employed in designing and deploying digital health
METHODS
This review will draw on the JBI updated methodological guidance for scoping reviews. A search will be conducted on CINAHL, MEDLINE (Ovid), Embase, Engineering Village, Web of Science, Scopus, and Psych INFO. This review will consider published research studies and unpublished work (grey literature). Studies will be included if they applied trauma-informed care in designing or deploying digital health for patients across all geographical locations. Or if they provide trauma-informed recommendations on how developers should develop digital health. Studies will be limited to only English language publications within the last 10 years. Two independent reviewers will screen the titles, abstracts, and then a full-text review. Data will be extracted into a data extraction tool developed for this study
RESULTS
The scoping review was undergoing a full search as of February 2023. The main results will synthesize the peer-reviewed and grey literature on adopting trauma-informed care practices in digital health research and development. The study is expected to be completed by 2023 and the results published in a peer-reviewed journal
CONCLUSIONS
The findings of this scoping review would be very useful for people with various traumatic disorders who adopt digital health interventions as complementary and/or alternative channels for accessing healthcare
... 8,9 There is also an established body of literature demonstrating harms from public health interventions. 4 As school-based mental health interventions similarly aim to change adolescents' thoughts, feelings or behaviours, it is reasonable that this too might have negative effects for some individuals. ...
In recent years, there have been extensive efforts in secondary schools to prevent, treat and raise awareness of adolescent mental health problems. For some adolescents, these efforts are essential and will lead to a reduction in clinical symptoms. However, it is also vital to assess whether, for others, the current approach might be causing iatrogenic harm. A growing body of quantitative research indicates that some aspects of school-based mental health interventions increase distress or clinical symptoms, relative to control activities, and qualitative work indicates that this may be partly due to the interventions themselves.
Background: School physical education is an important population-level health intervention for improving youth fitness. The purpose of this study is to determine the causal impact of New York City’s PE Works program on student cardiorespiratory fitness.
Methods: This longitudinal study (2014-2019) includes 581 elementary schools (n=315,999 4th/5th-grade students; 84% non-white; 74% who qualify for free or reduced-price meals). We apply the parametric g-formula to address schools’ time-varying exposure to intervention components and time-varying confounding.
Results: After four years of staggered PE Works implementation, 49.7% of students per school (95% CI: 42.6%, 54.2%) met age/sex-specific cardiorespiratory fitness standards. Had PE Works not been implemented, we estimate 45.7% (95% CI: 36.9%, 52.1%) would have met fitness standards. Had PE Works been fully implemented in all schools from the program’s inception, we estimate 57.4% (95% CI: 49.1%, 63.3%) would have met fitness standards. Adding a PE teacher, alone, had the largest impact (6.4% (95% CI: 1.0, 12.0) increase).
Conclusion: PE Works, which included providing PE teachers, training for classroom teachers, and administrative/teacher support for PE, positively impacted student cardiorespiratory health. Mandating and funding multilevel, multicomponent PE programs is an important public health intervention to increase children’s cardiorespiratory fitness.
Importance
The 1980 and 1986 Swedish so-called speed premium policies aimed at protecting parents’ income-based parental leave benefits for birth intervals shorter than 24 and 30 months, respectively, but indirectly encouraged shorter birth spacing and childbearing at older ages, both risk factors for several perinatal health outcomes. Whether those policy changes are associated with perinatal health remains unknown.
Objective
To evaluate the association between the 1980 and 1986 speed premium policies and perinatal health outcomes.
Design, Setting, and Participants
This cross-sectional study investigated data from 1 762 784 singleton births in the Swedish Medical Birth Register from January 1, 1974, through December 31, 1991. Data were analyzed from October 11, 2022, to December 12, 2023.
Interventions
Speed premium policy introduction (January 1, 1980) and extension (January 1, 1986).
Main Outcomes and Measures
Total population register data were used in an interrupted time series analysis with segmented logistic regression to calculate the odds of preterm birth, low birth weight, small for gestational age (SGA) at preterm, and stillbirth measured before and after the speed premium policy reforms. Subgroup analyses by maternal origin were conducted to evaluate changes by different policy responses.
Results
Among 1 762 784 births analyzed, 4.8% were preterm (of which 12.0% were SGA), 3.2% had low birth weight, and 0.3% were stillbirths. The 1980 speed premium policy was associated with a 0.3% monthly increase in the odds of preterm birth compared with the period before the reform (odds ratio [OR], 1.0029 [95% CI, 1.002-1.004]), equivalent to a 26.4% increase from January 1, 1980, to December 31, 1985. After the 1986 relaxation of the policy, preterm birth odds decreased 0.5% per month (OR, 0.9951 [95% CI, 0.994-0.996]), equivalent to an 11.1% decrease across the next 6 years. Low birth weight displayed a similar pattern for both reform periods, that is, increased 0.2% (OR, 1.0021; 95% CI, 1.001-1.003) per month in 1980 through 1985 compared with baseline, and decreased 0.3% (OR, 0.9975; 95% CI, 0.996-0.998) per month in the following period, but was attenuated when considering low birth weight at term. Odds of SGA at preterm were decreased after 1980 (OR, 0.9965; 95% CI, 0.994-0.999) but not in 1986 (OR, 1.0009; 95% CI, 0.998-1.003), whereas stillbirths did not change following either reform (1980: OR, 1.0020 [95% CI, 0.999-1.005]; 1986: OR, 1.0002 [95% CI, 0.997-1.003]). Subgroup analyses suggested that perinatal health changes were restricted to births to Swedish- and Nordic-born mothers, the primary groups to adjust their fertility behaviors to the reforms.
Conclusions and Relevance
Despite its economic advantages for couples, especially for mothers, the introduction of the speed premium policy was associated with adverse perinatal health consequences, particularly for preterm births. Family policies should be carefully designed with a “Health in All Policies” lens to avoid possible unintended repercussions for fertility behaviors and, in turn, perinatal health.
Background
Schools have a duty of care to prevent violence between students but a significant amount of dating and relationship violence and gender-based violence occurs in schools. These are important public health issues with important longitudinal consequences for young people.
Objectives
To understand functioning and effectiveness of school-based interventions for the prevention of dating and relationship violence and gender-based violence.
Review methods
We undertook a mixed-methods systematic review to synthesise different types of evidence relating to school-based interventions for the prevention of dating and relationship violence and gender-based violence to understand if, how and in what ways these interventions are effective.
We searched 21 databases and 2 trial registers and undertook forwards and backwards citation chasing, author contact and other supplementary search methods. Searches identified all literature published to June 2021. All screening was undertaken in duplicate and independently, and we quality appraised all included studies.
Results
We included 247 reports (68 outcome evaluations, 137 process evaluations). Synthesis of intervention components produced an intervention typology: single-component, curricular, multicomponent, and multilevel programmes. Synthesis of intervention theories suggested that interventions aiming to increase students’ sense of school belonging and sense of safety in the school building could encourage increased learning of prosocial skills and increased prosocial peer norms, and so potentially reducing dating and relationship violence and gender-based violence. Synthesis of factors affecting delivery highlighted school organisation and leaders who believed in the importance of addressing dating and relationship violence/gender-based violence, along with time and resources to deliver the interventions. The ease with which the intervention could be delivered and modified was also important.
Meta-analysis found stronger evidence for intervention effectiveness in reducing dating and relationship violence than for gender-based violence, with significant long-term impacts on dating and relationship violence victimisation and perpetration, and some evidence that interventions in high-income countries could be effective for reducing victimisation and perpetration of gender-based violence in the long-term. Impacts on knowledge and attitudes were primarily short-term. Network meta-analysis did not suggest superiority of any intervention type. Moderation evidence suggested interventions reduced dating and relationship violence perpetration in boys more than girls, but reduced gender-based violence perpetration more in girls. Metaregression by intervention component did not explain heterogeneity in effectiveness, but qualitative comparative analysis suggested that reducing perpetration was important to reducing victimisation, and that perpetration could be reduced via focus on interpersonal skills, guided practice and (for gender-based violence) implementation of social structural components.
Limitations
Despite an exhaustive search, trials may have been missed and risk of publication bias was high for several analyses.
Conclusions
This is the most comprehensive systematic review of school-based interventions for dating and relationship violence and gender-based violence to date. It is clear that the prevention of dating and relationship violence and gender-based violence in schools will require longer-term investment to show benefit.
Future work
Future research is needed to understand why intervention effectiveness appears stronger for dating and relationship violence than gender-based violence.
Study registration
The study is registered as PROSPERO CRD42020190463.
Funding
This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: NIHR130144) and is published in full in Public Health Research ; Vol. 12, No. 3. See the NIHR Funding and Awards website for further award information.
Backround
The evidence base for interventions for child mental health and neurodevelopment is weak and the current capacity for rigorous evaluation limited. We describe some of the challenges that make this field particularly difficult and expensive for evaluation studies.
Methods
We describe and review the use of novel study designs and analysis methodology for their potential to improve this situation.
Results
While several novel designs appeared ill‐suited to our field, systematic review found others that offered potential but had yet to be widely adopted, some not at all.
Conclusions
While funding is inevitably a constraint, we argue that improvements in the evidence base of both current and new treatments will only be achieved by the adoption of a number of these new technologies and study designs, the consistent application of rigorous constructive but demanding standards, and the engagement of the public, patients, clinical and research services to build a design, recruitment, and analysis infrastructure.
Background
A public mental health lens is increasingly required to better understand the complex and multifactorial influences of interpersonal, community and institutional systems on the mental health of children and adolescents.
Methods
This research review (1) provides an overview of public mental health and proposes a new interactional schema that can guide research and practice, (2) summarises recent evidence on public mental health interventions for children and adolescents, (3) highlights current challenges for this population that might benefit from additional attention and (4) discusses methodological and conceptual hurdles and proposes potential solutions.
Results
In our evidence review, a broad range of universal, selective and indicated interventions with a variety of targets, mechanisms and settings were identified, some of which (most notably parenting programmes and various school‐based interventions) have demonstrated small‐to‐modest positive effects. Few, however, have achieved sustained mental health improvements.
Conclusions
There is an opportunity to re‐think how public mental health interventions are designed, evaluated and implemented. Deliberate design, encompassing careful consideration of the aims and population‐level impacts of interventions, complemented by measurement that embraces complexity through more in‐depth characterisation, or ‘phenotyping’, of interpersonal and environmental elements is needed. Opportunities to improve child and adolescent mental health outcomes are gaining unprecedented momentum. Innovative new methodology, heightened public awareness, institutional interest and supportive funding can enable enhanced study of public mental health that does not shy away from complexity.
Motivation is crucial for older adults' adherence to physical therapy. Recent advancements in virtual reality (VR) technology has expanded its applications in clinical practice, showing potential for enjoyable and engaging experiences that can support well-being and cultivate motivation.
The introduction of VR in clinical practice does not happen in isolation, devoid of human actors, or without contextual circumstances. The intersection between the academic project’s procedures and operations, opposite the end-users and the organisation’s culture, significantly influences the implementation process.
This thesis presents an interdisciplinary collaboration with two rehabilitation facilities in Frederiksberg Municipality, Denmark, to explore the motivational capabilities of VR combined with cycle ergometers for older adults. It is an account of the efforts to research and design novel user applications with the users for the users to facilitate the technology and disseminate knowledge of clinical VR to healthcare workers, implement and improve existing solutions, and evaluate technology and user acceptance.
Basic principles in designing studies to assess the effects of interventions
Background: Faecal incontinence is an under-reported but debilitating health problem that affects people of all ages, and particularly older people aged 65 years and above living in care homes, many of whom have comorbidity such as dementia. Prevalence of faecal incontinence is high in the group, but the exact prevalence is unclear. Faecal incontinence can have significant negative impact, including low self-esteem, feeling stigmatised (and leading to social isolation), and sometimes death. In older people, faecal incontinence is not only the consequence of age-related anorectal deficits such as reduced anal sphincter pressure, but also cognitive decline, care home placement, diarrhoea, constipation and/or effects of polypharmacy. However, faecal incontinence remains a taboo subject because people with the condition are too embarrassed to discuss their symptoms with their family or health care workers. Health care workers, on the other hand, do not routinely broach the topic with patients perhaps because of therapeutic nihilistic attitudes (the belief that nothing can be done to help). In a care home, where most residents live with dementia, this nihilism can mean that residents are not assessed to find out why they are incontinent, thus resulting in the routine use of incontinence pads by care staff. Within the care homes, intimate care such as continence care, bathing and dressing of residents is mostly carried out by care assistants (and occasionally by registered nurses). The care home managers often avoid these messier dirty works because care work for the older people involve bodily dysfunctions and discharges such as blood, vomit, urine, faeces, illness, and death. Therefore, the emotional labour of the care homes’ care workers is an important skill that has therapeutic value to both the care staff and the residents experiencing faecal incontinence. The development of a theory-driven, context-dependent intervention to manage FI is needed for this population.
Methods: The overall aim of this thesis was to develop a context-dependent, complex intervention for the management of faecal incontinence in people living with dementia in care homes and test it for feasibility and potential efficacy. Underpinned by realist programme theories situated within the UK Medical Research Council framework for development and feasibility phases of intervention development, three steps of the framework were iteratively followed. A systematic review (PhD Paper 1) identified the burden and correlates of faecal incontinence among older people living in care homes, and potential modifiable risks factors. A Cochrane systematic review of interventions for faecal incontinence in care homes (PhD Paper 2) did not find any intervention that accounted for the care home residents’ characteristics or dementia. Therefore, some previously published realist programme theories were tested with care home stakeholders using realist evaluation approaches to develop an intervention for faecal incontinence that is context dependent. The intervention developed included toileting exercises (scheduled and prompted toileting), physical exercises (mobility and upper arms movement), conservative management (dietary and fluid intake, and review of polypharmacy) and staff education. Lastly, a pre/post feasibility study (nested in multiple case studies) was carried out in 16 care home residents from two care home units, all of whom had faecal incontinence at baseline and had dementia.
Results: Paper 1 included 23 studies and found the medians for reported prevalence of isolated faecal incontinence, double incontinence, and all types of faecal incontinence in care home residents as 3.5% [interquartile range (IQR) = 2.8%], 47.1% (IQR = 32.1%), and 42.8% (IQR = 21.1%), respectively. The Cochrane review (PhD Paper 2) included only four randomised controlled trials and found no clear evidence on what interventions work for this group. Stakeholder consultation was used to refine previous programme theories and then to develop an intervention. During feasibility testing of this intervention, the study was undermined by poor engagement by the care home staff. It was unclear what intervention had been carried out in one of the two units due to very poor documentation by the care staff. There was no overall significant difference in frequency of faecal incontinence episodes among the care home residents between baseline (four weeks prior to the intervention) and the last four weeks at the end of the 8-week intervention (mean and standard deviation (SD) of faecal incontinence episodes over the four weeks: 50.63 and 52. 94 (p=0.77). When the two care home units are compared, there were also no significant changes in the mean (SD) number of faecal incontinence episodes among the residents of Unit-1 and Unit-2 at baseline [52.50 (± 19.54) and 48.75 (± 20.31)], and four weeks to the end of the intervention [53.13 (± 23.33) and 52.75 (± 24.52)] respectively.
Conclusion: Although there were some changes in stool consistency among individual residents, the changes did not result in an overall reduction of faecal incontinence episodes in the participating care home units. In practice, unless regulatory bodies such as the Care Quality Commission include measures to reduce faecal incontinence (and as a safeguarding issue such as falls and pressure areas), or the care staff believe that incontinence among older people living with dementia in care homes can be ameliorated by intervention, the management of faecal incontinence is likely to remain as reactive measures by the care staff. Research in this context needs to be influenced by the care home managers who run the day-to-day activities of the care home, or risk implementation failure.
Aim:
To evaluate the effectiveness of a breastfeeding support programme on reducing infant formula use and to investigate indications for formula in newborn infants in Sweden.
Methods:
A quasi-experimental study design was carried out. It included 255 mother-infant pairs in a control group, who received standard care and 254 pairs in an intervention group, who took part in a breastfeeding support programme. Data were collected by reviewing patient records from two regional hospitals in Uppsala and Gotland and recruitment took place between 2017 and 2019.
Results:
Median age of mothers were 31 years (range 20-49) and median gestational age of infants were 39+6 weeks/days (range 37+0-42+4). The intervention did not reduce infant formula use. In total, 87/507 (17%) of the infants received formula. Among children receiving formula 30/87 (34%) had a medical indication, whereas 57/87 (66%) had no medical indication. Main reasons for medically indicated formula use were hypoglycaemia, 13/30 (43%), and weight loss, 13/30 (43%). Main reasons for non-medical use were mothers'/parents' wishes, 25/57 (44%) and infants' dissatisfaction, 11/57 (19%).
Conclusion:
Continued efforts are needed to develop effective breastfeeding interventions with increased focus on infant formula reduction.
Der Begriff Care Leaver:in adressiert und kollektiviert junge Menschen, die zumindest zeitweise und auf der Grundlage eines Hilfeplanverfahrens, außerhalb der Herkunftsfamilie in stationären Wohnformen (u.a. Wohngruppen, Wohngemeinschaften, betreutes Wohnen) oder in der Vollzeitpflege (u.a. Fremdpflege, Pflegefamilien, Verwandtschaftspflege, Netzwerkpflege) aufgewachsen sind und von dort den Weg ins Erwachsenenleben beginnen. Für die Gruppe der in der Regel soziokulturell, bildungsbezogen und politökonomisch benachteiligten Heranwachsenden hat sich nicht nur im Fachdiskurs, sondern ebenso vonseiten der Selbstvertretungsvereine die Bezeichnung Care Leaver:in durchgesetzt (u.a. Careleaver e.V. Deutschland, Care Leaver Verein Österreich, International Care Leavers network). Neben der Erfahrung im Kinder- und Jugendhilfekontext hat in den letzten Jahrzehnten insbesondere der strukturelle und lebensweltliche Übergang von der Jugendhilfe ins eigenverantwortliche Erwachsenenleben an sozialpädagogischer Aufmerksamkeit, sozialwissenschaftlicher Forschungstätigkeit und vermehrter Projektaktivität gewonnen, um die überwiegend riskanten und deprivierenden Übergangsbedingungen in einen sozial- und bildungswissenschaftlichen sowie jugendpolitischen Diskurs zu bringen. Im deutschsprachigen Raum gibt es wenig empirisches Grundlagenwissen darüber, wie sich Lebenslagen, Lebensverläufe und Lebenskonzepte Heranwachsender mit Erfahrung im Kinder- und Jugendhilfekontext während der heterogenen Leaving Care Prozesse gestalten. Vornehmlich die (Aus-) Bildungs- und Berufswege, die soziokulturellen Lebenslagen sowie die soziostrukturellen und personalen Teilhabemöglichkeiten und -barrieren sind nur partiell erforscht und unzureichend beachtet.
Inwieweit Kinder- und Jugendhilfekontexte das Wohlbefinden und den Bildungs- und Berufserfolg während der Leaving Care Prozesse und im Zuge des sich entwickelnden Erwachsenenalters beeinflussen, wurde daher mithilfe eines offenen, qualitativen und rekonstruktiven Ansatzes empirisch und explorativ untersucht Im Fokus stehen die Teilhabedimensionen Bildung und Gesundheit, da sich die Wechselwirkung dieser Dimensionen im partizipativen Forschungsprozess als primäre und sekundäre Zweckmäßigkeit zur kohärenten Lebensgestaltung im jungen Erwachsenenalter dokumentiert haben. Auf Grundlage der partizipativen Forschungspraxis wurde der Frage nachgegangen, weshalb die jungen Menschen die Erfahrungen in den Kinder- und Jugendhilfekontexten als Belastung in ihrer gegenwärtigen Lebenslage wahrnehmen. Damit wird die Kinder- und Jugendhilfeerfahrung im gesellschaftlichen Kontext verortet und es erfolgt eine soziogenetische Annäherung an das diskursiv hergestellte kollektive Heimtrauma.
Mit dem Begriff des kollektiven Heimtrauma können im Kinder- und Jugendhilfekontext sequentielle Traumaprozesse in den Blick genommen und erforscht werden, die als öko-bio-psycho-soziale Antwort auf selbstbezogene, interpersonale und kollektive Gewalt- und Entfremdungserfahrungen Schmerz herstellen und Heranwachsende nachhaltig verwunden. Die Traumafolgen sind dann wiederum die Lösung zum Überleben und bilden Strukturen und Verhaltensstrategien aus, die nicht nur konstruktiv und lösungsorientiert sind. Insgesamt hat der partizipative Forschungsprozess mit der Fokus- und/oder Referenzgruppe zur kollektiven Katharsis beigetragen, kann allerdings nicht den Anspruch erheben, die beschädigten Beziehungen und Familienkonstellationen, die biografischen Kränkungen und krisenhaften Übergänge, die körperlichen Symptomatik, die gesellschaftlichen Verletzungen sowie die existenziellen Verunsicherungen und Verletzungen der axiologischen Dimension zu schützen, befreien, ermächtigen, heilen oder ganz zu machen. Wenn das kollektive Heimtrauma das Problem ist, dann sind partizipative Forschungsprozesse zwar nicht die Lösung, aber eine Möglichkeit um Räume zu öffnen, in denen Anbindung und Realisation angeregt werden kann. Im Sinne einer demokratischen und menschenrechtsorientierten Staatsordnung und Verwaltung sind die Stimmen der jungen Erwachsenen zudem unerlässlich, wenn es um die Erarbeitung von Gerechtigkeit geht.
Keywords: Rekonstruktive Sozial- und Bildungsforschung, Partizipative Forschung, Netzwerkforschung, Leaving Care, Traumaprozesse und -folgen, Wohlbefinden
Background
Health systems have a critical role in a multi-sectoral response to domestic violence against women (DVAW). However, the evidence on interventions is skewed towards high income countries, and evidence based interventions are not easily transferred to low-and middle-income countries (LMIC) where significant social, cultural and economic differences exist. We evaluated feasibility and acceptability of implementation of an intervention (HERA - Healthcare Responding to Violence and Abuse) to improve the response to DVAW in two primary health care clinics (PHC) in Brazil.
Methods
The study design is a mixed method process and outcome evaluation, based on training attendance records, semi-structured interviews (with 13 PHC providers, two clinic directors and two women who disclosed domestic violence), and identification and referral data from the Brazilian Epidemiological Surveillance System (SINAN).
Results
HERA was feasible and acceptable to women and PHC providers, increased providers’ readiness to identify DVAW and diversified referrals outside the health system. The training enhanced the confidence and skills of PHC providers to ask directly about violence and respond to women’s disclosures using a women centred, gender and human rights perspective. PHC providers felt safe and supported when dealing with DVAW because HERA emphasised clear roles and collective action within the clinical team. A number of challenges affected implementation including: differential managerial support for the Núcleo de Prevenção da Violência (Violence Prevention Nucleus - NPV) relating to the allocation of resources, monitoring progress and giving feedback; a lack of higher level institutional endorsement prioritising DVAW work; staff turnover; a lack of feedback from external support services to PHC clinics regarding DVAW cases; and inconsistent practices regarding documentation of DVAW.
Conclusion
Training should be accompanied by system-wide institutional change including active (as opposed to passive) management support, allocation of resources to support roles within the NPV, locally adapted protocols and guidelines, monitoring progress and feedback. Communication and coordination with external support services and documentation systems are crucial and need improvement. DVAW should be prioritised within leadership and governance structures, for example, by including DVAW work as a specific commissioning goal.
Evidence to support government programs to improve public health often is weak. Recognition of this "knowledge gap" has led to calls for more and better evaluation, but decisions about priorities for evaluation also need to be addressed in regard to financial restraint.
Using England's Healthy Community Challenge Fund as a case study, this article presents a set of questions to stimulate and structure debate among researchers, funders, and policymakers and help make decisions about evaluation within and between complex public health interventions as they evolve from initial concept to dissemination of full-scale intervention packages.
This approach can be used to identify the types of knowledge that might be generated from any evaluation, given the strength of evidence available in response to each of five questions, and to support a more systematic consideration of resource allocation decisions, depending on the types of knowledge required.
The principles of this approach may be generalizable, and should be tested and refined for other complex public health and wider social interventions.
Administrative reform has led to a strong increase in the use of performance assessment instruments in the public sector. However, this has also led to several unintended consequences, such as the performance paradox, tunnel vision, and “analysis paralysis.” These unintended consequences can reduce the quality of the knowledge about actual levels of performance or even negatively affect performance. Examples can be found in all policy sectors. The authors argue that certain characteristics of the public sector–such as ambiguous policy objectives, discretionary authority of street–level bureaucrats, simultaneous production and consumption of services, and the disjunction of costs and revenues–increase the risk of a performance paradox, either unintentionally or deliberately. Performance assessment should therefore take the special characteristics of the public sector into account and develop systems that can handle contested and multiple performance indicators, striking a balance in the degree of “measure pressure” and minimizing dysfunctional effects.
Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance
To evaluate the effectiveness of youth development in reducing teenage pregnancy, substance use, and other outcomes.
Prospective matched comparison study.
54 youth service sites in England.
Young people (n=2724) aged 13-15 years at baseline deemed by professionals as at risk of teenage pregnancy, substance misuse, or school exclusion or to be vulnerable.
Intensive, multicomponent youth development programme including sex and drugs education (Young People's Development Programme) versus standard youth provision.
Various, including pregnancy, weekly cannabis use, and monthly drunkenness at 18 months.
Young women in the intervention group more commonly reported pregnancy than did those in the comparison group (16% v 6%; adjusted odds ratio 3.55, 95% confidence interval 1.32 to 9.50). Young women in the intervention group also more commonly reported early heterosexual experience (58% v 33%; adjusted odds ratio 2.53, 1.09 to 5.92) and expectation of teenage parenthood (34% v 24%; 1.61, 1.07 to 2.43).
No evidence was found that the intervention was effective in delaying heterosexual experience or reducing pregnancies, drunkenness, or cannabis use. Some results suggested an adverse effect. Although methodological limitations may at least partly explain these findings, any further implementation of such interventions in the UK should be only within randomised trials.
Conventional thinking about preventive interventions focuses over simplistically on the "package" of activities and/or their educational messages. An alternative is to focus on the dynamic properties of the context into which the intervention is introduced. Schools, communities and worksites can be thought of as complex ecological systems. They can be theorised on three dimensions: (1) their constituent activity settings (e.g., clubs, festivals, assemblies, classrooms); (2) the social networks that connect the people and the settings; and (3) time. An intervention may then be seen as a critical event in the history of a system, leading to the evolution of new structures of interaction and new shared meanings. Interventions impact on evolving networks of person-time-place interaction, changing relationships, displacing existing activities and redistributing and transforming resources. This alternative view has significant implications for how interventions should be evaluated and how they could be made more effective. We explore this idea, drawing on social network analysis and complex systems theory.
This article explored developmental and intervention evidence relevant to iatrogenic effects in peer-group interventions. Longitudinal research revealed that "deviancy training" within adolescent friendships predicts increases in delinquency, substance use, violence, and adult maladjustment. Moreover, findings from 2 experimentally controlled intervention studies suggested that peer-group interventions increase adolescent problem behavior and negative life outcomes in adulthood, compared with control youth. The data from both experimental studies suggested that high-risk youth are particularly vulnerable to peer aggregations, compared with low-risk youth. We proposed that peer aggregation during early adolescence, under some circumstances, inadvertently reinforces problem behavior. Two developmental processes are discussed that might account for the powerful iatrogenic effects.
To determine the effectiveness of a brief cognitive behavioural intervention in reducing the incidence of sexually transmitted infections among gay men.
Randomised controlled trial with 12 months' follow up.
Sexual health clinic in London.
343 gay men with an acute sexually transmitted infection or who reported having had unprotected anal intercourse in the past year.
Number of new sexually transmitted infections diagnosed during follow up and self reported incidence of unprotected anal intercourse.
72% (361/499) of men invited to enter the study did so. 90% (308/343) of participants returned at least one follow up questionnaire or re-attended the clinic and requested a check up for sexually transmitted infections during follow up. At baseline, 37% (63/172) of the intervention group and 30% (50/166) of the control group reported having had unprotected anal intercourse in the past month. At 12 months, the proportions were 27% (31/114) and 32% ( 39/124) respectively (P=0.56). However, 31% (38/123) of the intervention group and 21% (35/168) of controls had had at least one new infection diagnosed at the clinic (adjusted odds ratio 1.66, 95% confidence interval 1.00 to 2.74). Considering only men who requested a check up for sexually transmitted infections, the proportion diagnosed with a new infection was 58% (53/91) for men in the intervention group and 43% (35/81) for men in the control group (adjusted odds ratio 1.84, 0.99 to 3.40). Using a regional database that includes information from 23 sexual health clinics in London, we determined that few participants had attended other sexual health clinics.
This behavioural intervention was acceptable and feasible to deliver, but it did not reduce the risk of acquiring a new sexually transmitted infection among these gay men at high risk. Even carefully designed interventions should not be assumed to bring benefit. It is important to evaluate their effects in randomised trials with objective clinical end points.
To assess the effects of interventions to promote walking in individuals and populations.
Systematic review.
Published and unpublished reports in any language identified by searching 25 electronic databases, by searching websites, reference lists, and existing systematic reviews, and by contacting experts.
Systematic search for and appraisal of controlled before and after studies of the effects of any type of intervention on how much people walk, the distribution of effects on walking between social groups, and any associated effects on overall physical activity, fitness, risk factors for disease, health, and wellbeing.
We included 19 randomised controlled trials and 29 non-randomised controlled studies. Interventions tailored to people's needs, targeted at the most sedentary or at those most motivated to change, and delivered either at the level of the individual (brief advice, supported use of pedometers, telecommunications) or household (individualised marketing) or through groups, can encourage people to walk more, although the sustainability, generalisability, and clinical benefits of many of these approaches are uncertain. Evidence for the effectiveness of interventions applied to workplaces, schools, communities, or areas typically depends on isolated studies or subgroup analysis.
The most successful interventions could increase walking among targeted participants by up to 30-60 minutes a week on average, at least in the short term. From a perspective of improving population health, much of the research currently provides evidence of efficacy rather than effectiveness. Nevertheless, interventions to promote walking could contribute substantially towards increasing the activity levels of the most sedentary.
Administrative reform has led to a strong increase in the use of performance assessment instruments in the public sector. However, this has also led to several unintended consequences, such as the performance paradox, tunnel vision, and “analysis paralysis.” These unintended consequences can reduce the quality of the knowledge about actual levels of performance or even negatively affect performance. Examples can be found in all policy sectors. The authors argue that certain characteristics of the public sector–such as ambiguous policy objectives, discretionary authority of street–level bureaucrats, simultaneous production and consumption of services, and the disjunction of costs and revenues–increase the risk of a performance paradox, either unintentionally or deliberately. Performance assessment should therefore take the special characteristics of the public sector into account and develop systems that can handle contested and multiple performance indicators, striking a balance in the degree of “measure ...
‘If in this book harsh words are spoken about some of the greatest among the intellectual leaders of mankind, my motive is not, I hope, to belittle them. it springs rather from my conviction that, if our civilization is to survive, we must break with the habit of deference to great men.’
Public health interventions may have a range of adverse effects. However, there is limited guidance as to how evaluations should address the possibility of adverse effects. This discussion paper briefly presents a framework for thinking about the potential harms of public health interventions, focusing on the following categories: direct harms; psychological harms; equity harms; group and social harms; and opportunity harms. We conclude that the possibility of adverse effects needs to be taken into account by those implementing and evaluating interventions, and requires a broad perspective on the potential impacts of public health strategies.
Background:
Some effective public health interventions may increase inequalities by disproportionately benefiting less disadvantaged groups ('intervention-generated inequalities' or IGIs). There is a need to understand which types of interventions are likely to produce IGIs, and which can reduce inequalities.
Methods:
We conducted a rapid overview of systematic reviews to identify evidence on IGIs by socioeconomic status. We included any review of non-healthcare interventions in high-income countries presenting data on differential intervention effects on any health status or health behaviour outcome. Results were synthesised narratively.
Results:
The following intervention types show some evidence of increasing inequalities (IGIs) between socioeconomic status groups: media campaigns; and workplace smoking bans. However, for many intervention types, data on potential IGIs are lacking. By contrast, the following show some evidence of reducing health inequalities: structural workplace interventions; provision of resources; and fiscal interventions, such as tobacco pricing.
Conclusion:
Our findings are consistent with the idea that 'downstream' preventive interventions are more likely to increase health inequalities than 'upstream' interventions. More consistent reporting of differential intervention effectiveness is required to help build the evidence base on IGIs.
Background:
The effectiveness of social skills training/social network restructuring in the primary and secondary prevention of drug use was examined in a multiethnic cohort of 296 female adolescents ages 14 to 19 years who were pregnant or parenting and/or at risk for drug use.
Methods:
Subjects were randomly assigned to one of two conditions: (a) PALS Skills Training or (b) a control intervention involving no skills training. PALS Skills Training is a combination of cognitive and behavioral techniques to improve social skills and to restructure the teens' social network. All students also participated in a 16-week normative education "Facts of Life" course.
Results:
The prevalence of alcohol and any drug use increased significantly over the three assessment periods in the PALS Skills group but not in the No Skills group. Teens in the PALS Skills group who reported no drug use at baseline were 2.9 times as likely to be using marijuana than teens in the No Skills group at 3 months postintervention. PALS Skills Training was no more effective in the secondary prevention of drug use than the control intervention.
Conclusions:
Social skills training was found to be ineffective as a means of primary prevention among non-drug-using high-risk adolescents and may even be counterproductive as a means of primary prevention of marijuana use in this population. When combined with normative information on drug use prevalence, acceptability, and hazards, social skills training is no more effective as a means of secondary prevention than normative education alone.
A paradoxical drug reaction constitutes an outcome that is opposite from the outcome that would be expected from the drug’s known actions. There are three types:
1
A paradoxical response in a condition for which the drug is being explicitly prescribed.
2
Paradoxical precipitation of a condition for which the drug is indicated, when the drug is being used for an alternative indication.
3
Effects that are paradoxical in relation to an aspect of the pharmacology of the drug but unrelated to the usual indication.
In bidirectional drug reactions, a drug may produce opposite effects, either in the same or different individuals, the effects usually being different from the expected beneficial effect. Paradoxical and bidirectional drug effects can sometimes be harnessed for benefit; some may be adverse.
Such reactions arise in a wide variety of drug classes. Some are common; others are reported in single case reports. Paradoxical effects are often adverse, since they are opposite the direction of the expected effect. They may complicate the assessment of adverse drug reactions, pharmacovigilance, and clinical management. Bidirectional effects may be clinically useful or adverse. From a clinical toxicological perspective, altered pharmacokinetics or pharmacodynamics in overdose may exacerbate paradoxical and bidirectional effects. Certain antidotes have paradoxical attributes, complicating management.
Apparent clinical paradoxical or bidirectional effects and reactions ensue when conflicts arise at different levels in self-regulating biological systems, as complexity increases from subcellular components, such as receptors, to cells, tissues, organs, and the whole individual. These may be incompletely understood. Mechanisms of such effects include different actions at the same receptor, owing to changes with time and downstream effects; stereochemical effects; multiple receptor targets with or without associated temporal effects; antibody-mediated reactions; three-dimensional architectural constraints; pharmacokinetic competing compartment effects; disruption and non-linear effects in oscillating systems, systemic overcompensation, and other higherlevel feedback mechanisms and feedback response loops at multiple levels. Here we review and provide a compendium of multiple class effects and individual reactions, relevant mechanisms, and specific clinical toxicological considerations of antibiotics, immune modulators, antineoplastic drugs, and cardiovascular, CNS, dermal, endocrine, musculoskeletal, gastrointestinal, haematological, respiratory, and psychotropic agents.
Universal screening for mental health problems and suicide risk is at the forefront of the national agenda for youth suicide prevention, yet no study has directly addressed the potential harm of suicide screening.
To examine whether asking about suicidal ideation or behavior during a screening program creates distress or increases suicidal ideation among high school students generally or among high-risk students reporting depressive symptoms, substance use problems, or suicide attempts.
A randomized controlled study conducted within the context of a 2-day screening strategy. Participants were 2342 students in 6 high schools in New York State in 2002-2004. Classes were randomized to an experimental group (n = 1172), which received the first survey with suicide questions, or to a control group (n = 1170), which did not receive suicide questions.
Distress measured at the end of the first survey and at the beginning of the second survey 2 days after the first measured on the Profile of Mood States adolescent version (POMS-A) instrument. Suicidal ideation assessed in the second survey.
Experimental and control groups did not differ on distress levels immediately after the first survey (mean [SD] POMS-A score, 5.5 [9.7] in the experimental group and 5.1 [10.0] in the control group; P = .66) or 2 days later (mean [SD] POMS-A score, 4.3 [9.0] in the experimental group and 3.9 [9.4] in the control group; P = .41), nor did rates of depressive feelings differ (13.3% and 11.0%, respectively; P = .19). Students exposed to suicide questions were no more likely to report suicidal ideation after the survey than unexposed students (4.7% and 3.9%, respectively; P = .49). High-risk students (defined as those with depression symptoms, substance use problems, or any previous suicide attempt) in the experimental group were neither more suicidal nor distressed than high-risk youth in the control group; on the contrary, depressed students and previous suicide attempters in the experimental group appeared less distressed (P = .01) and suicidal (P = .02), respectively, than high-risk control students.
No evidence of iatrogenic effects of suicide screening emerged. Screening in high schools is a safe component of youth suicide prevention efforts.
An evidence synthesis of a medical intervention should assess the balance of benefits and harms. Investigators performing systematic reviews of harms face challenges in finding data, rating the quality of harms reporting, and synthesizing and displaying data from different sources. Systematic reviews of harms often rely primarily on published clinical trials. Identifying important harms of treatment and quantifying the risk associated with them, however, often require a broader range of data sources, including unpublished trials, observational studies, and unpublished information on published trials submitted to the U.S. Food and Drug Administration. Each source of data has some potential for yielding important information. Criteria for judging the quality of harms assessment and reporting are still in their early stages of development. Investigators conducting systematic reviews of harms should consider empirically validating the criteria they use to judge the validity of studies reporting harms. Synthesizing harms data from different sources requires careful consideration of internal validity, applicability, and sources of heterogeneity. This article highlights examples of approaches to methodologic issues associated with performing systematic reviews of harms from 96 Evidence-based Practice Center evidence reports.
A substantial number of women who enter substance abuse treatment have a history of trauma and meet criteria for posttraumatic stress disorder (PTSD). Fear regarding the extent to which PTSD treatment can evoke negative consequences remains a research question. This study explored adverse events related to the implementation of an integrated treatment for women with trauma and substance use disorder (Seeking Safety) compared with a nontrauma-focused intervention (Women's Health Education). Three hundred fifty-three women enrolled in community substance abuse treatment were randomized to 1 of the 2 study groups and monitored weekly for adverse events. There were no differences between the two intervention groups in the number of women reporting study-related adverse events (28 [9.6%] for the Seeking Safety group and 21[7.2%] for the Women's Health Education group). Implementing PTSD treatment in substance abuse treatment programs appears to be safe, with minimal impact on intervention-related adverse psychiatric and substance abuse symptoms. More research is needed on the efficacy of such interventions to improve outcomes of PTSD and substance use.
Despite the recent declines in rates of teenage pregnancy, relatively little is known about the few programs that have been successful in reducing adolescent pregnancy.
Six agencies in New York City each randomly assigned 100 disadvantaged 13-15-year-olds to their usual youth program or to the intervention being tested--the Children's Aid Society-Carrera program, a year-round afterschool program with a comprehensive youth development orientation. Both program and control youth were followed for three years. Multivariate regression analyses assessed the effects of program participation on the odds of current sexual activity, use of a condom along with a hormonal contraceptive, pregnancy and access to good health care.
Seventy-nine percent of participants remained in the program for three full years. Female program participants had significantly lower odds than controls of being sexually active (odds ratio, 0.5) and of having experienced a pregnancy (0.3). They had significantly elevated odds of having used a condom and a hormonal method at last coitus (2.4). However, participation in the program created no significant impact on males' sexual and reproductive behavior outcomes. Nonetheless, program participants of both genders had elevated odds of having received good primary health care (2.0-2.1).
This program is one of only four whose evaluation has successfully documented declines in teenage pregnancy using a random-assignment design. Better outcomes among males may be achieved if programs reach them even earlier than their teenage years.
Physician and patient
- W Hooker
Hooker W. Physician and patient. New York: Baker and Scribner, 1847.
Meta-ethnography: synthesizing qualittive studies
- G Noblit
- R Hare
Noblit G, Hare R. Meta-ethnography: synthesizing qualittive studies. London: Sage
Publications ltd, 1988.
When interventions harm
- TJ Dishion
- J McCord
- F Poulin