Development of a program theory for osteoporosis patient education in Denmark: a qualitative study based on realist evaluation.

BACKGROUND: Osteoporosis patient education is offered in many countries worldwide. When evaluating complex interventions like these, it is important to understand how and why the intervention leads to effects. This study aimed to develop a program theory of osteoporosis patient education in Danish municipalities with a focus on examining the mechanisms of change i.e. what is about the programs that generate change. METHODS: The program theory was developed in an iterative process. The initial draft was based on a previous published systematic review, and subsequently the draft was continually refined based on findings from observations (10 h during osteoporosis patient education) and interviews (individual interviews with six employees in municipalities and three health professionals at hospitals, as well as four focus group interviews with participants in patient education (in total 27 informants)). The transcribed interviews were analyzed using thematic analysis and with inspiration from realist evaluation the mechanisms as well as the contextual factors and outcomes were examined. RESULTS: Based on this qualitative study we developed a program theory of osteoporosis patient education and identified four mechanisms: motivation, recognizability, reassurance, and peer reflection. For each mechanism we examined how contextual factors activated the mechanism as well as which outcomes were achieved. For instance, the participants' motivation is activated when they meet in groups, and thereafter outcomes such as more physical activity may be achieved. Recognizability is activated by the participants' course of disease, which may lead to better ergonomic habits. Reassurance may result in more physical activity, and this mechanism is activated in newly diagnosed participants without previous fractures. Peer reflection is activated when the participants meet in groups, and the outcome healthier diet may be achieved. CONCLUSIONS: We developed a program theory and examined how and why osteoporosis patient education is likely to be effective. Understanding these prerequisites is important for future implementation and evaluation of osteoporosis patient education.

Exploring targeted preventive health check interventions - a realist synthesis.

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.

Development of an intervention for the social reintegration of adolescents and young adults affected by cancer.

BACKGROUND: In Denmark, around 500 adolescents and young adults (AYAs) aged 15-29 are diagnosed with cancer each year. AYAs affected by cancer constitute a vulnerable group in need of special support in pursuing everyday life as young people. These needs are, however, not currently being adequately met. This study explores the distinctive needs of AYAs aged 15-25 and affected by cancer with the aim of developing and designing an intervention that accommodates these needs and allows AYAs to pursue everyday life following active cancer treatment. METHODS: We combined multiple qualitative methods to conduct six sub-studies: 1) participant observation among support groups for AYAs affected by cancer, 2) field visit at a large Danish hospital, 3) qualitative interviews with AYAs currently or previously diagnosed with cancer, 4) qualitative interviews with practitioners working with young cancer patients or AYAs with chronic conditions, 5) an interactive workshop with practitioners, and 6) an interactive workshop with AYAs. The empirical material was collected between May 2016 and April 2019. The empirical material was read, analysed thematically and coded into the themes; 1) diagnosis and treatment, 2) form of education and 3) age, financial challenges and legal entitlements. RESULTS: Across the empirical material, we found that AYAs' cancer experience was heterogeneous. The needs of AYAs differed according to 1) diagnosis and treatment, 2) type of education and 3) age, financial situation and legal entitlements. The findings demonstrate a need for a tailored intervention accommodating the variety of opportunities, requirements and challenges of AYAs with cancer. We propose an intervention consisting of a multidisciplinary team sited at the hospital where the individual AYA receives treatment. The team's main task will be to maintain AYAs' social competences and ease their return to everyday life after serious illness by balancing educational requirements with cancer treatment. CONCLUSION: Based on the perspectives of practitioners and AYAs affected by cancer, this study outlines an intervention designed as a care pathway in which a multidisciplinary team provides individual and tailored support to AYAs with cancer from the time of diagnosis during and beyond active cancer treatment.

The practice of hope in public health interventions: a qualitative single-case study.

This study examines hope practices in the context of participation in a public health intervention. Theoretically, the study builds upon Cheryl Mattingly's notion of hope as a practice, which renders the possibility of examining participants actions, interactions and challenges with participating. This analytical lens contributes knowledge about how interventions are incorporated into participants' hopes for a future life and the consequences of intervening in peoples' everyday lives. The study builds on empirical material from a pilot study of the primary preventive intervention known as TOF (Tidlig Opsporing og Forebyggelse-a Danish acronym for 'Early Detection and Prevention') which aimed to identify high risk individuals and provide targeted preventive services. A by-product of a larger qualitative study, itself based on the TOF pilot study in 2019, this single-case study illustrates how participants' life situation influence how they interpret and manage activities in a public health intervention. The study shows how the practice of hope in public health interventions is closely linked to participants' own interpretations of how participation can lead to a life worth living. The findings, which show that participants' needs, and life situation influence the ways in which they respond to an intervention, adds to the complexity in intervention research. Further, the study illustrates some of the ethical challenges that arise when researchers intervene in people's everyday life. It reinforces the need for ongoing critical reflection and attention to be directed at how those being studied articulate and practice hope.

This study examines hope practices in the context of participation in a public health intervention. Theoretically, the study builds upon Cheryl Mattingly's notion of hope as a practice, which renders the possibility of examining participants actions, interactions and challenges when participating in public health interventions. The analytical lens contributes knowledge about how interventions are incorporated into participants' hopes for a future life and the consequences of intervening in peoples' everyday lives. A by-product of a larger qualitative study, itself based on the TOF intervention (Tidlig Opsporing og Forebyggelse­a Danish acronym for 'Early Detection and Prevention') which aimed to identify high risk individuals and provide targeted preventive services, this single-case study illustrates how hope is practiced in relation to participation in a public health intervention. The study shows how the practice of hope in public health interventions is closely linked to participants' own interpretations of how participation can lead to a life worth living. Further, the study illustrates some of the ethical challenges that arise when researchers intervene in people's everyday life. It reinforces the need for ongoing critical reflection and attention to be directed at how those being studied articulate and practice hope.

'Motivational work': a qualitative study of preventive health dialogues in general practice.

BACKGROUND: The aim of this article is to explore preventive health dialogues in general practice in the context of a pilot study of a Danish primary preventive intervention 'TOF' (a Danish acronym for 'Early Detection and Prevention') carried out in 2016. The intervention consisted of 1) a stratification of patients into one of four groups, 2) a digital support system for both general practitioners and patients, 3) an individual digital health profile for each patient, and 4) targeted preventive services in either general practice or a municipal health center. METHODS: The empirical material in this study was obtained through 10 observations of preventive health dialogues conducted in general practices and 18 semi-structured interviews with patients and general practitioners. We used the concept of 'motivational work' as an analytical lens for understanding preventive health dialogues in general practice from the perspectives of both general practitioners and patients. RESULTS: While the health dialogues in TOF sought to reveal patients' motivations, understandings, and priorities related to health behavior, we find that the dialogues were treatment-oriented and structured around biomedical facts, numeric standards, and risk factor guidance. Overall, we find that numeric standards and quantification of motivation lessens the dialogue and interaction between General Practitioner and patient and that contextual factors relating to the intervention framework, such as a digital support system, the general practitioners' perceptions of their professional position as well as the patients' understanding of prevention -in an interplay-diminished the motivational work carried out in the health dialogues. CONCLUSION: The findings show that the influence of different kinds of context adds to the complexity of prevention in the clinical encounter which help to explain why motivational work is difficult in general practice.

Why do general practitioners not refer patients to behaviour-change programmes after preventive health checks? A mixed-method study.

BACKGROUND: This study was embedded in the Check-In randomised controlled trial that investigated the effectiveness of general practice-based preventive health checks on adverse health behaviour and early detection of non-communicable diseases offered to individuals with low socioeconomic positions. Despite successful recruitment of patients, the intervention had no effect. One reason for the lack of effectiveness could be low rates of referral to behaviour-change programmes in the municipality, resulting in a low dose of the intervention delivered. The aim of this study is to examine the referral pattern of the general practitioners and potential barriers to referring eligible patients to these behaviour-change programmes. METHODS: A mixed-method design was used, including patients' questionnaires, recording sheet from the health checks and semi-structured qualitative interviews with general practitioners. All data used in the study were collected during the time of the intervention. Logistic regressions were used to estimate odds ratios for being eligible and for receiving referrals. The qualitative empirical material was analysed thematically. Emerging themes were grouped, discussed and the material was re-read. The themes were reviewed alongside the analysis of the quantitative material to refine and discuss the themes. RESULTS: Of the 364 patients, who attended the health check, 165 (45%) were marked as eligible for a referral to behaviour-change programme by their general practitioner and of these, 90 (55%) received referrals. Daily smoking (OR = 3.22; 95% CI:2.01-5.17), high-risk alcohol consumption (OR = 2.66; 95% CI:1.38-5.12), obesity (OR = 2.89; 95% CI:1.61-5.16) and poor lung function (OR = 2.05; 95% CI:1.14-3.70) were all significantly associated with being eligible, but not with receiving referral. Four themes emerged as the main barriers to referring patients to behaviour-change programmes: 1) general practitioners' responsibility and ownership for their patients, 2) balancing information and accepting a rejection, 3) assessment of the right time for behavioural change and 4) general practitioners' attitudes towards behaviour-change programmes in the municipality. CONCLUSION: We identified important barriers among the general practitioners which influenced whether the patients received referrals to behaviour-change programmes in the municipality and thereby influenced the dose of intervention delivered in Check-In. The findings suggest that an effort is needed to assist the collaboration between general practices and the municipalities' primary preventive services. TRIAL REGISTRATION: Clinical Trials NCT01979107 ; October 25, 2013.

Using general practitioners to recruit individuals with low socioeconomic position to preventive health checks is feasible: a cross sectional study.

Objective: To test whether demographic and health-related characteristics are associated with non-attendance of preventive health checks offered to individuals with low levels of education using proactive recruitment by the general practitioners. Design: A cross-sectional study. Setting: 32 general practice clinics in Copenhagen, Denmark. Subjects: A total of 549 individuals aged 45-64, with low levels of education, enrolled in the intervention group of a randomised controlled trial on preventive health checks offered by general practitioner. Main outcome measures: Non-attendance of the preventive health checks. Methods: (i) Descriptive characteristics of attendees and non-attendees and (ii) crude and adjusted multi-level logistic regression to examine associations of individual characteristics with non-attendance of preventive health checks. Results: Overall, 33% did not attend the prescheduled preventive health checks at their general practitioners. Non-attendees were more likely to live without a partner, be of non-Western origin, be daily smokers, have poor self-rated health, have higher pulmonary symptoms score, have increased level of stress, have low levels of self-efficacy, have metabolic risk factors or non-communicable diseases and have had no contact with their general practitioner within the past year. Conclusion: The findings suggest that, it is feasible to use general practitioners for recruiting individuals for preventive health checks. However, even in a trial targeting individuals with low levels of education, there are differences between attendees and non-attendees, with a more adverse health behaviour profile and worse health status observed among the non-attendees. KEY POINTS Current awareness • Non-attendance of preventive health checks offered to the general population is associated with low socioeconomic position and adverse health behaviours. Main statements • It is feasible to use general practitioners proactively in recruitment to preventive health checks offered to individuals with low socioeconomic positions. • In a trial targeting individuals with low levels of education, there were differences between attendees and non-attendees. • Non-attendance was associated with daily smoking, poor self-rated health, high stress and no contact with the general practitioner within the last year.

Balancing trust and power: a qualitative study of GPs perceptions and strategies for retaining patients in preventive health checks.

OBJECTIVE: Little is known about how strategies of retaining patients are acted out by general practitioners (GPs) in the clinical encounter. With this study, we apply Grimens' (2009) analytical connection between trust and power to explore how trust and power appear in preventive health checks from the GPs' perspectives, and in what way trust and power affect and/or challenge strategies towards retaining patients without formal education. DESIGN: Data in this study were obtained through semi-structured interviews with GPs participating in an intervention project, as well as observations of clinical encounters. RESULTS: From the empirical data, we identified three dimensions of respect: respect for the patient's autonomy, respect for professional authority and respect as a mutual exchange. A balance of respect influenced trust in the relationship between GP and patients and the transfer of power in the encounter. The GPs articulated that a balance was needed in preventive health checks in order to establish trust and thus retain the patient in the clinic. One way this balance of respect was carried out was with the use of humour. CONCLUSIONS: To retain patients without formal education in the clinical encounter, the GPs balanced trust and power executed through three dimensions of respect. In this study, retaining patients was equivalent to maintaining a trusting relationship. A strategic use of the three dimensions of respect was applied to balance trust and power and thus build or maintain a trusting relationship with patients. KEY POINTS Little is known about how strategies for retaining patients are acted out by GPs in preventive health checks. • Retaining patients requires a balance of trust and power, which is executed through three dimensions of respect by the GPs. • Challenges of recruiting and retaining patients in public health initiatives might be associated with the balance of respect.

Conceptualizing negotiation in the clinical encounter - A scoping review using principles from critical interpretive synthesis.

OBJECTIVE: Negotiation as an analytical concept in research about clinical encounters is vague. We aim to provide a conceptual synthesis of key characteristics of the process of negotiation in clinical encounters based on a scoping review. METHODS: We conducted a scoping review of relevant literature in Embase, Psych Info, Global Health and SCOPUS. We included 25 studies from 1737 citations reviewed. RESULTS: We found that the process of negotiation is socially situated depending on the individual patient and professional, a dynamic element of the interaction that may occur both tacitly and explicitly at all stages of the encounter and is not necessarily tied to a specific health problem. Hence, negotiation is complex and influenced by both social, biomedical, and temporal contexts. CONCLUSIONS: We found that negotiation between patient and health professional occurs at all stages of the clinical encounter. Negotiation is influenced by social, temporal, and biomedical contexts that encompass the social meeting between patient and health professional. We suggest that health professionals strive to be attentive to patients' tacit negotiation practices. This will strengthen the recognition of the patients' actual wishes for their course of treatment which can thus guide the health professionals' recommendations and treatment.

How do oilcloth sessions work? A realist evaluation approach to exploring ripple effects in an implementation strategy.

PURPOSE: To explore the mechanisms of the implementation strategy, "oilcloth sessions" and understand and explain the ripple effects of oilcloth sessions as a strategy to implement a new emergency department. DESIGN/METHODOLOGY/APPROACH: A qualitative design was used whereby data were collected using field notes from an ethnographic study of the oilcloth sessions and follow-up semi-structured interviews with staff, managers and key employees who participated in the oilcloth sessions. The data analysis was inspired by the realist evaluation approach of generative causality proposed by Pawson and Tilley. FINDINGS: The primary ripple effect was that the oilcloth sessions were used for different purposes than the proposed program theory, including being used as: (1) a stage, (2) a battlefield, (3) a space for imagination and (4) a strategic management tool influencing the implementation outcomes. The results bring essential knowledge that may help to explain why and how a well-defined implementation strategy has unplanned outcomes. ORIGINALITY/VALUE: Unintended outcomes of implementation strategies are an underexplored issue. This study may help implementation researchers rethink the activities required to reduce unintended negative outcomes or explore potential unplanned outcomes and, in this way, hinder or enhance outcomes, effectiveness and sustainability. Future studies within implementation research should incorporate attention to unintended outcomes to fully understand the impact of implementation strategies.

The effectiveness of general practice-based health checks on health behaviour and incidence on non-communicable diseases in individuals with low socioeconomic position: a randomised controlled trial in Denmark.

BACKGROUND: The effectiveness of health checks aimed at the general population is disputable. However, it is not clear whether health checks aimed at certain groups at high risk may reduce adverse health behaviour and identify persons with metabolic risk factors and non-communicable diseases (NCDs). OBJECTIVES: To assess the effect of general practice-based health checks on health behaviour and incidence on NCDs in individuals with low socioeconomic position. METHODS: Individuals with no formal education beyond lower secondary school and aged 45-64 years were randomly assigned to the intervention group of a preventive health check or to control group of usual care in a 1:1 allocation. Randomisation was stratified by gender and 5-year age group. Due to the real-life setting, blinding of participants was only possible in the control group. Effects were analysed as intention to treat (ITT) and per protocol. The trial was undertaken in 32 general practice units in Copenhagen, Denmark. INTERVENTION: Invitation to a prescheduled preventive health check from the general practitioner (GP) followed by a health consultation and an offer of follow-up with health risk behaviour change or preventive medical treatment, if necessary. PRIMARY OUTCOME MEASURES: Smoking status at 12-month follow-up. Secondary outcomes included status in other health behaviours such as alcohol consumption, physical activity and body mass index (measured by self-administered questionnaire), as well as incidence of metabolic risk factors and NCDs such as hypertension, hypercholesterolaemia, chronic obstructive pulmonary disease, diabetes mellitus, hypothyroidism, hyperthyroidism and depression (drawn from national healthcare registries). RESULTS: 1104 participants were included in the study. For the primary outcome, 710 participants were included in the per protocol analysis, excluding individuals who did not attend the health check, and 1104 participants were included in the ITT analysis. At 12-month follow-up, 37% were daily smokers in the intervention group and 37% in the control group (ORs=0.99, 95% CI: 0.76 to 1.30). No difference in health behaviour nor in the incidence of metabolic risk factors and NCDs between the intervention and control group were found. Side effects were comparable across the two groups. CONCLUSION: The lack of effectiveness may be due to low intensity of intervention, a high prevalence of metabolic risk factors and NCDs among the participants at baseline as well as a high number of contacts with the GPs in general or to the fact that general practices are not an effective setting for prevention. TRIAL REGISTRATION NUMBER: NCT01979107.