Co-designing municipal multimorbidity rehabilitation leveraging health literacy and social networks: Protocol for the CURIA study.

Background: Managing multimorbidity poses significant challenges for individuals, their families, and society due to issues with health information comprehension, communication with healthcare providers, and navigating the healthcare system. These challenges emphasise the critical need to prioritize individual and organisational health literacy. Multimorbidity is associated with a lack of social support for health; however, social networks and community dynamics can enhance health literacy. The "Co-designing municipal rehabilitation" (CURIA) project targets enhancing individual and organisational health literacy, and social networks for individuals with multimorbidity, with the overall aim of addressing health inequity through a collaborative local co-design process involving stakeholders. Methods: The CURIA study employs a mixed-method approach that initially explores the health literacy experiences of individuals with multimorbidity participating in rehabilitation programs in selected Danish municipalities and the practices of professionals overseeing these programs. The subsequent co-design process will comprise individuals with multimorbidity, their relatives, municipalities, general practitioners, civil society, and knowledge institutions working together. This iterative and collaborative process involves tailoring and aligning health literacy needs with responsiveness within the context of local healthcare systems and developing supportive social networks. Discussion: Given the increasing burden of multimorbidity, there is an urgent need to develop evidence-based practice for multimorbidity rehabilitation practices, developed in collaboration with municipalities and civil society. Emphasising self-care support for individuals, managing complex rehabilitation needs, and involving individuals in intervention prioritisation and customisation are crucial aspects addressed by CURIA to enhance health literacy and align municipal rehabilitation with identified needs.

It's a hard process - Nursing students' lived experiences leading to dropping out of their education; a qualitative study.

BACKGROUND: Dropout from nursing education is a serious problem worldwide. Student nurse attrition has a profound effect not only on the nursing profession and patient care, but also on the students themselves. Dropout is recognized as a complex phenomenon that has multiple causes. A more detailed and nuanced understanding of the complexity behind dropout is needed if we are to retain more nursing students. AIM: To explore the students' experiences and considerations before dropping out and their reflections after dropping out to gain a deeper understanding of the factors that prompted them to leave their nursing education. DESIGN/METHOD: A qualitative explorative design inspired by Gadamer's philosophical hermeneutics was used to explore the students' lived experiences and considerations concerning dropping out. Qualitative telephone interviews were conducted on 15 nursing students. RESULTS: The analysis revealed three main themes that disclosed and elucidated the nursing students' reasons for dropping out: (i) Resources to make a difference and help others; (ii) Clinical practice was more demanding than expected; (iii) The learning environment was important - the social environment was essential. CONCLUSION: The students encountered a lack of support to deal with the difficult emotions that arose when witnessing serious illness and death. They expressed feeling overwhelmed by their vulnerability and called for support to develop resilience. The social environment and a sense of belonging to the nursing profession were cited by students as being essential to this support.

An Intervention Offering Self-management Support Through mHealth and Health Coaching to Patients With Prostate Cancer: Interpretive Description of Patients' Experiences and Perspectives.

BACKGROUND: Observational management strategies such as active surveillance and watchful waiting are considered to be acceptable approaches in patients with low-risk localized prostate cancer and a safe alternative to aggressive treatment. During observational management, treatment is postponed until the disease progresses, which often never occurs. However, approximately 90% of patients with a low-risk disease choose aggressive treatment owing to anxiety. Strategies to address anxiety are needed for optimal management of this population and to improve the quality of life of patients with low-risk localized prostate cancer. A review highlighted that mobile health (mHealth) in tandem with health coaching can support patients' self-management of health behaviors and improve well-being. OBJECTIVE: This study aims to explore patients' experiences with and perspectives on an intervention offering self-management support through the use of mHealth devices and health coaching to identify supportive features that enable patients to perform sustainable changes that improve well-being. METHODS: We used an interpretive description approach, combining semistructured interviews with 13 purposively selected patients with prostate cancer and participant observations of patient-coach interactions in coaching sessions. The interviews were transcribed and analyzed. The self-determination theory was used as a theoretical lens. Field notes and coaching notes from each session were used to orient data generation and confirm or challenge the analysis. RESULTS: Our analysis suggested that patients' self-awareness and psychological identity influenced their experiences with and perspectives on the self-management support offered by mHealth and health coaching in clinical practice. The patients' individual experiences and perspectives indicated that they placed themselves in a dynamic continuum of sustaining or repressing their identity, self-awareness, and individual qualities. Our analysis revealed 4 interacting themes, all related to the psychological identity of the patients. CONCLUSIONS: For the group of patients with prostate cancer to experience well-being, we found it important for them to sustain their self-image when offered a self-management intervention. Motivation and autonomy were important aspects for the individual patients to sustain their self-image throughout the intervention. In contrast, demotivation and a sense of paternalism could result in fostering an experience of having to repress self-awareness.

Healthcare Professionals' Experiences and Perspectives of Facilitating Self-Management Support for Patients with Low-Risk Localized Prostate Cancer via mHealth and Health Coaching.

Introduction: Self-monitoring of self-management interventions with the use of mobile health (mHealth) can enhance patients' well-being. Research indicates that mHealth and health coaching act symbiotically to providing a more constructive outcome. Nurse coaches seem to have a significant role in translating the patients' tracked data. Objective: The objective was to explore healthcare professionals' experiences of an intervention offering self-management support through mHealth and health coaching for patients with prostate cancer. Methods: We used the interpretive description methodology, combining semi-structured individual and focus group interviews and participant observations of patient-coach interactions and use of mHealth in coaching sessions. The study was conducted between June 2017 and August 2020. Results: The nurse coaches experienced motivation and autonomy when possessing the right competences for coaching. Furthermore, the nurse coaches experienced conflicting expectations of their roles when having to integrate mHealth. Conclusion: The experience of being competent, autonomous, and confident is important for the nurse coaches to be mentally present during the coaching sessions. On the other hand, the findings indicate that having the sense of not being confident in one's own ability to perform leads to reduced motivation.

Combining mHealth and health-coaching for improving self-management in chronic care. A scoping review.

BACKGROUND: Self-management approaches are widely used to improve chronic care. In this context, health care professionals call for efficient tools to engage patients in managing their illness. Mobile health (mHealth), defined by WHO as medical and public health practice supported by mobile devices, is demonstrated to enhance self-management and health-coaching as an engaging tool in supporting behaviour change. Nevertheless, it is unclear how health-coaching and mHealth can benefit from each other. OBJECTIVE: We conducted a scoping review to provide a literature-overview and identify any existing gaps in knowledge of mHealth in combination with health-coaching interventions for improving self-management in patients with chronic diseases. PATIENT INVOLVEMENT: No patients were involved in the review process. METHODS: The five-stage framework by Arksey and O'Malley was used. The review surveys; PubMed, CINAHL, Embase, Scopus, and PsycInfo. Two independent reviewers performed review selection and characterization. RESULTS: The review points at two approaches; (i) coaching used to support mHealth and (ii) mHealth as support for coaching. The findings suggest that patients prefer physical interactions to telecommunication. mHealth was primarily used to facilitate telecommunication and to monitor disease aspects. DISCUSSION: We found that mHealth and health-coaching interventions benefit from each other. The review report on a considerable unclarity in the coaching-methods and that the patients were more satisfied with physical interactions than mHealth. We suggest to prioritize human contact and to explore more personalized health technology. PRACTICAL VALUE: This scoping review can provide a framework for researchers and care providers to support discussion and introduction of new approaches and technology in self-management for patients with chronic diseases, thereby improving patients' quality of life.

BCG Vaccination at Birth and Rate of Hospitalization for Infection Until 15 Months of Age in Danish Children: A Randomized Clinical Multicenter Trial.

BACKGROUND: The bacillus Calmette-Guérin (BCG) vaccine against tuberculosis might reduce the non-tuberculosis-related child mortality rate in low-income settings. We tested the hypothesis that BCG vaccination at birth would reduce early childhood hospitalization for infection in Denmark, a high-income setting. Hospitalization for infection was a secondary outcome in a randomized trial with the primary aim to estimate the potential non-specific effects of BCG vaccination at birth on all-cause hospitalization. METHODS: A total of 4262 children included in the Danish Calmette Study were assigned randomly to either receive the BCG vaccine or not and were followed through the Danish National Patient Register. The outcome was number of hospitalizations for infection until the age of 15 months. Data were analyzed by Cox regression in intention-to-treat (ITT) and per-protocol (PP) analyses. RESULTS: In the ITT analysis, we observed 588 hospitalizations for infection (mean, 0.28 hospitalization per child) among the 2129 children allocated to receive the BCG vaccine and 595 hospitalizations for infection (mean, 0.28 hospitalization per child) among the 2133 children allocated to the control group (hazard ratio [HR], 0.99 [95% confidence interval (CI), 0.85-1.15]). The PP analysis yielded an HR of 1.00 (95% CI, 0.86-1.16).Predefined interaction ITT analyses showed that among 740 children with a BCG-vaccinated mother, the HR for BCG-vaccinated children was 0.65 (95% CI, 0.45-0.94); the HR for children who had a non-BCG-vaccinated mother was 1.10 (95% CI, 0.93-1.29) (P = .01, test of no interaction). Cesarean delivery modified the effect of BCG vaccination (HRs, 0.73 [95% CI, 0.54-0.99] in children born by cesarean section vs 1.10 [95% CI, 0.92-1.30] in other children; P = .02). When the outcome was defined as time to first hospitalization, the HR for premature children after BCG vaccination was 1.81 (95% CI, 0.95-3.43), whereas the HR was 0.94 (95% CI, 0.82-1.08) for children born at term (P = .05). CONCLUSION: BCG vaccination did not affect the rate of hospitalization for infection up to the age of 15 months in Danish children. In future studies, the role of maternal BCG-vaccination, premature birth, and cesarean delivery needs further exploration.

Mothers' informational needs when deciding to have their newborn infant vaccinated with BCG. A Mixed-methods design.

OBJECTIVE: To explore the informational needs of mothers with different levels of education in order to improve counselling about vaccination. METHODS: In the setting of a large vaccination trial, mothers' assessments and yield of written information in combination with telephone consultations were evaluated in a survey. Furthermore, searching strategies for additional information were investigated. Mothers' perspectives on informational needs were explored in focus group discussions. RESULTS: Out of 2025 mothers, 95% felt well-informed. Of the 4% not feeling well-informed, there were significantly more mothers with basic schooling and nontheoretical education. There was no correlation between searching for additional information and feeling well-informed. The telephone consultation was found to be very supportive for the decision. CONCLUSION: The written information was digestible over time. The telephone consultation ensured the mothers' understanding by tailoring and deriving meaning from the information to her special needs. Moreover, it helped the mothers gain an overview of risks and benefits and inspired confidence. These findings indicate that the telephone consultation improved health literacy. PRACTICE IMPLICATIONS: Individual counselling about vaccines is required in addition to information about side effects and accurate instructions on how to react upon them.

"Lay epidemiology": an important factor in Danish parents' decision of whether to allow their child to receive a BCG vaccination. A qualitative exploration of parental perspective.

BACKGROUND: Vaccination is used worldwide to prevent infectious diseases. However, vaccination programmes in western countries face challenges in sustaining high coverage rates. The aim of this study was to explore how parents in Denmark make a decision about whether to allow their child to receive a Bacille Calmette Guerin vaccine at birth for the purpose of achieving non-specific effects on the immune system. METHODS: A total of five focus groups were conducted with expectant mothers and fathers. Written information about the vaccine and information about the hypothesis of non-specific effects of the vaccine were delivered in order to discuss considerations and determinants of parents' decisions. RESULTS: Heritable factors and the possibility of stimulating the immune system of the child to achieve less atopic diseases and fewer infections were identified as arguments in favour of receiving the BCG vaccine. Arguments against receiving BCG mainly focused on concerns about its described and non-described side effects. Both arguments for and arguments against the vaccine were seen as parents attempt to make an individual risk evaluation for their child. Attitudes and beliefs in the local network were identified as important for parents' decisions. DISCUSSION: It is discussed how "lay epidemiology" characterizes parents' risk evaluation as an individual addition to the population-based risk declaration. It is furthermore discussed how health professionals should engage with both the empirical element and the value element of "Lay epidemiology". CONCLUSION: "Lay epidemiology" forms the basis for the parental decision of whether to allow their child to receive a BCG vaccination. Attitudes and beliefs about the causes and distribution of illnesses in the family or local network influence parents' risk evaluations. It would be ideal for parents if health professionals focused their communication about the BCG vaccine on individual risk evaluations.

Neonatal BCG has no effect on allergic sensitization and suspected food allergy until 13 months.

BACKGROUND: Vaccination with Bacillus Calmette-Guérin (BCG) is used in many countries as protection against tuberculosis. Studies have suggested that BCG may also have non-specific effects, reducing non-tuberculosis mortality, morbidity, and atopic manifestations. In this study, we evaluated the effect of neonatal BCG vaccination on allergic sensitization and suspected food allergy at 13 months of age. METHODS: The Danish Calmette Study was conducted from 2012 to 2015 at three Danish hospitals. Within 7 days of birth, the 4262 newborns of 4184 included mothers were randomized 1:1 to BCG or to a no-intervention control group. Exclusion criteria were gestational age <32 weeks, birth weight <1000 g, known immunodeficiency, or no Danish-speaking parent. Follow-up information was collected through telephone interviews at 3 and 13 months of age. Subgroups of participants were offered blood sampling at 13 months of age. RESULTS: By 13 months of age, the parents and/or general practitioners of 5.6% (117/2089) of the children in the BCG group and 6.1% (126/2061) of the control group suspected food allergy, resulting in a risk ratio comparing BCG-vaccinated children with control children of 0.91 (95% CI 0.71-1.16). Among 1370 blood samples, sensitization (Phadiatop Infant >0.35 kUA/L) was found in 55 of 743 (7.4%) children in the BCG group and 50 of 627 (8.0%) of the control group (risk ratio 0.94 [0.65-1.36]). CONCLUSION: In this randomized clinical trial, neonatal BCG had no significant effect on suspected food allergy or on sensitization at 13 months of age.

Neonatal BCG vaccination has no effect on recurrent wheeze in the first year of life: A randomized clinical trial.

BACKGROUND: Recurrent wheeze (RW) is frequent in childhood. Studies have suggested that BCG vaccination can have nonspecific effects, reducing general nontuberculosis morbidity, including respiratory tract infections and atopic diseases. The mechanisms behind these nonspecific effects of BCG are not fully understood, but a shift from a TH2 to a TH1 response has been suggested as a possible explanation. OBJECTIVE: We hypothesized that BCG at birth would reduce the cumulative incidence of RW during the first year of life. METHODS: The Danish Calmette Study is a multicenter randomized trial conducted from 2012-2015 at 3 Danish hospitals. The 4262 newborns of 4184 included mothers were randomized 1:1 to BCG (SSI strain 1331) or to a no-intervention control group within 7 days of birth; siblings were randomized together as one randomization unit. Exclusion criteria were gestational age of less than 32 weeks, birth weight of less than 1000 g, known immunodeficiency, or no Danish-speaking parent. Information was collected through telephone interviews and clinical examinations at 3 and 13 months of age; data collectors were blind to randomization group. RW was defined in several ways, with the main definition being physician-diagnosed and medically treated RW up to 13 months of age. RESULTS: By 13 months, 211 (10.0%) of 2100 children in the BCG group and 195 (9.4%) of 2071 children in the control group had received a diagnosis of RW from a medical doctor and received antiasthma treatment (relative risk, 1.07; 95% CI, 0.89-1.28). Supplementary analyses were made, including an analysis of baseline risk factors for development of RW. CONCLUSION: Neonatal BCG had no effect on the development of RW before 13 months of age.

BCG vaccination at birth and early childhood hospitalisation: a randomised clinical multicentre trial.

BACKGROUND: The BCG vaccine is administered to protect against tuberculosis, but studies suggest there may also be non-specific beneficial effects upon the infant immune system, reducing early non-targeted infections and atopic diseases. The present randomised trial tested the hypothesis that BCG vaccination at birth would reduce early childhood hospitalisation in Denmark, a high-income setting. METHODS: Pregnant women planning to give birth at three Danish hospitals were invited to participate. After parental consent, newborn children were allocated to BCG or no intervention within 7 days of age. Randomisation was stratified by prematurity. The primary study outcome was number of all-cause hospitalisations analysed as repeated events. Hospitalisations were identified using The Danish National Patient Register. Data were analysed by Cox proportional hazards models in intention-to-treat and per-protocol analyses. RESULTS: 4184 pregnant women were randomised and their 4262 children allocated to BCG or no intervention. There was no difference in risk of hospitalisation up to 15 months of age; 2129 children randomised to BCG experienced 1047 hospitalisations with a mean of 0.49 hospitalisation per child compared with 1003 hospitalisations among 2133 control children (mean 0.47), resulting in a HR comparing BCG versus no BCG of 1.05 (95% CI 0.93 to 1.18) (intention-to-treat analysis). The effect of BCG was the same in children born at term (1.05 (0.92 to 1.18)) and prematurely (1.07 (0.63 to 1.81), p=0.94). The effect was also similar in the two sexes and across study sites. The results were essentially identical in the per-protocol analysis and after adjustment for baseline characteristics. CONCLUSIONS: BCG vaccination at birth did not reduce the risk of hospitalisation for somatic acquired disease until 15 months of age in this Danish study population. TRIAL REGISTRATION NUMBER: NCT01694108, results.

Bacillus Calmette-Guérin vaccination at birth: Effects on infant growth. A randomized clinical trial.

BACKGROUND: Bacillus Calmette-Guérin vaccine (BCG) induces a complex, pro-inflammatory immune response. Obesity is associated with low-grade inflammation. AIMS: The purpose of the study was to test whether BCG at birth has effects on infant growth and body composition. STUDY DESIGN, SUBJECTS, AND OUTCOME MEASURES: The Danish Calmette Study is a randomized, clinical trial. The study was conducted at three university hospitals and randomized 4262 children of gestational age ≥32weeks to receive BCG within seven days of birth or to a no-intervention control group. Follow-up consisted of clinical examinations. Outcome measures were weight and length at 3months, and weight, length, mid upper-arm circumference, and triceps and subscapular skinfold at 13months. Data collectors were blinded to allocation. Anthropometric measurements were converted to z-scores using WHO reference population. RESULTS: Follow-up was 94% complete at 3 and 13months after birth. The children were bigger than the WHO reference population. There was no effect of BCG on weight z-score at 13months (-0.028 [95% confidence interval: -0.085 to 0.029], p=0.34). There was no effect on weight and length at 3months, or length, mid-upper-arm circumference, or triceps and subscapular skinfold at 13months. CONCLUSION: In this study, vaccination with BCG at birth did not have effects on child growth or body composition at 13months. TRIAL REGISTRATION: www.clinicaltrials.gov, registration number NCT01694108.

Adverse reactions to the Bacillus Calmette-Guérin (BCG) vaccine in new-born infants-an evaluation of the Danish strain 1331 SSI in a randomized clinical trial.

OBJECTIVE: To evaluate adverse reactions of the Bacillus Calmette-Guérin (BCG) Statens Serum Institut (SSI) (Danish strain 1331) used as intervention in a randomized clinical trial. DESIGN: A randomized clinical multicenter trial, The Danish Calmette Study, randomizing newborns to BCG or no intervention. Follow-up until 13 months of age. SETTING: Pediatric and maternity wards at three Danish university hospitals. PARTICIPANTS: All women planning to give birth at the three study sites (n=16,521) during the recruitment period were invited to participate in the study. Four thousand one hundred and eighty four families consented to participate and 4262 children, gestational age 32 weeks and above, were randomized: 2129 to BCG vaccine and 2133 to no vaccine. None of the participants withdrew because of adverse reactions. MAIN OUTCOME AND MEASURE: Trial-registered adverse reactions after BCG vaccination at birth. Follow-up at 3 and 13 months by telephone interviews and clinical examinations. RESULTS: Among the 2118 BCG-vaccinated children we registered no cases of severe unexpected adverse reaction related to BCG vaccination and no cases of disseminated BCG disease. Two cases of regional lymphadenitis were hospitalized and thus classified as serious adverse reactions related to BCG. The most severe adverse reactions were 10 cases of suppurative lymphadenitis. This was nearly a fivefold increase compared to what was expected based on the summary of product characteristics of the vaccine. All cases were treated conservatively and recovered. Six of 10 (60%) families of children experiencing suppurative lymphadenitis compared to 117/2071 (6%) of those with no lymphadenitis indicated that the vaccine had more adverse effects than expected (p-value <0.001). CONCLUSIONS AND RELEVANCE: BCG vaccination was associated with only mild morbidity and no mortality. A higher incidence of suppurative lymphadenitis than expected was observed. All children were treated conservatively without sequelae or complications. TRIAL REGISTRATION: Trial registration number NCT01694108 at www.clinicaltrials.gov.

Lack of a Negative Effect of BCG-Vaccination on Child Psychomotor Development: Results from the Danish Calmette Study - A Randomised Clinical Trial.

OBJECTIVES: To assess the non-specific effect of Bacillus Calmette-Guérin (BCG) vaccination at birth on psychomotor development. DESIGN: This is a pre-specified secondary outcome from a randomised, clinical trial. SETTING: Maternity units and paediatric wards at three university hospitals in Denmark. PARTICIPANTS: Children born at gestational age (GA) 32 weeks and above. All women planning to give birth at the three sites were invited during the recruitment period. Out of 4262 randomised children, 144 were premature (GA < 37 weeks). There were 2129 children (71 premature) randomised to BCG and 2133 randomised (73 premature) to the control group. INTERVENTIONS: BCG vaccination 0.05 ml was given intradermally in the upper left arm at the hospital within seven days of birth. Children in the control group did not receive any intervention. Parents were not blinded to allocation. MAIN OUTCOME MEASURES: Psychomotor development measured using Ages and Stages Questionnaire (ASQ) completed by the parents at 12 months. Additionally, parents of premature children (gestational age < 37 weeks) completed an ASQ at 6 and 22 months. Developmental assessment was available for 3453/4262 (81%). RESULTS: The mean difference in ASQ score at 12 months adjusted for age and prematurity was -0.7 points (BCG vs. control, 95% confidence interval; -3.7 to 2.4), p = 0.67, corresponding to an effect size of Cohen's d = -0.015 (-0.082 to 0.052). The mean difference in ASQ score for premature children at 22 months was -7.8 points (-20.6 to 5.0, p = 0.23), d = -0.23 (-0.62 to 0.15). CONCLUSIONS: A negative non-specific effect of BCG vaccination at birth on psychomotor development was excluded in term children. TRIAL REGISTRATION: ClinicalTrials.gov NCT01694108.

Bacillus Calmette-Guérin immunisation at birth and morbidity among Danish children: A prospective, randomised, clinical trial.

BACKGROUND: Studies from low-income countries report positive non-specific effects of early Bacillus Calmette-Guérin (BCG) immunisation on childhood health and survival. Neonatal immunisation with BCG may prime the immune system and offer partial protection against other infectious and possibly allergic diseases. The potential clinical value of these non-specific effects has not yet been examined in a large randomised trial in high-income countries. METHODS: The Danish Calmette Study is a multicentre randomised clinical trial conducted between October 2012 and November 2015. Within the first 7 days of life, infants were randomly assigned to intra-dermal vaccination with BCG or no intervention. At 3 and 13 months of age structured telephone interviews and clinical examinations of the children were conducted. In a subgroup of children blood samples were drawn and stool samples collected at age 4 days, 3 and 13 months. Thymus index was assessed by ultrasound in a subgroup at randomisation and at 3 months. The primary study outcome is hospitalisation within the first 15 months of life as assessed in Danish health registers. Secondary outcomes include infectious disease hospitalisations, wheezing, eczema, use of prescribed medication, growth, development, thymus index, T- and B-cell subpopulations assessed by flow cytometry, in vitro cytokine responses and specific antibody responses to other vaccines. Adverse reactions were registered. DISCUSSION: With participation of 4184 families and more than 93% adherence to clinical follow-up at 3 and 13 months, this randomised clinical trial has the potential to create evidence regarding non-specific effects of BCG vaccination in a high-income setting.