Corrigendum to "Association of high cortisol levels in pregnancy and altered fetal growth. Results from the MAASTHI, a prospective cohort study, Bengaluru" [The Lancet Regional Health - Southeast Asia 14 (2023) 100196].

[This corrects the article DOI: 10.1016/j.lansea.2023.100196.].

Effectiveness of the Assessment of Burden of Chronic Conditions (ABCC)-tool in patients with asthma, COPD, type 2 diabetes mellitus, and heart failure: A pragmatic clustered quasi-experimental study in the Netherlands.

BACKGROUND: The Assessment of Burden of Chronic Conditions (ABCC)-tool was developed to optimise chronic care. OBJECTIVES: This study aimed to assess the effectiveness of the ABCC-tool in patients with COPD, asthma, type 2 diabetes, and/or heart failure in primary care in the Netherlands. METHODS: The study had a pragmatic, clustered, two-armed, quasi-experimental design. The intervention group (41 general practices; 176 patients) used the ABCC-tool during routine consultations and the control group (14 general practices; 61 patients) received usual care. The primary outcome was a change in perceived quality of care (PACIC; Patient Assessment of Chronic Illness Care) after 18 months. Secondary outcomes included change in the PACIC after 6 and 12 months, and in quality of life (EQ-5D-5L; EuroQol-5D-5L), capability well-being (ICECAP-A; ICEpop CAPability measure for Adults), and patients' activation (PAM; Patient Activation Measure) after 6, 12, and 18 months for the total group and conditions separately. RESULTS: We observed a significant difference in the PACIC after 6, 12, and 18 months (18 months: 0.388 points; 95%CI: 0.089-0.687; p = 0.011) for the total group and after 6 and 12 months for type 2 diabetes. After 18 months, we observed a significant difference in the PAM for the total group but not at 6 and 12 months, and not for type 2 diabetes. All significant effects were in favour of the intervention group. No significant differences were found for the EQ-5D-5L and the ICECAP-A. CONCLUSION: Use of the ABCC-tool has a positive effect on perceived quality of care and patients' activation, which makes the tool ready for use in clinical practice. Healthcare providers (e.g. general practitioners and practice nurses) can use the tool to provide person-centred care.Trial registration number: ClinicalTrials.gov Registry (NCT04127383).

The Assessment of Burden of Chronic Conditions (ABCC)-tool aims to support disease management for one or multiple chronic condition(s), currently COPD, asthma, type 2 diabetes, and heart failure.Statistically significant differences in patients' perceived quality of care and patient activation were found between the group that used the ABCC-tool and the care-as-usual group. No effect was found on generic quality of life or capability well-being.Healthcare providers can use the ABCC-tool in primary care.

Undesirable Levels of Practice Behaviours and Associated Knowledge amongst Community Health Workers in Rural South India Responsible for Type 2 Diabetes Screening and Management.

BACKGROUND: Type 2 diabetes (T2DM) poses an enormous global health care challenge, especially among rural communities. Healthcare in these areas can be inadequate and inaccessible due to socio-demographic barriers. To overcome this situation, many low- and middle-income countries are resorting to task shifting, using community health workers (CHWs) for diabetes management. However, its successful implementation depends on the practice behaviours and knowledge of these workers. OBJECTIVE: This cross-sectional study aimed to evaluate the proficiency of CHWs involved in diabetes screening and management in rural South India by identifying the existing practice behaviours and knowledge gaps. METHODS: Employing a customised questionnaire, developed through inputs from experts and government officials, we assessed practice behaviours and the corresponding knowledge base of 275 CHWs. Analytical methodologies consisted of descriptive statistics, logistic regression, and mosaic plots for comprehensive data interpretation. RESULTS: The study showcased significant deficiencies in both practice behaviours (97%) and knowledge (95%) with current mean levels ranging from 48 to 50%, respectively, among the participants. The identified areas of insufficiency were broadly representative of the core competencies required for effective diabetes management, encompassing diabetes diagnosis and referral, HbA1c testing, diabetes diet, diabetes type and self-management, microvascular complications and their screening, peripheral neuropathy management, and diabetes risk assessment. In several areas, correct practice behaviour was reported by a relatively large number of CHWs despite incorrect answers to the related knowledge questions such as referral to the health centres, self-management, and calculation of diabetes risk assessment. CONCLUSION: This study highlights widespread deficiencies (97% CHWs) in diabetes management practices and knowledge (95% CHWs). To overcome these deficiencies, a thorough needs assessments is vital for effective CHW training. Training of CHWs should not only identify prior knowledge and/or behaviour but also their interrelationship to help create a robust and flexible set of practice behaviours.

Recommendations for Improving Chronic Care in Times of a Pandemic Based on Patient Experiences.

OBJECTIVES: The COVID-19 pandemic had a profound and pervasive impact on the health of chronic care patients and disrupted care systems worldwide. Our research aimed to assess the impact of the pandemic on chronic care provision and provide recommendations for improving care provision, based on patient experiences. DESIGN: Qualitative semi-structured interviews were held among patients with chronic obstructive pulmonary disease (COPD) or heart failure. SETTING AND PARTICIPANTS: Using stratified sampling, 23 patients with COPD, heart failure, or both were recruited to participate in semi-structured interviews. In the summer of 2021, online interviews were conducted. METHODS: An iterative process was adopted to analyze the data. Going back and forth through the data and our analytical structure, we first coded the data, and subsequently developed categories, themes, and aggregate dimensions. The data were synthesized in a data structure and a data table, which were analyzed using an interpretative approach. RESULTS: We found 3 dimensions through which care might be improved: (1) proactive and adaptive health care organization and use of innovative technologies, (2) assistance in maintaining patient resilience and coping strategies, and (3) health care built on outreaching and person-centered care enabling identification of individual patient needs. Experiences of impaired accessibility to care, altered and unmet care demands and patient needs, and the negative impact of national containment strategies on patient resilience support the need for improvement in these dimensions. CONCLUSIONS AND IMPLICATIONS: The in-depth insight gained on the impact of the pandemic on chronic care provision was used to propose recommendations for improving care, supported by not only the what and how but also the why developments require additional efforts made by policymakers and change agents, augmented by structural use and development of innovations. Health care organizations should be enabled to rapidly respond to changing internal and external environments, develop and implement innovations, and match care to patient needs.

Antibiotics Versus Placebo for Acute Bacterial Conjunctivitis: Findings From a Cochrane Systematic Review.

PURPOSE: To summarize key findings from a Cochrane review of the benefits and safety of antibiotic therapy compared with placebo (or vehicle) for acute bacterial conjunctivitis. DESIGN: Systematic review and meta-analysis. METHODS: We included placebo-controlled randomized controlled trials (RCTs) that compared topical antibiotics with placebo. We followed Cochrane methods for trial selection, data extraction, risk of bias assessment, and evidence synthesis. RESULTS: Twenty-one RCTs involving 8805 participants with acute bacterial conjunctivitis were included. Fifteen (71%) RCTs examined fluoroquinolone (FQ) drops, 3 tested macrolides, alone or in combination with steroids, and another 3 compared other non-FQ antibiotics. Intention-to-treat estimates suggested that compared with placebo, antibiotics may increase clinical recovery by 26% (risk ratio [RR]: 1.26; 95% confidence interval [CI]: 1.09-1.46) at the end of therapy (5 RCTs, 1474 participants). Modified intention-to-treat estimates, in which only participants with laboratory-confirmed bacterial conjunctivitis were analyzed, indicated that antibiotics were associated with 53% higher likelihood of microbiological cure as compared with placebo (RR: 1.53; 95% CI: 1.34-1.74; 10 RCTs, 2827 participants). Non-FQs (RR: 4.05; 95% CI: 1.36-12.00), but not FQs (RR: 0.70; 95% CI: 0.54-0.90), were likely to increase treatment-associated ocular complications such as eye pain, discomfort, and allergic reactions; the certainty of level of evidence was very low. CONCLUSIONS: Moderate level certainty of evidence suggested that antibiotics may increase the likelihood of clinical recovery and microbiological clearance compared with placebo. Very low-level certainty of evidence suggested that antibiotics may be associated with potential harm in patients with acute bacterial conjunctivitis, but the potential risk of bias from study design, inconsistency in outcome measurement, and reporting limit the evidence to very low certainty.

Effects of School-Based Health-Promoting Activities on Children's Health: A Pragmatic Real-World Study.

More insight into the health effects of scaled-up school-based interventions in real-world settings is vital to sustainably integrate health in all schools. This study investigated the effectiveness of the scaled-up Healthy Primary School of the Future (HPSF) initiative in real-world school contexts on children's health (behaviours). From 2019 to 2022, eleven Dutch primary schools implemented HPSF-related activities. In 315 children from study years four to six (aged 7-11 years) from these schools, anthropometric measurements were performed, and questionnaires assessing the children's dietary behaviours and physical activity were administered. COVID-19 greatly limited the implementation of HPSF-related activities. Therefore, the results were compared between schools categorised as medium implementers and schools categorised as low implementers. After correction for baseline, waist circumference in the medium implementer group was significantly higher at one-year follow-up (B = 1.089, p = 0.003) and two-year follow-up (B = 1.665, p < 0.001) compared with waist circumference in the low implementer group. No significant effects were observed for other outcomes. This study showed hardly any effects of the scaled-up HPSF initiative, mainly due to the limited implementation caused by COVID-19. More research investigating the real-world effectiveness of HPSF and comparable programmes is greatly encouraged to advance the field of school-based health promotion.

Association of high cortisol levels in pregnancy and altered fetal growth. Results from the MAASTHI, a prospective cohort study, Bengaluru.

Background: The role of maternal stress levels on mothers' mental health and fetal growth has been previously studied. However, the evidence linking cortisol exposure during pregnancy to growth outcomes in infants is sparsely available from lower and middle-income countries. We aim to investigate the association of serum cortisol levels in pregnancy with infant birth outcomes and postpartum depressive symptoms in a public health facility in India. Methods: The current study is a part of the maternal antecedents of adiposity and studying the transgenerational role of hyperglycemia and insulin (MAASTHI) prospective cohort. We assessed the relationship between maternal exposure to serum cortisol and adverse neonatal outcomes and postpartum depressive symptoms. Serum cortisol levels in stored blood samples were measured in 230 pregnant women as a biomarker for stress during pregnancy. Pregnant women between 18 and 45 years of age were recruited for the study, presenting at ≥14 weeks of gestation and providing voluntary written informed consent. The Edinburgh Postnatal Depression Scale assessed postpartum depressive symptoms, and detailed infant anthropometric measurements were carried out at birth. Findings: We found that higher levels (>17.66 µg/L) are significantly associated with low birth weight (OR = 2.28; 95% CI 1.21-4.32) and lower weight for length (OR = 2.16; 95% CI 1.07-4.35). The odds of developing postpartum depressive symptoms in pregnant women with higher mean cortisol cut-off levels is 2.3-fold [OR: 2.33, 95% CI (1.17, 4.64)] compared than women with lower cortisol levels. No significant association was found between serum cortisol and infants' birth weight for gestational age, head circumference, the sum of skinfold thickness, and crown-rump length. Interpretation: Our results support the hypothesis that higher maternal cortisol levels may adversely impact birth weight, weight for length in newborns, and postpartum depressive symptoms in mothers. Funding: This study was supported by the India Alliance Senior Fellowship [Grant No. IA/CPHS/20/1/505278] awarded to Giridhara R. Babu.

Investigating the rationale for COPD maintenance therapy prescription across Europe, findings from a multi-country study.

This study aims to understand healthcare professionals' thoughts and motivations about optimal management and treatment of patients with chronic obstructive pulmonary disease (COPD). We conducted a DELPHI survey through an online questionnaire distributed to 220 panellists from six European countries and a discrete choice experiment to describe the relationship between selected clinical criteria and the initial COPD treatment of choice. One hundred twenty-seven panellists (general practitioners [GPs] and pulmonologists) completed the survey. Despite the familiarity and use (89.8%) of the GOLD classification for initial treatment selection, a frequent use of LAMA/LABA/ICS was noted. In fact, panellists agreed that inhaled corticosteroids (ICS) are over-prescribed in the primary care setting. Our study showed that GPs felt less confident than pulmonologists with ICS withdrawal. This mismatch observed between best practice and behaviour indicates the need to increase awareness and efforts to improve the adherence to guidelines in clinical practice.

Maternal depressiveness and infant growth outcomes: Findings from the MAASTHI cohort study in India.

OBJECTIVE: The study aims to examine the association between depressiveness in mothers on infant obesity and stunting at one year of age. METHODS: We enrolled 4829 pregnant women, followed them up at public health facilities in Bengaluru for one year after birth. We collected information on women's sociodemographic characteristics, obstetric history, depressive symptoms during pregnancy and delivery within 48 h. We took infant anthropometric measurements at birth and one year. We used chi-square tests, and calculated an unadjusted odds ratio using univariate logistic regression. We used multivariate logistic regression to examine the association between maternal depressiveness, childhood adiposity, and stunting. RESULTS: We found that the prevalence of depressiveness was 31.8% in mothers who delivered in public health facilities in Bengaluru. Infants born to mothers with depressiveness at birth had 3.9 times higher odds of having larger waist circumference than infants born to mothers with no depressiveness (AOR: 3.96, 95% Confidence Interval: 1.24,12.58) and 1.9 times higher odds of having a larger sum of skinfold thickness (AOR: 1.99, 95% CI: 1.18,3.38). Additionally, we found that infants born to mothers with depressiveness at birth had 1.7 times higher odds of stunting than infants born to mothers with no depressiveness (AOR: 1.72; 95%CI: 1.22,2.43) after adjusting for confounders. CONCLUSION: Our study highlights a high prevalence of depressiveness among mothers seeking antenatal care at a public hospital is associated with an increased risk of infant adiposity and stunting at one year. Further research is needed to understand the underlying mechanisms and identify effective interventions.

Vitamin B6 Levels and Impaired Folate Status but Not Vitamin B12 Associated with Low Birth Weight: Results from the MAASTHI Birth Cohort in South India.

Vitamins B12 and B6 and folate are known to have implications for pregnancy outcomes. We aimed to describe B6, B12, and folate status in pregnancy and investigate their associations with low birth weight and preterm delivery in mothers recruited from public hospitals in urban Bengaluru. Pregnant women between 18 and 45 years were included in the MAASTHI prospective cohort study. Each participant's age, socioeconomic status, and anthropometry were recorded during baseline and followed up after delivery. Blood samples were collected between the 24th and 32nd weeks of gestation and stored at -80° for analysis. B6, B12, folate, homocysteine, and methylmalonic acid (MMA) levels were analyzed in the stored samples. We found low plasma vitamin B12, folate, and B6 levels in 48.5%, 42.0%, and 10.4% of the women (n = 230), respectively. Elevated MMA and homocysteine were observed among 73.6% and 6.1% of the women, respectively. We found B6 levels were significantly associated with birth weight (ß(SE) -0.002(0.0), p = 0.001) after adjusting for age, parity, adiposity, gestational diabetes, and socioeconomic status of the mother. Those with impaired folate deficiency were twice at risk (AOR 1.95 (1.29, 3.07), p = 0.002) of low birth weight. Vitamin B6 levels and impaired folate status were associated with low birth weight in the MAASTHI birth cohort.

The ADEM2 project: early pathogenic mechanisms of preschool wheeze and a randomised controlled trial assessing the gain in health and cost-effectiveness by application of the breath test for the diagnosis of asthma in wheezing preschool children.

BACKGROUND: The prevalence of asthma-like symptoms in preschool children is high. Despite numerous efforts, there still is no clinically available diagnostic tool to discriminate asthmatic children from children with transient wheeze at preschool age. This leads to potential overtreatment of children outgrowing their symptoms, and to potential undertreatment of children who turn out to have asthma. Our research group developed a breath test (using GC-tof-MS for VOC-analysis in exhaled breath) that is able to predict a diagnosis of asthma at preschool age. The ADEM2 study assesses the improvement in health gain and costs of care with the application of this breath test in wheezing preschool children. METHODS: This study is a combination of a multi-centre, parallel group, two arm, randomised controlled trial and a multi-centre longitudinal observational cohort study. The preschool children randomised into the treatment arm of the RCT receive a probability diagnosis (and corresponding treatment recommendations) of either asthma or transient wheeze based on the exhaled breath test. Children in the usual care arm do not receive a probability diagnosis. Participants are longitudinally followed up until the age of 6 years. The primary outcome is disease control after 1 and 2 years of follow-up. Participants of the RCT, together with a group of healthy preschool children, also contribute to the parallel observational cohort study developed to assess the validity of alternative VOC-sensing techniques and to explore numerous other potential discriminating biological parameters (such as allergic sensitisation, immunological markers, epigenetics, transcriptomics, microbiomics) and the subsequent identification of underlying disease pathways and relation to the discriminative VOCs in exhaled breath. DISCUSSION: The potential societal and clinical impact of the diagnostic tool for wheezing preschool children is substantial. By means of the breath test, it will become possible to deliver customized and high qualitative care to the large group of vulnerable preschool children with asthma-like symptoms. By applying a multi-omics approach to an extensive set of biological parameters we aim to explore (new) pathogenic mechanisms in the early development of asthma, creating potentially interesting targets for the development of new therapies. TRIAL REGISTRATION: Netherlands Trial Register, NL7336, Date registered 11-10-2018.

Understanding the healthcare providers' perspective for bringing the assessment of burden of chronic conditions tool to practice: a protocol for an implementation study.

INTRODUCTION: The Assessment of Burden of Chronic Conditions (ABCC) tool is developed and validated to support and facilitate a personalised approach to care for people with chronic conditions. The benefit of using the ABCC-tool greatly depends on how it is implemented. To enable a deeper understanding of when, how and by whom the ABCC-tool is used, this study protocol describes the design of an implementation study in which the context, experiences and implementation process of the ABCC-tool by primary care healthcare providers (HCPs) in the Netherlands will be investigated. METHODS AND ANALYSIS: This protocol describes an implementation study alongside an effectiveness trial, in which the ABCC-tool is evaluated in general practices. The implementation strategy of the tool in the trial confines to providing written information and an instruction video explaining the technical use of the ABCC-tool. The outcomes include a description of: (1) the barriers and facilitators of HCPs for implementation of the ABCC-tool, guided by the Consolidated Framework for Implementation Research (CFIR) and (2) the implementation outcomes guided by the Reach-Effect-Adoption-Implementation-Maintenance (RE-AIM) framework Carroll's fidelity framework. All outcomes will be gathered through individual semistructured interviews throughout 12 months of use. Interviews will be audiorecorded and transcribed. Transcripts will be analysed using content analysis for identifying barriers and facilitators (based on CFIR) and thematic analyses of HCPs' experiences (based on the RE-AIM and the fidelity frameworks). ETHICS AND DISSEMINATION: The presented study was approved by the Medical Ethics Committee of Zuyderland Hospital, Heerlen (METCZ20180131). Written informed consent is mandatory prior to participation in the study. The results from the study in this protocol will be disseminated through publication in peer-reviewed scientific journals and conference presentations.

A qualitative study assessing how reach and participation can be improved in workplace smoking cessation programs.

INTRODUCTION: Randomized controlled trials have demonstrated the effectiveness of workplace smoking cessation programs. However, with low participation rates reported, it is important to understand the barriers and facilitators for the reach and participation of employees in workplace smoking cessation programs. The objective of the present study is to uncover the needs of employees regarding reach and participation when implementing a workplace program to address smoking cessation. METHODS: We carried out 19 semi-structured qualitative interviews in 2019 based on the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) Framework with current and former smoking employees of organizations with ≥100 employees in the Netherlands. Some of the interviewees had experience with a cessation program. Data were analyzed using the Framework method. RESULTS: The main barriers according to employees were insufficient promotion of the cessation program, completing the program in the employee's own time and working night shifts and peak hours. Facilitators included being actively approached to participate by a colleague, positive reactions from colleagues about employee's participation in the program, providing the program on location and integrating the program as part of the organization's vitality policy. CONCLUSIONS: Effective workplace programs for smoking cessation can stimulate cessation but implementers often experience low participation rates. Our study presents recommendations to improve the recruitment and participation of employees in a workplace smoking cessation program, such as using active communication strategies, training managers to stimulate smoking employees to participate and making the program as accessible as possible by reimbursing time spent and offering the program at the workplace or nearby. Integrating the smoking cessation program into wider company vitality policy will also aid continued provision of the program.

Validity and Reliability of the Assessment of Burden of Chronic Conditions Scale in the Netherlands.

PURPOSE: The Assessment of Burden of Chronic Conditions (ABCC) tool was developed to improve care by facilitating shared decision making and self-management. It assesses and visualizes the experienced burden of 1 or multiple chronic conditions and integrates it in daily care. The aim of this study is to evaluate whether the ABCC scale is valid and reliable in people with chronic obstructive pulmonary disease (COPD), asthma, or type 2 diabetes (T2D). METHODS: The Saint George Respiratory Questionnaire (SGRQ), the Standardized Asthma Quality of Life Questionnaire (AQLQ-S), and the Audit of Diabetes Dependent Quality of Life Questionnaire (ADDQoL19) were compared with the ABCC scale to assess convergent validity. The internal consistency was evaluated using Cronbach's α. Test-retest reliability was evaluated at a 2-week interval. RESULTS: A total of 65 people with COPD, 62 with asthma, and 60 with T2D were included. The ABCC scale correlated, in accordance with hypotheses, with the SGRQ (75% of correlations ≥0.7), AQLQ-S (100%), and ADDQoL19 (75%). The ABCC scale was internally consistent with a Cronbach's α of 0.90, 0.92, and 0.91 for the total score for people with COPD, asthma, and T2D, respectively. The ABCC scale had a good test-retest reliability with an intraclass correlation coefficient of 0.95, 0.93, and 0.95 for people with COPD, asthma, and T2D, respectively. CONCLUSIONS: The ABCC scale is a valid and reliable questionnaire that can be used within the ABCC tool for people with COPD, asthma, or T2D. Future research should indicate whether this applies to people with multimorbidity, and what the effects and experiences are upon clinical use.

Effect of an educational intervention on diet and physical activity among school-aged adolescents in Delhi -The i-PROMISe (PROMoting health literacy in Schools) Plus Study.

Purpose: Emerging lifestyle changes due to rapid urbanization have led to an epidemiological transition and the rising prevalence of obesity is responsible for major non-communicable diseases (NCDs) which have further aggravated due to the COVID-19 pandemic. This study aims to assess the effectiveness of a comprehensive school-based intervention on diet and physical activity-related behavior of adolescents. Methods: In 2019, a cluster-randomized controlled trial was conducted in randomly selected (n = 8) private schools. A 2-year intervention program was implemented over consecutive academic years (2019-2020 and 2020-2021) with students who were in the 6th and 7th grades when the study began. Four schools were randomly assigned to the intervention (n = 794) and four schools to the control group (n = 774). Results: The difference in changes in diet and physical-activity-related behaviors of the students between the intervention and control schools were not significant in the intention to treat analysis probably due to the large drop-out due to COVID-19 measures: 304 students were available for follow-up in the intervention group and 122 in the control group (391 cases were excluded to make data comparable with baseline survey). The intake of vegetables (once a day) [ß = 0.35, OR = 1.42, 95% CI (1.03, 1.95)] in the per-protocol analysis has increased among adolescents in the intervention group as compared to the control group. Conclusion: The findings of this study indicated a positive effect of the intervention on diet and physical-activity-related changes in the expected direction and highlights the importance of addressing such behavior to prevent obesity among adolescents and thus NCDs in the later stage of life.

The Psychosocial Impact of the COVID-19 Pandemic on Chronic Care Patients.

OBJECTIVES: The COVID-19 pandemic has had a profound and pervasive impact on psychosocial health and disrupted care systems world-wide. Our research aims to assess the psychosocial impact of the pandemic and related changes in chronic care provision on patients with chronic obstructive pulmonary disease (COPD) and heart failure. DESIGN: A qualitative survey using semi-structured interviews was held among patients with COPD and heart failure. SETTING AND PARTICIPANTS: Using randomized sampling, 23 patients with COPD, heart failure, or both were recruited to participate in semi-structured interviews. Interviews were held by phone or videocall. The survey was held during the summer of 2021, when strict national containment strategies were widely implemented but gradually loosened and vaccination was ongoing. METHODS: Inductive coding using Gioia's approach was used to analyze the data in Atlas.Ti 9.1 software. Using an iterative approach, the data were synthesized in a data structure and data table, which was analyzed using an interpretative approach. RESULTS: We found 3 aggregate dimensions in which the COVID-19 pandemic has a negative impact on psychosocial health of patients with chronic disease: (1) perceived vulnerability to disease, (2) influence of health policy, and (3) a mismatch of supply and demand of health care. In these dimensions, the impact of the COVID-19 crisis was found to have a negative impact on psychosocial well-being, compounded by national strategies to contain the pandemic and a disruption of chronic care for patients. CONCLUSIONS AND IMPLICATIONS: Health care providers should be aware of a multidimensional nature of psychosocial distress for chronic disease patients due to the COVID-19 crisis. Future practice and health policy could be improved by increasing awareness among health care providers, promote regular attention for psychosocial well-being of patients, provision of clear information related to the pandemic, and strategies to secure continuity of care. Results of this study might be further explored in larger studies.

Challenges in evaluating implementation and effectiveness in real-world settings: evaluation proposal for school-based health-promoting intervention.

There are various research designs and approaches to investigate how health-promoting activities are implemented in complex, real-world systems, and to identify potential health effects that might occur following implementation. Although literature describes guidelines to perform and report about implementation research and effect evaluations, no specific guidelines exist on analysing and reporting about the combination of effectiveness data and implementation data collected as part of intervention evaluation in complex and diverse settings. This paper describes the evaluation of primary school-based health-promoting activities in complex systems. Furthermore, an approach for data categorization inspired by Rogers' Diffusion of Innovations theory is presented that can facilitate structuring the study's results and relating the degree of implementation to any impact on effectiveness outcomes that might be observed. Researchers interested in using this approach for data categorization have to ensure that the following three conditions are met: (i) data on an intervention's efficacy in a controlled setting with optimal implementation is available; (ii) key points that define an intervention's optimal implementation are available and (iii) an evaluation study is performed, collecting both effectiveness data and implementation data in a real-world context. This data categorization approach can be useful to generate more insight into an intervention's effectiveness under varying circumstances, and optimal support and advice can be provided to stakeholders to achieve maximum impact of population-based health-promoting interventions in complex, real-world systems. However, the proposed approach is a first suggestion and further testing and adaptation is necessary to increase its usefulness. Knowledge and experience sharing among researchers performing comparable research can increase the knowledge base regarding this subject.

Headroom Analysis for Early Economic Evaluation: A Systematic Review.

OBJECTIVES: The headroom analysis is an early economic evaluation that quantifies the highest price at which an intervention may still be cost effective. Currently, there is no comprehensive review on how it is applied. This study investigated the application of the headroom analysis, specifically (1) how the headroom analysis is framed (2) the analytical approach and sources of evidence used, and (3) how expert judgement is used and reported. METHODS: A systematic search was conducted in PubMed, Embase, Web of Science, EconLit, and Google Scholar on 28 April 2022. Studies were eligible if they reported an application of the headroom analysis. Data were presented in tabular form and summarised descriptively. RESULTS: We identified 42 relevant papers. The headroom analysis was applied to medicines (29%), diagnostic or screening tests (29%), procedures, programmes and systems (21%), medical devices (19%), and a combined test and device (2%). All studies used model-based analyses, with 40% using simple models and 60% using more comprehensive models. Thirty-three percent of the studies assumed perfect effectiveness of the health technology, while 67% adopted realistic assumptions. Ten percent of the studies calculated an effectiveness-seeking headroom instead of a cost-seeking headroom. Expert judgement was used in 71% of the studies; 23 studies (55%) used expert opinion, 6 studies (14%) used expert elicitation, and 1 study (2%) used both. CONCLUSIONS: Because the application of the headroom analysis varies considerably, we recommend its appropriate use and clear reporting of analytical approaches, level of evidence available, and the use of expert judgement.

The Effects of a Multi-Component School-Based Nutrition Education Intervention on Children's Determinants of Fruit and Vegetable Intake.

Evidence suggests that multi-component school-based health-promoting interventions have great potential to improve children's fruit and vegetable intake. However, interventions that combine classroom-based curricula with experiential learning strategies (e.g., cooking) are relatively seldom described. This study investigates the short-term and longer-term effects of a multi-component school-based nutrition education intervention combining classroom-based and experiential learning strategies on children's determinants of their fruit and vegetable intake (knowledge, taste preferences, attitudes, and intention). Using a comparative quasi-experimental study design, data were collected, via child-reported questionnaires, at the baseline, directly after the intervention, and three months after the intervention from 4 control and 15 intervention classes from Dutch primary schools. A total of 192 children in grades three and four (aged 8-10 years) constituted the participants. After correction for the baseline, sex, age, and the fruit or vegetable product assessed in the questionnaire; the intervention group showed a significant increase in knowledge (p = 0.001; standardized effect size (ES = 0.60), taste preference (p = 0.002; ES = 0.52), attitude towards the assessed fruit or vegetable product (p = 0.004; ES = 0.48), and general attitude towards healthy products (p = 0.01; ES = 0.39) over the short term, when compared to the control group. The effects of the intervention did not continue to be significant over the longer term. The findings implicate short-term intervention success, although more research and intervention adaptations are recommended to increase the impact of such programs, especially over the long term.

How to promote a healthy lifestyle among schoolchildren: Development of an intervention module (i-PROMISe).

Objective: Lifestyle preferences are inculcated in childhood and once established, persist into adulthood. The Project PROMoting Health LIteracy in School (i-PROMISe) aims to promote a healthy lifestyle among students for the universal prevention of non-communicable diseases (NCDs) like diabetes. Study design: Qualitative study using focus-group-discussions (FGDs) and In-Depth Interviews (IDI). Method: Project was undertaken in two-phases in two private schools in New Delhi, India. In phase-one, FGDs with students (grades IV to VIII) and IDIs with teachers were conducted to ascertain their perceptions of diabetes prevention and management according to the Health Belief Model. The data was analyzed using a thematic framework method. In phase-two, the resources were pre-tested and participants' feedback was requested on the duration, quality, and understanding of the resources. Results: In total, 89 students and 17 teachers participated in phase-one (n = 54 [in FGDs] and n = 5 [in IDIs]) and phase-two (n = 35 students and n = 12 teachers in FGDs). In phase-one, themes that emerged included: diabetes was considered a disease of the elderly; misconceptions about susceptibility to these diseases were common; children were largely aware of measures to prevent these diseases, but barriers to adopting a healthy lifestyle existed. Based on the findings, a comprehensive module was developed, which consisted of a teacher's manual with interactive activities and short films. The resources (teacher's manual and short films) were well received and contributed to a better understanding of diabetes and other NCDs; myths/misconceptions were clarified. Conclusion: Development of resources using participatory approach can be effective in promoting and reinforcing healthy behaviours among school going children to prevent and control NCDs in schools.