Measuring up: the significance of measurement invariance in cardiovascular research.

Cardiovascular research frequently involves comparing patient-reported outcomes across groups. These groups can include individuals from different countries or that have different cardiovascular conditions, and it is frequently assumed that their understanding of the assessed outcome is similar. However, to ascertain that this is indeed the case, measurement invariance needs to be evaluated. This psychometric property helps us understand whether a test measures the same underlying construct in the same way across different groups. In the absence of measurement invariance, conclusions regarding group comparisons of the construct at hand may be inappropriate. This methods corner paper provides an overview of measurement invariance as well as an example of how it can be evaluated.

Taking Charge of Your Health: Enabling Patient Empowerment in Cardiovascular Care.

Guidelines and consensus in cardiovascular care in recent years have called for patients to be more involved in their care, which can be achieved by becoming more empowered. Yet, there is little clarity on how healthcare professionals can help the patients achieve this goal. The present paper defines patient empowerment, its benefits and the different strategies that can be used in healthcare to empower them. Moreover, potential barriers in the empowering process are also discussed.

The longitudinal association between patient empowerment and patient-reported outcomes: What is the direction of effect?

BACKGROUND: Theoretical literature and cross-sectional studies suggest empowerment is associated with other patient-reported outcomes (PROs). However, it is not known if patient empowerment is leading to improvements in other PROs or vice versa. AIMS: The present study aimed to examine the direction of effects between patient empowerment and PROs in young persons with congenital heart disease (CHD). METHODS: As part of the STEPSTONES-CHD trial, adolescents with CHD from seven pediatric cardiology centers in Sweden were included in a longitudinal observational study (n = 132). Data were collected when patients were 16 (T0), 17 (T1) and 18 ½ years old (T2). The Gothenburg Young Persons Empowerment Scale (GYPES) was used to measure patient empowerment. Random intercepts cross-lagged panel models between patient empowerment and PROs (communication skills; patient-reported health; quality of life; and transition readiness) were undertaken. RESULTS: We found a significant cross-lagged effect of transition readiness over patient empowerment between T1 and T2, signifying that a higher level of transition readiness predicted a higher level of patient empowerment. No other significant cross-lagged relationships were found. CONCLUSION: Feeling confident before the transition to adult care is necessary before young persons with CHD can feel in control to manage their health and their lives. Clinicians interested in improving patient empowerment during the transitional period should consider targeting transition readiness.

Gothenburg Empowerment Scale (GES): psychometric properties and measurement invariance in adults with congenital heart disease from Belgium, Norway and South Korea.

BACKGROUND: Patient empowerment is associated with improvements in different patient-reported and clinical outcomes. However, despite being widely researched, high quality and theoretically substantiated disease-generic measures of patient empowerment are lacking. The few good instruments that are available have not reported important psychometric properties, including measurement invariance. The aim of this study was to assess the psychometric properties of the 15-item Gothenburg Empowerment Scale (GES), with a particular focus on measurement invariance of the GES across individuals from three countries. METHODS: Adults with congenital heart disease from Belgium, Norway and South Korea completed the GES and other patient-reported outcomes as part of an international, cross-sectional, descriptive study called APPROACH-IS II. The scale's content (missing data) and factorial validity (confirmatory factor analyses), measurement invariance (multi-group confirmatory factor analyses), responsiveness (floor and ceiling effects) and reliability (internal consistency) were assessed. RESULTS: Content validity, responsiveness and reliability were confirmed. Nonetheless, metric but not scalar measurement invariance was supported when including the three countries, possibly because the scale performed differently in the sample from South Korea. A second set of analyses supported partial scalar invariance for a sample that was limited to Norway and Belgium. CONCLUSION: Our study offers preliminary evidence that GES is a valid and reliable measure of patient empowerment in adults with congenital heart disease. However, cross-country comparisons must be made with caution, given the scale did not perform equivalently across the three countries.

Adolescents With Congenital Heart Disease: What Do They Know About Reproductive Health and Risks?

BACKGROUND: Studies show that adolescents with congenital heart disease (CHD) lack knowledge about reproductive health in relation to their CHD. OBJECTIVE: The aims were to investigate (i) the proportion of adolescents with CHD receiving information about reproductive health, (ii) the level of reproductive health knowledge in adolescents with CHD, and (iii) potential correlates for receiving information about reproductive health. METHODS: A total of 202 adolescents aged 14 to 18 years (mean age 15.7 ± 1.1 years) with CHD completed the Knowledge Scale for Adults with Congenitally Malformed Hearts and were asked if they had received information about contraception and pregnancies or if this would be of interest. RESULTS: Few adolescents could recall receiving information about contraceptives (5%) and pregnancies (15%). Furthermore, only 24% adolescents wanted information about contraceptives, and 42% of the female adolescents wanted information about pregnancies. There was a higher probability of male adolescents wanting information about contraceptives. Knowledge about reproductive health varied regarding knowledge about why they had been born with CHD (68%), knowledge about the hereditary nature of the CHD (48%), and if sexual activity could worsen their CHD (70%). However, few (11%) had knowledge about the elevated risk of having a child with CHD. Age was associated with a higher probability of having knowledge about the risks of having a child with CHD. CONCLUSIONS: The low number of adolescents receiving information about contraceptives and pregnancies may have implications for future health and family planning. Future research is needed to identify and evaluate successful communication strategies that help to identify adolescents' preferences on how to approach this sensitive topic.

Definitions, instruments and correlates of patient empowerment: A descriptive review.

OBJECTIVE: This review aimed to: (i) inventory the definitions and measurements of patient empowerment in healthcare literature; (ii) appraise the conceptual and methodological rigor of included studies; and (iii) identify correlates of patient empowerment in persons with chronic conditions. METHODS: Four databases were searched to identify articles measuring patient empowerment in persons with chronic conditions, used a quantitative design and provided evidence on correlates of patient empowerment. Seventy-six articles were included and analyzed by descriptive statistics and summative content analysis. RESULTS: The articles used a range of definitions (n = 35) and instruments (n = 38), evaluating a range of correlates in four categories: sociodemographic characteristics, clinical outcomes, patient-reported outcomes and patient-reported experiences. The most frequent associations were between patient empowerment and age (n = 21), sex (n = 15), educational level (n = 15) and quality of life (n = 18). However, they were not always significant. CONCLUSION: The broad variation of definitions and instruments highlights the lack of consensus on how to interpret and measure patient empowerment. Although several covariates have been evaluated, there are few studies assess the same relationships. PRACTICE IMPLICATIONS: Consensus on a definition and measurement of patient empowerment is needed to improve the quality of future research and to provide a more cohesive body of knowledge.

Empowering Young Persons with Congenital Heart Disease: Using Intervention Mapping to Develop a Transition Program - The STEPSTONES Project.

PURPOSE: Describe the implementation of intervention mapping in the development of a transition program that aims to empower adolescents with congenital heart disease. DESIGN AND METHODS: To gain a better understanding of the problem, we conducted a literature review, focus group and individual interviews, and a cross-sectional survey. This information helped us decide on the scope of the intervention, relevant theories, determinants, formulate performance and change objectives and identify adequate evidence-based change methods. Once the transition program had been designed, effectiveness and process evaluation studies were planned. RESULTS: Young persons with congenital heart disease have insufficient disease-related knowledge, self-management skills and high parental involvement. The transition program involves three meetings with a trained transition coordinator over a two-and-a-half-year period and targets young persons with congenital heart disease and their parents. The transition coordinators use change techniques such as goal-setting, modeling and active learning in order to target three personal determinants (knowledge, self-efficacy and self-management). CONCLUSIONS: The use of intervention mapping may lead to designing interventions tailored to the needs of the targeted population. The transition program described in this paper is currently being evaluated in a hybrid experimental design with simultaneous undertaking of the process evaluation. PRACTICE IMPLICATIONS: This transition program can lead to the empowerment of young persons with congenital heart disease and help them in the process of becoming more responsible for their care. If proven effective, it can be implemented for other chronic conditions.

The Scope of Research on Transfer and Transition in Young Persons With Chronic Conditions.

PURPOSE: To determine the amount, type, and evidence level of published literature on transfer and/or transition of young people with chronic conditions (CCs) and to describe the characteristics of such studies. METHODS: Databases including PubMed, CINAHL, Web of Science, and Scopus were searched for publications in English, French, Spanish, Dutch, or Swedish. Included publications were related to transfer and/or transition of young persons (10-25 years) with a CC. Grey literature was excluded. Region and country where the study was performed, type of study design, study population (i.e., type of CC, sample size, group), and data collection methods were extracted from the studies. RESULTS: We included 952 publications for data analysis, of which 790 were quantitative, 128 qualitative, and 34 multimethods or mixed methods studies. Only seven studies were experimental designs, and the majority (n = 341) were categorized as expert opinion or narrative reviews. Endocrinology and neurology were the most common medical specialties involved in the studies, and young persons were the most represented group, while health-care providers were involved the least. CONCLUSIONS: The majority of publications are categorized at the lowest evidence level. Furthermore, evidence is limited to a certain group of medical specialties.

Burden on parents of children with haemophilia: The impact of sociodemographic and child's medical condition.

AIMS AND OBJECTIVES: To describe the perceived burden on parents of children with severe or moderate haemophilia and the impact of sociodemographic aspects and the child's medical condition on this. BACKGROUND: Parents of children with haemophilia face a multitude of demands. The child needs frequent intravenous injections, hospital visits, extra supervision and care. The child's illness and related management might have psychosocial effects on the parents. DESIGN: A multicentre, cross-sectional study. METHODS: Caregiver burden was evaluated in 102 parents of children with haemophilia, using the HEMOCAB questionnaire which consists of 54 items divided into 13 domains which are to be answered on a 5-point Likert scale. To assess the impact of sociodemographic aspects and clinical data on parental burden, linear regression analyses were undertaken. The study followed the STROBE checklist throughout the research process. RESULTS: Greater burden was seen in parents of children with past or present inhibitors, in parents of younger children, if a family member administered the clotting factor and in parents of children with overweight/obesity. No significant differences in burden were observed for type of haemophilia, if the child had bleeding in the past 12 months, if the child self-infused, had another family member with haemophilia or if the parent had more children. CONCLUSIONS: Parental perceived burden can be negatively affected by the child's medical condition; our results underline that healthcare professionals need to be aware of increased parental burden if the child is young, has or had inhibitors and has overweight/obesity. RELEVANCE TO CLINICAL PRACTICE: More psychosocial support from the healthcare professionals needs to be directed towards parents of younger children and particularly the parents of young children with inhibitors, thus decreasing the parental burden. Parental burden may be reduced if healthcare professionals more actively treat overweight and refer children to appropriate specialists.

Ready for Transfer to Adult Care? A Triadic Evaluation of Transition Readiness in Adolescents With Congenital Heart Disease and Their Parents.

Transfer to adult care for adolescents with chronic conditions ought to be determined by transition readiness. The aims of this study were (a) to describe the level of readiness for transition in adolescents with congenital heart disease, (b) to compare adolescents' assessment of transition readiness with their parents' assessments, and (c) to study potential correlates of transition readiness. A total of 157 triads of adolescents aged 14 to 18 years and their parents completed the Readiness for Transition Questionnaire. Adolescents scored higher on overall readiness than their parents. Multivariable analyses revealed that higher levels of adolescents' overall readiness were associated with a less threatening view of the illness, a higher level of empowerment, and with higher mothers' and fathers' overall readiness scores. Adolescents' responsibility scores were positively associated with age and parental adolescent responsibility scores. Parental involvement scores were negatively associated with adolescents' age and positively with the mothers' parental involvement scores. By using a triadic evaluation, the results of the present study significantly extend what is currently known about this population.

Patient empowerment and its correlates in young persons with congenital heart disease.

OBJECTIVE: The objective of this study was to measure the level of empowerment and identify its correlates in young persons with congenital heart disease. STUDY DESIGN: Patients aged 14-18 years with congenital heart disease, and under active follow-up in one of four paediatric cardiology centres in Sweden were invited to participate in a cross-sectional study. A total of 202 young persons returned the questionnaires. Patient empowerment was measured with the Gothenburg Young Persons Empowerment Scale that allows the calculation of total and subscale scores. Univariate and multivariate linear regression analyses were undertaken to analyse possible correlates, including: sex, age, health behaviours, knowledge of congenital heart disease, quality of life, patient-reported health, congenital heart disease complexity, transition readiness and illness perception. RESULTS: The mean empowerment score was 54.6±10.6 (scale of 15-75). Univariate analyses showed that empowerment was associated with age, quality of life, transition readiness, illness perception, health behaviours and patient-reported health (perceived physical appearance, treatment anxiety, cognitive problems and communication issues). However, multivariable linear regression analyses identified that only transition readiness (ß=0.28, P<0.001) and communication (ß=0.36, P<0.001) had a positive association with patient empowerment. These variables were also significantly associated with the subscale scores of the empowerment scale of knowledge and understanding ( P<0.001), shared decision-making ( P<0.001) and enabling others ( P<0.01). The overall models' explained variance ranged from 8% to 37%. CONCLUSION: Patient empowerment was associated with transition readiness and fewer problems communicating. While it is not possible to establish the directionality of the associations, interventions looking to increase empowerment could benefit from using these variables (or measurements) for evaluation purposes.

Parental uncertainty about transferring their adolescent with congenital heart disease to adult care.

AIMS: To study parent's levels of uncertainty related to the transfer from pediatric to adult care in adolescents with congenital heart disease (CHD) and to identify potentially correlating factors. BACKGROUND: Parents acknowledge that during transition they struggle with finding ways of feeling secure in handing over the responsibility and letting go of control. Well-prepared and informed parents who feel secure are most likely better skilled to support their adolescent and to hand over the responsibility. DESIGN: A cross-sectional study. METHODS: Overall, 351 parents were included (35% response rate). Parental uncertainty was assessed using a Linear Analogue Scale (0-100). Data were collected between January - August 2016. Potential correlates were assessed using the readiness for transition questionnaire and sociodemographic data. RESULTS: The mean parental uncertainty score was 42.5. Twenty-four percent of the parents had a very low level of uncertainty (score 0-10) and 7% had a very high level (score 91-100). Overall, 26% of the mothers and 36% of the fathers indicated that they had not started thinking of the transfer yet. The level of uncertainty was negatively associated with the level of perceived overall readiness. Adolescents' age, sex, CHD complexity, and parental age were not related to uncertainty. CONCLUSION: A wide range in the levels of uncertainty was found. Parents who were less involved in the care, or perceived their adolescent as readier for the transition, felt less uncertain. Still, thirty percent of the parents had not started to think about the transfer to adult care.

Patient empowerment in young persons with chronic conditions: Psychometric properties of the Gothenburg Young Persons Empowerment Scale (GYPES).

PURPOSE: Empowerment in patients can lead to a higher participation in care and self-management skills. However, there are a limited number of high-quality instruments to assess empowerment and its various dimensions in young persons. The aim was to develop and assess the psychometric properties of the Gothenburg Young Persons Empowerment Scale (GYPES). METHODS: The GYPES is a 15-item questionnaire designed to measure patient empowerment in young persons with chronic conditions. Three studies were conducted to evaluate the psychometric properties of the scale. Studies I and II assessed face, content and factorial validity, as well as responsiveness and reliability in young persons with congenital heart disease and diabetes. After these studies problematic items were identified and reworded and the final version of the GYPES was tested in young persons with diabetes in study III. RESULTS: The content and face validity of the scale was confirmed in study I. Confirmatory factor analyses (CFA) in study II supported the five-factor structure of the GYPES. However, one item had a low factor loading. The scale was revised and evaluated in study III. CFA of this version supported adequate model fit with factor loadings ranging from 0.385-0.941. A second-order model had an adequate fit to the data. Cronbach's alpha for the overall scale was 0.858 and for each subscale, alphas range from 0.609-0.858. CONCLUSIONS: GYPES was developed to measure patient empowerment in young persons with chronic conditions. Preliminary evidence supports that the GYPES may be a valid and reliable tool for assessing young persons' empowerment.

Person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood: a study protocol for a hybrid randomised controlled trial (STEPSTONES project).

INTRODUCTION: When a young person grows up, they evolve from an independent child to an empowered adult. If an individual has a chronic condition, this additional burden may hamper adequate development and independence. Transition programmes for young persons with chronic disorders aim to provide the necessary skills for self-management and participation in care. However, strong evidence on the effects of these interventions is lacking. Therefore, as part of the STEPSTONES project (Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS), we propose a trial to assess the effectiveness of a structured, person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood. METHODS/DESIGN: STEPSTONES will use a hybrid experimental design in which a randomised controlled trial is embedded in a longitudinal, observational study. It will be conducted in 4 paediatric cardiology centres in Sweden. 2 centres will be allocated to the randomised controlled trial group, assigning patients randomly to the intervention group (n=63) or the comparison group (n=63). The other 2 centres will form the intervention-naïve control group (n=63). The primary outcome is the level of patient empowerment, as measured by the Gothenburg Young Persons Empowerment Scale (GYPES). ETHICS AND DISSEMINATION: The study has been approved by the Regional Ethical Board of Gothenburg, Sweden. Findings will be reported following the CONSORT statement and disseminated at international conferences and as published papers in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02675361; pre-results.

Assessing the level of evidence on transfer and transition in young people with chronic conditions: protocol of a scoping review.

BACKGROUND: Life-long specialized care is of the utmost importance to safeguard longevity as well as the quality of life in children diagnosed with a chronic condition (CC). Provision of life-long care, however, infers transfers to different settings in line with person's development status. Young people with CC (10-25 years) will transfer care from a pediatric towards an adult-oriented care setting. As a transfer of care is associated with a change of care context, healthcare team, responsibilities, expectations, and roles, patients need to be prepared for this alteration. One type of preparatory intervention is the provision of transitional care. Transition prepares adolescents for the responsibilities associated with adult care and age through support, education, skills demonstration, and guidance. The past decades, increasing attention has been paid towards the concept of transfer and transition, both in clinical practice and research. Numerous consensus papers have been established, emphasizing the need for the establishment of a transition program for young patients with CC. To date, it remains, however, unclear what the overall level of evidence is on transfer and transition in this population. This scoping review aims to analyze and determine the level of evidence of published literature on transfer and transition of young people diagnosed with CC. METHOD: MEDLINE, CINAHL, Scopus, and Web of Science databases will be searched for relevant publications. Any publication in English, Spanish, German, or French, related to transfer and/or transition in young people with CC will be included. A three-staged approach will identify relevant papers, comprising systematic database searches, application of snowball method, and citation searching. Study selection will be performed through screening of titles/abstracts followed by a full-text assessment using a standardized selection form. Data extraction will be performed by two reviewers independently using a pilot-tested, standardized form. Descriptive statistics and content analysis will be applied to present the results. Bibliometric visualization techniques will be performed with VOS viewer®. DISCUSSION: Our review will map the overall level of evidence of published literature on transfer and transition in young people with CC. It will provide guidance for future research initiatives, clinical practice, and policy makers.