Development of an International Standard Set of Outcomes and Measurement Methods for Routine Practice for Adults with Epilepsy: The International Consortium for Health Outcomes Measurement Consensus Recommendations.

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. Therefore, the International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy and their representatives to develop minimum sets of standardized outcomes and outcomes measurement methods for clinical practice that support patient-clinician decision-making and quality improvement. Consensus methods identified 20 core outcomes. Measurement tools were recommended based on their evidence of strong clinical measurement properties, feasibility, and cross-cultural applicability. The essential outcomes included many non-seizure outcomes: anxiety, depression, suicidality, memory and attention, sleep quality, functional status, and the social impact of epilepsy. The proposed set will facilitate the implementation of the use of patient-centered outcomes in daily practice, ensuring holistic care. They also encourage harmonization of outcome measurement, and if widely implemented should reduce the heterogeneity of outcome measurement, accelerate comparative research, and facilitate quality improvement efforts.

Development of an International Standard Set of Outcomes and Measurement Methods for Routine Practice for Infants, Children, and Adolescents with Epilepsy: The International Consortium for Health Outcomes Measurement Consensus Recommendations.

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy, and their representatives to develop minimum sets of standardized outcomes and outcome measurement methods for clinical practice. Using modified Delphi consensus methods with consecutive rounds of online voting over 12 months, a core set of outcomes and corresponding measurement tool packages to capture the outcomes were identified for infants, children, and adolescents with epilepsy. Consensus methods identified 20 core outcomes. In addition to the outcomes identified for the ICHOM Epilepsy adult standard set, behavioral, motor, and cognitive/language development outcomes were voted as essential for all infants and children with epilepsy. The proposed set of outcomes and measurement methods will facilitate the implementation of the use of patient-centered outcomes in daily practice.

Weight Stigma in Latin America, Asia, the Middle East, and Africa: A Scoping Review.

INTRODUCTION: Being stigmatized because of one's weight can pose physical, mental, and social challenges. While weight stigma and its consequences are established throughout Europe, North America, and Australasia, less is known about weight stigma in other regions. The objective of this study was to identify the extent and focus of weight stigma research in Latin America, Asia, the Middle East, and Africa. METHODS: A scoping review of weight stigma research in Latin America, Asia, the Middle East, and Africa was conducted. SCOPUS and PsychINFO databases were searched, and weight stigma experts were contacted to identify relevant literature. Sources were classified based on country/region, population, setting, and category of weight stigma researched. RESULTS: A total of 130 sources were identified from 33 countries and territories. Results indicate that weight stigma has been investigated across populations and settings, mainly focusing on manifestations of weight stigma through experiences, practices, drivers, and personal outcomes of these manifestations. CONCLUSIONS: Weight stigma is a developing global health concern not restricted to Europe, North America, and Australasia. The extent and focus of weight stigma research in Latin America, Asia, the Middle East, and Africa vary between countries and regions leaving several research gaps that require further investigation.

Exploring the limitations of language interpretation: A qualitative study on clinicians' experiences at French Office of Immigration and Integration.

The concordance of communication between patients and health professionals is essential to promoting positive health outcomes. However, concordance may be broken where language barriers exist therefore creating a need to use interpretation services. This is the case when rapid diagnostic testing (RDT) of HIV, HBV, and HCV is offered to migrants. The use of interpreters to establish communication with patients having limited French proficiency (LFP) however, is often not used and can be problematic. Despite being offered, interpretation services are frequently underutilised, which makes communication challenging. This problem has not received enough attention in the literature, particularly in a technologically advanced setting where solutions may be found. Our objective was to explore how interpreters are used within the context of medical consultations when RDT for HIV, HBV, and HCV is offered to legal migrants with LFP. A cross-sectional qualitative study was used with a purposive sample that included doctors and nurses who had conducted rapid screening tests with migrants in four centers in France and who had access to interpretive services. Semi-structured interviews explored healthcare providers' (HP) use of interpreters at the OFII. The use of professional or ad hoc interpreters, telephone interpreters, and the equivalence of concepts such as health literacy between the HP and the interpreter were explored. The utility of a new tool to promote communication concordance was evaluated. Twenty interviews were conducted with eleven doctors and nine nurses with a median age of 58 years (25-67 years). All participants had access to interpretive services although many did not solicit them because of 1) unawareness on how to use the services, 2) preconceived notions of the length of time to involve an interpreter and how this would add to consultation times, or 3) the proximity of an ad hoc interpreter. Not using interpreter services could result in RDTs not being offered to immigrants. Subjects such as confidentiality, the embarrassment of a third party's presence, the lack of appropriate training and differing levels of health literacy were also discussed by participants. Insight from HPs allows us to better understand how both telephone and in-person interpretation are used, viewed, and why they are underused to communicate with limited French language skills patients. Our findings will help us develop a conceptual model for a digital communication tool to overcome barriers with migrant patients with limited French language skills.

Portuguese translation, cultural adaptation, and validation of the Person-Centred Practice Inventory - Staff (PCPI-S).

Aiming to translate, culturally adapt, and psychometrically evaluate the Person-centred Practice Inventory - Staff (PCPI-S) for Portuguese healthcare professionals, this methodological study was conducted sequentially in two phases. Phase I followed the 10-steps recommendations from the ISPOR taskforce for translation and cultural adaptation of patient reported outcome measures. Phase II comprised a quantitative cross-sectional virtual survey of the translated PCPI-S with healthcare professionals, who were reached through snowball sampling from both primary and specialized care settings. The psychometric properties of the PCPI-S were determined by assessing reliability and construct validity. A sample of 304 healthcare professionals participated in Phase II. Ceiling effects were found. The overall internal consistency was excellent (> 0.9). The confirmatory factor analysis showed a good model fit after minor modifications, revealing construct validity, and supporting the theoretical framework. In conclusion, the three-factorial model of PCPI-S adjusted to the studied sample is a valid and reliable instrument to assess the perceptions of healthcare professionals on person-centred practice in various Portuguese clinical contexts. Considering the ceiling effects, the effect of social desirability should be explored.

Fostering Patient-Clinician Communication to Promote Rapid HIV, Hepatitis B Virus, and Hepatitis C Virus Diagnostic Testing: Conceptual Development of a Multilingual App.

BACKGROUND: Migrants are disproportionately affected by HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV). Clinicians, at times, fail to offer rapid diagnostic testing (RDT) for these viruses when a language barrier exists in the patient-clinician relationship, therefore creating missed testing opportunities. Although their effectiveness has been demonstrated elsewhere, conventional, in-person interpreters are costly and underused in practice. Furthermore, clinicians often call upon ad hoc interpreters, which introduces complexities in the clinical relationship. Digital solutions exist to diminish the burden of language barriers; however, the challenges of developing a multilingual and multicultural app have yet to be documented with respect to RDT in the nonfrancophone migrant population in France. OBJECTIVE: Our goal was to design a multilingual app to overcome language barriers, health literacy barriers, and fears related to being tested to promote RDT of HIV, HBV, and HCV in the nonfrancophone migrant population in France. METHODS: A combination of qualitative methods, agile development, and user-centered design was used. We conducted 2 focus groups (FGs) with 12 participants, including physicians, nurses, and social workers conducting RDT, as well as 1 modified Delphi survey with 68 participants including physicians and nurses. FGs explored the content (risk factors and medical history), functions (cultural adaptation and instant translation), and interface ergonomics (graphics and font) needed in the app. The Delphi presented 95 content items that the researchers sought to include in the app. RESULTS: Using FGs to inform the Delphi survey, we scientifically determined the app's content consisting of 95 items using expert consensus, developed a mock-up, and conducted initial user testing. We created an app that contains both migrant and clinician interfaces and includes a sociodemographic, risk assessment, health literacy, and testing barrier questionnaires available in 11 languages. Educational content is related to HIV, HBV, and HCV, along with the ability to understand whether the migrant agrees to be tested. CONCLUSIONS: This study allowed us to conceptualize a multilingual app that aims to increase the acceptance of RDT for HIV, HBV, and HCV. The specific features of the Assistant intelligent au dépistage des allophones app were designed to overcome the testing barriers in the nonfrancophone migrant population. The next phase will be an implementation study, as we intend to validate our app.

Portuguese translation, cultural adaptation, and validation of the Person-Centred Practice Inventory - Staff (PCPI-S) / Tradução, adaptação cultural e validação do Inventário da Prática Centrada na Pessoa, profissionais de saúde (PCPI-S)

Abstract Aiming to translate, culturally adapt, and psychometrically evaluate the Person-centred Practice Inventory - Staff (PCPI-S) for Portuguese healthcare professionals, this methodological study was conducted sequentially in two phases. Phase I followed the 10-steps recommendations from the ISPOR taskforce for translation and cultural adaptation of patient reported outcome measures. Phase II comprised a quantitative cross-sectional virtual survey of the translated PCPI-S with healthcare professionals, who were reached through snowball sampling from both primary and specialized care settings. The psychometric properties of the PCPI-S were determined by assessing reliability and construct validity. A sample of 304 healthcare professionals participated in Phase II. Ceiling effects were found. The overall internal consistency was excellent (> 0.9). The confirmatory factor analysis showed a good model fit after minor modifications, revealing construct validity, and supporting the theoretical framework. In conclusion, the three-factorial model of PCPI-S adjusted to the studied sample is a valid and reliable instrument to assess the perceptions of healthcare professionals on person-centred practice in various Portuguese clinical contexts. Considering the ceiling effects, the effect of social desirability should be explored.

Resumo Com o objetivo de traduzir, adaptar culturalmente e avaliar psicometricamente o Inventário para a Prática Centrada na Pessoa para profissionais de saúde (PCPI-S) em diversos contextos de prestação de cuidados, este estudo metodológico realizou-se em duas fases sequenciais. A Fase I seguiu as recomendações de dez etapas da taskforce da ISPOR para tradução e adaptação cultural de medidas de resultados auto reportados. A Fase II incluiu um estudo cross-sectional do PCPI-S traduzido com profissionais de saúde, que foram alcançados por meio de amostragem snowball em contextos de cuidados primários e diferenciados. A psicometria do PCPI-S foi analisada pela avaliação da confiabilidade e validade de construto. Uma amostra de 304 profissionais de saúde participou da Fase II. Efeitos de teto foram encontrados. A consistência interna geral foi excelente (> 0,9). A análise fatorial confirmatória mostrou um bom ajuste do modelo e validade de construto, refletindo o referencial teórico. Concluindo, o modelo tri-fatorial do PCPI-S ajustado à amostra estudada é um instrumento válido e fiável para avaliar as percepções dos profissionais de saúde sobre a prática centrada na pessoa em vários contextos de cuidados portugueses. Considerando os efeitos teto, a desejabilidade social deve ser explorada.

Effect of the COVID-19 pandemic on surgery for indeterminate thyroid nodules (THYCOVID): a retrospective, international, multicentre, cross-sectional study.

BACKGROUND: Since its outbreak in early 2020, the COVID-19 pandemic has diverted resources from non-urgent and elective procedures, leading to diagnosis and treatment delays, with an increased number of neoplasms at advanced stages worldwide. The aims of this study were to quantify the reduction in surgical activity for indeterminate thyroid nodules during the COVID-19 pandemic; and to evaluate whether delays in surgery led to an increased occurrence of aggressive tumours. METHODS: In this retrospective, international, cross-sectional study, centres were invited to participate in June 22, 2022; each centre joining the study was asked to provide data from medical records on all surgical thyroidectomies consecutively performed from Jan 1, 2019, to Dec 31, 2021. Patients with indeterminate thyroid nodules were divided into three groups according to when they underwent surgery: from Jan 1, 2019, to Feb 29, 2020 (global prepandemic phase), from March 1, 2020, to May 31, 2021 (pandemic escalation phase), and from June 1 to Dec 31, 2021 (pandemic decrease phase). The main outcomes were, for each phase, the number of surgeries for indeterminate thyroid nodules, and in patients with a postoperative diagnosis of thyroid cancers, the occurrence of tumours larger than 10 mm, extrathyroidal extension, lymph node metastases, vascular invasion, distant metastases, and tumours at high risk of structural disease recurrence. Univariate analysis was used to compare the probability of aggressive thyroid features between the first and third study phases. The study was registered on ClinicalTrials.gov, NCT05178186. FINDINGS: Data from 157 centres (n=49 countries) on 87 467 patients who underwent surgery for benign and malignant thyroid disease were collected, of whom 22 974 patients (18 052 [78·6%] female patients and 4922 [21·4%] male patients) received surgery for indeterminate thyroid nodules. We observed a significant reduction in surgery for indeterminate thyroid nodules during the pandemic escalation phase (median monthly surgeries per centre, 1·4 [IQR 0·6-3·4]) compared with the prepandemic phase (2·0 [0·9-3·7]; p<0·0001) and pandemic decrease phase (2·3 [1·0-5·0]; p<0·0001). Compared with the prepandemic phase, in the pandemic decrease phase we observed an increased occurrence of thyroid tumours larger than 10 mm (2554 [69·0%] of 3704 vs 1515 [71·5%] of 2119; OR 1·1 [95% CI 1·0-1·3]; p=0·042), lymph node metastases (343 [9·3%] vs 264 [12·5%]; OR 1·4 [1·2-1·7]; p=0·0001), and tumours at high risk of structural disease recurrence (203 [5·7%] of 3584 vs 155 [7·7%] of 2006; OR 1·4 [1·1-1·7]; p=0·0039). INTERPRETATION: Our study suggests that the reduction in surgical activity for indeterminate thyroid nodules during the COVID-19 pandemic period could have led to an increased occurrence of aggressive thyroid tumours. However, other compelling hypotheses, including increased selection of patients with aggressive malignancies during this period, should be considered. We suggest that surgery for indeterminate thyroid nodules should no longer be postponed even in future instances of pandemic escalation. FUNDING: None.

Evaluating Clinician Expectations of mHealth Solutions to Increase Rapid-Screening for HIV and Hepatitis in Migrant Populations in France: Qualitative Study.

BACKGROUND: Migrants underuse screening opportunities for HIV, hepatitis B, and hepatitis C despite elevated risk factors for contracting these infections. Language barriers are an often given as reasons for limiting access to services. Translation and communication apps increase communication and overall patient satisfaction in the patient-provider relationship. In the development and adoption of new technology, expectations play an important role. OBJECTIVE: This study aimed to explore health care professionals' opinions and attitudes regarding their screening practices with migrants and their expectations for a new communication tool that could improve migrants' screening use. METHODS: In this qualitative study, a purposive (diverse) sampling method was used to invite doctors and nurses who conduct rapid screening tests with migrants from 4 centers of the French Office of Immigration and Integration in 3 geographic regions of France. Semistructured interviews were conducted to survey their opinions on the rapid testing of migrants, the use of telephone interpreters, the concept of health literacy, and their expectations of a new communication tool that could overcome language barriers and promote rapid screening in the new migrant population. RESULTS: In all, 20 interviews were conducted with 11 doctors and 9 nurses with a median age of 58 (range 25-67) years. Participants favored the integration of an innovative communication tool in the context of rapid screening of migrants. However, there were concerns related to the implementation and added value of the tool while migrants were already reluctant to be screened. Expectations were for a tool that would present information in simplified French or a chosen language but also supports a positive attitude toward screening. Health professionals also expressed the wish that the technology could help with the collection of health data. CONCLUSIONS: Feedback from health professionals provides a better understanding of potential formats, characteristics, functions, content, and use of an innovative, digital method to communicate with migrants with limited French proficiency. Findings contribute to the conceptual development of an electronic app and its implementation within the ApiDé study, which aims to validate a digital app to address language barriers to increase the use of screening among migrants with limited French proficiency in France.

Method considerations and study protocol for a Nordic multi-centre prospective study on outcomes in rare paediatric epilepsy surgery subgroups.

Epilepsy surgery is a therapeutic option for selected children with drug-resistant epilepsy. Children who are surgical candidates have a high prevalence of neurodevelopmental comorbidities. There is a lack of adequately sized prospective studies in a number of rare surgical subgroups, especially of outcome domains such as cognitive level and health-related quality-of-life. In this article, we describe method considerations and a study protocol for a Nordic population-based multi-centre follow-up programme covering seizure as well as non-seizure outcomes in children aged <4 years undergoing resective epilepsy surgery and children aged ≤18 years undergoing hemispherotomy, callosotomy or surgery for hypothalamic hamartoma.

Validation of the Swedish version of PROMIS-29v2 and FACIT-Dyspnea Index in patients with systemic sclerosis.

PURPOSE: To evaluate the reliability, internal consistency, and construct validity of the Swedish versions of PROMIS-29 and Functional Assessment of Chronic Illness Therapy-Dyspnea (FACIT-Dyspnea) instruments in patients with systemic sclerosis (SSc). METHODS: In a cross-sectional study, consecutive SSc patients completed a paper-based survey. Internal consistency was assessed using Cronbach's alpha. Test-retest reliability was tested employing weighted Kappa (Kw) and intra-class correlation coefficient (ICC). Construct validity was evaluated by hypotheses testing using RAND-36, MRC Dyspnea score, Scleroderma Health Assessment Questionnaire (SHAQ) and clinical measurements. RESULTS: Forty-nine patients (86% female; 73% limited cutaneous SSc) completed the survey. The mean disease duration was 11 years and mean SHAQ was 0.5. Internal consistency and test-retest reliability were good with the exception of PROMIS-29 anxiety. PROMIS-29, FACIT-Dyspnea, and Functional limitation showed strong correlations to corresponding RAND-36 domains (|rs|=0.67 to -0.85). Relevant PROMIS-29 domains, FACIT-Dyspnea and Functional limitation correlated strongly to SHAQ and VAS overall disease severity (|rs|=0.60 to -0.75). Ceiling effects (>15%) were found in six PROMIS-29 domains and in both FACIT-Dyspnea and Functional limitations. Four (4/5) hypotheses were confirmed. CONCLUSIONS: PROMIS-29 and FACIT-Dyspnea meet the requirements for reliability and have adequate construct validity in Swedish patients with SSc.Implications for rehabilitationPROMIS-29v2 and Functional Assessment of Chronic Illness Therapy-Dyspnea (FACIT-Dyspnea) Index are patient outcome measures that gain increasing interest for the evaluation of patient with rheumatologic diseases.PROMIS-29v2 and FACIT-Dyspnea Index meet the requirements for reliability and have adequate construct validity compared to legacy measures in Swedish patients with systemic sclerosis.Translation and validation of PROMs is important for studies of rare diseases in multi-center collaborations.

Perceived stigma in adults with epilepsy in Sweden and associations with country of birth, socioeconomic status, and mental health.

BACKGROUND: Stigma contributes to negative health outcomes and amplifies health disparities in epilepsy. This study aimed to investigate associations of perceived stigma with the country of birth and socioeconomic status (SES). METHODS: This is a cross-sectional questionnaire study. Participants were recruited consecutively from three demographically different neurology outpatient clinics in the southwest of Sweden. Participants responded to a questionnaire concerning their epilepsy, country of birth, mother tongue, and different SES-variables. The Neuro-QOL stigma scale and the Jacoby stigma scale were applied to assess stigma and the Hospital Anxiety and Depression Scale (HADS) and PROMIS Mental Health scale were applied to assess mental health. RESULTS: In total 161 adults with epilepsy were included in the cohort. The median Neuro-QOL stigma score was 48.3, and was higher among foreign-born than in native-born participants (foreign-born in non-European country 52.3, in other European country 49.8, and in native-born 47.0, p = 0.003). Other factors associated with Neuro-QOL were seizure frequency last year (≥2 seizures 52.4 compared to 1 seizure 50.9 and no seizures 44.3, p < 0.001), having had seizures in public (yes 50.9 compared to no 44.7, p = 0.035), HADS depression score ≥11 (57.4 compared to 47.8 for score <11 points, p < 0.001), HADS anxiety score ≥11 (53.5 compared to 46.8 for score <11 points, p < 0.001), and lower PROMIS Mental Health score (42.9 for PROMIS < 40 compared to 54.4 for PROMIS > 60, p < 0.01). A stepwise multiple regression analysis indicated that having had seizures the last year increased the average Neuro-QOL stigma score with 5.89 and appeared as the most determining factor for the Neuro-QOL stigma score among the variables investigated. CONCLUSIONS: It is important that the concerns of foreign-born patients are acknowledged and that the focus of seizure control and the detection and treatment of comorbidities are prioritized in the management of epilepsy and perceived stigma.

Factors of family impact in a Swedish-German cohort of children born with esophageal atresia.

BACKGROUND: After repair of esophageal atresia (EA), childhood survivors commonly present with digestive and respiratory morbidity, and around 55% have associated anomalies. Although it is known that these problems can reduce health-related quality of life in children with EA, less is understood about the impact on the family. We aimed to identify factors related to family impact in children with EA. METHODS: One parent each of a child with EA (2-18 years) in 180 families from Sweden and Germany answered the PedsQL™ Family Impact Module as the dependent variable. The independent variables were the child's parent-reported health-related quality of life as measured by PedsQL™ 4.0, current symptoms, school situation, and parent/family characteristics together with child clinical data from the medical records. RESULTS: Stepwise multivariable regression analysis showed a multifactorial model of the total family impact scores (R2 = 0.60), with independent factors being the child's overall generic health-related quality of life, school-absence ≥ 1/month, severe tracheomalacia, a family receiving carer's allowance, and a parent with no university/college education, p < 0.05. Logistic regression analysis showed that an increased number of symptoms in the child the preceding 4 weeks lowered the family impact scores; however, the child's feeding (R2 = 0.35) and digestive symptoms (R2 = 0.25) explained more in the variation of scores than the child's respiratory symptoms (R2 = 0.09), p < 0.0001. CONCLUSIONS: Family functioning may be a contributing factor to the maintenance of child health. The study findings suggest multifactorial explanations to family impact in children with EA, which are essential when optimizing the support to these families in clinical and psychosocial practice. Future research should explore experiences of family impact from all family members' perspectives and multicenter studies are warranted to understand better the effectiveness of psychosocial-educational interventions to families of children with EA.

The Development of an mHealth Tool for Children With Long-term Illness to Enable Person-Centered Communication: User-Centered Design Approach.

BACKGROUND: Children with long-term illnesses frequently experience symptoms that could negatively affect their daily lives. These symptoms are often underreported in health care. Despite a large number of mobile health (mHealth) tools, few are based on a theoretical framework or supported by scientific knowledge. Incorporating universal design when developing a product can promote accessibility and facilitate person-centered communication. OBJECTIVE: The aim of this study is to identify the symptom-reporting needs of children with cancer and congenital heart defects that could be satisfied by using a mobile app. Another aim is to evaluate how the child might interact with the app by considering universal design principles and to identify parents' views and health care professionals' expectations and requirements for an mHealth tool. METHODS: User-centered design is an iterative process that focuses on an understanding of the users. The adapted user-centered design process includes 2 phases with 4 stages. Phase 1 involved interviews with 7 children with long-term illnesses, 8 parents, and 19 health care professionals to determine their needs and wishes for support; a workshop with 19 researchers to deepen our understanding of the needs; and a workshop with developers to establish a preliminary tool to further investigate needs and behaviors. Phase 2 involved interviews with 10 children with long-term illnesses, 9 parents, and 21 health care professionals to evaluate the mock-up (prototype) of the mHealth tool. Data were synthesized using the interpretive description technique. RESULTS: A total of 4 aspects of needs emerged from the synthesis of the data, as follows: different perspectives on provided and perceived support; the need for an easy-to-use, non-clinic-based tool to self-report symptoms and to facilitate communication; the need for safety by being in control and reaching the child's voice; and a way of mapping the illness journey to facilitate recall and improve diagnostics. The children with long-term illnesses expressed a need to not only communicate about pain but also communicate about anxiety, fatigue, fear, and nausea. CONCLUSIONS: The findings of this study indicated that the PicPecc (Pictorial Support in Person-Centered Care for Children) app is a potential solution for providing communicative support to children with long-term illnesses dealing with multiple symptoms and conditions. The interview data also highlighted symptoms that are at risk of being overlooked if they are not included in the mobile app. Further studies are needed to include usability testing and evaluation in hospitals and home care settings.

A Standard Set of Value-Based Patient-Centered Outcomes and Measures of Overall Health in Adults.

BACKGROUND: The definition of population-specific outcomes is an essential precondition for the implementation of value-based health care. We developed a minimum standard outcome set for overall adult health (OAH) to facilitate the implementation of value-based health care in tracking, comparing, and improving overall health care outcomes of adults across multiple conditions, which would be of particular relevance for primary care and public health populations. METHODS: The International Consortium for Health Outcomes Measurement (ICHOM) convened an international panel (patients, clinicians, and topic experts). Following the development of a conceptual framework, a modified Delphi method (supported by public consultations) was implemented to identify, in sequence, the relevant domains, the best instruments for measuring them, the timing of measurement, and the relevant adjustment variables. FINDINGS: Outcomes were identified in relation to overall health status and the domains of physical, mental, and social health. Three instruments covering these domains were identified: PROMIS Scale v1.2-Global Health (10 items), WHO Wellbeing Index (5 items), and the WHO Disability Assessment Schedule 2.0 (12 items). Case-mix variables included a range of sociodemographic and biometric measures. Yearly measurement was proposed for all outcomes and most case-mix variables. INTERPRETATION: The ICHOM OAH Standard Set has been developed through consensus-based methods based on predefined criteria following high standards for the identification and selection of high-quality measures The involvements of a wide range of stakeholders supports the acceptability of the set, which is readily available for use and feasibility testing in clinical settings.

Features of Childhood Growth, Lifestyle, and Environment Associated with a Cardiometabolic Risk Score in Young Adults.

INTRODUCTION: In young adults, metabolic syndrome (MS) is rare. To better assess the risks for future cardiovascular disease (CVD), a cardiometabolic score can be used, ranking the disease risk in each subject. The score is a continuous variable, summarizing the individual z-scores for waist circumference, blood pressure, blood levels of glucose, triglycerides, and high-density-lipoprotein cholesterol. Our main aim was to assess the association between early childhood growth and the cardiometabolic score in young adults. METHODS: Study participants were recruited among subjects in the longitudinal population-based GrowUp 1990 Gothenburg study. Those with information on weight and length at birth, as well as weight, height, waist circumference, and parental body mass index (BMI) at 10 years of age were invited to participate in a health survey at 18-20 years of age. Five hundred and thirteen young adults (female 51%) were included. Multivariable linear stepwise regression analysis was applied. RESULTS: The mean (standard deviation) BMI was 22.2 (3.26) in males and 21.3 (2.69) kg/m2 in females; the cardiometabolic score was 0.24 (3.12) and -0.22 (3.18), respectively. A statistically significantly higher score (p < 0.001) was seen in individuals with MS, as defined by IDF. After controlling for adult lifestyle features, the BMI z-score at 10 years of age was a significant risk factor in both sexes for an elevated cardiometabolic score in early adulthood with mean [standard error] beta 0.47 [0.19], p = 0.014 in males, and 0.82 [017], p < 0.0001 in females. In males, a high maternal BMI and low age at adiposity rebound and in females, high birth weight were also associated with a statistically significant risk. Additionally, contraceptive use in females was a risk factor for an elevated cardiometabolic score and in males, a high lifestyle-related index score showed a protective association with the cardiometabolic score. CONCLUSION: A high BMI z-score at 10 years of age is a risk factor for the cardiometabolic state in young adults, an outcome pointing to the preventive potential of monitoring BMI in 10-year-old schoolchildren. This finding must however be validated in a new large cohort. Moreover, in young adults in whom MS is rare, the cardiometabolic score seems to be a promising and more powerful tool to detect risks for CVD later in life than using MS categorization.

Psychometrics of three Swedish physical pediatric item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS)®: pain interference, fatigue, and physical activity.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS®) aims to provide self-reported item banks for several dimensions of physical, mental and social health. Here we investigate the psychometric properties of the Swedish pediatric versions of the Physical Health item banks for pain interference, fatigue and physical activity which can be used in school health care and other clinical pediatric settings. Physical health has been shown to be more important for teenagers' well-being than ever because of the link to several somatic and mental conditions. The item banks are not yet available in Sweden. METHODS: 12- to 19-year-old participants (n = 681) were recruited in public school settings, and at a child- and psychiatric outpatient clinic. Three one-factor models using CFA were performed to evaluate scale dimensionality. We analyzed monotonicity and local independence. The items were calibrated by fitting the graded response model. Differential Item analyses (DIF) for age, gender and language were calculated. RESULTS: As part of the three one-factor models, we found support that each item bank measures a unidimensional construct. No monotonicity or local dependence were found. We found that 11 items had significant lack of fit in the item response theory (IRT) analyses. The result also showed DIF for age (seven items) and language (nine items). However, the differences on item fits and effect sizes of McFadden were negligible. After considering the analytic results, graphical illustration, item content and clinical relevance we decided to keep all items in the item banks. CONCLUSIONS: We translated and validated the U.S. PROMIS item banks pain interference, fatigue and physical activity into Swedish by applying CFA, IRT and DIF analyses. The results suggest adequacy of the translations in terms of their psychometrics. The questionnaires can be used in school health and other pediatric care. Future studies can be to use Computerized Adaptive Testing (CAT), which provide fewer but reliable items to the test person compared to classical testing.

Swedish translation and cross-cultural adaptation of eight pediatric item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS)®.

BACKGROUND: This study is part of the Swedish initiative for the establishment of standardized, modern patient-reported measures for national use in Swedish healthcare. The goal was to translate and culturally adapt eight pediatric Patient-Reported Outcomes Measurement Information System (PROMIS®) item banks (anger, anxiety, depressive symptoms, family relationships, fatigue, pain interference, peer relationships and physical activity) into Swedish. METHODS: Authorization to translate all currently available pediatric PROMIS item banks (autumn, 2016) into Swedish was obtained from the PROMIS Health Organization. The translation followed the Functional Assessment of Chronic Illness Therapy translation recommendations with one major modification, which was the use of a bilingual multi-professional review workshop. The following steps were applied: translation, reconciliation, a two-day multi professional reviewer workshop, back translation, and cognitive debriefing with eleven children (8-17 years) before final review. The bilingual multi-professional review workshop provided a simultaneous, in-depth assessment from different professionals. The group consisted of questionnaire design experts, researchers experienced in using patient-reported measures in healthcare, linguists, and pediatric healthcare professionals. RESULTS: All item banks had translation issues that needed to be resolved. Twenty-four items (20.7%) needed resolution at the final review stage after cognitive debriefing. The issues with translations included 1. Lack of matching definitions with items across languages (6 items); 2. Problems related to language, vocabulary, and cultural differences (6 items); and 3. Difficulties in adaptation to age-appropriate language (12 items). CONCLUSIONS: The translated and adapted versions of the eight Swedish pediatric PROMIS item banks are linguistically acceptable. The next stage will be cross-cultural validation studies in Sweden. Despite the fact that there are cultural differences between Sweden and the United States, our translation processes have successfully managed to address all issues. Expert review groups from already-established networks and processes regarding pediatric healthcare throughout the country will facilitate the future implementation of pediatric PROMIS item banks in Sweden.

Evaluating pictorial support in person-centred care for children (PicPecc): a protocol for a crossover design study.

INTRODUCTION: This study protocol outlines the evaluation of the pictorial support in person-centred care for children (PicPecc). PicPecc is a digital tool used by children aged 5-17 years to self-report symptoms of acute lymphoblastic leukaemia, who undergo high-dose methotrexate treatments. The design of the digital platform follows the principles of universal design using pictorial support to provide accessibility for all children regardless of communication or language challenges and thus facilitating international comparison. METHODS AND ANALYSIS: Both effect and process evaluations will be conducted. A crossover design will be used to measure the effect/outcome, and a mixed-methods design will be used to measure the process/implementation. The primary outcome in the effect evaluation will be self-reported distress. Secondary outcomes will be stress levels monitored via neuropeptides, neurosteroids and peripheral steroids indicated in plasma blood samples; frequency of in-app estimation of high levels of distress by the children; children's use of analgesic medicine and person centeredness evaluated via the questionnaire Visual CARE Measure. For the process evaluation, qualitative interviews will be carried out with children with cancer, their legal guardians and case-related healthcare professionals. These interviews will address experiences with PicPecc in terms of feasibility and frequency of use from the child's perspective and value to the caseworker. Interview transcripts will be analysed using an interpretive description methodology. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Swedish Ethical Review Authority (reference 2019-02392; 2020-02601; 2020-06226). Children, legal guardians, healthcare professionals, policymaking and research stakeholders will be involved in all stages of the research process according to Medical Research Council's guidelines. Research findings will be presented at international cancer and paediatric conferences and published in scientific journals. TRIAL REGISTRATION: ClinicalTrials.gov; NCT04433650.