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Background Comprehensive School Health (CSH) is an internationally recognized approach that transforms the whole school environment and culture of the school, while wholistically addressing school health. Research has demonstrated the effectiveness of taking a CSH approach to support the creation of health-enhancing behaviors among students while also improving educational outcomes. Despite its effectiveness, there is currently a lack of evaluative tools for schools and school authorities (i.e., school districts, divisions, boards) to measure wholistic shifts in school culture and the conditions present to support implementation. Methods Using a sequential mixed-methods approach, we developed and piloted a tool for use by schools and school authorities to plan and evaluate their CSH efforts using the previously established Essential Conditions for taking a CSH Approach . Phase 1 utilized a qualitative, participatory approach to develop the tool and assess face and content validity. Phase 2 utilized a quantitative approach to pilot test and examine the construct validity, and internal consistency of the instrument. Results Phase 1 results provide evidence of content/face validity for the instrument, with Phase 2 providing promising results indicating high reliability of many of the survey items and mixed results for construct validity, likely due to sample size limitations. At the school level all but one Essential Condition reached an acceptable level of internal consistency (Cronbach’s alpha less than 0.70), and six of eight Essential Conditions at the school-authority level met the acceptable threshold value. At the school level, standardized root mean squared residual (SRMR) values for all but one Essential Condition indicated a good fit; at the school-authority level, SRMR values for six of eight Essential Conditions indicated a good fit. As most analyses did not produce chi-square estimates, model fitting results are interpreted with caution. Conclusions This study adds to the existing knowledge base for CSH implementation, through the development of a user-friendly evaluative tool for ongoing data collection related to healthy school community process indicators, with encouraging pilot results. This has important practical application and can benefit the broad adoption, scaling, and long-term evaluation of interventions taking a CSH approach.

While it is well-known that being emotionally competent contributes to improving the well-being and academic performance of students, there are few validated Spanish instruments that can assist teachers in assessing emotional competencies in early primary education children. In this study, we present the development and validation of the Emotional Development on Early Primary Education Scale (EDEPES) for students aged between 5 and 8 years. The study included a sample of 1113 students enrolled in the first and second grades of primary education in different educational centers in Spain. A preliminary version of the questionnaire with around 41 items was distributed, along with measures of anxiety (CAS) and academic performance (average score). These measures were taken at two time points with a 6-month interval. The results supported a 4-factor model of 28 items, comprising emotional competencies of emotional awareness, emotion regulation, emotional autonomy, and social competence, along with a higher-order factor to measure overall emotional competence. The EDEPES-28 demonstrated satisfactory reliability and criterion validity, showing significant associations with anxiety and academic performance. Furthermore, the results supported the assumptions of measurement invariance, revealing gender differences in both courses, with these distinctions being more pronounced in the second course, and girls obtaining higher scores. In conclusion, the EDEPES-28 proves to be a useful and easy-to-use instrument for teachers to assess the emotional competencies of early primary education students.

Background Financial toxicity from cancer treatments is rising as an important patient-reported outcome. Its relevance was first assessed in the context of privately financed healthcare system, where the financial hardship caused by out-of-pocket payments negatively affects survival, while fewer evidence exists on its role in countries where care is financed by the public health care system. Head and Neck Cancer (HNC) patients face an increased risk for financial toxicity due to multimodal treatment and relevant out of pocket costs. The aim of this study was to develop and validate an Italian version of the Canadian Financial Index of Toxicity (FIT) questionnaire, defined FITALY. Methods FIT questionnaire was translated through a forward-backward process by two investigators independently, and the process was reviewed by a certified medical scientific English native speaker. Once reached consensus upon Italian translation, two Health Economics experts were consulted to adapt the questionnaire to Italian socio-economic context. The FITALY questionnaire v1.0 hereby developed was anonymously administered to two consecutive groups of 30 patients who had received curative, multimodal treatment for HNC cancer at ASST Spedali Civili of Brescia, Italy. A cognitive debriefing form was simultaneously administered to ask patients to exclude recurring and redundant items and include new relevant items. Results The 14-item FITALY questionnaire provides a global evaluation of financial toxicity ranging from 0 to 100. The questionnaire is divided into 4 domains: financial burden (6 items), exploring the objective financial toxicity burden; financial distress (2 items), which refers to the psychological distress related to financial toxicity; out-of-pocket costs (4 items), which focus on medical expenses paid by the patient; and loss of productivity (2 items), that investigates the disease impact on both patient’s and caregiver’s job activity. Conclusions Starting from the Canadian 9-item FIT questionnaire, we developed and validated the Italian 14-item FITALY questionnaire. Prospective application to a cohort of Italian HNC patients is ongoing.

Suicidality in the child and adolescent population is a major public health concern. There is, however, a lack of developmentally sensitive valid and reliable instruments that can capture data on risk, and clinical and psychosocial mediators of suicidality in young people. In this study, we aimed to develop and assess the validity of instruments evaluating the psychosocial risk and protective factors for suicidal behaviours in the adolescent population. In Phase 1, based on a systematic literature review of suicidality, focus groups, and expert panel advice, the risk factors and protective factors (resilience factors) were identified and the adolescent, parent, and clinician versions of the STOP-Suicidality Risk Factors Scale (STOP-SRiFS) and the Resilience Factors Scale (STOP-SReFS) were developed. Phase 2 involved instrument validation and comprised of two samples (Sample 1 and 2). Sample 1 consisted of 87 adolescents, their parents/carers, and clinicians from the various participating centres, and Sample 2 consisted of three sub-samples: adolescents (n = 259) who completed STOP-SRiFS and/or the STOP-SReFS scales, parents (n = 213) who completed one or both of the scales, and the clinicians who completed the scales (n = 254). The STOP-SRiFS demonstrated a good construct validity—the Cronbach Alpha for the adolescent (α = 0.864), parent (α = 0.842), and clinician (α = 0.722) versions of the scale. Test–retest reliability, inter-rater reliability, and content validity were good for all three versions of the STOP-SRiFS. The sub-scales generated using Exploratory Factor Analysis (EFA) were the (1) anxiety and depression risk, (2) substance misuse risk, (3) interpersonal risk, (4) chronic risk, and (5) risk due to life events. For the STOP-SRiFS, statistically significant correlations were found between the Columbia-Suicide Severity Rating Scale (C-SSRS) total score and the adolescent, parent, and clinical versions of the STOP-SRiFS sub-scale scores. The STOP-SRiFS showed good psychometric properties. This study demonstrated a good construct validity for the STOP-SReFS—the Cronbach Alpha for the three versions were good (adolescent: α = 0.775; parent: α = 0.808; α = clinician: 0.808). EFA for the adolescent version of the STOP-SReFS, which consists of 9 resilience factors domains, generated two factors (1) interpersonal resilience and (2) cognitive resilience. The STOP-SReFS Cognitive Resilience sub-scale for the adolescent was negatively correlated (r = − 0.275) with the C-SSRS total score, showing that there was lower suicidality in those with greater Cognitive Resilience. The STOP-SReFS Interpersonal resilience sub-scale correlations were all negative, but none of them were significantly different to the C-SSRS total scores for either the adolescent, parent, or clinician versions of the scales. This is not surprising, because the items in this sub-scale capture a much larger time-scale, compared to the C-SSRS rating period. The STOP-SReFS showed good psychometric properties. The STOP-SRiFS and STOP-SReFS are instruments that can be used in future studies about suicidality in children and adolescents.

This article describes the development and validation of a survey instrument, the Writing Strategies for Motivational Regulation Questionnaire ( WSMRQ ), designed to measure Chinese university students’ reported use of motivational regulation strategies in writing in English as a second/foreign language (L2). Conceptualized in a self-regulated learning framework, the WSMRQ was developed and validated. Two independent samples of 359 and 373 Chinese university students were recruited. The data were subject to exploratory factory analyses (EFA) and confirmatory factor analyses (CFA), respectively, to evaluate the psychometric properties of the instrument. Results of the EFA revealed a five-factor structure of motivational regulation strategies: Interesting enhancement, performance self-talk, mastery self-talk, emotional control, and environment structuring. The CFA results from another sample supported a five-factor correlated model with the best fit, confirming the validity and reliability of the WSMRQ. The significant, moderate correlations between the five motivational regulation strategies and writing scores showed the instrument's reasonable predictive validity. Pedagogical implications are also discussed.

IntroductionRett syndrome (RTT) is a pervasive neurodevelopmental disorder that presents with deficits in brain functioning leading to language and learning regression, characteristic hand stereotypies and developmental delay. Different mutations in the gene implicated in RTT—methyl-CpG-binding protein 2 (MECP2) establishes RTT as a disorder with divergent symptomatology ranging from individuals with severe to milder phenotypes. A reliable and single multidimensional questionnaire is needed that can embrace all symptoms, and the relationships between them, and can map clinically meaningful data to symptomatology across the lifespan in patients with RTT. As part of the HealthTracker-based Tailored Rett Intervention and Assessment Longitudinal (TRIAL) database, the Rett Evaluation of Symptoms and Treatments (REST) Questionnaire will be able to marry with the physiological aspects of the disease obtained using wearable sensor technology, along with genetic and psychosocial data to stratify patients. Taken together, the web-based TRIAL database will empower clinicians and researchers with the confidence to delineate between different aspects of disorder symptomatology to streamline care pathways for individuals or for those patients entering clinical trials. This protocol describes the anticipated development of the REST questionnaire and the TRIAL database which links with the outcomes of the wearable sensor technology, and will serve as a barometer for longitudinal patient monitoring in patients with RTT.Methods and analysisThe US Food and Drug Administration Guidance for Patient-Reported Outcome Measures will be used as a template to inform the methodology of the study. It will follow an iterative framework that will include item/concept identification, item/concept elicitation in parent/carer-mediated focus groups, expert clinician feedback, web-based presentation of questionnaires, initial scale development, instrument refinement and instrument validation.Ethics and disseminationThe study has received favourable opinion from the National Health Service (NHS) Research Ethics Committee (REC): NHS Research Ethics Committee (REC)—London, Bromley Research Ethics Committee (reference: 15/LO/1772).

Human papillomavirus (HPV) is a highly widespread virus which is responsible for one of the most common sexually transmitted infections. Two main preventative strategies exist: anti-HPV vaccination and cervical screening. Health-care workers play a key role in promoting public health campaigns; however, vaccine hesitancy is an often under-recognized challenge. To investigate the overall knowledge of HPV and HPV-related issues, as well as the attitudes and practices of health professionals towards recommending the anti-HPV vaccine, an ad hoc knowledge, attitudes, and practices (KAP) questionnaire was developed and validated in a sample of 139 Israeli pediatricians, gynecologists, and internal medicine doctors. The KAP questionnaire was found to be psychometrically valid and sound (with an rKR-20 coefficient of 0.74 for the second part and a Cronbach’s alpha of 0.85 for the third part). Furthermore, the present study confirmed the importance of health-care providers in recommending the immunization practice. Parents that had been strongly advised by health-care providers to vaccinate their children accepted immunization for their girls (odds ratio (OR) 1.09 (95% CI 1.04–1.14)) and boys (OR 1.06 (95% CI 1.02–1.10)), had a lower probability of deciding to postpone the immunization appointment (OR 0.81 (95% CI 0.66–0.98)), had fewer doubts and concerns about the vaccine (OR 0.69 (95% CI 0.54–0.89)), and had a lower probability of refusing the vaccination (OR 0.93 (95% CI 0.86–0.99)). Interestingly, the use of new, emerging tools such as ad hoc websites, applications, and other interactive devices reduced vaccine hesitancy (OR 0.90 (95% CI 0.82–0.99)) and concerns about the side-effects of the vaccine (OR 0.92 (95% CI 0.86–0.99)). However, among Israeli health-care workers, knowledge was generally moderate, with updated information lacking in about 30% of surveyed health-care providers and approximately 20% of them not recommending the anti-HPV vaccine among boys. This study has practical implications for policy- and decision-makers in that they should be aware of the overall level of knowledge among health-care workers and should implement ad hoc educational interventions to address gaps in knowledge and help medical providers routinely recommend the anti-HPV vaccine both to male and female children and adolescents.

Background The theoretical framework of acceptability (TFA) was developed in response to recommendations that acceptability should be assessed in the design, evaluation and implementation phases of healthcare interventions. The TFA consists of seven component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy) that can help to identify characteristics of interventions that may be improved. The aim of this study was to develop a generic TFA questionnaire that can be adapted to assess acceptability of any healthcare intervention. Methods Two intervention-specific acceptability questionnaires based on the TFA were developed using a 5-step pre-validation method for developing patient-reported outcome instruments: 1) item generation; 2) item de-duplication; 3) item reduction and creation; 4) assessment of discriminant content validity against a pre-specified framework (TFA); 5) feedback from key stakeholders. Next, a generic TFA-based questionnaire was developed and applied to assess prospective and retrospective acceptability of the COVID-19 vaccine. A think-aloud method was employed with two samples: 10 participants who self-reported intention to have the COVID-19 vaccine, and 10 participants who self-reported receiving a first dose of the vaccine. Results 1) The item pool contained 138 items, identified from primary papers included in an overview of reviews. 2) There were no duplicate items. 3) 107 items were discarded; 35 new items were created to maximise coverage of the seven TFA constructs. 4) 33 items met criteria for discriminant content validity and were reduced to two intervention-specific acceptability questionnaires, each with eight items. 5) Feedback from key stakeholders resulted in refinement of item wording, which was then adapted to develop a generic TFA-based questionnaire. For prospective and retrospective versions of the questionnaire, no participants identified problems with understanding and answering items reflecting four TFA constructs: affective attitude, burden, perceived effectiveness, opportunity costs. Some participants encountered problems with items reflecting three constructs: ethicality, intervention coherence, self-efficacy. Conclusions A generic questionnaire for assessing intervention acceptability from the perspectives of intervention recipients was developed using methods for creating participant-reported outcome measures, informed by theory, previous research, and stakeholder input. The questionnaire provides researchers with an adaptable tool to measure acceptability across a range of healthcare interventions.

This paper introduces a new definition for burnout and investigates the psychometric properties of the Burnout Assessment Tool (BAT). In a prior qualitative study, 49 practitioners were interviewed about their conceptualization of burnout (part 1). Using a dialectical approach, four core dimensions—exhaustion, mental distance, and impaired emotional and cognitive impairment—and three secondary dimensions—depressed mood, psychological distress, and psychosomatic complaints—emerged, which constitute the basis of the BAT. In the second study, the psychometric characteristics of the BAT were investigated in a representative sample of 1500 Flemish employees, focusing on factorial validity, reliability, and construct validity, respectively. Results demonstrate the assumed four-factor structure for the core dimensions, which is best represented by one general burnout factor. Contrary to expectations, instead of a three-factor structure, a two-factor structure was found for the secondary dimensions. Furthermore, the BAT and its subscales show adequate reliability. Convergent validity and discriminant validity with other burnout measures—including the MBI and OLBI—was demonstrated, as well as discriminant validity with other well-being constructs, such as work engagement and workaholism.

Background Content validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM's content validity and grading the quality of the evidence in systematic reviews of PROMs. Methods An online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales ('strongly disagree' to 'strongly agree'), and provided arguments for their ratings. Results Discussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM. Discussion The consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice.