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Background Colorectal cancer (CRC) screening for average risk adults age 45 and older continues to be underutilized in the USA. One factor consistently associated with CRC screening completion is clinician recommendation. Understanding the barriers and facilitators of clinical adoption of emerging CRC screening strategies is important in developing effective intervention strategies to improve CRC screening rates. We aimed to develop a questionnaire based on the Theoretical Domains Framework (TDF) to assess determinants of clinical adoption of novel CRC screening strategies, using the multi-target stool DNA test (mt-sDNA; Cologuard®) as an example, and test the psychometric properties of this questionnaire on a sample of US clinicians. Methods A web survey was administered between November and December 2019 to a national panel of clinicians including primary care clinicians (PCCs) and gastroenterologists (GIs) to assess 10 TDF constructs with 55 items. Confirmatory factor analysis (CFA) was used to examine whether the a priori domain structure was supported by the data. Discriminant validity of domains was tested with Heterotrait-Monotrait ratio (HTMT). Internal consistency for each scale was assessed using Cronbach’s alpha. Criterion validity was assessed with self-reported mt-sDNA use and mt-sDNA recommendation as the outcomes. Results Complete surveys were received from 814 PCCs and 159 GIs (completion rate, 24.7% of 3299 PCCs and 29.6% of 538 GIs). Providers were excluded from analysis if they indicated not recommending CRC screening to average-risk patients (final N = 973). The final questionnaire consisted of 38 items covering 5 domains: (1) knowledge; (2) skills; (3) identity and social influence; (4) optimism, beliefs about consequences, and intentions; and (5) environmental context and resources. CFA results confirmed a reasonable fit (CFI = 0.948, SRMR = 0.057, RMSEA = 0.080). The domains showed sufficient discriminant validity (HTMT < 0.85), good internal consistency (McDonald’s omega > 0.76), and successfully differentiated providers who reported they had ordered mt-sDNA from those who never ordered mt-sDNA and differentiated providers who reported routinely recommending mt-sDNA from those who reported not recommending mt-sDNA. Conclusions Findings provide initial evidence for the validity and internal consistency of this TDF-based questionnaire in measuring potential determinants of mt-sDNA adoption for average-risk CRC screening. Further investigation of validity and reliability is needed when adapting this questionnaire to other novel CRC screening strategy contexts.

Background Given the importance of screening pregnant women’s distress, it was intended to investigate the psychometric properties of the Persian version of the Tilburg Pregnancy Distress Scale (TPDS-P) for screening pregnancy distress. Methods This methodological psychometric study was conducted with participation of 360 pregnant women. The TPDS was translated into Persian. Factor analysis was used to investigate the construct validity. The results of the correlation test between the results of the two questionnaires, Depression Anxiety Stress Scales-21 (DASS-21) and TPDS-P, were used to determine the criterion validity of TPDS-P. Internal consistency of the items was calculated by the Cronbach's alpha coefficient. Stability of the results was examined by test-retest method and Intra-class Correlation Coefficient (ICC) was calculated. Examining the structure of the factors derived from exploratory factor analysis, fitness of the model was done through confirmatory factor analysis. Statistical analysis was done using SPSS software. Results Kaiser-Meyer-Olkin (KMO) was 0.846 (p = 0.001). Sixteen items of TPDS-P accounted for 51.42 percent variances. The TPDS-P exhibited appropriate fitness. There was poor to moderate but significant direct correlation between the subscales of DASS-21 and TPDS-P. Cronbach’s alpha coefficient of the TPDS-P was 0.81 and ICC was 0.70. Conclusions TPDS-P, with appropriate validity and reliability, can be used as a practical scale to evaluate women's distress during pregnancy in Farsi-speaking societies.

Background Clinical experience is a crucial activity for nursing students. The way students` perceive clinical placement exerts an immense influence on the learning process. This study aims to test the psychometric properties of a 19-item version of the Clinical Learning Environment Inventory under Polish clinical conditions. Method For this study, Discriminant validity and Cronbach’s alpha reliabilities were computed. In order to measure content validity, the criterion validity Generalized Self Efficacy Scale and the Life Orientation Test - Revised were used. Results Cronbach’s Alpha for the Clinical Facilitator Support of Learning Scale and the Satisfaction with Clinical Placement scale is 0.949 and 0.901, respectively. The Spearman’s rank correlation coefficient indicates the existence of a positive correlation between the students’ satisfaction with clinical placement and their [overall] life optimism. Age correlates negatively with perceived teacher support and positively with satisfaction with clinical placement. The sense of self-efficacy correlates negatively with their satisfaction with clinical placement. Clinical Learning Environment Inventory − 19 could be a useful tool to evaluate the quality of the clinical learning process in Polish conditions.

Background There is extensive concern about older people’s care in institutions, especially recently in the past years. One of the reasons is linked to the cases of elder abuse, not only shown by academic and scientific sources, but also by social and mass media and their impact on public perception of the institutional setting. What is more, current COVID-19 pandemic consequences on older people have provoked alarm and worry especially about what is happening in institutions. Methods The sample for this study consists of 286 staff working in nursing homes in Spain. This study aimed to assess the psychometric properties of the Professional Good Care Scale in Nursing Homes (GCS-NH). Results Results of parallel analyses and exploratory factor analyses (EFAs) showed a four-factor model for the 32-item scale: humanization (9 items), non-infantilization (10 items), respect (7 items) and empowerment (6 items). Then, psychometric properties were tested analysing internal consistency (reliability) and convergent, divergent and criterion validity. High internal consistency (reliability) and different validity evidence were obtained for the total scores of the GCS-NH and its subscales. GCS-NH scores were also capable of detecting risk of probable institutional elder abuse. Conclusions Results show that this scale is an appropriate, valid, and reliable multidimensional instrument to evaluate good care in older institutionalized people by staff. Good care is an outcome of a complex construct in which a wide range of factors converge (staff, older people, and environmental characteristics). The GCS-NH has potential to be used as a multidimensional tool to assess good care.

Background Polish physicians and researchers lack an extensive and precise instrument in their native language for evaluating sexual dysfunction in individuals with neurogenic disorders. The aim of this study was to create a culturally adapted, validated, Polish language version of the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-15) for persons with multiple sclerosis (MS) and spinal cord injury (SCI). Methods International recommendations and standardized methods for instrument validation were followed. Sexually active patients with MS and SCI completed the MSISQ-15, International Index of Erection Function (IIEF-15, men), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-31, women). IIEF-15 and PISQ-31 were used as reference questionnaires. Responses were collected at baseline (test) and after 2 weeks (re-test). Results We recruited 299 Polish-speaking patients with MS or SCI. Interviews disclosed that the translated questionnaire had optimal content validity/cross-cultural adaptation. MSISQ-15 scores correlated significantly with the severity of sexual dysfunction as evaluated by IIEF-15 (r = − 0.487) and PISQ-31 (r = − 0.709). These correlations substantiated the high quality construct/criterion validity. An analysis of reliability presented good internal consistency (Cronbach’s alpha of 0.93 for the total score of MS patients and 0.86 for the total score of SCI patients) and reproducibility (intraclass correlation coefficients of 0.91 for the total score of MS patients and 0.92 for the total score of SCI patients). There were no ceiling or floor effects. Conclusions The Polish version of MSISQ-15 exhibited excellent measurement properties. It is a suitable and reliable instrument to assess sexual dysfunction in MS and SCI individuals. The Polish MSISQ-15 will enhance routine clinical practice and assist research for neurogenic patients in Poland.

Background Disability is a vital public health issue for health care programs. Affluent countries usually prioritize disability-related research, while often it remains neglected in resource-poor countries like Nepal. The aim of this study was to make available a translated and culturally adapted version of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) for measuring disability in the Nepalese population. Methods WHODAS 2.0 (12-items version) was translated into Nepali using a standard forward–backward translation protocol. Purposive and convenience recruitment of participants with psychiatric disabilities was done at the Psychiatry services in a tertiary care hospital. Age and gender-matched participants with physical disabilities were selected from the Internal Medicine department, and participants with no disability were recruited from their accompanying persons. A structured interview in Nepali including the translated WHODAS 2.0 was administered to all participants. Exploratory factor analysis and parallel analysis assessed the construct validity. Content validity was explored, and a quality of life instrument was used for establishing criterion validity. Reliability was measured via Cronbach alpha. Mann–Whitney test explored score differences between the disabled and non-disabled. Results In total, 149 persons [mean age: 40.6 (12.8); 43.6% males, 56.4% females; 61.7% disabled, 38.3% non-disabled] consented to participate. Parallel analysis indicated that a single factor was adequate for the Nepali WHODAS version that captured 45.4% of the total variance. The translated scale got a good Cronbach alpha (= 0.89). Satisfactory construct, content and criterion validity was found. The WHODAS total scores showed a significant difference between the disabled and non-disabled (U = 2002.5; p = 0.015). However, the difference between psychiatric and physical disabilities was not significant, which underscores that the scale is rating disability in general. Conclusion The one-factor structure of the translated and culturally adapted Nepali-version of WHODAS 2.0 showed acceptable validity and an adequate reliability. For epidemiological research purposes, this version of WHODAS 2.0 is now available for measuring global disability in Nepal.

Background and objective Quality of life (QoL) is a multi-dimensional concept and its assessment is one of important themes of care for older people. Assessing QoL in older people needs specific scales. The aim of this study was to culturally adapt and investigate the psychometric properties of the Persian version of brief Older People’s Quality of Life questionnaire (OPQOL-brief) in an Iranian older population. Methods This methodological cross-sectional study was conducted among 525 Persian-speaking older people (aged 60 and over), living in Isfahan, Iran. Translation of the OPQOL-brief questionnaire was performed using forward–backward method. Test–retest reliability was evaluated through Intra Class Correlation (ICC) coefficient and internal consistency by using Cronbach’s α. Construct validity was investigated by using exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and Latent class analysis (LCA). Criterion, convergent and discriminant validities were also assessed. Results Persian version of the OPQOL-brief showed good test–retest reliability (ICC = 0.842, 95% CI = 0.73–0.91; P P Conclusion The Persian version of the OPQOL-brief is a reliable and valid instrument for assessing QoL with applicability in a broad range of older Persian language population.

Background This study explores the factor structure of the Indonesian version of the GHQ-12 based on several theoretical perspectives and determines the threshold for optimum sensitivity and specificity. Through a focus group discussion, we evaluate the practicality of the GHQ-12 as a screening tool for mental health problems among adult primary care patients in Indonesia. Methods This is a prospective study exploring the construct validity, criterion validity and reliability of the GHQ-12, conducted with 676 primary care patients attending 28 primary care clinics randomised for participation in the study. Participants’ GHQ-12 scores were compared with their psychiatric diagnosis based on face-to-face clinical interviews with GPs using the CIS-R. Exploratory and Confirmatory Factor Analyses determined the construct validity of the GHQ-12 in this population. The appropriate threshold score of the GHQ-12 as a screening tool in primary care was determined using the receiver operating curve. Prior to data collection, a focus group discussion was held with research assistants who piloted the screening procedure, GPs, and a psychiatrist, to evaluate the practicality of embedding screening within the routine clinic procedures. Results Of all primary care patients attending the clinics during the recruitment period, 26.7% agreed to participate (676/2532 consecutive patients approached). Their median age was 46 (range 18–82 years); 67% were women. The median GHQ-12 score for our primary care sample was 2, with an interquartile range of 4. The internal consistency of the GHQ-12 was good (Cronbach’s α = 0.76). Four factor structures were fitted on the data. The GHQ-12 was found to best fit a one-dimensional model, when response bias is taken into consideration. Results from the ROC curve indicated that the GHQ-12 is ‘fairly accurate’ when discriminating primary care patients with indication of mental disorders from those without, with average AUC of 0.78. The optimal threshold of the GHQ-12 was either 1/2 or 2/3 point depending on the intended utility, with a Positive Predictive Value of 0.68 to 0.73 respectively. The screening procedure was successfully embedded into routine patient flow in the 28 clinics. Conclusions The Indonesian version of the GHQ-12 could be used to screen primary care patients at high risk of mental disorders although with significant false positives if reasonable sensitivity is to be achieved. While it involves additional administrative burden, screening may help identify future users of mental health services in primary care that the country is currently expanding.

Background Depression affects about 30% of stroke survivors within 5 years. Timely diagnosis and management of post-stroke depression facilitate motor recovery and improve independence. The original version of the Patient Health Questionnaire-9 (PHQ-9) is recognized as a good screening tool for post-stroke depression. However, no validation studies have been undertaken for the use of the Thai PHQ-9 in screening for depression among Thai stroke patients. Methods The objectives were to determine the criterion validity and reliability of the Thai PHQ-9 in screening for post-stroke depression by comparing its results with those of a psychiatric interview as the gold standard. First-ever stroke patients aged ≥45 years with a stroke duration 2 weeks–2 years were administered the Thai PHQ-9. The gold standard was a psychiatric interview leading to a DSM-5 diagnosis of depressive disorder and adjustment disorder with a depressed mood. The summed-scored-based diagnosis of depression with the PHQ-9 was obtained. Validity and reliability analyses, and a receiver operating characteristic curve analysis, were performed. Results In all, 115 stroke patients with a mean age of 64 years (SD: 10 years) were enrolled. The mean PHQ-9 score was 5.2 (SD: 4.8). Using the DSM-5 criteria, 11 patients (9.6%) were diagnosed with depressive disorder, 12 patients (10.5%) were diagnosed with adjustment disorder with a depressed mood. Both disorders were combined as a group of post-stroke depression. The Thai PHQ-9 had satisfactory internal consistency (Cronbach’s alpha: 0.78). The algorithm-based diagnosis of the Thai PHQ-9 had low sensitivity (0.52) but very high specificity (0.94) and positive likelihood ratio (9.6). Used as a summed-scored-based diagnosis, an optimal cut-off score of six revealed a sensitivity of 0.87, specificity of 0.75, positive predictive value of 0.46, negative predictive value of 0.95, and positive likelihood ratio of 3.5. The area under the curve was 0.87 (95% CI: 0.78–0.96). Conclusions The Thai PHQ-9 has acceptable psychometric properties for detecting a mixture of major depression and adjustment disorder in post-stroke patients, with a recommended cut-off score of ≥6 for a Thai population.

Background As patient-reported outcome, the Child Oral Impacts on Daily Performances (C-OIDP) has been commonly used for assessing children’s oral health needs in order to facilitate oral health service planning. It was translated and cross-culturally adapted into Turkish in 2008. Since then, there is no study to assess its psychometric properties in Turkish child population. This cross–sectional study aimed to investigate the psychometric properties and factor structure of the Turkish version of the C-OIDP for use in Turkish primary school children. Methods The Turkish translated version was tested on a convenience sample of primary school children aged 11 to 12 years attending two public schools in Istanbul. Data were collected by clinical examinations, face-to-face interviews and self-completed questionnaires. The internal consistency, test–retest reliability, construct validity using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), criterion related validity (concurrent and discriminant) were evaluated. Results A total of 208 children were subjected to the tested the C-OIDP. Overall, 93.7% of them reported at least one oral impact in the last 3 months. The most frequently affected performances were “eating” (72.1%) and “cleaning mouth”, while the performance with the lowest impact was “studying” (13%). The internal consistency and reproducibility of the C-OIDP were acceptable, with a Cronbach’s alpha of 0.73 and an intra-class correlation coefficient of 0.83. The EFA yielded a two-factor model termed “functional limitation” and “psychosocial limitation”. CFA identified the two- factor model which fit the data better than the previously proposed three-factor model, namely physical, psychological and social health. Having malocclusion, the presence of gum disease, reported history of oral problems in the mouth, dissatisfaction with oral health, bad self-rated oral health and having a problem-oriented pattern of dental attendance were found to be the most important factors related to worse oral health- related quality of life, supporting its criterion–related validity. Conclusion This study provided preliminary evidence the psychometric properties of the C-OIDP index among Turkish school children aged 11–12 years. It may be applied to evaluate the oral health impact on quality of life in this population.

Background There is no physiotherapy-specific quality indicator tool available to evaluate physiotherapy care for people with hip and/or knee osteoarthritis (OA). This study aimed to develop a patient-reported quality indicator tool (QUIPA) for physiotherapy management of hip and knee OA and to assess its reliability and validity. Methods To develop the QUIPA tool, quality indicators were initially developed based on clinical guideline recommendations most relevant to physiotherapy practice and those of an existing generic OA quality indicator tool. Draft items were then further refined using patient focus groups. Test-retest reliability, construct validity (hypothesis testing) and criterion validity were then evaluated. Sixty-five people with hip and/or knee OA attended a single physiotherapy consultation and completed the QUIPA tool one, twelve- and thirteen-weeks after. Physiotherapists (n = 9) completed the tool post-consultation. Patient test-retest reliability was assessed between weeks twelve and thirteen. Construct validity was assessed with three predefined hypotheses and criterion validity was based on agreement between physiotherapists and participants at week one. Results A draft list of 23 clinical guideline recommendations most relevant to physiotherapy was developed. Following feedback from three patient focus groups, the final QUIPA tool contained 18 items (three subscales) expressed in lay language. The test-retest reliability estimates (Cohen’s Kappa) for single items ranged from 0.30–0.83 with observed agreement of 64–94%. The intraclass correlation coefficient (ICC) and 95% confidence interval (CI) for the Assessment and Management Planning subscale was 0.70 (0.54, 0.81), Core Recommended Treatments subscale was 0.84 (0.75, 0.90), Adjunctive Treatments subscale was 0.70 (0.39, 0.87) and for the total QUIPA score was 0.80 (0.69, 0.88). All predefined hypotheses regarding construct validity were confirmed. However, agreement between physiotherapists and participants for single items showed large measurement error (Cohen’s Kappa estimates ranged from − 0.04-0.59) with the ICC (95% CI) for the total score being 0.11 (− 0.14, 0.34). Conclusions The QUIPA tool showed acceptable test-retest reliability for subscales and total score but inadequate reliability for individual items. Construct validity was confirmed but criterion validity for individual items, subscales and the total score was inadequate. Further research is needed to refine the QUIPA tool to improve its clinimetric properties before implementation.

Methodological quality (risk of bias) assessment is an important step before study initiation usage. Therefore, accurately judging study type is the first priority, and the choosing proper tool is also important. In this review, we introduced methodological quality assessment tools for randomized controlled trial (including individual and cluster), animal study, non-randomized interventional studies (including follow-up study, controlled before-and-after study, before-after/ pre-post study, uncontrolled longitudinal study, interrupted time series study), cohort study, case-control study, cross-sectional study (including analytical and descriptive), observational case series and case reports, comparative effectiveness research, diagnostic study, health economic evaluation, prediction study (including predictor finding study, prediction model impact study, prognostic prediction model study), qualitative study, outcome measurement instruments (including patient - reported outcome measure development, content validity, structural validity, internal consistency, cross-cultural validity/ measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, and responsiveness), systematic review and meta-analysis, and clinical practice guideline. The readers of our review can distinguish the types of medical studies and choose appropriate tools. In one word, comprehensively mastering relevant knowledge and implementing more practices are basic requirements for correctly assessing the methodological quality.

Background Chronic urticaria is defined as the appearance of urticarial lesions and/or angioedema during a period of more than six weeks. We aimed at developing the Portuguese version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) and at testing its reliability and the content, construct and criterion validity. Methods The forward-backward approach to a linguistic equivalence was followed, after which a clinical review and a cognitive debriefing with patients were performed. The intraclass correlation coefficient checked test-retest reliability with patients filling the same questionnaire with one week apart and the Cronbach’s alpha indicator assessed the internal consistency. Construct validity was tested by an exploratory factor analysis and by hypothesis tests involving sociodemographic and clinical patient characteristics, including the urticaria control test (UCT). On the other hand, criterion validity was tested through correlations with the Short-Form Health Survey SF-36, EQ-5D-5 L, and the Dermatology Quality of Life Index (DLQI). Results A total of 162 patients from seven hospital units were included. The mean (standard deviation) age was 42.6 (13.3) and 81.6% were female. CU-Q2oL was entirely filled by all respondents. Internal consistency was 0.947 for the overall score, ranging from 0.661 (limits) to 0.899 (sleep problems) and the corresponding reproducibility indicator was 0.910, based on 23 patients and ranging from 0.711 (swelling) and 0.957 (looks). Exploratory factor analysis in general confirmed the original structure originally obtained by the authors. All CU-Q2oL dimensions were highly correlated with DLQI Index and differentiated well between males and females, and between different levels of wheals and pruritus. In addition, moderate negative correlations were found between Cu-Q2oL scores and the dimensions from SF-36 and EQ-5D-5 L. Conclusions The satisfactory metric properties confirmed the cultural adaptation and validity of CU-Q2oL into Portuguese population, providing the clinicians with a valid tool to evaluate the impact of chronic urticaria on patient’s QoL and therefore adjust their treatment. Trial registration number Not applicable.

Background The Prolapse Quality of Life (P-QoL) is a disease-specific instrument designed to measure the health-related quality of life in women with prolapse; however, there is no Amharic version of the instrument. The aim of this study were to translate the P-QoL into Amharic and evaluate its psychometric properties among adult women. Methods We followed an intercultural adaptation procedure to translate and adapt the P-QoL. A forward–backward translation, face validity interviews with experts and cognitive debriefing of the translated version with ten adults from the target group were performed. The Amharic version was then completed by 230 adult women with and without POP symptoms. All women were examined using a simplified Pelvic Organ Prolapse Quantification (SPOP-Q) system. We examined internal consistency (Cronbach’s alpha) and test–retest reliability (intraclass correlation coefficient = ICC). Confirmatory factor analysis (CFA) was conducted and model fit was discussed. We extracted a new factor structure by exploratory factor analysis (EFA). Criterion validity was also assessed against the SPOP-Q stage. Results The translated measure was found acceptable by the experts and target group, with only minor adaptations required for the Amharic context. It had high internal consistency (α = 0.96) and test–retest reliability (ICC = 0.87; p

Background In Eritrea, highly centralized mental health care services and lack of trained psychiatric personnel at primary health care units remain a challenge to the mental health care system. These problems can be minimized by introducing screening programs with a simple screening tool for mental disorders in the primary health care settings. Thus, this study aimed to assess the validity of the WHO self-reporting questionnaire 20 (SRQ-20) in Tigrigna version for use in Eritrean primary health care setting. Methods The SRQ-20 was translated into a local language (Tigrinya) in a process of forward and backward translation. SRQ-20 data were collected in a primary health care setting on 266 respondents. Internal reliability was tested using Cronbach’s alpha. Factorial validity was done using principal component analysis with varimax rotation to investigate whether SRQ-20 items properly measure the underlying dimensions of mental illness. Criterion validity was analyzed by looking at the relationship between the SRQ-20 and Brief Psychiatric Rating Scale using Pearson’s correlation coefficient. Sensitivity, specificity and the predictive values of the screening instrument were used to assess how well the results of SRQ-20 correspond with the criterion instrument. Results The SRQ-20 had good internal reliability (α = 0.78). Factor analysis yielded two factors, explaining 31.2% of the total variance. The instrument performed well in detecting common mental disorders, with an area under the curve (AUC) of 0.879 (SE = 0.23, 95% CI 0.83–0.92) to the overall sample and with optimal cut-off score at 5/6 with sensitivity 78.6% and specificity 81.5%. Cut-off scores were different for women (5/6) and men (4/5). For male participants, the AUC statistic was 0.877 (SE = 0.04, 95% CI 0.79–0.96) and 0.871 (SE = 0.02 95% CI 0.81–0.92) for female participants. Conclusion The Tigrinya version of the SRQ-20 can be used for screening probable common mental disorders in Eritrean primary health care setting, but cut-off scores need to be adjusted for men and women separately.

Background The Child Perceptions Questionnaire (CPQ) belongs to a set of questionnaires measuring Child Oral Health Quality of Life (COHQOL). The CPQ is used to collect the perceptions of children on the impact of oral diseases on their quality of life. This cross-sectional study was aimed to translate the CPQ8-10 into French language and evaluate its psychometric properties. Methods The translation process complied with international recommendations. The final French version was tested on children aged 8-10 years old attending consultations in a Parisian public hospital and divided into three groups: children with oral-facial clefts, children with dental anomalies linked to a rare disease other than clefts and children presumed to be healthy and without anomalies. The internal consistency relating to the reliability of CPQ8-10 was evaluated by Cronbach’s alpha. The intra-class correlation was used to measure reproducibility at the test-retest level. Construct validity was evaluated by Spearman’s correlation and tested using factor analysis. The discriminant validity was assessed using Kruskall Wallis test. Criterion validity was calculated using Spearman’s correlation. Results One hundred seventy-six children participated in this study. During the translation process, minor changes were made. The French version showed good reliability with a Cronbach’s alpha of 0.81 for the total scale. The ICC of the test-retest was excellent (=0.90) demonstrating good reproducibility. The construct validity was acceptable with a statistically significant correlation between the scores of the French-CPQ8-10 and the evaluation of oral health (r = 0. 381 and p

Background Physical injury and psychological disorder following a motor vehicle crash (MVC) is a public health concern. The objective of this research was to determine rates of major depressive disorder (MDD) and post-traumatic stress disorder (PTSD) in adults with MVC-related injury engaged in compensation, and to determine the capacity (e.g. sensitivity and specificity) of two psychometric scales for estimating the presence of MDD and PTSD. Methods Participants included 109 adults with MVC-related injury engaged in compensation during 2015 to 2017, in Sydney, Australia. The mean time from MVC to baseline assessment was 11 weeks. Comprehensive assessment was conducted at baseline, and the Depression Anxiety Stress Scales (DASS-21) and the Impact of Event Scale-Revised (IES-R) were administered to determine probable MDD and PTSD. An online psychiatric interview, based on Diagnostic and Statistical Manual for Mental Disorders (DSM-5), was used to diagnose actual MDD and PTSD, acknowledged as gold standard diagnostic criteria. One-way multivariate analyses of variance established criterion validity of the DASS-21 and IES-R, and sensitivity and specificity analyses were conducted to determine the most sensitive cut-off points for detecting probable MDD and PTSD. Results Substantial rates of MDD (53.2%) and PTSD (19.3%) were found. The DASS-21 and IES-R were shown to have excellent criterion validity for detecting MDD and PTSD in injured participants. A range of cut-off points were investigated and shown to have acceptable sensitivity and specificity for detecting MDD and PTSD in an injured population engaged in compensation. The preferred cut-off points based on this study are: to detect MDD, a DASS-21 total score of 30 and/or a DASS-21 depression score of 10; to detect PTSD, IES-R scores of 33–40 and/or a DASS-21 anxiety score of 7–8. Conclusions Major psychological disorder is prevalent following a MVC. Results suggest the DASS-21 and IES-R are suitable for use in clinical/compensation settings to detect probable MDD and PTSD soon after a MVC in physically injured people engaged in compensation. These results provide positive direction in the public health arena for improving mental health outcomes. Trial Registration Clinical Trials registration number: ANZCTR - ACTRN12615000326594 (9th April 2015).

Background Health systems guidance (HSG) provides recommendations to address health systems challenges. No tools exist to inform HSG developers and users about the components of high quality HSG and to differentiate between HSG of varying quality. In response, we developed a tool to assist with the development, reporting and appraisal of HSG – the Appraisal of Guidelines for Research and Evaluation–Health Systems (AGREE-HS). This paper reports on the validity, usability and initial measurement properties of the AGREE-HS. Methods To establish face validity (Study 1), stakeholders completed a survey about the AGREE-HS and provided feedback on its content and structure. Revisions to the tool were made in response. To establish usability (Study 2), the revised tool was applied to 85 HSG documents and the appraisers provided feedback about their experiences via an online survey. An initial test of the revised tool’s measurement properties, including internal consistency, inter-rater reliability and criterion validity, was conducted. Additional revisions to the tool were made in response. Results In Study 1, the AGREE-HS Overview, User Manual, quality item content and structure, and overall assessment questions were rated favourably. Participants indicated that the AGREE-HS would be useful, feasible to use, and that they would apply it in their context. In Study 2, participants indicated that the quality items were easy to understand and apply, and the User Manual, usefulness and usability of the tool were rated favourably. Study 2 participants also indicated intentions to use the AGREE-HS. Conclusions The AGREE-HS comprises a User Manual, five quality items and two overall assessment questions. It is available at agreetrust.org. Electronic supplementary material The online version of this article (10.1186/s12961-018-0334-9) contains supplementary material, which is available to authorized users.

Background Brachial hemiparesis is one of the most frequent sequelae of stroke, leading to important functional disability given the role of the upper limb in executing activities of daily living (ADL). The Stroke Upper Limb Capacity Scale (SULCS) is a stroke-specific assessment instrument that evaluates functional capacity of the upper limb based on the execution of 10 tasks. The objective of this study is the transcultural adaptation and psychometric validation of the Portuguese version of the SULCS. Methods A Portuguese version of the SULCS was developed, using the process of forward-backward translation, after authorisation from the author of the original scale. Then, a multicentre study was conducted in Portuguese stroke patients (n = 122) to validate the psychometric properties of the instrument. The relationship between sociodemographic and clinical characteristics was used to test construct validity. The relationship between SULCS scores and other instruments was used to test criterion validity. Results Semantic and linguistic adaptation of the SULCS was executed without substantial issues and allowed the development of a Portuguese version. The application of this instrument suggested the existence of celling effect (19.7% of participants with maximum score). Reliability was demonstrated through the intraclass correlation coefficient of 0.98. As for construct validity, SULCS was sensible to muscle tonus and aphasia. SULCS classification impacted the scores of the Motor Evaluation Scale for Upper Extremity in Stroke (MESUPES) and the Stroke Impact Scale (SIS). Conclusions The present version of SULCS shows valid and reliable cultural adaptation, with good reliability and stability.

Background: Mental well-being is an important, yet understudied, area of research, partly due to lack of appropriate population-based measures. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) was developed to meet the needs for such a measure. This article assesses the psychometric properties of the Norwegian version of the WEMWBS, and its short-version (SWEMWBS) among a sample of primary health care patients who participated in the evaluation of Prompt Mental Health Care (PMHC), a novel Norwegian mental health care program aimed to increase access to treatment for anxiety and depression. Methods: Forward and back-translations were conducted, and 1168 patients filled out an electronic survey including the WEMWBS, and other mental health scales. The original dataset was randomly divided into a training sample (≈70%) and a validation sample (≈30%). Parallel analysis and confirmatory factor analysis were carried out to assess construct validity and precision. The final models were cross-validated in the validation sample by specifying a model with fixed parameters based on the estimates from the trainings set. Criterion validity and measurement invariance of the (S) WEMWBS were examined as well. Results: Support was found for the single factor hypothesis in both scales, but similar to previous studies, only after a number of residuals were allowed to correlate (WEMWBS: CFI = 0.99; RMSEA = 0.06, SWEMWBS: CFI = .99; RMSEA = 0.06). Further analyses showed that the correlated residuals did not alter the meaning of the underlying construct and did not substantially affect the associations with other variables. Precision was high for both versions of the WEMWBS (>.80), and scalar measurement invariance was obtained for gender and age group. The final measurement models displayed adequate fit statistics in the validation sample as well. Correlations with other mental health scales were largely in line with expectations. No statistically significant differences were found in mean latent (S)WEMWBS scores for age and gender. Conclusion: Both WEMWBS scales appear to be valid and precise instruments to measure mental well-being in primary health care patients. The results encourage the use of mental well-being as an outcome in future epidemiological, clinical, and evaluation studies, and may as such be valuable for both research and public health practice. publishedVersion

Background Health-related quality of life (HRQoL) has been positioned as one of the major endpoints in oncology. Thus, there is a need to validate cancer-site specific survey instruments. This study aimed to perform a transcultural adaptation of the 50-item Expanded Prostate cancer Index Composite (EPIC) questionnaire for HRQoL in prostate cancer patients and to validate the psychometric properties of the French-language version. Methods The EPIC questionnaire measures urinary, bowel, sexual and hormonal domains. The first step, corresponding to transcultural adaptation of the original English version of the EPIC was performed according to the back translation technique. The second step, comprising the validation of the psychometric properties of the EPIC questionnaire, was performed in patients under treatment for localized prostate cancer (treatment group) and in patients cured of prostate cancer (cured group). The EORTC QLQ-C30 and QLQ-PR25 prostate cancer module were also completed by patients to assess criterion validity. Two assessments were performed, i.e., before and at the end of treatment for the Treatment group, to assess sensitivity to change; and at 2 weeks’ interval in the Cured group to assess test-retest reliability. Psychometric properties were explored according to classical test theory. Results The first step showed overall good acceptability and understanding of the questionnaire. In the second step, 215 patients were included from January 2012 to June 2014: 125 in the Treatment group, and 90 in the Cured group. All domains exhibited good internal consistency, except the bowel domain (Cronbach’s α = 0.61). No floor effect was observed. Test-retest reliability assessed in the cured group was acceptable, expect for bowel function (intraclass coefficient = 0.68). Criterion validity was good for each domain and subscale. Construct validity was not demonstrated for the hormonal and bowel domains. Sensitivity to change was exhibited for 5/8 subscales and 2/4 summary scores for patients who experienced toxicities during treatment. Conclusions The French EPIC questionnaire seems to have adequate psychometric properties, comparable to those exhibited by the original English-language version, except for the construct validity, which was not available in original version.

Background Mental health literacy has received great attention recently to improve mental health knowledge, decrease stigma and enhance help-seeking behaviors. We conducted a systematic review to critically appraise the qualities of studies evaluating the measurement properties of mental health knowledge tools and the quality of included measurement properties. Methods We searched PubMed, PsycINFO, EMBASE, CINAHL, the Cochrane Library, and ERIC for studies addressing psychometrics of mental health knowledge tools and published in English. We applied the COSMIN checklist to assess the methodological quality of each study as “excellent”, “good”, “fair”, or “indeterminate”. We ranked the level of evidence of the overall quality of each measurement property across studies as “strong”, “moderate”, “limited”, “conflicting”, or “unknown”. Results We identified 16 mental health knowledge tools in 17 studies, addressing reliability, validity, responsiveness or measurement errors. The methodological quality of included studies ranged from “poor” to “excellent” including 6 studies addressing the content validity, internal consistency or structural validity demonstrating “excellent” quality. We found strong evidence of the content validity or internal consistency of 6 tools; moderate evidence of the internal consistency, the content validity or the reliability of 8 tools; and limited evidence of the reliability, the structural validity, the criterion validity, or the construct validity of 12 tools. Conclusions Both the methodological qualities of included studies and the overall evidence of measurement properties are mixed. Based on the current evidence, we recommend that researchers consider using tools with measurement properties of strong or moderate evidence that also reached the threshold for positive ratings according to COSMIN checklist.

Background Evaluation of functional status is difficult in neurological and neurosurgical early rehabilitation patients. The Early Rehabilitation Index (ERI) was introduced in Germany over 20 years ago, but since then validation studies are lacking. The ERI (range −325 to 0 points) includes highly relevant items including the necessity of intermittent mechanical ventilation or tracheostomy. Methods The present paper analyzed data from a German multi-center study, enrolling 754 neurological early rehabilitation patients. Together with ERI, Barthel Index (BI), Glasgow Coma Scale (GCS), Glasgow Outcome Score Extended, Coma Remission Scale (CRS), Functional Ambulation Categories and length of stay were obtained. Results ERI showed significant improvements from admission to discharge (p

Background Waist, hip, and neck circumference measurements are cost-effective, non-invasive, useful markers for body fat distribution and disease risk. For epidemiology and intervention studies, including body circumference measurements in self-report surveys could be informative. However, few studies have assessed the test-retest reliability and criterion validity of a self-report tool feasible for use in large scale studies. Methods At home, mothers of young children viewed a brief, online instructional video on how to measure their waist, hip, and neck circumferences. Afterwards, they created a homemade paper measuring tape from a downloaded file with scissors and tape, took all measurements in duplicate, and entered them into an online survey. A few weeks later, participants visited an anthropometrics lab where they measured themselves again, and trained technicians (n = 9) measured participants in duplicate using standard equipment and procedures. To assess differences between self- and technician-measured circumferences, duplicate measurements for participant home self-measurements, participant lab self-measurements, and technician measurements each were averaged and Wilcoxon signed-rank tests conducted. Agreement between all possible pairs of measurements were examined using Intraclass Correlations (ICCs) and Bland-Altman plots. Results Participants (n = 41; aged 38.05 ± 3.54SD years; 71 % white) were all mothers that had at least one child under the age of 12 yrs. Technical error of measurements for self- and technician- duplicate measurements varied little (0.08 to 0.76 inches) and had very high reliability (≥0.90). Intraclass Correlations (ICC) comparing self vs technician were high (0.97, 0.96, and 0.84 for waist, hip, and neck). Comparison of self-measurements at home vs lab revealed high test-retest reliability (ICC ≥ 0.87). Differences between participant self- and technician measurements were small (i.e., mean difference ranged from −0.13 to 0.06 inches) with nearly all (≥93 %) differences within Bland-Altman limits of agreement and

Depression is an important and growing contributor to the burden of disease around the world and evidence suggests the experience of depression varies cross-culturally. Efforts to improve the integration of services for depression in primary care are increasing globally, meaning that culturally valid measures that are acceptable for use in primary care settings are needed. We conducted a scoping review of 27 studies that validated or used 10 measures of depression in Vietnamese populations. We reviewed the validity of the instruments as reported in the studies and qualitatively assessed cultural validity and acceptability for use in primary care. We found much variation in the methods used to validate the measures, with an emphasis on criterion validity and reliability. Enhanced evaluation of content and construct validity is needed to ensure validity within diverse cultural contexts such as Vietnam. For effective use in primary care, measures must be further evaluated for their brevity and ease of use. To identify appropriate measures for use in primary care in diverse populations, assessment must balance standard validity testing with enhanced testing for appropriateness in terms of culture, language, and gender and for acceptability for use in primary care.

Background Adequate monitoring of older adults’ physical activity (PA) is essential to develop effective health promotion programs. The present study examined criterion validity and test-retest reliability of the long International Physical Activity Questionnaire (IPAQ-L), adapted for Belgian, community-dwelling older adults (65y and older). Methods Participants (n = 434) completed the last seven days version of IPAQ-L, modified for the Belgian population of community-dwelling older adults. This elderly-adapted version of IPAQ-L combined vigorous and moderate activities, and questions on gait speed and recreational cycling were added. Furthermore, participants wore an ActiGraph GT3X(+) accelerometer for at least five days. Criterion validity was determined by comparing self-reported weekly minutes of moderate-to-vigorous physical activity (MVPA) and weekly minutes of total PA with accelerometer data, defined by two different cut points (Freedson vs. Copeland). To examine test-retest reliability, a subsample of 29 participants completed IPAQ-L for a second time within a ten day interval. Results IPAQ-L showed moderate criterion validity for measuring weekly minutes of MVPA and total PA (Spearman’s ρ range 0.33–0.40). However, plots on agreement between self-reported and accelerometer PA showed a systematic over-reporting of IPAQ-L for MVPA. In contrast, plots indicated that IPAQ-L under-estimated levels of total PA, however, this under-estimation of total PA was substantially lower than the observed over-reporting of MVPA. Test-retest reliability was moderate-to-good for work-related PA, domestic PA, MVPA and total PA (ICC range 0.52–0.81), but poorer for transportation and recreational PA (ICC 0.44 and 0.43, respectively). Conclusions Criterion validity results suggest that IPAQ-L is more valid to measure older adults’ weekly minutes of total PA than weekly MVPA minutes. Moreover, results might imply that content validity of IPAQ-L can be improved if specific light-intensity PA items are incorporated into IPAQ-L. Test-retest reliability of IPAQ-L was moderate to good, except for weekly minutes of transportation and recreational PA, probably due to week-to-week variability of these behaviors. Electronic supplementary material The online version of this article (doi:10.1186/s12889-015-1785-3) contains supplementary material, which is available to authorized users.

Background There are limited data on the prevalence and approaches to screening for depression among pregnant women living in resource poor settings with high HIV burden. Methods We studied the reliability and accuracy of the Center for Epidemiologic Studies Depression (CES-D) scale in 123 (36 HIV-infected and 87 -uninfected) pregnant women receiving antenatal care at Gulu Regional Referral Hospital, Uganda. CES-D scores were compared to results from the psychiatrist-administered Mini-International Neuropsychiatric Interview (MINI) for current major depressive disorder (MDD), a “gold standard” for assessing depression. We employed measures of internal consistency (Cronbach’s alpha), and criterion validity [Area Under the Receiver Operating Characteristic Curve (AUROC), sensitivity (Se), specificity (Sp), and positive predictive value (PPV)] to evaluate the reliability and validity of the CES-D scale. Results 35.8% of respondents were currently experiencing an MDD, as defined from outputs of the MINI-depression module. The CES-D had high internal consistency (Cronbach’s alpha = 0.92) and good discriminatory ability in detecting MINI-defined current MDDs (AUROC = 0.82). The optimum CES-D cutoff score for the identification of probable MDD was between 16 and 17. A CES-D cutoff score of 17, corresponding to Se, Sp, and PPV values of 72.7%, 78.5%, and 76.5%, is proposed for adoption in this population and performs well for HIV-infected and -uninfected women. After adjusting for baseline differences between the HIV subgroups (maternal age and marital status), HIV-infected pregnant women scored 6.2 points higher on the CES-D than HIV-uninfected women (p = 0.032). Conclusions The CES-D is a suitable instrument for screening for probable major depression among pregnant women of mixed HIV status attending antenatal services in northern Uganda. Electronic supplementary material The online version of this article (doi:10.1186/s12888-014-0303-y) contains supplementary material, which is available to authorized users.

Background: Pediatric Quality of Life Inventory (PedsQL) is a measure to assess health-related quality of life (HRQoL) in children and adolescents. It is formed by 23 items adapted to children age and includes a parent proxy report version. With four multidimensional subscales and three summary scores, it measures health as defined by WHO. The concepts measured by this instrument are `physical functioning' (8 items), `emotional functioning' (5 items), `social functioning' (5 items) and `school functioning' (5 items). It also measures a `total scale score' (23 items), a `physical health summary score' (8 items) and a `psychosocial health summary score' (15 items). The aim of this paper is to present the main results of the cultural adaptation and validation of the PedsQL into European Portuguese. Methods: The Portuguese version was the result of a forward-backward translation process, with a cognitive debriefing analysis, guaranteeing face validity and semantic equivalence. Children aged 5-7 and 8-12 were randomly selected and were asked to fill a socio-demographic data survey and the Portuguese versions of PedsQL and KINDL, another HRQoL measure for children and adolescents. They were divided into three groups, healthy children, children with type I diabetes and children with spina bifida. The reliability was tested for reproducibility (ICC) and internal consistency (Cronbach's alpha). The construct validity (known-groups discriminant validity) was supported by differences between self-reports from healthy children and children with chronic conditions, and from children with chronic diseases and their parents. The criterion validity was tested after the correlations of the scores obtained by both children and adolescents HRQoL assessment instruments. Results: A total of 179 children and 97 parents were recruited. PedsQL demonstrated good levels of reproducibility (r > 0.95 in all versions) and acceptable levels of internal consistency with Cronbach's alpha at 0.70 on most scales. Concordance values between children's and parents' perceptions ranged between 0.36 and 0.78 and the correlations with KINDL questionnaire were excellent, supporting concurrent validity. Conclusions: The Portuguese version of the PedsQL demonstrated acceptable psychometric properties for future research and clinical practice for children aged 5-12.

Background Transplant recipients are expected to adhere to a lifelong immunosuppressant therapeutic regimen. However, nonadherence to treatment is an underestimated problem for which no properly validated measurement tool is available for Portuguese-speaking patients. We aimed to initially validate the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS®) to accurately estimate immunosuppressant nonadherence in Brazilian transplant patients. Methods The BAASIS® (English version) was transculturally adapted and its psychometric properties were assessed. The transcultural adaptation was performed using the Guillemin protocol. Psychometric testing included reliability (intraobserver and interobserver reproducibility, agreement, Kappa coefficient, and the Cronbach’s alpha) and validity (content, criterion, and construct validities). Results The final version of the transculturally adapted BAASIS® was pretested, and no difficulties in understanding its content were found. The intraobserver and interobserver reproducibility variances (0.007 and 0.003, respectively), the Cronbach’s alpha (0.7), Kappa coefficient (0.88) and the agreement (95.2%) suggest accuracy, preciseness and reliability. For construct validity, exploratory factorial analysis demonstrated unidimensionality of the first three questions (r = 0.76, r = 0.80, and r = 0.68). For criterion validity, the adapted BAASIS® was correlated with another self-report instrument, the Measure of Adherence to Treatment, and showed good congruence (r = 0.65). Conclusions The BAASIS® has adequate psychometric properties and may be employed in advance to measure adherence to posttransplant immunosuppressant treatments. This instrument will be the first one validated to use in this specific transplant population and in the Portuguese language.

Physical inactivity is one of the four leading risk factors for global mortality. Accurate measurement of physical activity (PA) and in particular by physical activity questionnaires (PAQs) remains a challenge. The aim of this paper is to provide an updated systematic review of the reliability and validity characteristics of existing and more recently developed PAQs and to quantitatively compare the performance between existing and newly developed PAQs. A literature search of electronic databases was performed for studies assessing reliability and validity data of PAQs using an objective criterion measurement of PA between January 1997 and December 2011. Articles meeting the inclusion criteria were screened and data were extracted to provide a systematic overview of measurement properties. Due to differences in reported outcomes and criterion methods a quantitative meta-analysis was not possible. In total, 31 studies testing 34 newly developed PAQs, and 65 studies examining 96 existing PAQs were included. Very few PAQs showed good results on both reliability and validity. Median reliability correlation coefficients were 0.62–0.71 for existing, and 0.74–0.76 for new PAQs. Median validity coefficients ranged from 0.30–0.39 for existing, and from 0.25–0.41 for new PAQs. Although the majority of PAQs appear to have acceptable reliability, the validity is moderate at best. Newly developed PAQs do not appear to perform substantially better than existing PAQs in terms of reliability and validity. Future PAQ studies should include measures of absolute validity and the error structure of the instrument.

Background: We have previously reported on the development of a cancer-specific screening instrument for anxiety and depression (PSSCAN). No information on cut-off scores or their meaning for diagnosis was available when PSSCAN was first described. Needed were additional analyses to recommend empirically justified cut-off scores as well as data norms for healthy adult samples so as to lend meaning to the recommended cut-off scores. Methods: We computed sensitivity/specificity indices based on a sample of 101 cancer patients who had provided PSSCAN data on anxiety and depression and who had completed another standardized instrument with strong psychometrics. Next, we compared mean scores for four samples with known differences in health status, a healthy community sample (n = 561), a sample of patients with a representative mix of cancer subtypes (n = 570), a more severely ill sample of in-patients with cancer (n = 78), and a community sample with a chronic illness other than cancer (n = 85). Results: Sensitivity/specificity analyses revealed that an excellent balance of sensitivity/specificity was achievable with 92%/98% respectively for clinical anxiety and 100% and 86% respectively for clinical depression. Newly diagnosed patients with cancer were no more anxious than healthy community controls but showed elevations in depression scores. Both, patients with chronic illness other than cancer and those with longer-standing cancer diagnoses revealed greater levels of distress than newly diagnosed cancer patients or healthy adult controls. Conclusion: These additional data on criterion validity and community versus patient norms for PSSCAN serve to enhance its utility for clinical practice.

The Eating Beliefs Questionnaire (EBQ; Groves, Abbott & Baillie, 2015) is a 32-item self-report questionnaire assessing positive and negative beliefs about binge-eating, which are implicated in the maintenance of binge-eating in keeping with Cooper et al.'s (2004) cognitive model. The EBQ was shown to be a valid and reliable measure of eating-related beliefs with excellent psychometric properties. The EBQ has yet to be cross-validated with a clinical sample, and clinical cut-off scores have not been determined. In order to address these issues, a sample of 739 participants was recruited (544 community, 195 clinical: 95 with a diagnosed eating disorder and 100 obese Ps). Participants completed the test-battery, of which 54 clinical participants completed the test-battery before and after receiving psychological treatment for binge-eating, and 38 community participants completed the test-battery again after a lapse of two-weeks. The results of a Confirmatory Factor Analysis will be presented, including evaluation of the EBQ's psychometric properties (internal consistency, criterion validity, construct validity, agreement, reliability, responsiveness, and interpretability). Results will be interpreted with regard to current cognitive models and the EBQ's utility for use in clinical and research settings will also be discussed.

Background To translate and validate the Chinese version of the Quality Of Life Radiation Therapy Instrument and the Head & Neck Module (QOL-RTI/H&N), a disease-specific scale to measure quality of life (QOL) for patients with head and neck cancer (HNC) who received radiotherapy. Methods The QOL-RTI/H&N was translated and validated according to the standard process: a translation and back-translation procedure, pilot testing and a validation study. HNC patients were enrolled from the Cancer Center of Sun Yat-sen University and assessed using the QOL-RTI/H&N, QLQ-C30 and QLQ-H&N35. Reliability (internal consistency reliability, split-half reliability and test-retest reliability), validity (content validity, construct validity, criterion validity and discriminant validity), and responsiveness analysis were performed to evaluate the psychometric characteristics of the QOL-RTI/H&N. Results A total of 238 patients (99.2%) completed the questionnaire. Item RTI23 had 16.0% missing data. Other items had low percentages of missing data (0.4% or 0.8%) or no missing data. The average time to finish the scale was 9.8 minutes. Cronbach's alpha of the domains ranged from 0.41 to 0.77. The split-half reliability coefficients ranged from 0.43 to 0.77. All of the intra-class correlation coefficients were equal to or greater than 0.8. All of the item-own domain correlation coefficients were greater than those of the item-other domain. Confirmatory factor analysis showed that Comparative Fit Index, Normed Fit Index and Non-Normed Fit Index were equal to 1.00. Root Mean Square Error of Approximation was 0.01, with 90% CI (0.00, 0.10). The domain scores of the QOL-RTI/H&N were significantly correlated with those of the QLQ-C30 or QLQ-H&N3. All domain scores of patients in different radiotherapy stages were statistically significant (P

Background: Diet is a major modifiable contributing factor in the etiology of dental caries. The purpose of this paper is to examine the reliability and cross-cultural validity of the Japanese version of the Food Frequency Questionnaire to assess dietary intake in relation to dental caries risk in Japanese. Methods: The 38-item Food Frequency Questionnaire, in which Japanese food items were added to increase content validity, was translated into Japanese, and administered to two samples. The first sample comprised 355 pregnant women with mean age of 29.2 +/- 4.2 years for the internal consistency and criterion validity analyses. Factor analysis (principal components with Varimax rotation) was used to determine dimensionality. The dietary cariogenicity score was calculated from the Food Frequency Questionnaire and used for the analyses. Salivary mutans streptococci level was used as a semi-quantitative assessment of dental caries risk and measured by Dentocult SM. Dentocult SM scores were compared with the dietary cariogenicity score computed from the Food Frequency Questionnaire to examine criterion validity, and assessed by Spearman's correlation coefficient (r(s)) and Kruskal-Wallis test. Test-retest reliability of the Food Frequency Questionnaire was assessed with a second sample of 25 adults with mean age of 34.0 +/- 3.0 years by using the intraclass correlation coefficient analysis. Results: The Japanese language version of the Food Frequency Questionnaire showed high test-retest reliability (ICC = 0.70) and good criterion validity assessed by relationship with salivary mutans streptococci levels (r(s) = 0.22; p < 0.001). Factor analysis revealed four subscales that construct the questionnaire (solid sugars, solid and starchy sugars, liquid and semisolid sugars, sticky and slowly dissolving sugars). Internal consistency were low to acceptable (Cronbach's alpha = 0.67 for the total scale, 0.46-0.61 for each subscale). Mean dietary cariogenicity scores were 50.8 +/- 19.5 in the first sample, 47.4 +/- 14.1, and 40.6 +/- 11.3 for the first and second administrations in the second sample. The distribution of Dentocult SM score was 6.8% (score = 0), 34.4% (score = 1), 39.4% (score = 2), and 19.4% (score = 3). Participants with higher scores were more likely to have higher dietary cariogenicity scores (p < 0.001; Kruskal-Wallis test). Conclusions: These results provide the preliminary evidence for the reliability and validity of the Japanese language Food Frequency Questionnaire.

Background: The Upper Limb Functional Index (ULFI) is an internationally widely used outcome measure with robust, valid psychometric properties. The purpose of study is to develop and validate a ULFI Spanish-version (ULFI-Sp). Methods: A two stage observational study was conducted. The ULFI was cross-culturally adapted to Spanish through double forward and backward translations, the psychometric properties were then validated. Participants (n = 126) with various upper limb conditions of >12 weeks duration completed the ULFI-Sp, QuickDASH and the Euroqol Health Questionnaire 5 Dimensions (EQ-5D-3 L). The full sample determined internal consistency, concurrent criterion validity, construct validity and factor structure; a subgroup (n = 35) determined reliability at seven days. Results: The ULFI-Sp demonstrated high internal consistency (α = 0.94) and reliability (r = 0.93). Factor structure was one-dimensional and supported construct validity. Criterion validity with the EQ-5D-3 L was fair and inversely correlated (r = �0.59). The QuickDASH data was unavailable for analysis due to excessive missing responses. Conclusions: The ULFI-Sp is a valid upper limb outcome measure with similar psychometric properties to the English language version.

Background Health assessment measurements for patients with Rheumatoid arthritis (RA) have to be meaningful, valid and relevant. A commonly used questionnaire for patients with RA is the Stanford Health Assessment Questionnaire Disability Index (HAQ), which has been available in Swedish since 1988. The HAQ has been revised and improved several times and the latest version is the Multi Dimensional Health Assessment Questionnaire (MDHAQ). The aim of this study was to translate the MDHAQ to Swedish conditions and to test the validity and reliability of this version for persons with RA. Methods Translation and adaption of the MDHAQ were performed according to guidelines by Guillemin et al. The translated version was tested for face validity and test-retest in a group of 30 patients with RA. Content validity, criterion validity and internal consistency were tested in a larger study group of 83 patients with RA. Reliability was tested with test-retest and Cronbach´s alpha for internal consistency. Two aspects of validity were explored: content and criterion validity. Content validity was tested with a content validity index. Criterion validity was tested with concurrent validity by exploring the correlation between the MDHAQ-S and the AIMS2-SF. Floor and ceiling effects were explored. Results Test-retest with intra-class correlation coefficient (ICC) gave a coefficient of 0.85 for physical function and 0.79 for psychological properties. Reliability test with Cronbach´s alpha gave an alpha of 0.65 for the psychological dimension and an alpha of 0.88 for the physical dimension of the MDHAQ-S. The average sum of the content validity index for each item was of the MDHAQ-S was 0.94. The MDHAQ-S had mainly a moderate correlation with the AIMS2-SF, except for the social dimension of the AIMS2-SF, which had a very low correlation with the MDHAQ-S. Conclusions The MDHAQ-S was considered to be reliable and valid, but further research is needed concerning sensitivity to change.