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Background: Interest in collecting Patient Reported Outcomes using electronic methods such as mobile phones has increased in recent years. However there is debate about the level of measurement equivalence between the traditional paper and newer electronic modes. Information about the acceptability of the electronic versions to respondents is also required. The aim of this study is to compare the equivalence of delivering a widely used generic measure of health status (EQ-5D-5L) across two administration modes (paper and mobile phone).Methods: Respondents from a research cohort of people in South Yorkshire were identified, and randomly allocated to one of two administration modes (paper vs. mobile phone) based on stratifications for age and gender (and across a range of self-reported health conditions). A parallel group design was used where each respondent only completed EQ-5D-5L using one of the modes. In total, 70 respondents completed the measure in the mobile phone arm, and 66 completed the standard paper version. Follow up usability questions were also included to assess the acceptability of the mobile version of EQ-5D-5L. Measurement equivalence was compared at the dimension, utility score and visual analogue scale level using chi square analysis and ANOVA, and by comparing mean differences to an estimated minimally important difference value.Results: Response rates were higher in the mobile arm. The mean EQ-5D-5L utility and VAS scores, and the frequency of respondents endorsing individual EQ-5D-5L dimension response levels did not significantly differ across the administration modes. The majority of the mobile arm agreed that the mobile version of EQ-5D-5L was easy to complete, and that the phone was easy to use, and that they would complete mobile health measures again.Conclusions: Completing health status measures such as EQ-5D using mobile phones produces equivalent results to more traditional methods, but with added benefits (for example lessening the burden of data entry). Respondents are positive towards completing questionnaires using these methods. The results provide evidence that electronic measures are valid for use to collect data in a range of settings including clinical trials, routine care, and in health diary settings. [ABSTRACT FROM AUTHOR]

Background: Electronic formats of patient-reported outcome (PRO) measures are now routinely used in clinical research studies. When changing from a validated paper and pen to electronic administration it is necessary to establish their equivalence. This study reports on the value of Rasch analysis in this process.Methods: Three groups of US pulmonary hypertension (PH) patients participated. The first completed an electronic version of the CAMPHOR Activity Limitation scale (e-sample) and this was compared with two pen and paper administrated samples (pp1 and pp2). The three databases were combined and analysed for fit to the Rasch model. Equivalence was evaluated by differential item functioning (DIF) analyses.Results: The three datasets were matched randomly in terms of sample size (n = 147). Mean age (years) and percentage of male respondents were as follows: e-sample (51.7, 16.0 %); pp1 (50.0, 14.0 %); pp2 (55.5, 40.4 %). The combined dataset achieved fit to the Rasch model. Two items showed evidence of borderline DIF. Further analyses showed the inclusion of these items had little impact on Rasch estimates indicating the DIF identified was unimportant.Conclusions: Differences between the performance of the electronic and pen and paper administrations of the CAMPHOR Activity Limitation scale were minor. The results were successful in showing how the Rasch model can be used to determine the equivalence of alternative formats of PRO measures. [ABSTRACT FROM AUTHOR]

Background: The ICECAP measures potentially offer a broader assessment of quality of life and well-being, in comparison to measures routinely used in economic evaluation, such as the EQ-5D-3 L. This broader assessment may allow measurement of the full effects of an intervention or treatment. Previous research has indicated that the ICECAP-O (for older people) and EQ-5D-3 L measure provide complementary information. This paper aims to determine similar information for the ICECAP-A (for the entire adult population) in terms of whether the measure is a substitute or complement to the EQ-5D-3 L.Methods: Data from the BEEP trial - a multi-centre, pragmatic, randomised controlled trial - were used. Spearman rank correlations and exploratory factor analytic methods were used to assess whether ICECAP-A and EQ-5D-3 L are measuring the same, or different, constructs.Results: A correlation of 0.49 (p < 0.01) was found between the ICECAP-A tariff score and the EQ-5D-3 L index. Using the pooled items of the EQ-5D-3 L and the ICECAP-A a two factor solution was optimal, with the majority of EQ-5D-3 L items loading onto one factor and the majority of ICECAP-A items onto another.Conclusion: The results presented in this paper indicate that ICECAP-A and EQ-5D-3 L are measuring two different constructs and provide largely different, complementary information. Results showed a similarity to results presented by Davis et al. using the ICECAP-O.Trial Registration: ISRCTN 93634563. [ABSTRACT FROM AUTHOR]

The Health Behavior in School-aged Children is a cross-national study collecting data on social and health indicators on adolescents in 43 countries. The study provides comparable data on health behaviors and health outcomes through the use of a common protocol, which have been a back bone of the study sine its initiation in 1983. Recent years, researchers within the study have noticed a questionable comparability on the widely used item on self-rated health. One of the four response categories to the item "Would you say your health is….?" showed particular variation, as the response category "Fair" varied from 20 % in Latvia and Moldova to 3-4 % in Bulgaria and Macedonia. A qualitative mini-survey of the back-translations showed that the response category "Fair" had a negative slant in 25 countries, a positive slant in 10 countries and was considered neutral in 9 countries. This finding indicates that there are what may be called semantic issues affecting comparability in international studies, since the same original word (in an English original) is interpreted differently across countries and cultures. The paper test and discuss a few possible explanations to this, however, only leaving to future studies to hold a cautious approach to international comparisons if working with the self-rated health item with four response categories. [ABSTRACT FROM AUTHOR]

Background: The efficacy of ALO-02, an abuse-deterrent formulation containing extended-release oxycodone and sequestered naltrexone, in the treatment of chronic low back pain (CLBP) was studied in a 12-week randomized controlled trial. Primary efficacy endpoint results have been published previously (Rauck et al., 2015). The current paper focuses on patient-reported outcomes for health-related quality of life (HRQL), work productivity, and activity impairment that were assessed during this study.Methods: This was a double-blind, placebo-controlled, randomized withdrawal study in patients with moderate-to-severe CLBP. After a screening period (≤2 weeks), patients entered an open-label titration period (4-6 weeks). Treatment responders were then randomized to a double-blind placebo-controlled treatment period (12 weeks). HRQL was assessed using changes in the Short Form-36 v2 Health Survey (SF-36v2) and the EuroQol-5 Dimensions Health Questionnaire 3-Level version (EQ-5D-3L). Work productivity and regular activities were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP).Results: A total of 410 patients received ALO-02 during the open-label titration period, of which 280 (intent-to-treat (ITT) population) were treated during the double-blind placebo-controlled treatment period (placebo, n = 134; ALO-02, n = 146). Significant improvement was observed for all SF-36v2 subscales and component scores (p < 0.005) and the EQ-5D-3L summary index and visual analog scale (p < 0.0001) during the titration period. Improvement was also significant (p < 0.0001) for all WPAI:SHP outcomes except 'work time missed due to CLBP' for the titration period. Significant differences favoring ALO-02 compared with placebo were only observed for the SF-36v2 Bodily Pain subscale (p ≤ 0.0232; ITT population) during the double-blind treatment period and the overall study period (screening to the end of the double-blind treatment period). The percentage change in activity impairment due to low back pain subscale of the WPAI:SHP significantly favored ALO-02 compared with placebo for the ITT population when considering the overall study period (p = 0.0040).Conclusions: HRQL, work productivity, and activity impairment may be improved with ALO-02 treatment.Trial Registration: ClinicalTrials.gov NCT01571362 , registered April 3, 2012. [ABSTRACT FROM AUTHOR]

Background: This paper investigates the properties and performance of the two generic measures, EQ-5D and SF-12, for Health-Related Quality of Life (HRQoL) assessments of pregnant women living with HIV in Kunming City, Yiliang County, Daguan County, Longchuan County, Tengchong County, Longling County and Fengqing County in Yunnan Province, China.Methods: As part of a screening programme for the prevention of mother-to-child transmission of HIV (PMTCT), a retrospective cross-sectional survey was conducted in the seven Maternal and Infant Health Care centers in Yunnan Province, China, between April and June of 2016. The demographic and HIV infection-related information used in the study was collected through questionnaires designed by the study's staff. HRQoL information was collected using two generic scales: EQ-5D and SF-12.Results: A total sample of one hundred and one pregnant women with a mean age of 30.4 ± 5.1 years was investigated. Average time elapsed since infection diagnoses was 5.8 ± 3.4 years. Only one infant (1.0%) was HIV positive, and 56 (55.4%) infants were HIV negative. The HIV status of 44 (43.6%) infants was unknown. The relationship between the EQ-5D functional dimensions and the PCS-12 and the relationship between the EQ-5D anxiety/depression dimension and the MCS-12 were stronger. Those whose PCS-12 and MCS-12 scores were at the median or lower were classified as being in worse health, while those over the median were classified as being in better health. Respondents who reported no problem on each of the EQ-5D dimensions was divided according to the median SF-12 component scores. Those who scored at the median or lower than the median were classified as being in worse health, while those higher than the median were classified as being in better health. The VAS scores were also significantly different than the median split of the SF-12 scores for these subjects.Conclusion: EQ-5D and SF-12 showed a discrimination ability in measuring the HRQoL of pregnant women living with HIV. The construct validity was identified for EQ-5D and SF-12 in the study. The respective constructs of EQ-5D and EQ-VAS may not overlap. Pregnant women living with HIV in the study gave more weight to their mental health when they provided a total health rating in EQ-VAS. EQ-VAS could explain the limitations of the EQ-5D dimension scores with ceiling effects in the survey. The results of our study could help to determine the suitable HRQoL instruments for pregnant women living with HIV and provide evidence for the proper comparison of EQ-5D and SF-12. [ABSTRACT FROM AUTHOR]

Background: The Adult Social Care Outcomes Toolkit (ASCOT-SCT4) is a multi-attribute utility index designed for the evaluation of long-term social care services. The measure comprises eight attributes that capture aspects of social care-related quality of life. The instrument has previously been validated with a sample of older adults who used home care services in England. This paper aims to demonstrate the instrument's test-retest reliability and provide evidence for its validity in a diverse sample of adults who use publicly-funded, community-based social care in England.Methods: A survey of 770 social care service users was conducted in England. A subsample of 100 services users participated in a follow-up interview between 7 and 21 days after baseline. Spearman rank correlation coefficients between the ASCOT-SCT4 index score and the EQ-5D-3 L, the ICECAP-A or ICECAP-O and overall quality of life were used to assess convergent validity. Data on variables hypothesised to be related to the ASCOT-SCT4 index score, as well as rating of individual attributes, were also collected. Hypothesised relationships were tested using one-way ANOVA or Fisher's exact test. Test-retest reliability was assessed using the intra-class correlation coefficient for the ASCOT-SCT4 index score at baseline and follow-up.Results: There were moderate to strong correlations between the ASCOT-SCT4 index and EQ-5D-3 L, the ICECAP-A or ICECAP-O, and overall quality of life (all correlations ≥ 0.3). The construct validity was further supported by statistically significant hypothesised relationships between the ASCOT-SCT4 index and individual characteristics in univariate and multivariate analysis. There was also further evidence for the construct validity for the revised Food and drink and Dignity items. The test-retest reliability was considered to be good (ICC = 0.783; 95% CI: 0.678-0.857).Conclusions: The ASCOT-SCT4 index has good test-retest reliability for adults with physical or sensory disabilities who use social care services. The index score and the attributes appear to be valid for adults receiving social care for support reasons connected to underlying mental health problems, and physical or sensory disabilities. Further reliability testing with a wider sample of social care users is warranted, as is further exploration of the relationship between the ASCOT-SCT4, ICECAP-A/O and EQ-5D-3 L indices. [ABSTRACT FROM AUTHOR]

Background: The prevalence of diabetes mellitus (DM) is increasing dramatically, placing considerable financial burden on the healthcare budget of each country. Patient self-management is crucial for the control of blood glucose, which largely determines the chances of developing diabetes-related complications. Self-management interventions vary widely, and a method is required for assessing the impact of self-management. This paper describes the development of a questionnaire intended for use to measure the impact of self-management in diabetes.Methods: An iterative development process was undertaken to identify the attributes of self-management using 5 steps. First, a literature review was undertaken to identify and understand themes relating to self-management of DM to inform a topic guide. Second, the topic guide was further refined following consultation with a Patient and Public Involvement group. Third, the topic guide was used to inform semi-structured interviews with patients with Type 1 DM (T1DM) and Type 2 DM (T2DM) to identify how self-management of DM affects individuals. Fourth, the research team considered potential attributes alongside health attributes from an existing measure (Diabetes Health Profile, DHP) to produce an instrument reflecting both health and self-management outcomes simultaneously. Finally, a draft instrument was tested in a focus group to determine the wording and acceptability.Results: Semi-structured interviews were carried out with 32 patients with T1DM and T2DM. Eight potential attributes were identified: fear/worry/anxiety, guilt, stress, stigma, hassle, control, freedom, and feeling supported. Four of these self-management attributes were selected with four health attributes (mood, worry about hypos (hypoglycaemic episodes), vitality and social limitations) to produce the Health and Self-Management in Diabetes (HASMIDv1) questionnaire.Conclusions: HASMIDv1 is a short questionnaire that contains eight items each with four response levels to measure the impact of self-management in diabetes for both T1DM and T2DM. The measure was developed using a mixed-methods approach that involved semi-structured interviews with people with diabetes. The measure has high face validity. Ongoing research is being undertaken to assess the validity of this questionnaire for measuring the impact of self-management interventions in economic evaluation. [ABSTRACT FROM AUTHOR]

Background: The Health of the Nation Outcomes Scale (HoNOS) is recommended for use by the English National Service Framework for Mental Health and by the working group on outcome indicators for severe mental illnesses to the Department of Health. It was developed to measure the health and social functioning of people with severe mental illness. Since the development of the HoNOS many have debated its latent structure. This paper examines the latent structure of the HoNOS using current factor analysis techniques.Method: HoNOS data for 12,910 patients with ICD10 diagnoses F20 to F29 at a UK National Health Service Mental Health Trust were analysed using exploratory, confirmatory and bifactor analysis for categorical data. The fit of models was assessed using relative and absolute fit indices.Results: Exploratory followed by confirmatory factor analysis identified a four factor solution which fit the data better than existing models. The corresponding bifactor factor solution identified three robust factors and one weak factor after accounting for a general factor. The factor loadings on the general factor were not appreciably different when compared to a unidimensional factor solution indicating the existence of a common trait.Conclusion: Existing models proposed in the literature did not fit well in our data. Factor analysis identified a new four factor solution. These factors showed clinical relevance according to published literature. The bifactor model demonstrated that there is not much loss of information when the HoNOS is used as a unidimensional construct. Further studies should explore this structure in larger samples and in alternative sample populations. A bifactor approach may have implications for how the HoNOS is used in practice, since there is ongoing debate on whether HoNOS item scores should be aggregated for interpretation. [ABSTRACT FROM AUTHOR]

Background: This paper describes the cross-cultural adaptation of the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) into Malay version (Malay PIDAQ), an oral health-related quality of life (OHRQoL) instrument specific for orthodontics for Malaysian adolescents between 12 and 17 years old.Methods: The PIDAQ was cross-culturally adapted into Malay version by forward- and backward-translation processes, followed by psychometric validations. After initial investigation of the conceptual suitability of the measure for the Malaysian population, the PIDAQ was translated into Malay, pilot tested and back translated into English. Psychometric properties were examined across two age groups (319 subjects aged 12-14 and 217 subjects aged 15-17 years old) for factor structure, internal consistency, reproducibility, discriminant and construct validity, criterion validity, and assessment of floor and ceiling effects.Results: Fit indices by confirmatory factor analysis showed good fit statistics (comparative fit index = 0.936, root-mean-square error of approximation = 0.064) and invariance across age groups. Internal consistency and reproducibility tests were satisfactory (Cronbach's α = 0.71-0.91; intra-class correlations = 0.72-0.89). Significant differences in Malay PIDAQ mean scores were observed between subjects with severe malocclusion and those with slight malocclusion based on a self-rated and an investigator-rated malocclusion index, for all subscales and all age groups (p < 0.05). Construct validity of the Malay PIDAQ subscales with those who rated themselves with excellent to poor dental appearance and those who felt they needed or did not need braces, showed significant associations for all age groups (p < 0.05). Criterion validity also showed significant association between the Malay PIDAQ scores with those with and without impact on daily activities attributed to malocclusion. There were no ceiling effects detected but floor effects were detected for the Aesthetic Concern subscale.Conclusion: The study has provided initial evidence for the validity and reliability of the Malay PIDAQ to assess the impact of malocclusion on the OHRQoL of 12-17 year old Malaysian adolescents. [ABSTRACT FROM AUTHOR]

Background: Quality of life (QoL) is an important measure and outcome within chronic disease management and treatment, including substance use disorders (SUD). The aim of this paper was to investigate correlates of poorer QoL of individuals entering SUD treatment in Norway, in order to identify subgroups that may most benefit from different interventions.Methods: Twenty-one treatment facilities invited all incoming patients to participate. Five hundred forty-nine patients who enrolled between December 2012 and April 2015 are analyzed. QoL, substance use, mental and physical comorbidities, and exercise behaviors were measured. Multinomial regression analysis was used to determine variables significantly associated with poorer QoL.Results: The majority of both genders (75 %) reported "poor" or "very poor" QoL at intake. Depression showed a strong association with poor QoL (relative risk ratio [RRR] 3.3, 95 % confidence interval [CI] 1.0-10.3) and very poor QoL (RRR 3.8, 1.2-11.8) among women. Physical inactivity among men was associated with very poor QoL (RRR 2.0, 1.1-3.7), as was reporting eating most meals alone (RRR 2.6, 1.4-4.8). Evaluating one's weight as too low was also associated with poor QoL (RRR 2.0, 1.0-3.9) and very poor QoL (RRR 2.0, 1.1-3.7) among men. Consuming methadone/buprenorphine was a protective factor for men reporting poor QoL (RRR 0.5, 0.3-0.9) and very poor QoL (RRR 0.4, 0.2-0.9), as well as for women reporting very poor QoL (RRR 0.2, 0.0-0.6).Conclusions: Factors associated with poorer QoL among other healthy and clinical populations, such as impaired social and physical well-being and psychological distress, were also seen associated in this sample. Treatment should be targeted towards patients with these particular vulnerabilities in addition to focusing on substance-related factors, and interventions proven to improve the QoL of other populations with these vulnerabilities should be explored in a SUD context. [ABSTRACT FROM AUTHOR]

Background: The Connor-Davidson Resilience Scale (CD-RISC) is inarguably one of the best-known instruments in the field of resilience assessment. However, the criteria for the psychometric quality of the instrument were based only on classical test theory.Method: The aim of this paper has focused on the calibration of the CD-RISC with a nonclinical sample of 444 adults using the Rasch-Andrich Rating Scale Model, in order to clarify its structure and analyze its psychometric properties at the level of item.Results: Two items showed misfit to the model and were eliminated. The remaining 22 items form basically a unidimensional scale. The CD-RISC has good psychometric properties. The fit of both the items and the persons to the Rasch model was good, and the response categories were functioning properly. Two of the items showed differential item functioning.Conclusions: The CD-RISC has an obvious ceiling effect, which suggests to include more difficult items in future versions of the scale. [ABSTRACT FROM AUTHOR]

Background: We present the detailed protocol set up to investigate how agonistic sport affects the self-perceived psychological and emotional well-being of disabled young people.Methods: The study will be carried out on a number of subjects as large as 800-1200, using well-established indices that give a quantitative measure of such well-being, namely SF-12 and PGWBI. The related questionnaires will be administered to the participants to a forthcoming international event, the European Para-Youth Games, 9-15 October 2017, Liguria, Italy, as well as to a reference population of a similar number of subjects, made up of young disabled people that do not practice agonistic sport.Discussion: We expect that the outcomes of the study may strongly impact not only the socio-sanitary field but also society in general, as disabled people can be considered an extreme situation in the issue of balancing individual needs and environment to pursue psychological well-being.Trial Registration: ISRCTN14389453 (29 June 2017). [ABSTRACT FROM AUTHOR]

Objectives: Our study discusses health related quality of life (HRQOL) as measured by 36-item Short Form (SF-36) for rural-to-urban migrants in China, and assesses the validity and reliability of the SF-36 for this group.Methods: In 2012,765 rural-to-urban migrant respondents chosen by probability and the non-probability sampling methods have completed the survey in Wuhan, Mid-China. The reliability of SF-36 is analyzed by Cronbach's alpha (α) coefficient, split-half coefficient, theta (θ) and omega (Ω) coefficient, the validity is calculated by confirmatory factor analysis (CFA) and known-group methods.Result: Split-half reliability coefficient is 0.717. Cronbach's alpha coefficient is 0.776. Theta and omega coefficient are 0.862 and 0.903 respectively. CFA statistical analysis results are shown as follows: GFI = 0.926, Chi-Square/Df = 2.059, RMSEA = 0.037, CFI = 0.939. Physical and mental component summary (PCS/MCS) scores are tabulated by known-group variables and show a statistical significance.Conclusion: In general, SF-36 is a reliable and valid instrument for measuring HRQOL of rural-to-urban migrants in China. Furthermore, Chinese migrants have lived and worked in a hard environment, their salaries are much lower than that of the counterparts, HRQOL of this group is also a little lower and deserves much attention from society. [ABSTRACT FROM AUTHOR]

Background: The assessment of fear of recurrence (FCR) is crucial for understanding an important psychological state in patients diagnosed and treated for cancer. The study aim was to determine psychometric details of a seven question self-report scale (FCR7) and a short form (FCR4) based upon items already used in various extensive measures of FCR.Methods: Two consecutive samples of patients (breast and colorectal) were recruited from a single specialist cancer centre. The survey instrument contained the FCR7 items, Hospital Anxiety and Depression Scale (HADS), and demographic details. Clinical information was obtained from patient hospital records. Statistical analyses were performed using classical test and item response theory approaches, to demonstrate unidimensional factor structure and testing key parameters. Construct validity was inspected through nomological and theoretical prediction.Results: Internal consistency was demonstrated by alpha coefficients (FCR4: 0.93 and FCR7: 0.92). Both scales (FCR7 & FCR4) were associated with the HADs subscales as predicted. Patients who experienced chemotherapy, minor aches/pains, thought avoidance of cancer and high cancer risk belief were more fearful. Detailed inspection of item responses profile provided some support for measurement properties of scales.Conclusion: The internal consistency, and pattern of key associations and discriminability indices provided positive psychometric evidence for these scales. The brief measures of FCR may be considered for audit, screening or routine use in clinical service and research investigations. [ABSTRACT FROM AUTHOR]

Background: The Recovery Assessment Scale-revised (RAS-R) is a self-report instrument measuring mental health recovery. The purpose of the present study was to translate and adapt the RAS-R into the Norwegian language and to investigate its psychometric properties in terms of factor structure, convergent and discriminant validity and reliability in the Norwegian context.Methods: The present study is a cross-sectional multi-centre study. After a pilot test, the Norwegian version of the RAS-R was distributed to 231 service users in mental health specialist and community services. The factor structure of the instrument was investigated by a confirmatory factor analysis (CFA), and internal consistency was assessed by Cronbach's alpha.Results: The RAS-R was found to be acceptable and feasible for service users. The original five-factor structure was confirmed. All model fit indices, including the standardised root mean square residual (SRMR), which is independent of the χ2-test, met the criteria for an acceptable model fit. Internal consistencies within sub-scales as measured by Cronbach's alpha ranged from 0.65 to 0.85. Cronbach's alpha for the total scale was 0.90. As expected, some redundancy between factors existed (in particular among the factors Personal confidence and hope, Goal and success orientation and Not dominated by symptoms).Conclusions: The Norwegian RAS-R showed acceptable psychometric properties in terms of convergent validity and reliability, and fit indices from the CFA confirmed the original factor structure. We recommend the Norwegian RAS-R as a tool in service users' and health professionals' collaborative work towards the service users' recovery goals and as an outcome measure in larger evaluations. [ABSTRACT FROM AUTHOR]

Background: Catquest questionnaire was originally developed in Swedish to measure patients' self-assessed visual function to evaluate the benefit of cataract surgery. The result of the Rasch analysis leading to the creation of the nine-item short form of Catquest, (Catquest-9SF), and it had been translated and validated in English. The aim is therefore to evaluate the translated Catquest-9SF questionnaire in Malay and Chinese (Mandarin) language version for measuring patient-reported visual function among cataract population in Malaysia.Methods: The English version of Catquest-9SF questionnaire was translated and back translated into Malay and Chinese languages. The Malay and Chinese translated versions were self-administered by 236 and 202 pre-operative patients drawn from a cataract surgery waiting list, respectively. The translated Catquest-9SF data and its four response options were assessed for fit to the Rasch model.Results: The Catquest-9SF performed well in the Malay and Chinese translated versions fulfilling all criteria for valid measurement, as demonstrated by Rasch analysis. Both versions of questionnaire had ordered response thresholds, with a good person separation (Malay 2.84; and Chinese 2.59) and patient separation reliability (Malay 0.89; Chinese 0.87). Targeting was 0.30 and -0.11 logits in Malay and Chinese versions respectively, indicating that the item difficulty was well suited to the visual abilities of the patients. All items fit a single overall construct (Malay infit range 0.85-1.26, outfit range 0.73-1.13; Chinese infit range 0.80-1.51, outfit range 0.71-1.36), unidimensional by principal components analysis, and was free of Differential Item Functioning (DIF).Conclusions: These results support the good overall functioning of the Catquest-9SF in patients with cataract. The translated questionnaire to Malay and Chinese-language versions are reliable and valid in measuring visual disability outcomes in the Malaysian cataract population. [ABSTRACT FROM AUTHOR]

Background: Endometriosis is a common gynecological disorder that causes inflammation and pelvic pain. Endometriosis-related pain is best captured with patient-reported outcome (PRO) measures, however, assessment of endometriosis-related pain in clinical trials has been difficult in the absence of a reliable and valid PRO instrument. We describe the development of the Endometriosis Pain Daily Diary (EPDD), an electronic PRO developed as a survey instrument to assess endometriosis-related pain and its impact on patients' lives.Methods: The EPDD was initially developed on the basis of an existing Endometriosis Pain and Bleeding Diary, a targeted review of relevant literature, clinical expert interviews, and open-ended (concept elicitation) patient interviews in the United States (US) and Japan which captured patients' experience with endometriosis. Cognitive interviews of patients with endometriosis were conducted to evaluate patient comprehension of the EPDD items. A conceptual model of endometriosis was developed, and meetings with US and European regulatory authorities provided feedback for validating the EPDD in the context of clinical trials. Translatability assessments of the EPDD were conducted to confirm its appropriate interpretation and ease of completion across 17 languages.Results: The iterative development progressed through three versions of the instrument. The EPDDv1 included 18 items relating to dysmenorrhea/pelvic pain, dyspareunia and sexual activity, bleeding, hot flashes, daily activities, and use of rescue medication. The EPDDv2 was a larger 43-item survey tested in cognitive interviews and subsequently revised to yield the current 11-item EPDDv3, consisting of five core items relating to dysmenorrhea, non-menstrual pelvic pain, and dyspareunia, and six extension items relating to sexual activity, daily activities, and use of rescue medication.Conclusions: The EPDD is a PRO for the evaluation of endometriosis-related pain and its associated impacts on patients' lives. The EPDD represents an important step in providing a PRO that is relevant to patients with endometriosis-related pain in the context of a clinical study setting (ie, fit-for-purpose), designed to evaluate pain associated with endometriosis, including regulatory agency support for its further exploration in clinical trials. [ABSTRACT FROM AUTHOR]

Background: Patient reported outcome measures (PROMs) are widely used in mental healthcare research for quality of life assessment but most fail to capture the breadth of health and non-health domains that can be impacted. We report the psychometric validation of a novel, multi-dimensional instrument based on Amartya Sen's capability approach intended for use as an outcome measure in mental health research.Methods: The Oxford Capabilities Questionnaire for Mental Health (OxCAP-MH) is a 16-item self-complete capability measure that covers multiple domains of functioning and welfare. Data for validation of the instrument were collected through a national randomised controlled trial of community treatment orders for patients with psychosis. Complete OxCAP-MH data were available for 172 participants. Internal consistency was established with Cronbach's alpha; an interclass correlation coefficient was used to assess test-retest reliability in a sub-sample (N = 50) tested one week apart. Construct validity was established by comparing OxCAP-MH total scores with established instruments of illness severity and functioning: EuroQol (EQ-5D), Brief Psychiatric Rating Scale (BPRS), Global Assessment of Functioning (GAF) and Objective Social Outcomes Index (SIX). Sensitivity was established by calculating standard error of measurement using distributional methods.Results: The OxCAP-MH showed good internal consistency (Cronbach's alpha 0.79) and test-retest reliability (ICC = 0.86). Convergent validity was evidenced by strong correlations with the EQ-5D (VAS 0.52, p < .001) (Utility 0.45, p < .001), and divergent validity through more modest associations with the BPRS (-0.41, p < .001), GAF (0.24, p < .001) and SIX (0.12, p = ns). A change of 9.2 points on a 0-100 scale was found to be meaningful on statistical grounds.Conclusions: The OxCAP-MH has demonstrable reliability and construct validity and represents a promising multi-dimensional alternative to existing patient-reported outcome measures for quality of life used in mental health research. [ABSTRACT FROM AUTHOR]

Background: Systemic therapy-induced diarrhea (STID) is a common side effect experienced by more than half of cancer patients. Despite STID-associated complications and poorer quality of life (QoL), no validated assessment tools exist to accurately assess STID occurrence and severity to guide clinical management. Therefore, we developed and validated a patient-reported questionnaire (STIDAT).Methods: The STIDAT was developed using the FDA iterative process for patient-reported outcomes. A literature search uncovered potential items and questions for questionnaire construction used by oncology clinicians to develop questions for the preliminary instrument. The instrument was evaluated on its face validity and content validity by patient interviews. Repetitive, similar and different themes uncovered from patient interviews were implemented to revise the instrument to the version used for validation. Patients starting high-risk STID treatments were monitored using the STIDAT, bowel diaries and EORTC QLQ-C30. The STIDAT was evaluated for construct validity using exploratory factor analysis (EFA) using minimal residual method with Promax rotation, reliability and consistency. A weighted scoring system was developed and a receiver-operating characteristic (ROC) curve evaluated the tool's ability to detect STID occurrence. Median scores and variability were analysed to determine how well it differentiates between diarrhea severities. A post-hoc analysis determined how diarrhea severity impacted QoL of cancer patients.Results: Patients defined diarrhea based on presence of watery stool. The STIDAT assessed patient's perception of having diarrhea, daily number of bowel movements, daily number of diarrhea episodes, antidiarrheal medication use, the presence of urgency, abdominal pain, abdominal spasms or fecal incontinence, patient's perception of diarrhea severity, and QoL. These dimensions were sorted into four clusters using EFA - patient's perception of diarrhea, frequency of diarrhea, fecal incontinence and abdominal symptoms. Cronbach's alpha was 0.78; kappa ranged from 0.934-0.952, except for abdominal spasms (κ = 0.0455). The positive predictive value was 96.4%, with the minimum score of 1.35 predicting a positive STID occurrence. Patients with moderate or severe diarrhea experience significant decreases in QoL compared to those with no diarrhea.Conclusions: This is the first patient-reported questionnaire that accurately predicts the occurrence and severity of diarrhea in oncology patients via assessing several bowel habit dimensions. [ABSTRACT FROM AUTHOR]

Background: Angina pectoris causes substantial psychological and functional disabilities and adversely effects quality of life in patients. The aim of this study was to investigate the psychometric properties including validity and reliability of the Farsi version of the Seattle angina questionnaire.Methods: The 'forward-backward' procedure was applied to translate this questionnaire from English to Farsi. The translated version of the Seattle angina questionnaire was assessed in terms of validity and reliability with a convenience sample of 200 patients suffering from angina pectoris who were recruited from the inpatient ward (post CCU) and outpatient department at two teaching hospitals in an urban area of Iran. Validity was assessed using content, face and construct validity. The calculation of the Cronbach's alpha coefficient and the test-retest method helped with the assessment of reliability of the questionnaire's five subscales. Construct validity of the questionnaire was evaluated using exploratory factor analysis.Results: The results of exploratory factor analysis indicated a five-factor solution for the questionnaire including 'physical limitation in middle to strenuous activities', 'physical limitation in slight activities', 'angina pattern and discomfort of treatment', 'treatment satisfaction' and 'disease perception' that jointly accounted for 64.42% of variance observed. Convergent validity was mostly supported by the pattern of association between the Seattle angina questionnaire-Farsi version and the SF-36. Cronbach's alpha of the subscales ranged from 0.60 to 0.86 and test-retest scores ranged from 0.79 to 0.97 indicating a good range of reliability.Conclusions: The Seattle angina questionnaire-Farsi version had acceptable psychometric properties. Therefore, it can be used to assess health-related quality of life and assess the effects of different medical and nursing interventions on patients' quality of life. [ABSTRACT FROM AUTHOR]

Background: Cleft lip and/or palate (CL/P) is a common congenital craniofacial anomaly that may negatively affect an individual's appearance, health-related quality of life, or speech. In Spain, Colombia, and Chile the overall prevalence of CL/P ranges from 0.53 to 1.59 cases per 1000 live births. Currently, there is no patient-reported outcome (PRO) instrument that is specific for patients with CL/P. The CLEFT-Q is a new PRO instrument developed to measure outcomes of treatment in patients 8 to 29 years of age with CL/P. The aim of this study was to translate and culturally adapt the CLEFT-Q for use in Colombia, Chile, and Spain.Methods: The CLEFT-Q was translated from English to 3 Spanish language varieties (Colombian, Chilean, and Spanish (Spain)) and Catalan. Translation and cultural adaptation guidelines set forth by the International Society for Pharmacoeconomics and Outcomes Research were followed.Results: The field- test version of the CLEFT-Q consisted of 13 scales (total 154 items) measuring appearance, health-related quality of life, and facial function. Forward translations revealed 10 (7%) items that were difficult to translate into Chilean, and back translations identified 34 (22%) and 21 (13%) items whose meaning differed from the English version in at least 1 of the 3 Spanish varieties and Catalan respectively. Twenty-one participants took part in cognitive debriefing interviews. Participants were recruited from plastic surgery centres in Bogotá, Colombia (n = 4), Santiago, Chile (n = 7), and Barcelona, Spain (n = 10). Most participants were males (n = 14, 67%) and were diagnosed with CL/P (n = 17, 81%). Participants reported difficulty understanding 1 item in the Colombian, 1 item in the Spanish (Spain), and 11 items from the Catalan version. Comparison of the 3 Spanish varieties revealed 61 (40%) of the 154 items whose wording differed across the 3 Spanish versions.Conclusion: Translation and cultural adaptation processes provided evidence of transferability of the CLEFT-Q scales into 3 Spanish varieties and Catalan, as semantic, idiomatic, experiential, and conceptual equivalence of the items, instructions, and response options were achieved. [ABSTRACT FROM AUTHOR]

Background: The Questionnaire on Pain caused by Spasticity (QPS) is a modular patient- and observer-reported outcome measure of spasticity-related pain (SRP) in children with cerebral palsy (CP). Originally developed for an English-speaking population, we conducted a psychometric validation of a recently developed Chinese language version of the QPS.Methods: This was a prospective, observational study involving 137 children/adolescents with CP and upper and/or lower limb spasticity and their parents at three sites in China. Six QPS modules were used, three each for upper and lower limb SRP assessment: a patient self-report module; an interviewer-administered module used by site staff based on the cognitive, communicative, and motor abilities of a patient; and a parent/caregiver module administered for all children as an observer-reported outcome to complement the patient-reported outcome. If no assessment by the patient was possible because of age or cognitive impairments, only the parent/caregiver module was completed. Two visits with a 3-week interval provided data to evaluate and establish administrative ease of use, scoring of the QPS (factor analyses, Rasch analyses), reliability (Cronbach's α, intraclass correlation coefficient), validity (correlations with quality of life [PedsQL™], motor impairment [Gross Motor Function Classification System, Gross Motor Function Measure-66, Manual Ability Classification System], and spasticity [Ashworth Scale, Modified Tardieu Scale]).Results: For most children, clinic staff reported no difficulties associated with general QPS use or deciding which module to use. Children (and parents) who reported more demanding activities also reported higher levels of associated SRP (or observed SRP behavior). Activity-related SRP items were combined for a total QPS score. Cronbach's α was low for child self-report, but was acceptable for interviewer-administered and parent reports on SRP. Test-retest reliability was high for all modules. Moderate-strong associations were frequently seen between QPS and quality of life, and were particularly strong in the child self-report group. Relatively weak associations were observed between QPS and motor impairment and spasticity.Conclusions: This first study was successful in providing initial evidence for the psychometric properties. Clinic staff were able to administer the QPS modules easily, and both children and parents were able to complete the designated QPS appropriately. [ABSTRACT FROM AUTHOR]

Background: This study aims to cross-culturally adapt the original English-language COHIP-SF 19 to Arabic culture and to test its psychometric properties in a community sample.Methods: The Arabic COHIP-SF 19 was developed and its psychometric properties were examined in a population-based sample of 876 schoolchildren who were aged 12 years of age, in Benghazi, Libya. The Arabic COHIP-SF 19 was tested for its internal consistency, reproducibility, construct validity, factorial validity and floor as well as ceiling effects. A Mann-Whitney U test was used to compare the mean scores of COHIP-SF 19 by participants' caries status and self-reported oral health rating, satisfaction and treatment need.Results: The Arabic COHIP-SF 19 was successfully and smoothly developed. It showed an acceptable level of equivalence to the original version. Overall, the internal consistency and reproducibility were acceptable to excellent, with a Cronbach's alpha of 0.84 and an intra-class correlation coefficient (ICC) of 0.76. All hypotheses predefined to test construct validity were confirmed. That is, children who had active dental caries, and who rated their oral health as poor, were not satisfied with their oral health or indicated the need of treatment had lower COHIP-SF 19 scores (P < 0.05). Floor or ceiling effects were not observed. The exploratory Factorial analysis suggested a 4-component solution and deletion of one item.Conclusion: The Arabic COHIP-SF 19 was successfully developed. The measure demonstrated satisfactory reliability and validity to estimate OHRQoL in a representative sample of 12-year-old schoolchildren. [ABSTRACT FROM AUTHOR]

Background: Many quality-of-life studies have been conducted in healthcare settings, but few have used Microsoft Excel to incorporate Cronbach's α with dimension coefficient (DC) for describing a scale's characteristics. To present a computer module that can report a scale's validity, we manipulated datasets to verify a DC that can be used as a factor retention criterion for demonstrating its usefulness in a patient safety culture survey (PSC).Methods: Microsoft Excel Visual Basic for Applications was used to design a computer module for simulating 2000 datasets fitting the Rasch rating scale model. The datasets consisted of (i) five dual correlation coefficients (correl. = 0.3, 0.5, 0.7, 0.9, and 1.0) on two latent traits (i.e., true scores) following a normal distribution and responses to their respective 1/3 and 2/3 items in length; (ii) 20 scenarios of item lengths from 5 to 100; and (iii) 20 sample sizes from 50 to 1000. Each item containing 5-point polytomous responses was uniformly distributed in difficulty across a ± 2 logit range. Three methods (i.e., dimension interrelation ≥0.7, Horn's parallel analysis (PA) 95% confidence interval, and individual random eigenvalues) were used for determining one factor to retain. DC refers to the binary classification (1 as one factor and 0 as many factors) used for examining accuracy with the indicators sensitivity, specificity, and area under receiver operating characteristic curve (AUC). The scale's reliability and DC were simultaneously calculated for each simulative dataset. PSC real data were demonstrated with DC to interpret reports of the unit-based construct validity using the author-made MS Excel module.Results: The DC method presented accurate sensitivity (=0.96), specificity (=0.92) with a DC criterion (≥0.70), and AUC (=0.98) that were higher than those of the two PA methods. PA combined with DC yielded good sensitivity (=0.96), specificity (=1.0) with a DC criterion (≥0.70), and AUC (=0.99).Conclusions: Advances in computer technology may enable healthcare users familiar with MS Excel to apply DC as a factor retention criterion for determining a scale's unidimensionality and evaluating a scale's quality. [ABSTRACT FROM AUTHOR]

Background: The Kessler Psychological Distress Scale has been widely used in assessing psychological distress among general and clinical populations from different cultural backgrounds. To our knowledge, however, researchers have not yet validated any translated versions in Arabic. The purpose of this study was to test the reliability and validity of Arabic translations of the ten item (K10) and six item (K6) versions among public sector employees in the Occupied Palestinian Territories.Methods: As part of a larger research project on life satisfaction, researchers collected data from 234 Palestinian social workers in June and July of 2016. The survey included several mental health measures, including the K10, which were translated from English to Arabic by an experienced language expert. In the current study, we tested reliability by measuring internal consistency using Cronbach's alpha coefficient. Next, we assessed factor structure using variance-covariance matrix with maximum likelihood estimation. Confirmatory factor analysis was performed to examine three competing models: unidimensional K10 model, unidimensional K6 model and two-factor K6 model. Fit indices and parameter estimates were reported. Last, convergent validity was examined by assessing correlations with Generalized Anxiety Disorder (GAD-7) and Somatic Symptoms Scale (SSS-8).Results: The mean scores for the K6 and K10 were, respectively, 12.87 (SD = 4.02) and 21.8 (SD = 6.7), indicative of mild to moderate levels of distress. Scale reliability analysis showed satisfactory results on both K6 and K10 versions (Cronbach's α = .81 (K6) and .88 (K10)). Among three competing models, the two-factor K6 scale demonstrated the best model fit with high factorial correlations (r = .60, p < .001). Moreover, the K6 has high convergent validity with GAD-7 (r = .66, p < .001) and SSS-8 (r = .61, p < .001).Conclusion: Results indicated that the translated version of the two-factor K6 scale is a valid and reliable measurement of psychological distress. Our findings suggest that practitioners and researchers can use this instrument in screening and assessing psychological symptoms with Arabic-speaking populations. [ABSTRACT FROM AUTHOR]

Background: Economic environmental factors represent important barriers to participation and have deleterious effects on quality of life (QOL) in persons with spinal diseases (SpD). While economic factors are anchored in the International Classification of Functioning, Disability and Health, their influence on QOL and participation from patients' perspectives is an infrequent focus of research. The aim of the present research is to calibrate a culturally adapted Rasch-based questionnaire assessing economic QOL in patients with SpD.Methods: The 11-items of the German economic-QOL-scale were answered by 325 patients with SpD on a four-point Likert-scale. Fit to the Rasch measurement model was investigated by testing for stochastic ordering of the items, unidimensionality, local independence, and differential item functioning (DIF).Results: After adjusting for local dependency, fit to the Rasch model was achieved with a non-significant item-trait interaction (chi-squaredf = 20 = 34.8, p = 0.021). The person separation reliability equaled 0.88, the scale was free from age- or gender-related DIF, and unidimensionality could be verified.Conclusions: The Rasch-based German version of the economic-QOL-scale represents a suitable instrument to investigate the influences of economic factors on patients' QOL at a group and individual level. It can be easily applied in research and practice and may be administered quickly in combination with other instruments. The short test duration implies a low test burden for patients and a minimum of time expenditure by clinicians when evaluating the results. [ABSTRACT FROM AUTHOR]

Background: Many existing patient-reported outcome measures are extensive regarding both patient burden and administration, and in terms of analysing and reporting results. The VascuQoL-6 (VQ6) - a short version of the original Vascular Quality of Life Questionnaire (VascuQoL), a disease-specific instrument for peripheral arterial disease - was recently developed. However, the VQ6 has not yet been empirical tested with regard to content validity, construct validity and test retest reliability. Our aim was, therefore, to explore both the validity and the reliability of the VQ-6 in a target population with established peripheral arterial disease.Methods: Two hundred patients treated at two vascular centres were consecutively recruited for the survey. Administered questionnaires included VQ6 and the Short Form Health Survey-36 (SF-36). Out of the 200 patients, 150 also received a second VQ6 questionnaire for a test-retest assessment. Further, a purposive sample of 22 patients consented to participate in cognitive interviews. All included patients suffer from peripheral arterial disease. The questionnaire data was tested by both Rasch analysis and traditional psychometric methods, while the cognitive interviews were analysed descriptively.Results: The validity and reliability of the VQ6, as tested in a target population without the surrounding 19 items from the original VascuQoL, was high, in general, and a good fit to the Rasch model was observed. Further, an excellent internal consistency and significant correlations between comparable dimensions in SF-36 were demonstrated. In the test-retest analysis, the percentage agreement was somewhat poor (<70%) in the six items. However, no systematic disagreements between the two assessments were seen in any of the six items, and the test-retest assessment for the VQ6 sum score showed an acceptable intraclass correlation coefficient (0.86). Finally, all items in the VQ6 were considered as both understandable and relevant by the interviewed patients.Conclusions: The VQ6 has acceptable to good psychometric properties with regard to data quality, scale assumptions, targeting, validity and reliability. Further, VQ6 seems to be easy to use and comprehend within the target population of patients with PAD. [ABSTRACT FROM AUTHOR]

Background: Knee osteoarthritis (OA) represents a heavy burden for patients and the society as a whole. The Oxford Knee Score (OKS) is a well known tool to assess the quality of life in patients with Knee OA. The purpose of this study was to analyze the psychometric properties of the Spanish version of the OKS, including its reliability, validity, and responsiveness.Methods: Prospective observational study that included 397 patients diagnosed with knee OA according to the criterion of the American Rheumatism Association, which were recruited in 3 different Spanish regions. Their self-perceived health-related quality of life (HRQL) was assessed through 3 questionnaires: a generic one (the EQ-5D-5 L) and two specific ones adapted to Spanish (the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Oxford Knee Score (OKS). The follow-up period was 6 months, and the acceptability of the OKS was evaluated, together with its psychometric properties, presence of ceiling and floor effects, validity, reliability, and sensitivity to change.Results: The OKS was fully answered in 99.5% of cases, with no evidence of ceiling or floor effects. Its factor structure can be explained in a single dimension. Its discriminating capacity was very good compared to the groups generated by the WOMAC and the EQ-5D-5 L. The correlation of the OKS with the dimensions of the latter questionnaires was around 0.7. The test-retest reliability was excellent (ICC 0.993; CI 95%: 0.990-0.995) and so was its internal consistency (Cronbach's α = 0.920). The effect size was 0.7 for moderate improvements in the HQRL, which is similar to that of the dimensions of the WOMAC and greater than for the EQ-5D-5 L. The minimum clinically significant difference that was detected by the questionnaire was 6.1 points, and the minimum detectable change was 4.4 points.Conclusions: The Spanish-adapted version of the OKS is a useful, valid tool for assessing the perceived HRQL in patients suffering from knee OA, with psychometric properties similar to the WOMAC, and that allows for discriminating the patient's condition at a particular moment as well as for appraising changes over time. [ABSTRACT FROM AUTHOR]

Background: The responsiveness of the Early Childhood Oral Health Impact Scale (ECOHIS) has varied greatly across studies; hence, we hypothesized that this discrepancy could be related to the complexity of dental treatment received. Thus, we aimed to evaluate the responsiveness of the ECOHIS to changes in oral health-related quality of life (OHRQoL) following dental treatments of varying complexity in preschool children.Methods: Preschool children aged 3 to 6 years were selected; their parents responded to the ECOHIS at baseline. The parents responded to the ECOHIS again and a global transition question 30 days after the children were treated. The type of treatment received by the children was categorized according to complexity, as follows: 1) non-operative treatment only, 2) restorative treatment, and 3) endodontic treatment and/or tooth extraction. Change scores and effect sizes (ES) were calculated for total scores, as well as considering the different treatment types and global transition question responses.Results: Of the 152 children who completed the study, the ECOHIS yielded large ES for total scores (0.89). The children showed increasing ES values associated with better perception of improvement, assessed by the global transition question. The magnitude of ES after treatment was related to treatment complexity (0.53, 0.92 and 1.43, for children who received non-operative treatment only, restorative treatment, and endodontic treatment and/or tooth extraction, respectively).Conclusions: Parents whose children required more complex dental treatment are more likely to perceive treatment-related changes to OHRQoL assessed with the ECOHIS. [ABSTRACT FROM AUTHOR]

Background: Shoulder pain is a common musculoskeletal disorder in Chinese population, which affects more than 1,3 billion individuals. To the best of our knowledge, there has been no available Chinese-language version of measurements of shoulder pain and disability so far. Moreover, the Constant-Murley score (CMS) questionnaire is a universally recognized patient-reported questionnaire for clinical practice and research. The present study was designed to evaluate a Chinese translational version of CMS and subsequently assess its reliability and validity.Methods: The Chinese translational version of CMS was formulated by means of forward-backward translation. Meanwhile, a final review was carried out by an expert committee, followed by conducting a test of the pre-final version. Therefore, the reliability and validity of the Chinese translational version of CMS could be assessed using the internal consistency, construct validity, factor analysis, reliability and floor and ceiling effects. Specifically, the reliability was assessed by testing the internal consistency (Cronbach's α) and test-retest reliability (intraclass coefficient correlation [ICC]), while the construct validity was evaluated via comparison between the Chinese translational version of CMS with visual analog scale (VAS) score and the 36-Item Short Form Health Survey (SF-36, Spearman correlation).Results: The questionnaire was verified to be acceptable after distribution among 120 subjects with unilateral shoulder pain. Factor analysis had revealed a two-factor and 10-item solution. Moreover, the assessment results indicated that the Chinese translational version of CMS questionnaire harbored good internal consistency (Cronbach's α = 0.739) and test-retest reliability (ICC = 0.827). In addition, the Chinese translational version of CMS was moderately correlated with VAS score (r = 0.497) and SF-36 (r = 0.135). No obvious floor and ceiling effects were observed in the Chinese translational version of CMS questionnaire.Conclusion: Chinese translational version of CMS exhibited good reliability, which is relatively acceptable and is likely to be widely used in this population. [ABSTRACT FROM AUTHOR]

Background: DEMQOL and DEMQOL-Proxy are widely used patient reported outcome measures (PROMs) of health related quality of life in people with dementia (PWD). Growing interest in routine use of PROMs in health care calls for more robust instruments that are potentially fit for reliable and valid comparisons at the micro-level (patients) and meso-level (clinics, hospitals, care homes).Methods: We used modern psychometric methods (based on the Rasch model) to re-evaluate DEMQOL (1428 PWDs) and DEMQOL-Proxy (1022 carers) to ensure they are fit for purpose. We evaluated scale to sample targeting, ordering of item thresholds, item fit to the model, and differential item functioning (sex, age, relationship), local independence, unidimensionality and reliability on the full set of items and a smaller item set.Results: For both DEMQOL and DEMQOL-Proxy the smaller item set performed better than the original item set. We developed revised scores using the items from the smaller set.Conclusions: We have improved the scoring of DEMQOL and DEMQOL-Proxy using the Rasch measurement model. Future work should focus on the problems identified with content and response options. [ABSTRACT FROM AUTHOR]

Background: The NEI VFQ-25 has undergone psychometric evaluation in patients with varying ocular conditions and the general population. However, important limitations which may affect the interpretation of clinical trial results have been previously identified, such as concerns with reliability and validity. The purpose of this study was to evaluate the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) and make recommendations for a revised scoring structure, with a view to improving its psychometric performance and interpretability.Methods: Rasch Measurement Theory analyses were conducted in two stages using pooled baseline NEI VFQ-25 data for 2487 participants with retinal diseases enrolled in six clinical trials. In stage 1, we examined: scale-to-sample targeting; thresholds for item response options; item fit statistics; stability; local dependence; and reliability. In stage 2, a post-hoc revision of the scoring structure (VFQ-28R) was created and psychometrically re-evaluated.Results: In stage 1, we found that the NEI VFQ-25 was mis-targeted to the sample, and had disordered response thresholds (15/25 items) and mis-fitting items (8/25 items). However, items appeared to be stable (differential item functioning for three items), have minimal item dependency (one pair of items) and good reliability (person-separation index, 0.93). In stage 2, the modified Rasch-scored NEI VFQ-28-R was assessed. It comprised two broad domains: Activity Limitation (19 items) and Socio-Emotional Functioning (nine items). The NEI VFQ-28-R demonstrated improved performance with fewer disordered response thresholds (no items), less item misfit (three items) and improved population targeting (reduced ceiling effect) compared with the NEI VFQ-25.Conclusions: Compared with the original version, the proposed NEI VFQ-28-R, with Rasch-based scoring and a two-domain structure, appears to offer improved psychometric performance and interpretability of the vision-related quality of life scale for the population analysed. [ABSTRACT FROM AUTHOR]

Background: Positive psychological constructs that can moderate or mediate the negative impact of disease activity on health-related quality of life (HRQOL) in patients with rheumatoid arthritis (RA) have not been explored widely. This study aimed to assess the associations of disease activity, resilience with HRQOL and the moderating and mediating roles of resilience among Chinese RA patients.Methods: A multi-center, cross-sectional study was conducted in RA inpatients in northeast of China. A total 298 subjects completed the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) and Ego-Resiliency Scale (ERS) to measure HRQOL and resilience. For the SF-36, physical function, physical role limitation, bodily pain and general health perception are gathered into physical component summary (PCS), while vitality, social functioning, emotional role limitation and mental health are gathered into mental component summary (MCS). Disease activity was evaluated by the Disease Activity Score 28-C-reactive protein (DAS28-CRP). Hierarchical regression analysis was applied to examine the associations of disease activity, resilience and the disease activity*resilience interaction with PCS and MCS, respectively. Asymptotic and resampling strategies were utilized to examine the mediating role of resilience.Results: The mean scores of PCS and MCS were 40.67 and 59.14, respectively. Disease activity was negatively associated with both PCS and MCS, and resilience was only positively associated with MCS. The disease activity*resilience interaction term were significantly associated with MCS (β = 0.144, P = 0.003). The associations between disease activity and MCS were gradually reduced in low (1 SD below the mean, β = -0.369, P < 0.001), mean (β = -0.218, P < 0.001) and high (1 SD above the mean, β = -0.068, P = 0.369) groups of resilience. Resilience acted as a partial mediator in the disease activity-MCS association (effect size was -0.085, BCa 95% CI: -0.159, -0.028).Conclusions: Disease activity was negatively associated with both physical and mental HRQOL, and resilience was only positively associated with mental HRQOL. Resilience could attenuate and mediate the association between disease activity and mental HRQOL. In addition to controlling disease activity, targeted intervention strategies designed for resilience should be strengthened to improve the HRQOL of this population. [ABSTRACT FROM AUTHOR]

Background: Liver Retransplantation (Re-LT) procedures are associated with an increased risk of morbidity and mortality. Up to date, there is no knowledge on the health-related quality of life and the mental status of these patients.Methods: Health-Related Quality of Life (HRQoL) was assessed by using the Short Form 36 (SF-36) Health Survey and Mental Status was assessed by using the Hospital Anxiety and Depression Scale (HADS). The patients were examined in different assessments: During regular check-up examinations in the LT outpatient department in 2011 (Survey 1) and in a postal survey in 2013 (Survey 2). Their medical data was collected by using an established database.Results: We received eligible surveys of 383 patients (55.6%) with a history of LT, of which 15 (3.9%) had undergone Re-LT (Re-LT group). These patients were compared to a group of 60 patients who had undergone only one LT. With regard to their HRQoL, the Re-LT group had significantly lower scores on the scales of physical function (PF, p = 0.026), their role-physical (RP, p = 0.008), their vitality (VIT, p = 0.040), and their role-emotional (RE, p = 0.005). The scores for anxiety and depression did not differ significantly between the groups. In a multiple regression analysis, chronic kidney disease was found to be an independent risk factor for decreased scores of PF (p = 0.023).Conclusions: Patients who have to undergo Re-LT procedures are faceing impairments in physical aspects of a HRQoL. Together with clinical results from other studies, the findings of the present examination underline the need for an optimized organ distribution strategy since not all patients listed for Re-LT appear to benefit from it. [ABSTRACT FROM AUTHOR]

Background: To develop a culturally adapted and validated Bengali Short Form SF 12v2 among Rheumatoid arthritis (RA) patients.Methods: The English SF 12v2 was translated, adapted and back translated into and from Bengali, pre-tested by 60 patients. The Bengali SF 12v2 was administered twice with 14 days interval to 130 Bangladeshi RA patients. The psychometric properties of the Bengali SF 12v2 were assessed. Test-retest reliability was assessed by intra-class correlation coefficient (ICC) and Spearman's rank correlation coefficient and internal consistency by Cronbach's alpha. Content validity was assessed by index for content validity (ICV) and floor and ceiling effects. To determine convergent and discriminant validity a Bengali Health Assessment Questionnaire (B-HAQ) was used. Factor analysis was done.Results: The Bengali SF 12v2 was well accepted by the patients in the pre-test and showed good reliability. Internal consistency for both physical and mental component was satisfactory; Cronbach's alpha was 0.9. ICC exceeded 0.9 in all domains. Spearman's rho for all domains exceeded 0.8. The physical health component of Bengali SF 12v2 had convergent validity to the B-HAQ. Its mental health component had discriminant validity to the B-HAQ. The ICV of content validity was 1 for all items. Factor analysis revealed two factors a physical and a mental component.Conclusions: The interviewer-administered Bengali SF 12v2 appears to be an acceptable, reliable, and valid instrument for measuring health-related quality of life in Bengali speaking RA patients. Further evaluation in the general population and in different medical conditions should be done. [ABSTRACT FROM AUTHOR]

Background: The Musculoskeletal Tumor Society (MSTS) scoring system is a disease-specific instrument to determine the physical and mental health for patients with extremity sarcoma. This study aims to investigate the reliability and validity of the Chinese version of the MSTS, and to evaluate functional outcomes of the surgical treatment of lower extremity sarcoma using the Chinese MSTS.Methods: A cohort of 98 patients who had undergone surgery for lower extremity sarcoma were included. All the patients completed the clinical assessment with the Chinese MSTS and the Chinese Toronto Extremity Salvage Score (TESS). Assessment of psychometric properties was carried out through reliability and validity test. The reliability of Chinese MSTS was evaluated through test-retest analysis, inter-observer analysis and internal consistency. The inter-observer and test-retest reliability was analyzed with intra-class correlation coefficient (ICC). The internal consistency was evaluated by Cronbach's α, with a value >0.70 considered acceptable. The discriminant validity was evaluated through comparison of the MSTS score between patients undergoing amputation surgeries and those undergoing limb-salvage surgeries. The construct validity was evaluated with the factor analysis.Results: The mean MSTS score was 21.5 ± 7.1. The ICC was 0.91 (95% confidence interval (CI) = 0.85-0.96) for the test-retest reliability and 0.90 (95% CI = 0.86-0.93) for the inter-observer analysis. The test for internal consistency showed a Cronbach's α of 0.86 for the MSTS. Patients undergoing amputation surgery had remarkably lower MSTS score than patients undergoing limb-salvage surgeries (18.8 ± 5.4 vs. 23.5 ± 6.3, p = 0.005), which indicated a good discrinimant validity of the Chinese MSTS. The factor analysis indicated a 1-factor model with acceptable goodness of fit.Conclusions: The Chinese MSTS scoring system is a reliable and valid instrument with well-accepted psychometric properties. Through application of the Chinese MSTS, we demonstrated that patients receiving limb-salvage surgeries may have better functional outcome and QoL than those undergoing amputation surgeries. [ABSTRACT FROM AUTHOR]

Background: Social care-related quality of life is a key outcome indicator used in the evaluation of social care interventions and policy. It is not, however, always possible to collect quality of life data by self-report even with adaptations for people with cognitive or communication impairments. A new proxy-report version of the Adult Social Care Outcomes Toolkit (ASCOT) measure of social care-related quality of life was developed to address the issues of wider inclusion of people with cognitive or communication difficulties who may otherwise be systematically excluded. The development of the proxy-report ASCOT questionnaire was informed by literature review and earlier work that identified the key issues and challenges associated with proxy-reported outcomes.Methods: To evaluate the acceptability and content validity of the ASCOT-Proxy, qualitative cognitive interviews were conducted with unpaid carers or care workers of people with cognitive or communication impairments. The proxy respondents were invited to 'think aloud' while completing the questionnaire. Follow-up probes were asked to elicit further detail of the respondent's comprehension of the format, layout and content of each item and also how they weighed up the options to formulate a response.Results: A total of 25 unpaid carers and care workers participated in three iterative rounds of cognitive interviews. The findings indicate that the items were well-understood and the concepts were consistent with the item definitions for the standard self-completion version of ASCOT with minor modifications to the draft ASCOT-Proxy. The ASCOT-Proxy allows respondents to rate the proxy-proxy and proxy-patient perspectives, which improved the acceptability of proxy report.Conclusions: A new proxy-report version of ASCOT was developed with evidence of its qualitative content validity and acceptability. The ASCOT-Proxy is ready for empirical testing of its suitability for data collection as a self-completion and/or interview questionnaire, and also evaluation of its psychometric properties. [ABSTRACT FROM AUTHOR]

Background: Cancer is now becoming a leading cause of death. Chemotherapy is an important treatment for cancer patients. These patients also need consultation during their treatment to improve quality of life and decrease psychological disorders. The objectives of the study were to develop, implement and evaluate the effectiveness of a chemotherapy counseling module by pharmacists among oncology patients on their quality of life and psychological outcomes in Malaysia.Method: A single-blind randomized controlled trial was carried out among 162 oncology patients undergoing chemotherapy from July 2013 to February 2014 in a government hospital with oncology facilities in Malaysia. Participants were randomized to either the intervention group or the control group. Chemotherapy counseling using the module on 'Managing Patients on Chemotherapy' by Pharmacists was delivered to the intervention group. The outcome measures were assessed at baseline, first follow-up and second follow-up and third follow-up post-intervention. Chi-square, independent samples t-test and two-way repeated measures ANOVA were conducted in the course of the data analyses.Results: In assessing the impact of the chemotherapy counseling module, the study revealed that the module along with repetitive counseling showed significant improvement of quality of life in the intervention group as compared to the control group with a large effect size in physical health (p = 0.001, partial Ƞ2 = 0.66), psychological (p = 0.001, partial Ƞ2 = 0.65), social relationships (p = 0.001, partial Ƞ2 = 0.30), and environment (p = 0.001, partial Ƞ2 = 0.67) and decrease in the anxiety (p = 0.000; partial Ƞ2 = 0.23), depression (p = 0.000; partial Ƞ2 = 0.40).Conclusion: The module on 'Managing Patients on Chemotherapy' along with repetitive counseling by pharmacists has been shown to be effective in improving quality of life and decreasing anxiety and depression among oncology patients undergoing chemotherapy.Trial Registration Number: National Medical Research Register (NMRR) of Malaysia and given a registration number NMRR-12-1057-12,363 on 21 December 2012. [ABSTRACT FROM AUTHOR]

Background: Obesity is associated to increased risk of metabolic comorbidity as well as increased mortality. Notably, obesity is also associated to the impairment of the psychological status and of quality of life. Only three questionnaires are available in the Italian language evaluating the health-related quality of life in subjects with obesity. The aim of the present study was to test the validity and reliability of the Italian version of the Laval Questionnaire.Methods: The original French version was translated into Italian and back-translated by a French native speaker. 273 subjects with obesity (Body Mass Index ≥ 30 kg/m2) were enrolled; the Italian version of the Laval Questionnaire and the O.R.Well-97 questionnaire were administered in order to assess health- related quality of life. The Laval questionnaire consists of 44 items distributed in 6 domains (symptoms, activity/mobility, personal hygiene/clothing, emotions, social interaction, sexual life). Disability and overall psychopathology levels were assessed through the TSD-OC test (SIO test for obesity correlated disabilities) and the SCL-90 (Symptom Checklist-90) questionnaire, respectively. To verify the validity of the Italian version, the analysis of internal consistency, test-retest reliability, and construct validity were performed.Results: The observed proportion of agreement concordance of results was 50.2% with Cohen's K = 0.336 (CI 95%: 0.267-0.404), indicating a fair agreement between the two tests. Test-retest correlation was statistically significant (ρ = 0.82; p < 0.01); validity (standardized Chronbach's alpha) was considered reliable (α > 0.70). The analysis of construct validity showed a statistically significant association in terms of both total score (ρ = -0.66) and scores at each single domain (p < 0.01). A high correlation (p < 0.01) was observed between Laval questionnaire total and single domain scores and other related measures (Body Mass Index, TSD-OC scores, SCL-90 global severity index), revealing a high construct validity of the test.Conclusions: The Italian version of the Laval Questionnaire is a valid and reliable measure to assess the health-related quality of life in subjects with obesity. [ABSTRACT FROM AUTHOR]

Background: Understanding of the physical, functional and psychosocial health problems and needs of cancer survivors requires cross-national and cross-cultural standardization of health-related quality of life (HRQoL) questionnaires that capture the full range of issues relevant to cancer survivors. To our knowledge, only one study has investigated in a comprehensive way whether a questionnaire used to evaluate HRQoL in cancer patients under active treatment is also reliable and valid when used among (long-term) cancer survivors. In this study we evaluated, in an international context, the psychometrics of HRQoL questionnaires for use among long-term, disease-free, survivors of testicular and prostate cancer.Methods: In this cross-sectional study, we recruited long-term survivors of testicular and prostate cancer from Northern and Southern Europe and from the United Kingdom who had participated in two phase III EORTC clinical trials. Participants completed the SF-36 Health Survey, the EORTC QLQ-C30 questionnaire, the QLQ-PR25 (for prostate cancer) or the QLQ-TC26 (for testicular cancer) questionnaires, and the Impact of Cancer questionnaire. Testicular cancer survivors also completed subscales from the Nordic Questionnaire for Monitoring the Age Diverse Workforce.Results: Two hundred forty-two men (66% response rate) were recruited into the study. The average time since treatment was more than 10 years. Overall, there were few missing questionnaire data, although scales related to sexuality, satisfaction with care and relationship concerns of men without partners were missing in more than 10% of cases. Debriefing showed that in general the questionnaires were accepted well. Many of the survivors scored at the upper extremes of the questionnaires, resulting in floor and ceiling effects in 64% of the scales. All of the questionnaires investigated met the threshold of 0.70 for group level reliability, with the exception of the QLQ-TC26 (mean reliability .64) and the QLQ-PR25 (mean reliability .69). The questionnaires were able to discriminate clearly between patients with and without comorbid conditions.Conclusions: The currently available HRQoL questionnaires exhibit acceptable psychometric properties and were well received by patients, but additional efforts are needed to ensure that the full range of survivor-specific issues is assessed. [ABSTRACT FROM AUTHOR]

Background: Having a visual impairment affects quality of life, daily functioning and participation. To assess rehabilitation needs of visually impaired children and young adults, the Participation and Activity Inventory for Children and Youth (PAI-CY) and Young Adults (PAI-YA) were developed. The PAI-CY comprises four questionnaires for different age categories: 0-2 years, 3-6 years, 7-12 years and 13-17 years. This pilot study assesses the feasibility and acceptability of the PAI-CY and PAI-YA, and the relevance of the content of the questionnaires.Methods: In addition to the regular admission procedure, the PAI-CY and PAI-YA were completed by 30 participants (six per questionnaire). For the PAI-CY, parents completed the questionnaire online prior to admission. From age 7 years onwards, children completed the questionnaire face-to-face with a rehabilitation professional during the admission procedure. Young adults completed the PAI-YA online. Subsequently, participants and professionals administered an evaluation form.Results: Overall, 85% of the parents rated all aspects of the PAI-CY neutral to positive, whereas 100% of all children and young adults were neutral to positive on all aspects, except for the duration to complete. The main criticism of professionals was that they were unable to identify actual rehabilitation needs using the questionnaires. Minor adjustments were recommended for the content of questions.Conclusions: Parents, children and young adults were mostly satisfied with the questionnaires, however, professionals suggested some changes. The adaptations made should improve satisfaction with content, clarification of questions, and satisfaction with the questionnaires in compiling a rehabilitation plan. Although face and content validity has been optimized, a larger field study is taking place to further develop and evaluate the questionnaires. [ABSTRACT FROM AUTHOR]

Background: Although body temperature is one of four key vital signs routinely monitored and treated in clinical practice, relatively little is known about the symptoms associated with febrile states. The purpose of this study was to assess the validity, reliability and feasibility of the Fever Assessment Tool (FAST) in an acute care research setting.Methods: Qualitative: To assess content validity and finalize the FAST instrument, 12 adults from an inpatient medical-surgical unit at the National Institutes of Health (NIH) Clinical Center participated in cognitive interviews within approximately 12 h of a febrile state (tympanic temperature ≥ 38° Celsius). Quantitative: To test reliability, validity and feasibility, 56 new adult inpatients completed the 21-item FAST.Results: The cognitive interviews clarified and validated the content of the final 21-item FAST. Fifty-six patients completed the FAST from two to 133 times during routine vital sign assessment, yielding 1,699 temperature time points. Thirty-four percent of the patients (N = 19) experienced fever at one or more time points, with a total of 125 febrile time points. Kuder-Richardson 20 (KR-20) reliability of the FAST was 0.70. Four nonspecific symptom categories, Tired or Run-Down (12), Sleepy (13), Weak or Lacking Energy (11), and Thirsty (9) were among the most frequently reported symptoms in all participants. Using Generalized Estimating Equations (GEE), the odds of reporting eight symptoms, Warm (4), Sweating (5), Thirsty (9), General Body Aches (10), Weak or Lacking Energy (11), Tired or Run Down (12) and Difficulty Breathing (17), were increased when patients had a fever (Fever Now), compared to the two other subgroups-patients who had a fever, but not at that particular time point, (Fever Not Now) and patients who never had a fever (Fever Never). Many, but not all, of the comparisons were significant in both groups.Conclusion: Results suggest the FAST is reliable, valid and easy to administer. In addition to symptoms usually associated with fever (e.g. feeling warm), symptoms such as Difficulty Breathing (17) were identified with fever. Further study in a larger, more diverse patient population is warranted.Trial Registration: Clinical Trials Number: NCT01287143 (January 2011). [ABSTRACT FROM AUTHOR]

Background: There is growing interest in health related quality of life (HRQoL) as an outcome measure in international trials. However, there might be differences in the conceptualization of HRQoL across different socio-cultural groups. The objectives of current study were: (I) to compare HRQoL, measured with the short form (SF)-36 of Dutch and Chinese traumatic brain injury (TBI) patients 1 year after injury and; (II) to assess whether differences in SF-36 profiles could be explained by cultural differences in HRQoL conceptualization. TBI patients are of particular interest because this is an important cause of diverse impairments and disabilities in functional, physical, emotional, cognitive, and social domains that may drastically reduce HRQoL.Methods: A prospective cohort study on adult TBI patients in the Netherlands (RUBICS) and a retrospective cohort study in China were used to compare HRQoL 1 year post-injury. Differences on subscales were assessed with the Mann-Whitney U-test. The internal consistency, interscale correlations, item-internal consistency and item-discriminate validity of Dutch and Chinese SF-36 profiles were examined. Confirmatory factor analysis was performed to assess whether Dutch and Chinese data fitted the SF-36 two factor-model (physical and mental construct).Results: Four hundred forty seven Dutch and 173 Chinese TBI patients were included. Dutch patients obtained significantly higher scores on role limitations due to emotional problems (p < .001) and general health (p < .001), while Chinese patients obtained significantly higher scores on physical functioning (p < .001) and bodily pain (p = .001). Scores on these subscales were not explained by cultural differences in conceptualization, since item- and scale statistics were all sufficient. However, differences among Dutch and Chinese patients were found in the conceptualization of the domains vitality, mental health and social functioning.Conclusions: One year after TBI, Dutch and Chinese patients reported a different pattern of HRQoL. Further, there might be cultural differences in the conceptualization of some of the SF-36 subscales, which has implications for outcome evaluation in multi-national trials. [ABSTRACT FROM AUTHOR]

Background: The Swallowing Quality-of-Life Questionnaire (SWAL-QoL) is considered the gold standard for assessing health-related QoL in oropharyngeal dysphagia. The Dutch translation (DSWAL-QoL) and its adjusted version (aDSWAL-QoL) have been validated using classical test theory (CTT). However, these scales have not been tested against the Rasch measurement model, which is required to establish the structural validity and objectivity of the total scale and subscale scores. Thus, the purpose of this study was to examine the psychometric properties of these scales using item analysis according to the Rasch model.Methods: Item analysis with the Rasch model was performed using RUMM2030 software with previously collected data from a validation study of 108 patients. The assessment included evaluations of overall model fit, reliability, unidimensionality, threshold ordering, individual item and person fits, differential item functioning (DIF), local item dependency (LID) and targeting.Results: The analysis could not establish the psychometric properties of either of the scales or their subscales because they did not fit the Rasch model, and multidimensionality, disordered thresholds, DIF, and/or LID were found. The reliability and power of fit were high for the total scales (PSI = 0.93) but low for most of the subscales (PSI < 0.70). The targeting of persons and items was suboptimal. The main source of misfit was disordered thresholds for both the total scales and subscales. Based on the results of the analysis, adjustments to improve the scales were implemented as follows: disordered thresholds were rescaled, misfit items were removed and items were split for DIF. However, the multidimensionality and LID could not be resolved. The reliability and power of fit remained low for most of the subscales.Conclusions: This study represents the first analyses of the DSWAL-QoL and aDSWAL-QoL with the Rasch model. Relying on the DSWAL-QoL and aDSWAL-QoL total and subscale scores to make conclusions regarding dysphagia-related HRQoL should be treated with caution before the structural validity and objectivity of both scales have been established. A larger and well-targeted sample is recommended to derive definitive conclusions about the items and scales. Solutions for the psychometric weaknesses suggested by the model and practical implications are discussed. [ABSTRACT FROM AUTHOR]

Background: The World Health Organization Disability Assessment Schedule (WHODAS-2.0) has been adapted and validated in several cultures, but data on performance in the African context are lacking. The aim of the study was to evaluate the validity and psychometric properties of the WHODAS-2.0 among people with severe mental disorders (SMD) and their caregivers in a rural African setting.Methods: The content validity of the 36 item WHODAS was assessed using free listing and pile sorting in 36 community members. Cognitive interviewing was conducted with 20 people with SMD and 20 caregivers to assess comprehensibility. Convergent validity and sensitivity to change were evaluated in a facility-based cohort study of new or acutely relapsed cases of people with SMD (n = 150) and their caregivers (n = 150) consecutively recruited from a psychiatric clinic. A repeat assessment was conducted in a sub-sample (n = 84) after 6 weeks. Confirmatory factor analysis was used to evaluate construct validity in people with SMD (n = 250) and their caregivers (n = 250).Results: Internal consistency of the items of the overall scale and each domain ranged from very good (alpha = 0.82) to excellent (alpha = 0.98). Scores on the WHODAS-2.0 correlated highly with a locally developed measure of functioning (r = 0.88) and moderately with clinical symptom severity (r = 0.52). The WHODAS- 2.0 was sensitive to treatment changes (effect size = 0.50). As hypothesized, the six sub-scales loaded highly onto the general disability factor and each item loaded significantly onto their respective domains. The factor loadings of each item in the one factor model of the brief version of WHODAS (12 item) were also high. For both 12- and 36-item scales the goodness of fit indices, were close to, but outside of, recommended ranges. The caregiver data of both the 36 and 12 item versions had similar psychometric properties, but higher mean values and better responsiveness to change.Conclusions: Our study showed that both the 12 and 36 item versions of the WHODAS 2.0 have acceptable validity and psychometric properties and can be used as a cross-cultural measure; however, careful and rigorous adaptation is required for rural African settings. [ABSTRACT FROM AUTHOR]

Background: Item response theory (IRT) has been increasingly applied to patient-reported outcome (PRO) measures. The purpose of this study is to apply IRT to examine item properties (discrimination and severity of depressive symptoms), measurement precision and score comparability across five depression measures, which is the first study of its kind in the Chinese context.Methods: A clinical sample of 207 Hong Kong Chinese outpatients was recruited. Data analyses were performed including classical item analysis, IRT concurrent calibration and IRT true score equating. The IRT assumptions of unidimensionality and local independence were tested respectively using confirmatory factor analysis and chi-square statistics. The IRT linking assumptions of construct similarity, equity and subgroup invariance were also tested. The graded response model was applied to concurrently calibrate all five depression measures in a single IRT run, resulting in the item parameter estimates of these measures being placed onto a single common metric. IRT true score equating was implemented to perform the outcome score linking and construct score concordances so as to link scores from one measure to corresponding scores on another measure for direct comparability.Results: Findings suggested that (a) symptoms on depressed mood, suicidality and feeling of worthlessness served as the strongest discriminating indicators, and symptoms concerning suicidality, changes in appetite, depressed mood, feeling of worthlessness and psychomotor agitation or retardation reflected high levels of severity in the clinical sample. (b) The five depression measures contributed to various degrees of measurement precision at varied levels of depression. (c) After outcome score linking was performed across the five measures, the cut-off scores led to either consistent or discrepant diagnoses for depression.Conclusions: The study provides additional evidence regarding the psychometric properties and clinical utility of the five depression measures, offers methodological contributions to the appropriate use of IRT in PRO measures, and helps elucidate cultural variation in depressive symptomatology. The approach of concurrently calibrating and linking multiple PRO measures can be applied to the assessment of PROs other than the depression context. [ABSTRACT FROM AUTHOR]

Background: Quality of life refers to a person's experienced standard of health, comfort and happiness and is typically measured using subjective self-report scales. Despite increasing scientific interest in the value of dogs to human health and the growing demand for trained service dogs, to date no research has reported how service dogs may affect client perceptions of quality of life.Method: We compared quality of life scores on the 16 item Flanagan quality of life scale from individuals who owned a trained service dog with those who were eligible to receive a dog, but did not yet have one (waiting list control). Data were analysed separately from two groups; those with a service dog trained for individuals with physical disabilities (with physical service dog: n = 72; waiting for a service dog: n = 24; recruited from Dogs for Good database) and those with a hearing service dog (with hearing service dog = 111; waiting for a service dog = 30; recruited from Hearing Dogs for Deaf People database).Results: When controlling for age and gender individuals scored higher on total quality of life scores if they owned a service dog or a hearing service dog, but this was only statistically significant for those with a service dog. Both groups (physical service dog and hearing service dog) scored significantly higher on items relating to health, working, learning and independence if they owned a service dog, in comparison to those on the waiting list. Those with a physical service dog also scored significantly higher on items relating to recreational activities (including items relating to reading/listening to music, socialising, creative expression), and those involving social interactions (including items relating to participating in organisations, socialising, relationship with relatives). Additionally, those with a physical service dog scored higher on understanding yourself and material comforts than those on the waiting list control. In contrast, those with a hearing service dog appeared to receive fewer benefits on items relating to social activities.Conclusions: Owning a service dog can bring significant specific and potentially general benefits to the quality of life of individuals with physical disabilities and hearing impairments. These benefits may have considerable implications for individuals with disabilities, society and the economy by promoting independence, learning and working abilities. [ABSTRACT FROM AUTHOR]

Background: Urinary tract infection (UTI) is a common condition in primary care. Patient-reported outcome measures (PROMs) are crucial in the evaluation of interventions to improve diagnosis, treatment and prognosis of UTI. The aim of this study was to identify an existing condition-specific PROM to measure symptom severity, bothersomeness and impact on daily activities for adult patients with suspected urinary tract infection in primary care; or, in the absence of such a PROM, to test items identified from existing PROMs for coverage and relevance in single and group interviews and to psychometrically validate the resulting PROM.Methods: The literature was searched for existing PROMs covering the three domains. Items from the identified PROMs were tested in single and group interviews. The resulting symptom diary was psychometrically validated using the partial credit Rasch model for polytomous items in a cohort of 451 women participating in two studies regarding UTI.Results: No existing PROM fulfilled the inclusion criteria. Content validation resulted in one domain concerning symptom severity (18 items), one concerning bothersomeness (18 items), and one concerning impact on daily activities (7 items). Psychometrical validation resulted in four dimensions in each of the first two domains and one dimension in the third domain.Conclusions: Domains were not unidimensional, which meant that we identified dimensions of patient-experienced UTI that differed substantially from those previously found. We recommend that future studies on UTI, in which PROMs are to be used, should ensure high content validity of their outcome measures and unidimensionality of the included dimensions. [ABSTRACT FROM AUTHOR]

Background: The Malay version of the Psychosocial Impact of Dental Aesthetics Questionnaire has been validated for use by Malaysian adolescents. Although Malay is their national language, English is widely used as the lingua franca among Malaysians of different ethnicities. This study aimed to validate an English version of the PIDAQ adapted for use by Malaysian adolescents to optimize data capture from adolescents who prefer English as the medium for communication.Methods: The published English version of PIDAQ was pilot tested on 12- to 17-year-old adolescents, resulting in a few modifications to suit the Malaysian variety of English. Psychometric properties were tested on 393 adolescents who attended orthodontic practices and selected schools. Malocclusion was assessed using the Malocclusion Index, an aggregation of Perception of Occlusion Scale and the Aesthetic Component of the Index of Orthodontic Treatment Need, by the subjects (MI-S) and investigators (MI-D). Data were analysed for internal consistency and age-associated invariance, discriminant, construct and criterion validities, reproducibility and floor and ceiling effects using AMOS v.20 and SPSS v.20.Results: The item Don't like own teeth on video of the Aesthetic Concern (AC) subscale was not relevant to a large proportion of participants (11.7%). Therefore, it was removed and the Malaysian English PIDAQ was analysed based on 22 items instead of 23 items. Confirmatory factor analysis showed good fit statistics (comparative fit index: 0.902, root-mean-square error of approximation: 0.066). Internal consistency was good for the Dental Self-Confidence, Social Impact and Psychological Impact subscales (Cronbach's alpha: 0.70-0.95) but lower (0.52-0.62) though acceptable for the AC subscale as it consisted of only 2 items. The reproducibility test was acceptable (intra-class correlations: 0.53-0.78). For all PIDAQ subscales, the MI-S and MI-D scores of those with severe malocclusion differed significantly from those with no or slight malocclusion. There were significant associations between the PIDAQ subscales with ranking of perceived dental appearance, need for braces and impact of malocclusion on daily activities. There were no floor or ceiling effects.Conclusion: The adapted Malaysian English PIDAQ demonstrated adequate psychometric properties that are valid and reliable for assessment of psychological impacts of dental aesthetics among Malaysian adolescents. [ABSTRACT FROM AUTHOR]