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Purpose: Patient-reported outcome (PRO) measures are essential for assessing subjective patient experiences. Interactive voice response (IVR) data collection provides advantages for clinical trial design by standardizing and centralizing the assessment. Prior to adoption of IVR as a mode of PRO administration in the Testosterone Trials (TTrials), we compared IVR to paper versions of the instruments to be used.Methods: IVR versions of the FACIT-Fatigue scale and Psychosexual Daily Questionnaire, Question 4, were developed. In one pilot study, IVR versions of these scales were compared to paper versions in 25 men ≥ 65 years at each of two clinical sites. In another study, IVR versions of the SF-36 Vitality Scale (SF-36), Positive and Negative Affect Scale, and Patient Health Questionnaire were evaluated in comparison with previously validated paper versions in 25 men at two clinical sites. Both paper and IVR versions of each instrument were administered in counterbalanced order, and test-retest reliability was evaluated by repeated administration of the test. Bland-Altman plots were used to assess the degree of agreement. Test-retest correlations for each measure were also determined.Results: Satisfactory agreement was observed between IVR and paper versions of each study measure. Specifically, linear and highly positive associations were observed consistently across the study for IVR and paper versions of all study measures. These ranged from r = 0.91-0.99. Test-retest reliability for all measures was acceptable or better (r = 0.70-0.90).Conclusions: The IVR versions of TTrials endpoints in these two studies performed consistently well in comparison with paper versions. [ABSTRACT FROM AUTHOR]

Purpose: Patient-reported outcome (PRO) measures originally developed for paper administration are increasingly being administered electronically in clinical trials and other health research studies. Three published meta-analyses of measurement equivalence among paper and electronic modes aggregated findings across hundreds of PROs, but there has not been a similar meta-analysis that addresses a single PRO, partly because there are not enough published measurement equivalence studies using the same PRO. Because the SF-36(R) Health Survey (SF-36) is a widely used PRO, the aim of this study was to conduct a meta-analysis of measurement equivalence studies of this survey.Methods: A literature search of several medical databases used search terms for variations of "SF-36" or "SF-12" and "equivalence" in the title or abstract of English language publications. The eight scale scores and two summary measures of the SF-36 and SF-12 were transformed to norm-based scores (NBS) using developer guidelines. A threshold of within ± 2 NBS points was set as the margin of equivalence. Comprehensive meta-analysis software was used.Results: Twenty-five studies were included in the meta-analysis. Results indicated that mean differences across domains and summary scores ranged from 0.01 to 0.39 while estimates of agreement ranged from 0.76 to 0.91, all well within the equivalence threshold. Moderator analyses showed that time between administration, survey language, and type of electronic device did not influence equivalence.Conclusions: The results of the meta-analysis support equivalence of paper-based and electronic versions of the SF-36 and SF-12 across a variety of disease populations, countries, and electronic modes. [ABSTRACT FROM AUTHOR]

Purpose: To assess the equivalence of patient-reported outcome (PRO) survey responses across Web, interactive voice response system (IVRS), and paper modes of administration.Methods: Postoperative colorectal cancer patients with home Web/e-mail and phone were randomly assigned to one of the eight study groups: Groups 1-6 completed the survey via Web, IVRS, and paper, in one of the six possible orders; Groups 7-8 completed the survey twice, either by Web or by IVRS. The 20-item survey, including the MSKCC Bowel Function Instrument (BFI), the LASA Quality of Life (QOL) scale, and the Subjective Significance Questionnaire (SSQ) adapted to bowel function, was completed from home on consecutive days. Mode equivalence was assessed by comparison of mean scores across modes and intraclass correlation coefficients (ICCs) and was compared to the test-retest reliability of Web and IVRS.Results: Of 170 patients, 157 completed at least one survey and were included in analysis. Patients had mean age 56 (SD = 11), 53% were male, 81% white, 53% colon, and 47% rectal cancer; 78% completed all assigned surveys. Mean scores for BFI total score, BFI subscale scores, LASA QOL, and adapted SSQ varied by mode by less than one-third of a score point. ICCs across mode were: BFI total score (Web-paper = 0.96, Web-IVRS = 0.97, paper-IVRS = 0.97); BFI subscales (range = 0.88-0.98); LASA QOL (Web-paper = 0.98, Web-IVRS = 0.78, paper-IVRS = 0.80); and SSQ (Web-paper = 0.92, Web-IVRS = 0.86, paper-IVRS = 0.79).Conclusions: Mode equivalence was demonstrated for the BFI total score, BFI subscales, LASA QOL, and adapted SSQ, supporting the use of multiple modes of PRO data capture in clinical trials. [ABSTRACT FROM AUTHOR]

Background: Electronic implementation of questionnaires has many advantages, but there may be concerns that it alters versions that were validated on paper.Objective: To determine whether electronic implementation alters responses to the SF-36 and asthma quality of life questionnaire (AQLQ), compared to paper implementation.Methods: Patients with asthma presenting to a pneumologist were asked for consent to participate. Each patient completed both forms of each questionnaire. The order of presentation was alternated sequentially, with the first patient completing the electronic version first. Each patient waited at least 2 hours between completions to minimize recollection of answers. For both the SF-36 and AQLQ, intraclass correlations coefficients were calculated to compare patients' scores, for each scale and overall, on the electronic and paper versions.Results: Sixty-eight patients (mean age: 48 years, 50 females) of 311 contacted were enrolled. Overall intraclass correlation coefficients for the SF-36 and AQLQ were excellent (0.965 and 0.991 respectively). For paper versions, eight questions (AQLQ) and 24 (SF-36) were left blank and nine questions (SF-36) were answered incorrectly by patients selecting more than one answer. Electronic data for one patient could not be retrieved.Conclusion: Collecting SF-36 and AQLQ data electronically can decrease the number of spoiled responses without altering the results. Successful implementation depends on proper instruction of the respondent in the handling of the electronic instrument. [ABSTRACT FROM AUTHOR]

In this study we evaluated indicators of the feasibility, reliability, and validity of the Child Health Questionnaire-Child Form (CHQ-CF). We compared the results in a subgroup of adolescents who completed the standard paper version of the CHQ-CF with the results in another subgroup of adolescents who completed an internet version, i.e., an online, web-based CHQ-CF questionnaire. Under supervision at school, 1,071 adolescents were randomized to complete the CHQ-CF and items on chronic conditions by a paper questionnaire or by an internet administered questionnaire. The participation rate was 87%; age range 13–17 years. The internet administration resulted in fewer missing answers. All but one multi-item scale showed internal consistency reliability (Cronbach’s α > 0.70). All scales clearly discriminated between adolescents with no, a few, or many self-reported chronic conditions. The paper administration resulted in statistically significant, higher scores on 4 of 10 CHQ-CF scales compared with the internet administration ( P < 0.05), but Cohen’s effect sizes d were ≤ 0.21. Mode of administration interacted significantly with age ( P < 0.05) on four CHQ-CF scales, but Cohen’s effect sizes for these differences were also ≤ 0.21. This study supports the feasibility, internal consistency reliability of the scales, and construct validity of the CHQ-CF administered by either a paper questionnaire or online questionnaire. Given Cohen’s suggested guidelines for the interpretation of effect sizes, i.e., 0.20–0.50 indicates a small effect, differences in CHQ-CF scale scores between paper and internet administration can be considered as negligible or small. [ABSTRACT FROM AUTHOR]

Objectives: To develop a paper-and-pencil semi-adaptive test for 5 domains of health-related quality of life (PAT-5D-QOL) based on item response theory (IRT). Methods: The questionnaire uses items from previously developed item banks for 5 domains: (1) walking, (2) handling objects, (3) daily activities, (4) pain or discomfort, and (5) feelings. For each domain, respondents are initially classified into 4 functional levels. Depending on the level, they are instructed to respond to a different set of 5 additional questions. IRT scores for each domain and overall health utility scores are obtained using a simple spreadsheet. The questions were selected using psychometric and conceptual criteria. The format of the questionnaire was developed through focus groups and cognitive interviews. Feasibility was tested in two population surveys. A simulation study was conducted to compare PAT-5D-QOL with a computerized adaptive test (CAT-5D-QOL) and a fixed questionnaire, developed from the same item banks, in terms of accuracy, bias, precision, and ceiling and floor effects. Results: Close to 90 % of the participants in feasibility studies followed the skip instructions properly. In a simulation study, scores on PAT-5D-QOL for all domains tended to be more accurate, more precise, less biased, and less affected by a ceiling effect than scores on a fixed IRT-based questionnaire of the same length. PAT-5D-QOL was slightly inferior to a fully adaptive instrument. Conclusions: PAT-5D-QOL is a novel, semi-adaptive, IRT-based measure of health-related quality of life with a broad range of potential applications. [ABSTRACT FROM AUTHOR]

Purpose: Many paper-and-pencil (P&P) questionnaires have been migrated to electronic platforms. Differential item and test functioning (DIF and DTF) analysis constitutes a superior research design to assess measurement equivalence across modes of administration. The purpose of this study was to demonstrate an item response theory (IRT)-based DIF and DTF analysis to assess the measurement equivalence of a Web-based version and the original P&P format of the Four-Dimensional Symptom Questionnaire (4DSQ), measuring distress, depression, anxiety, and somatization.Methods: The P&P group (n = 2031) and the Web group (n = 958) consisted of primary care psychology clients. Unidimensionality and local independence of the 4DSQ scales were examined using IRT and Yen's Q3. Bifactor modeling was used to assess the scales' essential unidimensionality. Measurement equivalence was assessed using IRT-based DIF analysis using a 3-stage approach: linking on the latent mean and variance, selection of anchor items, and DIF testing using the Wald test. DTF was evaluated by comparing expected scale scores as a function of the latent trait.Results: The 4DSQ scales proved to be essentially unidimensional in both modalities. Five items, belonging to the distress and somatization scales, displayed small amounts of DIF. DTF analysis revealed that the impact of DIF on the scale level was negligible.Conclusions: IRT-based DIF and DTF analysis is demonstrated as a way to assess the equivalence of Web-based and P&P questionnaire modalities. Data obtained with the Web-based 4DSQ are equivalent to data obtained with the P&P version. [ABSTRACT FROM AUTHOR]

Purpose: To validate electronic versions of the Mini Pediatric and Pediatric Asthma Caregiver's Quality of Life Questionnaires (MiniPAQLQ and PACQLQ, respectively), determine completion times and correlate QOL of children and caregivers.Methods: A total of 63 children and 64 caregivers completed the paper and electronic MiniPAQLQ or PACQLQ. Agreement between versions of each questionnaire was summarized by intraclass correlation coefficients (ICC). The correlation between MiniPAQLQ and PACQLQ scores from child-caregiver pairs was assessed using Pearson's correlation coefficient.Results: There was no significant difference (mean difference = 0.1, 95% CI -0.1, 0.2) in MiniPAQLQ Overall Scores between paper (5.9 ± 1.0, mean ± SD) and electronic (5.8 ± 1.0) versions, or any of the domains. ICCs ranged from 0.89 (Overall) to 0.86 (Emotional Function). Overall PACQLQ scores for both versions were comparable (5.9 ± 0.9 and 5.8 ± 1.0; mean difference = 0.0; 95% CI -0.1, 0.2). ICCs ranged from 0.81 (Activity Limitation) to 0.88 (Emotional Function). The electronic PACQLQ took 26 s longer (95% CI 11, 41; p < 0.001). Few participants (3-11%) preferred the paper format. MiniPAQLQ and PACQLQ scores were significantly correlated (all p < 0.05) for Overall (r paper = 0.33, r electronic = 0.27) and Emotional Function domains (r paper = 0.34, r electronic = 0.29).Conclusions: These electronic QOL questionnaires are valid, and asthma-related QOL of children and caregivers is related. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effects of mode, order of administration, and the interaction of mode and order on health-related quality of life scales when self-administered by mixed mode (paper-mode and web-mode) for measurement equivalence. Methods: Health-related quality of life data was analyzed from the Cancer of the Prostate Strategic Urologic Research Endeavor using the Medical Outcomes Study (MOS) Short Form-36 (SF-36) and the University of California Los Angeles Prostate Cancer Index (UCLA-PCI). A randomized crossover design assigned participants to two groups with a preferred 2-5-day washout period. Cognitive debriefing evaluated participants' mode preference. Results: Of the 245 men enrolled, 85 % completed both modes. The majority were White (97 %), college educated (66 %), reported an annual income >$75,000 (46 %), and a median age of 69 years. Intraclass correlation coefficients were high for each item on both instruments ( r = .54-.97). Exact percentage agreement for yes/no items was high (≥.88). For the SF-36, significant differences were observed for order of administration (physical component and physical function scores) and for the interaction between mode and order (mental component, role emotional, social function, vitality, and mental health scores). For the UCLA-PCI, the largest difference was 12.8 points lower for sexual bother for order of administration by web-mode first ( p = .03). Seventy percent preferred the web-mode, 21 % had no preference, and 9 % preferred the paper-mode. Conclusion: Web-mode and paper-mode administrations of the SF-36 and UCLA-PCI are equivalent in men with prostate cancer, implying that mixed-mode survey administration is warranted. [ABSTRACT FROM AUTHOR]

Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone. [ABSTRACT FROM AUTHOR]

Patient-reported outcome (PRO) questionnaires considered in this paper contain multiple subscales, although not all subscales are equally relevant for administration in all target patient populations. A group of measurement experts, developers, license holders, and other scientific-, regulatory-, payer-, and patient-focused stakeholders participated in a panel to discuss the benefits and challenges of a modular approach, defined here as administering a subset of subscales out of a multi-scaled PRO measure. This paper supports the position that it is acceptable, and sometimes preferable, to take a modular approach when administering PRO questionnaires, provided that certain conditions have been met and a rigorous selection process performed. Based on the experiences and perspectives of all stakeholders, using a modular approach can reduce patient burden and increase the relevancy of the items administered, and thereby improve measurement precision and eliminate wasted data without sacrificing the scientific validity and utility of the instrument. The panelists agreed that implementing a modular approach is not expected to have a meaningful impact on item responses, subscale scores, variability, reliability, validity, and effect size estimates; however, collecting additional evidence for the impact of context may be desirable. It is also important to recognize that adequate rationale and evidence (e.g., of fit-for-purpose status and relevance to patients) and a robust consensus process that includes patient perspectives are required to inform selection of subscales, as in any other measurement circumstance, is expected. We believe that the considerations discussed within (content validity, administration context, and psychometric factors) are relevant across multiple therapeutic areas. [ABSTRACT FROM AUTHOR]

Objective: To examine the psychometric properties of an Internet version of a children and young person's quality of life measure originally designed as a paper questionnaire. Methods: Participants were 3,440 children aged 10 and 11 years in Northern Ireland who completed the KIDSCREEN-27 online as part of a general attitudinal survey. The questionnaire was animated using cartoon characters that are familiar to most children and the questions appeared on screen and were read aloud by actors. Results: Exploratory principal component analysis of the online version of the questionnaire supported the existence of five components in line with the paper version. The items loaded on the components that would be expected based on previous findings with five domains-physical well-being, psychological well-being, autonomy and parents, social support and peers, and school environment. Internal consistency reliability of the five domains was measured using Cronbach's alpha, and the results suggested that the scale scores were reliable. The domain scores were similar to those reported in the literature for the paper version. Conclusions: These results suggest that the factor structure and internal consistency reliability scores of the KIDSCREEN-27 embedded within an online survey are comparable to those reported in the literature for the paper version. [ABSTRACT FROM AUTHOR]

Purpose: Meaningful thresholds are needed to interpret patient-reported outcome measure (PROM) results. This paper introduces a new method, based on item response theory (IRT), to estimate such thresholds. The performance of the method is examined in simulated datasets and two real datasets, and compared with other methods. Methods: The IRT method involves fitting an IRT model to the PROM items and an anchor item indicating the criterion state of interest. The difficulty parameter of the anchor item represents the meaningful threshold on the latent trait. The latent threshold is then linked to the corresponding expected PROM score. We simulated 4500 item response datasets to a 10-item PROM, and an anchor item. The datasets varied with respect to the mean and standard deviation of the latent trait, and the reliability of the anchor item. The real datasets consisted of a depression scale with a clinical depression diagnosis as anchor variable and a pain scale with a patient acceptable symptom state (PASS) question as anchor variable. Results: The new IRT method recovered the true thresholds accurately across the simulated datasets. The other methods, except one, produced biased threshold estimates if the state prevalence was smaller or greater than 0.5. The adjusted predictive modeling method matched the new IRT method (also in the real datasets) but showed some residual bias if the prevalence was smaller than 0.3 or greater than 0.7. Conclusions: The new IRT method perfectly recovers meaningful (interpretational) thresholds for multi-item questionnaires, provided that the data satisfy the assumptions for IRT analysis. [ABSTRACT FROM AUTHOR]

Purpose: To develop and validate a health-related quality of life (HRQoL) questionnaire for patients with current or previous coronavirus disease (COVID-19) in an international setting. Methods: This multicenter international methodology study followed standardized guidelines for a four-phase questionnaire development. Here, we report on the pretesting and validation of our international questionnaire. Adults with current or previous COVID-19, in institutions or at home were eligible. In the pretesting, 54 participants completed the questionnaire followed by interviews to identify administration problems and evaluate content validity. Thereafter, 371 participants completed the revised questionnaire and a debriefing form to allow preliminary psychometric analysis. Validity and reliability were assessed (correlation-based methods, Cronbach's α, and intra-class correlation coefficient). Results: Eleven countries within and outside Europe enrolled patients. From the pretesting, 71 of the 80 original items fulfilled the criteria for item-retention. Most participants (80%) completed the revised 71-item questionnaire within 15 min, on paper (n = 175) or digitally (n = 196). The final questionnaire included 61 items that fulfilled criteria for item retention or were important to subgroups. Item-scale correlations were > 0.7 for all but nine items. Internal consistency (range 0.68–0.92) and test–retest results (all but one scale > 0.7) were acceptable. The instrument consists of 15 multi-item scales and six single items. Conclusion: The Oslo COVID-19 QLQ-W61© is an international, stand-alone, multidimensional HRQoL questionnaire that can assess the symptoms, functioning, and overall quality of life in COVID-19 patients. It is available for use in research and clinical practice. Further psychometric validation in larger patient samples will be performed. [ABSTRACT FROM AUTHOR]

In the present study, the equivalence of paper and pencil assessment versus computer assessment of two self-administered questionnaires was investigated by means of a randomized cross-over design. Therefore, 105 out-patients with diabetes were invited to participate; 76 patients completed both the computer and the paper and pencil version of the Well-being Questionnaire (WBQ) and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) in a randomized order, with a mean interval of 7 days. The scales showed high test-retest correlations and the means, dispersions, kurtosis and skewness were found to be approximately the same in both versions. In both modes of assessment, the depression and the energy scale proved to be sensitive for carry-over effects, resulting in better well-being scores at the second measurement. Almost all subjects reported that using the personal computer in the realization of a questionnaire was easy. It is concluded that the paper and pencil and the computerized versions of the WBQ and DTSQ can be considered equivalent. Therefore, the norms and cut-off scores obtained from paper and pencil assessments can be used in computerized versions of the WBQ and DTSQ and vice versa. [ABSTRACT FROM AUTHOR]

Background: Data from subjective patient-reported outcome measures (PROMs) are now being used in the health sector to make or support decisions about individuals, groups and populations. Contemporary validity theorists define validity not as a statistical property of the test but as the extent to which empirical evidence supports the interpretation of test scores for an intended use. However, validity testing theory and methodology are rarely evident in the PROM validation literature. Application of this theory and methodology would provide structure for comprehensive validation planning to support improved PROM development and sound arguments for the validity of PROM score interpretation and use in each new context.Objective: This paper proposes the application of contemporary validity theory and methodology to PROM validity testing.Illustrative Example: The validity testing principles will be applied to a hypothetical case study with a focus on the interpretation and use of scores from a translated PROM that measures health literacy (the Health Literacy Questionnaire or HLQ).Discussion: Although robust psychometric properties of a PROM are a pre-condition to its use, a PROM's validity lies in the sound argument that a network of empirical evidence supports the intended interpretation and use of PROM scores for decision making in a particular context. The health sector is yet to apply contemporary theory and methodology to PROM development and validation. The theoretical and methodological processes in this paper are offered as an advancement of the theory and practice of PROM validity testing in the health sector. [ABSTRACT FROM AUTHOR]

Purpose: The EORTC QLQ-H&N35 (H&N35) is widely used to measure quality of life in head and neck cancer patients. The aims of this study were to obtain insight into a) the languages in which the H&N35 has been used and the psychometric properties in those languages, b) the study designs, and c) its acceptance by patients and investigators. Methods: A systematic literature review was performed searching for all original papers that had used at least one item of the H&N35. Identified papers were read and the information about methodological issues abstracted statistically analysed. Results: A total of 136 papers were identified. The H&N35 was administered in 19 different languages in 27 countries. The study design was cross-sectional in the majority of studies (53 %), prospective cohort studies (31 %), phase-II-trials (7 %), phase-III-trials (6 %) and case–control studies (1 %). The scales with the highest percentages of missing values were Sexuality (11.5 %) and Speech (7 %). The median Cronbach’s alpha of the multi-item scales ranged from 0.61 (Senses) to 0.93 (Sexuality). Construct validity was rarely investigated. On average, 12 scales (range 0-18) of the instrument were used by the investigators. The scale most often used was swallowing (in 85 % of studies) and least often used was Weight Gain (39 %). Conclusion: The H&N35 is widely used throughout the world, mainly in observational studies, and has demonstrated robust psychometric features in different languages. However, some methodological problems reported imply that the instrument can be improved in some areas. [ABSTRACT FROM AUTHOR]

Purpose: An Internet-based tool for reporting and analysing patient-reported outcomes (PROs) has been developed. The tool enables merging PROs with blood test results and allows for computation of treatment responses. Data may be visualized by graphical analysis and may be exported for downstream statistical processing. The aim of this study was to investigate, whether patients with myeloproliferative neoplasms (MPNs) were willing and able to use the tool and fill out questionnaires regularly.Methods: Participants were recruited from the outpatient clinic at the Department of Haematology, Roskilde University Hospital, Denmark. Validated questionnaires that were used were European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, Myeloproliferative Neoplasm Symptom Assessment Form, Brief Fatigue Inventory and Short Form 36 Health Survey. Questionnaires were filled out ≥ 6 months online or on paper according to participant preference. Regularity of questionnaire submission was investigated, and participant acceptance was evaluated by focus-group interviews.Results: Of 135 invited patients, 118 (87 %) accepted participation. One hundred and seven participants (91 %) preferred to use the Internet-based tool. Of the 118 enrolled participants, 104 (88 %) submitted PROs regularly ≥ 6 months. The focus-group interviews revealed that the Internet-based tool was well accepted.Conclusion: The Internet-based approach and regular collection of PROs are well accepted with a high participation rate, persistency and adherence in a population of MPN patients. The plasticity of the platform allows for adaptation to patients with other medical conditions. [ABSTRACT FROM AUTHOR]

Purpose: Previous studies using the WHOQOL measures have demonstrated that the relationship between individual items and the underlying quality of life (QoL) construct may differ between cultures. If unaccounted for, these differing relationships can lead to measurement bias which, in turn, can undermine the reliability of results.Methods: We used item response theory (IRT) to assess differential item functioning (DIF) in WHOQOL data from diverse language versions collected in UK, Zimbabwe, Russia, and India (total N = 1332). Data were fitted to the partial credit 'Rasch' model. We used four item banks previously derived from the WHOQOL-100 measure, which provided excellent measurement for physical, psychological, social, and environmental quality of life domains (40 items overall). Cross-cultural differential item functioning was assessed using analysis of variance for item residuals and post hoc Tukey tests. Simulated computer-adaptive tests (CATs) were conducted to assess the efficiency and precision of the four items banks.Results: Splitting item parameters by DIF results in four linked item banks without DIF or other breaches of IRT model assumptions. Simulated CATs were more precise and efficient than longer paper-based alternatives.Discussion: Assessing differential item functioning using item response theory can identify measurement invariance between cultures which, if uncontrolled, may undermine accurate comparisons in computer-adaptive testing assessments of QoL. We demonstrate how compensating for DIF using item anchoring allowed data from all four countries to be compared on a common metric, thus facilitating assessments which were both sensitive to cultural nuance and comparable between countries. [ABSTRACT FROM AUTHOR]

Objective: Quality of life (QoL) is still assessed using paper-based and fixed-length questionnaires, which is one reason why QoL measurements have not been routinely implemented in clinical practice. Providing new QoL measures that combine computer technology with modern measurement theory may enhance their clinical use. The aim of this study was to develop a QoL multidimensional computerized adaptive test (MCAT), the SQoL-MCAT, from the fixed-length SQoL questionnaire for patients with schizophrenia.Methods: In this multicentre cross-sectional study, we collected sociodemographic information, clinical characteristics (i.e., duration of illness, the PANSS, and the Calgary Depression Scale), and quality of life (i.e., SQoL). The development of the SQoL-CAT was divided into three stages: (1) multidimensional item response theory (MIRT) analysis, (2) multidimensional computerized adaptive test (MCAT) simulations with analyses of accuracy and precision, and (3) external validity.Results: Five hundred and seventeen patients participated in this study. The MIRT analysis found that all items displayed good fit with the multidimensional graded response model, with satisfactory reliability for each dimension. The SQoL-MCAT was 39% shorter than the fixed-length SQoL questionnaire and had satisfactory accuracy (levels of correlation >0.9) and precision (standard error of measurement <0.55 and root mean square error <0.3). External validity was confirmed via correlations between the SQoL-MCAT dimension scores and symptomatology scores.Conclusion: The SQoL-MCAT is the first computerized adaptive QoL questionnaire for patients with schizophrenia. Tailored for patient characteristics and significantly shorter than the paper-based version, the SQoL-MCAT may improve the feasibility of assessing QoL in clinical practice. [ABSTRACT FROM AUTHOR]

Purpose: Cost-effectiveness analyses (CEAs) of screening can be highly sensitive to the health-related quality of life (HRQoL) effects of screen tests and subsequent treatment. Accordingly, accurate assessment of HRQoL is essential. We reviewed the literature regarding HRQoL in cervical prevention and management in order to appraise the current evidence regarding this important input to CEA.Methods: We searched the MEDLINE, Scopus and EconLit databases for studies that estimated HRQoL in cervical cancer prevention and management published January 1995-December 2015. The primary inclusion criterion was for studies that assess HRQoL using the EQ-5D. Data were abstracted from eligible studies on setting, elicitation group, sample size, elicitation instruments, health state valuations, study design and follow-up. We assessed the quality and comparability of the studies with a particular focus on the HRQoL reported across states and groups.Results: Fifteen papers met the inclusion criteria. Most used patient elicitation groups (n = 11), 2 used the general public and 2 used a mix of both. Eight studies were cross-sectional and seven were longitudinal. Six studies used both the EQ-5D-3L and the EQ-VAS together with other measures of overall HRQoL or condition-specific instruments. Extensive heterogeneity was observed across study characteristics.Conclusions: Our results reveal the challenges of sourcing reliable estimates of HRQoL for use in CEAs of cervical cancer prevention and treatment. The EQ-5D appears insufficiently sensitive for some health states. A more general problem is the paucity of HRQoL estimates for many health states and their change over time. [ABSTRACT FROM AUTHOR]

Self-completed questionnaires (usually distributed by post) and visual analogue scales (VAS) are common means for collecting valuations for hypothetical EQ-5D health states. Although opportunities for respondents to comment on aspects of the exercise are often included, these data have rarely been the focus of analyses. This paper, therefore, reports on solicited and unsolicited written comments received in a New Zealand survey in 1999 to which 1360 people responded of whom approximately 50% made comments. The comments were systematically analysed via an inductive process that allowed principal themes to emerge with respect to understanding the peculiarities of respondents' valuations, particularly common 'data problems', and their perceptions as to the adequacy or otherwise of the EQ-5D classification system. From our findings we conclude that the valuation exercise imposes a substantial cognitive burden on respondents and many do not understand it (for a variety of reasons documented in the paper). Also, although there is some evidence for expanding the EQ-5D (generic) health-related quality of life dimensions, more research as to whether this holds for a larger sample and across cultural settings is needed. We offer recommendations for future research into understanding respondents' cognitive processes and possible revisions to the design and administration of the EQ-5D. [ABSTRACT FROM AUTHOR]

Purpose: Different health state utility (HSU) instruments produce different utilities for the same individuals, thereby compromising the intended comparability of economic evaluations of health care interventions. When developing crosswalks, previous studies have indicated nonlinear relationships. This paper inquires into the degree of nonlinearity across the four most widely used HSU-instruments and proposes exchange rates that differ depending on the severity levels of the health state utility scale.Methods: Overall, 7933 respondents from six countries, 1760 in a non-diagnosed healthy group and 6173 in seven disease groups, reported their health states using four different instruments: EQ-5D-5L, SF-6D, HUI-3 and 15D. Quantile regressions investigate the degree of nonlinear relationships between these instruments. To compare the instruments across different disease severities, we split the health state utility scale into utility intervals with 0.2 successive decrements in utility starting from perfect health at 1.00. Exchange rates (ERs) are calculated as the mean utility difference between two utility intervals on one HSU-instrument divided by the difference in mean utility on another HSU-instrument.Results: Quantile regressions reveal significant nonlinear relationships across all four HSU-instruments. The degrees of nonlinearities differ, with a maximum degree of difference in the coefficients along the health state utility scale of 3.34 when SF-6D is regressed on EQ-5D. At the lower end of the health state utility scale, the exchange rate from SF-6D to EQ-5D is 2.11, whilst at the upper end it is 0.38.Conclusion: Comparisons at different utility levels illustrate the fallacy of using linear functions as crosswalks between HSU-instruments. The existence of nonlinear relationships between different HSU-instruments suggests that level-specific exchange rates should be used when converting a change in utility on the instrument used, onto a corresponding utility change had another instrument been used. Accounting for nonlinearities will increase the validity of the comparison for decision makers when faced with a choice between interventions whose calculations of QALY gains have been based on different HSU-instruments. [ABSTRACT FROM AUTHOR]

This brief communication responds to the paper by Jeong and Cho (Qual Life Res 26(4):903-911, 2017) that has described activity pacing in limited terms of adjusting activities through going at a slower rate and taking breaks. Activity pacing was reported as not involving goal setting, in comparison to other strategies for long-term conditions such as Acceptance and Commitment Therapy. This brief communication aims to challenge this limited perception of activity pacing in light of numerous studies that recognise pacing to be a more complex strategy. Pacing is considered to be a multifaceted coping strategy, including broad themes of not only adjusting activities, but also planning activities, having consistent activity levels, acceptance of current abilities and gradually increasing activities, and one that includes goal setting as a key facet. It is essential that pacing is both defined and measured as a multifaceted strategy in order to assess the outcomes of pacing, and for meaningful comparisons with other strategies regarding efficacy for the management of long-term conditions. [ABSTRACT FROM AUTHOR]

Purpose: Service user involvement in instrument development is increasingly recognised as important, but is often not done and seldom reported. This has adverse implications for the content validity of a measure. The aim of this paper is to identify the types of items that service users felt were important to be included or excluded from a new Recovering Quality of Life measure for people with mental health difficulties.Methods: Potential items were presented to service users in face-to-face structured individual interviews and focus groups. The items were primarily taken or adapted from current measures and covered themes identified from earlier qualitative work as being important to quality of life. Content and thematic analysis was undertaken to identify the types of items which were either important or unacceptable to service users.Results: We identified five key themes of the types of items that service users found acceptable or unacceptable; the items should be relevant and meaningful, unambiguous, easy to answer particularly when distressed, do not cause further upset, and be non-judgemental. Importantly, this was from the perspective of the service user.Conclusions: This research has underlined the importance of service users' views on the acceptability and validity of items for use in developing a new measure. Whether or not service users favoured an item was associated with their ability or intention to respond accurately and honestly to the item which will impact on the validity and sensitivity of the measure. [ABSTRACT FROM AUTHOR]

Background: No current guidance is available in the UK on the choice of preference-based measure (PBM) that should be used in obtaining health-related quality of life from children. The aim of this study is to review the current usage of PBMs for obtaining health state utility values in child and adolescent populations, and to obtain information on patient and parent-proxy respondent preferences in completing PBMs in the UK.Methods: A literature review was conducted to determine which instrument is most frequently used for child-based economic evaluations and whether child or proxy responses are used. Instruments were compared on dimensions, severity levels, elicitation and valuation methods, availability of value sets and validation studies, and the range of utility values generated. Additionally, a series of focus groups of parents and young people (11-20 years) were convened to determine patient and proxy preferences.Results: Five PBMs suitable for child populations were identified, although only the Health Utilities Index 2 (HUI2) and Child Heath Utility 9D (CHU-9D) have UK value sets. 45 papers used PBMs in this population, but many used non-child-specific PBMs. Most respondents were parent proxies, even in adolescent populations. Reported missing data ranged from 0.5 to 49.3%. The focus groups reported their experiences with the EQ-5D-Y and CHU-9D. Both the young persons' group and parent/proxy groups felt that the CHU-9D was more comprehensive but may be harder for a proxy to complete. Some younger children had difficulty understanding the CHU-9D questions, but the young persons' group nonetheless preferred responding directly.Conclusion: The use of PBMs in child populations is increasing, but many studies use PBMs that do not have appropriate value sets. Parent proxies are the most common respondents, but the focus group responses suggest it would be preferred, and may be more informative, for older children to self-report or for child-parent dyads to respond. [ABSTRACT FROM AUTHOR]

Purpose: To examine the psychometric properties and suitability for use within the context of cerebral palsy research in children and adolescents of generic preference-based outcome measures (PROMs).Methods: Nine electronic databases were searched in this systematic review. The consensus-based standards for the selection of health measurement instruments (COSMIN) checklist were used to measure the psychometric properties of the PROMs. A meta-analysis was used to pool correlation coefficients for convergent validity using the Schmidt-Hunter method. Heterogeneity was assessed using the I-squared statistic (I2).Results: Four preference-based PROMs were identified from eight studies: Health Utilities Index-Mark 2 and 3 (HUI-2 and HUI-3, respectively), the Assessment Quality of Life-4 dimension (AQoL-4D) and the EuroQol-5 dimension 3 level (EQ-5D-3L). Only the HUI system was primarily developed for application with children/adolescents though health-state values for scoring the PROM were elicited from adults. The HUI-3 covered the most relevant constructs though it excludes important modules of health-related quality of life (HRQOL) such as activity limitations and participation restrictions. In terms of psychometric properties, evidence was presented for only five of COSMIN measurement properties: reliability (HUI3), measurement error (HUI-3), content validity (HUI-2 and HUI-3), Hypotheses testing (HUI-3 and AQoL-4D) and criterion validity (HUI-3). No papers reported on internal consistency, structural validity, cross-cultural validity or responsiveness of the preference-based measures in children and adolescents with cerebral palsy.Conclusions: This review highlights the dearth in studies using preference-based PROMs to measure HRQOL associated with cerebral palsy in children and adolescents. The HUI-3 demonstrated the strongest psychometric properties, though it does not cover all dimensions relevant to this population. [ABSTRACT FROM AUTHOR]

Purpose: Children and adolescents are vulnerable to dental problems and oral diseases. This paper presents the development of two multi-item self-report scales for use in assessing oral health status of children and adolescents.Methods: Following the Patient-Reported Outcome Measurement Information System framework, survey questions were designed using a newly developed conceptual model. These items were administered to 334 children and adolescents (8-17 years) along with concurrent dental exams. Exploratory and confirmatory factor analyses were conducted and the item response theory graded response model was used to estimate item parameters and oral health status scores and to identify short-form items. The items were selected by high level of information and wide coverage of different domains to assess Child Oral Health Status Index (COHSI) and treatment referral recommendations (RR).Results: The long form consists of 28 items. The short-form includes 12 items (8 for COHSI and 7 for RR with 3 common items).The intra-class correlations between long form and short-form were 0.90 for COHSI and 0.87 for RR.Conclusion: The short-forms provide a possible solution for the longstanding challenge of oral health evaluation for large populations of children and adolescents. The calibrated long form provides the foundation for computer adaptive test administration. These oral health assessment toolkits can be used for oral health screening, surveillance program, policy planning, and research. [ABSTRACT FROM AUTHOR]

Purpose: Economic evaluations of mental health interventions often measure health benefit in terms of utility values derived from the EQ-5D. For the five-level version of the EQ-5D, there are two methods of estimating utility [crosswalk and stated preference (5L-SP)]. This paper explores potential impacts for researchers and decision-makers when comparing utility values derived from either method in the specific context of mental health.Methods: Baseline EQ-5D-5L data from three large randomised controlled trials of interventions for mental health conditions were analysed. Utility values were generated using each method. Mean utility values were compared using a series of t tests on pooled data and subgroups. Scenario analyses explored potential impacts on cost-effectiveness decisions.Results: EQ-5D data were available for 1399 participants. The mean utility value for each trial was approximately 0.08 higher when estimated using the 5L-SP approach compared to crosswalk (p < 0.0001). The difference was greatest among people reporting extreme anxiety/depression (mean utility 5L-SP 0.309, crosswalk 0.084; difference = 0.225; p < 0.0001). Identical improvements in health status were associated with higher costs to gain one QALY with the 5L-SP approach; this is more pronounced when improvements are across all domains compared to improvements on the anxiety/depression domain only.Conclusions: The two approaches produce significantly different utility values in people with mental health conditions. Resulting differences in cost per QALY estimates suggest that thresholds of cost-effectiveness may also need to be reviewed. Researchers and decision-makers should exercise caution when comparing or synthesising data from trials of mental health interventions using different utility estimation approaches. [ABSTRACT FROM AUTHOR]

Purpose: This paper describes the international, cross-cultural development of four disease-specific EORTC QoL questionnaires, to supplement the EORTC QLQ-C30, for patients with Hodgkin lymphoma (HL), high- or low-grade non-Hodgkin lymphoma (HG/LG-NHL), and CLL.Methods: Questionnaire development was conducted according to guidelines from the EORTC Quality of Life Group. Phase I comprised generation of QoL issues relevant to patients. Phase II included operationalization and assessment of item relevance. In phase III, items were pretested in a cross-cultural sample.Results: In Phase I, 75 issues were identified through focus groups and systematic literature searches. Interviews with 80 health-care professionals and 245 patients resulted in a provisional module of 38 items (phase II) representing items relevant for all or at least one of the four malignancies. In Phase III, this was tested in 337 patients from five European countries and resulted in a questionnaire with 27 items for HL (EORTC QLQ-HL27), 29 items for HG-NHL (EORTC QLQ-NHL-HG29), 20 items for LG-NHL (EORTC QLQ-NHL-LG20) and 17 items for CLL (EORTC QLQ-CLL17).Conclusions: This study provides four new EORTC modules for use in clinical research and routine practice in conjunction with the EORTC QLQ-C30 for assessing QoL in patients with lymphoma and CLL. [ABSTRACT FROM AUTHOR]

Purpose: The concept of maximising well-being, as opposed to merely treating mental disorder, is a powerful current theme in the area of mental health. Clearly this emphasises the need for appropriate valid and reliable measures of general well-being. This paper examines the appropriateness of a number of measures in this area and concludes that existing assessment tools fail to address the full range of aspects of personal well-being. This paper therefore presents the psychometric properties, validity and reliability of a new measure of well-being-the BBC Well-being Scale. Methods: A total of 1,940 participants completed the new measure, the Goldberg scales of anxiety and depression, the 'List of Threatening Experiences' life events scale, a modified version of the Response Styles Questionnaire and a modified version of the Internal, Personal and Situational Attributions Questionnaire presented via the internet. Results: Exploratory factor-analysis suggested a three-factor solution including themes of psychological well-being, physical health and well-being and relationships. The total 24-item scale had good internal consistency (α = .935) and correlated significantly with key demographic variables and measures of concurrent validity. Conclusions: The new measure-the BBC Well-being Scale-is recommended for research and clinical purposes. [ABSTRACT FROM AUTHOR]

Purpose: It has been argued that generic health-related quality of life measures are not sensitive to certain disease-specific improvements; condition-specific preference-based measures may offer a better alternative. This paper assesses the validity, responsiveness and sensitivity of a cancer-specific preference-based measure, the EORTC-8D, relative to the EQ-5D-3L.Methods: A longitudinal prospective population-based cancer genomic cohort, Cancer 2015, was utilised in the analysis. EQ-5D-3L and the EORTC QLQ-C30 (which gives EORTC-8D values) were asked at baseline (diagnosis) and at various follow-up points (3 months, 6 months, 12 months). Baseline values were assessed for convergent validity, ceiling effects, agreement and sensitivity. Quality-adjusted life-years (QALYs) were estimated and similarly assessed. Multivariate regression analyses were employed to understand the determinants of the difference in QALYs.Results: Complete case analysis of 1678 patients found that the EQ-5D-3L values at baseline were significantly lower than the EORTC-8D values (0.748 vs 0.829, p < 0.001). While the correlation between the instruments was high, agreement between the instruments was poor. The baseline health state values using both instruments were found to be sensitive to a number of patient and disease characteristics, and discrimination between disease states was found to be similar. Mean generic QALYs (estimated using the EQ-5D-3L) were significantly lower than condition-specific QALYs (estimated using the EORTC-8D) (0.860 vs 0.909, p < 0.001). The discriminatory power of both QALYs was similar.Conclusions: When comparing a generic and condition-specific preference-based instrument, divergences are apparent in both baseline health state values and in the estimated QALYs over time for cancer patients. The variability in sensitivity between the baseline values and the QALY estimations means researchers and decision makers are advised to be cautious if using the instruments interchangeably. [ABSTRACT FROM AUTHOR]

Purpose: This paper evaluated the impact of cleft-related surgery on the oral health-related quality of life (OHRQoL) of youth with cleft over time.Methods: Data were derived from a 5-year, multi-center, prospective, longitudinal study of 1196 youth with cleft lip and/or palate and their caregivers. Eligible youth were between 7.5 and 18.5 years old, spoke English or Spanish, and were non-syndromic. During each observational period, which included baseline, and 1- and 2-year post-baseline follow-up visits, youths and their caregivers completed the Child Oral Health Impact Profile, a validated measure of OHRQoL. Multilevel mixed-effects models were used to analyze the effects of receipt of craniofacial surgery on OHRQoL over time.Results: During the course of this study a total of 516 patients (43 %) received at least one surgery. Youth in the surgery recommendation group had lower self- (β = -2.18, p < 0.05) and proxy-rated (β = -2.92, p < 0.02) OHRQoL when compared to non-surgical self- and proxy-rated OHRQoL at baseline. Both surgical and non-surgical youth (β = 3.73, p < 0.001) and caregiver (β = 1.91, p < 0.05) ratings of OHRQoL improved over time. There was significant incremental improvement (time × surgery interaction) in self-reported OHRQoL for youth postsurgery (β = 1.04, p < 0.05), but this postsurgery increment was not seen in the caregiver proxy ratings.Conclusions: Surgical intervention impacts OHRQoL among youth with cleft. Youth who were surgical candidates had lower baseline self- and caregiver-rated OHRQoL when compared to non-surgical youth. Youth who underwent cleft-related surgery had significant incremental improvements in self-rated but not caregiver (proxy)-rated OHRQoL after surgery. [ABSTRACT FROM AUTHOR]

This paper describes constructing the Assessment of Quality of Life (AQoL) instrument; designed to measure health-related quality of life (HRQoL), and to be the descriptive system for a multi-attribute utility instrument. Unlike previous utility instruments' descriptive systems, the AQoL's has been developed using state-of-the-art psychometric procedures. The result is a descriptive system which emphasizes five different facets of HRQoL and which can claim to have construct validity. Based on the WHO's definition of health a model of HRQoL was developed. Items were written by focus groups of doctors and the researchers. These were administered to a construction sample, comprising hospital patients, and community members chosen at random. Final construction was through an iterative process of factor and reliability analyses. The AQoL measures 5 dimensions: illness, independent living, social relationships, physical senses and psychological wellbeing. Each has three items. Exploratory factor analysis showed the dimensions were orthogonal, and each was unidimensional. Internal consistency was alpha = 0.81. Structural equation modeling explored its internal structure; the comparative fit index was 0.90. These preliminary results indicate the AQoL has the prerequisite qualities for a psychometric HRQoL instrument for evaluation; replication with a larger sample is needed to verify these findings. Scaling it for economic evaluation using utilities is being undertaken. Respondents have indicated the AQoL is easy to understand and is quickly completed. Its initial properties suggest it may be widely applicable. [ABSTRACT FROM AUTHOR]

The article comments on comparing translations of the European Organization for Research in the Treatment of Cancer questionnaire-C30 using differential item functioning (DIF) analysis. The author addresses the strengths and weaknesses of the paper. The first strength of the paper is the sheer magnitude of the data set that is analyzed; second, the reliance on an effect size statistic; and third, the consultation with bilingual experts regarding differences in nuance between different language versions of the test. On the other hand, the author also discusses the weaknesses of the paper.

Purpose: Patient-reported outcome measures (PROMs) are designed to assess patients' perceived health states or health-related quality of life. However, PROMs are susceptible to missing data, which can affect the validity of conclusions from randomised controlled trials (RCTs). This review aims to assess current practice in the handling, analysis and reporting of missing PROMs outcome data in RCTs compared to contemporary methodology and guidance. Methods: This structured review of the literature includes RCTs with a minimum of 50 participants per arm. Studies using the EQ-5D-3L, EORTC QLQ-C30, SF-12 and SF-36 were included if published in 2013; those using the less commonly implemented HUI, OHS, OKS and PDQ were included if published between 2009 and 2013. Results: The review included 237 records (4-76 per relevant PROM). Complete case analysis and single imputation were commonly used in 33 and 15 % of publications, respectively. Multiple imputation was reported for 9 % of the PROMs reviewed. The majority of publications (93 %) failed to describe the assumed missing data mechanism, while low numbers of papers reported methods to minimise missing data (23 %), performed sensitivity analyses (22 %) or discussed the potential influence of missing data on results (16 %). Conclusions: Considerable discrepancy exists between approved methodology and current practice in handling, analysis and reporting of missing PROMs outcome data in RCTs. Greater awareness is needed for the potential biases introduced by inappropriate handling of missing data, as well as the importance of sensitivity analysis and clear reporting to enable appropriate assessments of treatment effects and conclusions from RCTs. [ABSTRACT FROM AUTHOR]

Purpose: This paper aims to estimate the comorbidity of mental disorders and chronic physical conditions and to describe the impact of these conditions on health-related quality of life (HRQoL) in a sample of older primary care (PC) attendees by gender.Methods: Cross-sectional survey, conducted in 77 PC centres in Catalonia (Spain) on 1192 patients over 65 years old. Using face-to-face interviews, we assessed HRQoL (SF-12), mental disorders (SCID and MINI structured clinical interviews), chronic physical conditions (checklist), and disability (Sheehan disability scale). We used multivariate quantile regressions to model which factors were associated with the physical component summary-short form 12 and mental component summary-short form 12.Result: The most frequent comorbidity in both men and women was mood disorder with chronic pain and arthrosis. Mental disorders mainly affected 'mental' QoL, while physical disorders affected 'physical' QoL. Mental disorders had a greater impact on HRQoL than chronic physical conditions, with mood and adjustment disorders being the most disabling conditions. There were some gender differences in the impact of mental and chronic physical conditions on HRQoL. Anxiety disorders and pain had an impact on HRQoL but only in women. Respiratory diseases had an effect on the MCS in women, but only affected the PCS in men.Conclusions: Mood and adjustment disorders had the greatest impact on HRQoL. The impact profile of mental and chronic physical conditions differs between genders. Our results reinforce the need for screening for mental disorders (mainly depression) in older patients in PC. [ABSTRACT FROM AUTHOR]

Objective: This paper evaluates the effectiveness of motivational enhancement therapy plus cognitive behavioural therapy on depressive symptoms, glycosylated haemoglobin, fasting glucose, body mass index (BMI), and health-related quality of life in type II diabetes patients.Methods: A controlled trial was conducted to compare patients who received the behavioural intervention with untreated controls on measures of health outcomes. A total of 31 intervention group participants and 30 controls were selected from patients that met the inclusion criteria from a hospital-based endocrinology outpatient department. The outcome measures including depressive symptoms, glycosylated haemoglobin, fasting glucose, BMI, and both physical and mental quality of life were collected before (T1), after (T2), and after 90 days (T3) following the intervention.Results: The experimental group showed a significant reduction in glycosylated haemoglobin, fasting glucose, and depressive symptoms and a significant increase in physical quality of life and mental quality of life at T2 and T3, while patients in the control group with usual care showed no changes over time.Conclusion: The behavioural intervention facilitated a significant improvement in psychological adjustment and glycemic control, thus strengthening diabetes control skills and leading to healthy outcomes. It is feasible that nurses and psychiatrists can deliver the behavioural intervention for diabetes patients to decrease their depressive symptoms. Sharing discussion and problem-solving experiences is particularly helpful method for self-control, and these will be beneficially influential on further research. [ABSTRACT FROM AUTHOR]

Purpose: To derive EQ-5D-5L Spanish population norms based on a national representative sample adjusted by age, gender and region.Methods: A representative sample of the Spanish general population (n = 21,007) was used in a cross-sectional study. The source of data was the Spanish National Health Survey 2011-2012. All socio-demographic factors and clinical characteristics were carried to a descriptive analysis. All variables were stratified by region, gender and age-group.Results: The utility value 1 is the most repeated (62%) in this representative population sample. This study showed a deterioration of health states as age increases. Overall, men reported better health status than women. In relation to ceiling effect by regions, there was little difference with the highest scores. Conversely, the lowest score corresponds to Galicia.Conclusions: The paper reports EQ-5D-5L normative data for Spanish general population, based on a national representative sample adjusted by region, gender and age-group. These results may serve as reference data of the population health status. A regional difference in health status could be observed, which might suggest that policies aiming to reduce regional inequalities are important. [ABSTRACT FROM AUTHOR]

Objective: The clinical symptoms of schizophrenia are associated with serious social, quality of life and functioning alterations. Typically, data on health utilities are not available in clinical studies in schizophrenia. This makes the economic evaluation of schizophrenia treatments challenging. The purpose of this article was to provide a mapping function to predict unobserved utility values in patients with schizophrenia from the available clinical and socio-demographic information.Methods: The analysis was performed using data from EuroSC, a 2-year, multi-centre, cohort study conducted in France (N = 288), Germany (N = 618), and the UK (N = 302), totalling 1208 patients. Utility was calculated based on the EQ-5D questionnaire. The relationships between the utility values and the patients' socio-demographic and clinical characteristics (Positive and Negative Syndrome Scale--PANSS, Calgary Depression Scale for Schizophrenia--CDSS, Global Assessment of Functioning--GAF, extra-pyramidal symptoms measured by Barnes Akathisia Scale-BAS, age, sex, country, antipsychotic type) were modelled using a random and a fixed individual effects panel linear model.Results: The analysis demonstrated the prediction ability of the used parameters for estimating utility measures in patients with schizophrenia. Although there are small variations between countries, the same variables appear to be the key predictors. From a clinical perspective, age, gender, psychopathology, and depression were the most important predictors associated with the EQ-5D.Conclusion: This paper proposed a reliable, robust and easy-to-apply mapping method to estimate EQ-5D utilities based on demographic and clinical measures in schizophrenia. [ABSTRACT FROM AUTHOR]

Purpose: The macular degeneration quality of life (MacDQoL) instrument is a validated condition-specific measure of quality of life in patients with macular degeneration. This paper presents the first mapping algorithm to predict EQ-5D from responses to the MacDQoL instrument.Methods: Responses to the MacDQoL and EQ-5D-3L instruments from 482 patients were collected from the IVAN multicentre trial of two alternative drug treatments for neovascular age-related macular degeneration. Regression specifications were estimated using OLS, censored least absolute deviation, Tobit and two-part models. Their predictive performance was assessed using mean squared error. An internal validation sample based on a random selection of 25 % of patients was used to assess the performance of the model estimated on the remaining 75 % of patients.Results: A two-part model had the best predictive performance on the full sample. The covariates of this model include responses and weighted impact scores for all 23 condition-specific domains of the MacDQoL, and responses to a general MacDQoL quality of life question. The selected models were successful at predicting means and standard deviations of target populations, but prediction is weaker at the upper and lower extremes of the EQ-5D-3L distribution.Conclusion: The mapping algorithms provide a means of predicting EQ-5D-3L index scores from MacDQoL scores, and could facilitate cost-effectiveness analyses when the latter but not the former are available to researchers. Further validation of the performance of the algorithms using external data would provide a means of establishing the robustness of the algorithms. [ABSTRACT FROM AUTHOR]

Purpose: The Strengths and Difficulties Questionnaire (SDQ) is a behavioural screening tool for children. The SDQ is increasingly used as the primary outcome measure in population health interventions involving children, but it is not preference based; therefore, its role in allocative economic evaluation is limited. The Child Health Utility 9D (CHU9D) is a generic preference-based health-related quality of-life measure. This study investigates the applicability of the SDQ outcome measure for use in economic evaluations and examines its relationship with the CHU9D by testing previously published mapping algorithms. The aim of the paper is to explore the feasibility of using the SDQ within economic evaluations of school-based population health interventions.Methods: Data were available from children participating in a cluster randomised controlled trial of the school-based roots of empathy programme in Northern Ireland. Utility was calculated using the original and alternative CHU9D tariffs along with two SDQ mapping algorithms. t tests were performed for pairwise differences in utility values from the preference-based tariffs and mapping algorithms.Results: Mean (standard deviation) SDQ total difficulties and prosocial scores were 12 (3.2) and 8.3 (2.1). Utility values obtained from the original tariff, alternative tariff, and mapping algorithms using five and three SDQ subscales were 0.84 (0.11), 0.80 (0.13), 0.84 (0.05), and 0.83 (0.04), respectively. Each method for calculating utility produced statistically significantly different values except the original tariff and five SDQ subscale algorithm.Conclusion: Initial evidence suggests the SDQ and CHU9D are related in some of their measurement properties. The mapping algorithm using five SDQ subscales was found to be optimal in predicting mean child health utility. Future research valuing changes in the SDQ scores would contribute to this research. [ABSTRACT FROM AUTHOR]

In the original publication of the article, the right number of participants included in the analysis should be 2107 and not 2118 as written in the paper. The flow-chart and corrected SF-36 scores for the 2015 data set for this article should have appeared as follows: Fig. 1 and Table 3. These changes did not influence the results. The authors would like to apologize for any inconvenience caused. [ABSTRACT FROM AUTHOR]

Purpose: Genetic associations with self-reported physical functioning (SPF) are less well-studied than genetic associations with performance-measured physical functioning (PPF). We review the literature on the associations of genetic variations on SPF. We provide an overview of SPF assessment, genetic contributions to SPF including heritability, effects of genetic variations and mutations, and effects of interventions on the gene-SPF relationship. We also aim to provide directions for future research. Methods: A computerized literature search using PubMed, Web of Science, and PsychInfo was conducted to select relevant literature published up to November 2013. Inclusion criteria were the use of an SPF questionnaire, original articles in English on human subjects, published in peer-reviewed journals and reporting significant associations between SPF and the genome. Results: Nineteen articles were included. SPF was commonly assessed with the Short Form-36 questionnaire involving mainly convenience samples of either older persons or chronically ill. Heritability estimates were 10-30 %. Candidate genes associated with SPF could be ascribed to biological pathways associated with neurodegeneration, physiological systems regulation, or cell regulation. The APOE gene associated with neurodegeneration was most studied ( n = 3). Three papers included both SPF and PPF assessments. No genome-wide association study on SPF has been conducted. Conclusions: Associations between SPF and the genome have been investigated in selected populations in a limited number of publications. Future research should consider increasing sample variation and incorporate both SPF and PPF assessments. Also, longitudinal studies should be conducted in order to elicit stronger conclusions regarding the genetic associations with SPF. [ABSTRACT FROM AUTHOR]

Purpose: The cross-cultural equivalence of patient-reported outcome (PRO) instruments is critical when they are used in international settings. The Universalist model of equivalence was proposed as a framework to investigate cross-cultural equivalence. The purpose of this paper was to illustrate how quantitative methods can be used to investigate cross-cultural equivalence within this framework. Methods: The six types of equivalence of the Universalist model were reviewed from a statistical perspective and statistical techniques allowing addressing the underlying question were identified. These methods are described and examples are provided of how they can be applied. An integrated pragmatic approach to the exploration of cross-cultural equivalence was developed based on these methods. Results: The statistical techniques identified were factor analysis to explore conceptual equivalence, differential item functioning to explore semantic and item equivalence, and comparison of measurement properties for the measurement equivalence. The statistical techniques addressing operational equivalence were found to be diverse and highly specific to the operational aspect under investigation. Functional equivalence involves a comprehensive appraisal of the potential impact of the results of the other equivalences on the conclusions of the research. This structured appraisal of functional equivalence offers a framework for a comprehensive, but flexible, approach for the efficient application of statistical analyses to explore cross-cultural equivalence of PRO instruments. Conclusion: The different types of equivalence of the Universalist model can be investigated using quantitative methods. An integrated approach, which could be used in a variety of settings, was developed to allow the whole notion of cross-cultural equivalence to be comprehensively and efficiently addressed. [ABSTRACT FROM AUTHOR]

The National Institutes of Health sponsored Patient-Reported Outcome Measurement Information System (PROMIS) aimed to create item banks and computerized adaptive tests (CATs) across multiple domains for individuals with a range of chronic diseases. Web-based software was created to enable a researcher to create study-specific Websites that could administer PROMIS CATs and other instruments to research participants or clinical samples. This paper outlines the process used to develop a user-friendly, free, Web-based resource (Assessment CenterSM) for storage, retrieval, organization, sharing, and administration of patient-reported outcomes (PRO) instruments. Joint Application Design (JAD) sessions were conducted with representatives from numerous institutions in order to supply a general wish list of features. Use Cases were then written to ensure that end user expectations matched programmer specifications. Program development included daily programmer “scrum” sessions, weekly Usability Acceptability Testing (UAT) and continuous Quality Assurance (QA) activities pre- and post-release. Assessment Center includes features that promote instrument development including item histories, data management, and storage of statistical analysis results. This case study of software development highlights the collection and incorporation of user input throughout the development process. Potential future applications of Assessment Center in clinical research are discussed. [ABSTRACT FROM AUTHOR]

The use of item banks and computerized adaptive testing (CAT) begins with clear definitions of important outcomes, and references those definitions to specific questions gathered into large and well-studied pools, or “banks” of items. Items can be selected from the bank to form customized short scales, or can be administered in a sequence and length determined by a computer programmed for precision and clinical relevance. Although far from perfect, such item banks can form a common definition and understanding of human symptoms and functional problems such as fatigue, pain, depression, mobility, social function, sensory function, and many other health concepts that we can only measure by asking people directly. The support of the National Institutes of Health (NIH), as witnessed by its cooperative agreement with measurement experts through the NIH Roadmap Initiative known as PROMIS (www.nihpromis.org), is a big step in that direction. Our approach to item banking and CAT is practical; as focused on application as it is on science or theory. From a practical perspective, we frequently must decide whether to re-write and retest an item, add more items to fill gaps (often at the ceiling of the measure), re-test a bank after some modifications, or split up a bank into units that are more unidimensional, yet less clinically relevant or complete. These decisions are not easy, and yet they are rarely unforgiving. We encourage people to build practical tools that are capable of producing multiple short form measures and CAT administrations from common banks, and to further our understanding of these banks with various clinical populations and ages, so that with time the scores that emerge from these many activities begin to have not only a common metric and range, but a shared meaning and understanding across users. In this paper, we provide an overview of item banking and CAT, discuss our approach to item banking and its byproducts, describe testing options, discuss an example of CAT for fatigue, and discuss models for long term sustainability of an entity such as PROMIS. Some barriers to success include limitations in the methods themselves, controversies and disagreements across approaches, and end-user reluctance to move away from the familiar. [ABSTRACT FROM AUTHOR]

Introduction: This paper reports on the development of a new measure of health-related quality of life for use among patients with gastro-oesophageal reflux disease (GORD), funded as part of the REFLUX trial. This is a large UK multi centre trial that aims to compare the clinical and cost effectiveness of minimal access surgery with best medical treatment for patients with GORD within the NHS.Method: Potential items were identified via a series of interviews and focus groups carried out with patients who were receiving/had received medical or surgical treatment for GORD. The final measure consisted of 31 items covering 7 categories (Heartburn; Acid reflux; Wind; Eating and swallowing; Bowel movements; Sleep; Work, physical and social activities). The measure produced two outputs: a quality of life score (RQLS) and five Reflux symptom scores. Reliability (internal consistency), criterion validity with the SF-36 and, sensitivity to change in terms of relationship with reported change in prescribed medication were assessed amongst a sample of 794 patients recruited into the trial.Results: The measure was shown to be internally consistent, to show criterion validity with the SF-36 and sensitive to changes in patients use of prescribed medication at baseline and 3 month follow-up.Discussion: The Reflux questionnaire is a new self-administered questionnaire for use amongst patients with GORD. Initial findings suggest that the new measure is valid, reliable, acceptable to respondents and simple to administer in both a clinical and research context. [ABSTRACT FROM AUTHOR]

Objective: To design a Health-related Quality of Life (HRQoL) instrument for HIV-infected people in the era of highly active antiretroviral therapy (HAART).Methods: The self-administered questionnaire was developed by an Italian network including researchers, physicians, people living with HIV, national institutions and community-based organizations (CBO) through several steps: (1) review of existing HRQoL literature and questionnaires for HIV-infected people; (2) selection of relevant domains measuring HRQoL in HIV-infected people, and identification of new domains related to new aspects of HRQoL concerning HAART-treated individuals; (3) conduction of two pre-test analyses in independent groups of Italian HIV-positive people (n approximately =100) distributed throughout the country. The objectives of the first pre-test were to verify the usefulness of the questionnaire, to construct a form easily understandable by everyone, to define the domains and their significance; the second pre-test aimed at evaluating and reshaping the questionnaire based on a statistical analysis of the outcomes of first pre-test; (4) validation analysis. A large cohort of people with HIV infection was recruited for the last step.Results: The internal consistence reliability (Cronbach's alpha) was >or=0.70 for all domains. Most domains had Cronbach's coefficient >0.80. All domains demonstrated convergent and discriminant validity. The final version of ISSQoL includes two sections: HRQoL Core Evaluation Form (9 domains) and Additional Important Areas for HRQoL (6 domains). The ISSQoL was administered together with two additional forms: a Daily Impact of Symptoms Form and a Demographic Information Form. The Additional Important Areas for HRQoL include social support, interaction with medical staff, treatment impact, body changes, life planning, and motherhood/fatherhood.Conclusion: The data reported in the present paper provide preliminary evidence of the reliability and validity of the ISSQoL questionnaire for the measurement of HRQoL in HIV-infected people. The direct involvement of HIV-positive people in all the phases of the project was a key aspect of our work. [ABSTRACT FROM AUTHOR]

The Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is increasingly used in psychiatry because it gives emphasis to the subjective perspective of patients on physical, psychological and social domains. This paper reports on the validation of the Italian version of the Q-LES-Q in a large multicenter study (EQUIP) conducted at five Italian sites on outpatients in treatment for anxiety disorders. Study participants underwent a broad assessment of psychopathology including the MINI-International Neuropsychiatric Interview, the Symptom Checklist (SCL-90) and the Clinical Global Impression (CGI). Cronbach's alpha was used to determine the internal consistency of the Q-LES-Q areas and Pearson's r was used to analyze the correlation between the areas of Q-LES-Q and those of the other instruments. The internal consistency of the Q-LES-Q proved to be substantial (>0.80 in each of the areas) as well as the test-retest reliability. The convergent validity of the Q-LES-Q vs. the Work and Social Adjustment Scale was examined. High correlations were found between scales measuring similar constructs in the two instruments and lower correlation between scales measuring different constructs. In conclusion, the Italian version of the Q-LES-Q proved to be as valid and reliable as the original English version. [ABSTRACT FROM AUTHOR]