Search

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: 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]

Purpose: To extend knowledge about measurement equivalence of depression measures assessed by tablet and paper-pencil administration, the present study evaluated the effect of mode of administration (MoA) on scale and item level for the Patient Health Questionnaire (PHQ-9) and the Aachen Depression Item Bank (ADIB) in elderly patients.Methods: Primary care patients (N = 193, ≥60 years) were assessed following a crossover design in Leipzig, Germany. All participants filled out the PHQ-9 and the ADIB in both MoAs under study. Effects of MoA were analyzed by intra-class correlation, mixed-effects regression, and differential item functioning (DIF). Additionally, detection rates between both MoAs were compared using receiver operating characteristics analysis compared to a diagnostic interview (SCID-I, N = 163).Results: No effect of MoA was found in the PHQ-9 on scale score or item level. Two ADIB items showed DIF according to MoA. In terms of discriminatory power, MoA did not influence detection rates of both instruments.Conclusions: In summary, our findings suggest that no severe effect of mode of administration on self-report assessments of depression should be expected. It can be concluded that tablets provide a valid way to electronically assess depressive symptoms in elderly patients. Yet changes in item presentation can influence the psychometric properties and require equivalence testing using sophisticated analyses on item level such as DIF. [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]

Purpose: In surveys and in research, proxies such as family members may be used to assess patient health-related quality of life. The aim of this research is to help cancer researchers select a validated health-related quality of life tool if they anticipate using proxy-reported data.Methods: Systematic review and methodological appraisal of studies examining the concordance of paired adult cancer patient and proxy responses for multidimensional, validated HRQOL tools. We searched PubMed, CINAHL, PsycINFO and perused bibliographies of reviewed papers. We reviewed concordance assessment methods, results, and associated factors for each validated tool.Results: A total of 32 papers reporting on 29 study populations were included. Most papers were cross-sectional (N = 20) and used disease-specific tools (N = 19), primarily the FACT and EORTC. Patient and proxy mean scores were similar on average for tools and scales, with most mean differences <10 points but large standard deviations. Average ICCs for the FACT and EORTC ranged from 0.35 to 0.62, depending on the scale. Few papers (N = 15) evaluated factors associated with concordance, and results and measurement approaches were inconsistent. The EORTC was the most commonly evaluated disease-specific tool (N = 5 papers). For generic tools, both concordance and associated factor information was most commonly available for the COOP/WONCA (N = 3 papers). The MQOL was the most frequently evaluated end-of-life tool (N = 3 papers).Conclusions: Proxy and patient scores are similar on average, but there is large, clinically important residual variability. The evidence base is strongest for the EORTC (disease-specific tools), COOP/WONCA (generic tools), and MQOL (end-of-life-specific tools). [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]

Purpose: Patient experiences with symptom care need to be assessed and documented to ensure successful management of cancer-related symptoms. This paper details one method for creating symptom management quality improvement (SMQI) reports, including case-mix adjustment of patient-reported measures. Qualitative data regarding the acceptability of these reports at participating cancer centers (CCs) are also provided.Methods: Data were collected from 2226 patients treated at 16 CCs via mailed/Web questionnaires. Twelve items assessing patient perceptions of symptom management-pain, fatigue, emotional distress-served as key quality indicators. Medico-demographic variables suitable for case-mix adjustment were selected using an index score combining predictive power and heterogeneity across CCs. SMQI reports were designed with staff feedback and produced for each CC, providing crude and adjusted CC-specific rates, along with study-wide rates for comparison purposes.Results: Cancer type and participant educational level were selected for case-mix adjustment based upon high index scores. The Kendall rank correlation coefficient showed that case-mix adjustments changed the ranking of CCs on the key quality indicators (% Δ rank range: 5-22 %). The key quality indicators varied across CCs (all p < 0.02). SMQI reports were well received by CC staff, who described plans to share them with key personnel (e.g., cancer committee, navigator).Conclusions: This paper provides one method for creating hospital-level SMQI reports, including case-mix adjustment. Variation between CCs on key quality indicators, even after adjustment, suggested room for improvement. SMQI reports based on patient-reported data can inform and motivate efforts to improve care through professional/patient education and applying standards of care. [ABSTRACT FROM AUTHOR]

While the use of PROs in research is well established, many challenges lie ahead as their use is extended to other applications. There is consensus that health outcome evaluations that include PROs along with clinician-reported outcomes and administrative data are necessary to inform clinical and policy decisions. The initiatives presented in this paper underline evolving recognition that PROs play a unique role in adding the patient perspective alongside clinical (e.g., blood pressure) and organizational (e.g., admission rates) indicators for evaluating the effects of new products, selecting treatments, evaluating quality of care, and monitoring the health of the population. In this paper, we first explore the use of PRO measures to support drug approval and labeling claims. We critically evaluate the evidence and challenges associated with using PRO measures to improve healthcare delivery at individual and population levels. We further discuss the challenges associated with selecting from the abundance of measures available, opportunities afforded by agreeing on common metrics for constructs of interest, and the importance of establishing an evidence base that supports integrating PRO measures across the healthcare system to improve outcomes. We conclude that the integration of PROs as a key end point within individual patient care, healthcare organization and program performance evaluations, and population surveillance will be essential for evaluating whether increased healthcare expenditure is translating into better health outcomes. [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: The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. This paper describes the development of physical and mental health summary scores for the PROMIS-29 v2.0.Method: We conducted factor analyses of PROMIS-29 scales on data collected from two internet panels (n = 3000 and 2000).Results: Confirmatory factor analyses provided support for a physical health factor defined by physical function, pain (interference and intensity), and ability to participate in social roles and activities, and a mental health factor defined primarily by emotional distress (anxiety and depressive symptoms). Reliabilities for these two summary scores were 0.98 (physical health) and 0.97 (mental health). Correlations of the PROMIS-29 v2.0 physical and mental health summary scores with chronic conditions and other health-related quality of life measures were consistent with a priori hypotheses.Conclusions: This study develops and provides preliminary evidence supporting the reliability and validity of PROMIS-29 v2.0 physical and mental health summary scores that can be used in future studies to assess impacts of health care interventions and track changes in health over time. Further evaluation of these and alternative summary measures is recommended. [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: 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: 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: Patient-reported outcome measures (PROMs), which are generic or condition-specific, are used for a number of reasons, including clinical care, clinical trials, and in national-level efforts to monitor the quality of health care delivery. Creating PROMs that meet different purposes without overburdening patients, healthcare systems, providers, and data systems is paramount. The objective of this study was to test a generalizable method to incorporate condition-specific issues into generic PROM measures as a first step to producing PROMs that efficiently provide a standardized score. This paper outlines the method and preliminary findings focused on a PROM for osteoarthritis of the knee (OA-K).Methods: We used a mixed-methods approach and PROMIS® measures to test development of a combined generic and OA-K-specific PROM. Qualitative methods included patient focus groups and provider interviews to identify impacts of OA-K important to patients. We then conducted a thematic analysis and an item gap analysis: identified areas covered by existing generic PROMIS measures, identified "gap" areas not covered, compared gap areas to legacy instruments to verify relevance, and developed new items to address gaps. We then performed cognitive testing on new items and drafted an OA-K-specific instrument based on findings.Results: We identified 52 existing PROMIS items and developed 24 new items across 14 domains.Conclusions: We developed a process for creating condition-specific instruments that bridge gaps in existing generic measures. If successful, the methodology will create instruments that efficiently gather the patient's perspective while allowing health systems, researchers, and other interested parties to monitor and compare outcomes over time, conditions, and populations. [ABSTRACT FROM AUTHOR]

Purpose: Character strength is described as a positive and organized pattern of emotions, thoughts, and behaviors. It serves as a schema that organizes categories of information toward the self, others, and the world, and provides the self-aware knowledge that facilitates the pursuit of goals, values, and ethical principles. Recent research has suggested that three reliable factors emerge from the measures of character strengths: caring, inquisitiveness, and self-control. The goal of this paper is to develop a psychometrically sound short measure of character strength.Methods: The questions were addressed in two studies using two independent samples: a cross-cultural (i.e., 518 Asians and 556 Westerners) sample, and a cross-population (i.e., 175 community participants and 171 inpatients) sample in China.Results: Findings from the exploratory and confirmatory factor analysis suggested a cross-cultural three-factor model of character strength that could be measured by the Three-dimensional Inventory of Character Strengths (TICS). A multigroup confirmatory factor analysis further indicated that the number of factors and factor loadings was invariant in the medical and community samples. This result indicated that the brief inventory could be applied to a medical context. Internal reliability, content validity, and predictive validity were good, although the predictive validity of the three character strengths for psychological symptoms in the medical sample was more modest than that in the community sample.Conclusions: TICS is expected to be used for screening populations at risk, and a tool to aid mental health professionals in group-based treatment/intervention planning. It also should be noted that this short inventory should be used with caution for individual decision making. [ABSTRACT FROM AUTHOR]

Purpose: The Patient-Reported Outcomes Measurement Information System® (PROMIS®) was designed to develop, validate, and standardize item banks to measure key domains of physical, mental, and social health in chronic conditions. This paper reports the calibration and validation testing of the PROMIS Self-Efficacy for Managing Chronic Conditions measures.Methods: PROMIS Self-Efficacy for Managing Chronic Conditions item banks comprise five domains, Self-Efficacy for Managing: Daily Activities, Symptoms, Medications and Treatments, Emotions, and Social Interactions. Banks were calibrated in 1087 subjects from two data sources: 837 patients with chronic neurologic conditions (epilepsy, multiple sclerosis, neuropathy, Parkinson disease, and stroke) and 250 subjects from an online Internet sample of adults with general chronic conditions. Scores were compared with one legacy scale: Self-Efficacy for Managing Chronic Disease 6-Item scale (SEMCD6) and five PROMIS short forms: Global Health (Physical and Mental), Physical Function, Fatigue, Depression, and Anxiety.Results: The sample was 57% female, mean age = 53.8 (SD = 14.7), 76% white, 21% African American, 6% Hispanic, and 76% with greater than high school education. Full-item banks were created for each domain. All measures had good internal consistency and correlated well with SEMCD6 (r  = 0.56-0.75). Significant correlations were seen between the Self-Efficacy measures and other PROMIS short forms (r  > 0.38).Conclusions: The newly developed PROMIS Self-Efficacy for Managing Chronic Conditions measures include five domains of self-efficacy that were calibrated across diverse chronic conditions and show good internal consistency and cross-sectional validity. [ABSTRACT FROM AUTHOR]

Purpose: Educational attainment has been shown to be positively associated with mental health and a potential buffer to stressful events. One stressful life event likely to affect everyone in their lifetime is bereavement. This paper assesses the effect of educational attainment on mental health post-bereavement.Methods: By utilising large administrative datasets, linking Census returns to death records and prescribed medication data, we analysed the bereavement exposure of 208,332 individuals aged 25-74 years. Two-level multi-level logistic regression models were constructed to determine the likelihood of antidepressant medication use (a proxy of mental ill health) post-bereavement given level of educational attainment.Results: Individuals who are bereaved have greater antidepressant use than those who are not bereaved, with over a quarter (26.5 %) of those bereaved by suicide in receipt of antidepressant medication compared to just 12.4 % of those not bereaved. Within individuals bereaved by a sudden death, those with a university degree or higher qualifications are 73 % less likely to be in receipt of antidepressant medication compared to those with no qualifications, after full adjustment for demographic, socio-economic and area factors (OR 0.27, 95 % CI 0.09,0.75). Higher educational attainment and no qualifications have an equivalent effect for those bereaved by suicide.Conclusions: Education may protect against poor mental health, as measured by the use of antidepressant medication, post-bereavement, except in those bereaved by suicide. This is likely due to the improved cognitive, personal and psychological skills gained from time spent in education. [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]

Purpose: People with Parkinson's disease (PD) may experience stigma due to their visible features of movement and communication difficulties. This paper aimed to examine the role of experienced stigma in health-related quality of life (QOL), after controlling for personal and clinical characteristics.Methods: This is a preliminary analysis of a subset of baseline data from the Social Self-Management of Parkinson's Disease Study (SocM-PD), an ongoing 3-year prospective cohort study. Seventy-three people with PD (M age = 65.72, 29 women) participated in this study. Hierarchical multiple regression analyses were used to determine the role of stigma in QOL, after controlling for gender, disease severity, depression, and motor difficulties of daily living.Results: Significant correlations were found between QOL with gender (r = .26), disease severity (r = .38), depression (r = .65), motor difficulties of daily living (r = .71), and stigma (r = .83). After controlling for the significant covariates, stigma made a significant and unique contribution to the explanation of QOL by 13.7 % (p < 0.001). A final hierarchical multiple regression with stigma and the 4 covariates revealed an overall model that explained 77.8 % of the total variance of QOL (F [5, 63] = 48.79, p < 0.001).Conclusions: Experienced stigma appears to be a key determinant of QOL in people with PD. The results suggest the importance of further understanding stigma in PD to develop possible intervention strategies. Future work is also needed to verify the results with a larger and longitudinal dataset of the SocM-PD. [ABSTRACT FROM AUTHOR]

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: 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: User-generated content on social media sites, such as health-related online forums, offers researchers a tantalizing amount of information, but concerns regarding scientific application of such data remain. This paper compares and contrasts symptom cluster patterns derived from messages on a breast cancer forum with those from a symptom checklist completed by breast cancer survivors participating in a research study.Methods: Over 50,000 messages generated by 12,991 users of the breast cancer forum on MedHelp.org were transformed into a standard form and examined for the co-occurrence of 25 symptoms. The k-medoid clustering method was used to determine appropriate placement of symptoms within clusters. Findings were compared with a similar analysis of a symptom checklist administered to 653 breast cancer survivors participating in a research study.Results: The following clusters were identified using forum data: menopausal/psychological, pain/fatigue, gastrointestinal, and miscellaneous. Study data generated the clusters: menopausal, pain, fatigue/sleep/gastrointestinal, psychological, and increased weight/appetite. Although the clusters are somewhat different, many symptoms that clustered together in the social media analysis remained together in the analysis of the study participants. Density of connections between symptoms, as reflected by rates of co-occurrence and similarity, was higher in the study data.Conclusions: The copious amount of data generated by social media outlets can augment findings from traditional data sources. When different sources of information are combined, areas of overlap and discrepancy can be detected, perhaps giving researchers a more accurate picture of reality. However, data derived from social media must be used carefully and with understanding of its limitations. [ABSTRACT FROM AUTHOR]

Purpose: The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a new, state-of-the-art assessment system for measuring patient-reported health and well-being of adults and children. It has the potential to be more valid, reliable, and responsive than existing PROMs. The items banks are designed to be self-reported and completed by children aged 8-18 years. The PROMIS items can be administered in short forms or through computerized adaptive testing. This paper describes the translation and cultural adaption of nine PROMIS item banks (151 items) for children in Dutch-Flemish.Methods: The translation was performed by FACITtrans using standardized PROMIS methodology and approved by the PROMIS Statistical Center. The translation included four forward translations, two back-translations, three independent reviews (at least two Dutch, one Flemish), and pretesting in 24 children from the Netherlands and Flanders.Results: For some items, it was necessary to have separate translations for Dutch and Flemish: physical function-mobility (three items), anger (one item), pain interference (two items), and asthma impact (one item). Challenges faced in the translation process included scarcity or overabundance of possible translations, unclear item descriptions, constructs broader/smaller in the target language, difficulties in rank ordering items, differences in unit of measurement, irrelevant items, or differences in performance of activities. By addressing these challenges, acceptable translations were obtained for all items.Conclusion: The Dutch-Flemish PROMIS items are linguistically equivalent to the original USA version. Short forms are now available for use, and entire item banks are ready for cross-cultural validation in the Netherlands and Flanders. [ABSTRACT FROM AUTHOR]

Purpose: This paper describes the long-term health and quality of life (QOL) outcomes of Vietnam veterans with combat-related limb loss.Methods: This mixed-method, cross-sectional study analyzes survey data of 247 Vietnam veterans with combat-related limb loss measuring several comorbidities [measured as ever diagnosed], PTSD using the PTSD Checklist Military (PCL-M), depression using the Patient Health Questionnaire (PHQ-8), and QOL using the SF-12. In-depth interviews with 20 such veterans about their health and QOL experiences were conducted.Results: Of 247 Vietnam veterans, most report good to excellent health (79.7 %) and several comorbidities: arthritis (61.1 %), cardiovascular disease (18.2 %), diabetes (22.7 %), obesity (17.4 %), phantom-limb pain (76.1 %), back pain (76.5 %), PTSD (15.8 %), and depression (17.8 %). Those with depression fared worse on the SF-12 physical component summary score (PCS), whereas those with arthritis, depression, and PTSD fared worse on the SF-12 mental component summary score. Interview data describe these comorbidities and QOL from the veterans' perspective and illustrate how such comorbidities may be directly related to the veterans' combat and/or limb loss experiences.Conclusion: The prevalence of these health issues and the adverse effects of some of these on QOL underscore the importance of effective rehabilitation over the life course, especially including better mental health care and pain management. [ABSTRACT FROM AUTHOR]

Purpose: Gender nonconformity, that is, transgressing conventionally "masculine" vs. "feminine" characteristics, is often stigmatized. Stigmatization and discrimination are social stressors that raise risk of adverse mental and physical health outcomes and may drive health inequities. However, little is known about the relationship between such social stressors and health-related quality of life (HRQOL). This paper aimed to examine associations between perceived gender nonconformity and HRQOL in a cohort of U.S. adolescents and young adults.Methods: Using data from 8408 participants (18-31 years) in the U.S. Growing Up Today Study (93% white, 88% middle-to-high income), we estimated risk ratios (RRs) for the association of gender nonconformity (three levels: highly gender conforming, moderately conforming, and gender nonconforming) and HRQOL using the EuroQol questionnaire (EQ-5D-5L). Models were adjusted for demographic characteristics, including sexual orientation identity.Results: Gender nonconformity was independently associated with increased risk of having problems with mobility [RR (95% confidence interval): 1.76 (1.16, 2.68)], usual activities [2.29 (1.67, 3.13)], pain or discomfort [1.59, (1.38, 1.83)], and anxiety or depression [1.72 (1.39, 2.13)], after adjusting for sexual orientation and demographic characteristics. Decrements in health utility by gender nonconformity were observed: compared to persons who were highly gender conforming, mean health utility was lower for the moderately gender conforming [beta (SE): -0.011 (.002)] and lowest for the most gender nonconforming [-0.034 (.005)].Conclusions: In our study, HRQOL exhibited inequities by gender nonconformity. Future studies, including in more diverse populations, should measure the effect of gender-related harassment, discrimination, and violence victimization on health and HRQOL. [ABSTRACT FROM AUTHOR]

Purpose: This study assessed the uptake of the CONsolidated Standards of Reporting Trials (CONSORT)-Patient-Reported Outcomes (PRO) statement; determined if use of CONSORT-PRO was associated with more complete reporting of PRO endpoints in randomised controlled trials (RCTs) and identified the extent to which high-impact journals publishing RCTs with PRO endpoints endorse CONSORT-PRO.Methods: CONSORT-PRO citations were identified by systematically searching Medline, EMBASE and Google from 2013 (year CONSORT-PRO released) to 17 December 2015. RCTs that cited CONSORT-PRO (cases) were compared to a comparable control sample of RCTs in terms of adherence to CONSORT-PRO using t tests. General linear models assessed the relationship between CONSORT-PRO score and key, pre-specified variables. The 100 highest-impact journals that published RCTs with PRO endpoints (2014-2015) were identified via a systematic Medline search. Instructions for authors were reviewed to determine whether journals endorsed CONSORT-PRO.Results: Total CONSORT-PRO scores ranged from 47 to 100% for cases and 25-96% for controls. Cases had significantly higher total CONSORT-PRO scores compared to controls: t = 2.64, p = 0.01. 'Citing CONSORT-PRO', 'journal endorsing CONSORT-PRO' and 'dedicated PRO paper' were significant predictors of higher CONSORT-PRO adherence score: R 2 = 0.48, p < 0.001. 11/100 top-ranked journals endorsed CONSORT-PRO in their instructions to authors, seven of these journals published RCTs included as cases in this study.Conclusion: This study demonstrated improved PRO reporting associated with journal endorsement and author use of the CONSORT-PRO extension. Despite growing awareness, more work is needed to promote appropriate use of CONSORT-PRO to improve completeness of reporting; in particular, stronger journal endorsement of CONSORT-PRO. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of the study was to examine the contributions of parents' health and distress to parent's and children's assessments of children's health.Methods: We used baseline data from a longitudinal study of 364 children (ages 4-12) about to undergo surgery and their parents in a Southern California pediatric hospital. We used the 20-item child self-reported CHRIS 2.0 general health and the parallel parent-reported measure of the child's health, along with a measure of parental distress about the child's health were administered in the perioperative period. Other measures included parents' physical and mental health, quality of life, distress over their child's health, and number and extent of other health problems of the child and siblings.Results: On average, parents' reports about the child were consistently and statistically significantly higher than children's self-reports across all sub-dimensions of the CHRIS 2.0 measure. Parents' personal health was positively associated with their reports of the child's health. More distressed parents were closer to the child's self-reports, but reported poorer personal health.Conclusion: Parent-child differences in this study of young children's health were related to parental distress. Exploring the nature of the gap between parents and children in assessments of children's health could improve effective clinical management for the child and enhance family-centered pediatric care. Future studies are needed to assess the generalizability of CHRIS 2.0 to other health settings and conditions and to other racial/ethnic groups. [ABSTRACT FROM AUTHOR]

Background and Aim: 'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MApping onto Preference-based measures reporting Standards (MAPS) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies.Methods: In the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items was created by a working group comprised of six health economists and one Delphi methodologist. A two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community was used to identify a list of essential reporting items from this larger list.Results: From the initial de novo list of 29 candidate items, a set of 23 essential reporting items was developed. The items are presented numerically and categorised within six sections, namely (1) title and abstract; (2) introduction; (3) methods; (4) results; (5) discussion; and (6) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document.Conclusions: It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in 5 years' time. [ABSTRACT FROM AUTHOR]

Purpose: Anger and irritability are common and impairing symptoms in children. The PROMIS Anger scales assess self- and parent-reported irritable and angry mood over the past 7 days. The aim of this study was to evaluate the psychometric properties of the German version of the PROMIS Parent Proxy Short Form v1.0—Anger and to provide normative data. Methods: To evaluate the psychometric properties, data from the study ADOPT Epidemiology were used. In this study, the PROMIS Anger Scale was administered to a population-based sample of n = 8746 parents of children aged 8–12 years. Psychometric analyses were carried out including the investigation of distribution characteristics, factor structure, model fit, internal consistency, and congruent validity. Normative data were calculated as percentile ranks and T-scores. Results: The PROMIS Anger Scale demonstrated good psychometric properties, including satisfactory distribution characteristics, unidimensionality, good internal consistency as well as congruent validity. German normative data for the PROMIS Anger Scale are presented. Conclusion: Based on first psychometric analyses, the German version of the PROMIS Anger Scale can be recommended for use in research and practice; however, further investigations using clinical data are needed. The normative data will allow researchers and clinicians an interpretation of the test scores in future applications. [ABSTRACT FROM AUTHOR]

Purpose: Quality of life (QoL) has been the subject of increasing interest in oncology. Most examinations of QoL have focused on health-related QoL, while other factors often remain unconsidered. Moreover, QoL questionnaires implicitly assume that the subjective importance of the various QoL domains is identical from one patient to the next. The aim of this study was to analyze QoL in a broader sense, considering the subjective importance of the QoL components. Methods: A sample of 173 male urologic patients was surveyed twice: once while hospitalized (t1) and once again 3 months later (t2). Patients completed the Questions on Life Satisfaction questionnaire (FLZ-M), which includes satisfaction and importance ratings for eight dimensions of QoL. A control group was taken from the general population (n = 477). Results: Health was the most important QoL dimension for both the patient and the general population groups. While satisfaction with health was low in the patient group, the satisfaction ratings of the other seven domains were higher in the patient group than in the general population. The satisfaction with the domain partnership/sexuality showed a significant decline from t1 to t2. Multiple regression analyses showed that the domains health and income contributed most strongly to the global QoL score at t2 in the patient group. Conclusion: Health is not the only relevant category when assessing QoL in cancer patients; social relationships and finances are pertinent as well. Importance ratings contribute to a better understanding of the relevance of the QoL dimensions for the patients. [ABSTRACT FROM AUTHOR]

Aim: A systematic literature review of immuno-oncology trials was conducted to assess the potential impact of open-label vs double-blind trial design on patient-reported outcome (PRO) data. Methods: A systematic search of indexed literature published from January 2009 to May 2019 was conducted using PubMed/MEDLINE, Cochrane Library, and EMBASE database. All randomized clinical trials (RCTs) of immuno-oncology therapies on advanced cancer patients reporting PRO data were identified. Descriptive analyses were performed to quantify differences at baseline and over time, by the type of study, regarding questionnaire completion rate and PRO scores. Results: In total, 23 studies were retained (15 open-label, 8 blinded). At baseline, no difference in completion rate was observed between arms irrespective of trial design (absolute mean difference of 2.8% and 2.2% for open label and blinded studies, respectively). No clinically significant difference in baseline PRO scores was observed between arms. Over time, impact on PRO scores could not be identified due to the limited number of studies, heterogeneity of questionnaires and tumor types. Conclusions: Trial design had no impact on PRO completion rate or baseline scores. Future research should involve analyses by specific cancer types and ideally compare individual data from two similar RCTs (blinded vs. open-label). [ABSTRACT FROM AUTHOR]

Introduction: This study investigates comments that prostate cancer patients spontaneously write in the margins of the Expanded Prostate Cancer Index Short Form (EPIC-26) questionnaire. We aim to show the possible barriers that patients face while answering the survey, and to consider how these barriers may affect the response data generated. We investigate the kind of information patients' comments on EPIC-26 contain, and patients' motivations to provide this information. We also study why some EPIC domains spark more comments than others. Method: We analyzed 28 pages of transcribed comments and four pages of supplementary letters from our survey participants (n = 496). Using inductive content analysis, we generated 10 categories describing the content of participants' comments, and four themes demonstrating their motives for commenting. The comments regarding each EPIC domain were quantified to discover any differences between domains. Results: The sexual domain of EPIC-26 provoked over half of all comments. Patients without recent sexual activity or desire had difficulties answering sexual function questions 8–10. The lack of instructions on whether to take erectile aid use into account when answering erectile function questions led to a diversity of answering strategies. Patients with urinary catheters could not find suitable answer options for questions 1–4. All domains sparked comments containing additional information about experienced symptoms. Conclusion: Patients are mainly willing to report their symptoms, but a lack of suitable answer options causes missing data and differing answering strategies in the sexual and urinary domains of EPIC-26, weakening the quality of the response data received. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43. Methods: In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods. Results: From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |r|< 0.4 in 17 out of 19 scales; hence, performance status was regarded as an unsuitable anchor. The ROC approach yielded an implausible MIC and was also discarded. The remaining approaches worked well and delivered MID values ranging from 10 to 14; the MIC for deterioration ranged from 8 to 16 and the MIC for improvement from − 3 to − 14. Conclusions: For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate. [ABSTRACT FROM AUTHOR]

Purpose: To identify the effects of whole body vibration (WBV) on health-related quality of life (HRQOL) in patients with chronic conditions.Methods: Five databases (the Cochrane Library, PubMed, Medline, EBSCO, and Web of science) were searched (from inception until April 30, 2019) for original articles. All studies were randomized controlled trials reporting the effects of WBV on HRQOL. Two independent reviewers extracted trial data and assessed the risk of bias using the risk of bias tool recommended by the Cochrane Back Review Group.Results: Of the 349 articles that were screened, 17 articles, including 763 participants with various chronic conditions, met the inclusion criteria. Six studies reported significant improvements in HRQOL. No evidence was observed to suggest that WBV was more effective than other types of exercises. The study participants, exercise protocols, HRQOL instruments, study duration, and frequency as well as amplitude of WBV varied across the studies. Meta-analysis was not conducted due to the heterogeneity of study designs and outcome measures.Conclusions: This study has demonstrated that WBV may improve HRQOL in patients with chronic conditions. However, the evidence was not strong enough to warrant recommendation and thus further high-quality studies with larger sample sizes and longer intervention durations are needed. [ABSTRACT FROM AUTHOR]

Purpose: End-stage renal disease patients' experience of care is an integral part of the assessment of the quality of the care provided at hemodialysis centers and is needed to promote patient choice, quality improvement, and accountability. The purpose of this study is to evaluate the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH-CAHPS®) survey and its equivalence in different age, gender, race, and education subgroups.Methods: The ICH-CAHPS survey was administered to 1454 patients from 32 dialysis facilities. For the characteristics compared, the sample had 756 participants younger than 65 years old, 739 men, 516 Black, 567 White, and 970 with less than high school diploma. Three different patient experience constructs were studied including nephrologist's communication and caring, quality of care and operations, and providing information to patients. We used item response theory analysis to examine the possibility of differential item functioning (DIF) by patient age, gender, race, and education separately after controlling for the other DIF characteristics and additional confounding variables including survey mode, mental, and general health status as well as duration on dialysis.Results: The three constructs studied were unidimensional and no major DIF was observed on the composites. Some non-equivalences were observed when confounders were not controlled for, suggesting that such covariates can be important factors in understanding the possibility of disparity in patients' experience.Conclusions: The ICH-CAHPS is a promising survey to elicit hemodialysis patients' experience that has good psychometric properties and provides a standardized tool for assessing age, gender, race, or education disparity. [ABSTRACT FROM AUTHOR]

Purpose: This study developed and tested preliminary measurement properties of a Chinese scale specifically designed to measure HRQOL in patients with chronic hepatitis B (CHBQOL).Methods: We conducted 94 individual interviews with CHB patients to solicit items and five hepatitis expert interviews along with three rounds of cognitive interviews to identify problems with relevance and understanding of content. A cross-sectional validation study was then conducted to evaluate measurement properties (n = 578). Factor analysis was used to determine the latent structure of the scale. Reliability was evaluated through Cronbach's alpha coefficients and intra-class correlation coefficients (ICCs). Measurement model adequacy, convergent, discriminant, and known-groups validity were also examined.Results: A scale of 30 items was drafted. After item reduction, the remaining 23 items were assigned to the CHBQOL Somatic symptoms, Emotional symptoms, Belief and Social stigma domains, which had acceptable goodness of fit (χ2/df = 3.13, GFI = 0.90, AGFI = 0.88, RMSEA = 0.06, SRMR = 0.05). All the CHBQOL domains had satisfactory reliability with Cronbach's α coefficients ranging from 0.73 to 0.91 and ICCs were higher than 0.70 except for Belief domain (ICC = 0.54). Convergent and discriminant validity were acceptable as supported by significant item-domain correlations (0.64-0.90). In general, the correlations between CHBQOL and the SF-36 dimensions met hypotheses. Significant differences were found by mean scores in the subgroups of demographic and clinical variables, supporting the known-groups validity.Conclusions: The CHBQOL instrument proved to be an appropriate tool for assessing HRQOL among Chinese CHB patients. [ABSTRACT FROM AUTHOR]

Purpose: The level of support needed for adaptive functioning and behavioral problems of individuals with intellectual disabilities (ID) can be a source of stress for caregivers. The aim of this study was to explore the moderating role of caregivers' age on the associations between these stressors and quality of life (QoL) of the family caregivers. As these sources of stress in people with ID can coexist, the triple interaction between stressors and age was also examined.Methods: 208 relatives (mean age = 50.98 years, SD = 12.86) of people with ID participated in the research. Participants answered a questionnaire with sociodemographic variables, measures of stressors (level of support for adaptive functioning of the people with ID and behavioral problems) and measures of QoL (WHOQOL-BREF).Results: The association between the level of support needed for adaptive functioning and lower QoL was only significant among older relatives, whereas the association between behavioral problems and lower QoL was only significant among younger relatives. A three-way interaction between behavioral problems, level of support needed, and age indicated that the association between the level of support for adaptive functioning and QoL in older relatives was greater when there were higher levels of behavioral problems.Conclusions: The role of caregivers' age in their QoL differs depending on the nature of the stressor, and an accumulation of stressors can have a particularly negative impact on older caregivers. Interventions should be adapted for caregivers of different ages and take into account the particular sources of stress they have to cope with. [ABSTRACT FROM AUTHOR]

Purpose: The Hospital Anxiety and Depression Scale (HADS-A) and State-Trait Anxiety Inventory (STAI-S) are popular instruments for assessing anxiety and are considered interchangeable, although little is known about their equivalence. Hence, we examined whether the two instruments are (i) equivalent with respect to determining the prevalence of probable clinical anxiety levels and (ii) reflect variation on a common anxiety attribute.Methods: Score and construct concordance were evaluated using equipercentile equating and bifactor modeling, respectively. Secondary data from the WEBCARE trial and the MIDAS study were used for the current study, where patients implanted with a first-time implantable cardioverter defibrillator completed both the HADS-A and the STAI-S within 10 days post implant.Results: Data from 710 patients were included in the analyses. Results showed that the STAI-S produced a higher prevalence rate than the HADS-A (39% vs. 23%). A crosswalk table was generated with equivalent scores and cutoffs for the HADS-A and STAI-S, respectively. Bifactoring suggested that HADS-A and STAI-S largely tapped into the same generic anxiety attributes.Conclusions: STAI-S and HADS-A reflect a common anxiety attribute, but using the recommended cutoff scores on the respective measures show very different prevalence rates and would classify patients as anxious with the STAI-S who would not be identified as such with the HADS-A. Clinicians and researchers should be aware of the inequivalence when using these measures for screening and determining the prevalence of probable clinical anxiety levels. [ABSTRACT FROM AUTHOR]

Purpose: We aim to describe the impact of diabetic retinopathy (DR) on health-related quality of life (HRQOL) among community-dwelling Chinese adults who had been previously diagnosed with type 2 diabetes mellitus (T2DM).Methods: A community-based survey including 913 patients with T2DM was conducted in Suzhou, China. Retinopathy lesions were graded according to the Airlie House classification system of the Early Treatment Diabetic Retinopathy Study. The HRQOL was measured by the Chinese version of the EuroQol Group's five-level EuroQol five-dimensional questionnaire (EQ-5D-5L). A Gamma distribution with log link was incorporated into linear regression models to assess the associations between DR and EQ-5D-5L health utility score.Results: The mean EQ-5D-5L index scores were 0.971 ± 0.082 among individuals with unilateral DR and 0.970 ± 0.145 among those with bilateral DR, which were lower compared with those without DR (0.986 ± 0.045, P = 0.02). In multivariate analysis adjusting for confounders, people with bilateral DR reported lower the EQ-5D index scores compared with those without DR. The presence of DR was significantly associated with problems in usual activities (odds ratio [OR] = 0.16, P = 0.02, comparing participants with unilateral vs. no DR; OR = 0.11; P = 0.01, comparing participants with bilateral vs. no DR). No significant variations in EQ-5D-5L index scores as well as different domains of health problems between individuals with unilateral and bilateral DR were observed (P > 0.05).Conclusion: Chinese T2DM patients with bilateral DR tend to report lower HRQOL scores compared with those without DR, especially in health problems associated with usual activities. [ABSTRACT FROM AUTHOR]

Purpose: In studying health inequality, poverty as measured by income is frequently used; however, this omits the aspects of non-monetary resources and social barriers to achieving improved living standard. Therefore, our study aimed to examine the associations of individual-level deprivation of material and social necessities with general physical and mental health beyond that of income poverty.Methods: A territory-wide two-stage stratified random sample of 2282 community-dwelling Hong Kong adults was surveyed between 2014 and 2015. Income poverty and a Deprivation Index were used as the main independent variables. General health was assessed using the validated 12-item Short-Form Health Survey version 2, from which physical component summary and mental component summary were derived.Results: Our results in multivariable ordinal logistic regressions consistently showed that, after adjusting for income poverty, socio-demographic and lifestyle factors, being deprived was significantly associated with worse physical (OR 1.66; CI 1.25-2.20) and mental health (OR 1.83; CI 1.43-2.35). Being income poor was also significantly associated with worse mental health (OR 1.63; CI 1.28-2.09) but only marginally with physical health (OR 1.34; CI 1.00-1.80) after adjustments.Conclusions: Income does not capture all aspects of poverty that are associated with adverse health outcomes. Deprivation of non-monetary resources has an independent effect on general health above and beyond the effect of income poverty. Policies should move beyond endowment and take into account the multidimensionality of poverty, in order to address the problem of health inequality. [ABSTRACT FROM AUTHOR]

Purpose: To develop bridging algorithms to score the Veterans Rand-12 (VR-12) scales for comparability to those of the SF-36® for facilitating multi-cohort studies using data from the National Cancer Institute Surveillance, Epidemiology, and End Results Program (SEER) linked to Medicare Health Outcomes Survey (MHOS), and to provide a model for minimizing non-statistical error in pooled analyses stemming from changes to survey instruments over time.Methods: Observational study of MHOS cohorts 1-12 (1998-2011). We modeled 2-year follow-up SF-36 scale scores from cohorts 1-6 based on baseline SF-36 scores, age, and gender, yielding 100 clusters using Classification and Regression Trees. Within each cluster, we averaged follow-up SF-36 scores. Using the same cluster specifications, expected follow-up SF-36 scores, based on cohorts 1-6, were computed for cohorts 7-8 (where the VR-12 was the follow-up survey). We created a new criterion validity measure, termed "extensibility," calculated from the square root of the mean square difference between expected SF-36 scale averages and observed VR-12 item score from cohorts 7-8, weighted by cluster size. VR-12 items were rescored to minimize this quantity.Results: Extensibility of rescored VR-12 items and scales was considerably improved from the "simple" scoring method for comparability to the SF-36 scales.Conclusions: The algorithms are appropriate across a wide range of potential subsamples within the MHOS and provide robust application for future studies that span the SF-36 and VR-12 eras. It is possible that these surveys in a different setting outside the MHOS, especially in younger age groups, could produce somewhat different results. [ABSTRACT FROM AUTHOR]

Purpose: There is a global increase in chronic, degenerative illnesses that require long-term intervention and support as a result of the aging population. The majority of support needs are met by informal family caregivers. While there have been three decades of research focusing on caregivers in general, the extent to which research has focused on Indigenous caregivers is unclear. Worldwide, Indigenous peoples face severe economic and health disadvantages that may make them even more vulnerable to the negative aspects of informal caregiving. The current systematic review aimed to synthesize the extant literature on Indigenous caregiver functioning and the interventions that are efficacious in alleviating Indigenous caregiver distress.Methods: Systematic review Inclusion criteria were peer-reviewed quantitative studies examining Indigenous caregiver functioning or evaluating Indigenous caregiver interventions.Results: 1172 unique records were located in the final search undertaken; only 7 articles, representing 6 unique studies, met the full inclusion criteria. Most studies contained numerous methodological weaknesses that compromised the reliability and validity of findings. Available studies suggest poor health and high burden among Indigenous relative to non-Indigenous caregivers. However, high levels of positive aspects of caregiving were reported in one study. A single intervention study suggests that poor health outcomes among Indigenous caregivers can be alleviated, though the quality and focus of this study was sub-optimal.Conclusions: Overall, there is very little quality evidence around Indigenous caregiver functioning. Future research in this area would benefit from greater adherence to the standards of research that contribute to a strong and reliable evidence base. [ABSTRACT FROM AUTHOR]

Purpose: We analyze the influence of the dramatic changes in the Spanish labor market during the crisis on the perceived health of the Spanish population.Methods: We use the longitudinal Living Conditions Survey database and multilevel longitudinal logistic models between 2007 and 2011, before and during the economic crisis in one of the European countries most affected by its consequences.Results: Unemployment (OR 1.75; p < 0.001), job insecurity (OR 1.38; p < 0.001), and being part of a household with severe material deprivation (OR 1.87; p = 0.004) increase the risk of having worsened perceived health. Available income, on the other hand, is a protective factor (OR 0.72; p < 0.001). Public expenditure policies have little impact on the perceived health. Labor market reforms reducing the degree of job insecurity and unemployment, together with income transfers to those at greater risk of social deprivation, can be more effective in improving the health of the population than the increase of aggregated social or health care expenditure.Conclusions: This study provides evidence of the influence that unemployment, job insecurity, and poverty exert on the perceived health of individuals, with data collected in Spain after the onset of the financial crisis. In addition, after analyzing public social expenditure, only expenditure on FPS seems to influence self-reported health, although to a very limited degree. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to systematically review the available literature on "quality of life" (QoL) or "health-related quality of life" (HRQoL) in Turner syndrome (TS) patients and to analyze the relations among height, puberty, and the use of growth hormone (GH) and the QoL of TS patients.Methods: An electronic bibliographic search was conducted through the PubMed, Embase, Bireme, Scopus, and Web of Science databases. The main terms were "Quality of Life" and "Turner syndrome."Results: Among the databases, 559 articles were found; after the selection process, 13 studies were selected. A quality assessment was conducted, and all the studies were of high quality. Eight well-known QoL questionnaires were used, and the selected studies presented factors that may be related to the QoL of TS patients, such as height, puberty, and GH use. However, a more detailed understanding of which factors are associated with the QoL of TS patients is still needed, which may be due to the lack of specific QoL instruments involving important aspects related to TS.Conclusion: The QoL of TS patients appears to be compromised, but existing data regarding the relations among height, puberty, and GH and QoL are still controversial. Although these factors should be carefully considered in TS patients, it was not possible to determine whether they have a significant relation with the QoL of TS patients. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the relationship between retrospectively and contemporaneously collected patient-reported outcome measures (PROMs) and the influence on this relationship of patients' age and socio-economic status and the length of time.Methods: Patients undergoing hip or knee replacement in four hospitals who had completed a pre-operative questionnaire were invited to recall their pre-operative health status shortly after surgery. The questionnaires included a disease-specific (Oxford Hip Score; Oxford Knee Score) and generic (EQ-5D-3L) PROM. Consistency and absolute agreement between contemporary and retrospective reports were investigated using intraclass correlations (ICCs). Differences were visualised using Bland-Altman plots. Linear regression analysis explored whether retrospective can predict contemporary PROMs.Results: Patients' recalled health statuses were similar to their contemporaneous reports, with no significant systematic bias. Absolute agreement for disease-specific PROMs was very strong (ICC 0.82) and stronger than for the generic PROM (ICC 0.60, 0.62). Agreement was consistently strong across the range of severity of a patient's condition, age and socio-economic status. Patients' age and socio-economic status had no significant influence on size of difference and direction of recall, although reliability of recall was slightly worse among the over-75s versus under-60s for hips (Oxford Hip Score ICC 0.88 vs. 0.78). Mean retrospective PROMs for groups or populations of patients can reliably predict what mean contemporary reports of PROMs would have been.Conclusion: Retrospective PROMs can be used to obtain a baseline assessment of health status when contemporary collection is not feasible or cost effective. Research is needed to determine the feasibility of retrospective PROMs in emergency admissions. [ABSTRACT FROM AUTHOR]

Purpose: Patient-reported outcome measures (PROMs) are frequently used in heterogeneous patient populations. PROM scores may lead to biased inferences when sources of heterogeneity (e.g., gender, ethnicity, and social factors) are ignored. Latent variable mixture models (LVMMs) can be used to examine measurement invariance (MI) when sources of heterogeneity in the population are not known a priori. The goal of this article is to discuss the use of LVMMs to identify invariant items within the context of test construction.Methods: The Draper-Lindely-de Finetti (DLD) framework for the measurement of latent variables provides a theoretical context for the use of LVMMs to identify the most invariant items in test construction. In an expository analysis using 39 items measuring daily activities, LVMMs were conducted to compare 1- and 2-class item response theory models (IRT). If the 2-class model had better fit, item-level logistic regression differential item functioning (DIF) analyses were conducted to identify items that were not invariant. These items were removed and LVMMs and DIF testing repeated until all remaining items showed MI.Results: The 39 items had an essentially unidimensional measurement structure. However, a 1-class IRT model resulted in many statistically significant bivariate residuals, indicating suboptimal fit due to remaining local dependence. A 2-class LVMM had better fit. Through subsequent rounds of LVMMs and DIF testing, nine items were identified as being most invariant.Conclusions: The DLD framework and the use of LVMMs have significant potential for advancing theoretical developments and research on item selection and the development of PROMs for heterogeneous populations. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to test psychometric properties of the Satisfaction with Life Scale (SWLS), to provide normative values, and to analyze associations between life satisfaction and sociodemographic and behavioral data.Methods: A German community sample (n = 9711) with an age range of 18-80 years was surveyed using the SWLS and several other questionnaires. Confirmatory factor analysis (CFA) was used to test the dimensionality of the SWLS. Invariance across gender and age groups was tested with multiple-group CFA. Associations between SWLS, sociodemographic variables, and behavioral variables were tested with ANOVAs.Results: Confirmatory factorial analysis results confirmed that the SWLS is a one-dimensional scale. Measurement invariance across gender was completely confirmed, while concerning age strict measurement invariance was confirmed. The effects of gender and age on satisfaction with life were weak. Satisfaction with life was associated with fatigue (r = - .49), the mental component of quality of life (r = .45), anxiety (r = - .42), dispositional optimism (r = .41), pessimism (r = - .34), sleep quality (r = - .32), and sociodemographic factors such as marital status, income, and occupational status. Non-smokers reported higher life satisfaction than smokers.Conclusions: Because of the good psychometric properties, the SWLS can be recommended for use in epidemiological research. Normative values based on a large community sample are provided. [ABSTRACT FROM AUTHOR]

Purpose: Clinician ratings of concurrent chemoradiation (CRT)-induced radiation pneumonitis (RP) in patients with non-small cell lung cancer (NSCLC) are based on both imaging and patient-reported lung symptoms. We compared the value of patient-reported outcomes versus normal-lung uptake of 18F-fluoro-2-deoxyglucose in positron emission computed tomography (FDG PET/CT) during the last week of treatment, for indicating the development of grade ≥ 2 RP within 4 months of CRT completion.Methods: 132 patients with NSCLC-reported RP-related symptoms (coughing, shortness of breath) repeatedly using the validated MD Anderson Symptom Inventory lung cancer module. Of these patients, 68 had FDG PET/CT scans that were analyzed for normal-lung mean standardized FDG uptake values (SUVmean) before, during, and up to 4 months after CRT. Clinicians rated RP using CTCAE version 3. Logistic regression models examined potential predictors for developing CTCAE RP ≥ 2.Results: For the entire sample, patient-rated RP-related symptoms during the last week of CRT correlated with clinically meaningful CTCAE RP ≥ 2 post-CRT (OR 2.74, 95% CI 1.25-5.99, P = 0.012), controlled for sex, age, mean lung radiation dose, comorbidity, and baseline symptoms. Moderate/severe patient-rated RP-related symptom score (≥ 4 on a 0-10 scale, P = 0.001) and normal-lung FDG uptake (SUVmean > 0.78, P = 0.002) in last week of CRT were equally strong predictors of post-CRT CTCAE RP ≥ 2 (C-index = 0.78, 0.77).Conclusions: During the last week of CRT, routine assessment of moderate-to-severe RP-related symptoms provides a simple way to identify patients with NSCLC who may be at risk for developing significant post-CRT RP, especially when PET/CT images of normal-lung FDG uptake are not available. [ABSTRACT FROM AUTHOR]

Purpose: While quality of life measures may be used to assess meaningful change and group differences, their scaling and validation often rely on a single occasion of measurement. Using the 13-item FACIT-Fatigue questionnaire at three timepoints, this study tests whether individual items change together in ways consistent with a general fatigue factor.Methods: The measurement model of derivatives (MMOD) is a novel method for measurement evaluation that directly assesses whether a given factor structure accurately describes how individual test items change over time. MMOD transforms item-level longitudinal data into a set of orthogonal change scores, each one representing either a within-person longitudinal mean or a different type of longitudinal change. These change scores are then factor analyzed and tested for invariance. This approach is applied to the FACIT-Fatigue scale in a sample of patients with renal cell carcinoma treated on 'ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) study 2805.Results: Analyses revealed strong evidence of unidimensionality, and apparent factorial invariance using traditional techniques. MMOD revealed a small but statistically significant difference in factor structure ([Formula: see text], [Formula: see text]), where factor loadings were weaker and more variable for measuring longitudinal change.Conclusions: The differences in factor structure were not large enough to substantially affect scale usage in this application, but they do reveal some variability across items in the FACIT-Fatigue in their ability to detect change. Future applications should consider differential sensitivity of individual items in multi-item scales, and perhaps even capitalize upon these differences by selecting items that are more sensitive to change. [ABSTRACT FROM AUTHOR]

Background: Refractory ascites (RA) is a complication of cirrhosis which is treated with large volume paracentesis (LVP) as the standard of care. Alfapump® system is a fully implantable pump system which reduces the need for LVP. The aim was to assess health-related quality of life (HRQL) in patients treated with alfapump® versus LVP.Methods: The data were collected in a multicenter open-label randomized controlled trial (clinicaltrials.gov #NCT01528410). Subjects with cirrhosis Child-Pugh class B or C accompanied by RA were randomized to receive alfapump® or LVP. The SF-36v2 and CLDQ scores were compared between the two treatment arms at screening and monthly during treatment.Results: Of 60 subjects randomized, HRQL data were available for 58 (N = 27 received alfapump® and N = 31 received LVP only). At baseline, no differences were seen between the treatment arms (all p > 0.05): age 61.9 ± 8.4, 79.3% male, MELD scores 11.7 ± 3.3, 85.2% Child-Pugh class B, 70.7% had alcoholic cirrhosis. The mean number of LVP events/subject was lower in alfapump® than LVP (1.1 vs. 8.6, p < 0.001). The HRQL scores showed a moderate improvement from the baseline levels in subjects treated with alfapump® (p < 0.05 for abdominal and activity scores of CLDQ) but not with LVP (all one-sided p > 0.05) in the first 3 months. Multivariate analysis showed that treatment with alfapump® was independently associated with better HRQL at 3 months (total CLDQ score: beta = 0.67 ± 0.33, p = 0.05).Conclusion: As compared to LVP, the use of alfapump® system is associated with both a reduction in the number of LVP events and improvement of health-related quality of life. [ABSTRACT FROM AUTHOR]