Showing papers in "Health and Quality of Life Outcomes in 2004"
TL;DR: The Treatment Satisfaction Questionnaire for Medication (TSQM) as mentioned in this paper is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication.
Abstract: Background: The objective of this study was to develop and psychometrically evaluate a general measure of patients' satisfaction with medication, the Treatment Satisfaction Questionnaire for Medication (TSQM). Methods: The content and format of 55 initial questions were based on a formal conceptual framework, an extensive literature review, and the input from three patient focus groups. Patient interviews were used to select the most relevant questions for further evaluation (n = 31). The psychometric performance of items and resulting TSQM scales were examined using eight diverse patient groups (arthritis, asthma, major depression, type I diabetes, high cholesterol, hypertension, migraine, and psoriasis) recruited from a national longitudinal panel study of chronic illness (n = 567). Participants were then randomized to complete the test items using one of two alternate scaling methods (Visual Analogue vs. Likert-type). Results: A factor analysis (principal component extraction with varimax rotation) of specific items revealed three factors (Eigenvalues > 1.7) explaining 75.6% of the total variance; namely Side effects (4 items, 28.4%, Cronbach's Alpha = .87), Effectiveness (3 items, 24.1%, Cronbach's Alpha = .85), and Convenience (3 items, 23.1%, Cronbach's Alpha = .87). A second factor analysis of more generally worded items yielded a Global Satisfaction scale (3 items, Eigenvalue = 2.3, 79.1%, Cronbach's Alpha = .85). The final four scales possessed good psychometric properties, with the Likert-type scaling method performing better than the VAS approach. Significant differences were found on the TSQM by the route of medication administration (oral, injectable, topical, inhalable), level of illness severity, and length of time on medication. Regression analyses using the TSQM scales accounted for 40–60% of variation in patients' ratings of their likelihood to persist with their current medication. Conclusion: The TSQM is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication. Preliminary evidence suggests that the TSQM may also be a good predictor of patients' medication adherence across different types of medication and patient populations.
741 citations
TL;DR: The findings confirm the existence of an inverse relationship between multimorbidity or comorbidy and QOL, however, additional studies are needed to clarify this relationship, including the various dimensions of QOL affected.
Abstract: Background
Many patients with several concurrent medical conditions (multimorbidity) are seen in the primary care setting. A thorough understanding of outcomes associated with multimorbidity would benefit primary care workers of all disciplines. The purpose of this systematic review was to clarify the relationship between the presence of multimorbidity and the quality of life (QOL) or health-related quality of life (HRQOL) of patients seen, or likely to be seen, in the primary care setting.
676 citations
TL;DR: The results demonstrate the preliminary reliability and validity of the PedsQL™ Family Impact Module in families with children with complex chronic health conditions.
Abstract: The PedsQL™ Measurement Model was designed to measure health-related quality of life (HRQOL) in children and adolescents. The PedsQL™ 4.0 Generic Core Scales were developed to be integrated with the PedsQL™ Disease-Specific Modules. The newly developed PedsQL™ Family Impact Module was designed to measure the impact of pediatric chronic health conditions on parents and the family. The PedsQL™ Family Impact Module measures parent self-reported physical, emotional, social, and cognitive functioning, communication, and worry. The Module also measures parent-reported family daily activities and family relationships. The 36-item PedsQL™ Family Impact Module was administered to 23 families of medically fragile children with complex chronic health conditions who either resided in a long-term care convalescent hospital or resided at home with their families. Internal consistency reliability was demonstrated for the PedsQL™ Family Impact Module Total Scale Score (α = 0.97), Parent HRQOL Summary Score (α = 0.96), Family Functioning Summary Score (α = 0.90), and Module Scales (average α = 0.90, range = 0.82 – 0.97). The PedsQL™ Family Impact Module distinguished between families with children in a long-term care facility and families whose children resided at home. The results demonstrate the preliminary reliability and validity of the PedsQL™ Family Impact Module in families with children with complex chronic health conditions. The PedsQL™ Family Impact Module will be further field tested to determine the measurement properties of this new instrument with other pediatric chronic health conditions.
475 citations
TL;DR: The proposed theoretical model, building on the Sprangers and Schwartz (1999) model and highlighting appraisal processes, provides a fully testable theoretical treatment of QOL and change in QOL, suggesting hypothesized causal relationships and explanatory pathways for both cross-sectional and longitudinal QOL research.
Abstract: Mounting evidence for response shifts in quality of life (QOL) appraisal indicates the need to include direct measurement of the appraisal process itself as a necessary part of QOL assessment. We propose that directly assessing QOL appraisal processes will not only improve our ability to interpret QOL scores in the traditional sense, but will also yield a deeper understanding of the appraisal process in the attribution of and divergence in meaning. The published evidence for response shift is reviewed, and an assessment paradigm is proposed that includes the explicit measurement of QOL appraisal process parameters: 1) induction of a frame of reference; 2) recall and sampling of salient experiences; 3) standards of comparison used to appraise experiences; and 4) subjective algorithm used to prioritize and combine appraisals to arrive at a QOL rating. A QOL Appraisal Profile, which measures key appraisal processes, is introduced as an adjunct to existing QOL scales. The proposed theoretical model, building on the Sprangers and Schwartz (1999) model and highlighting appraisal processes, provides a fully testable theoretical treatment of QOL and change in QOL, suggesting hypothesized causal relationships and explanatory pathways for both cross-sectional and longitudinal QOL research.
425 citations
TL;DR: The currently available methodological evidence points towards a high quality of the MRS scale to measure and to compare HRQoL of aging women in different regions and over time, it suggests a high reliability and high validity as far as the process of construct validation could be completed yet.
Abstract: This paper compiles data from different sources to get a first comprehensive picture of psychometric and other methodological characteristics of the Menopause Rating Scale (MRS) scale. The scale was designed and standardized as a self-administered scale to (a) to assess symptoms/complaints of aging women under different conditions, (b) to evaluate the severity of symptoms over time, and (c) to measure changes pre- and postmenopause replacement therapy. The scale became widespread used (available in 10 languages). A large multinational survey (9 countries in 4 continents) from 2001/ 2002 is the basis for in depth analyses on reliability and validity of the MRS. Additional small convenience samples were used to get first impressions about test-retest reliability. The data were centrally analyzed. Data from a postmarketing HRT study were used to estimate discriminative validity.
Reliability measures (consistency and test-retest stability) were found to be good across countries, although the sample size for test-retest reliability was small.
Validity: The internal structure of the MRS across countries was astonishingly similar to conclude that the scale really measures the same phenomenon in symptomatic women. The sub-scores and total score correlations were high (0.7–0.9) but lower among the sub-scales (0.5–0.7). This however suggests that the subscales are not fully independent. Norm values from different populations were presented showing that a direct comparison between Europe and North America is possible, but caution recommended with comparisons of data from Latin America and Indonesia. But this will not affect intra-individual comparisons within clinical trials. The comparison with the Kupperman Index showed sufficiently good correlations, illustrating an adept criterion-oriented validity. The same is true for the comparison with the generic quality-of-life scale SF-36 where also a sufficiently close association has been shown. The currently available methodological evidence points towards a high quality of the MRS scale to measure and to compare HRQoL of aging women in different regions and over time, it suggests a high reliability and high validity as far as the process of construct validation could be completed yet.
390 citations
TL;DR: The relationship between needs, satisfaction and quality of life, identify gaps in the current knowledge base, and encourage future research in these areas are explored.
Abstract: With the publication of its 100th paper, the new open access Journal Health and Quality of Life Outcomes (HQLO), achieves a significant milestone. Launching a journal in this field was not just a challenge with respect to nomenclature, [1] but also provided a forum for disseminating research which emphasises the unique contributions as well as the inter-relationships among determinants of health, provision of care, and outcomes. So far, prominence (as measured by the number of scientific manuscripts accepted for publication) has been given mainly to the unique contributions of health-related quality of life (HRQL). Other determinants like health needs and satisfaction have sporadically been considered [2-7]. A few additional papers have focused on approaches to detect ill health. In this editorial we would like to explore the relationship between needs, satisfaction and quality of life, identify gaps in the current knowledge base, and encourage future research in these areas.
378 citations
TL;DR: Lower within-person variability was responsible for the higher test-retest reliability of the interviewer-administered format while between person variability was similar for both formats.
Abstract: Assessment of health-related quality of life (HRQL) is important in patients with chronic obstructive pulmonary disease (COPD). Despite the high prevalence of COPD in Germany, Switzerland and Austria there is no validated disease-specific instrument available. The objective of this study was to translate the Chronic Respiratory Questionnaire (CRQ), one of the most widely used respiratory HRQL questionnaires, into German, develop an interviewer- and self-administered version including both standardised and individualised dyspnoea questions, and validate these versions in two randomised studies. We recruited three groups of patients with COPD in Switzerland, Germany and Austria. The 44 patients of the first group completed the CRQ during pilot testing to adapt the CRQ to German-speaking patients. We then recruited 80 patients participating in pulmonary rehabilitation programs to assess internal consistency reliability and cross-sectional validity of the CRQ. The third group consisted of 38 patients with stable COPD without an intervention to assess test-retest reliability. To compare the interviewer- and self-administered versions, we randomised patients in groups 2 and 3 to the interviewer- or self-administered CRQ. Patients completed both the standardised and individualised dyspnoea questions. For both administration formats and all domains, we found good internal consistency reliability (Crohnbach's alpha between 0.73 and 0.89). Cross-sectional validity tended to be better for the standardised compared to the individualised dyspnoea questions and cross-sectional validity was slightly better for the self-administered format. Test-retest reliability was good for both the interviewer-administered CRQ (intraclass correlation coefficients for different domains between 0.81 and 0.95) and the self-administered format (intraclass correlation coefficients between 0.78 and 0.86). Lower within-person variability was responsible for the higher test-retest reliability of the interviewer-administered format while between person variability was similar for both formats. Investigators in German-speaking countries can choose between valid and reliable self-and interviewer-administered CRQ formats.
339 citations
TL;DR: Dependency upon others to perform ADL was the main factor affecting HRQoL, and Danish EQ-5D social tariffs were used to value patients' HRQol.
Abstract: Dementia is a chronic illness associated with a progressive loss of cognitive and intellectual abilities, such as memory, judgment and abstract thinking. The objective of this study was to assess the health utilities of patients with dementia in Europe and identify the key factors influencing their Health-Related Quality of Life (HRQol). This study used cross-sectional data from the Odense study; a Danish cohort of patients aged 65–84 living in Odense, Denmark. A total of 244 patients with mild to severe dementia were interviewed together with a caregiver about their health status and activities of daily living (ADL). Alzheimer's disease was diagnosed according to the NINCDS-ADRDA criteria for probable dementia. Vascular dementia and other types of dementia were diagnosed according to the DSM-IIIR criteria. Severity of dementia was defined by score intervals on the Mini Mental State Examination score: mild (MMSE 20–30), moderate (MMSE 10–19), and severe (MMSE 0–9). Based on the ADL information, the patients' dependency level was defined as either dependent or independent. Questions from the Odense Study were mapped into each of the five dimensions of the EQ-5D in order to assess patients' HRQol. Danish EQ-5D social tariffs were used to value patients' HRQol. A regression analysis of EQ-5D values was conducted with backward selection on gender, age, severity, ADL level and setting in order to determine the main factor influencing HRQoL. The EQ-5D weight in patients independent upon others in ADL was 0.641 (95% CI: [0.612–0.669]), and in those dependent upon others was 0.343 (95% CI: [0.251–0.436]). Dependency upon others to perform ADL was the main factor affecting HRQoL.
300 citations
TL;DR: Evidence supporting the measurement properties of the MacNew Heart Disease Health-related Quality of Life Questionnaire, designed to evaluate how daily activities and physical, emotional, and social functioning are affected by coronary heart disease and its treatment, is reviewed.
Abstract: Background: The measurement of health, the effects of disease, and the impact of health care include not only an indication of changes in disease frequency and severity but also an estimate of patients' perception of health status before and after treatment. One of the more important developments in health care in the past decade may be the recognition that the patient's perspective is as legitimate and valid as the clinician's in monitoring health care outcomes. This has lead to the development of instruments to quantify the patients' perception of their health status before and after treatment. Methods: We review evidence supporting the measurement properties of the MacNew Heart Disease Health-related Quality of Life [MacNew] Questionnaire which was designed to evaluate how daily activities and physical, emotional, and social functioning are affected by coronary heart disease and its treatment. Results: Reliability was demonstrated by using internal consistency and the intraclass correlation coefficients for the three domains in the Dutch, English, Farsi, German, and Spanish versions of the MacNew. With internal consistency and intraclass correlation coefficients =>0.73, reliability is high. Validity of the MacNew was examined with factor analysis and three core underlying factors, physical, emotional, and social, were identified, explaining 63.0 – 66.5% of the observed variance and replicated in the translations with psychometric data. Construct validity of the MacNew was further demonstrated by extensive substantiation of the logical relationships, defined a priori, between items and other comparison tools. The MacNew is responsive and sensitive to changes in HRQL following various interventions for patients with heart disease with 11 of 13 effect size statistics >0.80. Taking an average of 10 minutes or less to complete, the respondent-burden for the MacNew is low and its acceptability is demonstrated by response rates of over 90%. Normative data are available for patients with myocardial infarction, angina, and heart failure in the English version. Conclusion: The MacNew may be a valuable tool for assessing and evaluating health related quality of life in patients with heart disease.
266 citations
TL;DR: There is still a need to continue researching and developing needs assessment instruments leading to effective intervention and improving quality of cancer care, and it is questionable whether any instrument can be developed meeting all the requirements.
Abstract: The assessment of needs for cancer care is a critical step in providing high quality care and achieving cancer patients' and families' satisfaction. Instruments can be used to assess needs and guide cancer care planning. This study discusses the importance of the needs assessment, relationships between needs, satisfaction and quality of life; and reviews the assessment instruments of needs experienced by cancer patients and their families. A systematic search was conducted in MEDLINE and CANCERLIT data bases. Instruments were evaluated based on their conceptual and measurement models as well as their demonstrated reliability and validity. The authors also sought information pertaining to instruments' burden of administration and responsiveness. Measures compromised by a lack of published psychometric description were not included. This search identified 17 patient needs assessment instruments and seven family needs assessment instruments. The development and psychometric proprieties of most of these instruments were well documented. However, data on their responsiveness and burden of administration were scarce. Each selected instrument meets some but not all of our criteria for validity, reliability, responsiveness and burden. It is questionable whether any instrument can be developed meeting all the requirements. However, there is still a need to continue researching and developing needs assessment instruments leading to effective intervention and improving quality of cancer care.
257 citations
TL;DR: The ESSI appears to be a valid and reliable measure of social support in patients undergoing treatment for coronary artery disease and may prove a valuable method of controlling for patient variability in outcomes studies where the outcomes are related to patients' social support.
Abstract: Previous investigations suggest an important role of social support in the outcomes of patients treated for ischemic heart disease. The ENRICHD Social Support Instrument (ESSI) is a 7-item self-report survey that assesses social support. Validity and reliability of the ESSI, however, has not been formally tested in patients undergoing percutaneous coronary intervention (PCI). The ESSI, along with the Short Form-36 (SF-36), was sequentially administered to a cohort of 271 patients undergoing PCI. The test-retest reliability was examined with an intra-class correlation coefficient by comparing scores among 174 patients who completed both instruments 5 and 6 months after their procedure. Internal reliability was assessed using Cronbach's alpha at the time of patients' baseline procedure. The concurrent validity of the ESSI was assessed by comparing scores between depressed (MHI-5 score < 44) vs. non-depressed patients. The correlation between the ESSI and the SF-36 Social Functioning sub-scale, an accepted measure of social functioning, was also examined. Test-retest reliability showed no significant differences in mean scores among ESSI questionnaires administered 1 month apart (27.8+/-1.4 vs 27.8+/-1.5, p = 0.98). The intra-class correlation coefficient was 0.94 and Cronbach's alpha was 0.88. Mean ESSI scores were significantly lower among depressed vs. non-depressed patients (24.6+/-1.7 vs 27+/-1.4, p < 0.018) and a positive albeit modest correlation with social functioning was seen (r = 0.19, p = 0.002). The ESSI appears to be a valid and reliable measure of social support in patients undergoing treatment for coronary artery disease. It may prove to be a valuable method of controlling for patient variability in outcomes studies where the outcomes are related to patients' social support.
TL;DR: The proposed psychometric model posits that the QOL true score is always contingent upon parameters of the appraisal process and calls into question existing methods for establishing the reliability and validity of QOL assessment tools and suggests several new approaches for describing the psychometric properties of these scales.
Abstract: The increasing evidence for response shift phenomena in quality of life (QOL) assessment points to the necessity to reconsider both the measurement model and the application of psychometric analyses. The proposed psychometric model posits that the QOL true score is always contingent upon parameters of the appraisal process. This new model calls into question existing methods for establishing the reliability and validity of QOL assessment tools and suggests several new approaches for describing the psychometric properties of these scales. Recommendations for integrating the assessment of appraisal into QOL research and clinical practice are discussed.
TL;DR: The study reveals that oral health impacts on quality of life in Thai primary school children were prevalent, but not severe and mainly related to difficulty eating and smiling.
Abstract: Background
Traditional methods of measuring oral health mainly use clinical dental indices and have been complemented by oral health related quality of life (OHRQoL) measures. Most OHRQoL studies have been on adults and elderly populations. There are no systematic OHRQoL studies of a population-based sample of children. The objective of this study was to assess the prevalence, characteristics and severity of oral impacts in primary school children.
TL;DR: Results indicate that stress-related variables as possible predictors influencing caregivers' quality of life include: patient and caregiver characteristics, stressors, stress appraisal, stress coping methods, and social support.
Abstract: This article reviews 19 studies (1987–2004) on quality of life for family caregivers helping those with chronic physical illness. Here we explore the concepts of and instruments used to measure caregivers' quality of life. We were particularly interested in understanding stress-related variables and documenting factors influencing quality of life based on family stress theory. Findings show that various positive and negative terms equated with quality of life were used to measure them. Results indicate that stress-related variables as possible predictors influencing caregivers' quality of life include: patient and caregiver characteristics, stressors, stress appraisal, stress coping methods, and social support. Our recommendations touch upon applying theory for intervention, developing measurement, making operable the concepts for measuring, and the need for longitudinal and comprehensive study.
TL;DR: This review confirms previous reports of limited use of QOL measures in paediatric clinical trials and provides information about availability and quality of measures which will be of especial value to trial developers.
Abstract: Background
The goal of much care in chronic childhood illness is to improve quality of life (QOL). However, surveys suggest QOL measures are not routinely included. In addition, there is little consensus about the quality of many QOL measures.
TL;DR: Results of this study show that both OA and RA have a significant impact on multiple dimensions of HRQOL among older adults, and suggest the CDCHRQOL items are suitable for use among Older adults and in mail surveys.
Abstract: Background
Health-related quality of life (HRQOL) is a key outcome in arthritis, but few population-based studies have examined the relationship of specific arthritic conditions, such as osteoarthritis (OA) and rheumatoid arthritis (RA) with HRQOL.
TL;DR: The performance of the MHI-5 and GHQ-12 in terms of predicting mental health problems and related help seeking behaviour is similar and a study is recommended to establish a valid, internationally comparable cut-off point.
Abstract: The objective is to compare the performance of the MHI-5 and GHQ-12, both measures of general mental health. Therefore, we studied the relationship of the GHQ-12 and MHI-5 with sociodemographic characteristics, self-reported visits to general practice and mental health care, and with diagnoses made by the general practitioner. Data were used from the Second Dutch National Survey of General Practice, which was carried out in 104 practices. This study combines data from a representative sample of the Dutch population with data from general practice. The agreement between the GHQ-12 and MHI-5 is only moderate. Both instruments are however similarly associated with demographic characteristics (except age), self-reported health care use, and psychological and social diagnoses in general practice. The performance of the MHI-5 and GHQ-12 in terms of predicting mental health problems and related help seeking behaviour is similar. An advantage of the MHI-5 is that it has been widely used, not only in surveys of mental health, but also in surveys of general health and quality of life, and it is shorter. A disadvantage of the MHI-5 is that there is no cut-off point. We recommend a study to establish a valid, internationally comparable cut-off point.
TL;DR: Clinical recognition of these specific chronic conditions or 4 or more of a list of chronic conditions may provide an opportunity for proactive clinical decision making to maximize physical functioning in these populations of persons with chronic medical conditions.
Abstract: Background: Primary care physicians are caring for increasing numbers of persons with comorbid chronic illness. Longitudinal information on health outcomes associated with specific chronic conditions may be particularly relevant in caring for these populations. Our objective was to assess the effect of certain comorbid conditions on physical well being over time in a population of persons with chronic medical conditions; and to compare these effects to that of hypertension alone. Methods: We conducted a secondary analysis of 4-year longitudinal data from the Medical Outcomes Study. A heterogeneous population of 1574 patients with either hypertension alone (referent) or one or more of the following conditions: diabetes, coronary artery disease, congestive heart failure, respiratory illness, musculoskeletal conditions and/or depression were recruited from primary and specialty (endocrinology, cardiology or mental health) practices within HMO and feefor-service settings in three U.S. cities. We measured categorical change (worse vs. same/better) in the SF-36® Health Survey physical component summary score (PCS) over 4 years. We used logistic regression analysis to determine significant differences in longitudinal change in PCS between patients with hypertension alone and those with other comorbid conditions and linear regression analysis to assess the contribution of the explanatory variables. Results: Specific diagnoses of CHF, diabetes and/or chronic respiratory disease; or 4 or more chronic conditions, were predictive of a clinically significant decline in PCS. Conclusions: Clinical recognition of these specific chronic conditions or 4 or more of a list of chronic conditions may provide an opportunity for proactive clinical decision making to maximize physical functioning in these populations.
TL;DR: HRQL is becoming more of an issue after renal transplantation and whether a specific immunosuppressive protocol is superior to others in terms of HRQL remains to be determined.
Abstract: With the improvements in short and long term graft and patient survival after renal transplantation over the last two decades Health-Related Quality of Life (HRQL) is becoming an important additional outcome parameter. Global and disease specific instruments are available to evaluate objective and subjective QOL. Among the most popular global tools is the SF-36, examples of disease specific instruments are the Kidney Transplant Questionnaire (KTQ), the Kidney Disease Questionnaire (KDQ) and the Kidney Disease-Quality of Life (KDQOL). It is generally accepted that HRQL improves dramatically after successful renal transplantation compared to patients maintained on dialysis treatment but listed for a transplant. It is less clear however which immunosuppressive regimen confers the best QOL. Only few studies compared the different regimens in terms of QOL outcomes. Although limited in number, these studies seem to favour non-cyclosporine based protocols. The main differences that could be observed between patients on cyclosporine versus tacrolimus or sirolimus therapy concern the domains of appearance and fatigue. This may be explained by two common adverse effects occurring under cyclosporine therapy, gingival hyperplasia and hair growth. Another more frequently occurring side effect under calcineurin inhibitor therapy is tremor, which may favour CNI free protocols. This hypothesis, however, has not been formally evaluated in a randomised trial using HRQL measurements. In summary HRQL is becoming more of an issue after renal transplantation. Whether a specific immunosuppressive protocol is superior to others in terms of HRQL remains to be determined.
TL;DR: The generic NEI-VFQ was similar to the disease-specific OSDI in its ability to measure the impact of Sjögren's syndrome-related dry eye on VT-HRQ, and associated with conventional objective measures of dry eye were modest.
Abstract: To examine the associations between vision-targeted health-related quality of life (VT-HRQ) and ocular surface parameters in patients with Sjogren's syndrome, a systemic autoimmune disease characterized by dry eye and dry mouth. Forty-two patients fulfilling European / American diagnostic criteria for Sjogren's syndrome underwent Schirmer testing without anesthesia, ocular surface vital dye staining; and measurement of tear film breakup time (TBUT). Subjects were administered the Ocular Surface Disease Index (OSDI) and the 25-item National Eye Institute Vision Functioning Questionnaire (NEI-VFQ). Main outcome measures included ocular surface parameters, OSDI subscales describing ocular discomfort (OSDI-symptoms), vision-related function (OSDI-function), and environmental triggers, and NEI-VFQ subscales. Participants (aged 31–81 y; 95% female) all had moderate to severe dry eye. Associations of OSDI subscales with the ocular parameters were modest (Spearman r (ρ) < 0.22) and not statistically significant. Associations of NEI-VFQ subscales with the ocular parameters reached borderline significance for the near vision subscale with TBUT (ρ = 0.32, p = .05) and for the distance vision subscale with van Bijsterveld score (ρ = 0.33, p = .04). The strongest associations of the two questionnaires were for: ocular pain and mental function with OSDI-symptoms (ρ = 0.60 and 0.45, respectively); and general vision, ocular pain, mental function, role function, and driving with OSDI-function (ρ = 0.60, 0.50, 0.61, 0.64, 0.57, and 0.67, respectively). Associations between conventional objective measures of dry eye and VT-HRQ were modest. The generic NEI-VFQ was similar to the disease-specific OSDI in its ability to measure the impact of Sjogren's syndrome-related dry eye on VT-HRQ.
TL;DR: It is emphasized that younger long-term survivors of breast cancer have a high QOL across several standardized measures, however, the long- term consequences of adjuvant therapy and the management of long- Term breast-related symptoms are two areas that may be important for clinicians and women with breast cancer in understanding and optimizing long-time QOL.
Abstract: The purpose of this report is to examine the correlates of quality of life (QOL) of a well-defined group of long-term breast cancer survivors diagnosed between the ages of 40 and 49. Women were eligible if they were diagnosed with invasive breast cancer or ductal carcinoma in situ 5 to 10 years before June 30, 1998 and were enrolled at Group Health Cooperative, a health maintenance organization in western Washington State. A questionnaire was mailed to 290 women; 216 were included in this analysis. The questionnaire included standardized measures of QOL [e.g., the Cancer Rehabilitation Evaluation System (CARES-SF) and SF-36] as well as general demographic and medical information. ANOVA and logistic regression were used to estimate correlates of self-reported QOL. The mean age at diagnosis was 44.4 years, and the average time since diagnosis was 7.3 years. Women reported high levels of functioning across several standardized QOL scales; mild impairment was found on the CARES-SF Sexual Scale. The presence of breast-related symptoms at survey, use of adjuvant therapy, having lower income, and type of breast surgery were significantly associated with lower QOL 5 to 10 years post-diagnosis on one or more of the scales. Our results emphasize that younger long-term survivors of breast cancer have a high QOL across several standardized measures. However, the long-term consequences of adjuvant therapy and the management of long-term breast-related symptoms are two areas that may be important for clinicians and women with breast cancer in understanding and optimizing long-term QOL.
TL;DR: This population-based sample of people living with HIV has been experiencing extremely high rates of impairments, activity limitations and participation restrictions, and the complex inter-relationships identified amongst the levels reveal lessons for programming, policy and research.
Abstract: To measure the prevalence of and associations among impairments, activity limitations and participation restrictions in persons living with HIV in British Columbia to inform support and care programs, policy and research. A cross-sectional population-based sample of persons living with HIV in British Columbia was obtained through an anonymous survey sent to members of the British Columbia Persons With AIDS Society. The survey addressed the experience of physical and mental impairments, and the experience and level of activity limitations and participation restrictions. Associations were measured in three ways: 1) impact of types of impairment on social restriction; 2) impact of specific limitations on social restriction; and 3) independent association of overall impairments and limitations on restriction levels. Logistic regression was used to measure associations with social restriction, while ordinal logistic regression was used to measure associations with a three-category measure of restriction level. The survey was returned by 762 (50.5%) of the BCPWA participants. Over ninety percent of the population experienced one or more impairments, with one-third reporting over ten. Prevalence of activity limitations and participation restrictions was 80.4% and 93.2%, respectively. The presence of social restrictions was most closely associated with mental function impairments (OR: 7.0 for impairment vs. no impairment; 95% CI: 4.7 – 10.4). All limitations were associated with social restriction. Among those with ≤ 200 CD4 cells/mm3, odds of being at a higher restriction level were lower among those on antiretrovirals (OR: 0.3 for antiretrovirals vs. no antiretrovirals; 95% CI: 0.1–0.9), while odds of higher restriction were increased with higher limitation (OR: 3.6 for limitation score of 1–5 vs. no limitation, 95%CI: 0.9–14.2; OR: 24.7 for limitation score > 5 vs. no limitation, 95%CI: 4.9–125.0). Among those with > 200 CD4 cells/mm3, the odds of higher restriction were increased with higher limitation (OR: 2.7 for limitation score of 1–5 vs. no limitation, 95%CI: 1.4–5.1; OR: 8.6 for limitation score > 5 vs. no limitation, 95%CI: 3.9–18.8), as well as by additional number of impairments (OR:1.2 for every additional impairment; 95% CI:1.1–1.3). This population-based sample of people living with HIV has been experiencing extremely high rates of impairments, activity limitations and participation restrictions. Furthermore, the complex inter-relationships identified amongst the levels reveal lessons for programming, policy and research in terms of the factors that contribute most to a higher quality of life.
TL;DR: The 12-item General Health Questionnaire contains three factors, namely Anxiety and Depression, Social Dysfunction, and Loss of Confidence, Nevertheless, using them separately does not offer many practical advantages in differentiating clinical groups or identifying association with clinical or health-related quality of life variables.
Abstract: Background: The 12-item General Health Questionnaire (GHQ-12) is widely used as a unidimensional instrument, but factor analyses tended to suggest that it contains two or three factors. Not much is known about the usefulness of the GHQ-12 factors, if they exist, in revealing between-patient differences in clinical states and health-related quality of life. Methods: We addressed this issue in a cross-sectional survey of out-patients with psychological disorders in Singapore. The participants (n = 120) completed the GHQ-12, the Beck Anxiety Inventory, and the Short-Form 36 Health Survey. Confirmatory factor analysis was used to compare six previously proposed factor structures for the GHQ-12. Factor scores of the bestfitting model, as well as the overall GHQ-12 score, were assessed in relation to clinical and healthrelated quality of life variables. Results: The 3-factor model proposed by Graetz fitted the data better than a unidimensional model, two 2-factor models, and two other 3-factor models. However, the three factors were strongly correlated. Their values varied in a similar fashion in relation to clinical and health-related quality of life variables. Conclusions: The 12-item General Health Questionnaire contains three factors, namely Anxiety and Depression, Social Dysfunction, and Loss of Confidence. Nevertheless, using them separately does not offer many practical advantages in differentiating clinical groups or identifying association with clinical or health-related quality of life variables.
TL;DR: The results show that the SF-36 has many features in common with other HRQoL outcomes: multi-dimensional, ordinal or discrete response categories with upper and lower bounds, and skewed distributions, so therefore, it is believed these results and conclusions will be appropriate for other HRZoL measures.
Abstract: We describe and compare four different methods for estimating sample size and power, when the primary outcome of the study is a Health Related Quality of Life (HRQoL) measure. These methods are: 1. assuming a Normal distribution and comparing two means; 2. using a non-parametric method; 3. Whitehead's method based on the proportional odds model; 4. the bootstrap. We illustrate the various methods, using data from the SF-36. For simplicity this paper deals with studies designed to compare the effectiveness (or superiority) of a new treatment compared to a standard treatment at a single point in time. The results show that if the HRQoL outcome has a limited number of discrete values (< 7) and/or the expected proportion of cases at the boundaries is high (scoring 0 or 100), then we would recommend using Whitehead's method (Method 3). Alternatively, if the HRQoL outcome has a large number of distinct values and the proportion at the boundaries is low, then we would recommend using Method 1. If a pilot or historical dataset is readily available (to estimate the shape of the distribution) then bootstrap simulation (Method 4) based on this data will provide a more accurate and reliable sample size estimate than conventional methods (Methods 1, 2, or 3). In the absence of a reliable pilot set, bootstrapping is not appropriate and conventional methods of sample size estimation or simulation will need to be used. Fortunately, with the increasing use of HRQoL outcomes in research, historical datasets are becoming more readily available. Strictly speaking, our results and conclusions only apply to the SF-36 outcome measure. Further empirical work is required to see whether these results hold true for other HRQoL outcomes. However, the SF-36 has many features in common with other HRQoL outcomes: multi-dimensional, ordinal or discrete response categories with upper and lower bounds, and skewed distributions, so therefore, we believe these results and conclusions using the SF-36 will be appropriate for other HRQoL measures.
TL;DR: Self-reported patient valuations for depression are important patient-reported outcomes for cost-effectiveness evaluations of new antidepressant compounds and help in further understanding patient compliance with antidepressant treatment.
Abstract: Major depressive disorder (MDD) is a prevalent psychiatric disorder associated with impaired patient functioning and reductions in health-related quality of life (HRQL). The present study describes the impact of MDD on patients' HRQL and examines preference-based health state differences by patient features and clinical characteristics. 95 French primary care practitioners recruited 250 patients with a DSM-IV diagnosis of MDD for inclusion in an eight-week follow-up cohort. Patient assessments included the Montgomery Asberg Depression Rating Scale (MADRS), the Clinical Global Impression of Severity (CGI), the Short Form-36 Item scale (SF-36), the Quality of Life Depression Scale (QLDS) and the EuroQoL (EQ-5D). The mean EQ-5D utility at baseline was 0.33, and 8% of patients rated their health state as worse than death. There were no statistically significant differences in utilities by demographic features. Significant differences were found in mean utilities by level of disease severity assessed by CGI. The different clinical response profiles, assessed by MADRS, were also revealed by EQ-5D at endpoint: 0.85 for responders remitters, 0.72 for responders non-remitter, and 0.58 for non-responders. Even if HRQL and EQ-5D were moderately correlated, they shared only 40% of variance between baseline and endpoint. Self-reported patient valuations for depression are important patient-reported outcomes for cost-effectiveness evaluations of new antidepressant compounds and help in further understanding patient compliance with antidepressant treatment.
TL;DR: A team approach addressing better understanding of how allergy-like conditions impair the HRQL may improve the management of the adolescent's health problems, both in health-care services and in schools.
Abstract: Health-related quality of life among adolescents with allergy-like conditions - with emphasis on food hypersensitivity
TL;DR: The MRS scale showed some evidence for its ability to measure treatment effects on quality of life across the full range of severity of complaints in aging women, however this however needs confirmation in other and better-designed clinical/outcome studies.
Abstract: The Menopause Rating Scale is a health-related Quality of Life scale developed in the early 1990s and step-by-step validated since then. No methodologically detailed work on the utility of the scale to assess health-related changes after treatment was published before. We analysed an open, uncontrolled post-marketing study with over 9000 women with pre- and post-treatment data of the MRS scale to critically evaluate the capacity of the scale to measure the health-related effects of hormone treatment independent from the severity of complaints at baseline. The improvement of complaints during treatment relative to the baseline score was 36% in average. Patients with little/no complaints before therapy improved by 11%, those with mild complaints at entry by 32%, with moderate by 44%, and with severe symptoms by 55% – compared with the baseline score. We showed that the distribution of complaints in women before therapy returned to norm values after 6 months of hormone treatment. We also provided weak evidence that the MRS results may well predict the assessment of the treating physician. Limitations of the study, however, may have lead to overestimating the utility of the MRS scale as outcome measure. The MRS scale showed some evidence for its ability to measure treatment effects on quality of life across the full range of severity of complaints in aging women. This however needs confirmation in other and better-designed clinical/outcome studies.
TL;DR: The adjusted proportional odds ratios for men relative to women (PORs > 1 = better) indicated that men reported significantly better HRQOL on all 5 SAQ dimensions as compared to women, as adjustment for traditional clinical variables fails to explain sex differences in health related quality of life outcomes.
Abstract: Although there have been substantial medical advances that improve the outcomes following cardiac ischemic events, gender differences in the treatment and course of recovery for patients with coronary artery disease (CAD) continue to exist. There is a general paucity of data comparing the health related quality of life (HRQOL) in men and women undergoing treatment for CAD. The purpose of this study was to compare HRQOL outcomes of men and women in Alberta, at one-year following initial catheterization, after adjustment for known demographic, co-morbid, and disease severity predictors of outcome. The HRQOL outcome data were collected by means of a self-reported questionnaire mailed to patients on or near the one-year anniversary of their initial cardiac catheterization. Using the Seattle Angina Questionnaire (SAQ), 5 dimensions of HRQOL were measured: exertional capacity, anginal stability, anginal frequency, quality of life and treatment satisfaction. Data from the APPROACH registry were used to risk-adjust the SAQ scale scores. Two analytical strategies were used including general least squares linear modeling, and proportional odds modeling sometimes referred to as the "ordinal logistic modeling". 3392 (78.1%) patients responded to the follow-up survey. The adjusted proportional odds ratios for men relative to women (PORs > 1 = better) indicated that men reported significantly better HRQOL on all 5 SAQ dimensions as compared to women. (PORs: Exertional Capacity 3.38 (2.75–4.15), Anginal Stability 1.23 (1.03–1.47), Anginal Frequency 1.70 (1.43–2.01), Treatment Satisfaction 1.27 (1.07–1.50), and QOL 1.74 (1.48–2.04). Women with CAD consistently reported worse HRQOL at one year follow-up compared to men. These findings underline the fact that conclusions based on research performed on men with CAD may not be valid for women and that more gender-related research is needed. Future studies are needed to further examine gender differences in psychosocial adjustment following treatment for CAD, as adjustment for traditional clinical variables fails to explain sex differences in health related quality of life outcomes.
TL;DR: The findings of this study suggest that person-centered variables such as personality, may account for some of the broad differences seen in outcome in schizophrenia spectrum disorders, including social outcomes.
Abstract: Research has indicated that stable individual differences in personality exist among persons with schizophrenia spectrum disorders predating illness onset that are linked to symptoms and self appraised quality of life. Less is known about how closely individual differences in personality are uniquely related to levels of social relationships, a domain of dysfunction in schizophrenia more often linked in the literature with symptoms and neurocognitive deficits. This study tested the hypothesis that trait levels of personality as defined using the five-factor model of personality would be linked to social function in schizophrenia. A self-report measure of the five factor model of personality was gathered along with ratings of social function, symptoms and assessments of neurocognition for 65 participants with schizophrenia or schizoaffective disorder. Univariate correlations and stepwise multiple regression indicated that frequency of social interaction was predicted by higher levels of the trait of Agreeableness, fewer negative symptoms, better verbal memory and at the trend level, lesser Neuroticism (R2 = .42, p < .0001). In contrast, capacity for intimacy was predicted by fewer negative symptoms, higher levels of Agreeableness, Openness, and Conscientiousness and at the trend level, fewer positive symptoms (R2 = .67, p < .0001). Taken together, the findings of this study suggest that person-centered variables such as personality, may account for some of the broad differences seen in outcome in schizophrenia spectrum disorders, including social outcomes. One interpretation of the results of this study is that differences in personality combine with symptoms and neurocognitive deficits to affect how persons with schizophrenia are able to form and sustain social connections with others.
TL;DR: The results showed a statistically significant relationship between all the dimensions of AcroQoL and the VAS (visual analogic scale) of EQ-5D and the evaluation of the item parameters confirmed the construct validity of the new instrument.
Abstract: Acromegaly is a chronic disease with an important impact on patients, Health Related Quality of Life (HRQoL). The ability to effectively measure Health Related Quality of Life is central to describing the impacts of disease or treatment upon the patient, therefore the importance of having a disease specific questionnaire for acromegaly. For the development of the AcroQoL questionnaire different sources of information were used: first a literature search was performed to identify relevant papers describing the impact of acromegaly in HRQoL, second the main domains of impact on HRQoL were identified by 10 experts endocrinologists, and third ten in-depth semi-structured interviews were conducted in acromegalic patients to identify domains and items related to the self-perceived impact of acromegaly in patients' life. After a proper qualitative analysis a preliminary 38 item questionnaire was obtained. Rasch analysis concluded with a final 22 item questionnaire. The measurement properties (validity and reliability) of the resulting final questionnaire were tested and compared using standard procedures (Cronbach's Alpha and item-total correlation). The evaluation of the item parameters confirmed the construct validity of the new instrument. Responsiveness to change was assessed in a small sample of 32 acromegalic patients with active disease in Spain who were administered the AcroQoL and the generic questionnaire EuroQoL 5-D. The results showed a statistically significant relationship between all the dimensions of AcroQoL and the VAS (visual analogic scale) of EQ-5D. An improvement in the global score of AcroQoL was related to a global improvement in the VAS of the EQ-5D. Following the current recommended standard methodology the Spanish questionnaire was translated into eleven other languages.